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White House Legislation - Signed

H.R. 2430 - FDA Reauthorization Act of 2017

 

One Hundred Fifteenth Congress
of the
United States of America

AT THE FIRST SESSION

Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and seventeen

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “FDA Reauthorization Act of 2017”.

SEC. 2. TABLE OF CONTENTS.

The table of contents for this Act is as follows:


Sec. 1. Short title.
Sec. 2. Table of contents.

TITLE I—FEES RELATING TO DRUGS

Sec. 101. Short title; finding.
Sec. 102. Authority to assess and use drug fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. Savings clause.

TITLE II—FEES RELATING TO DEVICES

Sec. 201. Short title; finding.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Conformity assessment pilot program.
Sec. 206. Reauthorization of review.
Sec. 207. Electronic format for submissions.
Sec. 208. Savings clause.
Sec. 209. Effective date.
Sec. 210. Sunset dates.

TITLE III—FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title; finding.
Sec. 302. Definitions.
Sec. 303. Authority to assess and use human generic drug fees.
Sec. 304. Reauthorization; reporting requirements.
Sec. 305. Sunset dates.
Sec. 306. Effective date.
Sec. 307. Savings clause.

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 401. Short title; finding.
Sec. 402. Definitions.
Sec. 403. Authority to assess and use biosimilar fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.

TITLE V—PEDIATRIC DRUGS AND DEVICES

Sec. 501. Best pharmaceuticals for children.
Sec. 502. Pediatric devices.
Sec. 503. Early meeting on pediatric study plan.
Sec. 504. Development of drugs and biological products for pediatric cancers.
Sec. 505. Additional provisions on development of drugs and biological products for pediatric use.

TITLE VI—REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

Sec. 601. Reauthorization of provision relating to exclusivity of certain drugs containing single enantiomers.
Sec. 602. Reauthorization of the critical path public-private partnerships.
Sec. 603. Reauthorization of orphan grants program.
Sec. 604. Protecting and strengthening the drug supply chain.
Sec. 605. Patient experience data.
Sec. 606. Communication plans.
Sec. 607. Orphan drugs.
Sec. 608. Pediatric information added to labeling.
Sec. 609. Sense of Congress on lowering the cost of prescription drugs.
Sec. 610. Expanded access.
Sec. 611. Tropical disease product application.

TITLE VII—DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

Sec. 701. Risk-based inspections for devices.
Sec. 702. Improvements to inspections process for device establishments.
Sec. 703. Reauthorization of inspection program.
Sec. 704. Certificates to foreign governments for devices.
Sec. 705. Facilitating international harmonization.
Sec. 706. Fostering innovation in medical imaging.
Sec. 707. Risk-based classification of accessories.
Sec. 708. Device pilot projects.
Sec. 709. Regulation of over-the-counter hearing aids.
Sec. 710. Report on servicing of devices.

TITLE VIII—IMPROVING GENERIC DRUG ACCESS

Sec. 801. Priority review of generic drugs.
Sec. 802. Enhancing regulatory transparency to enhance generic competition.
Sec. 803. Competitive generic therapies.
Sec. 804. Accurate information about drugs with limited competition.
Sec. 805. Suitability petitions.
Sec. 806. Inspections.
Sec. 807. Reporting on pending generic drug applications and priority review applications.
Sec. 808. Incentivizing competitive generic drug development.
Sec. 809. GAO study of issues regarding first cycle approvals of generic medicines.

TITLE IX—ADDITIONAL PROVISIONS

Sec. 901. Technical corrections.
Sec. 902. Annual report on inspections.
Sec. 903. Streamlining and improving consistency in performance reporting.
Sec. 904. Analysis of use of funds.
Sec. 905. Facilities management.

 

TITLE I—FEES RELATING TO DRUGS

SEC. 101. SHORT TITLE; FINDING.

(a) Short Title.—This title may be cited as the “Prescription Drug User Fee Amendments of 2017”.

(b) Finding.—The Congress finds that the fees authorized by the amendments made in this title will be dedicated toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities, as set forth in the goals identified for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

SEC. 102. AUTHORITY TO ASSESS AND USE DRUG FEES.

(a) Types Of Fees.—

(1) IN GENERAL.—Section 736(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(a)) is amended—

(A) in the matter preceding paragraph (1), by striking “fiscal year 2013” and inserting “fiscal year 2018”;

(B) in the heading of paragraph (1), by striking “AND SUPPLEMENT”;

(C) in paragraph (1), by striking “or a supplement” and “or supplement” each place either appears;

(D) in paragraph (1)(A)—

(i) in clause (i), by striking “(c)(4)” and inserting “(c)(5)”; and

(ii) in clause (ii), by striking “A fee established” and all that follows through “are required.” and inserting the following: “A fee established under subsection (c)(5) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval.”;

(E) in the heading of paragraph (1)(C), by striking “OR SUPPLEMENT”;

(F) in paragraph (1)(F)—

(i) in the heading, by striking “OR INDICATION”; and

(ii) by striking the second sentence;

(G) by striking paragraph (2) (relating to a prescription drug establishment fee);

(H) by redesignating paragraph (3) as paragraph (2);

(I) in the heading of paragraph (2), as so redesignated, by striking “PRESCRIPTION DRUG PRODUCT FEE” and inserting “PRESCRIPTION DRUG PROGRAM FEE”;

(J) in subparagraph (A) of such paragraph (2), by amending the first sentence to read as follows: “Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug program fee established for a fiscal year under subsection (c)(5) for each prescription drug product that is identified in such a human drug application approved as of October 1 of such fiscal year. ”;

(K) in subparagraph (B) of such paragraph (2)—

(i) in the heading of subparagraph (B), by inserting after “EXCEPTION” the following: “FOR CERTAIN PRESCRIPTION DRUG PRODUCTS”; and

(ii) by striking “A prescription drug product shall not be assessed a fee” and inserting “A prescription drug program fee shall not be assessed for a prescription drug product”; and

(L) by adding at the end of such paragraph (2) the following:

“(C) LIMITATION.—A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for prescription drug products identified in such approved human drug application.”.

(2) CONFORMING AMENDMENT.—Subparagraph (C) of section 740(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–12(a)(3)) is amended to read as follows:

“(C) LIMITATION.—An establishment shall be assessed only one fee per fiscal year under this section.”.

(b) Fee Revenue Amounts.—Subsection (b) of section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to read as follows:

“(b) Fee Revenue Amounts.—

“(1) IN GENERAL.—For each of the fiscal years 2018 through 2022, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of—

“(A) the annual base revenue for the fiscal year (as determined under paragraph (3));

“(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

“(C) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2));

“(D) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3));

“(E) the dollar amount equal to the additional direct cost adjustment for the fiscal year (as determined under subsection (c)(4)); and

“(F) additional dollar amounts for each fiscal year as follows:

“(i) $20,077,793 for fiscal year 2018.

“(ii) $21,317,472 for fiscal year 2019.

“(iii) $16,953,329 for fiscal year 2020.

“(iv) $5,426,896 for fiscal year 2021.

“(v) $2,769,609 for fiscal year 2022.

“(2) TYPES OF FEES.—Of the total revenue amount determined for a fiscal year under paragraph (1)—

“(A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and

“(B) 80 percent shall be derived from prescription drug program fees under subsection (a)(2).

“(3) ANNUAL BASE REVENUE.—For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

“(A) for fiscal year 2018, $878,590,000; and

“(B) for fiscal years 2019 through 2022, the dollar amount of the total revenue amount established under paragraph (1) for the previous fiscal year, not including any adjustments made under subsection (c)(3) or (c)(4).”.

(c) Adjustments; Annual Fee Setting.—Subsection (c) of section 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is amended to read as follows:

“(c) Adjustments; Annual Fee Setting.—

“(1) INFLATION ADJUSTMENT.—

“(A) IN GENERAL.—For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—

“(i) such annual base revenue for the fiscal year under subsection (b)(1)(A); and

“(ii) the inflation adjustment percentage under subparagraph (B).

“(B) INFLATION ADJUSTMENT PERCENTAGE.—The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—

“(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years; and

“(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 735(6)) for the first 3 years of the preceding 4 fiscal years.

“(2) CAPACITY PLANNING ADJUSTMENT.—

“(A) IN GENERAL.—For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with paragraph (1), such revenue shall be adjusted further for such fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for the process for the review of human drug applications.

“(B) INTERIM METHODOLOGY.—

“(i) IN GENERAL.—Until the capacity planning methodology described in subparagraph (C) is effective, the adjustment under this paragraph for a fiscal year shall be based on the product of—

“(I) the annual base revenue for such year, as adjusted for inflation under paragraph (1); and

“(II) the adjustment percentage under clause (ii).

“(ii) ADJUSTMENT PERCENTAGE.—The adjustment percentage under this clause for a fiscal year is the weighted change in the 3-year average ending in the most recent year for which data are available, over the 3-year average ending in the previous year, for—

“(I) the total number of human drug applications, efficacy supplements, and manufacturing supplements submitted to the Secretary;

“(II) the total number of active commercial investigational new drug applications; and

“(III) the total number of formal meetings scheduled by the Secretary, and written responses issued by the Secretary in lieu of such formal meetings, as identified in section I.H of the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.

“(C) CAPACITY PLANNING METHODOLOGY.—

“(i) DEVELOPMENT; EVALUATION AND REPORT.—The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of human drug applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. The report shall be published for public comment no later than the end of fiscal year 2020.

“(ii) ESTABLISHMENT AND IMPLEMENTATION.—After review of the report described in clause (i) and any public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—

“(I) replace the interim methodology under subparagraph (B);

“(II) incorporate such approaches and attributes as the Secretary determines appropriate; and

“(III) be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established.

“(D) LIMITATION.—Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fiscal year) and (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year).

“(E) PUBLICATION IN FEDERAL REGISTER.—The Secretary shall publish in the Federal Register notice under paragraph (5) of the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.

“(3) OPERATING RESERVE ADJUSTMENT.—

“(A) INCREASE.—For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if such an adjustment is necessary to provide for not more than 14 weeks of operating reserves of carryover user fees for the process for the review of human drug applications.

“(B) DECREASE.—If the Secretary has carryover balances for such process in excess of 14 weeks of such operating reserves, the Secretary shall decrease such fee revenue and fees to provide for not more than 14 weeks of such operating reserves.

“(C) NOTICE OF RATIONALE.—If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5) establishing fee revenue and fees for the fiscal year involved.

“(4) ADDITIONAL DIRECT COST ADJUSTMENT.—

“(A) IN GENERAL.—The Secretary shall, in addition to adjustments under paragraphs (1), (2), and (3), further increase the fee revenue and fees—

“(i) for fiscal year 2018, by $8,730,000; and

“(ii) for fiscal year 2019 and subsequent fiscal years, by the amount determined under subparagraph (B).

“(B) AMOUNT.—The amount determined under this subparagraph is—

“(i) $8,730,000, multiplied by

“(ii) the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All Items; Annual Index) for the most recent year of available data, divided by such Index for 2016.

“(5) ANNUAL FEE SETTING.—The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2017—

“(A) establish, for each such fiscal year, human drug application fees and prescription drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

“(B) publish such fee revenue and fees in the Federal Register.

“(6) LIMIT.—The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications.”.

(d) Fee Waiver Or Reduction.—Section 736(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended—

(1) in paragraph (1)—

(A) by inserting “or” at the end of subparagraph (B);

(B) by striking subparagraph (C); and

(C) by redesignating subparagraph (D) as subparagraph (C);

(2) by striking paragraph (3) (relating to use of standard costs);

(3) by redesignating paragraph (4) as paragraph (3); and

(4) in paragraph (3), as so redesignated—

(A) in subparagraphs (A) and (B), by striking “paragraph (1)(D)” and inserting “paragraph (1)(C)”; and

(B) in subparagraph (B)—

(i) by striking clause (ii);

(ii) by striking “shall pay” through “(i) application fees” and inserting “shall pay application fees”; and

(iii) by striking “; and” at the end and inserting a period.

(e) Effect Of Failure To Pay Fees.—Section 736(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is amended by striking “all fees” and inserting “all such fees”.

(f) Limitations.—Section 736(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by striking “supplements, prescription drug establishments, and prescription drug products” and inserting “prescription drug program fees”.

(g) Crediting And Availability Of Fees.—Section 736(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g)) is amended—

(1) in paragraph (3)—

(A) by striking “2013 through 2017” and inserting “2018 through 2022”; and

(B) by striking “and paragraph (4) of this subsection”; and

(2) by striking paragraph (4).

(h) Orphan Drugs.—Section 736(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended by striking “product and establishment fees” each place it appears and inserting “prescription drug program fees”.

SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.

Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) is amended—

(1) in subsection (a)(1)—

(A) in the matter before subparagraph (A), by striking “2013” and inserting “2018”; and

(B) in subparagraph (A), by striking “Prescription Drug User Fee Amendments of 2012” and inserting “Prescription Drug User Fee Amendments of 2017”;

(2) in subsection (b), by striking “2013” and inserting “2018”; and

(3) in subsection (d), by striking “2017” each place it appears and inserting “2022”.

SEC. 104. SUNSET DATES.

(a) Authorization.—Sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall cease to be effective October 1, 2022.

(b) Reporting Requirements.—Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) shall cease to be effective January 31, 2023.

(c) Previous Sunset Provision.—Effective October 1, 2017, subsections (a) and (b) of section 105 of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) are repealed.

SEC. 105. EFFECTIVE DATE.

The amendments made by this title shall take effect on October 1, 2017, or the date of the enactment of this Act, whichever is later, except that fees under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all human drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act.

SEC. 106. SAVINGS CLAUSE.

Notwithstanding the amendments made by this title, part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to human drug applications and supplements (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.

TITLE II—FEES RELATING TO DEVICES

SEC. 201. SHORT TITLE; FINDING.

(a) Short Title.—This title may be cited as the “Medical Device User Fee Amendments of 2017”.

(b) Finding.—The Congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

SEC. 202. DEFINITIONS.

(a) In General.—Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i) is amended—

(1) by redesignating paragraphs (8) through (13) as paragraphs (9) through (14), respectively;

(2) by inserting after paragraph (7) the following new paragraph:

“(8) The term ‘de novo classification request’ means a request made under section 513(f)(2)(A) with respect to the classification of a device.”;

(3) in subparagraph (D) of paragraph (10) (as redesignated by paragraph (1)), by striking “and submissions” and inserting “submissions, and de novo classification requests”; and

(4) in paragraph (11) (as redesignated by paragraph (1)), by striking “2011” and inserting “2016”.

(b) Conforming Amendment.—Section 714(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d–3(b)(1)) is amended by striking “737(8)” and inserting “737(9)”.

SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.

(a) Types Of Fees.—Section 738(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is amended—

(1) in paragraph (1), by striking “fiscal year 2013” and inserting “fiscal year 2018”; and

(2) in paragraph (2)—

(A) in subparagraph (A)—

(i) in the matter preceding clause (i), by striking “October 1, 2012” and inserting “October 1, 2017”;

(ii) in clause (viii), by striking “2” and inserting “3.4”; and

(iii) by adding at the end the following new clause:

“(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).”; and

(B) in subparagraph (B)(v)(I), by striking “or premarket notification submission” and inserting “premarket notification submission, or de novo classification request”.

(b) Fee Amounts.—Section 738(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows:

“(b) Fee Amounts.—

“(1) IN GENERAL.—Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2018 through 2022, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3).

“(2) BASE FEE AMOUNTS SPECIFIED.—For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:

“(3) TOTAL REVENUE AMOUNTS SPECIFIED.—For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:

“(A) $183,280,756 for fiscal year 2018.

“(B) $190,654,875 for fiscal year 2019.

“(C) $200,132,014 for fiscal year 2020.

“(D) $211,748,789 for fiscal year 2021.

“(E) $213,687,660 for fiscal year 2022.”.

(c) Annual Fee Setting; Adjustments.—Section 738(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended—

(1) in paragraph (1), by striking “2012” and inserting “2017”;

(2) in paragraph (2)—

(A) in subparagraph (A), by striking “2014” and inserting “2018”;

(B) by striking subparagraph (B) and inserting the following new subparagraph:

“(B) APPLICABLE INFLATION ADJUSTMENT.—The applicable inflation adjustment for fiscal year 2018 and each subsequent fiscal year is the product of—

“(i) the base inflation adjustment under subparagraph (C) for such fiscal year; and

“(ii) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2016.”;

(C) in subparagraph (C), in the heading, by striking “TO TOTAL REVENUE AMOUNTS”; and

(D) by amending subparagraph (D) to read as follows:

“(D) ADJUSTMENT TO BASE FEE AMOUNTS.—For each of fiscal years 2018 through 2022, the Secretary shall—

“(i) adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph (B) for such year; and

“(ii) if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).”; and

(3) in paragraph (3)—

(A) by striking “2014 through 2017” and inserting “2018 through 2022”; and

(B) by striking “further adjusted” and inserting “increased”.

(d) Small Businesses; Fee Waiver And Fee Reduction Regarding Premarket Approval Fees.—Section 738(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(d)) is amended—

(1) in paragraph (1), by striking “specified in clauses (i) through (v) and clauses (vii), (ix), and (x)” and inserting “specified in clauses (i) through (vii) and clauses (ix), (x), and (xi)”; and

(2) in paragraph (2)(C)—

(A) by striking “supplement, or” and inserting “supplement,”; and

(B) by inserting “, or a de novo classification request” after “class III device”.

(e) Small Businesses; Fee Reduction Regarding Premarket Notification Submissions.—Section 738(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking “50” and inserting “25”.

(f) Fee Waiver Or Reduction.—

(1) REPEAL.—Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection (f).

(2) CONFORMING AMENDMENTS.—

(A) Section 515(c)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended by striking “738(h)” and inserting “738(g)”.

(B) Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by paragraph (1), is further amended—

(i) by redesignating subsections (g) through (l) as subsections (f) through (k);

(ii) in subsection (a)(2)(A), by striking “(d), (e), and (f)” and inserting “(d) and (e)”; and

(iii) in subsection (a)(3)(A), by striking “and subsection (f)”.

(g) Effect Of Failure To Pay Fees.—Subsection (f)(1), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended—

(1) by striking “or periodic reporting concerning a class III device” and inserting “periodic reporting concerning a class III device, or de novo classification request”; and

(2) by striking “all fees” and inserting “all such fees”.

(h) Conditions.—Subsection (g)(1)(A), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended by striking “$280,587,000” and inserting “$320,825,000”.

(i) Crediting And Availability Of Fees.—Subsection (h), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended—

(1) in paragraph (3)—

(A) by striking “2013 through 2017” and inserting “2018 through 2022”; and

(B) by striking “subsection (c)” and all that follows through the period at the end and inserting “subsection (c).”; and

(2) by striking paragraph (4).

SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

(a) Performance Reports.—Section 738A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)) is amended—

(1) in paragraph (1)—

(A) in subparagraph (A)—

(i) by striking “2013” and inserting “2018”; and

(ii) by striking “the Medical Device User Fee Amendments of 2012” and inserting “the Medical Device User Fee Amendments of 2017”; and

(B) in subparagraph (B), by striking “the Medical Device User Fee Amendments Act of 2012” and inserting “the Medical Device User Fee Amendments of 2017”; and

(2) in paragraph (2), by striking “2013 through 2017” and inserting “2018 through 2022”.

(b) Reauthorization.—Section 738A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(b)) is amended—

(1) in paragraph (1), by striking “2017” and inserting “2022”; and

(2) in paragraph (5), by striking “2017” and inserting “2022”.

SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.

(a) In General.—Section 514 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d) is amended by adding at the end the following:

“(d) Pilot Accreditation Scheme For Conformity Assessment.—

“(1) IN GENERAL.—The Secretary shall establish a pilot program under which—

“(A) testing laboratories may be accredited, by accreditation bodies meeting criteria specified by the Secretary, to assess the conformance of a device with certain standards recognized under this section; and

“(B) subject to paragraph (2), determinations by testing laboratories so accredited that a device conforms with such standard or standards shall be accepted by the Secretary for purposes of demonstrating such conformity under this section unless the Secretary finds that a particular such determination shall not be so accepted.

“(2) SECRETARIAL REVIEW OF ACCREDITED LABORATORY DETERMINATIONS.—The Secretary may—

“(A) review determinations by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such determinations or processes of accredited bodies or testing laboratories and, following such review, taking additional measures under this Act, such as suspension or withdrawal of accreditation of such testing laboratory under paragraph (1)(A) or requesting additional information with respect to such device, as the Secretary determines appropriate; and

“(B) if the Secretary becomes aware of information materially bearing on safety or effectiveness of a device assessed for conformity by a testing laboratory so accredited, take such additional measures under this Act as the Secretary determines appropriate, such as suspension or withdrawal of accreditation of such testing laboratory under paragraph (1)(A), or requesting additional information with regard to such device.

“(3) IMPLEMENTATION AND REPORTING.—

“(A) PUBLIC MEETING.—The Secretary shall publish in the Federal Register a notice of a public meeting to be held no later than September 30, 2018, to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of, and a suitable framework and procedures and requirements for, the pilot program under this subsection.

“(B) PILOT PROGRAM GUIDANCE.—The Secretary shall—

“(i) not later than September 30, 2019, issue draft guidance regarding the goals and implementation of the pilot program under this subsection; and

“(ii) not later than September 30, 2021, issue final guidance with respect to the implementation of such program.

“(C) PILOT PROGRAM INITIATION.—Not later than September 30, 2020, the Secretary shall initiate the pilot program under this subsection.

“(D) REPORT.—The Secretary shall make available on the internet website of the Food and Drug Administration an annual report on the progress of the pilot program under this subsection.

“(4) SUNSET.—As of October 1, 2022—

“(A) the authority for accreditation bodies to accredit testing laboratories pursuant to paragraph (1)(A) shall cease to have force or effect;

“(B) the Secretary—

“(i) may not accept a determination pursuant to paragraph (1)(B) made by a testing laboratory after such date; and

“(ii) may accept such a determination made prior to such date;

“(C) except for purposes of accepting a determination described in subparagraph (B)(ii), the Secretary shall not continue to recognize the accreditation of testing laboratories accredited under paragraph (1)(A); and

“(D) the Secretary may take actions in accordance with paragraph (2) with respect to the determinations made prior to such date and recognition of the accreditation of testing laboratories pursuant to determinations made prior to such date.”.

SEC. 206. REAUTHORIZATION OF REVIEW.

Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m) is amended—

(1) in subsection (a)(3)—

(A) in subparagraph (A), by striking clauses (ii) and (iii) and inserting the following:

“(ii) a device classified under section 513(f)(2) or designated under section 515C(d);

“(iii) a device that is intended to be permanently implantable, life sustaining, or life supporting, unless otherwise determined by the Secretary in accordance with subparagraph (B)(i)(II) and listed as eligible for review under subparagraph (B)

(iii); or

“(iv) a device that is of a type, or subset of a type, listed as not eligible for review under subparagraph (B)(iii).”;

(B) by striking subparagraph (B) and inserting the following:

“(B) DESIGNATION FOR REVIEW.—The Secretary shall—

“(i) issue draft guidance on the factors the Secretary will use in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person, including—

“(I) the risk of the device type, or subset of such device type; and

“(II) whether the device type, or subset of such device type, is permanently implantable, life sustaining, or life supporting, and whether there is a detailed public health justification for permitting the review by an accredited person of such device type or subset;

“(ii) not later than 24 months after the date on which the Secretary issues such draft guidance, finalize such guidance; and

“(iii) beginning on the date such guidance is finalized, designate and post on the internet website of the Food and Drug Administration, an updated list of class I and class II device types, or subsets of such device types, and the Secretary’s determination with respect to whether each such device type, or subset of a device type, is eligible or not eligible for review by an accredited person under this section based on the factors described in clause (i).”; and

(C) by adding at the end the following:

“(C) INTERIM RULE.—Until the date on which the updated list is designated and posted in accordance with subparagraph (B)(iii), the list in effect on the date of enactment the Medical Device User Fee Amendments of 2017 shall be in effect.”;

(2) in subsection (b)—

(A) in paragraph (2)—

(i) by striking subparagraph (D); and

(ii) by redesignating subparagraph (E) as subparagraph (D); and

(B) in paragraph (3)—

(i) by redesignating subparagraph (E) as subparagraph (F);

(ii) in subparagraph (F) (as so redesignated), by striking “The operations of” and all that follows through “it will—” and inserting “Such person shall agree, at a minimum, to include in its request for accreditation a commitment to, at the time of accreditation, and at any time it is performing any review pursuant to this section—”; and

(iii) by inserting after subparagraph (D) the following new subparagraph:

“(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices.”; and

(3) in subsection (c), by striking “2017” and inserting “2022”.

SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.

Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k–1(b)) is amended by adding at the end the following new paragraph:

“(3) PRESUBMISSIONS AND SUBMISSIONS SOLELY IN ELECTRONIC FORMAT.—

“(A) IN GENERAL.—Beginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices described in paragraph (1) (and any appeals of action taken by the Secretary with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance.

“(B) DRAFT GUIDANCE.—The Secretary shall, not later than October 1, 2019, issue draft guidance providing for—

“(i) any further standards for the submission by electronic format required under subparagraph (A);

“(ii) a timetable for the establishment by the Secretary of such further standards; and

“(iii) criteria for waivers of and exemptions from the requirements of this subsection.

“(C) FINAL GUIDANCE.—The Secretary shall, not later than 1 year after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance.”.

SEC. 208. SAVINGS CLAUSE.

Notwithstanding the amendments made by this title, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.

SEC. 209. EFFECTIVE DATE.

The amendments made by this title shall take effect on October 1, 2017, or the date of the enactment of this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act received on or after October 1, 2017, regardless of the date of the enactment of this Act.

SEC. 210. SUNSET DATES.

(a) Authorization.—Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective October 1, 2022.

(b) Reporting Requirements.—Section 738A (21 U.S.C. 739j–1) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) shall cease to be effective January 31, 2023.

(c) Previous Sunset Provision.—Effective October 1, 2017, section 207(a) of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) is repealed.

TITLE III—FEES RELATING TO GENERIC DRUGS

SEC. 301. SHORT TITLE; FINDING.

(a) Short Title.—This title may be cited as the “Generic Drug User Fee Amendments of 2017”.

(b) Finding.—The Congress finds that the fees authorized by the amendments made in this title will be dedicated to human generic drug activities, as set forth in the goals identified for purposes of part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

SEC. 302. DEFINITIONS.

Section 744A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41) is amended—

(1) in paragraph (1)(B), by striking “application for a positron emission tomography drug.” and inserting “application—

“(i) for a positron emission tomography drug; or

“(ii) submitted by a State or Federal governmental entity for a drug that is not distributed commercially.”;

(2) by redesignating paragraphs (5) through (12) as paragraphs (6) through (13), respectively; and

(3) by inserting after paragraph (4) the following:

“(5) The term ‘contract manufacturing organization facility’ means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility.”.

SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES.

(a) Types Of Fees.—Section 744B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(a)) is amended—

(1) in the matter preceding paragraph (1), by striking “fiscal year 2013” and inserting “fiscal year 2018”;

(2) in paragraph (1), by adding at the end the following:

“(E) SUNSET.—This paragraph shall cease to be effective October 1, 2022.”;

(3) in paragraph (2)—

(A) by amending subparagraph (C) to read as follows:

“(C) NOTICE.—Not later than 60 days before the start of each of fiscal years 2018 through 2022, the Secretary shall publish in the Federal Register the amount of the drug master file fee established by this paragraph for such fiscal year.”; and

(B) in subparagraph (E)—

(i) in clause (i)—

(I) by striking “no later than the date” and inserting “on the earlier of—

“(I) the date”;

(II) by striking the period and inserting “; or”; and

(III) by adding at the end the following:

“(II) the date on which the drug master file holder requests the initial completeness assessment.”; and

(ii) in clause (ii), by striking “notice provided for in clause (i) or (ii) of subparagraph (C), as applicable” and inserting “notice provided for in subparagraph (C)”;

(4) in paragraph (3)—

(A) in the heading, by striking “AND PRIOR APPROVAL SUPPLEMENT”;

(B) in subparagraph (A), by striking “or a prior approval supplement to an abbreviated new drug application”;

(C) by amending subparagraphs (B) and (C) to read as follows:

“(B) NOTICE.—Not later than 60 days before the start of each of fiscal years 2018 through 2022, the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

“(C) FEE DUE DATE.—The fees required by subparagraphs (A) and (F) shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies.”;

(D) in subparagraph (D)—

(i) in the heading, by inserting “, IS WITHDRAWN PRIOR TO BEING RECEIVED, OR IS NO LONGER RECEIVED” after “RECEIVED”; and

(ii) by striking “The Secretary shall” and all that follows through the period and inserting the following:

“(i) APPLICATIONS NOT CONSIDERED TO HAVE BEEN RECEIVED AND APPLICATIONS WITHDRAWN PRIOR TO BEING RECEIVED.—The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 505(j)(5)(A) for a cause other than failure to pay fees, or that has been withdrawn prior to being received within the meaning of section 505(j)(5)(A).

“(ii) APPLICATIONS NO LONGER RECEIVED.—The Secretary shall refund 100 percent of the fee paid under subparagraph (A) for any abbreviated new drug application if the Secretary initially receives the application under section 505(j)(5)(A) and subsequently determines that an exclusivity period for a listed drug should have prevented the Secretary from receiving such application, such that the abbreviated new drug application is no longer received within the meaning of section 505(j)(5)(A).”;

(E) in subparagraph (E), by striking “or prior approval supplement”; and

(F) in the matter preceding clause (i) of subparagraph (F)—

(i) by striking “2012” and inserting “2017”; and

(ii) by striking “subsection (d)(3)” and inserting “subsection (d)(2)”;

(5) in paragraph (4)—

(A) in subparagraph (A)—

(i) in the matter preceding clause (i) and in clause (iii), by striking “, or intended to be identified, in at least one generic drug submission that is pending or” and inserting “in at least one generic drug submission that is”;

(ii) in clause (i), by striking “or intended to be identified in at least one generic drug submission that is pending or” and inserting “in at least one generic drug submission that is”;

(iii) in clause (ii), by striking “produces,” and all that follows through “such a” and inserting “is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such”; and

(iv) in clause (iii), by striking “to fees under both such clauses” and inserting “only to the fee attributable to the manufacture of the finished dosage forms”; and

(B) by amending subparagraphs (C) and (D) to read as follows:

“(C) NOTICE.—Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

“(D) FEE DUE DATE.—For each of fiscal years 2018 through 2022, the fees under subparagraph (A) for such fiscal year shall be due on the later of—

“(i) the first business day on or after October 1 of each such year; or

“(ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section for such year.”;

(6) by redesignating paragraph (5) as paragraph (6); and

(7) by inserting after paragraph (4) the following:

“(5) GENERIC DRUG APPLICANT PROGRAM FEE.—

“(A) IN GENERAL.—A generic drug applicant program fee shall be assessed annually as described in subsection (b)(2)(E).

“(B) AMOUNT.—The amount of fees established under subparagraph (A) shall be established under subsection (d).

“(C) NOTICE.—Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

“(D) FEE DUE DATE.—For each of fiscal years 2018 through 2022, the fees under subparagraph (A) for such fiscal year shall be due on the later of—

“(i) the first business day on or after October 1 of each such fiscal year; or

“(ii) the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year.”.

(b) Fee Revenue Amounts.—Section 744B(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(b)) is amended—

(1) in paragraph (1)—

(A) in subparagraph (A)—

(i) in the heading, by striking “2013” and inserting “2018”;

(ii) by striking “2013” and inserting “2018”;

(iii) by striking “$299,000,000” and inserting “$493,600,000”; and

(iv) by striking “Of that amount” and all that follows through the end of clause (ii); and

(B) in subparagraph (B)—

(i) in the heading, by striking “2014 THROUGH 2017” and inserting “2019 THROUGH 2022”;

(ii) by striking “2014 through 2017” and inserting “2019 through 2022”;

(iii) by striking “paragraphs (2) through (4)” and inserting “paragraphs (2) through (5)”; and

(iv) by striking “$299,000,000” and inserting “$493,600,000”; and

(2) in paragraph (2)—

(A) in the matter preceding subparagraph (A)—

(i) by striking “paragraph (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of fiscal years 2014 through 2017” and inserting “such paragraph for a fiscal year”; and

(ii) by striking “through (4)” and inserting “through (5)”;

(B) in subparagraph (A), by striking “Six percent” and inserting “Five percent”;

(C) by amending subparagraphs (B) and (C) to read as follows:

“(B) Thirty-three percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications).

“(C) Twenty percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a contract manufacturing organization facility shall be equal to one-third the amount of the fee for a facility that is not a contract manufacturing organization facility. The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions.”;

(D) in subparagraph (D)—

(i) by striking “Fourteen percent” and inserting “Seven percent”;

(ii) by striking “not less than $15,000 and not more than $30,000” and inserting “$15,000”; and

(iii) by striking “, as determined” and all that follows through the period at the end and inserting a period; and

(E) by adding at the end the following:

“(E) (i) Thirty-five percent shall be derived from fees under subsection (a)(5) (relating to generic drug applicant program fees). For purposes of this subparagraph, if a person has affiliates, a single program fee shall be assessed with respect to that person, including its affiliates, and may be paid by that person or any one of its affiliates. The Secretary shall determine the fees as follows:

“(I) If a person (including its affiliates) owns at least one but not more than 5 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee.

“(II) If a person (including its affiliates) owns at least 6 but not more than 19 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee.

“(III) If a person (including its affiliates) owns 20 or more approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a large size operation generic drug applicant program fee.

“(ii) For purposes of this subparagraph, an abbreviated new drug application shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by April 1 of the previous fiscal year.”.

(c) Adjustments.—Section 744B(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(c)) is amended—

(1) in paragraph (1)—

(A) by striking “2014” and inserting “2019”;

(B) by inserting “to equal the product of the total revenues established in such notice for the prior fiscal year multiplied” after “a fiscal year,”; and

(C) by striking the flush text following subparagraph (C); and

(2) in paragraph (2)—

(A) by striking “2017” each place it appears and inserting “2022”;

(B) by striking “the first 3 months of fiscal year 2018” and inserting “the first 3 months of fiscal year 2023”; and

(C) by striking “Such fees may only be used in fiscal year 2018.”.

(d) Annual Fee Setting.—Section 744B(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(d)) is amended—

(1) by striking paragraphs (1) and (2) and inserting the following:

“(1) FISCAL YEARS 2018 THROUGH 2022.—Not more than 60 days before the first day of each of fiscal years 2018 through 2022, the Secretary shall establish the fees described in paragraphs (2) through (5) of subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under subsection (c).”;

(2) by redesignating paragraph (3) as paragraph (2); and

(3) in paragraph (2) (as so redesignated), in the matter preceding subparagraph (A), by striking “fees under paragraphs (1) and (2)” and inserting “fee under paragraph (1)”.

(e) Identification Of Facilities.—Section 744B(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(f)) is amended—

(1) by striking paragraph (1);

(2) by redesignating paragraphs (2) through (4) as paragraphs (1) through (3), respectively;

(3) in paragraph (1) (as so redesignated)—

(A) by striking “paragraph (4)” and inserting “paragraph (3)”; and

(B) by striking “Such information shall” and all that follows through the end of subparagraph (B) and inserting “Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year.”; and

(4) in paragraph (2), as so redesignated—

(A) in the heading, by striking “CONTENTS OF NOTICE” and inserting “INFORMATION REQUIRED TO BE SUBMITTED”;

(B) in the matter preceding subparagraph (A), by striking “paragraph (2)” and inserting “paragraph (1)”;

(C) in subparagraph (A), by striking “or intended to be identified”;

(D) in subparagraph (D), by striking “and” at the end;

(E) in subparagraph (E), by striking the period and inserting “; and”; and

(F) by adding at the end the following:

“(F) whether the facility is a contract manufacturing organization facility.”.

(f) Effect Of Failure To Pay Fees.—Section 744B(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(g)) is amended—

(1) in paragraph (1), by adding at the end the following: “This paragraph shall cease to be effective on October 1, 2022.”;

(2) in paragraph (2)(C)(ii), by striking “of 505(j)(5)(A)” and inserting “of section 505(j)(5)(A)”; and

(3) by adding at the end the following:

“(5) GENERIC DRUG APPLICANT PROGRAM FEE.—

“(A) IN GENERAL.—A person who fails to pay a fee as required under subsection (a)(5) by the date that is 20 calendar days after the due date, as specified in subparagraph (D) of such subsection, shall be subject to the following:

“(i) The Secretary shall place the person on a publicly available arrears list.

“(ii) Any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received, within the meaning of section 505(j)(5)(A).

“(iii) All drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under section 502(aa).

“(B) APPLICATION OF PENALTIES.—The penalties under subparagraph (A) shall apply until the fee required under subsection (a)(5) is paid.”.

(g) Limitations.—Section 744B(h)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(h)(2)) is amended by striking “for Type II active pharmaceutical ingredient drug master files, abbreviated new drug applications and prior approval supplements, and generic drug facilities and active pharmaceutical ingredient facilities”.

(h) Crediting And Availability Of Fees.—Section 744B(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(i)) is amended—

(1) in paragraph (2)—

(A) in subparagraph (A), by striking “subparagraphs (C) and (D)” and inserting “subparagraph (C)”;

(B) by striking subparagraph (C) (relating to fee collection during first program year);

(C) in subparagraph (D)—

(i) in the heading, by striking “IN SUBSEQUENT YEARS”; and

(ii) by striking “(after fiscal year 2013)”; and

(D) by redesignating subparagraph (D) as subparagraph (C); and

(2) in paragraph (3), by striking “fiscal years 2013 through 2017” and inserting “fiscal years 2018 through 2022”.

(i) Information On Abbreviated New Drug Applications Owned By Applicants And Their Affiliates.—Section 744B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42) is amended by adding at the end the following:

“(o) Information On Abbreviated New Drug Applications Owned By Applicants And Their Affiliates.—

“(1) IN GENERAL.—By April 1 of each year, each person that owns an abbreviated new drug application, or a designated affiliate of such person, shall submit, on behalf of the person and the affiliates of such person, to the Secretary a list of—

“(A) all approved abbreviated new drug applications owned by such person; and

“(B) if any affiliate of such person also owns an abbreviated new drug application, all affiliates that own any such abbreviated new drug application and all approved abbreviated new drug applications owned by any such affiliate.

“(2) FORMAT AND METHOD.—The Secretary shall specify in guidance the format and method for submission of lists under this subsection.”.

SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.

Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) is amended—

(1) in subsection (a)—

(A) by striking “2013” and inserting “2018”; and

(B) by striking “Generic Drug User Fee Amendments of 2012” and inserting “Generic Drug User Fee Amendments of 2017”;

(2) in subsection (b), by striking “2013” and inserting “2018”; and

(3) in subsection (d), by striking “2017” each place it appears and inserting “2022”.

SEC. 305. SUNSET DATES.

(a) Authorization.—Sections 744A and 744B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–41; 379j–42) shall cease to be effective October 1, 2022.

(b) Reporting Requirements.—Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) shall cease to be effective January 31, 2023.

(c) Previous Sunset Provision.—

(1) IN GENERAL.—Effective October 1, 2017, section 304 of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) is repealed.

(2) CONFORMING AMENDMENT.—The Food and Drug Administration Safety and Innovation Act (Public Law 112–144) is amended in the table of contents in section 2 by striking the item relating to section 304.

SEC. 306. EFFECTIVE DATE.

The amendments made by this title shall take effect on October 1, 2017, or the date of the enactment of this Act, whichever is later, except that fees under part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all abbreviated new drug applications received on or after October 1, 2017, regardless of the date of the enactment of this Act.

SEC. 307. SAVINGS CLAUSE.

Notwithstanding the amendments made by this title, part 7 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to abbreviated new drug applications (as defined in such part as of such day) that were received by the Food and Drug Administration within the meaning of section 505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior approval supplements that were submitted, and drug master files for Type II active pharmaceutical ingredients that were first referenced on or after October 1, 2012, but before October 1, 2017, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.

TITLE IV—FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

SEC. 401. SHORT TITLE; FINDING.

(a) Short Title.—This title may be cited as the “Biosimilar User Fee Amendments of 2017”.

(b) Finding.—The Congress finds that the fees authorized by the amendments made in this title will be dedicated to expediting the process for the review of biosimilar biological product applications, including postmarket safety activities, as set forth in the goals identified for purposes of part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

SEC. 402. DEFINITIONS.

(a) Adjustment Factor.—Section 744G(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51(1)) is amended to read as follows:

“(1) The term ‘adjustment factor’ applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items) for October of the preceding fiscal year divided by such Index for October 2011.”.

(b) Biosimilar Biological Product.—Section 744G(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–51(3)) is amended by striking “means a product” and inserting “means a specific strength of a biological product in final dosage form”.

SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.

(a) Types Of Fees.—Section 744H(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(a)) is amended—

(1) in the matter preceding paragraph (1), by striking “fiscal year 2013” and inserting “fiscal year 2018”;

(2) in the heading of paragraph (1), by striking “BIOSIMILAR” and inserting “BIOSIMILAR BIOLOGICAL PRODUCT”;

(3) in paragraph (1)(A)(i), by striking “(b)(1)(A)” and inserting “(c)(5)”;

(4) in paragraph (1)(B)(i), by striking “(b)(1)(B) for biosimilar biological product development” and inserting “(c)(5) for the biosimilar biological product development program”;

(5) in paragraph (1)(B)(ii), by striking “annual biosimilar biological product development program fee” and inserting “annual biosimilar biological product development fee”;

(6) in paragraph (1)(B)(iii), by striking “annual biosimilar development program fee” and inserting “annual biosimilar biological product development fee”;

(7) in paragraph (1)(B), by adding at the end the following:

“(iv) REFUND.—If a person submits a marketing application for a biosimilar biological product before October 1 of a fiscal year and such application is accepted for filing on or after October 1 of such fiscal year, the person may request a refund equal to the annual biosimilar biological product development fee paid by the person for the product for such fiscal year. To qualify for consideration for a refund under this clause, a person shall submit to the Secretary a written request for such refund not later than 180 days after the marketing application is accepted for filing.”;

(8) in paragraph (1)(C), by striking “for a product effective October 1 of a fiscal year by,” and inserting “for a product, effective October 1 of a fiscal year, by,”;

(9) in paragraph (1)(D)—

(A) in clause (i) in the matter preceding subclause (I), by inserting “, if the person seeks to resume participation in such program,” before “pay a fee”;

(B) in clause (i)(I), by inserting after “grants a request” the following: “by such person”; and

(C) in clause (i)(II), by inserting after “discontinued)” the following: “by such person”;

(10) in the heading of paragraph (1)(E), by striking “BIOSIMILAR DEVELOPMENT PROGRAM”;

(11) in paragraph (1)(F)—

(A) in the subparagraph heading, by striking “BIOSIMILAR DEVELOPMENT PROGRAM”; and

(B) by amending clause (i) to read as follows:

“(i) REFUNDS.—Except as provided in subparagraph (B)(iv), the Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D).”;

(12) in paragraph (2)—

(A) in the paragraph heading, by striking “AND SUPPLEMENT”;

(B) by amending subparagraphs (A) and (B) to read as follows:

“(A) IN GENERAL.—Each person that submits, on or after October 1, 2017, a biosimilar biological product application shall be subject to the following fees:

“(i) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval.

“(ii) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required for approval. Such fee shall be equal to half of the amount of the fee described in clause (i).

“(B) RULE OF APPLICABILITY; TREATMENT OF CERTAIN PREVIOUSLY PAID FEES.—Any person who pays a fee under subparagraph (A), (B), or (D) of paragraph (1) for a product before October 1, 2017, but submits a biosimilar biological product application for that product after such date, shall—

“(i) be subject to any biosimilar biological product application fees that may be assessed at the time when such biosimilar biological product application is submitted; and

“(ii) be entitled to no reduction of such application fees based on the amount of fees paid for that product before October 1, 2017, under such subparagraph (A), (B), or (D).”;

(C) in the heading of subparagraph (D), by striking “OR SUPPLEMENT”;

(D) in subparagraphs (C) through (F), by striking “or supplement” each place it appears; and

(E) in subparagraph (D), by striking “or a supplement”;

(13) by amending paragraph (3) to read as follows:

“(3) BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM FEE.—

“(A) IN GENERAL.—Each person who is named as the applicant in a biosimilar biological product application shall pay the annual biosimilar biological product program fee established for a fiscal year under subsection (c)(5) for each biosimilar biological product that—

“(i) is identified in such a biosimilar biological product application approved as of October 1 of such fiscal year; and

“(ii) as of October 1 of such fiscal year, does not appear on a list, developed and maintained by the Secretary, of discontinued biosimilar biological products.

“(B) DUE DATE.—The biosimilar biological product program fee for a fiscal year shall be due on the later of—

“(i) the first business day on or after October 1 of each such year; or

“(ii) the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section.

“(C) ONE FEE PER PRODUCT PER YEAR.—The biosimilar biological product program fee shall be paid only once for each product for each fiscal year.

“(D) LIMITATION.—A person who is named as the applicant in a biosimilar biological product application shall not be assessed more than 5 biosimilar biological product program fees for a fiscal year for biosimilar biological products identified in such biosimilar biological product application.”.

(b) Fee Revenue Amounts.—Subsection (b) of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52) is amended to read as follows:

“(b) Fee Revenue Amounts.—

“(1) FISCAL YEAR 2018.—For fiscal year 2018, fees under subsection (a) shall be established to generate a total revenue amount equal to the sum of—

“(A) $45,000,000; and

“(B) the dollar amount equal to the fiscal year 2018 adjustment (as determined under subsection (c)(4)).

“(2) SUBSEQUENT FISCAL YEARS.—For each of the fiscal years 2019 through 2022, fees under subsection (a) shall, except as provided in subsection (c), be established to generate a total revenue amount equal to the sum of—

“(A) the annual base revenue for the fiscal year (as determined under paragraph (4));

“(B) the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

“(C) the dollar amount equal to the capacity planning adjustment for the fiscal year (as determined under subsection (c)(2)); and

“(D) the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(3)).

“(3) ALLOCATION OF REVENUE AMOUNT AMONG FEES; LIMITATIONS ON FEE AMOUNTS.—

“(A) ALLOCATION.—The Secretary shall determine the percentage of the total revenue amount for a fiscal year to be derived from, respectively—

“(i) initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1);

“(ii) biosimilar biological product application fees under subsection (a)(2); and

“(iii) biosimilar biological product program fees under subsection (a)(3).

“(B) LIMITATIONS ON FEE AMOUNTS.—Until the first fiscal year for which the capacity planning adjustment under subsection (c)(2) is effective, the amount of any fee under subsection (a) for a fiscal year after fiscal year 2018 shall not exceed 125 percent of the amount of such fee for fiscal year 2018.

“(C) BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT FEES.—The initial biosimilar biological product development fee under subsection (a)(1)(A) for a fiscal year shall be equal to the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.

“(D) REACTIVATION FEE.—The reactivation fee under subsection (a)(1)(D) for a fiscal year shall be equal to twice the amount of the annual biosimilar biological product development fee under subsection (a)(1)(B) for that fiscal year.

“(4) ANNUAL BASE REVENUE.—For purposes of paragraph (2), the dollar amount of the annual base revenue for a fiscal year shall be the dollar amount of the total revenue amount for the previous fiscal year, excluding any adjustments to such revenue amount under subsection (c)(3).”.

(c) Adjustments; Annual Fee Setting.—Section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52) is amended—

(1) by redesignating subsections (c) through (h) as subsections (d) through (i), respectively;

(2) in subsections (a)(2)(F) and (h) (as redesignated by paragraph (1)), by striking “subsection (c)” and inserting “subsection (d)”;

(3) in subsection (a)(4)(A), by striking “subsection (b)(1)(F)” and inserting “subsection (c)(5)”; and

(4) by inserting after subsection (b) the following:

“(c) Adjustments; Annual Fee Setting.—

“(1) INFLATION ADJUSTMENT.—

“(A) IN GENERAL.—For purposes of subsection (b)(2)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—

“(i) such annual base revenue for the fiscal year under subsection (b); and

“(ii) the inflation adjustment percentage under subparagraph (B).

“(B) INFLATION ADJUSTMENT PERCENTAGE.—The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—

“(i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 744G(13)) for the first 3 years of the preceding 4 fiscal years; and

“(ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of the process for the review of biosimilar biological product applications (as defined in section 744G(13)) for the first 3 years of the preceding 4 fiscal years.

“(2) CAPACITY PLANNING ADJUSTMENT.—

“(A) IN GENERAL.—Beginning with the fiscal year described in subparagraph (B)(ii)(II), the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year to reflect changes in the resource capacity needs of the Secretary for the process for the review of biosimilar biological product applications.

“(B) CAPACITY PLANNING METHODOLOGY.—

“(i) DEVELOPMENT; EVALUATION AND REPORT.—The Secretary shall obtain, through a contract with an independent accounting or consulting firm, a report evaluating options and recommendations for a new methodology to accurately assess changes in the resource and capacity needs of the process for the review of biosimilar biological product applications. The capacity planning methodological options and recommendations presented in such report shall utilize and be informed by personnel time reporting data as an input. The report shall be published for public comment not later than September 30, 2020.

“(ii) ESTABLISHMENT AND IMPLEMENTATION.—After review of the report described in clause (i) and receipt and review of public comments thereon, the Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—

“(I) incorporate such approaches and attributes as the Secretary determines appropriate; and

“(II) be effective beginning with the first fiscal year for which fees are set after such capacity planning methodology is established.

“(C) LIMITATION.—Under no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsections (b)(2)(A) (the annual base revenue for the fiscal year) and (b)(2)(B) (the dollar amount of the inflation adjustment for the fiscal year).

“(D) PUBLICATION IN FEDERAL REGISTER.—The Secretary shall publish in the Federal Register notice under paragraph (5) the fee revenue and fees resulting from the adjustment and the methodologies under this paragraph.

“(3) OPERATING RESERVE ADJUSTMENT.—

“(A) INTERIM APPLICATION; FEE REDUCTION.—Until the first fiscal year for which the capacity planning adjustment under paragraph (2) is effective, the Secretary may, in addition to the adjustment under paragraph (1), reduce the fee revenue and fees under this section for a fiscal year as the Secretary determines appropriate for long-term financial planning purposes.

“(B) GENERAL APPLICATION AND METHODOLOGY.—Beginning with the first fiscal year for which the capacity planning adjustment under paragraph (2) is effective, the Secretary may, in addition to the adjustments under paragraphs (1) and (2)—

“(i) reduce the fee revenue and fees under this section as the Secretary determines appropriate for long-term financial planning purposes; or

“(ii) increase the fee revenue and fees under this section if such an adjustment is necessary to provide for not more than 21 weeks of operating reserves of carryover user fees for the process for the review of biosimilar biological product applications.

“(C) FEDERAL REGISTER NOTICE.—If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5)(B) establishing fee revenue and fees for the fiscal year involved.

“(4) FISCAL YEAR 2018 ADJUSTMENT.—

“(A) IN GENERAL.—For fiscal year 2018, the Secretary shall adjust the fee revenue and fees under this section in such amount (if any) as needed to reflect an updated assessment of the workload for the process for the review of biosimilar biological product applications.

“(B) METHODOLOGY.—The Secretary shall publish under paragraph (5)(B) a description of the methodology used to calculate the fiscal year 2018 adjustment under this paragraph in the Federal Register notice establishing fee revenue and fees for fiscal year 2018.

“(C) LIMITATION.—No adjustment under this paragraph shall result in an increase in fee revenue and fees under this section in excess of $9,000,000.

“(5) ANNUAL FEE SETTING.—For fiscal year 2018 and each subsequent fiscal year, the Secretary shall, not later than 60 days before the start of each such fiscal year—

“(A) establish, for the fiscal year, initial and annual biosimilar biological product development fees and reactivation fees under subsection (a)(1), biosimilar biological product application fees under subsection (a)(2), and biosimilar biological product program fees under subsection (a)(3), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and

“(B) publish such fee revenue and fees in the Federal Register.

“(6) LIMIT.—The total amount of fees assessed for a fiscal year under this section may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of biosimilar biological product applications.”.

(d) Application Fee Waiver For Small Business.—Subsection (d)(1) of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52), as redesignated by subsection (c)(1), is amended—

(1) by striking subparagraph (B);

(2) by striking “; and” at the end of subparagraph (A) and inserting a period; and

(3) by striking “shall pay—” and all that follows through “application fees” and inserting “shall pay application fees”.

(e) Effect Of Failure To Pay Fees.—Subsection (e) of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52), as redesignated by subsection (c)(1), is amended by striking “all fees” and inserting “all such fees”.

(f) Crediting And Availability Of Fees.—Subsection (f) of section 744H of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52), as redesignated by subsection (c)(1), is amended—

(1) in paragraph (2)—

(A) by striking subparagraph (C) (relating to fee collection during first program year) and inserting the following:

“(C) COMPLIANCE.—The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs described in such subparagraph are not more than 15 percent below the level specified in such subparagraph.”; and

(B) in subparagraph (D)—

(i) in the heading, by striking “IN SUBSEQUENT YEARS”; and

(ii) by striking “(after fiscal year 2013)”; and

(2) in paragraph (3), by striking “2013 through 2017” and inserting “2018 through 2022”.

SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.

Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53) is amended—

(1) in subsection (a)—

(A) by striking “2013” and inserting “2018”; and

(B) by striking “Biosimilar User Fee Act of 2012” and inserting “Biosimilar User Fee Amendments of 2017”;

(2) in subsection (b), by striking “2013” and inserting “2018”;

(3) by striking subsection (d);

(4) by redesignating subsection (e) as subsection (d); and

(5) in subsection (d), as so redesignated, by striking “2017” each place it appears and inserting “2022”.

SEC. 405. SUNSET DATES.

(a) Authorization.—Sections 744G and 744H of the Federal Food, Drug, and Cosmetic Act shall cease to be effective October 1, 2022.

(b) Reporting Requirements.—Section 744I of the Federal Food, Drug, and Cosmetic Act shall cease to be effective January 31, 2023.

(c) Previous Sunset Provision.—

(1) IN GENERAL.—Effective October 1, 2017, section 404 of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) is repealed.

(2) CONFORMING AMENDMENT.—The Food and Drug Administration Safety and Innovation Act (Public Law 112–144) is amended in the table of contents in section 2 by striking the item relating to section 404.

SEC. 406. EFFECTIVE DATE.

The amendments made by this title shall take effect on October 1, 2017, or the date of the enactment of this Act, whichever is later, except that fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all biosimilar biological product applications received on or after October 1, 2017, regardless of the date of the enactment of this Act.

SEC. 407. SAVINGS CLAUSE.

Notwithstanding the amendments made by this title, part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to biosimilar biological product applications and supplements (as defined in such part as of such day) that were accepted by the Food and Drug Administration for filing on or after October 1, 2012, but before October 1, 2017, with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.

 

TITLE V—PEDIATRIC DRUGS AND DEVICES

SEC. 501. BEST PHARMACEUTICALS FOR CHILDREN.

Section 409I of the Public Health Service Act (42 U.S.C. 284m) is amended—

(1) in subsection (a)(2)(A)(ii), by inserting “and identification of biomarkers for such diseases, disorders, or conditions,” after “biologics,”;

(2) in subsection (c)—

(A) in paragraph (6)—

(i) by amending subparagraph (B) to read as follows:

“(B) AVAILABILITY OF REPORTS.—

“(i) IN GENERAL.—Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act) and not later than 90 days after submission of such report, shall be—

“(I) posted on the internet website of the National Institutes of Health in a manner that is accessible and consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—

“(aa) human research participants, including with respect to privacy, security, informed consent, and protected health information; and

“(bb) proprietary interests, confidential commercial information, and intellectual property rights; and

“(II) assigned a docket number by the Commissioner of Food and Drugs and made available for the submission of public comments.

“(ii) SUBMISSION OF COMMENTS.—An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the submitted comments shall become part of the docket file with respect to each of the drugs.”; and

(ii) in subparagraph (C), by striking “appropriate action” and all that follows through the period and inserting “action in a timely and appropriate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of the report under subparagraph (A), in accordance with paragraph (7).”; and

(B) in paragraph (7)—

(i) in the matter preceding subparagraph (A), by striking “During” and inserting “Within”;

(ii) in subparagraph (C)(i), by striking “place” and all that follows through “and of” and inserting “include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of”; and

(iii) in clause (ii), by striking “in the Federal Register and”;

(3) by striking subsection (d);

(4) by redesignating subsection (e) as subsection (d); and

(5) in paragraph (1) of subsection (d), as so redesignated, by striking “2013 through 2017” and inserting “2018 through 2022”.

SEC. 502. PEDIATRIC DEVICES.

(a) Pediatric Use Of Devices.—Section 515A(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–1(a)(3)) is amended—

(1) by redesignating subparagraphs (B) through (D) as subparagraphs (D) through (F), respectively;

(2) by inserting after subparagraph (A) the following:

“(B) any information, based on a review of data available to the Secretary, regarding devices used in pediatric patients but not labeled for such use for which the Secretary determines that approved pediatric labeling could confer a benefit to pediatric patients;

“(C) the number of pediatric devices that receive a humanitarian use exemption under section 520(m);”;

(3) in subparagraph (E), as so redesignated, by striking “; and” and inserting “;”;

(4) in subparagraph (F) (as so redesignated), by striking “(B), and (C).” and inserting “(C), (D), and (E);”; and

(5) by adding at the end the following:

“(G) the number of devices for which the Secretary relied on data with respect to adults to support a determination of a reasonable assurance of safety and effectiveness in pediatric patients; and

“(H) the number of devices for which the Secretary relied on data from one pediatric subpopulation to support a determination of a reasonable assurance of safety and effectiveness in another pediatric subpopulation.

For the items described in this paragraph, such report shall disaggregate the number of devices by pediatric subpopulation.”.

(b) Humanitarian Device Exemption.—Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is amended—

(1) in paragraph (4)—

(A) in subparagraph (B), by inserting “or an appropriate local committee” after “review committee” each place such term appears; and

(B) in the matter following subparagraph (B), by inserting “or an appropriate local committee” after “review committee” each place such term appears; and

(2) in paragraph (6)(A)(iv), by striking “2017” and inserting “2022”.

(c) Demonstration Grants For Improving Pediatric Availability.—Section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note)) is amended—

(1) in subsection (c)—

(A) in paragraph (4), by striking “and” at the end;

(B) in paragraph (5), by striking the period and inserting “; and”; and

(C) by adding at the end the following:

“(6) providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate.”; and

(2) in subsection (e), by striking “2013 through 2017” and inserting “2018 through 2022”.

(d) Meeting On Pediatric Device Development.—

(1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall convene a public meeting on the development, approval or clearance, and labeling of pediatric medical devices. The Secretary shall invite to such meeting representatives from the medical device industry, academia, recipients of funding under section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note), medical provider organizations, and organizations representing patients and consumers.

(2) TOPICS.—The meeting described in paragraph (1) shall include consideration of ways to—

(A) improve research infrastructure and research networks to facilitate the conduct of clinical studies of devices for pediatric populations that would result in the approval or clearance, and labeling, of medical devices for such populations;

(B) appropriately use extrapolation under section 515A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–1(b));

(C) enhance the appropriate use of postmarket registries and data to increase pediatric medical device labeling;

(D) increase Food and Drug Administration assistance to medical device manufacturers in developing devices for pediatric populations that are approved or cleared, and labeled, for their use; and

(E) identify current barriers to pediatric device development and incentives to address such barriers.

(3) REPORT.—The report submitted under section 515A(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–1(a)(3)) with respect to the calendar year in which the meeting described in paragraph (1) is held shall include a summary of, and responses to, recommendations raised in such meeting.

SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN.

(a) In General.—Clause (i) of section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)) is amended to read as follows:

“(i) shall meet with the applicant—

“(I) if requested by the applicant with respect to a drug or biological product that is intended to treat a serious or life-threatening disease or condition, to discuss preparation of the initial pediatric study plan, not later than the end-of-Phase 1 meeting (as such term is used in section 312.82(b) of title 21, Code of Federal Regulations, or successor regulations) or within 30 calendar days of receipt of such request, whichever is later;

“(II) to discuss the initial pediatric study plan as soon as practicable, but not later than 90 calendar days after the receipt of such plan under subparagraph (A); and

“(III) to discuss the bases for the deferral under subsection (a)(4) or a full or partial waiver under subsection (a)(5);”.

(b) Conforming Changes.—Section 505B(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)) is amended—

(1) in the heading of paragraph (2), by striking “MEETING” and inserting “MEETINGS”;

(2) in the heading of paragraph (2)(C), by striking “MEETING” and inserting “MEETINGS”;

(3) in clauses (ii) and (iii) of paragraph (2)(C), by striking “no meeting” each place it appears and inserting “no meeting under clause (i)(II)”; and

(4) in paragraph (3) by striking “meeting under paragraph (2)(C)(i)” and inserting “meeting under paragraph (2)(C)(i)(II)”.

SEC. 504. DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR PEDIATRIC CANCERS.

(a) Molecular Targets Regarding Cancer Drugs And Biological Products.—Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended—

(1) in subsection (a)—

(A) in paragraph (1)—

(i) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively, and adjusting the margins accordingly;

(ii) by striking “A person” and inserting the following:

“(A) GENERAL REQUIREMENTS.—Except with respect to an application for which subparagraph (B) applies, a person”;

(iii) in clause (i), as so redesignated, by striking “, or” at the end and inserting “; or”; and

(iv) by adding after subparagraph (A), as so designated by clause (ii), the following:

“(B) CERTAIN MOLECULARLY TARGETED CANCER INDICATIONS.—A person that submits, on or after the date that is 3 years after the date of enactment of the FDA Reauthorization Act of 2017, an original application for a new active ingredient under section 505 of this Act or section 351 of the Public Health Service Act, shall submit with the application reports on the investigation described in paragraph (3) if the drug or biological product that is the subject of the application is—

“(i) intended for the treatment of an adult cancer; and

“(ii) directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.”;

(B) in paragraph (2)(A), by striking “paragraph (1)” and inserting “paragraph (1)(A)”;

(C) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively;

(D) by inserting after paragraph (2) the following:

“(3) MOLECULARLY TARGETED PEDIATRIC CANCER INVESTIGATION.—

“(A) IN GENERAL.—With respect to a drug or biological product described in paragraph (1)(B), the investigation described in this paragraph is a molecularly targeted pediatric cancer investigation, which shall be designed to yield clinically meaningful pediatric study data, gathered using appropriate formulations for each age group for which the study is required, regarding dosing, safety, and preliminary efficacy to inform potential pediatric labeling.

“(B) EXTRAPOLATION OF DATA.—Paragraph (2)(B) shall apply to investigations described in this paragraph to the same extent and in the same manner as paragraph (2)(B) applies with respect to the assessments required under paragraph (1)(A).

“(C) DEFERRALS AND WAIVERS.—Deferrals and waivers under paragraphs (4) and (5) shall apply to investigations described in this paragraph to the same extent and in the same manner as such deferrals and waivers apply with respect to the assessments under paragraph (2)(B).”;

(E) in paragraph (4), as so redesignated—

(i) by striking “assessments required under paragraph (1)” each place it appears and inserting “assessments required under paragraph (1)(A) or reports on the investigation required under paragraph (1)(B)”;

(ii) in subparagraph (A)(ii)(I), by inserting “or reports on the investigation” after “assessments”;

(iii) in subparagraph (B)(ii), by striking “assessment under paragraph (1)” and inserting “assessment under paragraph (1)(A) or reports on the investigation under paragraph (1)(B)”; and

(iv) in subparagraph (C)(ii)(II), by inserting “or investigation” after “assessment”; and

(F) in paragraph (5), as so redesignated, by inserting “or reports on the investigation” after “assessments” each place it appears;

(2) in subsection (d)—

(A) by striking “subsection (a)(3)” each place it appears and inserting “subsection (a)(4)”;

(B) by inserting “And Reports On The Investigation” after “Submission Of Assessments” in the heading; and

(C) by inserting “or the investigation described in subsection (a)(3)” after “assessment described in subsection (a)(2)” each place it appears;

(3) in subsection (e)—

(A) in paragraph (1), by inserting “or the investigation described in subsection (a)(3)” after “under subsection (a)(2)”; and

(B) in paragraph (2)(A)(i), by inserting “or the investigation described in subsection (a)(3)” after “under subsection (a)(2)”; and

(4) by adding at the end the following:

“(m) List Of Primary Molecular Targets.—

“(1) IN GENERAL.—Within one year of the date of enactment of the FDA Reauthorization Act of 2017, the Secretary shall establish and update regularly, and shall publish on the internet website of the Food and Drug Administration—

“(A) a list of molecular targets considered, on the basis of data the Secretary determines to be adequate, to be substantially relevant to the growth and progression of a pediatric cancer, and that may trigger the requirements under this section; and

“(B) a list of molecular targets of new cancer drugs and biological products in development for which pediatric cancer study requirements under this section will be automatically waived.

“(2) CONSULTATION.—In establishing the lists described in paragraph (1), the Secretary shall consult the National Cancer Institute, members of the internal committee under section 505C, and the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, and shall take into account comments from the meeting under subsection (c).

“(3) RULE OF CONSTRUCTION.—Nothing in paragraph (1) shall be construed—

“(A) to require the inclusion of a molecular target on the list published under such paragraph as a condition for triggering the requirements under subsection (a)(1)(B) with respect to a drug or biological product directed at such molecular target; or

“(B) to authorize the disclosure of confidential commercial information, as prohibited under section 301(j) of this Act or section 1905 of title 18, United States Code.”.

(b) Orphan Drugs.—Section 505B(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(k)) is amended to read as follows:

“(k) Relation To Orphan Drugs.—

“(1) IN GENERAL; EXEMPTION FOR ORPHAN INDICATIONS.—Unless the Secretary requires otherwise by regulation and except as provided in paragraph (2), this section does not apply to any drug or biological product for an indication for which orphan designation has been granted under section 526.

“(2) APPLICABILITY DESPITE ORPHAN DESIGNATION OF CERTAIN INDICATIONS.—This section shall apply with respect to a drug or biological product for which an indication has been granted orphan designation under 526 if the investigation described in subsection (a)(3) applies to the drug or biological product as described in subsection (a)(1)(B).”.

(c) Meeting, Consultation, And Guidance.—

(1) MEETING.—The Secretary of Health and Human Services (referred to in this subsection as the “Secretary”), acting through the Commissioner of Food and Drugs and in collaboration with the Director of the National Cancer Institute, shall convene a public meeting not later than 1 year after the date of enactment of this Act to solicit feedback from physicians and researchers (including pediatric oncologists and rare disease specialists), patients, and other stakeholders to provide input on development of the guidance under paragraph (2) and the list under subsection (m) of section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as added by subsection (a). The Secretary shall seek input at such meeting on—

(A) the data necessary to determine that there is scientific evidence that a drug or biological product is directed at a molecular target that is considered to be substantially relevant to the growth or progression of a pediatric cancer;

(B) the data necessary to determine that there is scientific evidence that a molecular target is considered to be substantially relevant to the growth or progression of a pediatric cancer;

(C) the data needed to meet the requirement of conducting an investigation described in section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a);

(D) considerations when developing the list under section 505B(m) of the Federal Food, Drug, and Cosmetic Act that contains molecular targets shared between different tumor types;

(E) the process the Secretary shall utilize to update regularly a list of molecular targets that may trigger a pediatric study under section 505B of the Federal Food, Drug, and Cosmetic Act, as so amended, and how often such updates shall occur;

(F) how to overcome the challenges related to pediatric cancer drug and biological product development, including issues related to the ethical, practical, and other barriers to conducting clinical trials in pediatric cancer with small patient populations;

(G) scientific or operational challenges associated with performing an investigation described in section 505B(a)(1)(B) of the Federal Food, Drug, and Cosmetic Act, including the effect on pediatric studies currently underway in a pediatric patient population, treatment of a pediatric patient population, and the ability to complete adult clinical trials;

(H) the advantages and disadvantages of innovative clinical trial designs in addressing the development of cancer drugs or biological products directed at molecular targets in pediatric cancer patients;

(I) the ways in which the Secretary can improve the current process outlined under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) to encourage additional research and development of pediatric cancer treatments;

(J) the ways in which the Secretary might streamline and improve the written request process, including when studies contained in a request under such section 505A are not feasible due to the ethical, practical, or other barriers to conducting clinical trials in pediatric cancer populations;

(K) how the Secretary will facilitate collaboration among pediatric networks, academic centers and experts in pediatric cancer to conduct an investigation described in such section 505B(a)(3);

(L) how the Secretary may facilitate collaboration among sponsors of same-in-class drugs and biological products that would be subject to the requirements for an investigation under such section 505B based on shared molecular targets; and

(M) the ways in which the Secretary will help to mitigate the risks, if any, of discouraging the research and development of orphan drugs when implementing such section 505B as amended.

(2) GUIDANCE.—Not later than 2 years after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue final guidance on implementation of the amendments to section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) regarding molecularly targeted cancer drugs made by this section, including—

(A) the scientific criteria, types of data, and regulatory considerations for determining whether a molecular target is substantially relevant to the growth or progression of a pediatric cancer and would trigger an investigation under section 505B of the Federal Food, Drug, and Cosmetic Act, as amended;

(B) the process by which the Secretary will engage with sponsors to discuss determinations, investigation requirements, deferrals, waivers, and any other issues that need to be resolved to ensure that any required investigation based on a molecular target can be reasonably conducted;

(C) the scientific or operational challenges for which the Secretary may issue deferrals or waivers for an investigation described in subsection (a)(3) of such section 505B, including adverse impacts on current pediatric studies underway in a pediatric patient population, studies involving drugs designated as orphan drugs, treatment of a pediatric patient population, or the ability to complete adult clinical trials;

(D) how the Secretary and sponsors will facilitate collaboration among pediatric networks, academic centers, and experts in pediatric cancer to conduct an investigation described in subsection (a)(3) of such section 505B;

(E) scientific and regulatory considerations for study designs, including the applicability of innovative clinical trial designs for pediatric cancer drug and biological product developments under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c);

(F) approaches to streamline and improve the amendment process, including when studies contained in a request under such section 505A are not feasible due to the ethical, practical, or other barriers to conducting clinical trials in pediatric cancer populations;

(G) the process for submission of an initial pediatric study plan for the investigation described in section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(3)), including the process for a sponsor to meet and reach agreement with the Secretary on the initial pediatric study plan; and

(H) considerations for implementation of such section 505B, as so amended, and waivers of the requirements of such section 505B with regard to molecular targets for which several drugs or biological products may be under investigation.

(d) Report To Congress.—Section 508(b) of the Food and Drug Administration Safety and Innovation Act (21 U.S.C. 355c–1(b)) is amended—

(1) in paragraph (10), by striking “; and” and inserting “;”; and

(2) by striking paragraph (11) and inserting the following:

“(11) an assessment of the impact of the amendments to such section 505B made by the FDA Reauthorization Act of 2017 on pediatric research and labeling of drugs and biological products and pediatric labeling of molecularly targeted drugs and biological products for the treatment of cancer;

“(12) an assessment of the efforts of the Secretary to implement the plan developed under section 505C–1 of the Federal Food, Drug, and Cosmetic Act, regarding earlier submission of pediatric studies under sections 505A and 505B of such Act and section 351(m) of the Public Health Service Act, including—

“(A) the average length of time after the approval of an application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) before studies conducted pursuant to such section 505A, 505B, or section 351(m) are completed, submitted, and incorporated into labeling;

“(B) the average length of time after the receipt of a proposed pediatric study request before the Secretary responds to such request;

“(C) the average length of time after the submission of a proposed pediatric study request before the Secretary issues a written request for such studies;

“(D) the number of written requests issued for each investigational new drug or biological product prior to the submission of an application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act or section 351(a) of the Public Health Service Act; and

“(E) the average number, and range of numbers, of amendments to written requests issued, and the time the Secretary requires to review and act on proposed amendments to written requests;

“(13) a list of sponsors of applications or holders of approved applications who received exclusivity under such section 505A or such section 351(m) after receiving a letter issued under such section 505B(d)(1) for any drug or biological product before the studies referred to in such letter were completed and submitted;

“(14) a list of assessments and investigations required under such section 505B;

“(15) how many requests under such section 505A for molecular targeted cancer drugs, as defined by subsection (a)(1)(B) of such section 505B, approved prior to 3 years after the date of enactment of the FDA Reauthorization Act of 2017, have been issued by the Food and Drug Administration, and how many such requests have been completed; and

“(16) the Secretary’s assessment of the overall impact of the amendments made by section 504 of the FDA Reauthorization Act of 2017 on the conduct and effectiveness of pediatric cancer research and the orphan drug program, as well any subsequent recommendations.”.

(e) Rule Of Construction.—Nothing in this section, including the amendments made by this section, shall limit the authority of the Secretary of Health and Human Services to issue written requests under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) or section 351(m) of the Public Health Service Act (42 U.S.C. 262(m)), or to negotiate or implement amendments to such requests proposed by the an applicant.

(f) GAO Report.—

(1) IN GENERAL.—Beginning on the date that is 5 years after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study of the effectiveness of requiring assessments and investigations described in section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as amended by this section, in the development of drugs and biological products for pediatric cancer indications. The Comptroller General shall examine—

(A) the indications and associated molecular targets studied in assessments and investigations required for drugs or biological products intended for the treatment of an adult cancer;

(B) the indication for which the study was requested as compared to the indication requested under the new drug application filed by the sponsor;

(C) the number of pediatric cancer indications for which assessments and investigations have been required under such section 505B;

(D) the number of requests for deferral and waiver of pediatric assessments and investigations required under such section and the number of such deferral and waiver requests granted and denied;

(E) the number of orphan-designated indications for drugs and biological products for which assessments and investigations were required under such section;

(F) the number of drugs and biological products approved for the treatment of cancer in the pediatric population for which the supportive studies were required to be conducted under such section;

(G) the number of written requests made under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) relating to investigations required under subsection (a)(1)(B) of such section 505B; and

(H) any additional considerations by the Secretary regarding the effectiveness of requiring pediatric assessments described in such section 505B in the development of drugs and biological products for pediatric cancer indications.

(2) REVIEW.—The study under paragraph (1) shall include a review of the Food and Drug Administration’s use of the authority under section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as amended by this section, including the amendments to the deferral and waiver criteria under such section and how such criteria have been applied.

(3) CONSULTATION.—In conducting the study under paragraph (1), the Comptroller General of the United States shall consult with appropriate stakeholders that may be required to conduct the trials under section 505B of the Federal Food, Drug, and Cosmetic Act, and the ability of such stakeholders to adhere to the requests issued by the Food and Drug Administration.

(4) REPORT.—Not later than the date that is 6 years after the date of enactment of this Act, the Comptroller General of the United States shall submit a report containing the results of the study under paragraph (1) to the Secretary of Health and Human Services, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives.

SEC. 505. ADDITIONAL PROVISIONS ON DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR PEDIATRIC USE.

(a) Informing Internal Review Committee.—Section 505A(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(f)) is amended by adding at the end the following:

“(7) INFORMING INTERNAL REVIEW COMMITTEE.—The Secretary shall provide to the committee referred to in paragraph (1) any response issued to an applicant or holder with respect to a proposed pediatric study request.”.

(b) Action On Submissions.—

(1) IN GENERAL.—Section 505A(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(d)) is amended—

(A) by redesignating paragraphs (3) through (5) as paragraphs (4) through (6), respectively; and

(B) by inserting after paragraph (2) the following:

“(3) ACTION ON SUBMISSIONS.—The Secretary shall review and act upon a submission by a sponsor or holder of a proposed pediatric study request or a proposed amendment to a written request for pediatric studies within 120 calendar days of the submission.”.

(2) CONFORMING AMENDMENTS.—

(A) FEDERAL FOOD, DRUG, AND COSMETIC ACT.—Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a), as amended by paragraph (1), is further amended by striking subsection “(d)(3)” each place it appears and inserting “(d)(4)”.

(B) PUBLIC HEALTH SERVICE ACT.—Paragraphs (2), (3), and (4) of section 351(m) of the Public Health Service Act (42 U.S.C. 262(m)) are amended by striking “section 505A(d)(3)” each place it appears and inserting “section 505A(d)(4)”.

(c) Plan.—The Secretary of Health and Human Services, acting through the internal review committee established under section 505C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) shall, not later than one year after the date of enactment of this Act, develop and implement a plan to achieve, when appropriate, earlier submission of pediatric studies under section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) or section 351(m) of the Public Health Service Act (42 U.S.C. 262(m)). Such plan shall include recommendations to achieve—

(1) earlier discussion of proposed pediatric study requests and written requests with sponsors, and if appropriate, discussion of such requests at the meeting required under section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)(2)(C)), as amended by section 503(a);

(2) earlier issuance of written requests for a pediatric study under such section 505A, including for investigational new drugs prior to the submission of an application under section 505(b)(1) of such Act (21 U.S.C. 355(b)(1)); and

(3) shorter timelines, when appropriate, for the completion of studies pursuant to a written request under such section 505A or such section 351(m).

(d) Neonatology Expertise.—

(1) IN GENERAL.—Section 6(d) of the Best Pharmaceuticals for Children Act (21 U.S.C. 393a(d)) is amended by striking “For the 5-year period beginning on the date of enactment of this subsection, at” and inserting “At”.

(2) DRAFT GUIDANCE.—Not later than 2 years after the date of enactment of this Act, the Secretary shall issue draft guidance on clinical pharmacology considerations for neonatal studies for drugs and biological products.

(e) Submission Of Assessments.—Section 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)(1)) is amended by adding at the end the following: “The Secretary shall inform the Pediatric Advisory Committee of letters issued under this paragraph and responses to such letters.”.

(f) Internal Committee.—Section 505C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) is amended by inserting “or pediatric rare diseases” after “psychiatry”.

(g) Report On Labeling Of Orphan Drugs.—

(1) IN GENERAL.—Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and make publicly available, including through posting on the internet website of the Food and Drug Administration, a report on the lack of information in the labeling of drugs for indications that have received an orphan designation under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) with respect to the use of such drugs pediatric populations.

(2) CONTENTS.—The report described in paragraph (1) shall include—

(A) a list of drugs for which—

(i) an indication was granted an orphan designation under section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb);

(ii) an application described under section 505B(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)) for such indication was submitted to the Secretary of Health and Human Services on or after April 1, 1999; and

(iii) the labeling for such indication lacks important pediatric information, including information related to safety, dosing, and effectiveness;

(B) a description of the lack of information referred to in subparagraph (A)(iii) for each drug for an indication on such list; and

(C) Federal policy recommendations to improve the labeling of drugs for indications that have received an orphan designation under such section 526 with respect to the use of such drugs pediatric populations.”

 

TITLE VI—REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

SEC. 601. REAUTHORIZATION OF PROVISION RELATING TO EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.

Section 505(u)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(u)(4)) is amended by striking “2017” and inserting “2022”.

SEC. 602. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

Section 566(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–5(f)) is amended by striking “2013 through 2017” and inserting “2018 through 2022”.

SEC. 603. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.

Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is amended by striking “2013 through 2017” and inserting “2018 through 2022”.

SEC. 604. PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.

(a) Diverted Drugs.—Paragraph (1) of section 801(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is amended—

(1) by striking “(d)(1) Except as” and inserting “(d)(1)(A) Except as”; and

(2) by adding at the end the following:

“(B) Except as authorized by the Secretary in the case of a drug that appears on the drug shortage list under section 506E or in the case of importation pursuant to section 804, no drug that is subject to section 503(b)(1) may be imported into the United States for commercial use if such drug is manufactured outside the United States, unless the manufacturer has authorized the drug to be marketed in the United States and has caused the drug to be labeled to be marketed in the United States.”.

(b) Counterfeit Drugs.—Subsection (b) of section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following:

“(8) Notwithstanding subsection (a), any person who violates section 301(i)(3) by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit drug shall be imprisoned for not more than 10 years or fined in accordance with title 18, United States Code, or both.”.

SEC. 605. PATIENT EXPERIENCE DATA.

Section 569C(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–8c(c)(2)(A)) is amended by striking “impact of such disease or condition, or a related therapy,” and inserting “impact (including physical and psychosocial impacts) of such disease or condition, or a related therapy or clinical investigation”.

SEC. 606. COMMUNICATION PLANS.

Section 505–1(e)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355–1(e)(3)) is amended—

(1) in subparagraph (B), by striking “; or”;

(2) in subparagraph (C), by striking the period and inserting “; or”; and

(3) by adding at the end the following:

“(D) disseminating information to health care providers about drug formulations or properties, including information about the limitations or patient care implications of such formulations or properties, and how such formulations or properties may be related to serious adverse drug events associated with use of the drug.”.

SEC. 607. ORPHAN DRUGS.

(a) In General.—Section 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended—

(1) in subsection (a), in the matter following paragraph (2), by striking “such drug for such disease or condition” and inserting “the same drug for the same disease or condition”;

(2) in subsection (b)—

(A) in the matter preceding paragraph (1), by striking “If an application” and all that follows through “such license if” and inserting “During the 7-year period described in subsection (a) for an approved application under section 505 or license under section 351 of the Public Health Service Act, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if”;

(B) in paragraph (1), by striking “notice” and all that follows through “assure” and inserting “of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure”; and

(C) in paragraph (2), by striking “such holder provides” and inserting “the holder provides”; and

(3) by adding at the end the following:

“(c) Condition Of Clinical Superiority.—

“(1) IN GENERAL.—If a sponsor of a drug that is designated under section 526 and is otherwise the same, as determined by the Secretary, as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection (a) for the same rare disease or condition as the already approved drug, the Secretary shall require such sponsor, as a condition of such exclusive approval or licensure, to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug.

“(2) DEFINITION.—For purposes of paragraph (1), the term ‘clinically superior’ with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care.

“(d) Regulations.—The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on the date of enactment of the FDA Reauthorization Act of 2017, until such time as the Secretary promulgates regulations in accordance with this subsection, the Secretary may apply any definitions set forth in regulations that were promulgated prior to such date of enactment, to the extent such definitions are not inconsistent with the terms of this section, as amended by such Act.

“(e) Demonstration Of Clinical Superiority Standard.—To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary—

“(1) upon the designation of any drug under section 526, shall notify the sponsor of such drug in writing of the basis for the designation, including, as applicable, any plausible hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously approved drug; and

“(2) upon granting exclusive approval or licensure under subsection (a) on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary of the clinical superiority findings.”.

(b) Rule Of Construction.—Nothing in the amendments made by subsection (a) shall affect any determination under sections 526 and 527 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb, 360cc) made prior to the date of enactment of the FDA Reauthorization Act of 2017.

SEC. 608. PEDIATRIC INFORMATION ADDED TO LABELING.

Section 505A(o) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(o)) is amended—

(1) in the subsection heading, by striking “UNDER SECTION 505(J)”;

(2) in paragraph (1)—

(A) by striking “under section 505(j)” and inserting “under subsection (b)(2) or (j) of section 505”; and

(B) by striking “or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(F)” and inserting “, or by exclusivity under clause (iii) or (iv) of section 505(j)(5)(F), clause (iii) or (iv) of section 505(c)(3)(E), or section 527(a), or by an extension of such exclusivity under this section or section 505E”;

(3) in paragraph (2), in the matter preceding subparagraph (A)—

(A) by inserting “clauses (iii) and (iv) of section 505(c)(3)(E), or section 527,” after “section 505(j)(5)(F),”; and

(B) by striking “drug approved under section 505(j)” and inserting “drug approved pursuant to an application submitted under subsection (b)(2) or (j) of section 505”; and

(4) by amending paragraph (3) to read as follows:

“(3) PRESERVATION OF PEDIATRIC EXCLUSIVITY AND EXTENSIONS.—This subsection does not affect—

“(A) the availability or scope of exclusivity under—

“(i) this section;

“(ii) section 505 for pediatric formulations; or

“(iii) section 527;

“(B) the availability or scope of an extension to any such exclusivity, including an extension under this section or section 505E;

“(C) the question of the eligibility for approval under section 505 of any application described in subsection (b)(2) or (j) of such section that omits any other aspect of labeling protected by exclusivity under—

“(i) clause (iii) or (iv) of section 505(j)(5)(F);

“(ii) clause (iii) or (iv) of section 505(c)(3)(E); or

“(iii) section 527(a); or

“(D) except as expressly provided in paragraphs (1) and (2), the operation of section 505 or section 527.”.

SEC. 609. SENSE OF CONGRESS ON LOWERING THE COST OF PRESCRIPTION DRUGS.

It is the sense of the Congress that the Secretary of Health and Human Services should commit to engaging with the House of Representatives and the Senate to take administrative actions and enact legislative changes that—

(1) will lower the cost of prescription drugs for consumers and reduce the burden of such cost on taxpayers; and

(2) in lowering such cost, will—

(A) balance the need to encourage innovation with the need to improve affordability; and

(B) strive to increase competition in the pharmaceutical market, prevent anticompetitive behavior, and promote the timely availability of affordable, high-quality generic drugs and biosimilars.

SEC. 610. EXPANDED ACCESS.

(a) Patient Access To Investigational Drugs.—

(1) PUBLIC MEETING.—

(A) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”), acting through the Commissioner of Food and Drugs, in coordination with the Director of the National Institutes of Health, and in consultation with patients, health care providers, drug sponsors, bioethicists, and other stakeholders, shall, not later than 270 days after the date of enactment of this Act, convene a public meeting to discuss clinical trial inclusion and exclusion criteria to inform the guidance under paragraph (3). The Secretary shall inform the Comptroller General of the United States of the date when the public meeting will take place.

(B) TOPICS.—The Secretary shall make available on the internet website of the Food and Drug Administration a report on the topics discussed at the meeting described in subparagraph (A) within 90 days of such meeting. Such topics shall include discussion of—

(i) the rationale for, and potential barriers for patients created by, research clinical trial inclusion and exclusion criteria;

(ii) how appropriate patient populations can benefit from the results of trials that employ alternative designs;

(iii) barriers to participation in clinical trials, including—

(I) information regarding any potential risks and benefits of participation;

(II) regulatory, geographical, and socioeconomic barriers; and

(III) the impact of exclusion criteria on the enrollment in clinical trials of particular populations, including infants and children, pregnant and lactating women, seniors, individuals with advanced disease, and individuals with co-morbid conditions;

(iv) clinical trial designs and methods, including expanded access trials, that increase enrollment of more diverse patient populations, when appropriate, while facilitating the collection of data to establish safe use and support substantial evidence of effectiveness, including data obtained from expanded access trials; and

(v) how changes to clinical trial inclusion and exclusion criteria may impact the complexity and length of clinical trials, the data necessary to demonstrate safety and effectiveness, and potential approaches to mitigating those impacts.

(2) REPORT.—Not later than 1 year after the Secretary issues the report under paragraph (1)(B), the Comptroller General of the United States shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives on individual access to investigational drugs through the expanded access program under section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). The report shall include—

(A) a description of actions taken by manufacturers and distributors under section 561A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–0);

(B) consideration of whether Form FDA 3926 and the guidance documents titled “Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers” and “Individual Patient Expanded Access Applications: Form FDA 3926”, issued by the Food and Drug Administration in June 2016, have reduced application burden with respect to individuals and physicians seeking access to investigational new drugs pursuant to section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) and improved clarity for patients, physicians, and drug manufacturers about such process;

(C) consideration of whether the guidance or regulations issued to implement section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) have improved access for individual patients to investigational drugs who do not qualify for clinical trials of such investigational drugs, and what barriers to such access remain;

(D) an assessment of methods patients and health care providers use to engage with the Food and Drug Administration or drug sponsors on expanded access; and

(E) an analysis of the Secretary's report under paragraph (1)(B).

(3) GUIDANCE.—

(A) IN GENERAL.—Not later than 1 year after the publication of the report under paragraph (1)(B), the Secretary, acting through the Commissioner of Food and Drugs, shall issue one or more draft guidances regarding eligibility criteria for clinical trials. Not later than 1 year after the public comment period on each such draft guidance ends, the Secretary shall issue a revised draft guidance or final guidance.

(B) CONTENTS.—The guidance documents described in subparagraph (A) shall address methodological approaches that a manufacturer or sponsor of an investigation of a new drug may take to—

(i) broaden eligibility criteria for clinical trials and expanded access trials, especially with respect to drugs for the treatment of serious and life-threatening conditions or diseases for which there is an unmet medical need;

(ii) develop eligibility criteria for, and increase trial recruitment to, clinical trials so that enrollment in such trials more accurately reflects the patients most likely to receive the drug, as applicable and as appropriate, while establishing safe use and supporting findings of substantial evidence of effectiveness; and

(iii) use the criteria described in clauses (i) and (ii) in a manner that is appropriate for drugs intended for the treatment of rare diseases or conditions.

(b) Improving Institutional Review Board Review Of Single Patient Expanded Access Protocol.—Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue guidance or regulations, or revise existing guidance or regulations, to streamline the institutional review board review of individual patient expanded access protocols submitted under 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)). To facilitate the use of expanded access protocols, any guidance or regulations so issued or revised may include a description of the process for any person acting through a physician licensed in accordance with State law to request that an institutional review board chair (or designated member of the institutional review board) review a single patient expanded access protocol submitted under such section 561(b) for a drug. The Secretary shall update any relevant forms associated with individual patient expanded access requests under such section 561(b) as necessary.

(c) Expanded Access Policy Transparency.—Section 561A(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–0(f)) is amended—

(1) in the matter preceding paragraph (1), by striking “later” and inserting “earlier”;

(2) by striking paragraph (1);

(3) by redesignating paragraph (2) as paragraph (1);

(4) in paragraph (1) as so redesignated, by striking the period at the end and inserting “; or”; and

(5) by adding at the end the following:

“(2) as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast track product, or regenerative advanced therapy under subsection (a), (b), or (g), respectively, of section 506.”.

SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION.

(a) In General.—Subparagraph (A) of section 524(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is amended—

(1) in clause (i), by striking “and” at the end; and

(2) by adding at the end the following:

“(iii) that contains reports of one or more new clinical investigations (other than bioavailability studies) that are essential to the approval of the application and conducted or sponsored by the sponsor of such application; and

“(iv) that contains an attestation from the sponsor of the application that such reports were not submitted as part of an application for marketing approval or licensure by a regulatory authority in India, Brazil, Thailand, or any country that is a member of the Pharmaceutical Inspection Convention or the Pharmaceutical Inspection Cooperation Scheme prior to September 27, 2007.”.

(b) Effective Date.—The amendments made by subsection (a) shall apply to human drug applications submitted after September 30, 2017.

 

TITLE VII—DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES.

(a) In General.—Section 510(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)) is amended—

(1) by striking paragraph (2) and inserting the following:

“(2) RISK-BASED SCHEDULE FOR DEVICES.—

“(A) IN GENERAL.—The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph (1) that are engaged in the manufacture, propagation, compounding, or processing of a device or devices (referred to in this subsection as ‘device establishments’) in accordance with a risk-based schedule established by the Secretary.

“(B) FACTORS AND CONSIDERATIONS.—In establishing the risk-based schedule under subparagraph (A), the Secretary shall—

“(i) apply, to the extent applicable for device establishments, the factors identified in paragraph (4); and

“(ii) consider the participation of the device establishment, as applicable, in international device audit programs in which the United States participates or the United States recognizes for purposes of inspecting device establishments.”; and

(2) in paragraph (4)—

(A) in the matter preceding subparagraph (A), by striking “paragraph (3)” and inserting “paragraph (2) or (3)”; and

(B) in subparagraph (C), by inserting “or device” after “drug”.

(b) Foreign Inspections.—Section 809(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended by striking “section 510(h)(3)” and inserting “paragraph (2) or (3) of section 510(h)”.

SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE ESTABLISHMENTS.

(a) In General.—Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the following:

“(h) (1) In the case of inspections other than for-cause inspections, the Secretary shall review processes and standards applicable to inspections of domestic and foreign device establishments in effect as of the date of the enactment of this subsection, and update such processes and standards through the adoption of uniform processes and standards applicable to such inspections. Such uniform processes and standards shall provide for—

“(A) exceptions to such processes and standards, as appropriate;

“(B) announcing the inspection of the establishment within a reasonable time before such inspection occurs, including by providing to the owner, operator, or agent in charge of the establishment a notification regarding the type and nature of the inspection;

“(C) a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the officers or employees carrying out the inspection under subsection (a)(1) and the owner, operator, or agent in charge of the establishment concerning appropriate working hours during the inspection, and, to the extent feasible, advance notice of some records that will be requested; and

“(D) regular communications during the inspection with the owner, operator, or agent in charge of the establishment regarding inspection status, which may be recorded by either party with advance notice and mutual consent.

“(2) (A) The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request.

“(B) A request described in this subparagraph is a request for feedback—

“(i) that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and

“(ii) with respect to actions proposed to be taken by a device establishment in a response to a report received by such establishment pursuant to subsection (b) that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues (as determined by the Secretary).

“(3) Nothing in this subsection affects the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act.”.

(b) Guidance.—

(1) DRAFT GUIDANCE.—Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance that—

(A) specifies how the Food and Drug Administration will implement the processes and standards described in paragraph (1) of subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a), and the requirements described in paragraph (2) of such subsection (h);

(B) provides for standardized methods for communications described in such paragraphs;

(C) establishes, with respect to inspections of both domestic and foreign device establishments (as referred to in section 510(h)(2) of the Federal Food, Drug, and Cosmetic Act, as amended by subsection (a)), a standard timeframe for such inspections—

(i) that occurs over consecutive days; and

(ii) to which each investigator conducting such an inspection shall adhere unless the investigator identifies to the establishment involved a reason that more time is needed to conduct such investigation; and

(D) identifies practices for investigators and device establishments to facilitate the continuity of inspections of such establishments.

(2) FINAL GUIDANCE.—Not later than 1 year after providing notice and opportunity for public comment on the draft guidance issued under paragraph (1), the Secretary of Health and Human Services shall issue final guidance to implement subsection (h) of section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added by subsection (a).

(c) Adulterated Devices.—Subsection (j) of section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by inserting “or device” after “drug”.

SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM.

Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by striking “October 1, 2017” and inserting “October 1, 2022”.

SEC. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.

Subsection (e)(4) of section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is amended—

(1) by adding at the end the following:

“(E) (i) (I) If the Secretary denies a request for certification under subparagraph (A)(ii) with respect to a device manufactured in an establishment (foreign or domestic) registered under section 510, the Secretary shall provide in writing to the person seeking such certification the basis for such denial, and specifically identify the finding upon which such denial is based.

“(II) If the denial of a request as described in subclause (I) is based on grounds other than an injunction proceeding pursuant to section 302, seizure action pursuant to section 304, or a recall designated Class I or Class II pursuant to part 7, title 21, Code of Federal Regulations, and is based on the facility being out of compliance with part 820 of title 21, Code of Federal Regulations, the Secretary shall provide a substantive summary of the specific grounds for noncompliance identified by the Secretary.

“(III) With respect to a device manufactured in an establishment that has received a report under section 704(b), the Secretary shall not deny a request for certification as described in subclause (I) with respect to a device based solely on the issuance of that report if the owner, operator, or agent in charge of such establishment has agreed to a plan of correction in response to such report.

“(ii) (I) The Secretary shall provide a process for a person who is denied a certification as described in clause (i)(I) to request a review that conforms to the standards of section 517A(b).

“(II) Notwithstanding any previous review conducted pursuant to subclause (I), a person who has been denied a certification as described in clause (i)(I) may at any time request a review in order to present new information relating to actions taken by such person to address the reasons identified by the Secretary for the denial of certification, including evidence that corrective actions are being or have been implemented to address grounds for noncompliance identified by the Secretary.

“(III) Not later than 1 year after the date of enactment of the FDA Reauthorization Act of 2017, the Secretary shall issue guidance providing for a process to carry out this subparagraph. Not later than 1 year after the close of the comment period for such guidance, the Secretary shall issue final guidance.

“(iii) (I) Subject to subclause (II), this subparagraph applies to requests for certification on behalf of any device establishment registered under section 510, whether the establishment is located inside or outside of the United States, and regardless of whether such devices are to be exported from the United States.

“(II) If an establishment described in subclause (I) is not located within the United States and does not demonstrate that the devices manufactured, prepared, propagated, compounded, or processed at such establishment are to be exported from the United States, this subparagraph shall apply only if—

“(aa) the establishment has been inspected by the Secretary within 3 years of the date of the request; or

“(bb) the establishment participates in an audit program in which the United States participates or the United States recognizes, an audit under such program has been conducted, and the findings of such audit are provided to the Secretary within 3 years of the date of the request.”; and

(2) by moving the margins of subparagraphs (C) and (D) 4 ems to the left.

SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION.

Section 704(g) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the following:

“(15) (A) Notwithstanding any other provision of this subsection, the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization for purposes of conducting inspections of—

“(i) establishments that manufacture, prepare, propagate, compound, or process devices (other than types of devices licensed under section 351 of the Public Health Service Act), as required under section 510(h); or

“(ii) establishments required to register pursuant to section 510(i).

“(B) Nothing in this paragraph affects—

“(i) the authority of the Secretary to inspect any device establishment pursuant to this Act; or

“(ii) the authority of the Secretary to determine the official classification of an inspection.”.

SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING.

(a) Approval Of Applications For Certain Diagnostic Medical Imaging Devices.—Section 520 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 360j) is amended by adding at the end the following:

“(p) Diagnostic Imaging Devices Intended For Use With Contrast Agents.—

“(1) IN GENERAL.—The Secretary may, subject to the succeeding provisions of this subsection, approve an application (or a supplement to such an application) submitted under section 515 with respect to an applicable medical imaging device, or, in the case of an applicable medical imaging device for which a notification is submitted under section 510(k), may make a substantial equivalence determination with respect to an applicable medical imaging device, or may grant a request submitted under section 513(f)(2) for an applicable medical imaging device, if such application, notification, or request involves the use of a contrast agent that is not—

“(A) in a concentration, rate of administration, or route of administration that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in concentration, rate of administration, or route of administration exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device;

“(B) in a region, organ, or system of the body that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in region, organ, or system of the body exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device;

“(C) in a patient population that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines such differences in patient population exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device; or

“(D) in an imaging modality that is different from those described in the approved labeling of the contrast agent.

“(2) PREMARKET REVIEW.—The agency center charged with premarket review of devices shall have primary jurisdiction with respect to the review of an application, notification, or request described in paragraph (1). In conducting such review, such agency center may—

“(A) consult with the agency center charged with the premarket review of drugs or biological products; and

“(B) review information and data provided to the Secretary by the sponsor of a contrast agent in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, so long as the sponsor of such contrast agent has provided to the sponsor of the applicable medical imaging device that is the subject of such review a right of reference and the application is submitted in accordance with this subsection.

“(3) APPLICABLE REQUIREMENTS.—An application submitted under section 515, a notification submitted under section 510(k), or a request submitted under section 513(f)(2), as described in paragraph (1), with respect to an applicable medical imaging device shall be subject to the requirements of such respective section. Such application, notification, or request shall only be subject to the requirements of this Act applicable to devices.

“(4) DEFINITIONS.—For purposes of this subsection—

“(A) the term ‘applicable medical imaging device’ means a device intended to be used in conjunction with a contrast agent (or class of contrast agents) for an imaging use that is not described in the approved labeling of such contrast agent (or the approved labeling of any contrast agent in the same class as such contrast agent); and

“(B) the term ‘contrast agent’ means a drug that is approved under section 505 or licensed under section 351 of the Public Health Service Act, is intended for use in conjunction with an applicable medical imaging device, and—

“(i) is a diagnostic radiopharmaceutical, as defined in section 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or

“(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.”.

(b) Applications For Approval Of Contrast Agents Intended For Use With Certain Diagnostic Medical Imaging Devices.—Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:

“(y) Contrast Agents Intended For Use With Applicable Medical Imaging Devices.—

“(1) IN GENERAL.—The sponsor of a contrast agent for which an application has been approved under this section may submit a supplement to the application seeking approval for a new use following the authorization of a premarket submission for an applicable medical imaging device for that use with the contrast agent pursuant to section 520(p)(1).

“(2) REVIEW OF SUPPLEMENT.—In reviewing a supplement submitted under this subsection, the agency center charged with the premarket review of drugs may—

“(A) consult with the center charged with the premarket review of devices; and

“(B) review information and data submitted to the Secretary by the sponsor of an applicable medical imaging device pursuant to section 515, 510(k), or 513(f)(2) so long as the sponsor of such applicable medical imaging device has provided to the sponsor of the contrast agent a right of reference.

“(3) DEFINITIONS.—For purposes of this subsection—

“(A) the term ‘new use’ means a use of a contrast agent that is described in the approved labeling of an applicable medical imaging device described in section 520(p), but that is not described in the approved labeling of the contrast agent; and

“(B) the terms ‘applicable medical imaging device’ and ‘contrast agent’ have the meanings given such terms in section 520(p).”.

SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES.

(a) In General.—Subsection (f) of section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end the following new paragraph:

“(6) (A) Subject to the succeeding subparagraphs of this paragraph, the Secretary shall, by written order, classify an accessory under this section based on the risks of the accessory when used as intended and the level of regulatory controls necessary to provide a reasonable assurance of safety and effectiveness of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used.

“(B) The classification of any accessory distinct from another device by regulation or written order issued prior to December 13, 2016, shall continue to apply unless and until the accessory is reclassified by the Secretary, notwithstanding the classification of any other device with which such accessory is intended to be used. Nothing in this paragraph shall preclude the Secretary’s authority to initiate the classification of an accessory through regulation or written order, as appropriate.

“(C) (i) In the case of a device intended to be used with an accessory, where the accessory has been included in an application for premarket approval of such device under section 515 or a report under section 510(k) for clearance of such device and the Secretary has not classified such accessory distinctly from another device in accordance with subparagraph (A), the person filing the application or report (as applicable) at the time such application or report is filed—

“(I) may include a written request for the proper classification of the accessory pursuant to subparagraph (A);

“(II) shall include in any such request such information as may be necessary for the Secretary to evaluate, based on the least burdensome approach, the appropriate class for the accessory under subsection (a); and

“(III) shall, if the request under subclause (I) is requesting classification of the accessory in class II, include in the application an initial draft proposal for special controls, if special controls would be required pursuant to subsection (a)(1)(B).

“(ii) The Secretary’s response under section 515(d) or section 510(n) (as applicable) to an application or report described in clause (i) shall also contain the Secretary’s granting or denial of the request for classification of the accessory involved.

“(iii) The Secretary’s evaluation of an accessory under clause (i) shall constitute an order establishing a new classification for such accessory for the specified intended use or uses of such accessory and for any accessory with the same intended use or uses as such accessory.

“(D) For accessories that have been granted marketing authorization as part of a submission for another device with which the accessory involved is intended to be used, through an application for such other device under section 515(c), a report under section 510(k), or a request for classification under paragraph (2) of this subsection, the following shall apply:

“(i) Not later than the date that is one year after the date of enactment of the FDA Reauthorization Act of 2017 and at least once every 5 years thereafter, and as the Secretary otherwise determines appropriate, pursuant to this paragraph, the Secretary shall publish in the Federal Register a notice proposing a list of such accessories that the Secretary determines may be suitable for a distinct classification in class I and the proposed regulations for such classifications. In developing such list, the Secretary shall consider recommendations from sponsors of device submissions and other stakeholders for accessories to be included on such list. The notices shall provide for a period of not less than 60 calendar days for public comment. Within 180 days after the end of the comment period, the Secretary shall publish in the Federal Register a final action classifying such suitable accessories into class I.

“(ii) A manufacturer or importer of an accessory that has been granted such marketing authorization may submit to the Secretary a written request for the appropriate classification of the accessory based on the risks and appropriate level of regulatory controls as described in subparagraph (A), and shall, if the request is requesting classification of the accessory in class II, include in the submission an initial draft proposal for special controls, if special controls would be required pursuant to subsection (a)(1)(B). Such request shall include such information as may be necessary for the Secretary to evaluate, based on the least burdensome approach, the appropriate class for the accessory under subsection (a). The Secretary shall provide an opportunity for a manufacturer or importer to meet with appropriate personnel of the Food and Drug Administration to discuss the appropriate classification of such accessory prior to submitting a written request under this clause for classification of the accessory.

“(iii) The Secretary shall respond to a request made under clause (ii) not later than 85 calendar days after receiving such request by issuing a written order classifying the accessory or denying the request. If the Secretary does not agree with the recommendation for classification submitted by the manufacturer or importer, the response shall include a detailed description and justification for such determination. Within 30 calendar days after granting such a request, the Secretary shall publish a notice in the Federal Register announcing such response.

“(E) Nothing in this paragraph may be construed as precluding a manufacturer of an accessory of a new type from using the classification process described in subsection (f)(2) to obtain classification of such accessory in accordance with the criteria and requirements set forth in that subsection.”.

(b) Conforming Change.—Section 513(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by striking paragraph (9) (relating to classification of an accessory).

(c) Effective Date.—The amendments made by subsections (a) and (b) shall take effect on the date that is 60 days after the date of enactment of this Act.

SEC. 708. DEVICE PILOT PROJECTS.

(a) Postmarket Pilot.—Section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended by adding at the end the following:

“(i) Postmarket Pilot.—

“(1) IN GENERAL.—In order to provide timely and reliable information on the safety and effectiveness of devices approved under section 515, cleared under section 510(k), or classified under section 513(f)(2), including responses to adverse events and malfunctions, and to advance the objectives of part 803 of title 21, Code of Federal Regulations (or successor regulations), and advance the objectives of, and evaluate innovative new methods of compliance with, this section and section 522, the Secretary shall, within one year of the date of enactment of the FDA Reauthorization Act of 2017, initiate one or more pilot projects for voluntary participation by a manufacturer or manufacturers of a device or device type, or continue existing projects, in accordance with paragraph (3), that—

“(A) are designed to efficiently generate reliable and timely safety and active surveillance data for use by the Secretary or manufacturers of the devices that are involved in the pilot project;

“(B) inform the development of methods, systems, data criteria, and programs that could be used to support safety and active surveillance activities for devices included or not included in such project;

“(C) may be designed and conducted in coordination with a comprehensive system for evaluating medical device technology that operates under a governing board with appropriate representation of stakeholders, including patient groups and device manufacturers;

“(D) use electronic health data including claims data, patient survey data, or any other data, as the Secretary determines appropriate; and

“(E) prioritize devices and device types that meet one or more of the following criteria:

“(i) Devices and device types for which the collection and analysis of real world evidence regarding a device's safety and effectiveness is likely to advance public health.

“(ii) Devices and device types that are widely used.

“(iii) Devices and device types, the failure of which has significant health consequences.

“(iv) Devices and device types for which the Secretary—

“(I) has received public recommendations in accordance with paragraph (2)(B); and

“(II) has determined to meet one or more of the criteria under clause (i), (ii), or (iii) and is appropriate for such a pilot project.

“(2) PARTICIPATION.—The Secretary shall establish the conditions and processes—

“(A) under which a manufacturer of a device may voluntarily participate in a pilot project described in paragraph (1); and

“(B) for facilitating public recommendations for devices to be prioritized under such a pilot project, including requirements for the data necessary to support such a recommendation.

“(3) CONTINUATION OF ONGOING PROJECTS.—The Secretary may continue or expand projects, with respect to providing timely and reliable information on the safety and effectiveness of devices approved under section 515, cleared under section 510(k), or classified under section 513(f)(2), that are being carried out as of the date of the enactment of the FDA Reauthorization Act of 2017. The Secretary shall, beginning on such date of enactment, take such steps as may be necessary—

“(A) to ensure such projects meet the requirements of subparagraphs (A) through (E) of paragraph (1); and

“(B) to increase the voluntary participation in such projects of manufacturers of devices and facilitate public recommendations for any devices prioritized under such a project.

“(4) IMPLEMENTATION.—

“(A) CONTRACTING AUTHORITY.—The Secretary may carry out a pilot project meeting the criteria specified in subparagraphs (A) through (E) of paragraph (1) or a project continued or expanded under paragraph (3) by entering into contracts, cooperative agreements, grants, or other appropriate agreements with public or private entities that have a significant presence in the United States and meet the following conditions:

“(i) If such an entity is a component of another organization, the entity and the organization have established an agreement under which appropriate security measures are implemented to maintain the confidentiality and privacy of the data described in paragraph (1)(D) and such agreement ensures that the entity will not make an unauthorized disclosure of such data to the other components of the organization in breach of requirements with respect to confidentiality and privacy of such data established under such security measures.

“(ii) In the case of the termination or nonrenewal of such a contract, cooperative agreement, grant, or other appropriate agreement, the entity or entities involved shall comply with each of the following:

“(I) The entity or entities shall continue to comply with the requirements with respect to confidentiality and privacy referred to in clause (i) with respect to all data disclosed to the entity under such an agreement.

“(II) The entity or entities shall return any data disclosed to such entity pursuant to this subsection and to which it would not otherwise have access or, if returning such data is not practicable, destroy the data.

“(iii) The entity or entities shall have one or more qualifications with respect to—

“(I) research, statistical, epidemiologic, or clinical capability and expertise to conduct and complete the activities under this subsection, including the capability and expertise to provide the Secretary access to de-identified data consistent with the requirements of this subsection;

“(II) an information technology infrastructure to support electronic data and operational standards to provide security for such data, as appropriate;

“(III) experience with, and expertise on, the development of research on, and surveillance of, device safety and effectiveness using electronic health data; or

“(IV) such other expertise which the Secretary determines necessary to carry out such a project.

“(B) REVIEW OF CONTRACT IN THE EVENT OF A MERGER OR ACQUISITION.—The Secretary shall review any contract, cooperative agreement, grant, or other appropriate agreement entered into under this paragraph with an entity meeting the conditions specified in subparagraph (A) in the event of a merger or acquisition of the entity in order to ensure that the requirements specified in this subsection will continue to be met.

“(5) COMPLIANCE WITH REQUIREMENTS FOR RECORDS OR REPORTS ON DEVICES.—The participation of a manufacturer in pilot projects under this subsection or a project continued or expanded under paragraph (3) shall not affect the eligibility of such manufacturer to participate in any quarterly reporting program with respect to devices carried out under this section 519 or section 522. The Secretary may determine that, for a specified time period to be determined by the Secretary, a manufacturer’s participation in a pilot project under this subsection or a project continued or expanded under paragraph (3) may meet the applicable requirements of this section or section 522, if—

“(A) the project has demonstrated success in capturing relevant adverse event information; and

“(B) the Secretary has established procedures for making adverse event and safety information collected from such project public, to the extent possible.

“(6) PRIVACY REQUIREMENTS.—With respect to the disclosure of any health information collected through a project conducted under this subsection—

“(A) individually identifiable health information so collected shall not be disclosed when presenting any information from such project; and

“(B) any such disclosure shall be made in compliance with regulations issued pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note) and sections 552 and 552a of title 5, United States Code.

“(7) LIMITATIONS.—No pilot project under this subsection, or in coordination with the comprehensive system described in paragraph (1)(C), may allow for an entity participating in such project, other than the Secretary, to make determinations of safety or effectiveness, or substantial equivalence, for purposes of this Act.

“(8) OTHER PROJECTS REQUIRED TO COMPLY.—Paragraphs (1)(B), (4)(A)(i), (4)(A)(ii), (5), (6), and (7) shall apply with respect to any pilot project undertaken in coordination with the comprehensive system described in paragraph (1)(C) that relates to the use of real world evidence for devices in the same manner and to the same extent as such paragraphs apply with respect to pilot projects conducted under this subsection.

“(9) REPORT TO CONGRESS.—Not later than 18 months after the date of enactment of this Act, and annually thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report containing a description of the pilot projects being conducted under this subsection and projects continued or expanded pursuant to paragraph (3), including for each such project—

“(A) how the project is being implemented in accordance with paragraph (4), including how such project is being implemented through a contract, cooperative agreement, grant, or other appropriate agreement, if applicable;

“(B) the number of manufacturers that have agreed to participate in such project;

“(C) the data sources used to conduct such project;

“(D) the devices or device categories involved in such project;

“(E) the number of patients involved in such project; and

“(F) the findings of the project in relation to device safety, including adverse events, malfunctions, and other safety information.

“(10) SUNSET.—The Secretary may not carry out a pilot project initiated by the Secretary under this subsection after October 1, 2022.”.

(b) Report.—Not later than January 31, 2021, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall conduct a review through an independent third party to evaluate the strengths, limitations, and appropriate use of evidence collected pursuant to real world evidence pilot projects described in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 and subsection (i) of section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i), as amended by subsection (a), for informing premarket and postmarket decisionmaking for multiple device types, and to determine whether the methods, systems, and programs in such pilot projects efficiently generate reliable and timely evidence about the effectiveness or safety surveillance of devices.

SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING AIDS.

(a) In General.—Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as amended by section 708, is further amended by adding at the end the following:

“(q) Regulation Of Over-The-Counter Hearing Aids.—

“(1) DEFINITION.—

“(A) IN GENERAL.—In this subsection, the term ‘over-the-counter hearing aid’ means a device that—

“(i) uses the same fundamental scientific technology as air conduction hearing aids (as defined in section 874.3300 of title 21, Code of Federal Regulations) (or any successor regulation) or wireless air conduction hearing aids (as defined in section 874.3305 of title 21, Code of Federal Regulations) (or any successor regulation);

“(ii) is intended to be used by adults age 18 and older to compensate for perceived mild to moderate hearing impairment;

“(iii) through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customize it to the user’s hearing needs;

“(iv) may—

“(I) use wireless technology; or

“(II) include tests for self-assessment of hearing loss; and

“(v) is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.

“(B) EXCEPTION.—Such term does not include a personal sound amplification product intended to amplify sound for nonhearing impaired consumers in situations including hunting and bird-watching.

“(2) REGULATION.—An over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section 709(b) of the FDA Reauthorization Act of 2017 and shall be exempt from sections 801.420 and 801.421 of title 21, Code of Federal Regulations (or any successor regulations).”.

(b) Regulations To Establish Category.—

(1) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the “Secretary”), not later than 3 years after the date of enactment of this Act, shall promulgate proposed regulations to establish a category of over-the-counter hearing aids, as defined in subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) as amended by subsection (a), and, not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.

(2) REQUIREMENTS.—In promulgating the regulations under paragraph (1), the Secretary shall—

(A) include requirements that provide reasonable assurances of the safety and effectiveness of over-the-counter hearing aids;

(B) include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids;

(C) include requirements for appropriate labeling of over-the-counter hearing aids, including requirements that such labeling include a conspicuous statement that the device is only intended for adults age 18 and older, information on how consumers may report adverse events, information on any contraindications, conditions, or symptoms of medically treatable causes of hearing loss, and advisements to consult promptly with a licensed health care practitioner; and

(D) describe the requirements under which the sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.

(3) PREMARKET NOTIFICATION.—The Secretary shall make findings under section 510(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as amended by subsection (a)) require a report under section 510(k) to provide reasonable assurance of safety and effectiveness.

(4) EFFECT ON STATE LAW.—No State or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids (as defined in section 520(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as amended by subsection (a)) through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids.

(5) NO EFFECT ON PRIVATE REMEDIES.—Nothing in this section shall be construed to modify or otherwise affect the ability of any person to exercise a private right of action under any State or Federal product liability, tort, warranty, contract, or consumer protection law.

(c) New Guidance Issued.—Not later than the date on which final regulations are issued under subsection (b), the Secretary shall update and finalize the draft guidance of the Department of Health and Human Services entitled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products”, issued on November 7, 2013. Such updated and finalized guidance shall clarify which products, on the basis of claims or other marketing, advertising, or labeling material, meet the definition of a device in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and which products meet the definition of a personal sound amplification product, as set forth in such guidance.

(d) Report.—Not later than 2 years after the date on which the final regulations described in subsection (b)(1) are issued, the Secretary of Health and Human Services shall submit to Congress a report analyzing any adverse events relating to over-the-counter hearing aids (as defined in subsection (q)(1) of section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j)).

SEC. 710. REPORT ON SERVICING OF DEVICES.

(a) In General.—Not later than 270 days after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall post on the internet website of the Food and Drug Administration a report on the continued quality, safety, and effectiveness of devices (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) with respect to servicing (as defined in subsection (c)).

(b) Contents.—The report submitted under subsection (a) shall contain—

(1) the status of, and findings to date, with respect to, the proposed rule entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments” published in the Federal Register by the Food and Drug Administration on March 4, 2016 (81 Fed. Reg. 11477);

(2) information presented during the October 2016 public workshop entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers”;

(3) a description of the statutory and regulatory authority of the Food and Drug Administration with respect to the servicing of devices conducted by any entity, including original equipment manufacturers and third party entities;

(4) details regarding how the Food and Drug Administration currently regulates devices with respect to servicing to ensure safety and effectiveness, how the agency could improve such regulation using the authority described in paragraph (3), and whether additional authority is recommended;

(5) information on actions the Food and Drug Administration could take under the authority described in paragraphs (3) and (4) to assess the servicing of devices, including the size, scope, location, and composition of third party entities;

(6) information on actions the Food and Drug Administration could take to track adverse events caused by servicing errors performed by any entity, including original equipment manufacturers and third party entities;

(7) information regarding the regulation by States, the Joint Commission, or other regulatory bodies of device servicing performed by any entity, including original equipment manufacturers and third party entities; and

(8) any additional information determined by the Secretary (acting through the Commissioner) to be relevant to ensuring the quality, safety, and effectiveness of devices with respect to servicing.

(c) Servicing Defined.—In this section, the term “servicing” includes, with respect to a device, refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device.

 

TITLE VIII—IMPROVING GENERIC DRUG ACCESS

SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS.

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) is amended by adding at the end the following:

“(11) (A) Subject to subparagraph (B), the Secretary shall prioritize the review of, and act within 8 months of the date of the submission of, an original abbreviated new drug application submitted for review under this subsection that is for a drug—

“(i) for which there are not more than 3 approved drug products listed under paragraph (7) and for which there are no blocking patents and exclusivities; or

“(ii) that has been included on the list under section 506E.

“(B) To qualify for priority review under this paragraph, not later than 60 days prior to the submission of an application described in subparagraph (A) or that the Secretary may prioritize pursuant to subparagraph (D), the applicant shall provide complete, accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application, including facilities in corresponding Type II active pharmaceutical ingredients drug master files referenced in an application and sites or organizations involved in bioequivalence and clinical studies used to support the application, to enable the Secretary to make a determination regarding whether an inspection of a facility is necessary. Such information shall include the relevant (as determined by the Secretary) sections of such application, which shall be unchanged relative to the date of the submission of such application, except to the extent that a change is made to such information to exclude a facility that was not used to generate data to meet any application requirements for such submission and that is not the only facility intended to conduct one or more unit operations in commercial production. Information provided by an applicant under this subparagraph shall not be considered the submission of an application under this subsection.

“(C) The Secretary may expedite an inspection or reinspection under section 704 of an establishment that proposes to manufacture a drug described in subparagraph (A).

“(D) Nothing in this paragraph shall prevent the Secretary from prioritizing the review of other applications as the Secretary determines appropriate.

“(12) The Secretary shall publish on the internet website of the Food and Drug Administration, and update at least once every 6 months, a list of all drugs approved under subsection (c) for which all patents and periods of exclusivity under this Act have expired and for which no application has been approved under this subsection.”.

SEC. 802. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE GENERIC COMPETITION.

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 801, is further amended by adding at the end the following:

“(13) Upon the request of an applicant regarding one or more specified pending applications under this subsection, the Secretary shall, as appropriate, provide review status updates indicating the categorical status of the applications by each relevant review discipline.”.

SEC. 803. COMPETITIVE GENERIC THERAPIES.

(a) In General.—Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506G the following:

“SEC. 506H. COMPETITIVE GENERIC THERAPIES.

“(a) In General.—The Secretary may, at the request of an applicant of a drug that is designated as a competitive generic therapy pursuant to subsection (b), expedite the development and review of an abbreviated new drug application under section 505(j) for such drug.

“(b) Designation Process.—

“(1) REQUEST.—The applicant may request the Secretary to designate the drug as a competitive generic therapy.

“(2) TIMING.—A request under paragraph (1) may be made concurrently with, or at any time prior to, the submission of an abbreviated new drug application for the drug under section 505(j).

“(3) CRITERIA.—A drug is eligible for designation as a competitive generic therapy under this section if the Secretary determines that there is inadequate generic competition.

“(4) DESIGNATION.—Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary may—

“(A) determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and

“(B) if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy.

“(c) Actions.—In expediting the development and review of an application under subsection (a), the Secretary may, as requested by the applicant, take actions including the following:

“(1) Hold meetings with the applicant and the review team throughout the development of the drug prior to submission of the application for such drug under section 505(j).

“(2) Provide timely advice to, and interactive communication with, the applicant regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable.

“(3) Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review of such application, including with respect to drug-device combination products and other complex products.

“(4) Assign a cross-disciplinary project lead—

“(A) to facilitate an efficient review of the development program and application, including manufacturing inspections; and

“(B) to serve as a scientific liaison between the review team and the applicant.

“(d) Reporting Requirement.—Not later than one year after the date of the approval of an application under section 505(j) with respect to a drug for which the development and review is expedited under this section, the sponsor of such drug shall report to the Secretary on whether the drug has been marketed in interstate commerce since the date of such approval.

“(e) Definitions.—In this section:

“(1) The term ‘generic drug’ means a drug that is approved pursuant to section 505(j).

“(2) The term ‘inadequate generic competition’ means, with respect to a drug, there is not more than one approved drugs on the list of drugs described in section 505(j)(7)(A) (not including drugs on the discontinued section of such list) that is—

“(A) the reference listed drug; or

“(B) a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.

“(3) The term ‘reference listed drug’ means the listed drug (as such term is used in section 505(j)) for the drug involved.”.

(b) Guidance; Amended Regulations.—

(1) IN GENERAL.—

(A) ISSUANCE.—The Secretary of Health and Human Services shall—

(i) not later than 18 months after the date of enactment of this Act, issue draft guidance on section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); and

(ii) not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such section 506H.

(B) CONTENTS.—The guidance issued under this paragraph shall—

(i) specify the process and criteria by which the Secretary makes a designation under section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);

(ii) specify the actions the Secretary may take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and

(iii) include good review management practices for competitive generic therapies.

(2) AMENDED REGULATIONS.—The Secretary of Health and Human Services shall issue or revise any regulations as may be necessary to carry out this section not later than 2 years after the date of enactment of this Act.

SEC. 804. ACCURATE INFORMATION ABOUT DRUGS WITH LIMITED COMPETITION.

Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting after section 506H, as added by section 803, the following:

“SEC. 506I. PROMPT REPORTS OF MARKETING STATUS.

“(a) Notification Of Withdrawal.—The holder of an application approved under subsection (c) or (j) of section 505 shall notify the Secretary in writing 180 days prior to withdrawing the approved drug from sale, or if 180 days is not practicable as soon as practicable but not later than the date of withdrawal. The holder shall include with such notice the—

“(1) National Drug Code;

“(2) identity of the drug by established name and by proprietary name, if any;

“(3) new drug application number or abbreviated application number;

“(4) strength of the drug;

“(5) date on which the drug is expected to no longer be available for sale; and

“(6) reason for withdrawal of the drug.

“(b) Notification Of Drug Not Available For Sale.—The holder of an application approved under subsection (c) or (j) shall notify the Secretary in writing within 180 calendar days of the date of approval of the drug if the drug will not be available for sale within 180 calendar days of such date of approval. The holder shall include with such notice the—

“(1) identity of the drug by established name and by proprietary name, if any;

“(2) new drug application number or abbreviated application number;

“(3) strength of the drug;

“(4) date on which the drug will be available for sale, if known; and

“(5) reason for not marketing the drug after approval.

“(c) Additional One-Time Report.—Within 180 days of the date of enactment of this section, all holders of applications approved under subsection (c) or (j) of section 505 shall review the information in the list published under subsection 505(j)(7)(A) and shall notify the Secretary in writing that—

“(1) all of the application holder’s drugs in the active section of the list published under subsection 505(j)(7)(A) are available for sale; or

“(2) one or more of the application holder’s drugs in the active section of the list published under subsection 505(j)(7)(A) have been withdrawn from sale or have never been available for sale, and include with such notice the information required pursuant to subsection (a) or (b), as applicable.

“(d) Failure To Meet Requirements.—If a holder of an approved application fails to submit the information required under subsection (a), (b), or (c), the Secretary may move the application holder’s drugs from the active section of the list published under subsection 505(j)(7)(A) to the discontinued section of the list, except that the Secretary shall remove from the list in accordance with subsection 505(j)(7)(C) drugs the Secretary determines have been withdrawn from sale for reasons of safety of effectiveness.

“(e) Updates.—The Secretary shall update the list published under subsection 505(j)(7)(A) based on the information provided under subsections (a), (b), and (c) by moving drugs that are not available for sale from the active section to the discontinued section of the list, except that drugs the Secretary determines have been withdrawn from sale for reasons of safety or effectiveness shall be removed from the list in accordance with subsection 505(j)(7)(C). The Secretary shall make monthly updates to the list based on the information provided pursuant to subsections (a) and (b), and shall update the list based on the information provided under subsection (c) as soon as practicable.

“(f) Limitation On Use Of Notices.—Any notice submitted under this section shall not be made public by the Secretary and shall be used solely for the purpose of the updates described in subsection (e).”.

SEC. 805. SUITABILITY PETITIONS.

(a) In General.—It is the sense of Congress that the Food and Drug Administration shall meet the requirement under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(C)) and section 314.93(e) of title 21, Code of Federal Regulations, of responding to suitability petitions within 90 days of submission.

(b) Report.—The Secretary of Health and Human Services shall include in the annual reports under section 807—

(1) the number of pending petitions under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(C)); and

(2) the number of such petitions pending a substantive response for more than 180 days from the date of receipt.

SEC. 806. INSPECTIONS.

Within 6 months of the date of enactment of this Act, the Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports of observations from an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374). Such protocol shall—

(1) apply to responses to such reports pertaining to applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)—

(A) for which the approval is dependent upon remediation of conditions identified in the report;

(B) for which concerns related to observations from an inspection under such section 704 are the only barrier to approval; and

(C) where the drug that is the subject of the application is a drug—

(i) for which there are not more than 3 other approved applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that reference the same listed drug and for which there are less than 6 abbreviated new drug applications tentatively approved; or

(ii) that is included on the list under section 506E of such Act (21 U.S.C. 356e);

(2) address expedited re-inspection of facilities, as appropriate; and

(3) establish a 6-month timeline for completion of review of such responses to such reports.

SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND PRIORITY REVIEW APPLICATIONS.

Not later than 180 calendar days after the date of enactment of this Act, and quarterly thereafter until October 1, 2022, the Secretary of Health and Human Services shall post on the internet website of the Food and Drug Administration a report that provides, with respect to the months covered by the report—

(1) with respect to applications filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that, during the most recent calendar year, were subject to priority review under paragraph (11) of such section 505(j) (as added by section 801) or expedited development and review under section 506H of the Federal Food, Drug, and Cosmetic Act (as added by section 803), the numbers of such applications (with denotation of such applications that were filed prior to October 1, 2014) that are—

(A) awaiting action by the applicant;

(B) awaiting action by the Secretary; and

(C) approved by the Secretary;

(2) the number of applications filed under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) and prior approval supplements withdrawn in each month;

(3) the mean and median approval and tentative approval times and the number of review cycles for such applications;

(4) the number and type of meetings requested and held under such section 506H (as added by section 803); and

(5) the number of such applications on which the Secretary has taken action pursuant to subsection (c) of such section 506H (as added by section 803) and any effect such section 506H may have on the length of time for approval of applications under such section 505(j) and the number of review cycles for such approvals.

SEC. 808. INCENTIVIZING COMPETITIVE GENERIC DRUG DEVELOPMENT.

Section 505(j)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)) is amended—

(1) in subparagraph (B), by adding at the end the following:

“(v) 180-DAY EXCLUSIVITY PERIOD FOR COMPETITIVE GENERIC THERAPIES.—

“(I) EFFECTIVENESS OF APPLICATION.—Subject to subparagraph (D)(iv), if the application is for a drug that is the same as a competitive generic therapy for which any first approved applicant has commenced commercial marketing, the application shall be made effective on the date that is 180 days after the date of the first commercial marketing of the competitive generic therapy (including the commercial marketing of the listed drug) by any first approved applicant.

“(II) LIMITATION.—The exclusivity period under subclause (I) shall not apply with respect to a competitive generic therapy that has previously received an exclusivity period under subclause (I).

“(III) DEFINITIONS.—In this clause and subparagraph (D)(iv):

“(aa) The term ‘competitive generic therapy’ means a drug—

“(AA) that is designated as a competitive generic therapy under section 506H; and

“(BB) for which there are no unexpired patents or exclusivities on the list of products described in section 505(j)(7)(A) at the time of submission.

“(bb) The term ‘first approved applicant’ means any applicant that has submitted an application that—

“(AA) is for a competitive generic therapy that is approved on the first day on which any application for such competitive generic therapy is approved;

“(BB) is not eligible for a 180-day exclusivity period under clause (iv) for the drug that is the subject of the application for the competitive generic therapy; and

“(CC) is not for a drug for which all drug versions have forfeited eligibility for a 180-day exclusivity period under clause (iv) pursuant to subparagraph (D).”; and

(2) in subparagraph (D), by adding at the end the following:

“(iv) SPECIAL FORFEITURE RULE FOR COMPETITIVE GENERIC THERAPY.—The 180-day exclusivity period described in subparagraph (B)(v) shall be forfeited by a first approved applicant if the applicant fails to market the competitive generic therapy within 75 days after the date on which the approval of the first approved applicant’s application for the competitive generic therapy is made effective.”.

SEC. 809. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS OF GENERIC MEDICINES.

(a) Study By GAO.—The Comptroller General of the United States shall conduct a study to determine the following:

(1) The rate of first cycle approvals and tentative approvals for applications submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) during the period beginning on October 1, 2012, and ending on September 30, 2017. The rate of first cycle approvals and tentative approvals shall be determined and reported per each GDUFA cohort year during this period.

(2) If the rate determined pursuant to paragraph (1) for any GDUFA cohort year is lower than 20 percent, the reasons contributing to the relatively low rate of first cycle approvals and tentative approvals for generic drug applications shall be itemized, assessed, and reported. In making the assessment required by this paragraph, the Comptroller General shall consider, among other things, the role played by—

(A) the Food and Drug Administration’s implementation of approval standards for generic drug applications;

(B) the extent to which those approval standards are communicated clearly to industry and applied consistently during the review process;

(C) the procedures for reviewing generic drug applications, including timelines for review activities by the Food and Drug Administration;

(D) the extent to which those procedures are followed consistently (and those timelines are met) by the Food and Drug Administration;

(E) the processes and practices for communication between the Food and Drug Administration and sponsors of generic drug applications; and

(F) the completeness and quality of original generic drug applications submitted to the Food and Drug Administration.

(3) Taking into account the determinations made pursuant to paragraphs (1) and (2) and any review process improvements implemented pursuant to this Act, whether there are ways the review process for generic drugs could be improved to increase the rate of first cycle approvals and tentative approvals for generic drug applications. In making this determination, the Comptroller General shall consider, among other things, options for increasing review efficiency and communication effectiveness.

(b) Completion Date.—Not later than the expiration of the 2-year period beginning on the date of enactment of this Act, the Comptroller General shall complete the study under subsection (a) and submit a report describing the findings and conclusions of the study to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate.

(c) Definitions.—For purposes of this section:

(1) The term “GDUFA cohort year” means a fiscal year.

(2) The term “generic drug” means a drug that is approved or is seeking approval under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).

(3) The term “generic drug application” means an abbreviated new drug application for the approval of a generic drug under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).

(4) The term “Secretary” means the Secretary of Health and Human Services.

(5) (A) The term “first cycle approvals and tentative approvals” means the approval or tentative approval of a generic drug application after the Food and Drug Administration’s complete review of the application and without issuance of one or more complete response letters.

(B) For purposes of this paragraph, the term “complete response letter” means a written communication to the sponsor of a generic drug application or holder of a drug master file from the Food and Drug Administration describing all of the deficiencies that the Administration has identified in the generic drug application (including pending amendments) or drug master file that must be satisfactorily addressed before the generic drug application can be approved.

 

TITLE IX—ADDITIONAL PROVISIONS

SEC. 901. TECHNICAL CORRECTIONS.

(a) Section 3075(a) of the 21st Century Cures Act (Public Law 114–255) is amended—

(1) in the matter preceding paragraph (1), by striking “as amended by section 2074” and inserting “as amended by section 3102”; and

(2) in paragraph (2), by striking “section 2074(1)(C)” and inserting “section 3102(1)(C)”.

(b) Section 506G(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356g(b)(1)(A)) is amended by striking “identity” and inserting “identify”.

(c) Section 505F(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g(b)) is amended by striking “randomized” and inserting “traditional”.

(d) Section 505F(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355g(d)) is amended by striking “2” and inserting “3”.

(e) Section 510(h)(6) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(h)(6)) is amended by striking “February 1” and replacing with “May 1”.

(f) Effective as of the enactment of the 21st Century Cures Act (Public Law 114–255)—

(1) section 3051(a) of such Act is amended by striking “by inserting after section 515B” and inserting “by inserting after section 515A”; and

(2) section 515C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–3), as inserted by such section 3051(a), is redesignated as section 515B.

(g) Section 515B(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–3(f)(2)), as redesignated by subsection (e)(2) of this section, is amended by striking “a proposed guidance” and inserting “a draft version of that guidance”.

(h) Section 513(b)(5)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(5)(D)) is amended by striking “medical device submissions” and inserting “medical devices that may be specifically the subject of a review by a classification panel”.

SEC. 902. ANNUAL REPORT ON INSPECTIONS.

Not later than March 1 of each year, the Secretary of Health and Human Services shall post on the internet website of the Food and Drug Administration information related to inspections of facilities necessary for approval of a drug under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), approval of a device under section 515 of such Act (21 U.S.C. 360e), or clearance of a device under section 510(k) of such Act (21 U.S.C. 360(k)) that were conducted during the previous calendar year. Such information shall include the following:

(1) The median time following a request from staff of the Food and Drug Administration reviewing an application or report to the beginning of the inspection, and the median time from the beginning of an inspection to the issuance of a report pursuant to section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(b)).

(2) The median time from the issuance of a report pursuant to such section 704(b) to the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting for inspections for which the Secretary concluded that regulatory or enforcement action was indicated.

(3) The median time from the sending of a warning letter, issuance of an import alert, or holding of a regulatory meeting to resolution of the regulatory or enforcement action indicated for inspections for which the Secretary concluded that such action was indicated.

(4) The number of times that a facility was issued a report pursuant to such section 704(b) and approval of an application was delayed due to the issuance of a withhold recommendation.

SEC. 903. STREAMLINING AND IMPROVING CONSISTENCY IN PERFORMANCE REPORTING.

(a) PDUFA.—Section 736B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2(a)), as amended by section 103, is further amended by inserting after paragraph (2) the following:

“(3) REAL TIME REPORTING.—

“(A) IN GENERAL.—Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual performance report under this subsection.

“(B) DATA.—The Secretary shall post the following data in accordance with subparagraph (A):

“(i) The number and titles of draft and final guidance on topics related to the process for the review of human drug applications, and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.

“(ii) The number and titles of public meetings held on topics related to the process for the review of human drug applications, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017.

“(iii) The number of new drug applications and biological licensing applications approved.

“(iv) The number of new drug applications and biological licensing applications filed.

“(4) RATIONALE FOR PDUFA PROGRAM CHANGES.—Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

“(A) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

“(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of human drugs, including identifying drivers of such changes; and

“(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.”.

(b) MDUFA.—Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)(1)(A)), as amended by section 204, is further amended—

(1) by striking “Beginning with” and inserting the following:

“(i) GENERAL REQUIREMENTS.—Beginning with”; and

(2) by adding at the end the following:

“(ii) ADDITIONAL INFORMATION.—Beginning with fiscal year 2018, the annual report under this subparagraph shall include the progress of the Center for Devices and Radiological Health in achieving the goals, and future plans for meeting the goals, including—

“(I) the number of premarket applications filed under section 515 per fiscal year for each review division;

“(II) the number of reports submitted under section 510(k) per fiscal year for each review division; and

“(III) the number of expedited development and priority review designations under section 515C per fiscal year.

“(iii) REAL TIME REPORTING.—

“(I) IN GENERAL.—Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subclause (II) on the internet website of the Food and Drug Administration for such quarter and on a cumulative basis for such fiscal year, and may remove duplicative data from the annual report under this subparagraph.

“(II) DATA.—The Secretary shall post the following data in accordance with subclause (I):

“(aa) The number and titles of draft and final guidance on topics related to the process for the review of devices, and whether such guidances were issued as required by statute or pursuant to the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017; and

“(bb) The number and titles of public meetings held on topics related to the process for the review of devices, and if such meetings were required by statute or pursuant to a commitment under the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017.

“(iv) RATIONALE FOR MDUFA PROGRAM CHANGES.—Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

“(I) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

“(II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of devices, including identifying drivers of such changes; and

“(III) for each of the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.”.

(c) GDUFA.—Section 744C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43(a)), as amended by section 304, is further amended—

(1) by striking “Beginning with” and inserting the following:

“(1) GENERAL REQUIREMENTS.—Beginning with”; and

(2) by adding at the end the following:

“(2) REAL TIME REPORTING.—

“(A) IN GENERAL.—Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.

“(B) DATA.—The Secretary shall post the following data in accordance with subparagraph (A):

“(i) The number and titles of draft and final guidance on topics related to human generic drug activities and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017.

“(ii) The number and titles of public meetings held on topics related to human generic drug activities and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017.

“(3) RATIONALE FOR GDUFA PROGRAM CHANGES.—Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

“(A) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

“(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including identifying drivers of such changes; and

“(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.”.

(d) BsUFA.—Section 744I(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53(a)), as amended by section 404, is further amended—

(1) by striking “Beginning with” and inserting the following:

“(1) GENERAL REQUIREMENTS.—Beginning with”; and

(2) by adding at the end the following:

“(2) ADDITIONAL INFORMATION.—Beginning with fiscal year 2018, the report under this subsection shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—

“(A) information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort;

“(B) the number of original biosimilar biological product applications filed per fiscal year, and the number of approvals issued by the agency for such applications; and

“(C) the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals letters issued by the agency for such applications.

“(3) REAL TIME REPORTING.—

“(A) IN GENERAL.—Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter, the Secretary shall post the data described in subparagraph (B) for such quarter and on a cumulative basis for the fiscal year on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.

“(B) DATA.—The Secretary shall post the following data in accordance with subparagraph (A):

“(i) The number and titles of draft and final guidance on topics related to the process for the review of biosimilars, and whether such guidances were required by statute or pursuant to a commitment under the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.

“(ii) The number and titles of public meetings held on topics related to the process for the review of biosimilars, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.

“(4) RATIONALE FOR BSUFA PROGRAM CHANGES.—Beginning with fiscal year 2020, the Secretary shall include in the annual report under paragraph (1)—

“(A) data, analysis, and discussion of the changes in the number of full-time equivalents hired as agreed upon in the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

“(B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of biosimilar biological product applications, including identifying drivers of such changes; and

“(C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required.”.

SEC. 904. ANALYSIS OF USE OF FUNDS.

(a) PDUFA Reports.—

(1) ANALYSIS IN PDUFA PERFORMANCE REPORTS.—Section 736B(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2(a)), as amended by section 903(a), is further amended by adding at the end the following:

“(5) ANALYSIS.—For each fiscal year, the Secretary shall include in the report under paragraph (1) an analysis of the following:

“(A) The difference between the aggregate number of human drug applications filed and the aggregate number of approvals, accounting for—

“(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year;

“(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year.

“(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met performance enhancement goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year.

“(C) The most common causes and trends of external or other circumstances affecting the ability of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, Office of Regulatory Affairs, and the Food and Drug Administration to meet the review time and performance enhancement goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017”..”.

(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section 736B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h–2) is amended—

(A) by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and

(B) by inserting after subsection (b) the following:

“(c) Corrective Action Report.—Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

“(1) GOALS MET.—For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the human drug application review process.

“(2) GOALS MISSED.—For any of the goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

“(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which human drug applications that missed the review goal time were approved during the first cycle review, or application review goals were missed; and

“(B) with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.

“(d) Enhanced Communication.—

“(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

“(2) PARTICIPATION IN CONGRESSIONAL HEARING.—Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this part.”.

(b) MDUFA Reports.—

(1) ANALYSIS IN MDUFA PERFORMANCE REPORTS.—Section 738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)(1)(A)), as amended by section 903(b), is further amended by adding at the end the following:

“(iv) ANALYSIS.—For each fiscal year, the Secretary shall include in the report under clause (i) an analysis of the following:

“(I) The difference between the aggregate number of premarket applications filed under section 515 and aggregate reports submitted under section 510(k) and the aggregate number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for—

“(aa) the number of applications filed and reports submitted during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

“(bb) the aggregate number of applications for each fiscal year that did not meet the goals as identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year.

“(II) Relevant data to determine whether the Center for Devices and Radiological Health has met performance enhancement goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year.

“(III) The most common causes and trends for external or other circumstances affecting the ability of the Center for Devices and Radiological Health, the Office of Regulatory Affairs, or the Food and Drug Administration to meet review time and performance enhancement goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017”..”.

(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section 738A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)) is amended—

(A) by redesignating paragraphs (2) and (3) as paragraphs (4) and (5), respectively; and

(B) by inserting after paragraph (1) the following:

“(2) CORRECTIVE ACTION REPORT.—Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

“(A) GOALS MET.—For each fiscal year, if the Secretary determines, based on the analysis under paragraph (1)(A)(iv), that each of the goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the medical device application review process.

“(B) GOALS MISSED.—For each of the goals identified by the letters described in section 201(b) of the Medical Device User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

“(i) a justification for such determination;

“(ii) a description of the types of circumstances, in the aggregate, under which applications or reports submitted under section 515 or notifications submitted under section 510(k) missed the review goal times but were approved during the first cycle review, as applicable;

“(iii) a summary and any trends with regard to the circumstances for which a review goal was missed; and

“(iv) the performance enhancement goals that were not achieved during the previous fiscal year and a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.

“(3) ENHANCED COMMUNICATION.—

“(A) COMMUNICATIONS WITH CONGRESS.—Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of devices shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

“(B) PARTICIPATION IN CONGRESSIONAL HEARING.—Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this part.”.

(c) GDUFA Reports.—

(1) ANALYSIS IN GDUFA PERFORMANCE REPORTS.—Section 744C(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43(a)), as amended by section 903(c) is further amended by adding at the end the following:

“(4) ANALYSIS.—For each fiscal year, the Secretary shall include in the report an analysis of the following:

“(A) The difference between the aggregate number of abbreviated new drug applications filed and the aggregate number of approvals or aggregate number of complete response letters issued by the agency, accounting for—

“(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

“(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year.

“(B) Relevant data to determine whether the Food and Drug Administration has met the performance enhancement goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year.

“(C) The most common causes and trends for external or other circumstances that affected the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017”..”.

(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section 744C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–43) is amended—

(A) by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and

(B) by inserting after subsection (b) the following:

“(c) Corrective Action Report.—Beginning with fiscal year 2018, for each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

“(1) GOALS MET.—For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(4), that each of the goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the abbreviated new drug application review process.

“(2) GOALS MISSED.—For each of the goals identified by the letters described in section 301(b) of the Generic Drug User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

“(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which abbreviated new drug applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and

“(B) with respect to performance enhancement goals that were not achieved, a detailed description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.

“(d) Enhanced Communication.—

“(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

“(2) PARTICIPATION IN CONGRESSIONAL HEARING.—Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this part.”.

(d) BsUFA Reports.—

(1) ANALYSIS IN BSUFA PERFORMANCE REPORTS.—Section 744I(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53(a)) as amended by section 903(d) is further amended by adding at the end the following:

“(5) ANALYSIS.—For each fiscal year, the Secretary shall include in the report an analysis of the following:

“(A) The difference between the aggregate number of biosimilar biological product applications and supplements filed and the aggregate number of approvals issued by the agency, accounting for—

“(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and

“(ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year.

“(B) Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met the performance enhancement goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year.

“(C) The most common causes and trends for external or other circumstances affecting the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017.”.

(2) ISSUANCE OF CORRECTIVE ACTION REPORTS.—Section 744I of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–53), as amended by section 404, is further amended—

(A) by redesignating subsections (c) and (d) as subsections (e) and (f), respectively; and

(B) by inserting after subsection (b) the following:

“(c) Corrective Action Report.—Beginning with fiscal year 2018, and for each fiscal year for which fees are collected under this part, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and Committee on Appropriations of the Senate. The report shall include the following information, as applicable:

“(1) GOALS MET.—For each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(5), that each of the goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the biosimilar biological product application review process.

“(2) GOALS MISSED.—For each of the goals identified by the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2017 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—

“(A) a justification for such determination and a description of the types of circumstances and trends, as applicable, under which biosimilar biological product applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and

“(B) with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such fiscal year.

“(d) Enhanced Communication.—

“(1) COMMUNICATIONS WITH CONGRESS.—Each fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section.

“(2) PARTICIPATION IN CONGRESSIONAL HEARING.—Each fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this part.”.

SEC. 905. FACILITIES MANAGEMENT.

(a) Evaluation.—

(1) STUDY.—The Comptroller General of the United States shall conduct a study on the expenses incurred by the Food and Drug Administration related to facility maintenance and renovation in fiscal years 2012 through 2019. The study under this paragraph shall include the following:

(A) A review of purchases and expenses differentiated by appropriated funds, and resources authorized by the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) and this Act, as applicable, that contributed to—

(i) the maintenance of scientific equipment and any existing facility plan or plans to maintain previously purchased scientific equipment;

(ii) the renovation of facilities in the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health, and the purpose of such renovation including the need for the renovation;

(iii) the assets purchased or repaired under the “repair of facilities and acquisition” authority under parts 2, 3, 7, and 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.);

(iv) the maintenance and repair of facilities and fixtures, including a description of any unanticipated repairs and maintenance as well as scheduled repairs maintenance, and the budget plan for the scheduled or anticipated maintenance;

(v) the acquisition of furniture, a description of the furniture purchased, and the purpose of the furniture including purchases for the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health; and

(vi) the acquisition of other necessary materials and supplies by product category under the authority under parts 2, 3, 7, and 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.).

(B) An analysis of the Food and Drug Administration’s ability to further its public health mission and review medical products by incurring the expenses listed in clauses (i) through (vi) of subparagraph (A). In conducting the analysis, the Comptroller General shall request information from and consult with appropriate employees, including staff and those responsible for the fiscal decisions regarding facility maintenance and renovation for the agency.

(2) REPORT.—

(A) IN GENERAL.—The Comptroller General shall issue a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives not later than July 30, 2020, containing the results of the study under paragraph (1).

(B) RECOMMENDATIONS.—As part of the report under this paragraph, the Comptroller General may provide recommendations, as applicable, on methods through which the Food and Drug Administration may improve planning for—

(i) the maintenance, renovation, and repair of facilities;

(ii) the purchase of furniture or other acquisitions; and

(iii) ways the Food and Drug Administration may allocate the expenses described in clauses (i) and (ii) of paragraph (1)(A), as informed by the analysis under paragraph (1)(B).

(b) Administration.—

(1) PDUFA.—Section 736(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(f)) is amended by adding at the end the following:

“(3) LIMITATION.—Beginning on October 1, 2023, the authorities under section 735(7)(C) shall include only expenditures for leasing and necessary scientific equipment.”.

(2) MDUFA.—Section 738(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)) is amended by adding at the end the following:

“(3) LIMITATION.—Beginning on October 1, 2023, the authorities under section 737(9)(C) shall include only leasing and necessary scientific equipment.”.

(3) GDUFA.—Section 744B(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–42(e)) is amended—

(A) in the subsection heading, by striking “Limit” and inserting “Limitations”;

(B) by striking “The total amount” and inserting the following:

“(1) IN GENERAL.—The total amount”; and

(C) by adding at the end the following:

“(2) LEASING AND NECESSARY EQUIPMENT.—Beginning on October 1, 2023, the authorities under section 744A(11)(C) shall include only leasing and necessary scientific equipment.”.

(4) BSUFA.—Section 744H(e)(2)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–52(e)(2)(B)) is amended—

(A) in the subparagraph heading, by striking “LIMITATION” and inserting “LIMITATIONS”;

(B) by striking “The fees authorized” and inserting the following:

“(i) IN GENERAL.—The fees authorized”; and

(C) by adding at the end the following:

“(ii) LEASING AND NECESSARY EQUIPMENT.—Beginning on October 1, 2023, the authorities under section 744G(9)(C) shall include only leasing and necessary scientific equipment.”.



Speaker of the House of Representatives.



Vice President of the United States and
President of the Senate.

 

 

H.R. 873 - Global War on Terrorism War Memorial Act

 

One Hundred Fifteenth Congress
of the
United States of America

AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday, 
the third day of January, two thousand and seventeen

An Act

To authorize the Global War on Terror Memorial Foundation to establish the National Global War on Terrorism Memorial as a commemorative work in the District of Columbia, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “Global War on Terrorism War Memorial Act”.

SEC. 2. NATIONAL GLOBAL WAR ON TERRORISM MEMORIAL.

(a) Authorization To Establish Commemorative Work.—The Association may establish the National Global War on Terrorism Memorial as a commemorative work on Federal land in the District of Columbia and its environs to commemorate and honor the members of the Armed Forces that served on active duty in support of the Global War on Terrorism.

(b) Compliance With Standards For Commemorative Works Act.—

(1) IN GENERAL.—Except as provided in paragraph 2, the establishment of the memorial under this section shall be in accordance with chapter 89 of title 40, United States Code (commonly known as the “Commemorative Works Act”).

(2) NON-APPLICABILITY.—Subsections (b) and (c) of section 8903 of title 40, United States Code, shall not apply to this Act.

(c) Use Of Federal Funds Prohibited.—

(1) IN GENERAL.—Federal funds may not be used to pay any expense of the establishment of the memorial under this section.

(2) RESPONSIBILITY OF ASSOCIATION.—The Association shall be solely responsible for acceptance of contributions for, and payment of the expenses of, the establishment of the memorial.

(d) Deposit Of Excess Funds.—If, on payment of all expenses for the establishment of the memorial (including the maintenance and preservation amount required by section 8906(b)(1) of title 40, United States Code), or on expiration of the authority for the memorial under section 8903(e) of title 40, United States Code, there remains a balance of funds received for the establishment of the memorial, the Association shall transmit the amount of the balance to the Secretary of the Interior for deposit in the account provided for in section 8906(b)(3) of title 40, United States Code.

SEC. 3. DEFINITIONS.

In this Act:

(1) ASSOCIATION.—The term “Association” means the Global War on Terror Memorial Foundation, a corporation that is—

(A) organized under the laws of the State of Pennsylvania; and

(B) described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from taxation under section 501(a) of that Code.

(2) DISTRICT OF COLUMBIA AND ITS ENVIRONS.—The term “District of Columbia and its environs” has the meaning given that term in section 8902(a) of title 40, United States Code.

(3) GLOBAL WAR ON TERRORISM.—The term “Global War on Terrorism” means any contingency operation conducted by the Armed Forces in response to the terrorist attacks of September 11, 2001, or other terrorist attack.

(4) MEMORIAL.—The term “memorial” means the National Global War on Terrorism Memorial authorized to be established under section 2.



Speaker of the House of Representatives.  



Vice President of the United States and   
President of the Senate.

 

 

H.R. 510 - Rapid DNA Act of 2017

One Hundred Fifteenth Congress
of the
United States of America

AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday, 
the third day of January, two thousand and seventeen

An Act

To establish a system for integration of Rapid DNA instruments for use by law enforcement to reduce violent crime and reduce the current DNA analysis backlog.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “Rapid DNA Act of 2017”.

SEC. 2. RAPID DNA INSTRUMENTS.

(a) Standards.—Section 210303(a) of the DNA Identification Act of 1994 (42 U.S.C. 14131(a)) is amended by adding at the end the following:

“(5) (A) In addition to issuing standards as provided in paragraphs (1) through (4), the Director of the Federal Bureau of Investigation shall issue standards and procedures for the use of Rapid DNA instruments and resulting DNA analyses.

“(B) In this Act, the term ‘Rapid DNA instruments’ means instrumentation that carries out a fully automated process to derive a DNA analysis from a DNA sample.”.

(b) Index.—Paragraph (2) of section 210304(b) of the DNA Identification Act of 1994 (42 U.S.C. 14132(b)(2)) is amended to read as follows:

“(2) prepared by—

“(A) laboratories that—

“(i) have been accredited by a nonprofit professional association of persons actively involved in forensic science that is nationally recognized within the forensic science community; and

“(ii) undergo external audits, not less than once every 2 years, that demonstrate compliance with standards established by the Director of the Federal Bureau of Investigation; or

“(B) criminal justice agencies using Rapid DNA instruments approved by the Director of the Federal Bureau of Investigation in compliance with the standards and procedures issued by the Director under section 210303(a)(5); and”.

SEC. 3. CONFORMING AMENDMENTS RELATING TO COLLECTION OF DNA IDENTIFICATION INFORMATION.

(a) From Certain Federal Offenders.—Section 3 of the DNA Analysis Backlog Elimination Act of 2000 (42 U.S.C. 14135a) is amended—

(1) in subsection (b), by adding at the end the following: “The Director of the Federal Bureau of Investigation may waive the requirements under this subsection if DNA samples are analyzed by means of Rapid DNA instruments and the results are included in CODIS.”; and

(2) in subsection (c), by adding at the end the following:

“(3) The term ‘Rapid DNA instruments’ means instrumentation that carries out a fully automated process to derive a DNA analysis from a DNA sample.”.

(b) From Certain District Of Columbia Offenders.—Section 4 of the DNA Analysis Backlog Elimination Act of 2000 (42 U.S.C. 14135b) is amended—

(1) in subsection (b), by adding at the end the following: “The Director of the Federal Bureau of Investigation may waive the requirements under this subsection if DNA samples are analyzed by means of Rapid DNA instruments and the results are included in CODIS.”; and

(2) in subsection (c), by adding at the end the following:

“(3) The term ‘Rapid DNA instruments’ means instrumentation that carries out a fully automated process to derive a DNA analysis from a DNA sample.”.



Speaker of the House of Representatives.  



Vice President of the United States and   
President of the Senate.

 

 

H.R. 374 - An Act to remove the sunset provision of section 203 of Public Law 105–384, and for other purposes

One Hundred Fifteenth Congress
of the
United States of America

AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday, 
the third day of January, two thousand and seventeen

An Act

 

To remove the sunset provision of section 203 of Public Law 105–384, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. DUNGENESS CRAB FISHERY MANAGEMENT.

Section 203 of the Act entitled “An Act to approve a governing international fishery agreement between the United States and the Republic of Poland, and for other purposes”, approved November 13, 1998 (Public Law 105–38416 U.S.C. 1856 note), is amended—

(1) by striking subsection (i); and

(2) by redesignating subsection (j) as subsection (i).

 

Speaker of the House of Representatives.  


Vice President of the United States and   
President of the Senate.

 

 

S. 114 - VA Choice and Quality Employment Act of 2017

One hundred fifteenth Congress
of the
United States of America

AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday, 
the third day of January, two thousand and seventeen

 

An Act

 

To authorize appropriations and to appropriate amounts for the Veterans Choice Program of the Department of Veterans Affairs, to improve hiring authorities of the Department, to authorize major medical facility leases, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

 

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.—This Act may be cited as the “VA Choice and Quality Employment Act of 2017”.

(b) Table Of Contents.—The table of contents for this Act is as follows:


Sec. 1. Short title; table of contents.

TITLE I—APPROPRIATION OF AMOUNTS FOR VETERANS CHOICE PROGRAM


Sec. 101. Appropriation of amounts for Veterans Choice Program.

TITLE II—PERSONNEL MATTERS

Sec. 201. Modification to annual determination of staffing shortages in Veterans Health Administration.
Sec. 202. Establishment of Department of Veterans Affairs Executive Management Fellowship Program.
Sec. 203. Accountability of leaders for managing the Department of Veterans Affairs.
Sec. 204. Reemployment of former employees at Department of Veterans Affairs.
Sec. 205. Promotional opportunities for technical experts at Department of Veterans Affairs.
Sec. 206. Employment of students and recent graduates by Department of Veterans Affairs.
Sec. 207. Encouragement of transition of military medical professionals into employment with Veterans Health Administration.
Sec. 208. Recruiting database at Department of Veterans Affairs.
Sec. 209. Training for human resources professionals of Veterans Health Administration on recruitment and retention.
Sec. 210. Plan to hire directors of medical centers of Department of Veterans Affairs.
Sec. 211. Exit surveys at Department of Veterans Affairs.
Sec. 212. Requirement that physician assistants employed by the Department of Veterans Affairs receive competitive pay.
Sec. 213. Expansion of direct-hiring authority for Department of Veterans Affairs in case of shortage of highly qualified candnameates.
Sec. 214. Comptroller General of the United States assessment of succession planning at Department of Veterans Affairs.

TITLE III—MAJOR MEDICAL FACILITY LEASES

Sec. 301. Authorization of certain major medical facility leases of the Department of Veterans Affairs.
Sec. 302. Authorization of appropriations for medical facility leases.

TITLE IV—OTHER MATTERS

Sec. 401. Extension of reduction in amount of pension furnished by Department of Veterans Affairs for certain veterans covered by medicaname plans for services furnished by nursing facilities.
Sec. 402. Extension of requirement for collection of fees for housing loans guaranteed by Secretary of Veterans Affairs.
Sec. 403. Extension of authority to use income information.

 

 TITLE I—APPROPRIATION OF AMOUNTS FOR VETERANS CHOICE PROGRAM

SEC. 101. APPROPRIATION OF AMOUNTS FOR VETERANS CHOICE PROGRAM.

(a) In General.—There is authorized to be appropriated, and is appropriated, to the Secretary of Veterans Affairs, out of any funds in the Treasury not otherwise appropriated, $2,100,000,000 to be deposited in the Veterans Choice Fund under section 802 of the Veterans Access, Choice, and Accountability Act of 2014 (Public Law 113–14638 U.S.C. 1701 note).

(b) Availability.—The amount appropriated under subsection (a) shall remain available until expended.

 TITLE II—PERSONNEL MATTERS

SEC. 201. MODIFICATION TO ANNUAL DETERMINATION OF STAFFING SHORTAGES IN VETERANS HEALTH ADMINISTRATION.

Section 7412(a) of title 38, United States Code, is amended—

(1) by striking “the five occupations” and inserting “at a minimum, the five clinical occupations and the five nonclinical occupations”; and

(2) by striking “throughout the Department” and inserting “with respect to each medical center of the Department,”.

SEC. 202. ESTABLISHMENT OF DEPARTMENT OF VETERANS AFFAIRS EXECUTIVE MANAGEMENT FELLOWSHIP PROGRAM.

(a) Fellowship Program.—Chapter 7 of title 38, United States Code, is amended by adding at the end the following new subchapter:

“SUBCHAPTER III—EXECUTIVE MANAGEMENT FELLOWSHIP PROGRAM

“§ 741. Executive Management Fellowship Program

“(a) Fellowship Program.—There is in the Department an Executive Management Fellowship Program. The purpose of the program shall be to provnamee—

“(1) eligible employees of the Veterans Benefits Administration and the Veterans Health Administration with training and experience in the private sector; and

“(2) eligible employees of a private-sector entity with training and experience in the Department of Veterans Affairs.

“(b) Fellowship.— (1) A fellowship provnameed under this section is a 1-year fellowship during which—

“(A) with respect to a Department participant, the participant receives training and experience at a private-sector entity that is engaged in the administration and delivery of health care or other services similar to the benefits administered by the Secretary; and

“(B) with respect to a private-sector participant, the participant receives training and experience at the Veterans Benefits Administration or the Veterans Health Administration.

“(2) The Secretary shall enter into such agreements with private-sector entities as are necessary to carry out this section.

“(c) Selection Of Recipients.— (1) In August of each year, the Secretary shall select—

“(A) not fewer than 18 and not more than 30 eligible employees of the Veterans Benefits Administration and the Veterans Health Administration to receive a fellowship under this section; and

“(B) not fewer than 18 and not more than 30 eligible employees of private-sector entities to receive a fellowship under this section.

“(2) To the extent practicable, the Secretary shall select eligible employees under subparagraphs (A) and (B) of paragraph (1) from among eligible employees who are veterans in a manner that is reflective of the demographics of the veteran population of the United States and that whenever practicable provnamees a preference to such employees who represent or service rural areas.

“(d) Eligible Employees.—For the purposes of this section, an eligible employee is—

“(1) with respect to an employee of the Veterans Benefits Administration or the Veterans Health Administration, an employee who—

“(A) is compensated at a rate of basic pay not less than the minimum rate of basic pay payable for grade GS–14 of the General Schedule and not more than either the minimum rate of basic pay payable to a member of the Senior Executive Service under section 5382 of title 5 or the minimum rate of basic pay payable pursuant to chapter 74 of this title, as the case may be;

“(B) enters into an agreement with the Secretary under subsection (e); and

“(C) submits to the Secretary an application containing such information and assurances as the Secretary may require; and

“(2) with respect to an employee of a private-sector entity, an employee who—

“(A) is employed in a position whose duties and responsibilities are commensurate with an employee of the Department described in paragraph (1);

“(B) enters into an agreement with the Secretary under subsection (e); and

“(C) submits to the Secretary an application containing such information and assurances as the Secretary may require.

“(e) Agreements.— (1) An agreement between the Secretary and a Department participant shall be in writing, shall be signed by the participant, and shall include the following provisions:

“(A) The Secretary’s agreement to provnamee the participant with a fellowship under this section;

“(B) The participant’s agreement—

“(i) to accept the fellowship;

“(ii) after completion of the fellowship, to serve as a full-time employee in the Veterans Benefits Administration or the Veterans Health Administration for at least 2 years as specified in the agreement; and

“(iii) that, during the 2-year period beginning on the last day of the fellowship, the participant will not accept employment in the same industry as the industry of the private-sector entity at which the participant accepts the fellowship.

“(C) A provision that any financial obligation of the United States arising out of an agreement entered into under this subchapter, and any obligation of the participant which is conditioned on such agreement, is contingent upon funds being appropriated.

“(D) A statement of the damages to which the United States is entitled under this subchapter for the participant’s breach of the agreement.

“(E) Such other terms as the Secretary determines are required to be included in the agreement.

“(2) An agreement between the Secretary and a private-sector participant shall be in writing, shall be signed by the participant, and shall include the following provisions:

“(A) The Secretary’s agreement to provnamee the participant with a fellowship under this section.

“(B) The participant’s agreement to accept the fellowship.

“(C) Such other terms as the Secretary determines are required to be included in the agreement.

“(f) Treatment Of Recipients.— (1) A Department participant shall be consnameered an employee of the Department for all purposes, including for purposes of receiving a salary and benefits, and shall remain eligible for all promotion and incentive programs otherwise available to such an employee.

“(2) A private-sector participant shall be consnameered an employee of the private-sector entity that employs the participant for all purposes, including for purposes of receiving a salary and benefits, and during the fellowship shall be treated as a contractor of the Department.

“(g) Reports.— (1) Not later than 60 days after completing a fellowship under this section, a recipient of the fellowship shall submit to the Secretary a report on the fellowship.

“(2) Each such report shall describe the duties of the recipient during the fellowship and any recommendations of the recipient for the application by the Secretary of industry processes, technologies, and best practices.

“(3) Not later than 7 days after receiving each such report, the Secretary shall submit to the Committees on Veterans’ Affairs of the Senate and House of Representatives such report without change.

“(h) Definitions.—In this section:

“(1) The term ‘Department participant’ means an employee of the Veterans Benefits Administration or the Veterans Health Administration who is participating in the fellowship under this section.

“(2) The term ‘private-sector entity’ includes an entity operating under a public-private partnership.

“(3) The term ‘private-sector participant’ means an employee of a private-sector entity who is participating in the fellowship under this section.”.

(b) Deadline For Implementation.—Not later than 1 year after the date of the enactment of this Act, the Secretary of Veterans Affairs shall implement the Executive Management Fellowship Program required under section 741 of title 38, United States Code, as added by subsection (a).

(c) Clerical Amendment.—The table of sections at the beginning of chapter 7 of title 38, United States Code, is amended by adding at the end the following new items:

“SUBCHAPTER III—EXECUTIVE MANAGEMENT FELLOWSHIP PROGRAM


“741. Executive Management Fellowship Program.”.

SEC. 203. ACCOUNTABILITY OF LEADERS FOR MANAGING THE DEPARTMENT OF VETERANS AFFAIRS.

(a) In General.—Subchapter I of chapter 7 of title 38, United States Code, is amended by adding at the end the following new section:

“§ 725. Annual performance plan for political appointees

“(a) In General.—The Secretary shall conduct an annual performance plan for each political appointee of the Department that is similar to the annual performance plan conducted for an employee of the Department who is appointed as a career appointee (as that term is defined in section 3132(a) of title 5) within the Senior Executive Service at the Department.

“(b) Elements Of Plan.—Each annual performance plan conducted under subsection (a) with respect to a political appointee of the Department shall include an assessment of whether the appointee is meeting the following goals:

“(1) Recruiting, selecting, and retaining well-qualified indivnameuals for employment at the Department.

“(2) Engaging and motivating employees.

“(3) Training and developing employees and preparing those employees for future leadership roles within the Department.

“(4) Holding each employee of the Department that is a manager accountable for addressing issues relating to performance, in particular issues relating to the performance of employees that report to the manager.

“(c) Definition Of Political Appointee.—In this section, the term ‘political appointee’ means an employee of the Department who holds—

“(1) a position which has been excepted from the competitive service by reason of its confnameential, policy-determining, policy-making, or policy-advocating character; or

“(2) a position in the Senior Executive Service as a noncareer appointee (as such term is defined in section 3132(a) of title 5).”.

(b) Clerical Amendment.—The table of sections at the beginning of chapter 7 of such title is amended by inserting after the item relating to section 723 the following new item:


“725. Annual performance plan for political appointees.”.

 

SEC. 204. REEMPLOYMENT OF FORMER EMPLOYEES AT DEPARTMENT OF VETERANS AFFAIRS.

(a) In General.—Notwithstanding sections 3309 through 3318 of title 5, United States Code, the Secretary of Veterans Affairs may noncompetitively appoint a qualified former career or career conditional employee to any position within the competitive service at the Department of Veterans Affairs that is one grade or equivalent higher than the grade or equivalent of the position at the Department most recently occupied by the employee.

(b) Limitation.—The Secretary may not appoint a qualified former employee to a position that is more than one grade (or equivalent) higher than the position at the Department most recently occupied by the employee.

(c) Definition Of Qualified Former Employee.—For purposes of this section, the term “qualified former employee” means any indivnameual who—

(1) formerly occupied any career or career conditional position at the Department of Veterans Affairs within 2 years before applying for reemployment at the Department;

(2) voluntarily left such position, or was subject to a reduction in force, and had a satisfactory performance record while occupying such position; and

(3) since leaving such position has maintained licensing requirements, related to the position, if any, and gained skill, knowledge, or other factors related to the position.

 

SEC. 205. PROMOTIONAL OPPORTUNITIES FOR TECHNICAL EXPERTS AT DEPARTMENT OF VETERANS AFFAIRS.

Not later than one year after the date of the enactment of this Act, the Secretary of Veterans Affairs shall establish a promotional track system for employees of the Department of Veterans Affairs that the Secretary determines are technical experts pursuant to regulations prescribed by the Secretary for purposes of carrying out this section. Such system shall—

(1) provnamee any such employee the opportunity to advance within the Department without being required to transition to a management position; and

(2) for purposes of achieving career advancement—

(A) provnamee for the establishment of new positions within the Department; and

(B) notwithstanding any other provision of law, provnamee for increases in pay for any such employee.

 

SEC. 206. EMPLOYMENT OF STUDENTS AND RECENT GRADUATES BY DEPARTMENT OF VETERANS AFFAIRS.

(a) In General.—The Secretary of Veterans Affairs shall prescribe regulations to allow for excepted service appointments of students and recent graduates leading to conversion to career or career conditional employment of a student or recent graduate of a qualifying educational institution, as defined by the Department.

(b) Applicability.—The conversion authority described in subsection (a) shall be applicable to indivnameuals in good standing who—

(1) are employed in a qualifying internship or fellowship program at the Department;

(2) are employed in the Department in a volunteer capacity and performing substantive duties comparable to those of indivnameuals in internship or fellowship programs and meet the required number of hours for conversion;

(3) are employed in the Department under a contract or agreement with an external nonprofit organization and performing substantive duties comparable to those of indivnameuals in internship or fellowship programs;

(4) have received educational assistance under chapter 33 of title 38, United States Code; or

(5) graduated from a qualifying educational institution, as defined by the Department, and have not reached 30 years of age.

(c) Uniformity.—For the purposes of paragraphs (2) and (3) of subsection (b), hours of work performed by an indivnameual employed shall be consnameered equal to those performed by an indivnameual employed in a qualifying internship or fellowship program by the Department.

 

SEC. 207. ENCOURAGEMENT OF TRANSITION OF MILITARY MEDICAL PROFESSIONALS INTO EMPLOYMENT WITH VETERANS HEALTH ADMINISTRATION.

The Secretary of Veterans Affairs shall establish a program to encourage an indivnameual who serves in the Armed Forces with a military occupational specialty relating to the provision of health care to seek employment with the Veterans Health Administration when the indivnameual has been discharged or released from service in the Armed Forces or is contemplating separating from such service.

 

SEC. 208. RECRUITING DATABASE AT DEPARTMENT OF VETERANS AFFAIRS.

(a) Establishment.—The Secretary of Veterans Affairs shall establish a single database that lists—

(1) each vacant position in the Department of Veterans Affairs that the Secretary determines is critical to the mission of the Department, difficult to fill, or both; and

(2) each vacant position in the Department of Veterans Affairs for a mental health professional.

(b) Qualified Applicant.—If the Secretary determines that an applicant for a vacant position listed in the database established under subsection (a) is qualified for such position but does not select the applicant for such position, the Secretary, at the election of the applicant, may consnameer the applicant for other similar vacant positions listed in the database for which the applicant is qualified.

(c) Prolonged Vacancies.—If the Secretary does not fill a vacant position listed in the database established under subsection (a) after a period determined appropriate by the Secretary, the Secretary—

(1) may ensure that applicants described in subsection (b) are consnameered for such position; and

(2) may use the database established under subsection (a) to assist in filling such position.

(d) Report.—Not later than one year after the date of the enactment of this Act, the Secretary shall submit to Congress a report on the use and efficacy of the database established under subsection (a).

 

SEC. 209. TRAINING FOR HUMAN RESOURCES PROFESSIONALS OF VETERANS HEALTH ADMINISTRATION ON RECRUITMENT AND RETENTION.

(a) In General.—The Secretary of Veterans Affairs shall provnamee to human resources professionals of the Veterans Health Administration training on how to best recruit and retain employees of the Veterans Health Administration, including with respect to any recruitment and retention matters that are unique to the Veterans Health Administration pursuant to chapter 74 of title 38, United States Code, or other provisions of law.

(b) Virtual Training.—Training provnameed under this section shall be provnameed virtually.

(c) Amount Of Training.—The Secretary shall ensure that each human resources professional of the Veterans Health Administration receives the training described in subsection (a)—

(1) as soon as practicable after being hired by the Secretary as a human resources professional; and

(2) annually thereafter.

(d) Certification.—The Secretary shall require that each human resources professional of the Veterans Health Administration, upon the completion of the training described in subsection (a), certifies that the professional received the training and understands the information provnameed by the training.

(e) Annual Report.—Not less frequently than annually, the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report on the training described in subsection (a), including the cost of provnameing such training and the number of human resources professionals who received such training during the year covered by the report.

 

SEC. 210. PLAN TO HIRE DIRECTORS OF MEDICAL CENTERS OF DEPARTMENT OF VETERANS AFFAIRS.

(a) Plan.—Not later than 120 days after the date of the enactment of this Act, the Secretary of Veterans Affairs shall develop and implement a plan to hire highly qualified directors for each medical center of the Department of Veterans Affairs that lacks a permanent director as of the date of the plan.

(b) Priority.—The Secretary shall prioritize under the plan developed under subsection (a) the hiring of directors for medical centers that have not had a permanent director for the longest periods.

(c) Matters Included.—The plan developed under subsection (a) shall include the following:

(1) A deadline to hire directors of medical centers of the Department as described in such subsection.

(2) nameentification of the possible impediments to such hiring.

(3) nameentification of opportunities to promote and train candnameates from within the Department to senior executive positions in the Department, including as directors of medical centers.

(d) Submittal Of Plan.—Not later than 120 days after the date of the enactment of this Act, the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives the plan developed under subsection (a).

(e) Semiannual Reports.—Not later than 180 days after the date of the enactment of this Act, and not later than 180 days thereafter, the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a report containing a list of each medical center of the Department that lacks a permanent director as of the date of the report.

 

SEC. 211. EXIT SURVEYS AT DEPARTMENT OF VETERANS AFFAIRS.

(a) Exit Surveys Required.—

(1) IN GENERAL.—The Secretary of Veterans Affairs shall develop and carry out a standardized exit survey to be voluntarily completed by career and noncareer employees and executives of the Department of Veterans Affairs who voluntarily separate from the Department.

(2) CONSULTATION.—Such exit survey shall be developed in consultation with an appropriate non-Department entity with experience developing such surveys.

(b) Survey Content.—The survey shall include, at a minimum, the following:

(1) Reasons for leaving the Department.

(2) Efforts made by the supervisor of the employee to retain the indivnameual.

(3) The extent of job satisfaction and engagement during the employment.

(4) The intent of employee to either remain employed within the Federal Government or to leave employment with the Federal Government.

(5) Such other matters as the Secretary determines appropriate.

(c) Anonymity Of Survey Content.—The Secretary shall ensure that data collected under subsection (a)—

(1) is anonymized, including through the use of a location that allows for privacy;

(2) is not directly visible by another employee; and

(3) does not require the departing employee to input any personally nameentifiable data.

(d) Sharing Of Survey Data.—The Secretary shall ensure that the results of the survey required by subsection (a) are—

(1) aggregated at the Veterans Integrated Service Network level; and

(2) shared on an annual basis with directors and managers of facilities of the Department and the Veterans Integrated Service Networks.

(e) Annual Report.—

(1) IN GENERAL.—Not later than one year after the date of the enactment of this Act and not less frequently than once each year thereafter, the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans' Affairs of the House of Representatives a report containing the aggregate results of the exit survey under subsection (a) covering the year prior to the report.

(2) CONTENTS.—Each report submitted under paragraph (1) shall include, for the period covered by the report, the following:

(A) An analysis of the most common reasons employees choose to leave the Department.

(B) The steps the Secretary is taking to improve retention, particularly for mission-critical occupations.

(C) The demographic characteristics of employees choosing to leave the Department.

(D) Any legislative barriers to improving employee retention.

(E) The total number of employees who voluntarily separated from the Department and the number and percentage of whom took the exit survey under subsection (a).

 

SEC. 212. REQUIREMENT THAT PHYSICIAN ASSISTANTS EMPLOYED BY THE DEPARTMENT OF VETERANS AFFAIRS RECEIVE COMPETITIVE PAY.

Section 7451(a)(2) of title 38, United States Code, is amended—

(1) by redesignating subparagraph (B) as subparagraph (C);

(2) by inserting after subparagraph (A) the following new subparagraph (B):

“(B) Physician assistant.”; and

(3) in subparagraph (C), as redesignated by paragraph (1), by striking “and registered nurse” and inserting “registered nurse, and physician assistant”.

 

SEC. 213. EXPANSION OF DIRECT-HIRING AUTHORITY FOR DEPARTMENT OF VETERANS AFFAIRS IN CASE OF SHORTAGE OF HIGHLY QUALIFIED CANDnameATES.

Section 3304(a)(3)(B) of title 5, United States Code, is amended by inserting “(or, with respect to the Department of Veterans Affairs, that there exists a severe shortage of highly qualified candnameates)” after “severe shortage of candnameates”.

 

SEC. 214. COMPTROLLER GENERAL OF THE UNITED STATES ASSESSMENT OF SUCCESSION PLANNING AT DEPARTMENT OF VETERANS AFFAIRS.

(a) Assessment.—

(1) IN GENERAL.—The Comptroller General of the United States shall assess the extent to which key succession planning policies and gunameance at the Department of Veterans Affairs, including the Veterans Health Administration, the Veterans Benefits Administration, and the National Cemetery Administration, are consistent with leading practices for succession and workforce planning nameentified by Comptroller General.

(2) ADDITIONAL MATTERS.—In carrying out the assessment required by paragraph (1), the Comptroller General may assess such other matters as the Comptroller General consnameers appropriate.

(b) Report.—Not later than two years after the date of the enactment of this Act, the Comptroller General shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans' Affairs of the House of Representatives a report on the assessment carried out under subsection (a).

(c) Sense Of Congress On Study On Compliance With Policies And Gunameance.—It is the sense of Congress that—

(1) the Comptroller General should conduct a study to examine the extent to which a sampling of installations of the Department of Veterans Affairs are complying with policies and gunameance of the Department, as well as applicable leading practices; and

(2) the scope and timeframe of a study conducted as described in paragraph (1) may be dependent upon the findings of the Comptroller General with respect to the assessment carried out under subsection (a).

 

TITLE III—MAJOR MEDICAL FACILITY LEASES

SEC. 301. AUTHORIZATION OF CERTAIN MAJOR MEDICAL FACILITY LEASES OF THE DEPARTMENT OF VETERANS AFFAIRS.

The Secretary of Veterans Affairs may carry out the following major medical facility leases at the locations specified and in an amount for each lease not to exceed the amount specified for such location (not including any estimated cancellation costs):

(1) For a replacement outpatient clinic, Ann Arbor, Michigan, an amount not to exceed $4,247,000.

(2) For a new outpatient mental health clinic, Birmingham, Alabama, an amount not to exceed $6,649,000.

(3) For new research space, Boston, Massachusetts, an amount not to exceed $6,224,000.

(4) For a replacement research space, Charleston, South Carolina, an amount not to exceed $7,274,000.

(5) For a replacement outpatient clinic, Corpus Christi, Texas, an amount not to exceed $6,556,000.

(6) For a replacement outpatient clinic, Daytona Beach, Flornamea, an amount not to exceed $12,198,000.

(7) For a replacement Chief Business Office Purchased Care office space, Denver, Colorado, an amount not to exceed $14,784,000.

(8) For a replacement outpatient clinic, Fredericksburg, Virginia, an amount not to exceed $45,015,000.

(9) For a new outpatient clinic, Gainesville, Flornamea, an amount not to exceed $7,891,000.

(10) For an outpatient mental health clinic, Gainesville, Flornamea, an amount not to exceed $4,320,000.

(11) For a replacement outpatient clinic, Hampton Roads, Virginia, an amount not to exceed $18,141,000.

(12) For a replacement outpatient clinic, Indianapolis, Indiana, an amount not to exceed $7,876,000.

(13) For a replacement outpatient clinic, Jacksonville, Flornamea, an amount not to exceed $18,623,000.

(14) For a replacement outpatient clinic, Missoula, Montana, an amount not to exceed $6,942,000.

(15) For a replacement outpatient mental health clinic, Northern Colorado, Colorado, an amount not to exceed $8,904,000.

(16) For a replacement outpatient clinic, Ocala, Flornamea, an amount not to exceed $5,026,000.

(17) For a new outpatient clinic, Oxnard, California, an amount not to exceed $5,274,000.

(18) For a new outpatient clinic, Pike County, Georgia, an amount not to exceed $5,565,000.

(19) For a new outpatient clinic, Pittsburgh, Pennsylvania, an amount not to exceed $6,247,000.

(20) For a replacement outpatient clinic, Portland, Maine, an amount not to exceed $6,808,000.

(21) For a replacement outpatient clinic, Raleigh, North Carolina, an amount not to exceed $21,870,000.

(22) For a replacement outpatient clinic, phase II, Rochester, New York, an amount not to exceed $3,645,000.

(23) For a replacement research space, San Diego, California, an amount not to exceed $4,852,000.

(24) For a new outpatient clinic, Santa Rosa, California, an amount not to exceed $6,922,000.

(25) For a replacement mental health clinic, Tampa, Flornamea, an amount not to exceed $13,387,000.

(26) For a replacement outpatient clinic, Lakeland, Tampa, Flornamea, an amount not to exceed $10,760,000.

(27) For a replacement outpatient clinic, Terre Haute, Indiana, an amount not to exceed $4,102,000.

(28) For a replacement outpatient clinic, Rapname City, South Dakota, an amount not to exceed $4,532,000.

 

SEC. 302. AUTHORIZATION OF APPROPRIATIONS FOR MEDICAL FACILITY LEASES.

There is authorized to be appropriated to the Secretary of Veterans Affairs for fiscal year 2018 or the year in which funds are appropriated for the Medical Facilities account $274,634,000 for the major medical facility leases authorized in section 301.

 

TITLE IV—OTHER MATTERS

SEC. 401. EXTENSION OF REDUCTION IN AMOUNT OF PENSION FURNISHED BY DEPARTMENT OF VETERANS AFFAIRS FOR CERTAIN VETERANS COVERED BY MEDICAname PLANS FOR SERVICES FURNISHED BY NURSING FACILITIES.

Section 5503(d)(7) of title 38, United States Code, is amended by striking “September 30, 2024” and inserting “September 30, 2027”.

SEC. 402. EXTENSION OF REQUIREMENT FOR COLLECTION OF FEES FOR HOUSING LOANS GUARANTEED BY SECRETARY OF VETERANS AFFAIRS.

Section 3729(b)(2) of title 38, United States Code, is amended—

(1) in subparagraph (A)—

(A) in clause (iii), by striking “September 30, 2024” and inserting “September 30, 2027”; and

(B) in clause (iv), by striking “September 30, 2024” and inserting “September 30, 2027”;

(2) in subparagraph (B)—

(A) in clause (i), by striking “September 30, 2024” and inserting “September 30, 2027”; and

(B) in clause (ii), by striking “September 30, 2024” and inserting “September 30, 2027”;

(3) in subparagraph (C)—

(A) in clause (i), by striking “September 30, 2024” and inserting “September 30, 2027”; and

(B) in clause (ii), by striking “September 30, 2024” and inserting “September 30, 2027”; and

(4) in subparagraph (D)—

(A) in clause (i), by striking “September 30, 2024” and inserting “September 30, 2027”; and

(B) in clause (ii), by striking “September 30, 2024” and inserting “September 30, 2027”.

 

SEC. 403. EXTENSION OF AUTHORITY TO USE INCOME INFORMATION.

Section 5317(g) of title 38, United States Code, is amended by striking “September 30, 2024” and inserting “September 30, 2027”.



Speaker of the House of Representatives  


Vice Presnameent of the United States and Presnameent of the Senate  

H.R. 3364 - Countering America’s Adversaries Through Sanctions Act

 

H. R. 3364

AN ACT

To provide congressional review and to counter aggression by the Governments of Iran, the Russian Federation, and North Korea, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.—This Act may be cited as the “Countering America’s Adversaries Through Sanctions Act”.

(b) Table Of Contents.—The table of contents for this Act is as follows:

 

Sec. 1. Short title; table of contents.

TITLE I—SANCTIONS WITH RESPECT TO IRAN

 

Sec. 101. Short title.

Sec. 102. Definitions.

Sec. 103. Regional strategy for countering conventional and asymmetric Iranian threats in the Middle East and North Africa.

Sec. 104. Imposition of additional sanctions in response to Iran’s ballistic missile program.

Sec. 105. Imposition of terrorism-related sanctions with respect to the IRGC.

Sec. 106. Imposition of additional sanctions with respect to persons responsible for human rights abuses.

Sec. 107. Enforcement of arms embargos.

Sec. 108. Review of applicability of sanctions relating to Iran’s support for terrorism and its ballistic missile program.

Sec. 109. Report on coordination of sanctions between the United States and the European Union.

Sec. 110. Report on United States citizens detained by Iran.

Sec. 111. Exceptions for national security and humanitarian assistance; rule of construction.

Sec. 112. Presidential waiver authority.

TITLE II—SANCTIONS WITH RESPECT TO THE RUSSIAN FEDERATION AND COMBATING TERRORISM AND ILLICIT FINANCING

 

Sec. 201. Short title.

Subtitle A—Sanctions And Other Measures With Respect To The Russian Federation

 

Sec. 211. Findings.

Sec. 212. Sense of Congress.

PART 1—CONGRESSIONAL REVIEW OF SANCTIONS IMPOSED WITH RESPECT TO THE RUSSIAN FEDERATION

 

Sec. 215. Short title.

Sec. 216. Congressional review of certain actions relating to sanctions imposed with respect to the Russian Federation.

PART 2—SANCTIONS WITH RESPECT TO THE RUSSIAN FEDERATION

 

Sec. 221. Definitions.

Sec. 222. Codification of sanctions relating to the Russian Federation.

Sec. 223. Modification of implementation of Executive Order No. 13662.

Sec. 224. Imposition of sanctions with respect to activities of the Russian Federation undermining cybersecurity.

Sec. 225. Imposition of sanctions relating to special Russian crude oil projects.

Sec. 226. Imposition of sanctions with respect to Russian and other foreign financial institutions.

Sec. 227. Mandatory imposition of sanctions with respect to significant corruption in the Russian Federation.

Sec. 228. Mandatory imposition of sanctions with respect to certain transactions with foreign sanctions evaders and serious human rights abusers in the Russian Federation.

Sec. 229. Notifications to Congress under Ukraine Freedom Support Act of 2014.

Sec. 230. Standards for termination of certain sanctions with respect to the Russian Federation.

Sec. 231. Imposition of sanctions with respect to persons engaging in transactions with the intelligence or defense sectors of the Government of the Russian Federation.

Sec. 232. Sanctions with respect to the development of pipelines in the Russian Federation.

Sec. 233. Sanctions with respect to investment in or facilitation of privatization of state-owned assets by the Russian Federation.

Sec. 234. Sanctions with respect to the transfer of arms and related materiel to Syria.

Sec. 235. Sanctions described.

Sec. 236. Exceptions, waiver, and termination.

Sec. 237. Exception relating to activities of the National Aeronautics and Space Administration.

Sec. 238. Rule of construction.

PART 3—REPORTS

 

Sec. 241. Report on oligarchs and parastatal entities of the Russian Federation.

Sec. 242. Report on effects of expanding sanctions to include sovereign debt and derivative products.

Sec. 243. Report on illicit finance relating to the Russian Federation.

Subtitle B—Countering Russian Influence In Europe And Eurasia

 

Sec. 251. Findings.

Sec. 252. Sense of Congress.

Sec. 253. Statement of policy.

Sec. 254. Coordinating aid and assistance across Europe and Eurasia.

Sec. 255. Report on media organizations controlled and funded by the Government of the Russian Federation.

Sec. 256. Report on Russian Federation influence on elections in Europe and Eurasia.

Sec. 257. Ukranian energy security.

Sec. 258. Termination.

Sec. 259. Appropriate congressional committees defined.

Subtitle C—Combating Terrorism And Illicit Financing

PART 1—NATIONAL STRATEGY FOR COMBATING TERRORIST AND OTHER ILLICIT FINANCING

 

Sec. 261. Development of national strategy.

Sec. 262. Contents of national strategy.

PART 2—ENHANCING ANTITERRORISM TOOLS OF THE DEPARTMENT OF THE TREASURY

 

Sec. 271. Improving antiterror finance monitoring of funds transfers.

Sec. 272. Sense of Congress on international cooperation regarding terrorist financing intelligence.

Sec. 273. Examining the counter-terror financing role of the Department of the Treasury in embassies.

Sec. 274. Inclusion of Secretary of the Treasury on the National Security Council.

Sec. 275. Inclusion of all funds.

PART 3—DEFINITIONS

 

Sec. 281. Definitions.

Subtitle D—Rule Of Construction

 

Sec. 291. Rule of construction.

Sec. 292. Sense of Congress on the strategic importance of Article 5 of the North Atlantic Treaty.

TITLE III—SANCTIONS WITH RESPECT TO NORTH KOREA

 

Sec. 301. Short title.

Sec. 302. Definitions.

Subtitle A—Sanctions To Enforce And Implement United Nations Security Council Sanctions Against North Korea

 

Sec. 311. Modification and expansion of requirements for the designation of persons.

Sec. 312. Prohibition on indirect correspondent accounts.

Sec. 313. Limitations on foreign assistance to noncompliant governments.

Sec. 314. Amendments to enhance inspection authorities.

Sec. 315. Enforcing compliance with United Nations shipping sanctions against North Korea.

Sec. 316. Report on cooperation between North Korea and Iran.

Sec. 317. Report on implementation of United Nations Security Council resolutions by other governments.

Sec. 318. Briefing on measures to deny specialized financial messaging services to designated North Korean financial institutions.

Subtitle B—Sanctions With Respect To Human Rights Abuses By The Government Of North Korea

 

Sec. 321. Sanctions for forced labor and slavery overseas of North Koreans.

Sec. 322. Modifications to sanctions suspension and waiver authorities.

Sec. 323. Reward for informants.

Sec. 324. Determination on designation of North Korea as a state sponsor of terrorism.

Subtitle C—General Authorities

 

Sec. 331. Authority to consolidate reports.

Sec. 332. Rule of construction.

Sec. 333. Regulatory authority.

Sec. 334. Limitation on funds.

TITLE I—SANCTIONS WITH RESPECT TO IRAN

 

SEC. 101. SHORT TITLE.

This title may be cited as the “Countering Iran’s Destabilizing Activities Act of 2017”.

 

SEC. 102. DEFINITIONS.

In this title:

(1) ACT OF INTERNATIONAL TERRORISM.—The term “act of international terrorism” has the meaning given that term in section 14 of the Iran Sanctions Act of 1996 (Public Law 104–17250 U.S.C. 1701 note).

(2) APPROPRIATE CONGRESSIONAL COMMITTEES.—The term “appropriate congressional committees” has the meaning given that term in section 14 of the Iran Sanctions Act of 1996 (Public Law 104–17250 U.S.C. 1701 note).

(3) FOREIGN PERSON.—The term “foreign person” means a person that is not a United States person.

(4) IRANIAN PERSON.—The term “Iranian person” means—

(A) an individual who is a citizen or national of Iran; or

(B) an entity organized under the laws of Iran or otherwise subject to the jurisdiction of the Government of Iran.

(5) IRGC.—The term “IRGC” means Iran’s Islamic Revolutionary Guard Corps.

(6) KNOWINGLY.—The term “knowingly” has the meaning given that term in section 14 of the Iran Sanctions Act of 1996 (Public Law 104–17250 U.S.C. 1701 note).

(7) UNITED STATES PERSON.—The term “United States person” means—

(A) a United States citizen or an alien lawfully admitted for permanent residence to the United States; or

(B) an entity organized under the laws of the United States or of any jurisdiction within the United States, including a foreign branch of such an entity.

 

SEC. 103. REGIONAL STRATEGY FOR COUNTERING CONVENTIONAL AND ASYMMETRIC IRANIAN THREATS IN THE MIDDLE EAST AND NORTH AFRICA.

(a) In General.—Not later than 180 days after the date of the enactment of this Act, and every 2 years thereafter, the Secretary of State, the Secretary of Defense, the Secretary of the Treasury, and the Director of National Intelligence shall jointly develop and submit to the appropriate congressional committees and leadership a strategy for deterring conventional and asymmetric Iranian activities and threats that directly threaten the United States and key allies in the Middle East, North Africa, and beyond.

(b) Elements.—The strategy required by subsection (a) shall include at a minimum the following:

(1) A summary of the near- and long-term United States objectives, plans, and means for countering Iran’s destabilizing activities, including identification of countries that share the objective of countering Iran’s destabilizing activities.

(2) A summary of the capabilities and contributions of individual countries to shared efforts to counter Iran’s destabilizing activities, and a summary of additional actions or contributions that each country could take to further contribute.

(3) An assessment of Iran’s conventional force capabilities and an assessment of Iran’s plans to upgrade its conventional force capabilities, including its acquisition, development, and deployment of ballistic and cruise missile capabilities, unmanned aerial vehicles, and maritime offensive and anti-access or area denial capabilities.

(4) An assessment of Iran’s chemical and biological weapons capabilities and an assessment of Iranian plans to upgrade its chemical or biological weapons capabilities.

(5) An assessment of Iran’s asymmetric activities in the region, including—

(A) the size, capabilities, and activities of the IRGC, including the Quds Force;

(B) the size, capabilities, and activities of Iran’s cyber operations;

(C) the types and amount of support, including funding, lethal and nonlethal contributions, and training, provided to Hezbollah, Hamas, special groups in Iraq, the regime of Bashar al-Assad in Syria, Houthi fighters in Yemen, and other violent groups across the Middle East; and

(D) the scope and objectives of Iran’s information operations and use of propaganda.

(6) A summary of United States actions, unilaterally and in cooperation with foreign governments, to counter destabilizing Iranian activities, including—

(A) interdiction of Iranian lethal arms bound for groups designated as foreign terrorist organizations under section 219 of the Immigration and Nationality Act (8 U.S.C. 1189);

(B) Iran’s interference in international commercial shipping lanes;

(C) attempts by Iran to undermine or subvert internationally recognized governments in the Middle East region; and

(D) Iran’s support for the regime of Bashar al-Assad in Syria, including—

(i) financial assistance, military equipment and personnel, and other support provided to that regime; and

(ii) support and direction to other armed actors that are not Syrian or Iranian and are acting on behalf of that regime.

(c) Form Of Strategy.—The strategy required by subsection (a) shall be submitted in unclassified form, but may include a classified annex.

(d) Appropriate Congressional Committees And Leadership Defined.—In this section, the term “appropriate congressional committees and leadership” means—

(1) the Committee on Finance, the Committee on Banking, Housing, and Urban Affairs, the Committee on Foreign Relations, and the majority and minority leaders of the Senate; and

(2) the Committee on Ways and Means, the Committee on Financial Services, the Committee on Foreign Affairs, and the Speaker, the majority leader, and the minority leader of the House of Representatives.

 

SEC. 104. IMPOSITION OF ADDITIONAL SANCTIONS IN RESPONSE TO IRAN’S BALLISTIC MISSILE PROGRAM.

(a) Sense Of Congress.—It is the sense of Congress that the Secretary of the Treasury and the Secretary of State should continue to implement Executive Order No. 13382 (50 U.S.C. 1701 note; relating to blocking property of weapons of mass destruction delivery system proliferators and their supporters).

(b) Imposition Of Sanctions.—The President shall impose the sanctions described in subsection (c) with respect to any person that the President determines, on or after the date of the enactment of this Act—

(1) knowingly engages in any activity that materially contributes to the activities of the Government of Iran with respect to its ballistic missile program, or any other program in Iran for developing, deploying, or maintaining systems capable of delivering weapons of mass destruction, including any efforts to manufacture, acquire, possess, develop, transport, transfer, or use such capabilities;

(2) is a successor entity to a person referred to in paragraph (1);

(3) owns or controls or is owned or controlled by a person referred to in paragraph (1);

(4) forms an entity with the purpose of evading sanctions that would otherwise be imposed pursuant to paragraph (3);

(5) is acting for or on behalf of a person referred to in paragraph (1), (2), (3), or (4); or

(6) knowingly provides or attempts to provide financial, material, technological, or other support for, or goods or services in support of, a person referred to in paragraph (1), (2), (3), (4) or (5).

(c) Sanctions Described.—The sanctions described in this subsection are the following:

(1) BLOCKING OF PROPERTY.—The President shall block, in accordance with the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.), all transactions in all property and interests in property of any person subject to subsection (b) if such property and interests in property are in the United States, come within the United States, or are or come within the possession or control of a United States person.

(2) EXCLUSION FROM UNITED STATES.—The Secretary of State shall deny a visa to, and the Secretary of Homeland Security shall exclude from the United States, any person subject to subsection (b) that is an alien.

(d) Penalties.—A person that violates, attempts to violate, conspires to violate, or causes a violation of subsection (c)(1) or any regulation, license, or order issued to carry out that subsection shall be subject to the penalties set forth in subsections (b) and (c) of section 206 of the International Emergency Economic Powers Act (50 U.S.C. 1705) to the same extent as a person that commits an unlawful act described in subsection (a) of that section.

(e) Report On Contributions To Iran’s Ballistic Missile Program.—

(1) IN GENERAL.—Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter, the President shall submit to the appropriate congressional committees a report describing each person that—

(A) has, during the period specified in paragraph (2), conducted any activity that has materially contributed to the activities of the Government of Iran with respect to its ballistic missile program, or any other program in Iran for developing, deploying, or maintaining systems capable of delivering weapons of mass destruction, including any efforts to manufacture, acquire, possess, develop, transport, transfer, or use such capabilities;

(B) is a successor entity to a person referred to in subparagraph (A);

(C) owns or controls or is owned or controlled by a person referred to in subparagraph (A);

(D) forms an entity with the purpose of evading sanctions that could be imposed as a result of a relationship described in subparagraph (C);

(E) is acting for or on behalf of a person referred to in subparagraph (A), (B), (C), or (D); or

(F) is known or believed to have provided, or attempted to provide, during the period specified in paragraph (2), financial, material, technological, or other support for, or goods or services in support of, any material contribution to a program described in subparagraph (A) carried out by a person described in subparagraph (A), (B), (C), (D), or (E).

(2) PERIOD SPECIFIED.—The period specified in this paragraph is—

(A) in the case of the first report submitted under paragraph (1), the period beginning January 1, 2016, and ending on the date the report is submitted; and

(B) in the case of a subsequent such report, the 180-day period preceding the submission of the report.

(3) FORM OF REPORT.—Each report required by paragraph (1) shall be submitted in unclassified form but may include a classified annex.

 

SEC. 105. IMPOSITION OF TERRORISM-RELATED SANCTIONS WITH RESPECT TO THE IRGC.

(a) Findings.—Congress makes the following findings:

(1) The IRGC is subject to sanctions pursuant to Executive Order No. 13382 (50 U.S.C. 1701 note; relating to blocking property of weapons of mass destruction delivery system proliferators and their supporters), the Comprehensive Iran Sanctions, Accountability, and Divestment Act of 2010 (22 U.S.C. 8501 et seq.), Executive Order No. 13553 (50 U.S.C. 1701 note; relating to blocking property of certain persons with respect to serious human rights abuses by the Government of Iran), and Executive Order No. 13606 (50 U.S.C. 1701 note; relating to blocking the property and suspending entry into the United States of certain persons with respect to grave human rights abuses by the Governments of Iran and Syria via information technology).

(2) The Iranian Revolutionary Guard Corps–Quds Force (in this section referred to as the “IRGC–QF”) is the primary arm of the Government of Iran for executing its policy of supporting terrorist and insurgent groups. The IRGC–QF provides material, logistical assistance, training, and financial support to militants and terrorist operatives throughout the Middle East and South Asia and was designated for the imposition of sanctions by the Secretary of the Treasury pursuant to Executive Order No. 13224 (50 U.S.C. 1701 note; relating to blocking property and prohibiting transactions with persons who commit, threaten to commit, or support terrorism) in October 2007 for its support of terrorism.

(3) The IRGC, not just the IRGC–QF, is responsible for implementing Iran’s international program of destabilizing activities, support for acts of international terrorism, and ballistic missile program.

(b) In General.—Beginning on the date that is 90 days after the date of the enactment of this Act, the President shall impose the sanctions described in subsection (c) with respect to the IRGC and foreign persons that are officials, agents, or affiliates of the IRGC.

(c) Sanctions Described.—The sanctions described in this subsection are sanctions applicable with respect to a foreign person pursuant to Executive Order No. 13224 (50 U.S.C. 1701 note; relating to blocking property and prohibiting transactions with persons who commit, threaten to commit, or support terrorism).

 

SEC. 106. IMPOSITION OF ADDITIONAL SANCTIONS WITH RESPECT TO PERSONS RESPONSIBLE FOR HUMAN RIGHTS ABUSES.

(a) In General.—Not later than 90 days after the date of the enactment of this Act, and annually thereafter, the Secretary of State shall submit to the appropriate congressional committees a list of each person the Secretary determines, based on credible evidence, on or after the date of the enactment of this Act—

(1) is responsible for extrajudicial killings, torture, or other gross violations of internationally recognized human rights committed against individuals in Iran who seek—

(A) to expose illegal activity carried out by officials of the Government of Iran; or

(B) to obtain, exercise, defend, or promote internationally recognized human rights and freedoms, such as the freedoms of religion, expression, association, and assembly, and the rights to a fair trial and democratic elections; or

(2) acts as an agent of or on behalf of a foreign person in a matter relating to an activity described in paragraph (1).

(b) Sanctions Described.—

(1) IN GENERAL.—The President may, in accordance with the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.), block all transactions in all property and interests in property of a person on the list required by subsection (a) if such property and interests in property are in the United States, come within the United States, or are or come within the possession or control of a United States person.

(2) PENALTIES.—A person that violates, attempts to violate, conspires to violate, or causes a violation of paragraph (1) or any regulation, license, or order issued to carry out paragraph (1) shall be subject to the penalties set forth in subsections (b) and (c) of section 206 of the International Emergency Economic Powers Act (50 U.S.C. 1705) to the same extent as a person that commits an unlawful act described in subsection (a) of that section.

 

SEC. 107. ENFORCEMENT OF ARMS EMBARGOS.

(a) In General.—Except as provided in subsection (d), the President shall impose the sanctions described in subsection (b) with respect to any person that the President determines—

(1) knowingly engages in any activity that materially contributes to the supply, sale, or transfer directly or indirectly to or from Iran, or for the use in or benefit of Iran, of any battle tanks, armored combat vehicles, large caliber artillery systems, combat aircraft, attack helicopters, warships, missiles or missile systems, as defined for the purpose of the United Nations Register of Conventional Arms, or related materiel, including spare parts; or

(2) knowingly provides to Iran any technical training, financial resources or services, advice, other services or assistance related to the supply, sale, transfer, manufacture, maintenance, or use of arms and related materiel described in paragraph (1).

(b) Sanctions Described.—

(1) BLOCKING OF PROPERTY.—The President shall block, in accordance with the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.), all transactions in all property and interests in property of any person subject to subsection (a) if such property and interests in property are in the United States, come within the United States, or are or come within the possession or control of a United States person.

(2) EXCLUSION FROM UNITED STATES.—The Secretary of State shall deny a visa to, and the Secretary of Homeland Security shall exclude from the United States, any person subject to subsection (a) that is an alien.

(c) Penalties.—A person that violates, attempts to violate, conspires to violate, or causes a violation of subsection (b)(1) or any regulation, license, or order issued to carry out that subsection shall be subject to the penalties set forth in subsections (b) and (c) of section 206 of the International Emergency Economic Powers Act (50 U.S.C. 1705) to the same extent as a person that commits an unlawful act described in subsection (a) of that section.

(d) Exception.—The President is not required to impose sanctions under subsection (a) with respect to a person for engaging in an activity described in that subsection if the President certifies to the appropriate congressional committees that—

(1) permitting the activity is in the national security interest of the United States;

(2) Iran no longer presents a significant threat to the national security of the United States and to the allies of the United States; and

(3) the Government of Iran has ceased providing operational or financial support for acts of international terrorism and no longer satisfies the requirements for designation as a state sponsor of terrorism.

(e) State Sponsor Of Terrorism Defined.—In this section, the term “state sponsor of terrorism” means a country the government of which the Secretary of State has determined to be a government that has repeatedly provided support for acts of international terrorism for purposes of—

(1) section 6(j)(1)(A) of the Export Administration Act of 1979 (50 U.S.C. 4605(j)(1)(A)) (as continued in effect pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.));

(2) section 620A(a) of the Foreign Assistance Act of 1961 (22 U.S.C. 2371(a));

(3) section 40(d) of the Arms Export Control Act (22 U.S.C. 2780(d)); or

(4) any other provision of law.

 

SEC. 108. REVIEW OF APPLICABILITY OF SANCTIONS RELATING TO IRAN’S SUPPORT FOR TERRORISM AND ITS BALLISTIC MISSILE PROGRAM.

(a) In General.—Not later than 5 years after the date of the enactment of this Act, the President shall conduct a review of all persons on the list of specially designated nationals and blocked persons maintained by the Office of Foreign Assets Control of the Department of the Treasury for activities relating to Iran—

(1) to assess the conduct of such persons as that conduct relates to—

(A) any activity that materially contributes to the activities of the Government of Iran with respect to its ballistic missile program; or

(B) support by the Government of Iran for acts of international terrorism; and

(2) to determine the applicability of sanctions with respect to such persons under—

(A) Executive Order No. 13382 (50 U.S.C. 1701 note; relating to blocking property of weapons of mass destruction delivery system proliferators and their supporters); or

(B) Executive Order No. 13224 (50 U.S.C. 1701 note; relating to blocking property and prohibiting transactions with persons who commit, threaten to commit, or support terrorism).

(b) Implementation Of Sanctions.—If the President determines under subsection (a) that sanctions under an Executive order specified in paragraph (2) of that subsection are applicable with respect to a person, the President shall—

(1) impose sanctions with respect to that person pursuant to that Executive order; or

(2) exercise the waiver authority provided under section 112.

 

SEC. 109. REPORT ON COORDINATION OF SANCTIONS BETWEEN THE UNITED STATES AND THE EUROPEAN UNION.

(a) In General.—Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter, the President shall submit to the appropriate congressional committees a report that includes the following:

(1) A description of each instance, during the period specified in subsection (b)—

(A) in which the United States has imposed sanctions with respect to a person for activity related to the proliferation of weapons of mass destruction or delivery systems for such weapons to or by Iran, support for acts of international terrorism by Iran, or human rights abuses in Iran, but in which the European Union has not imposed corresponding sanctions; and

(B) in which the European Union has imposed sanctions with respect to a person for activity related to the proliferation of weapons of mass destruction or delivery systems for such weapons to or by Iran, support for acts of international terrorism by Iran, or human rights abuses in Iran, but in which the United States has not imposed corresponding sanctions.

(2) An explanation for the reason for each discrepancy between sanctions imposed by the European Union and sanctions imposed by the United States described in subparagraphs (A) and (B) of paragraph (1).

(b) Period Specified.—The period specified in this subsection is—

(1) in the case of the first report submitted under subsection (a), the period beginning on the date of the enactment of this Act and ending on the date the report is submitted; and

(2) in the case of a subsequent such report, the 180-day period preceding the submission of the report.

(c) Form Of Report.—The report required by subsection (a) shall be submitted in unclassified form but may include a classified annex.

 

SEC. 110. REPORT ON UNITED STATES CITIZENS DETAINED BY IRAN.

(a) In General.—Not later than 90 days after the date of the enactment of this Act, and every 180 days thereafter, the President shall submit to the appropriate congressional committees and leadership a report on United States citizens, including United States citizens who are also citizens of other countries, detained by Iran or groups supported by Iran that includes—

(1) information regarding any officials of the Government of Iran involved in any way in the detentions; and

(2) a summary of efforts the United States Government has taken to secure the swift release of those United States citizens.

(b) Form Of Report.—The report required by subsection (a) shall be submitted in unclassified form, but may include a classified annex.

(c) Appropriate Congressional Committees And Leadership Defined.—In this section, the term “appropriate congressional committees and leadership” means—

(1) the Committee on Finance, the Committee on Banking, Housing, and Urban Affairs, the Committee on Foreign Relations, and the majority and minority leaders of the Senate; and

(2) the Committee on Ways and Means, the Committee on Financial Services, the Committee on Foreign Affairs, and the Speaker, the majority leader, and the minority leader of the House of Representatives.

 

SEC. 111. EXCEPTIONS FOR NATIONAL SECURITY AND HUMANITARIAN ASSISTANCE; RULE OF CONSTRUCTION.

(a) In General.—The following activities shall be exempt from sanctions under sections 104, 105, 106, and 107:

(1) Any activity subject to the reporting requirements under title V of the National Security Act of 1947 (50 U.S.C. 3091 et seq.), or to any authorized intelligence activities of the United States.

(2) The admission of an alien to the United States if such admission is necessary to comply with United States obligations under the Agreement between the United Nations and the United States of America regarding the Headquarters of the United Nations, signed at Lake Success June 26, 1947, and entered into force November 21, 1947, or under the Convention on Consular Relations, done at Vienna April 24, 1963, and entered into force March 19, 1967, or other applicable international obligations of the United States.

(3) The conduct or facilitation of a transaction for the sale of agricultural commodities, food, medicine, or medical devices to Iran or for the provision of humanitarian assistance to the people of Iran, including engaging in a financial transaction relating to humanitarian assistance or for humanitarian purposes or transporting goods or services that are necessary to carry out operations relating to humanitarian assistance or humanitarian purposes.

(b) Implementation.—The President may exercise all authorities provided under sections 203 and 205 of the International Emergency Economic Powers Act (50 U.S.C. 1702 and 1704) to carry out this Act.

(c) Rule Of Construction.—Nothing in this Act shall be construed to limit the authority of the President under the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.).

(d) Definitions.—In this section:

(1) AGRICULTURAL COMMODITY.—The term “agricultural commodity” has the meaning given that term in section 102 of the Agricultural Trade Act of 1978 (7 U.S.C. 5602).

(2) GOOD.—The term “good” has the meaning given that term in section 16 of the Export Administration Act of 1979 (50 U.S.C. 4618) (as continued in effect pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.)).

(3) MEDICAL DEVICE.—The term “medical device” has the meaning given the term “device” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).

(4) MEDICINE.—The term “medicine” has the meaning given the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).

 

SEC. 112. PRESIDENTIAL WAIVER AUTHORITY.

(a) Case-By-Case Waiver Authority.—

(1) IN GENERAL.—The President may waive, on a case-by-case basis and for a period of not more than 180 days, a requirement under section 104, 105, 106, 107, or 108 to impose or maintain sanctions with respect to a person, and may waive the continued imposition of such sanctions, not less than 30 days after the President determines and reports to the appropriate congressional committees that it is vital to the national security interests of the United States to waive such sanctions.

(2) RENEWAL OF WAIVERS.—The President may, on a case-by-case basis, renew a waiver under paragraph (1) for an additional period of not more than 180 days if, not later than 15 days before that waiver expires, the President makes the determination and submits to the appropriate congressional committees a report described in paragraph (1).

(3) SUCCESSIVE RENEWAL.—The renewal authority provided under paragraph (2) may be exercised for additional successive periods of not more than 180 days if the President follows the procedures set forth in paragraph (2), and submits the report described in paragraph (1), for each such renewal.

(b) Contents Of Waiver Reports.—Each report submitted under subsection (a) in connection with a waiver of sanctions under section 104, 105, 106, 107, or 108 with respect to a person, or the renewal of such a waiver, shall include—

(1) a specific and detailed rationale for the determination that the waiver is vital to the national security interests of the United States;

(2) a description of the activity that resulted in the person being subject to sanctions;

(3) an explanation of any efforts made by the United States, as applicable, to secure the cooperation of the government with primary jurisdiction over the person or the location where the activity described in paragraph (2) occurred in terminating or, as appropriate, penalizing the activity; and

(4) an assessment of the significance of the activity described in paragraph (2) in contributing to the ability of Iran to threaten the interests of the United States or allies of the United States, develop systems capable of delivering weapons of mass destruction, support acts of international terrorism, or violate the human rights of any person in Iran.

(c) Effect Of Report On Waiver.—If the President submits a report under subsection (a) in connection with a waiver of sanctions under section 104, 105, 106, 107, or 108 with respect to a person, or the renewal of such a waiver, the President shall not be required to impose or maintain sanctions under section 104, 105, 106, 107, or 108, as applicable, with respect to the person described in the report during the 30-day period referred to in subsection (a).

TITLE II—SANCTIONS WITH RESPECT TO THE RUSSIAN FEDERATION AND COMBATING TERRORISM AND ILLICIT FINANCING

 

SEC. 201. SHORT TITLE.

This title may be cited as the “Countering Russian Influence in Europe and Eurasia Act of 2017”.

Subtitle A—Sanctions And Other Measures With Respect To The Russian Federation

 

SEC. 211. FINDINGS.

Congress makes the following findings:

(1) On March 6, 2014, President Barack Obama issued Executive Order No. 13660 (79 Fed. Reg. 13493; relating to blocking property of certain persons contributing to the situation in Ukraine), which authorizes the Secretary of the Treasury, in consultation with the Secretary of State, to impose sanctions on those determined to be undermining democratic processes and institutions in Ukraine or threatening the peace, security, stability, sovereignty, and territorial integrity of Ukraine. President Obama subsequently issued Executive Order No. 13661 (79 Fed. Reg. 15535; relating to blocking property of additional persons contributing to the situation in Ukraine) and Executive Order No. 13662 (79 Fed. Reg. 16169; relating to blocking property of additional persons contributing to the situation in Ukraine) to expand sanctions on certain persons contributing to the situation in Ukraine.

(2) On December 18, 2014, the Ukraine Freedom Support Act of 2014 was enacted (Public Law 113–27222 U.S.C. 8921 et seq.), which includes provisions directing the President to impose sanctions on foreign persons that the President determines to be entities owned or controlled by the Government of the Russian Federation or nationals of the Russian Federation that manufacture, sell, transfer, or otherwise provide certain defense articles into Syria.

(3) On April 1, 2015, President Obama issued Executive Order No. 13694 (80 Fed. Reg. 18077; relating to blocking the property of certain persons engaging in significant malicious cyber-enabled activities), which authorizes the Secretary of the Treasury, in consultation with the Attorney General and the Secretary of State, to impose sanctions on persons determined to be engaged in malicious cyber-hacking.

(4) On July 26, 2016, President Obama approved a Presidential Policy Directive on United States Cyber Incident Coordination, which states, “certain cyber incidents that have significant impacts on an entity, our national security, or the broader economy require a unique approach to response efforts”.

(5) On December 29, 2016, President Obama issued an annex to Executive Order No. 13694, which authorized sanctions on the following entities and individuals:

(A) The Main Intelligence Directorate (also known as Glavnoe Razvedyvatel’noe Upravlenie or the GRU) in Moscow, Russian Federation.

(B) The Federal Security Service (also known as Federalnaya Sluzhba Bezopasnosti or the FSB) in Moscow, Russian Federation.

(C) The Special Technology Center (also known as STLC, Ltd. Special Technology Center St. Petersburg) in St. Petersburg, Russian Federation.

(D) Zorsecurity (also known as Esage Lab) in Moscow, Russian Federation.

(E) The autonomous noncommercial organization known as the Professional Association of Designers of Data Processing Systems (also known as ANO PO KSI) in Moscow, Russian Federation.

(F) Igor Valentinovich Korobov.

(G) Sergey Aleksandrovich Gizunov.

(H) Igor Olegovich Kostyukov.

(I) Vladimir Stepanovich Alexseyev.

(6) On January 6, 2017, an assessment of the United States intelligence community entitled, “Assessing Russian Activities and Intentions in Recent U.S. Elections” stated, “Russian President Vladimir Putin ordered an influence campaign in 2016 aimed at the United States presidential election.” The assessment warns that “Moscow will apply lessons learned from its Putin-ordered campaign aimed at the U.S. Presidential election to future influence efforts worldwide, including against U.S. allies and their election processes”.

 

SEC. 212. SENSE OF CONGRESS.

It is the sense of Congress that the President—

(1) should continue to uphold and seek unity with European and other key partners on sanctions implemented against the Russian Federation, which have been effective and instrumental in countering Russian aggression in Ukraine;

(2) should engage to the fullest extent possible with partner governments with regard to closing loopholes, including the allowance of extended prepayment for the delivery of goods and commodities and other loopholes, in multilateral and unilateral restrictive measures against the Russian Federation, with the aim of maximizing alignment of those measures; and

(3) should increase efforts to vigorously enforce compliance with sanctions in place as of the date of the enactment of this Act with respect to the Russian Federation in response to the crisis in eastern Ukraine, cyber intrusions and attacks, and human rights violators in the Russian Federation.

PART 1—CONGRESSIONAL REVIEW OF SANCTIONS IMPOSED WITH RESPECT TO THE RUSSIAN FEDERATION

 

SEC. 215. SHORT TITLE.

This part may be cited as the “Russia Sanctions Review Act of 2017”.

 

SEC. 216. CONGRESSIONAL REVIEW OF CERTAIN ACTIONS RELATING TO SANCTIONS IMPOSED WITH RESPECT TO THE RUSSIAN FEDERATION.

(a) Submission To Congress Of Proposed Action.—

(1) IN GENERAL.—Notwithstanding any other provision of law, before taking any action described in paragraph (2), the President shall submit to the appropriate congressional committees and leadership a report that describes the proposed action and the reasons for that action.

(2) ACTIONS DESCRIBED.—

(A) IN GENERAL.—An action described in this paragraph is—

(i) an action to terminate the application of any sanctions described in subparagraph (B);

(ii) with respect to sanctions described in subparagraph (B) imposed by the President with respect to a person, an action to waive the application of those sanctions with respect to that person; or

(iii) a licensing action that significantly alters United States’ foreign policy with regard to the Russian Federation.

(B) SANCTIONS DESCRIBED.—The sanctions described in this subparagraph are—

(i) sanctions provided for under—

(I) this title or any provision of law amended by this title, including the Executive orders codified under section 222;

(II) the Support for the Sovereignty, Integrity, Democracy, and Economic Stability of Ukraine Act of 2014 (22 U.S.C. 8901 et seq.); or

(III) the Ukraine Freedom Support Act of 2014 (22 U.S.C. 8921 et seq.); and

(ii) the prohibition on access to the properties of the Government of the Russian Federation located in Maryland and New York that the President ordered vacated on December 29, 2016.

(3) DESCRIPTION OF TYPE OF ACTION.—Each report submitted under paragraph (1) with respect to an action described in paragraph (2) shall include a description of whether the action—

(A) is not intended to significantly alter United States foreign policy with regard to the Russian Federation; or

(B) is intended to significantly alter United States foreign policy with regard to the Russian Federation.

(4) INCLUSION OF ADDITIONAL MATTER.—

(A) IN GENERAL.—Each report submitted under paragraph (1) that relates to an action that is intended to significantly alter United States foreign policy with regard to the Russian Federation shall include a description of—

(i) the significant alteration to United States foreign policy with regard to the Russian Federation;

(ii) the anticipated effect of the action on the national security interests of the United States; and

(iii) the policy objectives for which the sanctions affected by the action were initially imposed.

(B) REQUESTS FROM BANKING AND FINANCIAL SERVICES COMMITTEES.—The Committee on Banking, Housing, and Urban Affairs of the Senate or the Committee on Financial Services of the House of Representatives may request the submission to the Committee of the matter described in clauses (ii) and (iii) of subparagraph (A) with respect to a report submitted under paragraph (1) that relates to an action that is not intended to significantly alter United States foreign policy with regard to the Russian Federation.

(5) CONFIDENTIALITY OF PROPRIETARY INFORMATION.—Proprietary information that can be associated with a particular person with respect to an action described in paragraph (2) may be included in a report submitted under paragraph (1) only if the appropriate congressional committees and leadership provide assurances of confidentiality, unless such person otherwise consents in writing to such disclosure.

(6) RULE OF CONSTRUCTION.—Paragraph (2)(A)(iii) shall not be construed to require the submission of a report under paragraph (1) with respect to the routine issuance of a license that does not significantly alter United States foreign policy with regard to the Russian Federation.

(b) Period For Review By Congress.—

(1) IN GENERAL.—During the period of 30 calendar days beginning on the date on which the President submits a report under subsection (a)(1)—

(A) in the case of a report that relates to an action that is not intended to significantly alter United States foreign policy with regard to the Russian Federation, the Committee on Banking, Housing, and Urban Affairs of the Senate and the Committee on Financial Services of the House of Representatives should, as appropriate, hold hearings and briefings and otherwise obtain information in order to fully review the report; and

(B) in the case of a report that relates to an action that is intended to significantly alter United States foreign policy with regard to the Russian Federation, the Committee on Foreign Relations of the Senate and the Committee on Foreign Affairs of the House of Representatives should, as appropriate, hold hearings and briefings and otherwise obtain information in order to fully review the report.

(2) EXCEPTION.—The period for congressional review under paragraph (1) of a report required to be submitted under subsection (a)(1) shall be 60 calendar days if the report is submitted on or after July 10 and on or before September 7 in any calendar year.

(3) LIMITATION ON ACTIONS DURING INITIAL CONGRESSIONAL REVIEW PERIOD.—Notwithstanding any other provision of law, during the period for congressional review provided for under paragraph (1) of a report submitted under subsection (a)(1) proposing an action described in subsection (a)(2), including any additional period for such review as applicable under the exception provided in paragraph (2), the President may not take that action unless a joint resolution of approval with respect to that action is enacted in accordance with subsection (c).

(4) LIMITATION ON ACTIONS DURING PRESIDENTIAL CONSIDERATION OF A JOINT RESOLUTION OF DISAPPROVAL.—Notwithstanding any other provision of law, if a joint resolution of disapproval relating to a report submitted under subsection (a)(1) proposing an action described in subsection (a)(2) passes both Houses of Congress in accordance with subsection (c), the President may not take that action for a period of 12 calendar days after the date of passage of the joint resolution of disapproval.

(5) LIMITATION ON ACTIONS DURING CONGRESSIONAL RECONSIDERATION OF A JOINT RESOLUTION OF DISAPPROVAL.—Notwithstanding any other provision of law, if a joint resolution of disapproval relating to a report submitted under subsection (a)(1) proposing an action described in subsection (a)(2) passes both Houses of Congress in accordance with subsection (c), and the President vetoes the joint resolution, the President may not take that action for a period of 10 calendar days after the date of the President’s veto.

(6) EFFECT OF ENACTMENT OF A JOINT RESOLUTION OF DISAPPROVAL.—Notwithstanding any other provision of law, if a joint resolution of disapproval relating to a report submitted under subsection (a)(1) proposing an action described in subsection (a)(2) is enacted in accordance with subsection (c), the President may not take that action.

(c) Joint Resolutions Of Disapproval Or Approval Defined.—In this subsection:

(1) JOINT RESOLUTION OF APPROVAL.—The term “joint resolution of approval” means only a joint resolution of either House of Congress—

(A) the title of which is as follows: “A joint resolution approving the President's proposal to take an action relating to the application of certain sanctions with respect to the Russian Federation.”; and

(B) the sole matter after the resolving clause of which is the following: “Congress approves of the action relating to the application of sanctions imposed with respect to the Russian Federation proposed by the President in the report submitted to Congress under section 216(a)(1) of the Russia Sanctions Review Act of 2017 on _______ relating to ________.”, with the first blank space being filled with the appropriate date and the second blank space being filled with a short description of the proposed action.

(2) JOINT RESOLUTION OF DISAPPROVAL.—The term “joint resolution of disapproval” means only a joint resolution of either House of Congress—

(A) the title of which is as follows: “A joint resolution disapproving the President's proposal to take an action relating to the application of certain sanctions with respect to the Russian Federation.”; and

(B) the sole matter after the resolving clause of which is the following: “Congress disapproves of the action relating to the application of sanctions imposed with respect to the Russian Federation proposed by the President in the report submitted to Congress under section 216(a)(1) of the Russia Sanctions Review Act of 2017 on _______ relating to ________.”, with the first blank space being filled with the appropriate date and the second blank space being filled with a short description of the proposed action.

(3) INTRODUCTION.—During the period of 30 calendar days provided for under subsection (b)(1), including any additional period as applicable under the exception provided in subsection (b)(2), a joint resolution of approval or joint resolution of disapproval may be introduced—

(A) in the House of Representatives, by the majority leader or the minority leader; and

(B) in the Senate, by the majority leader (or the majority leader's designee) or the minority leader (or the minority leader's designee).

(4) FLOOR CONSIDERATION IN HOUSE OF REPRESENTATIVES.—If a committee of the House of Representatives to which a joint resolution of approval or joint resolution of disapproval has been referred has not reported the joint resolution within 10 calendar days after the date of referral, that committee shall be discharged from further consideration of the joint resolution.

(5) CONSIDERATION IN THE SENATE.—

(A) COMMITTEE REFERRAL.—A joint resolution of approval or joint resolution of disapproval introduced in the Senate shall be—

(i) referred to the Committee on Banking, Housing, and Urban Affairs if the joint resolution relates to a report under subsection (a)(3)(A) that relates to an action that is not intended to significantly alter United States foreign policy with regard to the Russian Federation; and

(ii) referred to the Committee on Foreign Relations if the joint resolution relates to a report under subsection (a)(3)(B) that relates to an action that is intended to significantly alter United States foreign policy with respect to the Russian Federation.

(B) REPORTING AND DISCHARGE.—If the committee to which a joint resolution of approval or joint resolution of disapproval was referred has not reported the joint resolution within 10 calendar days after the date of referral of the joint resolution, that committee shall be discharged from further consideration of the joint resolution and the joint resolution shall be placed on the appropriate calendar.

(C) PROCEEDING TO CONSIDERATION.—Notwithstanding Rule XXII of the Standing Rules of the Senate, it is in order at any time after the Committee on Banking, Housing, and Urban Affairs or the Committee on Foreign Relations, as the case may be, reports a joint resolution of approval or joint resolution of disapproval to the Senate or has been discharged from consideration of such a joint resolution (even though a previous motion to the same effect has been disagreed to) to move to proceed to the consideration of the joint resolution, and all points of order against the joint resolution (and against consideration of the joint resolution) are waived. The motion to proceed is not debatable. The motion is not subject to a motion to postpone. A motion to reconsider the vote by which the motion is agreed to or disagreed to shall not be in order.

(D) RULINGS OF THE CHAIR ON PROCEDURE.—Appeals from the decisions of the Chair relating to the application of the rules of the Senate, as the case may be, to the procedure relating to a joint resolution of approval or joint resolution of disapproval shall be decided without debate.

(E) CONSIDERATION OF VETO MESSAGES.—Debate in the Senate of any veto message with respect to a joint resolution of approval or joint resolution of disapproval, including all debatable motions and appeals in connection with the joint resolution, shall be limited to 10 hours, to be equally divided between, and controlled by, the majority leader and the minority leader or their designees.

(6) RULES RELATING TO SENATE AND HOUSE OF REPRESENTATIVES.—

(A) TREATMENT OF SENATE JOINT RESOLUTION IN HOUSE.—In the House of Representatives, the following procedures shall apply to a joint resolution of approval or a joint resolution of disapproval received from the Senate (unless the House has already passed a joint resolution relating to the same proposed action):

(i) The joint resolution shall be referred to the appropriate committees.

(ii) If a committee to which a joint resolution has been referred has not reported the joint resolution within 2 calendar days after the date of referral, that committee shall be discharged from further consideration of the joint resolution.

(iii) Beginning on the third legislative day after each committee to which a joint resolution has been referred reports the joint resolution to the House or has been discharged from further consideration thereof, it shall be in order to move to proceed to consider the joint resolution in the House. All points of order against the motion are waived. Such a motion shall not be in order after the House has disposed of a motion to proceed on the joint resolution. The previous question shall be considered as ordered on the motion to its adoption without intervening motion. The motion shall not be debatable. A motion to reconsider the vote by which the motion is disposed of shall not be in order.

(iv) The joint resolution shall be considered as read. All points of order against the joint resolution and against its consideration are waived. The previous question shall be considered as ordered on the joint resolution to final passage without intervening motion except 2 hours of debate equally divided and controlled by the sponsor of the joint resolution (or a designee) and an opponent. A motion to reconsider the vote on passage of the joint resolution shall not be in order.

(B) TREATMENT OF HOUSE JOINT RESOLUTION IN SENATE.—

(i) If, before the passage by the Senate of a joint resolution of approval or joint resolution of disapproval, the Senate receives an identical joint resolution from the House of Representatives, the following procedures shall apply:

(I) That joint resolution shall not be referred to a committee.

(II) With respect to that joint resolution—

(aa) the procedure in the Senate shall be the same as if no joint resolution had been received from the House of Representatives; but

(bb) the vote on passage shall be on the joint resolution from the House of Representatives.

(ii) If, following passage of a joint resolution of approval or joint resolution of disapproval in the Senate, the Senate receives an identical joint resolution from the House of Representatives, that joint resolution shall be placed on the appropriate Senate calendar.

(iii) If a joint resolution of approval or a joint resolution of disapproval is received from the House, and no companion joint resolution has been introduced in the Senate, the Senate procedures under this subsection shall apply to the House joint resolution.

(C) APPLICATION TO REVENUE MEASURES.—The provisions of this paragraph shall not apply in the House of Representatives to a joint resolution of approval or joint resolution of disapproval that is a revenue measure.

(7) RULES OF HOUSE OF REPRESENTATIVES AND SENATE.—This subsection is enacted by Congress—

(A) as an exercise of the rulemaking power of the Senate and the House of Representatives, respectively, and as such is deemed a part of the rules of each House, respectively, and supersedes other rules only to the extent that it is inconsistent with such rules; and

(B) with full recognition of the constitutional right of either House to change the rules (so far as relating to the procedure of that House) at any time, in the same manner, and to the same extent as in the case of any other rule of that House.

(d) Appropriate Congressional Committees And Leadership Defined.—In this section, the term “appropriate congressional committees and leadership” means—

(1) the Committee on Banking, Housing, and Urban Affairs, the Committee on Foreign Relations, and the majority and minority leaders of the Senate; and

(2) the Committee on Financial Services, the Committee on Foreign Affairs, and the Speaker, the majority leader, and the minority leader of the House of Representatives.

PART 2—SANCTIONS WITH RESPECT TO THE RUSSIAN FEDERATION

 

SEC. 221. DEFINITIONS.

In this part:

(1) APPROPRIATE CONGRESSIONAL COMMITTEES.—The term “appropriate congressional committees” means—

(A) the Committee on Banking, Housing, and Urban Affairs, the Committee on Foreign Relations, and the Committee on Finance of the Senate; and

(B) the Committee on Foreign Affairs, the Committee on Financial Services, and the Committee on Ways and Means of the House of Representatives.

(2) GOOD.—The term “good” has the meaning given that term in section 16 of the Export Administration Act of 1979 (50 U.S.C. 4618) (as continued in effect pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.)).

(3) INTERNATIONAL FINANCIAL INSTITUTION.—The term “international financial institution” has the meaning given that term in section 1701(c) of the International Financial Institutions Act (22 U.S.C. 262r(c)).

(4) KNOWINGLY.—The term “knowingly”, with respect to conduct, a circumstance, or a result, means that a person has actual knowledge, or should have known, of the conduct, the circumstance, or the result.

(5) PERSON.—The term “person” means an individual or entity.

(6) UNITED STATES PERSON.—The term “United States person” means—

(A) a United States citizen or an alien lawfully admitted for permanent residence to the United States; or

(B) an entity organized under the laws of the United States or of any jurisdiction within the United States, including a foreign branch of such an entity.

 

SEC. 222. CODIFICATION OF SANCTIONS RELATING TO THE RUSSIAN FEDERATION.

(a) Codification.—United States sanctions provided for in Executive Order No. 13660 (79 Fed. Reg. 13493; relating to blocking property of certain persons contributing to the situation in Ukraine), Executive Order No. 13661 (79 Fed. Reg. 15535; relating to blocking property of additional persons contributing to the situation in Ukraine), Executive Order No. 13662 (79 Fed. Reg. 16169; relating to blocking property of additional persons contributing to the situation in Ukraine), Executive Order No. 13685 (79 Fed. Reg. 77357; relating to blocking property of certain persons and prohibiting certain transactions with respect to the Crimea region of Ukraine), Executive Order No. 13694 (80 Fed. Reg. 18077; relating to blocking the property of certain persons engaging in significant malicious cyber-enabled activities), and Executive Order No. 13757 (82 Fed. Reg. 1; relating to taking additional steps to address the national emergency with respect to significant malicious cyber-enabled activities), as in effect on the day before the date of the enactment of this Act, including with respect to all persons sanctioned under such Executive orders, shall remain in effect except as provided in subsection (b).

(b) Termination Of Certain Sanctions.—Subject to section 216, the President may terminate the application of sanctions described in subsection (a) that are imposed on a person in connection with activity conducted by the person if the President submits to the appropriate congressional committees a notice that—

(1) the person is not engaging in the activity that was the basis for the sanctions or has taken significant verifiable steps toward stopping the activity; and

(2) the President has received reliable assurances that the person will not knowingly engage in activity subject to sanctions described in subsection (a) in the future.

(c) Application Of New Cyber Sanctions.—The President may waive the initial application under subsection (a) of sanctions with respect to a person under Executive Order No. 13694 or 13757 only if the President submits to the appropriate congressional committees—

(1) a written determination that the waiver—

(A) is in the vital national security interests of the United States; or

(B) will further the enforcement of this title; and

(2) a certification that the Government of the Russian Federation has made significant efforts to reduce the number and intensity of cyber intrusions conducted by that Government.

(d) Application Of New Ukraine-Related Sanctions.—The President may waive the initial application under subsection (a) of sanctions with respect to a person under Executive Order No. 13660, 13661, 13662, or 13685 only if the President submits to the appropriate congressional committees—

(1) a written determination that the waiver—

(A) is in the vital national security interests of the United States; or

(B) will further the enforcement of this title; and

(2) a certification that the Government of the Russian Federation is taking steps to implement the Minsk Agreement to address the ongoing conflict in eastern Ukraine, signed in Minsk, Belarus, on February 11, 2015, by the leaders of Ukraine, Russia, France, and Germany, the Minsk Protocol, which was agreed to on September 5, 2014, and any successor agreements that are agreed to by the Government of Ukraine.

 

SEC. 223. MODIFICATION OF IMPLEMENTATION OF EXECUTIVE ORDER NO. 13662.

(a) Determination That Certain Entities Are Subject To Sanctions.—The Secretary of the Treasury may determine that a person meets one or more of the criteria in section 1(a) of Executive Order No. 13662 if that person is a state-owned entity operating in the railway or metals and mining sector of the economy of the Russian Federation.

(b) Modification Of Directive 1 With Respect To The Financial Services Sector Of The Russian Federation Economy.—Not later than 60 days after the date of the enactment of this Act, the Secretary of the Treasury shall modify Directive 1 (as amended), dated September 12, 2014, issued by the Office of Foreign Assets Control under Executive Order No. 13662, or any successor directive (which shall be effective beginning on the date that is 60 days after the date of such modification), to ensure that the directive prohibits the conduct by United States persons or persons within the United States of all transactions in, provision of financing for, and other dealings in new debt of longer than 14 days maturity or new equity of persons determined to be subject to the directive, their property, or their interests in property.

(c) Modification Of Directive 2 With Respect To The Energy Sector Of The Russian Federation Economy.—Not later than 60 days after the date of the enactment of this Act, the Secretary of the Treasury shall modify Directive 2 (as amended), dated September 12, 2014, issued by the Office of Foreign Assets Control under Executive Order No. 13662, or any successor directive (which shall be effective beginning on the date that is 60 days after the date of such modification), to ensure that the directive prohibits the conduct by United States persons or persons within the United States of all transactions in, provision of financing for, and other dealings in new debt of longer than 60 days maturity of persons determined to be subject to the directive, their property, or their interests in property.

(d) Modification Of Directive 4.—Not later than 90 days after the date of the enactment of this Act, the Secretary of the Treasury shall modify Directive 4, dated September 12, 2014, issued by the Office of Foreign Assets Control under Executive Order No. 13662, or any successor directive (which shall be effective beginning on the date that is 90 days after the date of such modification), to ensure that the directive prohibits the provision, exportation, or reexportation, directly or indirectly, by United States persons or persons within the United States, of goods, services (except for financial services), or technology in support of exploration or production for new deepwater, Arctic offshore, or shale projects—

(1) that have the potential to produce oil; and

(2) that involve any person determined to be subject to the directive or the property or interests in property of such a person who has a controlling interest or a substantial non-controlling ownership interest in such a project defined as not less than a 33 percent interest.

 

SEC. 224. IMPOSITION OF SANCTIONS WITH RESPECT TO ACTIVITIES OF THE RUSSIAN FEDERATION UNDERMINING CYBERSECURITY.

(a) In General.—On and after the date that is 60 days after the date of the enactment of this Act, the President shall—

(1) impose the sanctions described in subsection (b) with respect to any person that the President determines—

(A) knowingly engages in significant activities undermining cybersecurity against any person, including a democratic institution, or government on behalf of the Government of the Russian Federation; or

(B) is owned or controlled by, or acts or purports to act for or on behalf of, directly or indirectly, a person described in subparagraph (A);

(2) impose five or more of the sanctions described in section 235 with respect to any person that the President determines knowingly materially assists, sponsors, or provides financial, material, or technological support for, or goods or services (except financial services) in support of, an activity described in paragraph (1)(A); and

(3) impose three or more of the sanctions described in section 4(c) of the of the Ukraine Freedom Support Act of 2014 (22 U.S.C. 8923(c)) with respect to any person that the President determines knowingly provides financial services in support of an activity described in paragraph (1)(A).

(b) Sanctions Described.—The sanctions described in this subsection are the following:

(1) ASSET BLOCKING.—The exercise of all powers granted to the President by the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) to the extent necessary to block and prohibit all transactions in all property and interests in property of a person determined by the President to be subject to subsection (a)(1) if such property and interests in property are in the United States, come within the United States, or are or come within the possession or control of a United States person.

(2) EXCLUSION FROM THE UNITED STATES AND REVOCATION OF VISA OR OTHER DOCUMENTATION.—In the case of an alien determined by the President to be subject to subsection (a)(1), denial of a visa to, and exclusion from the United States of, the alien, and revocation in accordance with section 221(i) of the Immigration and Nationality Act (8 U.S.C. 1201(i)), of any visa or other documentation of the alien.

(c) Application Of New Cyber Sanctions.—The President may waive the initial application under subsection (a) of sanctions with respect to a person only if the President submits to the appropriate congressional committees—

(1) a written determination that the waiver—

(A) is in the vital national security interests of the United States; or

(B) will further the enforcement of this title; and

(2) a certification that the Government of the Russian Federation has made significant efforts to reduce the number and intensity of cyber intrusions conducted by that Government.

(d) Significant Activities Undermining Cybersecurity Defined.—In this section, the term “significant activities undermining cybersecurity” includes—

(1) significant efforts—

(A) to deny access to or degrade, disrupt, or destroy an information and communications technology system or network; or

(B) to exfiltrate, degrade, corrupt, destroy, or release information from such a system or network without authorization for purposes of—

(i) conducting influence operations; or

(ii) causing a significant misappropriation of funds, economic resources, trade secrets, personal identifications, or financial information for commercial or competitive advantage or private financial gain;

(2) significant destructive malware attacks; and

(3) significant denial of service activities.

 

SEC. 225. IMPOSITION OF SANCTIONS RELATING TO SPECIAL RUSSIAN CRUDE OIL PROJECTS.

Section 4(b)(1) of the Ukraine Freedom Support Act of 2014 (22 U.S.C. 8923(b)(1)) is amended by striking “on and after the date that is 45 days after the date of the enactment of this Act, the President may impose” and inserting “on and after the date that is 30 days after the date of the enactment of the Countering Russian Influence in Europe and Eurasia Act of 2017, the President shall impose, unless the President determines that it is not in the national interest of the United States to do so,”.

 

SEC. 226. IMPOSITION OF SANCTIONS WITH RESPECT TO RUSSIAN AND OTHER FOREIGN FINANCIAL INSTITUTIONS.

Section 5 of the Ukraine Freedom Support Act of 2014 (22 U.S.C. 8924) is amended—

(1) in subsection (a)—

(A) by striking “may impose” and inserting “shall impose, unless the President determines that it is not in the national interest of the United States to do so,”; and

(B) by striking “on or after the date of the enactment of this Act” and inserting “on or after the date of the enactment of the Countering Russian Influence in Europe and Eurasia Act of 2017”; and

(2) in subsection (b)—

(A) by striking “may impose” and inserting “shall impose, unless the President determines that it is not in the national interest of the United States to do so,”; and

(B) by striking “on or after the date that is 180 days after the date of the enactment of this Act” and inserting “on or after the date that is 30 days after the date of the enactment of the Countering Russian Influence in Europe and Eurasia Act of 2017”.

 

SEC. 227. MANDATORY IMPOSITION OF SANCTIONS WITH RESPECT TO SIGNIFICANT CORRUPTION IN THE RUSSIAN FEDERATION.

Section 9 of the Sovereignty, Integrity, Democracy, and Economic Stability of Ukraine Act of 2014 (22 U.S.C. 8908(a)) is amended—

(1) in subsection (a)—

(A) in the matter preceding paragraph (1), by striking “is authorized and encouraged to” and inserting “shall”; and

(B) in paragraph (1)—

(i) by striking “President determines is” and inserting “President determines is, on or after the date of the enactment of the Countering Russian Influence in Europe and Eurasia Act of 2017,”; and

(ii) by inserting “or elsewhere” after “in the Russian Federation”;

(2) by redesignating subsection (d) as subsection (e);

(3) in subsection (c), by striking “The President” and inserting “except as provided in subsection (d), the President”; and

(4) by inserting after subsection (c) the following:

“(d) Application Of New Sanctions.—The President may waive the initial application of sanctions under subsection (b) with respect to a person only if the President submits to the appropriate congressional committees—

“(1) a written determination that the waiver—

“(A) is in the vital national security interests of the United States; or

“(B) will further the enforcement of this Act; and

“(2) a certification that the Government of the Russian Federation is taking steps to implement the Minsk Agreement to address the ongoing conflict in eastern Ukraine, signed in Minsk, Belarus, on February 11, 2015, by the leaders of Ukraine, Russia, France, and Germany, the Minsk Protocol, which was agreed to on September 5, 2014, and any successor agreements that are agreed to by the Government of Ukraine.”.

 

SEC. 228. MANDATORY IMPOSITION OF SANCTIONS WITH RESPECT TO CERTAIN TRANSACTIONS WITH FOREIGN SANCTIONS EVADERS AND SERIOUS HUMAN RIGHTS ABUSERS IN THE RUSSIAN FEDERATION.

(a) In General.—The Support for the Sovereignty, Integrity, Democracy, and Economic Stability of Ukraine Act of 2014 (22 U.S.C. 8901 et seq.) is amended by adding at the end the following:

“SEC. 10. MANDATORY IMPOSITION OF SANCTIONS WITH RESPECT TO CERTAIN TRANSACTIONS WITH PERSONS THAT EVADE SANCTIONS IMPOSED WITH RESPECT TO THE RUSSIAN FEDERATION.

 

“(a) In General.—The President shall impose the sanctions described in subsection (b) with respect to a foreign person if the President determines that the foreign person knowingly, on or after the date of the enactment of the Countering Russian Influence in Europe and Eurasia Act of 2017—

“(1) materially violates, attempts to violate, conspires to violate, or causes a violation of any license, order, regulation, or prohibition contained in or issued pursuant to any covered Executive order, this Act, or the Ukraine Freedom Support Act of 2014 (22 U.S.C. 8921 et seq.); or

“(2) facilitates a significant transaction or transactions, including deceptive or structured transactions, for or on behalf of—

“(A) any person subject to sanctions imposed by the United States with respect to the Russian Federation; or

“(B) any child, spouse, parent, or sibling of an individual described in subparagraph (A).

“(b) Sanctions Described.—The sanctions described in this subsection are the exercise of all powers granted to the President by the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) to the extent necessary to block and prohibit all transactions in all property and interests in property of a person determined by the President to be subject to subsection (a) if such property and interests in property are in the United States, come within the United States, or are or come within the possession or control of a United States person.

“(c) Implementation; Penalties.—

“(1) IMPLEMENTATION.—The President may exercise all authorities provided to the President under sections 203 and 205 of the International Emergency Economic Powers Act (50 U.S.C. 1702 and 1704) to carry out subsection (b).

“(2) PENALTIES.—A person that violates, attempts to violate, conspires to violate, or causes a violation of subsection (b) or any regulation, license, or order issued to carry out subsection (b) shall be subject to the penalties set forth in subsections (b) and (c) of section 206 of the International Emergency Economic Powers Act (50 U.S.C. 1705) to the same extent as a person that commits an unlawful act described in subsection (a) of that section.

“(d) Application Of New Sanctions.—The President may waive the initial application of sanctions under subsection (b) with respect to a person only if the President submits to the appropriate congressional committees—

“(1) a written determination that the waiver—

“(A) is in the vital national security interests of the United States; or

“(B) will further the enforcement of this Act;

“(2) in the case of sanctions imposed under this section in connection with a covered Executive order described in subparagraph (A), (B), (C), or (D) of subsection (f)(1), a certification that the Government of the Russian Federation is taking steps to implement the Minsk Agreement to address the ongoing conflict in eastern Ukraine, signed in Minsk, Belarus, on February 11, 2015, by the leaders of Ukraine, Russia, France, and Germany, the Minsk Protocol, which was agreed to on September 5, 2014, and any successor agreements that are agreed to by the Government of Ukraine; and

“(3) in the case of sanctions imposed under this section in connection with a covered Executive order described in subparagraphs (E) or (F) of subsection (f)(1), a certification that the Government of the Russian Federation has made significant efforts to reduce the number and intensity of cyber intrusions conducted by that Government.

“(e) Termination.—Subject to section 216 of the Russia Sanctions Review Act of 2017, the President may terminate the application of sanctions under subsection (b) with respect to a person if the President submits to the appropriate congressional committees—

“(1) a notice of and justification for the termination; and

“(2) a notice that—

“(A) the person is not engaging in the activity that was the basis for the sanctions or has taken significant verifiable steps toward stopping the activity; and

“(B) the President has received reliable assurances that the person will not knowingly engage in activity subject to sanctions under subsection (a) in the future.

“(f) Definitions.—In this section:

“(1) COVERED EXECUTIVE ORDER.—The term ‘covered Executive order’ means any of the following:

“(A) Executive Order No. 13660 (79 Fed. Reg. 13493; relating to blocking property of certain persons contributing to the situation in Ukraine).

“(B) Executive Order No. 13661 (79 Fed. Reg. 15535; relating to blocking property of additional persons contributing to the situation in Ukraine).

“(C) Executive Order No. 13662 (79 Fed. Reg. 16169; relating to blocking property of additional persons contributing to the situation in Ukraine).

“(D) Executive Order No. 13685 (79 Fed. Reg. 77357; relating to blocking property of certain persons and prohibiting certain transactions with respect to the Crimea region of Ukraine).

“(E) Executive Order No. 13694 (80 Fed. Reg. 18077; relating to blocking the property of certain persons engaging in significant malicious cyber-enabled activities), relating to the Russian Federation.

“(F) Executive Order No. 13757 (82 Fed. Reg. 1; relating to taking additional steps to address the national emergency with respect to significant malicious cyber-enabled activities), relating to the Russian Federation.

“(2) FOREIGN PERSON.—The term ‘foreign person’ has the meaning given such term in section 595.304 of title 31, Code of Federal Regulations (as in effect on the date of the enactment of this section).

“(3) STRUCTURED.—The term ‘structured’, with respect to a transaction, has the meaning given the term ‘structure’ in paragraph (xx) of section 1010.100 of title 31, Code of Federal Regulations (or any corresponding similar regulation or ruling).

“SEC. 11. MANDATORY IMPOSITION OF SANCTIONS WITH RESPECT TO TRANSACTIONS WITH PERSONS RESPONSIBLE FOR HUMAN RIGHTS ABUSES.

 

“(a) In General.—The President shall impose the sanctions described in subsection (b) with respect to a foreign person if the President determines that the foreign person, based on credible information, on or after the date of the enactment of this section—

“(1) is responsible for, complicit in, or responsible for ordering, controlling, or otherwise directing, the commission of serious human rights abuses in any territory forcibly occupied or otherwise controlled by the Government of the Russian Federation;

“(2) materially assists, sponsors, or provides financial, material, or technological support for, or goods or services to, a foreign person described in paragraph (1); or

“(3) is owned or controlled by, or acts or purports to act for or on behalf of, directly or indirectly, a foreign person described in paragraph (1).

“(b) Sanctions Described.—

“(1) ASSET BLOCKING.—The exercise of all powers granted to the President by the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) to the extent necessary to block and prohibit all transactions in all property and interests in property of a person determined by the President to be subject to subsection (a) if such property and interests in property are in the United States, come within the United States, or are or come within the possession or control of a United States person.

“(2) EXCLUSION FROM THE UNITED STATES AND REVOCATION OF VISA OR OTHER DOCUMENTATION.—In the case of an alien determined by the President to be subject to subsection (a), denial of a visa to, and exclusion from the United States of, the alien, and revocation in accordance with section 221(i) of the Immigration and Nationality Act (8 U.S.C. 1201(i)), of any visa or other documentation of the alien.

“(c) Application Of New Sanctions.—The President may waive the initial application of sanctions under subsection (b) with respect to a person only if the President submits to the appropriate congressional committees—

“(1) a written determination that the waiver—

“(A) is in the vital national security interests of the United States; or

“(B) will further the enforcement of this Act; and

“(2) a certification that the Government of the Russian Federation has made efforts to reduce serious human rights abuses in territory forcibly occupied or otherwise controlled by that Government.

“(d) Implementation; Penalties.—

“(1) IMPLEMENTATION.—The President may exercise all authorities provided to the President under sections 203 and 205 of the International Emergency Economic Powers Act (50 U.S.C. 1702 and 1704) to carry out subsection (b)(1).

“(2) PENALTIES.—A person that violates, attempts to violate, conspires to violate, or causes a violation of subsection (b)(1) or any regulation, license, or order issued to carry out subsection (b)(1) shall be subject to the penalties set forth in subsections (b) and (c) of section 206 of the International Emergency Economic Powers Act (50 U.S.C. 1705) to the same extent as a person that commits an unlawful act described in subsection (a) of that section.

“(e) Termination.—Subject to section 216 of Russia Sanctions Review Act of 2017, the President may terminate the application of sanctions under subsection (b) with respect to a person if the President submits to the appropriate congressional committees—

“(1) a notice of and justification for the termination; and

“(2) a notice—

“(A) that—

“(i) the person is not engaging in the activity that was the basis for the sanctions or has taken significant verifiable steps toward stopping the activity; and

“(ii) the President has received reliable assurances that the person will not knowingly engage in activity subject to sanctions under subsection (a) in the future; or

“(B) that the President determines that insufficient basis exists for the determination by the President under subsection (a) with respect to the person.”.

(b) Definition Of Appropriate Congressional Committees.—Section 2(2) of the Support for the Sovereignty, Integrity, Democracy, and Economic Stability of Ukraine Act of 2014 (22 U.S.C. 8901(2)) is amended—

(1) in subparagraph (A), by inserting “the Committee on Banking, Housing, and Urban Affairs,” before “the Committee on Foreign Relations”; and

(2) in subparagraph (B), by inserting “the Committee on Financial Services” before “the Committee on Foreign Affairs”.

 

SEC. 229. NOTIFICATIONS TO CONGRESS UNDER UKRAINE FREEDOM SUPPORT ACT OF 2014.

(a) Sanctions Relating To Defense And Energy Sectors Of The Russian Federation.—Section 4 of the Ukraine Freedom Support Act of 2014 (22 U.S.C. 8923) is amended—

(1) by redesignating subsections (g) and (h) as subsections (h) and (i), respectively;

(2) by inserting after subsection (f) the following:

 

“(g) Notifications And Certifications To Congress.—

“(1) IMPOSITION OF SANCTIONS.—The President shall notify the appropriate congressional committees in writing not later than 15 days after imposing sanctions with respect to a foreign person under subsection (a) or (b).

“(2) TERMINATION OF SANCTIONS WITH RESPECT TO RUSSIAN PRODUCERS, TRANSFERORS, OR BROKERS OF DEFENSE ARTICLES.—Subject to section 216 of the Russia Sanctions Review Act of 2017, the President may terminate the imposition of sanctions under subsection (a)(2) with respect to a foreign person if the President submits to the appropriate congressional committees—

“(A) a notice of and justification for the termination; and

“(B) a notice that—

“(i) the foreign person is not engaging in the activity that was the basis for the sanctions or has taken significant verifiable steps toward stopping the activity; and

“(ii) the President has received reliable assurances that the foreign person will not knowingly engage in activity subject to sanctions under subsection (a)(2) in the future.”; and

(3) in subparagraph (B)(ii) of subsection (a)(3), by striking “subsection (h)” and inserting “subsection (i)”.

(b) Sanctions On Russian And Other Foreign Financial Institutions.—Section 5 of the Ukraine Freedom Support Act of 2014 (22 U.S.C. 8924) is amended—

(1) by redesignating subsections (e) and (f) as subsections (f) and (g), respectively;

(2) by inserting after subsection (d) the following:

 

“(e) Notification To Congress On Imposition Of Sanctions.—The President shall notify the appropriate congressional committees in writing not later than 15 days after imposing sanctions with respect to a foreign financial institution under subsection (a) or (b).”; and

(3) in subsection (g), as redesignated by paragraph (1), by striking “section 4(h)” and inserting “section 4(i)”.

 

SEC. 230. STANDARDS FOR TERMINATION OF CERTAIN SANCTIONS WITH RESPECT TO THE RUSSIAN FEDERATION.

(a) Sanctions Relating To Undermining The Peace, Security, Stability, Sovereignty, Or Territorial Integrity Of Ukraine.—Section 8 of the Sovereignty, Integrity, Democracy, and Economic Stability of Ukraine Act of 2014 (22 U.S.C. 8907) is amended—

(1) by redesignating subsection (d) as subsection (e); and

(2) by inserting after subsection (c) the following:

 

“(d) Termination.—Subject to section 216 of the Russia Sanctions Review Act of 2017, the President may terminate the application of sanctions under subsection (b) with respect to a person if the President submits to the appropriate congressional committees a notice that—

“(1) the person is not engaging in the activity that was the basis for the sanctions or has taken significant verifiable steps toward stopping the activity; and

“(2) the President has received reliable assurances that the person will not knowingly engage in activity subject to sanctions under subsection (a) in the future.”.

(b) Sanctions Relating To Corruption.—Section 9 of the Sovereignty, Integrity, Democracy, and Economic Stability of Ukraine Act of 2014 (22 U.S.C. 8908) is amended—

(1) by redesignating subsection (d) as subsection (e); and

(2) by inserting after subsection (c) the following:

 

“(d) Termination.—Subject to section 216 of the Russia Sanctions Review Act of 2017, the President may terminate the application of sanctions under subsection (b) with respect to a person if the President submits to the appropriate congressional committees a notice that—

“(1) the person is not engaging in the activity that was the basis for the sanctions or has taken significant verifiable steps toward stopping the activity; and

“(2) the President has received reliable assurances that the person will not knowingly engage in activity subject to sanctions under subsection (a) in the future.”.

 

SEC. 231. IMPOSITION OF SANCTIONS WITH RESPECT TO PERSONS ENGAGING IN TRANSACTIONS WITH THE INTELLIGENCE OR DEFENSE SECTORS OF THE GOVERNMENT OF THE RUSSIAN FEDERATION.

(a) In General.—On and after the date that is 180 days after the date of the enactment of this Act, the President shall impose five or more of the sanctions described in section 235 with respect to a person the President determines knowingly, on or after such date of enactment, engages in a significant transaction with a person that is part of, or operates for or on behalf of, the defense or intelligence sectors of the Government of the Russian Federation, including the Main Intelligence Agency of the General Staff of the Armed Forces of the Russian Federation or the Federal Security Service of the Russian Federation.

(b) Application Of New Sanctions.—The President may waive the initial application of sanctions under subsection (a) with respect to a person only if the President submits to the appropriate congressional committees—

(1) a written determination that the waiver—

(A) is in the vital national security interests of the United States; or

(B) will further the enforcement of this title; and

(2) a certification that the Government of the Russian Federation has made significant efforts to reduce the number and intensity of cyber intrusions conducted by that Government.

(c) Delay Of Imposition Of Sanctions.—The President may delay the imposition of sanctions under subsection (a) with respect to a person if the President certifies to the appropriate congressional committees, not less frequently than every 180 days while the delay is in effect, that the person is substantially reducing the number of significant transactions described in subsection (a) in which that person engages.

(d) Requirement To Issue Guidance.—Not later than 60 days after the date of the enactment of this Act, the President shall issue regulations or other guidance to specify the persons that are part of, or operate for or on behalf of, the defense and intelligence sectors of the Government of the Russian Federation.

(e) Penalties.—A person that violates, attempts to violate, conspires to violate, or causes a violation of subsection (a) or any regulation, license, or order issued to carry out subsection (a) shall be subject to the penalties set forth in subsections (b) and (c) of section 206 of the International Emergency Economic Powers Act (50 U.S.C. 1705) to the same extent as a person that commits an unlawful act described in subsection (a) of that section.

 

SEC. 232. SANCTIONS WITH RESPECT TO THE DEVELOPMENT OF PIPELINES IN THE RUSSIAN FEDERATION.

(a) In General.—The President, in coordination with allies of the United States, may impose five or more of the sanctions described in section 235 with respect to a person if the President determines that the person knowingly, on or after the date of the enactment of this Act, makes an investment described in subsection (b) or sells, leases, or provides to the Russian Federation, for the construction of Russian energy export pipelines, goods, services, technology, information, or support described in subsection (c)—

(1) any of which has a fair market value of $1,000,000 or more; or

(2) that, during a 12-month period, have an aggregate fair market value of $5,000,000 or more.

(b) Investment Described.—An investment described in this subsection is an investment that directly and significantly contributes to the enhancement of the ability of the Russian Federation to construct energy export pipelines.

(c) Goods, Services, Technology, Information, Or Support Described.—Goods, services, technology, information, or support described in this subsection are goods, services, technology, information, or support that could directly and significantly facilitate the maintenance or expansion of the construction, modernization, or repair of energy export pipelines by the Russian Federation.

 

SEC. 233. SANCTIONS WITH RESPECT TO INVESTMENT IN OR FACILITATION OF PRIVATIZATION OF STATE-OWNED ASSETS BY THE RUSSIAN FEDERATION.

(a) In General.—The President shall impose five or more of the sanctions described in section 235 if the President determines that a person, with actual knowledge, on or after the date of the enactment of this Act, makes an investment of $10,000,000 or more (or any combination of investments of not less than $1,000,000 each, which in the aggregate equals or exceeds $10,000,000 in any 12-month period), or facilitates such an investment, if the investment directly and significantly contributes to the ability of the Russian Federation to privatize state-owned assets in a manner that unjustly benefits—

(1) officials of the Government of the Russian Federation; or

(2) close associates or family members of those officials.

(b) Application Of New Sanctions.—The President may waive the initial application of sanctions under subsection (a) with respect to a person only if the President submits to the appropriate congressional committees—

(1) a written determination that the waiver—

(A) is in the vital national security interests of the United States; or

(B) will further the enforcement of this title; and

(2) a certification that the Government of the Russian Federation is taking steps to implement the Minsk Agreement to address the ongoing conflict in eastern Ukraine, signed in Minsk, Belarus, on February 11, 2015, by the leaders of Ukraine, Russia, France, and Germany, the Minsk Protocol, which was agreed to on September 5, 2014, and any successor agreements that are agreed to by the Government of Ukraine.

 

SEC. 234. SANCTIONS WITH RESPECT TO THE TRANSFER OF ARMS AND RELATED MATERIEL TO SYRIA.

(a) Imposition Of Sanctions.—

(1) IN GENERAL.—The President shall impose on a foreign person the sanctions described in subsection (b) if the President determines that such foreign person has, on or after the date of the enactment of this Act, knowingly exported, transferred, or otherwise provided to Syria significant financial, material, or technological support that contributes materially to the ability of the Government of Syria to—

(A) acquire or develop chemical, biological, or nuclear weapons or related technologies;

(B) acquire or develop ballistic or cruise missile capabilities;

(C) acquire or develop destabilizing numbers and types of advanced conventional weapons;

(D) acquire significant defense articles, defense services, or defense information (as such terms are defined under the Arms Export Control Act (22 U.S.C. 2751 et seq.)); or

(E) acquire items designated by the President for purposes of the United States Munitions List under section 38(a)(1) of the Arms Export Control Act (22 U.S.C. 2778(a)(1)).

(2) APPLICABILITY TO OTHER FOREIGN PERSONS.—The sanctions described in subsection (b) shall also be imposed on any foreign person that—

(A) is a successor entity to a foreign person described in paragraph (1); or

(B) is owned or controlled by, or has acted for or on behalf of, a foreign person described in paragraph (1).

(b) Sanctions Described.—The sanctions to be imposed on a foreign person described in subsection (a) are the following:

(1) BLOCKING OF PROPERTY.—The President shall exercise all powers granted by the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) (except that the requirements of section 202 of such Act (50 U.S.C. 1701) shall not apply) to the extent necessary to block and prohibit all transactions in all property and interests in property of the foreign person if such property and interests in property are in the United States, come within the United States, or are or come within the possession or control of a United States person.

(2) ALIENS INELIGIBLE FOR VISAS, ADMISSION, OR PAROLE.—

(A) EXCLUSION FROM THE UNITED STATES.—If the foreign person is an individual, the Secretary of State shall deny a visa to, and the Secretary of Homeland Security shall exclude from the United States, the foreign person.

(B) CURRENT VISAS REVOKED.—

(i) IN GENERAL.—The issuing consular officer, the Secretary of State, or the Secretary of Homeland Security (or a designee of one of such Secretaries) shall revoke any visa or other entry documentation issued to the foreign person regardless of when issued.

(ii) EFFECT OF REVOCATION.—A revocation under clause (i) shall take effect immediately and shall automatically cancel any other valid visa or entry documentation that is in the possession of the foreign person.

(c) Waiver.—Subject to section 216, the President may waive the application of sanctions under subsection (b) with respect to a person if the President determines that such a waiver is in the national security interest of the United States.

(d) Definitions.—In this section:

(1) FINANCIAL, MATERIAL, OR TECHNOLOGICAL SUPPORT.—The term “financial, material, or technological support” has the meaning given such term in section 542.304 of title 31, Code of Federal Regulations (or any corresponding similar regulation or ruling).

(2) FOREIGN PERSON.—The term “foreign person” has the meaning given such term in section 594.304 of title 31, Code of Federal Regulations (or any corresponding similar regulation or ruling).

(3) SYRIA.—The term “Syria” has the meaning given such term in section 542.316 of title 31, Code of Federal Regulations (or any corresponding similar regulation or ruling).

 

SEC. 235. SANCTIONS DESCRIBED.

(a) Sanctions Described.—The sanctions to be imposed with respect to a person under section 224(a)(2), 231(b), 232(a), or 233(a) are the following:

(1) EXPORT-IMPORT BANK ASSISTANCE FOR EXPORTS TO SANCTIONED PERSONS.—The President may direct the Export-Import Bank of the United States not to give approval to the issuance of any guarantee, insurance, extension of credit, or participation in the extension of credit in connection with the export of any goods or services to the sanctioned person.

(2) EXPORT SANCTION.—The President may order the United States Government not to issue any specific license and not to grant any other specific permission or authority to export any goods or technology to the sanctioned person under—

(A) the Export Administration Act of 1979 (50 U.S.C. 4601 et seq.) (as continued in effect pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.));

(B) the Arms Export Control Act (22 U.S.C. 2751 et seq.);

(C) the Atomic Energy Act of 1954 (42 U.S.C. 2011 et seq.); or

(D) any other statute that requires the prior review and approval of the United States Government as a condition for the export or reexport of goods or services.

(3) LOANS FROM UNITED STATES FINANCIAL INSTITUTIONS.—The President may prohibit any United States financial institution from making loans or providing credits to the sanctioned person totaling more than $10,000,000 in any 12-month period unless the person is engaged in activities to relieve human suffering and the loans or credits are provided for such activities.

(4) LOANS FROM INTERNATIONAL FINANCIAL INSTITUTIONS.—The President may direct the United States executive director to each international financial institution to use the voice and vote of the United States to oppose any loan from the international financial institution that would benefit the sanctioned person.

(5) PROHIBITIONS ON FINANCIAL INSTITUTIONS.—The following prohibitions may be imposed against the sanctioned person if that person is a financial institution:

(A) PROHIBITION ON DESIGNATION AS PRIMARY DEALER.—Neither the Board of Governors of the Federal Reserve System nor the Federal Reserve Bank of New York may designate, or permit the continuation of any prior designation of, the financial institution as a primary dealer in United States Government debt instruments.

(B) PROHIBITION ON SERVICE AS A REPOSITORY OF GOVERNMENT FUNDS.—The financial institution may not serve as agent of the United States Government or serve as repository for United States Government funds.

The imposition of either sanction under subparagraph (A) or (B) shall be treated as one sanction for purposes of subsection (b), and the imposition of both such sanctions shall be treated as two sanctions for purposes of subsection (b).

(6) PROCUREMENT SANCTION.—The United States Government may not procure, or enter into any contract for the procurement of, any goods or services from the sanctioned person.

(7) FOREIGN EXCHANGE.—The President may, pursuant to such regulations as the President may prescribe, prohibit any transactions in foreign exchange that are subject to the jurisdiction of the United States and in which the sanctioned person has any interest.

(8) BANKING TRANSACTIONS.—The President may, pursuant to such regulations as the President may prescribe, prohibit any transfers of credit or payments between financial institutions or by, through, or to any financial institution, to the extent that such transfers or payments are subject to the jurisdiction of the United States and involve any interest of the sanctioned person.

(9) PROPERTY TRANSACTIONS.—The President may, pursuant to such regulations as the President may prescribe, prohibit any person from—

(A) acquiring, holding, withholding, using, transferring, withdrawing, transporting, importing, or exporting any property that is subject to the jurisdiction of the United States and with respect to which the sanctioned person has any interest;

(B) dealing in or exercising any right, power, or privilege with respect to such property; or

(C) conducting any transaction involving such property.

(10) BAN ON INVESTMENT IN EQUITY OR DEBT OF SANCTIONED PERSON.—The President may, pursuant to such regulations or guidelines as the President may prescribe, prohibit any United States person from investing in or purchasing significant amounts of equity or debt instruments of the sanctioned person.

(11) EXCLUSION OF CORPORATE OFFICERS.—The President may direct the Secretary of State to deny a visa to, and the Secretary of Homeland Security to exclude from the United States, any alien that the President determines is a corporate officer or principal of, or a shareholder with a controlling interest in, the sanctioned person.

(12) SANCTIONS ON PRINCIPAL EXECUTIVE OFFICERS.—The President may impose on the principal executive officer or officers of the sanctioned person, or on persons performing similar functions and with similar authorities as such officer or officers, any of the sanctions under this subsection.

(b) Sanctioned Person Defined.—In this section, the term “sanctioned person” means a person subject to sanctions under section 224(a)(2), 231(b), 232(a), or 233(a).

 

SEC. 236. EXCEPTIONS, WAIVER, AND TERMINATION.

(a) Exceptions.—The provisions of this part and amendments made by this part shall not apply with respect to the following:

(1) Activities subject to the reporting requirements under title V of the National Security Act of 1947 (50 U.S.C. 3091 et seq.), or any authorized intelligence activities of the United States.

(2) The admission of an alien to the United States if such admission is necessary to comply with United States obligations under the Agreement between the United Nations and the United States of America regarding the Headquarters of the United Nations, signed at Lake Success June 26, 1947, and entered into force November 21, 1947, under the Convention on Consular Relations, done at Vienna April 24, 1963, and entered into force March 19, 1967, or under other international agreements.

(b) Waiver Of Sanctions That Are Imposed.—Subject to section 216, if the President imposes sanctions with respect to a person under this part or the amendments made by this part, the President may waive the application of those sanctions if the President determines that such a waiver is in the national security interest of the United States.

(c) Termination.—Subject to section 216, the President may terminate the application of sanctions under section 224, 231, 232, 233, or 234 with respect to a person if the President submits to the appropriate congressional committees—

(1) a notice of and justification for the termination; and

(2) a notice that—

(A) the person is not engaging in the activity that was the basis for the sanctions or has taken significant verifiable steps toward stopping the activity; and

(B) the President has received reliable assurances that the person will not knowingly engage in activity subject to sanctions under this part in the future.

 

SEC. 237. EXCEPTION RELATING TO ACTIVITIES OF THE NATIONAL AERONAUTICS AND SPACE ADMINISTRATION.

(a) In General.—This Act and the amendments made by this Act shall not apply with respect to activities of the National Aeronautics and Space Administration.

(b) Rule Of Construction.—Nothing in this Act or the amendments made by this Act shall be construed to authorize the imposition of any sanction or other condition, limitation, restriction, or prohibition, that directly or indirectly impedes the supply by any entity of the Russian Federation of any product or service, or the procurement of such product or service by any contractor or subcontractor of the United States or any other entity, relating to or in connection with any space launch conducted for—

(1) the National Aeronautics and Space Administration; or

(2) any other non-Department of Defense customer.

 

SEC. 238. RULE OF CONSTRUCTION.

Nothing in this part or the amendments made by this part shall be construed—

(1) to supersede the limitations or exceptions on the use of rocket engines for national security purposes under section 1608 of the Carl Levin and Howard P. “Buck” McKeon National Defense Authorization Act for Fiscal Year 2015 (Public Law 113–291; 128 Stat. 3626; 10 U.S.C. 2271 note), as amended by section 1607 of the National Defense Authorization Act for Fiscal Year 2016 (Public Law 114–92; 129 Stat. 1100) and section 1602 of the National Defense Authorization Act for Fiscal Year 2017 (Public Law 114–328; 130 Stat. 2582); or

(2) to prohibit a contractor or subcontractor of the Department of Defense from acquiring components referred to in such section 1608.

PART 3—REPORTS

 

SEC. 241. REPORT ON OLIGARCHS AND PARASTATAL ENTITIES OF THE RUSSIAN FEDERATION.

(a) In General.—Not later than 180 days after the date of the enactment of this Act, the Secretary of the Treasury, in consultation with the Director of National Intelligence and the Secretary of State, shall submit to the appropriate congressional committees a detailed report on the following:

(1) Senior foreign political figures and oligarchs in the Russian Federation, including the following:

(A) An identification of the most significant senior foreign political figures and oligarchs in the Russian Federation, as determined by their closeness to the Russian regime and their net worth.

(B) An assessment of the relationship between individuals identified under subparagraph (A) and President Vladimir Putin or other members of the Russian ruling elite.

(C) An identification of any indices of corruption with respect to those individuals.

(D) The estimated net worth and known sources of income of those individuals and their family members (including spouses, children, parents, and siblings), including assets, investments, other business interests, and relevant beneficial ownership information.

(E) An identification of the non-Russian business affiliations of those individuals.

(2) Russian parastatal entities, including an assessment of the following:

(A) The emergence of Russian parastatal entities and their role in the economy of the Russian Federation.

(B) The leadership structures and beneficial ownership of those entities.

(C) The scope of the non-Russian business affiliations of those entities.

(3) The exposure of key economic sectors of the United States to Russian politically exposed persons and parastatal entities, including, at a minimum, the banking, securities, insurance, and real estate sectors.

(4) The likely effects of imposing debt and equity restrictions on Russian parastatal entities, as well as the anticipated effects of adding Russian parastatal entities to the list of specially designated nationals and blocked persons maintained by the Office of Foreign Assets Control of the Department of the Treasury.

(5) The potential impacts of imposing secondary sanctions with respect to Russian oligarchs, Russian state-owned enterprises, and Russian parastatal entities, including impacts on the entities themselves and on the economy of the Russian Federation, as well as on the economies of the United States and allies of the United States.

(b) Form Of Report.—The report required under subsection (a) shall be submitted in an unclassified form, but may contain a classified annex.

(c) Definitions.—In this section:

(1) APPROPRIATE CONGRESSIONAL COMMITTEES.—The term “appropriate congressional committees” means—

(A) the Committee on Banking, Housing, and Urban Affairs, the Committee on Foreign Relations, and the Committee on Finance of the Senate; and

(B) the Committee on Foreign Affairs, the Committee on Financial Services, and the Committee on Ways and Means of the House of Representatives.

(2) SENIOR FOREIGN POLITICAL FIGURE.—The term “senior foreign political figure” has the meaning given that term in section 1010.605 of title 31, Code of Federal Regulations (or any corresponding similar regulation or ruling).

 

SEC. 242. REPORT ON EFFECTS OF EXPANDING SANCTIONS TO INCLUDE SOVEREIGN DEBT AND DERIVATIVE PRODUCTS.

(a) In General.—Not later than 180 days after the date of the enactment of this Act, the Secretary of the Treasury, in consultation with the Director of National Intelligence and the Secretary of State, shall submit to the appropriate congressional committees a report describing in detail the potential effects of expanding sanctions under Directive 1 (as amended), dated September 12, 2014, issued by the Office of Foreign Assets Control under Executive Order No. 13662 (79 Fed. Reg. 16169; relating to blocking property of additional persons contributing to the situation in Ukraine), or any successor directive, to include sovereign debt and the full range of derivative products.

(b) Form Of Report.—The report required under subsection (a) shall be submitted in an unclassified form, but may contain a classified annex.

(c) Appropriate Congressional Committees Defined.—In this section, the term “appropriate congressional committees” means—

(1) the Committee on Banking, Housing, and Urban Affairs, the Committee on Foreign Relations, and the Committee on Finance of the Senate; and

(2) the Committee on Foreign Affairs, the Committee on Financial Services, and the Committee on Ways and Means of the House of Representatives.

 

SEC. 243. REPORT ON ILLICIT FINANCE RELATING TO THE RUSSIAN FEDERATION.

(a) In General.—Not later than 1 year after the date of the enactment of this Act, and not later than the end of each 1-year period thereafter until 2021, the Secretary of the Treasury shall submit to the appropriate congressional committees a report describing interagency efforts in the United States to combat illicit finance relating to the Russian Federation.

(b) Elements.—The report required by subsection (a) shall contain a summary of efforts by the United States to do the following:

(1) Identify, investigate, map, and disrupt illicit financial flows linked to the Russian Federation if such flows affect the United States financial system or those of major allies of the United States.

(2) Conduct outreach to the private sector, including information sharing efforts to strengthen compliance efforts by entities, including financial institutions, to prevent illicit financial flows described in paragraph (1).

(3) Engage and coordinate with allied international partners on illicit finance, especially in Europe, to coordinate efforts to uncover and prosecute the networks responsible for illicit financial flows described in paragraph (1), including examples of that engagement and coordination.

(4) Identify foreign sanctions evaders and loopholes within the sanctions regimes of foreign partners of the United States.

(5) Expand the number of real estate geographic targeting orders or other regulatory actions, as appropriate, to degrade illicit financial activity relating to the Russian Federation in relation to the financial system of the United States.

(6) Provide support to counter those involved in illicit finance relating to the Russian Federation across all appropriate law enforcement, intelligence, regulatory, and financial authorities of the Federal Government, including by imposing sanctions with respect to or prosecuting those involved.

(7) In the case of the Department of the Treasury and the Department of Justice, investigate or otherwise develop major cases, including a description of those cases.

(c) Briefing.—After submitting a report under this section, the Secretary of the Treasury shall provide briefings to the appropriate congressional committees with respect to that report.

(d) Coordination.—The Secretary of the Treasury shall coordinate with the Attorney General, the Director of National Intelligence, the Secretary of Homeland Security, and the Secretary of State in preparing each report under this section.

(e) Form.—Each report submitted under this section shall be submitted in unclassified form, but may contain a classified annex.

(f) Definitions.—In this section:

(1) APPROPRIATE CONGRESSIONAL COMMITTEES.—The term “appropriate congressional committees” means—

(A) the Committee on Banking, Housing, and Urban Affairs, the Committee on Foreign Relations, and the Committee on Finance of the Senate; and

(B) the Committee on Foreign Affairs, the Committee on Financial Services, and the Committee on Ways and Means of the House of Representatives.

(2) ILLICIT FINANCE.—The term “illicit finance” means the financing of terrorism, narcotics trafficking, or proliferation, money laundering, or other forms of illicit financing domestically or internationally, as defined by the President.

Subtitle B—Countering Russian Influence In Europe And Eurasia

 

SEC. 251. FINDINGS.

Congress makes the following findings:

(1) The Government of the Russian Federation has sought to exert influence throughout Europe and Eurasia, including in the former states of the Soviet Union, by providing resources to political parties, think tanks, and civil society groups that sow distrust in democratic institutions and actors, promote xenophobic and illiberal views, and otherwise undermine European unity. The Government of the Russian Federation has also engaged in well-documented corruption practices as a means toward undermining and buying influence in European and Eurasian countries.

(2) The Government of the Russian Federation has largely eliminated a once-vibrant Russian-language independent media sector and severely curtails free and independent media within the borders of the Russian Federation. Russian-language media organizations that are funded and controlled by the Government of the Russian Federation and disseminate information within and outside of the Russian Federation routinely traffic in anti-Western disinformation, while few independent, fact-based media sources provide objective reporting for Russian-speaking audiences inside or outside of the Russian Federation.

(3) The Government of the Russian Federation continues to violate its commitments under the Memorandum on Security Assurances in connection with Ukraine’s Accession to the Treaty on the Non-Proliferation of Nuclear Weapons, done at Budapest December 5, 1994, and the Conference on Security and Co-operation in Europe Final Act, concluded at Helsinki August 1, 1975 (commonly referred to as the “Helsinki Final Act”), which laid the ground-work for the establishment of the Organization for Security and Co-operation in Europe, of which the Russian Federation is a member, by its illegal annexation of Crimea in 2014, its illegal occupation of South Ossetia and Abkhazia in Georgia in 2008, and its ongoing destabilizing activities in eastern Ukraine.

(4) The Government of the Russian Federation continues to ignore the terms of the August 2008 ceasefire agreement relating to Georgia, which requires the withdrawal of Russian Federation troops, free access by humanitarian groups to the regions of South Ossetia and Abkhazia, and monitoring of the conflict areas by the European Union Monitoring Mission.

(5) The Government of the Russian Federation is failing to comply with the terms of the Minsk Agreement to address the ongoing conflict in eastern Ukraine, signed in Minsk, Belarus, on February 11, 2015, by the leaders of Ukraine, Russia, France, and Germany, as well as the Minsk Protocol, which was agreed to on September 5, 2014.

(6) The Government of the Russian Federation is—

(A) in violation of the Treaty between the United States of America and the Union of Soviet Socialist Republics on the Elimination of their Intermediate-Range and Shorter-Range Missiles, signed at Washington December 8, 1987, and entered into force June 1, 1988 (commonly known as the “INF Treaty”); and

(B) failing to meet its obligations under the Treaty on Open Skies, done at Helsinki March 24, 1992, and entered into force January 1, 2002 (commonly known as the “Open Skies Treaty”).

 

SEC. 252. SENSE OF CONGRESS.

It is the sense of Congress that—

(1) the Government of the Russian Federation bears responsibility for the continuing violence in Eastern Ukraine, including the death on April 24, 2017, of Joseph Stone, a citizen of the United States working as a monitor for the Organization for Security and Co-operation in Europe;

(2) the President should call on the Government of the Russian Federation—

(A) to withdraw all of its forces from the territories of Georgia, Ukraine, and Moldova;

(B) to return control of the borders of those territories to their respective governments; and

(C) to cease all efforts to undermine the popularly elected governments of those countries;

(3) the Government of the Russian Federation has applied, and continues to apply, to the countries and peoples of Georgia and Ukraine, traditional uses of force, intelligence operations, and influence campaigns, which represent clear and present threats to the countries of Europe and Eurasia;

(4) in response, the countries of Europe and Eurasia should redouble efforts to build resilience within their institutions, political systems, and civil societies;

(5) the United States supports the institutions that the Government of the Russian Federation seeks to undermine, including the North Atlantic Treaty Organization and the European Union;

(6) a strong North Atlantic Treaty Organization is critical to maintaining peace and security in Europe and Eurasia;

(7) the United States should continue to work with the European Union as a partner against aggression by the Government of the Russian Federation, coordinating aid programs, development assistance, and other counter-Russian efforts;

(8) the United States should encourage the establishment of a commission for media freedom within the Council of Europe, modeled on the Venice Commission regarding rule of law issues, that would be chartered to provide governments with expert recommendations on maintaining legal and regulatory regimes supportive of free and independent media and an informed citizenry able to distinguish between fact-based reporting, opinion, and disinformation;

(9) in addition to working to strengthen the North Atlantic Treaty Organization and the European Union, the United States should work with the individual countries of Europe and Eurasia—

(A) to identify vulnerabilities to aggression, disinformation, corruption, and so-called hybrid warfare by the Government of the Russian Federation;

(B) to establish strategic and technical plans for addressing those vulnerabilities;

(C) to ensure that the financial systems of those countries are not being used to shield illicit financial activity by officials of the Government of the Russian Federation or individuals in President Vladimir Putin’s inner circle who have been enriched through corruption;

(D) to investigate and prosecute cases of corruption by Russian actors; and

(E) to work toward full compliance with the Convention on Combating Bribery of Foreign Public Officials in International Business Transactions (commonly referred to as the “Anti-Bribery Convention”) of the Organization for Economic Co-operation and Development; and

(10) the President of the United States should use the authority of the President to impose sanctions under—

(A) the Sergei Magnitsky Rule of Law Accountability Act of 2012 (title IV of Public Law 112–20822 U.S.C. 5811 note); and

(B) the Global Magnitsky Human Rights Accountability Act (subtitle F of title XII of Public Law 114–32822 U.S.C. 2656 note).

 

SEC. 253. STATEMENT OF POLICY.

The United States, consistent with the principle of ex injuria jus non oritur, supports the policy known as the “Stimson Doctrine” and thus does not recognize territorial changes effected by force, including the illegal invasions and occupations of Abkhazia, South Ossetia, Crimea, Eastern Ukraine, and Transnistria.

 

SEC. 254. COORDINATING AID AND ASSISTANCE ACROSS EUROPE AND EURASIA.

(a) Authorization Of Appropriations.—There are authorized to be appropriated for the Countering Russian Influence Fund $250,000,000 for fiscal years 2018 and 2019.

(b) Use Of Funds.—Amounts in the Countering Russian Influence Fund shall be used to effectively implement, prioritized in the following order and subject to the availability of funds, the following goals:

(1) To assist in protecting critical infrastructure and electoral mechanisms from cyberattacks in the following countries:

(A) Countries that are members of the North Atlantic Treaty Organization or the European Union that the Secretary of State determines—

(i) are vulnerable to influence by the Russian Federation; and

(ii) lack the economic capability to effectively respond to aggression by the Russian Federation without the support of the United States.

(B) Countries that are participating in the enlargement process of the North Atlantic Treaty Organization or the European Union, including Albania, Bosnia and Herzegovina, Georgia, Macedonia, Moldova, Kosovo, Serbia, and Ukraine.

(2) To combat corruption, improve the rule of law, and otherwise strengthen independent judiciaries and prosecutors general offices in the countries described in paragraph (1).

(3) To respond to the humanitarian crises and instability caused or aggravated by the invasions and occupations of Georgia and Ukraine by the Russian Federation.

(4) To improve participatory legislative processes and legal education, political transparency and competition, and compliance with international obligations in the countries described in paragraph (1).

(5) To build the capacity of civil society, media, and other nongovernmental organizations countering the influence and propaganda of the Russian Federation to combat corruption, prioritize access to truthful information, and operate freely in all regions in the countries described in paragraph (1).

(6) To assist the Secretary of State in executing the functions specified in section 1287(b) of the National Defense Authorization Act for Fiscal Year 2017 (Public Law 114–32822 U.S.C. 2656 note) for the purposes of recognizing, understanding, exposing, and countering propaganda and disinformation efforts by foreign governments, in coordination with the relevant regional Assistant Secretary or Assistant Secretaries of the Department of State.

(c) Revision Of Activities For Which Amounts May Be Used.—The Secretary of State may modify the goals described in subsection (b) if, not later than 15 days before revising such a goal, the Secretary notifies the appropriate congressional committees of the revision.

(d) Implementation.—

(1) IN GENERAL.—The Secretary of State shall, acting through the Coordinator of United States Assistance to Europe and Eurasia (authorized pursuant to section 601 of the Support for East European Democracy (SEED) Act of 1989 (22 U.S.C. 5461) and section 102 of the Freedom for Russia and Emerging Eurasian Democracies and Open Markets Support Act of 1992 (22 U.S.C. 5812)), and in consultation with the Administrator for the United States Agency for International Development, the Director of the Global Engagement Center of the Department of State, the Secretary of Defense, the Chairman of the Broadcasting Board of Governors, and the heads of other relevant Federal agencies, coordinate and carry out activities to achieve the goals described in subsection (b).

(2) METHOD.—Activities to achieve the goals described in subsection (b) shall be carried out through—

(A) initiatives of the United States Government;

(B) Federal grant programs such as the Information Access Fund; or

(C) nongovernmental or international organizations, such as the Organization for Security and Co-operation in Europe, the National Endowment for Democracy, the Black Sea Trust, the Balkan Trust for Democracy, the Prague Civil Society Centre, the North Atlantic Treaty Organization Strategic Communications Centre of Excellence, the European Endowment for Democracy, and related organizations.

(3) REPORT ON IMPLEMENTATION.—

(A) IN GENERAL.—Not later than April 1 of each year, the Secretary of State, acting through the Coordinator of United States Assistance to Europe and Eurasia, shall submit to the appropriate congressional committees a report on the programs and activities carried out to achieve the goals described in subsection (b) during the preceding fiscal year.

(B) ELEMENTS.—Each report required by subparagraph (A) shall include, with respect to each program or activity described in that subparagraph—

(i) the amount of funding for the program or activity;

(ii) the goal described in subsection (b) to which the program or activity relates; and

(iii) an assessment of whether or not the goal was met.

(e) Coordination With Global Partners.—

(1) IN GENERAL.—In order to maximize cost efficiency, eliminate duplication, and speed the achievement of the goals described in subsection (b), the Secretary of State shall ensure coordination with—

(A) the European Union and its institutions;

(B) the governments of countries that are members of the North Atlantic Treaty Organization or the European Union; and

(C) international organizations and quasi-governmental funding entities that carry out programs and activities that seek to accomplish the goals described in subsection (b).

(2) REPORT BY SECRETARY OF STATE.—Not later than April 1 of each year, the Secretary of State shall submit to the appropriate congressional committees a report that includes—

(A) the amount of funding provided to each country referred to in subsection (b) by—

(i) the European Union or its institutions;

(ii) the government of each country that is a member of the European Union or the North Atlantic Treaty Organization; and

(iii) international organizations and quasi-governmental funding entities that carry out programs and activities that seek to accomplish the goals described in subsection (b); and

(B) an assessment of whether the funding described in subparagraph (A) is commensurate with funding provided by the United States for those goals.

(f) Rule Of Construction.—Nothing in this section shall be construed to apply to or limit United States foreign assistance not provided using amounts available in the Countering Russian Influence Fund.

(g) Ensuring Adequate Staffing For Governance Activities.—In order to ensure that the United States Government is properly focused on combating corruption, improving rule of law, and building the capacity of civil society, media, and other nongovernmental organizations in countries described in subsection (b)(1), the Secretary of State shall establish a pilot program for Foreign Service officer positions focused on governance and anticorruption activities in such countries.

 

SEC. 255. REPORT ON MEDIA ORGANIZATIONS CONTROLLED AND FUNDED BY THE GOVERNMENT OF THE RUSSIAN FEDERATION.

(a) In General.—Not later than 90 days after the date of the enactment of this Act, and annually thereafter, the President shall submit to the appropriate congressional committees a report that includes a description of media organizations that are controlled and funded by the Government of the Russian Federation, and any affiliated entities, whether operating within or outside the Russian Federation, including broadcast and satellite-based television, radio, Internet, and print media organizations.

(b) Form Of Report.—The report required by subsection (a) shall be submitted in unclassified form but may include a classified annex.

 

SEC. 256. REPORT ON RUSSIAN FEDERATION INFLUENCE ON ELECTIONS IN EUROPE AND EURASIA.

(a) In General.—Not later than 90 days after the date of the enactment of this Act, and annually thereafter, the President shall submit to the appropriate congressional committees and leadership a report on funds provided by, or funds the use of which was directed by, the Government of the Russian Federation or any Russian person with the intention of influencing the outcome of any election or campaign in any country in Europe or Eurasia during the preceding year, including through direct support to any political party, candidate, lobbying campaign, nongovernmental organization, or civic organization.

(b) Form Of Report.—Each report required by subsection (a) shall be submitted in unclassified form but may include a classified annex.

(c) Definitions.—In this section:

(1) APPROPRIATE CONGRESSIONAL COMMITTEES AND LEADERSHIP.—The term “appropriate congressional committees and leadership” means—

(A) the Committee on Foreign Relations, the Committee on Banking, Housing, and Urban Affairs, the Committee on Armed Services, the Committee on Homeland Security and Governmental Affairs, the Committee on Appropriations, the Select Committee on Intelligence, and the majority and minority leaders of the Senate; and

(B) the Committee on Foreign Affairs, the Committee on Financial Services, the Committee on Armed Services, the Committee on Homeland Security, the Committee on Appropriations, the Permanent Select Committee on Intelligence, and the Speaker, the majority leader, and the minority leader of the House of Representatives.

(2) RUSSIAN PERSON.—The term “Russian person” means—

(A) an individual who is a citizen or national of the Russian Federation; or

(B) an entity organized under the laws of the Russian Federation or otherwise subject to the jurisdiction of the Government of the Russian Federation.

 

SEC. 257. UKRANIAN ENERGY SECURITY.

(a) Statement Of Policy.—It is the policy of the United States—

(1) to support the Government of Ukraine in restoring its sovereign and territorial integrity;

(2) to condemn and oppose all of the destabilizing efforts by the Government of the Russian Federation in Ukraine in violation of its obligations and international commitments;

(3) to never recognize the illegal annexation of Crimea by the Government of the Russian Federation or the separation of any portion of Ukrainian territory through the use of military force;

(4) to deter the Government of the Russian Federation from further destabilizing and invading Ukraine and other independent countries in Central and Eastern Europe and the Caucuses;

(5) to assist in promoting reform in regulatory oversight and operations in Ukraine’s energy sector, including the establishment and empowerment of an independent regulatory organization;

(6) to encourage and support fair competition, market liberalization, and reliability in Ukraine’s energy sector;

(7) to help Ukraine and United States allies and partners in Europe reduce their dependence on Russian energy resources, especially natural gas, which the Government of the Russian Federation uses as a weapon to coerce, intimidate, and influence other countries;

(8) to work with European Union member states and European Union institutions to promote energy security through developing diversified and liberalized energy markets that provide diversified sources, suppliers, and routes;

(9) to continue to oppose the NordStream 2 pipeline given its detrimental impacts on the European Union’s energy security, gas market development in Central and Eastern Europe, and energy reforms in Ukraine; and

(10) that the United States Government should prioritize the export of United States energy resources in order to create American jobs, help United States allies and partners, and strengthen United States foreign policy.

(b) Plan To Promote Energy Security In Ukraine.—

(1) IN GENERAL.—The Secretary of State, in coordination with the Administrator of the United States Agency for International Development and the Secretary of Energy, shall work with the Government of Ukraine to develop a plan to increase energy security in Ukraine, increase the amount of energy produced in Ukraine, and reduce Ukraine’s reliance on energy imports from the Russian Federation.

(2) ELEMENTS.—The plan developed under paragraph (1) shall include strategies for market liberalization, effective regulation and oversight, supply diversification, energy reliability, and energy efficiency, such as through supporting—

(A) the promotion of advanced technology and modern operating practices in Ukraine’s oil and gas sector;

(B) modern geophysical and meteorological survey work as needed followed by international tenders to help attract qualified investment into exploration and development of areas with untapped resources in Ukraine;

(C) a broadening of Ukraine’s electric power transmission interconnection with Europe;

(D) the strengthening of Ukraine’s capability to maintain electric power grid stability and reliability;

(E) independent regulatory oversight and operations of Ukraine’s gas market and electricity sector;

(F) the implementation of primary gas law including pricing, tariff structure, and legal regulatory implementation;

(G) privatization of government owned energy companies through credible legal frameworks and a transparent process compliant with international best practices;

(H) procurement and transport of emergency fuel supplies, including reverse pipeline flows from Europe;

(I) provision of technical assistance for crisis planning, crisis response, and public outreach;

(J) repair of infrastructure to enable the transport of fuel supplies;

(K) repair of power generating or power transmission equipment or facilities; and

(L) improved building energy efficiency and other measures designed to reduce energy demand in Ukraine.

(3) REPORTS.—

(A) IMPLEMENTATION OF UKRAINE FREEDOM SUPPORT ACT OF 2014 PROVISIONS.—Not later than 180 days after the date of the enactment of this Act, the Secretary of State shall submit to the appropriate congressional committees a report detailing the status of implementing the provisions required under section 7(c) of the Ukraine Freedom Support Act of 2014 (22 U.S.C. 8926(c)), including detailing the plans required under that section, the level of funding that has been allocated to and expended for the strategies set forth under that section, and progress that has been made in implementing the strategies developed pursuant to that section.

(B) IN GENERAL.—Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter, the Secretary of State shall submit to the appropriate congressional committees a report detailing the plan developed under paragraph (1), the level of funding that has been allocated to and expended for the strategies set forth in paragraph (2), and progress that has been made in implementing the strategies.

(C) BRIEFINGS.—The Secretary of State, or a designee of the Secretary, shall brief the appropriate congressional committees not later than 30 days after the submission of each report under subparagraph (B). In addition, the Department of State shall make relevant officials available upon request to brief the appropriate congressional committees on all available information that relates directly or indirectly to Ukraine or energy security in Eastern Europe.

(D) APPROPRIATE CONGRESSIONAL COMMITTEES DEFINED.—In this paragraph, the term “appropriate congressional committees” means—

(i) the Committee on Foreign Relations and the Committee on Appropriations of the Senate; and

(ii) the Committee on Foreign Affairs and the Committee on Appropriations of the House of Representatives.

(c) Supporting Efforts Of Countries In Europe And Eurasia To Decrease Their Dependence On Russian Sources Of Energy.—

(1) FINDINGS.—Congress makes the following findings:

(A) The Government of the Russian Federation uses its strong position in the energy sector as leverage to manipulate the internal politics and foreign relations of the countries of Europe and Eurasia.

(B) This influence is based not only on the Russian Federation’s oil and natural gas resources, but also on its state-owned nuclear power and electricity companies.

(2) SENSE OF CONGRESS.—It is the sense of Congress that—

(A) the United States should assist the efforts of the countries of Europe and Eurasia to enhance their energy security through diversification of energy supplies in order to lessen dependencies on Russian Federation energy resources and state-owned entities; and

(B) the Export-Import Bank of the United States and the Overseas Private Investment Corporation should play key roles in supporting critical energy projects that contribute to that goal.

(3) USE OF COUNTERING RUSSIAN INFLUENCE FUND TO PROVIDE TECHNICAL ASSISTANCE.—Amounts in the Countering Russian Influence Fund pursuant to section 254 shall be used to provide technical advice to countries described in subsection (b)(1) of such section designed to enhance energy security and lessen dependence on energy from Russian Federation sources.

(d) Authorization Of Appropriations.—There is authorized to be appropriated for the Department of State a total of $30,000,000 for fiscal years 2018 and 2019 to carry out the strategies set forth in subsection (b)(2) and other activities under this section related to the promotion of energy security in Ukraine.

(e) Rule Of Construction.—Nothing in this section shall be construed as affecting the responsibilities required and authorities provided under section 7 of the Ukraine Freedom Support Act of 2014 (22 U.S.C. 8926).

 

SEC. 258. TERMINATION.

The provisions of this subtitle shall terminate on the date that is 5 years after the date of the enactment of this Act.

 

SEC. 259. APPROPRIATE CONGRESSIONAL COMMITTEES DEFINED.

Except as otherwise provided, in this subtitle, the term “appropriate congressional committees” means—

(1) the Committee on Foreign Relations, the Committee on Banking, Housing, and Urban Affairs, the Committee on Armed Services, the Committee on Homeland Security and Governmental Affairs, the Committee on Appropriations, and the Select Committee on Intelligence of the Senate; and

(2) the Committee on Foreign Affairs, the Committee on Financial Services, the Committee on Armed Services, the Committee on Homeland Security, the Committee on Appropriations, and the Permanent Select Committee on Intelligence of the House of Representatives.

Subtitle C—Combating Terrorism And Illicit Financing

PART 1—NATIONAL STRATEGY FOR COMBATING TERRORIST AND OTHER ILLICIT FINANCING

 

SEC. 261. DEVELOPMENT OF NATIONAL STRATEGY.

(a) In General.—The President, acting through the Secretary, shall, in consultation with the Attorney General, the Secretary of State, the Secretary of Homeland Security, the Director of National Intelligence, the Director of the Office of Management and Budget, and the appropriate Federal banking agencies and Federal functional regulators, develop a national strategy for combating the financing of terrorism and related forms of illicit finance.

(b) Transmittal To Congress.—

(1) IN GENERAL.—Not later than 1 year after the date of the enactment of this Act, the President shall submit to the appropriate congressional committees a comprehensive national strategy developed in accordance with subsection (a).

(2) UPDATES.—Not later than January 31, 2020, and January 31, 2022, the President shall submit to the appropriate congressional committees updated versions of the national strategy submitted under paragraph (1).

(c) Separate Presentation Of Classified Material.—Any part of the national strategy that involves information that is properly classified under criteria established by the President shall be submitted to Congress separately in a classified annex and, if requested by the chairman or ranking member of one of the appropriate congressional committees, as a briefing at an appropriate level of security.

 

SEC. 262. CONTENTS OF NATIONAL STRATEGY.

The strategy described in section 261 shall contain the following:

(1) EVALUATION OF EXISTING EFFORTS.—An assessment of the effectiveness of and ways in which the United States is currently addressing the highest levels of risk of various forms of illicit finance, including those identified in the documents entitled “2015 National Money Laundering Risk Assessment” and “2015 National Terrorist Financing Risk Assessment”, published by the Department of the Treasury and a description of how the strategy is integrated into, and supports, the broader counter terrorism strategy of the United States.

(2) GOALS, OBJECTIVES, AND PRIORITIES.—A comprehensive, research-based, long-range, quantifiable discussion of goals, objectives, and priorities for disrupting and preventing illicit finance activities within and transiting the financial system of the United States that outlines priorities to reduce the incidence, dollar value, and effects of illicit finance.

(3) THREATS.—An identification of the most significant illicit finance threats to the financial system of the United States.

(4) REVIEWS AND PROPOSED CHANGES.—Reviews of enforcement efforts, relevant regulations and relevant provisions of law and, if appropriate, discussions of proposed changes determined to be appropriate to ensure that the United States pursues coordinated and effective efforts at all levels of government, and with international partners of the United States, in the fight against illicit finance.

(5) DETECTION AND PROSECUTION INITIATIVES.—A description of efforts to improve, as necessary, detection and prosecution of illicit finance, including efforts to ensure that—

(A) subject to legal restrictions, all appropriate data collected by the Federal Government that is relevant to the efforts described in this section be available in a timely fashion to—

(i) all appropriate Federal departments and agencies; and

(ii) as appropriate and consistent with section 314 of the International Money Laundering Abatement and Financial Anti-Terrorism Act of 2001 (31 U.S.C. 5311 note), to financial institutions to assist the financial institutions in efforts to comply with laws aimed at curbing illicit finance; and

(B) appropriate efforts are undertaken to ensure that Federal departments and agencies charged with reducing and preventing illicit finance make thorough use of publicly available data in furtherance of this effort.

(6) THE ROLE OF THE PRIVATE FINANCIAL SECTOR IN PREVENTION OF ILLICIT FINANCE.—A discussion of ways to enhance partnerships between the private financial sector and Federal departments and agencies with regard to the prevention and detection of illicit finance, including—

(A) efforts to facilitate compliance with laws aimed at stopping such illicit finance while maintaining the effectiveness of such efforts; and

(B) providing guidance to strengthen internal controls and to adopt on an industry-wide basis more effective policies.

(7) ENHANCEMENT OF INTERGOVERNMENTAL COOPERATION.—A discussion of ways to combat illicit finance by enhancing—

(A) cooperative efforts between and among Federal, State, and local officials, including State regulators, State and local prosecutors, and other law enforcement officials; and

(B) cooperative efforts with and between governments of countries and with and between multinational institutions with expertise in fighting illicit finance, including the Financial Action Task Force and the Egmont Group of Financial Intelligence Units.

(8) TREND ANALYSIS OF EMERGING ILLICIT FINANCE THREATS.—A discussion of and data regarding trends in illicit finance, including evolving forms of value transfer such as so-called cryptocurrencies, other methods that are computer, telecommunications, or Internet-based, cyber crime, or any other threats that the Secretary may choose to identify.

(9) BUDGET PRIORITIES.—A multiyear budget plan that identifies sufficient resources needed to successfully execute the full range of missions called for in this section.

(10) TECHNOLOGY ENHANCEMENTS.—An analysis of current and developing ways to leverage technology to improve the effectiveness of efforts to stop the financing of terrorism and other forms of illicit finance, including better integration of open-source data.

PART 2—ENHANCING ANTITERRORISM TOOLS OF THE DEPARTMENT OF THE TREASURY

 

SEC. 271. IMPROVING ANTITERROR FINANCE MONITORING OF FUNDS TRANSFERS.

(a) Study.—

(1) IN GENERAL.—To improve the ability of the Department of the Treasury to better track cross-border fund transfers and identify potential financing of terrorist or other forms of illicit finance, the Secretary shall carry out a study to assess—

(A) the potential efficacy of requiring banking regulators to establish a pilot program to provide technical assistance to depository institutions and credit unions that wish to provide account services to money services businesses serving individuals in Somalia;

(B) whether such a pilot program could be a model for improving the ability of United States persons to make legitimate funds transfers through transparent and easily monitored channels while preserving strict compliance with the Bank Secrecy Act (Public Law 91–508; 84 Stat. 1114) and related controls aimed at stopping money laundering and the financing of terrorism; and

(C) consistent with current legal requirements regarding confidential supervisory information, the potential impact of allowing money services businesses to share certain State examination information with depository institutions and credit unions, or whether another appropriate mechanism could be identified to allow a similar exchange of information to give the depository institutions and credit unions a better understanding of whether an individual money services business is adequately meeting its anti-money laundering and counter-terror financing obligations to combat money laundering, the financing of terror, or related illicit finance.

(2) PUBLIC INPUT.—The Secretary should solicit and consider public input as appropriate in developing the study required under subsection (a).

(b) Report.—Not later than 270 days after the date of the enactment of this Act, the Secretary shall submit to the Committee on Banking, Housing, and Urban Affairs and the Committee on Foreign Relations of the Senate and the Committee on Financial Services and the Committee on Foreign Affairs of the House of Representatives a report that contains all findings and determinations made in carrying out the study required under subsection (a).

 

SEC. 272. SENSE OF CONGRESS ON INTERNATIONAL COOPERATION REGARDING TERRORIST FINANCING INTELLIGENCE.

It is the sense of Congress that the Secretary, acting through the Under Secretary for Terrorism and Financial Crimes, should intensify work with foreign partners to help the foreign partners develop intelligence analytic capacities, in a financial intelligence unit, finance ministry, or other appropriate agency, that are—

(1) commensurate to the threats faced by the foreign partner; and

(2) designed to better integrate intelligence efforts with the anti-money laundering and counter-terrorist financing regimes of the foreign partner.

 

SEC. 273. EXAMINING THE COUNTER-TERROR FINANCING ROLE OF THE DEPARTMENT OF THE TREASURY IN EMBASSIES.

Not later than 180 days after the date of the enactment of this Act, the Secretary shall submit to the Committee on Banking, Housing, and Urban Affairs and the Committee on Foreign Relations of the Senate and the Committee on Financial Services and the Committee on Foreign Affairs of the House of Representatives a report that contains—

(1) a list of the United States embassies in which a full-time Department of the Treasury financial attaché is stationed and a description of how the interests of the Department of the Treasury relating to terrorist financing and money laundering are addressed (via regional attachés or otherwise) at United States embassies where no such attachés are present;

(2) a list of the United States embassies at which the Department of the Treasury has assigned a technical assistance advisor from the Office of Technical Assistance of the Department of the Treasury;

(3) an overview of how Department of the Treasury financial attachés and technical assistance advisors assist in efforts to counter illicit finance, to include money laundering, terrorist financing, and proliferation financing; and

(4) an overview of patterns, trends, or other issues identified by the Department of the Treasury and whether resources are sufficient to address these issues.

 

SEC. 274. INCLUSION OF SECRETARY OF THE TREASURY ON THE NATIONAL SECURITY COUNCIL.

(a) In General.—Section 101(c)(1) of the National Security Act of 1947 (50 U.S.C. 3021(c)(1)) is amended by inserting “the Secretary of the Treasury,” before “and such other officers”.

(b) Rule Of Construction.—The amendment made by subsection (a) may not be construed to authorize the National Security Council to have a professional staff level that exceeds the limitation set forth under section 101(e)(3) of the National Security Act of 1947 (50 U.S.C. 3021(e)(3)).

 

SEC. 275. INCLUSION OF ALL FUNDS.

(a) In General.—Section 5326 of title 31, United States Code, is amended—

(1) in the heading of such section, by striking “coin and currency”;

(2) in subsection (a)—

(A) by striking “subtitle and” and inserting “subtitle or to”; and

(B) in paragraph (1)(A), by striking “United States coins or currency (or such other monetary instruments as the Secretary may describe in such order)” and inserting “funds (as the Secretary may describe in such order),”; and

(3) in subsection (b)—

(A) in paragraph (1)(A), by striking “coins or currency (or monetary instruments)” and inserting “funds”; and

(B) in paragraph (2), by striking “coins or currency (or such other monetary instruments as the Secretary may describe in the regulation or order)” and inserting “funds (as the Secretary may describe in the regulation or order)”.

(b) Clerical Amendment.—The table of contents for chapter 53 of title 31, United States Code, is amended in the item relating to section 5326 by striking “coin and currency”.

PART 3—DEFINITIONS

 

SEC. 281. DEFINITIONS.

In this subtitle—

(1) the term “appropriate congressional committees” means—

(A) the Committee on Banking, Housing, and Urban Affairs, the Committee on Foreign Relations, Committee on Armed Services, Committee on the Judiciary, Committee on Homeland Security and Governmental Affairs, and the Select Committee on Intelligence of the Senate; and

(B) the Committee on Financial Services, the Committee on Foreign Affairs, the Committee on Armed Services, the Committee on the Judiciary, Committee on Homeland Security, and the Permanent Select Committee on Intelligence of the House of Representatives;

(2) the term “appropriate Federal banking agencies” has the meaning given the term in section 3 of the Federal Deposit Insurance Act (12 U.S.C. 1813);

(3) the term “Bank Secrecy Act” means—

(A) section 21 of the Federal Deposit Insurance Act (12 U.S.C. 1829b);

(B) chapter 2 of title I of Public Law 91–508 (12 U.S.C. 1951 et seq.); and

(C) subchapter II of chapter 53 of title 31, United States Code;

(4) the term “Federal functional regulator” has the meaning given that term in section 509 of the Gramm-Leach-Bliley Act (15 U.S.C. 6809);

(5) the term “illicit finance” means the financing of terrorism, narcotics trafficking, or proliferation, money laundering, or other forms of illicit financing domestically or internationally, as defined by the President;

(6) the term “money services business” has the meaning given the term under section 1010.100 of title 31, Code of Federal Regulations;

(7) the term “Secretary” means the Secretary of the Treasury; and

(8) the term “State” means each of the several States, the District of Columbia, and each territory or possession of the United States.

Subtitle D—Rule Of Construction

 

SEC. 291. RULE OF CONSTRUCTION.

Nothing in this title or the amendments made by this title (other than sections 216 and 236(b)) shall be construed to limit the authority of the President under the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.).

 

SEC. 292. SENSE OF CONGRESS ON THE STRATEGIC IMPORTANCE OF ARTICLE 5 OF THE NORTH ATLANTIC TREATY.

(a) Findings.—Congress makes the following findings:

(1) The principle of collective defense of the North Atlantic Treaty Organization (NATO) is immortalized in Article 5 of the North Atlantic Treaty in which members pledge that “an armed attack against one or more of them in Europe or North America shall be considered an attack against them all”.

(2) For almost 7 decades, the principle of collective defense has effectively served as a strategic deterrent for the member nations of the North Atlantic Treaty Organization and provided stability throughout the world, strengthening the security of the United States and all 28 other member nations.

(3) Following the September 11, 2001, terrorist attacks in New York, Washington, and Pennsylvania, the Alliance agreed to invoke Article 5 for the first time, affirming its commitment to collective defense.

(4) Countries that are members of the North Atlantic Treaty Organization have made historic contributions and sacrifices while combating terrorism in Afghanistan through the International Security Assistance Force and the Resolute Support Mission.

(5) The recent attacks in the United Kingdom underscore the importance of an international alliance to combat hostile nation states and terrorist groups.

(6) At the 2014 NATO summit in Wales, the member countries of the North Atlantic Treaty Organization decided that all countries that are members of NATO would spend an amount equal to 2 percent of their gross domestic product on defense by 2024.

(7) Collective defense unites the 29 members of the North Atlantic Treaty Organization, each committing to protecting and supporting one another from external adversaries, which bolsters the North Atlantic Alliance.

(b) Sense Of Congress.—It is the sense of Congress—

(1) to express the vital importance of Article 5 of the North Atlantic Treaty, the charter of the North Atlantic Treaty Organization, as it continues to serve as a critical deterrent to potential hostile nations and terrorist organizations;

(2) to remember the first and only invocation of Article 5 by the North Atlantic Treaty Organization in support of the United States after the terrorist attacks of September 11, 2001;

(3) to affirm that the United States remains fully committed to the North Atlantic Treaty Organization and will honor its obligations enshrined in Article 5; and

(4) to condemn any threat to the sovereignty, territorial integrity, freedom, or democracy of any country that is a member of the North Atlantic Treaty Organization.

TITLE III—SANCTIONS WITH RESPECT TO NORTH KOREA

 

SEC. 301. SHORT TITLE.

This title may be cited as the “Korean Interdiction and Modernization of Sanctions Act”.

 

SEC. 302. DEFINITIONS.

(a) Amendments To Definitions In The North Korea Sanctions And Policy Enhancement Act Of 2016.—

(1) APPLICABLE EXECUTIVE ORDER.—Section 3(1)(A) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9202(1)(A)) is amended—

(A) by striking “or Executive Order 13694” and inserting “Executive Order No. 13694”; and

(B) by inserting “or Executive Order No. 13722 (50 U.S.C. 1701 note; relating to blocking the property of the Government of North Korea and the Workers’ Party of Korea, and Prohibiting Certain Transactions With Respect to North Korea),” before “to the extent”.

(2) APPLICABLE UNITED NATIONS SECURITY COUNCIL RESOLUTION.—Section 3(2)(A) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9202(2)(A)) is amended by striking “or 2094 (2013)” and inserting “2094 (2013), 2270 (2016), or 2321 (2016)”.

(3) FOREIGN PERSON.—Section 3 of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9202) is amended—

(A) by redesignating paragraphs (5) through (14) as paragraphs (6) through (15), respectively; and

(B) by inserting after paragraph (4) the following new paragraph:

 

“(5) FOREIGN PERSON.—The term ‘foreign person’ means—

“(A) an individual who is not a United States citizen or an alien lawfully admitted for permanent residence to the United States; or

“(B) an entity that is not a United States person.”.

(4) LUXURY GOODS.—Paragraph (9) of section 3 of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9202), as redesignated by paragraph (3) of this subsection, is amended—

(A) in subparagraph (A), by striking “and” at the end;

(B) in subparagraph (B), by striking the period at the end and inserting “; and”; and

(C) by adding at the end the following new subparagraph:

 

“(C) also includes any items so designated under an applicable United Nations Security Council resolution.”.

(5) NORTH KOREAN PERSON.—Section 3 of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9202), as amended by paragraph (3) of this subsection, is further amended—

(A) by redesignating paragraphs (13) through (15) as paragraphs (14) through (16), respectively; and

(B) by inserting after paragraph (12) the following new paragraph:

 

“(13) NORTH KOREAN PERSON.—The term ‘North Korean person’ means—

“(A) a North Korean citizen or national; or

“(B) an entity owned or controlled by the Government of North Korea or by a North Korean citizen or national.”.

(b) Definitions For Purposes Of This Act.—In this title:

(1) APPLICABLE UNITED NATIONS SECURITY COUNCIL RESOLUTION; LUXURY GOODS.—The terms “applicable United Nations Security Council resolution” and “luxury goods” have the meanings given those terms, respectively, in section 3 of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9202), as amended by subsection (a).

(2) APPROPRIATE CONGRESSIONAL COMMITTEES; GOVERNMENT OF NORTH KOREA; UNITED STATES PERSON.—The terms “appropriate congressional committees”, “Government of North Korea”, and “United States person” have the meanings given those terms, respectively, in section 3 of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9202).

(3) FOREIGN PERSON; NORTH KOREAN PERSON.—The terms “foreign person” and “North Korean person” have the meanings given those terms, respectively, in paragraph (5) and paragraph (13) of section 3 of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9202(5) and 9202(13)), as added by subsection (a).

(4) PROHIBITED WEAPONS PROGRAM.—The term “prohibited weapons program” means—

(A) any program related to the development of nuclear, chemical, or biological weapons, and their means of delivery, including ballistic missiles; and

(B) any program to develop related materials with respect to a program described in subparagraph (A).

Subtitle A—Sanctions To Enforce And Implement United Nations Security Council Sanctions Against North Korea

 

SEC. 311. MODIFICATION AND EXPANSION OF REQUIREMENTS FOR THE DESIGNATION OF PERSONS.

(a) Expansion Of Mandatory Designations.—Section 104(a) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9214(a)) is amended—

(1) in paragraph (9), by striking “; or” and inserting “or any defense article or defense service (as such terms are defined in section 47 of the Arms Export Control Act (22 U.S.C. 2794));”;

(2) by redesignating paragraph (10) as paragraph (15);

(3) by inserting after paragraph (9) the following new paragraphs:

 

“(10) knowingly, directly or indirectly, purchases or otherwise acquires from North Korea any significant amounts of gold, titanium ore, vanadium ore, copper, silver, nickel, zinc, or rare earth minerals;

“(11) knowingly, directly or indirectly, sells or transfers to North Korea any significant amounts of rocket, aviation, or jet fuel (except for use by a civilian passenger aircraft outside North Korea, exclusively for consumption during its flight to North Korea or its return flight);

“(12) knowingly, directly or indirectly, provides significant amounts of fuel or supplies, provides bunkering services, or facilitates a significant transaction or transactions to operate or maintain, a vessel or aircraft that is designated under an applicable Executive order or an applicable United Nations Security Council resolution, or that is owned or controlled by a person designated under an applicable Executive order or applicable United Nations Security Council resolution;

“(13) knowingly, directly or indirectly, insures, registers, facilitates the registration of, or maintains insurance or a registration for, a vessel owned or controlled by the Government of North Korea, except as specifically approved by the United Nations Security Council;

“(14) knowingly, directly or indirectly, maintains a correspondent account (as defined in section 201A(d)(1)) with any North Korean financial institution, except as specifically approved by the United Nations Security Council; or”; and

(4) in paragraph (15), as so redesignated, by striking “(9)” and inserting “(14)”.

(b) Expansion Of Additional Discretionary Designations.—

(1) IN GENERAL.—Section 104(b)(1) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9214(b)(1)) is amended—

(A) in subparagraph (A), by striking “pursuant to an applicable United Nations Security Council resolution;” and inserting the following: “pursuant to—

“(i) an applicable United Nations Security Council resolution;

“(ii) any regulation promulgated under section 404; or

“(iii) any applicable Executive order;”;

(B) in subparagraph (B)(iii), by striking “or” at the end;

(C) in subparagraph (C), by striking the period at the end and inserting a semicolon; and

(D) by adding at the end the following new subparagraphs:

 

“(D) knowingly, directly or indirectly, purchased or otherwise acquired from the Government of North Korea significant quantities of coal, iron, or iron ore, in excess of the limitations provided in applicable United Nations Security Council resolutions;

“(E) knowingly, directly or indirectly, purchased or otherwise acquired significant types or amounts of textiles from the Government of North Korea;

“(F) knowingly facilitated a significant transfer of funds or property of the Government of North Korea that materially contributes to any violation of an applicable United National Security Council resolution;

“(G) knowingly, directly or indirectly, facilitated a significant transfer to or from the Government of North Korea of bulk cash, precious metals, gemstones, or other stores of value not described under subsection (a)(10);

“(H) knowingly, directly or indirectly, sold, transferred, or otherwise provided significant amounts of crude oil, condensates, refined petroleum, other types of petroleum or petroleum byproducts, liquified natural gas, or other natural gas resources to the Government of North Korea (except for heavy fuel oil, gasoline, or diesel fuel for humanitarian use or as excepted under subsection (a)(11));

“(I) knowingly, directly or indirectly, engaged in, facilitated, or was responsible for the online commercial activities of the Government of North Korea, including online gambling;

“(J) knowingly, directly or indirectly, purchased or otherwise acquired fishing rights from the Government of North Korea;

“(K) knowingly, directly or indirectly, purchased or otherwise acquired significant types or amounts of food or agricultural products from the Government of North Korea;

“(L) knowingly, directly or indirectly, engaged in, facilitated, or was responsible for the exportation of workers from North Korea in a manner intended to generate significant revenue, directly or indirectly, for use by the Government of North Korea or by the Workers’ Party of Korea;

“(M) knowingly conducted a significant transaction or transactions in North Korea’s transportation, mining, energy, or financial services industries; or

“(N) except as specifically approved by the United Nations Security Council, and other than through a correspondent account as described in subsection (a)(14), knowingly facilitated the operation of any branch, subsidiary, or office of a North Korean financial institution.”.

(2) EFFECTIVE DATE.—The amendments made by paragraph (1) take effect on the date of the enactment of this Act and apply with respect to conduct described in subparagraphs (D) through (N) of section 104(b)(1) of the North Korea Sanctions and Policy Enhancement Act of 2016, as added by paragraph (1), engaged in on or after such date of enactment.

(c) Mandatory And Discretionary Asset Blocking.—Section 104(c) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9214(c)) is amended—

(1) by striking “of a designated person” and inserting “of a person designated under subsection (a)”;

(2) by striking “The President” and inserting the following:

 

“(1) MANDATORY ASSET BLOCKING.—The President”; and

(3) by adding at the end the following new paragraph:

 

“(2) DISCRETIONARY ASSET BLOCKING.—The President may also exercise such powers, in the same manner and to the same extent described in paragraph (1), with respect to a person designated under subsection (b).”.

(d) Designation Of Additional Persons.—

(1) IN GENERAL.—Not later than 180 days after the date of the enactment of this Act, the President shall submit to the appropriate congressional committees a report including a determination as to whether reasonable grounds exist, and an explanation of the reasons for any determination that such grounds do not exist, to designate, pursuant to section 104 of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9214), as amended by this section, each of the following:

(A) The Korea Shipowners’ Protection and Indemnity Association, a North Korean insurance company, with respect to facilitating imports, exports, and reexports of arms and related materiel to and from North Korea, or for other activities prohibited by such section 104.

(B) Chinpo Shipping Company (Private) Limited, a Singapore corporation, with respect to facilitating imports, exports, and reexports of arms and related materiel to and from North Korea.

(C) The Central Bank of the Democratic People’s Republic of Korea, with respect to the sale of gold to, the receipt of gold from, or the import or export of gold by the Government of North Korea.

(D) Kumgang Economic Development Corporation (KKG), with respect to being an entity controlled by Bureau 39 of the Workers’ Party of the Government of North Korea.

(E) Sam Pa, also known as Xu Jinghua, Xu Songhua, Sa Muxu, Samo, Sampa, or Sam King, and any entities owned or controlled by such individual, with respect to transactions with KKG.

(F) The Chamber of Commerce of the Democratic People’s Republic of Korea, with respect to the exportation of workers in violation of section 104(a)(5) or of section 104(b)(1)(M) of such Act, as amended by subsection (b) of this section.

(2) FORM.—The report submitted under paragraph (1) may contain a classified annex.

 

SEC. 312. PROHIBITION ON INDIRECT CORRESPONDENT ACCOUNTS.

(a) In General.—Title II of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9221 et seq.) is amended by inserting after section 201 the following new section:

“SEC. 201A. PROHIBITION ON INDIRECT CORRESPONDENT ACCOUNTS.

“(a) In General.—Except as provided in subsection (b), if a United States financial institution has or obtains knowledge that a correspondent account established, maintained, administered, or managed by that institution for a foreign financial institution is being used by the foreign financial institution to provide significant financial services indirectly to any person, foreign government, or financial institution designated under section 104, the United States financial institution shall ensure that such correspondent account is no longer used to provide such services.

“(b) Exception.—A United States financial institution is authorized to process transfers of funds to or from North Korea, or for the direct or indirect benefit of any person, foreign government, or financial institution that is designated under section 104, only if the transfer—

“(1) arises from, and is ordinarily incident and necessary to give effect to, an underlying transaction that has been authorized by a specific or general license issued by the Secretary of the Treasury; and

“(2) does not involve debiting or crediting a North Korean account.

“(c) Definitions.—In this section:

“(1) CORRESPONDENT ACCOUNT.—The term ‘correspondent account’ has the meaning given that term in section 5318A of title 31, United States Code.

“(2) UNITED STATES FINANCIAL INSTITUTION.—The term ‘United States financial institution’ means has the meaning given that term in section 510.310 of title 31, Code of Federal Regulations, as in effect on the date of the enactment of this section.

“(3) FOREIGN FINANCIAL INSTITUTION.—The term ‘foreign financial institution’ has the meaning given that term in section 1010.605 of title 31, Code of Federal Regulations, as in effect on the date of the enactment of this section.”.

(b) Clerical Amendment.—The table of contents in section 1(b) of the North Korea Sanctions and Policy Enhancement Act of 2016 is amended by inserting after the item relating to section 201 the following new item:

 

“Sec. 201A. Prohibition on indirect correspondent accounts.”.

 

SEC. 313. LIMITATIONS ON FOREIGN ASSISTANCE TO NONCOMPLIANT GOVERNMENTS.

Section 203 of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9223) is amended—

(1) in subsection (b)—

(A) in the heading, by striking “Transactions In Lethal Military Equipment” and inserting “Transactions In Defense Articles Or Defense Services”;

(B) in paragraph (1), by striking “that provides lethal military equipment to the Government of North Korea” and inserting “that provides to or receives from the Government of North Korea a defense article or defense service, as such terms are defined in section 47 of the Arms Export Control Act (22 U.S.C. 2794), if the President determines that a significant type or amount of such article or service has been so provided or received”; and

(C) in paragraph (2), by striking “1 year” and inserting “2 years”;

(2) in subsection (d), by striking “or emergency” and inserting “maternal and child health, disease prevention and response, or”; and

(3) by adding at the end the following new subsection:

“(e) Report On Arms Trafficking Involving North Korea.—

“(1) IN GENERAL.—Not later than 180 days after the date of the enactment of this subsection, and annually thereafter for 5 years, the Secretary of State shall submit to the appropriate congressional committees a report that specifically describes the compliance of foreign countries and other foreign jurisdictions with the requirement to curtail the trade described in subsection (b)(1).

“(2) FORM.—The report required under paragraph (1) shall be submitted in unclassified form but may contain a classified annex.”.

 

SEC. 314. AMENDMENTS TO ENHANCE INSPECTION AUTHORITIES.

Title II of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9221 et seq.), as amended by section 102 of this Act, is further amended by striking section 205 and inserting the following:

205. ENHANCED INSPECTION AUTHORITIES.

“(a) Report Required.—

“(1) IN GENERAL.—Not later than 180 days after the date of the enactment of this section, and annually thereafter for 5 years, the President shall submit to the appropriate congressional committees a report—

“(A) identifying the operators of foreign sea ports and airports that knowingly—

“(i) significantly fail to implement or enforce regulations to inspect ships, aircraft, cargo, or conveyances in transit to or from North Korea, as required by applicable United Nations Security Council resolutions;

“(ii) facilitate the transfer, transshipment, or conveyance of significant types or quantities of cargo, vessels, or aircraft owned or controlled by persons designated under applicable United Nations Security Council resolutions; or

“(iii) facilitate any of the activities described in section 104(a);

“(B) describing the extent to which the requirements of applicable United Nations Security Council resolutions to de-register any vessel owned, controlled, or operated by or on behalf of the Government of North Korea have been implemented by other foreign countries;

“(C) describing the compliance of the Islamic Republic of Iran with the sanctions mandated in applicable United Nations Security Council resolutions;

“(D) identifying vessels, aircraft, and conveyances owned or controlled by the Reconnaissance General Bureau of the Workers’ Party of Korea; and

“(E) describing the diplomatic and enforcement efforts by the President to secure the full implementation of the applicable United Nations Security Council resolutions, as described in subparagraphs (A) through (C).

“(2) FORM.—The report required under paragraph (1) shall be submitted in unclassified form but may contain a classified annex.

“(b) Specific Findings.—Each report required under subsection (a) shall include specific findings with respect to the following ports and airports:

“(1) The ports of Dandong, Dalian, and any other port in the People’s Republic of China that the President deems appropriate.

“(2) The ports of Abadan, Bandar-e-Abbas, Chabahar, Bandar-e-Khomeini, Bushehr Port, Asaluyeh Port, Kish, Kharg Island, Bandar-e-Lenge, and Khorramshahr, and Tehran Imam Khomeini International Airport, in the Islamic Republic of Iran.

“(3) The ports of Nakhodka, Vanino, and Vladivostok, in the Russian Federation.

“(4) The ports of Latakia, Banias, and Tartous, and Damascus International Airport, in the Syrian Arab Republic.

“(c) Enhanced Security Targeting Requirements.—

“(1) IN GENERAL.—Except as provided in paragraph (2), the Secretary of Homeland Security may, using a layered approach, require enhanced screening procedures to determine whether physical inspections are warranted of any cargo bound for or landed in the United States that—

“(A) has been transported through a sea port or airport the operator of which has been identified by the President in accordance with subsection (a)(1) as having repeatedly failed to comply with applicable United Nations Security Council resolutions;

“(B) is aboard a vessel or aircraft, or within a conveyance that has, within the last 365 days, entered the territory or waters of North Korea, or landed in any of the sea ports or airports of North Korea; or

“(C) is registered by a country or jurisdiction whose compliance has been identified by the President as deficient pursuant to subsection (a)(2).

“(2) EXCEPTION FOR FOOD, MEDICINE, AND HUMANITARIAN SHIPMENTS.—Paragraph (1) shall not apply to any vessel, aircraft, or conveyance that has entered the territory or waters of North Korea, or landed in any of the sea ports or airports of North Korea, exclusively for the purposes described in section 208(b)(3)(B), or to import food, medicine, or supplies into North Korea to meet the humanitarian needs of the North Korean people.

“(d) Seizure And Forfeiture.—A vessel, aircraft, or conveyance used to facilitate any of the activities described in section 104(a) under the jurisdiction of the United States may be seized and forfeited, or subject to forfeiture, under—

“(1) chapter 46 of title 18, United States Code; or

“(2) part V of title IV of the Tariff Act of 1930 (19 U.S.C. 1581 et seq.).”.

 

SEC. 315. ENFORCING COMPLIANCE WITH UNITED NATIONS SHIPPING SANCTIONS AGAINST NORTH KOREA.

(a) In General.—The Ports and Waterways Safety Act (33 U.S.C. 1221 et seq.) is amended by adding at the end the following new section:

“SEC. 16. PROHIBITION ON ENTRY AND OPERATION.

 

“(a) Prohibition.—

“(1) IN GENERAL.—Except as otherwise provided in this section, no vessel described in subsection (b) may enter or operate in the navigable waters of the United States or transfer cargo in any port or place under the jurisdiction of the United States.

“(2) LIMITATIONS ON APPLICATION.—

“(A) IN GENERAL.—The prohibition under paragraph (1) shall not apply with respect to—

“(i) a vessel described in subsection (b)(1), if the Secretary of State determines that—

“(I) the vessel is owned or operated by or on behalf of a country the government of which the Secretary of State determines is closely cooperating with the United States with respect to implementing the applicable United Nations Security Council resolutions (as such term is defined in section 3 of the North Korea Sanctions and Policy Enhancement Act of 2016); or

“(II) it is in the national security interest not to apply the prohibition to such vessel; or

“(ii) a vessel described in subsection (b)(2), if the Secretary of State determines that the vessel is no longer registered as described in that subsection.

“(B) NOTICE.—Not later than 15 days after making a determination under subparagraph (A), the Secretary of State shall submit to the Committee on Foreign Affairs and the Committee on Transportation and Infrastructure of the House of Representatives and the Committee on Foreign Relations and the Committee on Commerce, Science, and Transportation of the Senate written notice of the determination and the basis upon which the determination was made.

“(C) PUBLICATION.—The Secretary of State shall publish a notice in the Federal Register of each determination made under subparagraph (A).

“(b) Vessels Described.—A vessel referred to in subsection (a) is a foreign vessel for which a notice of arrival is required to be filed under section 4(a)(5), and that—

“(1) is on the most recent list of vessels published in Federal Register under subsection (c)(2); or

“(2) more than 180 days after the publication of such list, is knowingly registered, pursuant to the 1958 Convention on the High Seas entered into force on September 30, 1962, by a government the agents or instrumentalities of which are maintaining a registration of a vessel that is included on such list.

“(c) Information And Publication.—The Secretary of the department in which the Coast Guard is operating, with the concurrence of the Secretary of State, shall—

“(1) maintain timely information on the registrations of all foreign vessels over 300 gross tons that are known to be—

“(A) owned or operated by or on behalf of the Government of North Korea or a North Korean person;

“(B) owned or operated by or on behalf of any country in which a sea port is located, the operator of which the President has identified in the most recent report submitted under section 205(a)(1)(A) of the North Korea Sanctions and Policy Enhancement Act of 2016; or

“(C) owned or operated by or on behalf of any country identified by the President as a country that has not complied with the applicable United Nations Security Council resolutions (as such term is defined in section 3 of such Act); and

“(2) not later than 180 days after the date of the enactment of this section, and periodically thereafter, publish in the Federal Register a list of the vessels described in paragraph (1).

“(d) Notification Of Governments.—

“(1) IN GENERAL.—The Secretary of State shall notify each government, the agents or instrumentalities of which are maintaining a registration of a foreign vessel that is included on a list published under subsection (c)(2), not later than 30 days after such publication, that all vessels registered under such government’s authority are subject to subsection (a).

“(2) ADDITIONAL NOTIFICATION.—In the case of a government that continues to maintain a registration for a vessel that is included on such list after receiving an initial notification under paragraph (1), the Secretary shall issue an additional notification to such government not later than 120 days after the publication of a list under subsection (c)(2).

“(e) Notification Of Vessels.—Upon receiving a notice of arrival under section 4(a)(5) from a vessel described in subsection (b), the Secretary of the department in which the Coast Guard is operating shall notify the master of such vessel that the vessel may not enter or operate in the navigable waters of the United States or transfer cargo in any port or place under the jurisdiction of the United States, unless—

“(1) the Secretary of State has made a determination under subsection (a)(2); or

“(2) the Secretary of the department in which the Coast Guard is operating allows provisional entry of the vessel, or transfer of cargo from the vessel, under subsection (f).

“(f) Provisional Entry Or Cargo Transfer.—Notwithstanding any other provision of this section, the Secretary of the department in which the Coast Guard is operating may allow provisional entry of, or transfer of cargo from, a vessel, if such entry or transfer is necessary for the safety of the vessel or persons aboard.

“(g) Right Of Innocent Passage And Right Of Transit Passage.—This section shall not be construed as authority to restrict the right of innocent passage or the right of transit passage as recognized under international law.

“(h) Foreign Vessel Defined.—In this section, the term ‘foreign vessel’ has the meaning given that term in section 110 of title 46, United States Code.”.

(b) Conforming Amendments.—

(1) SPECIAL POWERS.—Section 4(b)(2) of the Ports and Waterways Safety Act (33 U.S.C. 1223(b)(2)) is amended by inserting “or 16” after “section 9”.

(2) DENIAL OF ENTRY.—Section 13(e) of the Ports and Waterways Safety Act (33 U.S.C. 1232(e)) is amended by striking “section 9” and inserting “section 9 or 16”.

 

SEC. 316. REPORT ON COOPERATION BETWEEN NORTH KOREA AND IRAN.

(a) In General.—Not later than 180 days after the date of the enactment of this Act, and annually thereafter for 5 years, the President shall submit to the appropriate congressional committees and leadership a report that includes—

(1) an assessment of the extent of cooperation (including through the transfer of goods, services, technology, or intellectual property) between North Korea and Iran relating to their respective nuclear, ballistic missile development, chemical or biological weapons development, or conventional weapons programs;

(2) the names of any Iranian or North Korean persons that have knowingly engaged in or directed—

(A) the provision of material support to such programs; or

(B) the exchange of information between North Korea and Iran with respect to such programs;

(3) the names of any other foreign persons that have facilitated the activities described in paragraph (1); and

(4) a determination whether any of the activities described in paragraphs (1) and (2) violate United Nations Security Council Resolution 2231 (2015).

(b) Form.—The report required under subsection (a) shall be submitted in unclassified form but may contain a classified annex.

(c) Appropriate Congressional Committees And Leadership Defined.—In this section, the term “appropriate congressional committees and leadership” means—

(1) the Committee on Foreign Relations, the Committee on Banking, Housing, and Urban Affairs, and the majority and minority leaders of the Senate; and

(2) the Committee on Foreign Affairs, the Committee on Financial Services, the Committee on Ways and Means, and the Speaker, the majority leader, and the minority leader of the House of Representatives.

 

SEC. 317. REPORT ON IMPLEMENTATION OF UNITED NATIONS SECURITY COUNCIL RESOLUTIONS BY OTHER GOVERNMENTS.

(a) In General.—Not later than 180 days after the date of the enactment of this Act, and annually thereafter for 5 years, the President shall submit to the appropriate congressional committees and leadership a report that evaluates the degree to which the governments of other countries have knowingly failed to—

(1) close the representative offices of persons designated under applicable United Nations Security Council resolutions;

(2) expel any North Korean nationals, including diplomats, working on behalf of such persons;

(3) prohibit the opening of new branches, subsidiaries, or representative offices of North Korean financial institutions within the jurisdictions of such governments; or

(4) expel any representatives of North Korean financial institutions.

(b) Form.—The report required under subsection (a) shall be submitted in unclassified form but may contain a classified annex.

(c) Appropriate Congressional Committees And Leadership Defined.—In this section, the term “appropriate congressional committees and leadership” means—

(1) the Committee on Foreign Relations, the Committee on Banking, Housing, and Urban Affairs, and the majority and minority leaders of the Senate; and

(2) the Committee on Foreign Affairs, the Committee on Financial Services, the Committee on Ways and Means, and the Speaker, the majority leader, and the minority leader of the House of Representatives.

 

SEC. 318. BRIEFING ON MEASURES TO DENY SPECIALIZED FINANCIAL MESSAGING SERVICES TO DESIGNATED NORTH KOREAN FINANCIAL INSTITUTIONS.

(a) In General.—Not later than 180 days after the date of the enactment of this Act, and every 180 days thereafter for 5 years, the President shall provide to the appropriate congressional committees a briefing that includes the following information:

(1) A list of each person or foreign government the President has identified that directly provides specialized financial messaging services to, or enables or facilitates direct or indirect access to such messaging services for—

(A) any North Korean financial institution (as such term is defined in section 3 of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9202)) designated under an applicable United Nations Security Council resolution; or

(B) any other North Korean person, on behalf of such a North Korean financial institution.

(2) A detailed assessment of the status of efforts by the Secretary of the Treasury to work with the relevant authorities in the home jurisdictions of such specialized financial messaging providers to end such provision or access.

(b) Form.—The briefing required under subsection (a) may be classified.

Subtitle B—Sanctions With Respect To Human Rights Abuses By The Government Of North Korea

 

SEC. 321. SANCTIONS FOR FORCED LABOR AND SLAVERY OVERSEAS OF NORTH KOREANS.

(a) Sanctions For Trafficking In Persons.—

(1) IN GENERAL.—Section 302(b) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9241(b)) is amended—

(A) in paragraph (1), by striking “and” at the end;

(B) in paragraph (2), by striking the period at the end and inserting “; and”; and

(C) by adding at the end the following new paragraph:

 

“(3) a list of foreign persons that knowingly employ North Korean laborers, as described in section 104(b)(1)(M).”.

(2) ADDITIONAL DETERMINATIONS; REPORTS.—With respect to any country identified in section 302(b)(2) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9241(b)(2)), as amended by paragraph (1), the report required under section 302(a) of such Act shall—

(A) include a determination whether each person identified in section 302(b)(3) of such Act (as amended by paragraph (1)) who is a national or a citizen of such identified country meets the criteria for sanctions under—

(i) section 111 of the Trafficking Victims Protection Act of 2000 (22 U.S.C. 7108) (relating to the prevention of trafficking in persons); or

(ii) section 104(a) or 104(b)(1) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9214(a)), as amended by section 101 of this Act;

(B) be included in the report required under section 110(b) of the Trafficking Victims Protection Act of 2000 (22 U.S.C. 7107(b)) (relating to the annual report on trafficking in persons); and

(C) be considered in any determination that the government of such country has made serious and sustained efforts to eliminate severe forms of trafficking in persons, as such term is defined for purposes of the Trafficking Victims Protection Act of 2000.

(b) Sanctions On Foreign Persons That Employ North Korean Labor.—

(1) IN GENERAL.—Title III of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9241 et seq.) is amended by inserting after section 302 the following new sections:

“SEC. 302A. REBUTTABLE PRESUMPTION APPLICABLE TO GOODS MADE WITH NORTH KOREAN LABOR.

“(a) In General.—Except as provided in subsection (b), any significant goods, wares, articles, and merchandise mined, produced, or manufactured wholly or in part by the labor of North Korean nationals or citizens shall be deemed to be prohibited under section 307 of the Tariff Act of 1930 (19 U.S.C. 1307) and shall not be entitled to entry at any of the ports of the United States.

“(b) Exception.—The prohibition described in subsection (a) shall not apply if the Commissioner of U.S. Customs and Border Protection finds, by clear and convincing evidence, that the goods, wares, articles, or merchandise described in such paragraph were not produced with convict labor, forced labor, or indentured labor under penal sanctions.

“SEC. 302B. SANCTIONS ON FOREIGN PERSONS EMPLOYING NORTH KOREAN LABOR.

“(a) In General.—Except as provided in subsection (c), the President shall designate any person identified under section 302(b)(3) for the imposition of sanctions under subsection (b).

“(b) Imposition Of Sanctions.—

“(1) IN GENERAL.—The President shall impose the sanctions described in paragraph (2) with respect to any person designated under subsection (a).

“(2) SANCTIONS DESCRIBED.—The sanctions described in this paragraph are sanctions pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.) to block and prohibit all transactions in property and interests in property of a person designated under subsection (a), if such property and interests in property are in the United States, come within the United States, or are or come within the possession or control of a United States person.

“(c) Exception.—

“(1) IN GENERAL.—A person may not be designated under subsection (a) if the President certifies to the appropriate congressional committees that the President has received reliable assurances from such person that—

“(A) the employment of North Korean laborers does not result in the direct or indirect transfer of convertible currency, luxury goods, or other stores of value to the Government of North Korea;

“(B) all wages and benefits are provided directly to the laborers, and are held, as applicable, in accounts within the jurisdiction in which they reside in locally denominated currency; and

“(C) the laborers are subject to working conditions consistent with international standards.

“(2) RECERTIFICATION.—Not later than 180 days after the date on which the President transmits to the appropriate congressional committees an initial certification under paragraph (1), and every 180 days thereafter, the President shall—

“(A) transmit a recertification stating that the conditions described in such paragraph continue to be met; or

“(B) if such recertification cannot be transmitted, impose the sanctions described in subsection (b) beginning on the date on which the President determines that such recertification cannot be transmitted.”.

(2) CLERICAL AMENDMENT.—The table of contents in section 1(b) of the North Korea Sanctions and Policy Enhancement Act of 2016 is amended by inserting after the item relating to section 302 the following new items:

 

“Sec. 302A. Rebuttable presumption applicable to goods made with North Korean labor.

“Sec. 302B. Sanctions on foreign persons employing North Korean labor.”.

 

SEC. 322. MODIFICATIONS TO SANCTIONS SUSPENSION AND WAIVER AUTHORITIES.

(a) Exemptions.—Section 208(a) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9228(a)) is amended in the matter preceding paragraph (1)—

(1) by inserting “201A,” after “104,”; and

(2) by inserting “302A, 302B,” after “209,”.

(b) Humanitarian Waiver.—Section 208(b) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9228(b)(1)) is amended—

(1) by inserting “201A,” after “104,” in each place it appears; and

(2) by inserting “302A, 302B,” after “209(b),” in each place it appears.

(c) Waiver.—Section 208(c) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9228(c)) is amended in the matter preceding paragraph (1)—

(1) by inserting “201A,” after “104,”; and

(2) by inserting “302A, 302B,” after “209(b),”.

 

SEC. 323. REWARD FOR INFORMANTS.

Section 36(b) of the State Department Basic Authorities Act of 1956 (22 U.S.C. 2708(b)), is amended—

(1) in paragraph (9), by striking “or” at the end;

(2) in paragraph (10), by striking the period at the end and inserting a semicolon; and

(3) by adding at the end the following new paragraphs:

“(11) the identification or location of any person who, while acting at the direction of or under the control of a foreign government, aids or abets a violation of section 1030 of title 18, United States Code; or

“(12) the disruption of financial mechanisms of any person who has engaged in the conduct described in sections 104(a) or 104(b)(1) of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 2914(a) or (b)(1)).”.

 

SEC. 324. DETERMINATION ON DESIGNATION OF NORTH KOREA AS A STATE SPONSOR OF TERRORISM.

(a) Determination.—

(1) IN GENERAL.—Not later than 90 days after the date of the enactment of this Act, the Secretary of State shall submit to the appropriate congressional committees a determination whether North Korea meets the criteria for designation as a state sponsor of terrorism.

(2) FORM.—The determination required by paragraph (1) shall be submitted in unclassified form but may include a classified annex, if appropriate.

(b) State Sponsor Of Terrorism Defined.—For purposes of this section, the term “state sponsor of terrorism” means a country the government of which the Secretary of State has determined, for purposes of section 6(j) of the Export Administration Act of 1979 (50 U.S.C. 4605(j)) (as in effect pursuant to the International Emergency Economic Powers Act), section 620A of the Foreign Assistance Act of 1961 (22 U.S.C. 2371), section 40 of the Arms Export Control Act (22 U.S.C. 2780), or any other provision of law, is a government that has repeatedly provided support for acts of international terrorism.

Subtitle C—General Authorities

 

SEC. 331. AUTHORITY TO CONSOLIDATE REPORTS.

Any reports required to be submitted to the appropriate congressional committees under this title or any amendment made by this title that are subject to deadlines for submission consisting of similar units of time may be consolidated into a single report that is submitted to appropriate congressional committees pursuant to the earlier of such deadlines. The consolidated reports must contain all information required under this title or any amendment made by this title, in addition to all other elements mandated by previous law.

 

SEC. 332. RULE OF CONSTRUCTION.

Nothing in this title shall be construed to limit—

(1) the authority or obligation of the President to apply the sanctions described in section 104 of the North Korea Sanctions and Policy Enhancement Act of 2016 (22 U.S.C. 9214), as amended by section 311 of this Act, with regard to persons who meet the criteria for designation under such section, or in any other provision of law; or

(2) the authorities of the President pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.).

 

SEC. 333. REGULATORY AUTHORITY.

(a) In General.—The President shall, not later than 180 days after the date of the enactment of this Act, promulgate regulations as necessary for the implementation of this title and the amendments made by this title.

(b) Notification To Congress.—Not fewer than 10 days before the promulgation of a regulation under subsection (a), the President shall notify and provide to the appropriate congressional committees the proposed regulation, specifying the provisions of this title or the amendments made by this title that the regulation is implementing.

 

SEC. 334. LIMITATION ON FUNDS.

No additional funds are authorized to carry out the requirements of this title or of the amendments made by this title. Such requirements shall be carried out using amounts otherwise authorized.

Passed the House of Representatives July 25, 2017.

Attest:

 

Clerk.  

H.R. 3298 – Wounded Officers Recovery Act, 2017

One Hundred Fifteenth Congress
of the
United States of America

AT THE FIRST SESSION

Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and seventeen

An Act

To authorize the Capitol Police Board to make payments from the United States Capitol Police Memorial Fund to employees of the United States Capitol Police who have sustained serious line-of-duty injuries, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “Wounded Officers Recovery Act of 2017”.

SEC. 2. PAYMENTS FROM UNITED STATES CAPITOL POLICE MEMORIAL FUND FOR EMPLOYEES KILLED IN THE LINE OF DUTY OR SUSTAINING SERIOUS LINE-OF-DUTY INJURIES.

(a) Authorizing Payments From Fund.—Section 2 of Public Law 105–223 (2 U.S.C. 1952) is amended—

(1) in the section heading, by inserting “AND CERTAIN OTHER UNITED STATES CAPITOL POLICE EMPLOYEES” before the period at the end;

(2) by striking “Subject to the regulations” and inserting “(a) In General.—Except to the extent used or reserved for use under subsection (b) and subject to the regulations”; and

(3) by adding at the end the following new subsection:

“(b) Payments For Employees Killed In The Line Of Duty Or Sustaining Serious Line-Of-Duty Injuries.—In addition to the amounts paid under subsection (a), and in accordance with the regulations issued under section 4(b), amounts in the Fund may be paid to—

“(1) families of employees of the United States Capitol Police who were killed in the line of duty; or

“(2) employees of the United States Capitol Police who have sustained serious line-of-duty injuries.”.

(b) Regulations Of Capitol Police Board.—Section 4 of Public Law 105–223 (2 U.S.C. 1954) is amended—

(1) by striking “The Capitol Police Board” and inserting “(a) In General.—The Capitol Police Board”; and

(2) by adding at the end the following new subsection:

“(b) Regulations Governing Payments For Employees Killed In The Line Of Duty Or Sustaining Serious Line-Of-Duty Injuries.—In carrying out subsection (a), the Capitol Police Board shall issue specific regulations governing the use of the Fund for making payments to families of employees of the United States Capitol Police who were killed in the line of duty and employees of the United States Capitol Police who have sustained serious line-of-duty injuries (as authorized under section 2(b)), including regulations—

“(1) establishing the conditions under which the family of an employee or an employee is eligible to receive such a payment;

“(2) providing for the amount, timing, and manner of such payments; and

“(3) ensuring that any such payment is in addition to, and does not otherwise affect, any other form of compensation payable to the family of an employee or the employee, including benefits for workers’ compensation under chapter 81 of title 5, United States Code.”.

(c) Treatment Of Amounts Received In Response To Incident Of June 14, 2017.—The second sentence of section 1 of Public Law 105–223 (2 U.S.C. 1951) is amended by striking “deposit into the Fund” and inserting “deposit into the Fund, including amounts received in response to the shooting incident at the practice for the Congressional Baseball Game for Charity on June 14, 2017,”.

Speaker of the House of Representatives.

Vice President of the United States and
President of the Senate.

H.R. 1238 - Securing our Agriculture and Food Act

H. R. 1238

One Hundred Fifteenth Congress
of the United States of America

AT THE FIRST SESSION

Begun and held at the City of Washington on Tuesday, 
the third day of January, two thousand and seventeen

To amend the Homeland Security Act of 2002 to make the Assistant Secretary of Homeland Security for Health Affairs responsible for coordinating the efforts of the Department of Homeland Security related to food, agriculture, and veterinary defense against terrorism, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “Securing our Agriculture and Food Act”.

SEC. 2. COORDINATION OF FOOD, AGRICULTURE, AND VETERINARY DEFENSE AGAINST TERRORISM.

(a) In General.—Title V of the Homeland Security Act of 2002 (6 U.S.C. 311 et seq.) is amended by adding at the end the following new section:

“SEC. 528. COORDINATION OF DEPARTMENT OF HOMELAND SECURITY EFFORTS RELATED TO FOOD, AGRICULTURE, AND VETERINARY DEFENSE AGAINST TERRORISM.

“(a) Program Required.—The Secretary, acting through the Assistant Secretary for Health Affairs, shall carry out a program to coordinate the Department’s efforts related to defending the food, agriculture, and veterinary systems of the United States against terrorism and other high-consequence events that pose a high risk to homeland security.

“(b) Program Elements.—The coordination program required by subsection (a) shall include, at a minimum, the following:

“(1) Providing oversight and management of the Department’s responsibilities pursuant to Homeland Security Presidential Directive 9–Defense of United States Agriculture and Food.

“(2) Providing oversight and integration of the Department’s activities related to veterinary public health, food defense, and agricultural security.

“(3) Leading the Department’s policy initiatives relating to food, animal, and agricultural incidents, and the impact of such incidents on animal and public health.

“(4) Leading the Department’s policy initiatives relating to overall domestic preparedness for and collective response to agricultural terrorism.

“(5) Coordinating with other Department components, including U.S. Customs and Border Protection, as appropriate, on activities related to food and agriculture security and screening procedures for domestic and imported products.

“(6) Coordinating with appropriate Federal departments and agencies.

“(7) Other activities as determined necessary by the Secretary.

“(c) Rule Of Construction.—Nothing in this section may be construed as altering or superseding the authority of the Secretary of Agriculture or the Secretary of Health and Human Services.”.

(b) Clerical Amendment.—The table of contents in section 1(b) of the Homeland Security Act of 2002 is amended—

(1) by striking the items relating to sections 523, 524, 525, 526, and 527; and

(2) by inserting after the item relating to section 522 the following:

“Sec. 523. Guidance and recommendations.
“Sec. 524. Voluntary private sector preparedness accreditation and certification program.
“Sec. 525. Acceptance of gifts.
“Sec. 526. Integrated public alert and warning system modernization.
“Sec. 527. National planning and education.
“Sec. 528. Coordination of Department of Homeland Security efforts related to food, agriculture, and veterinary defense against terrorism.”.

 

Speaker of the House of Representatives.  

 

Vice President of the United States and   
President of the Senate.

S. 1094 - Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017

S.1094

One Hundred Fifteenth Congress

of the

United States of America

AT THE FIRST SESSION

Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and seventeen

An Act

To amend title 38, United States Code, to improve the accountability of employees of the Department of Veterans Affairs, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title.—This Act may be cited as the “Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017”.

(b) Table Of Contents.—The table of contents for this Act is as follows:


Sec. 1. Short title; table of contents.

TITLE I—OFFICE OF ACCOUNTABILITY AND WHISTLEBLOWER PROTECTION

Sec. 101. Establishment of Office of Accountability and Whistleblower Protection.
Sec. 102. Protection of whistleblowers in Department of Veterans Affairs.
Sec. 103. Report on methods used to investigate employees of Department of Veterans Affairs.

TITLE II—ACCOUNTABILITY OF SENIOR EXECUTIVES, SUPERVISORS, AND OTHER EMPLOYEES

Sec. 201. Improved authorities of Secretary of Veterans Affairs to improve accountability of senior executives.
Sec. 202. Improved authorities of Secretary of Veterans Affairs to improve accountability of employees.
Sec. 203. Reduction of benefits for Department of Veterans Affairs employees convicted of certain crimes.
Sec. 204. Authority to recoup bonuses or awards paid to employees of Department of Veterans Affairs.
Sec. 205. Authority to recoup relocation expenses paid to or on behalf of employees of Department of Veterans Affairs.
Sec. 206. Time period for response to notice of adverse actions against supervisory employees who commit prohibited personnel actions.
Sec. 207. Direct hiring authority for medical center directors and VISN directors.
Sec. 208. Time periods for review of adverse actions with respect to certain employees.
Sec. 209. Improvement of training for supervisors.
Sec. 210. Assessment and report on effect on senior executives at Department of Veterans Affairs.
Sec. 211. Measurement of Department of Veterans Affairs disciplinary process outcomes and effectiveness.

TITLE I—OFFICE OF ACCOUNTABILITY AND WHISTLEBLOWER PROTECTION

SEC. 101. ESTABLISHMENT OF OFFICE OF ACCOUNTABILITY AND WHISTLEBLOWER PROTECTION.

(a) In General.—Chapter 3 of title 38, United States Code, is amended by adding at the end the following new section:

“§ 323. Office of Accountability and Whistleblower Protection

“(a) Establishment.—There is established in the Department an office to be known as the ‘Office of Accountability and Whistleblower Protection’ (in this section referred to as the ‘Office’).

“(b) Head Of Office.—(1) The head of the Office shall be responsible for the functions of the Office and shall be appointed by the President pursuant to section 308(a) of this title.

“(2) The head of the Office shall be known as the ‘Assistant Secretary for Accountability and Whistleblower Protection’.

“(3) The Assistant Secretary shall report directly to the Secretary on all matters relating to the Office.

“(4) Notwithstanding section 308(b) of this title, the Secretary may only assign to the Assistant Secretary responsibilities relating to the functions of the Office set forth in subsection (c).

“(c) Functions.—(1) The functions of the Office are as follows:

“(A) Advising the Secretary on all matters of the Department relating to accountability, including accountability of employees of the Department, retaliation against whistleblowers, and such matters as the Secretary considers similar and affect public trust in the Department.

“(B) Issuing reports and providing recommendations related to the duties described in subparagraph (A).

“(C) Receiving whistleblower disclosures.

“(D) Referring whistleblower disclosures received under subparagraph (C) for investigation to the Office of the Medical Inspector, the Office of Inspector General, or other investigative entity, as appropriate, if the Assistant Secretary has reason to believe the whistleblower disclosure is evidence of a violation of a provision of law, mismanagement, gross waste of funds, abuse of authority, or a substantial and specific danger to public health or safety.

“(E) Receiving and referring disclosures from the Special Counsel for investigation to the Medical Inspector of the Department, the Inspector General of the Department, or such other person with investigatory authority, as the Assistant Secretary considers appropriate.

“(F) Recording, tracking, reviewing, and confirming implementation of recommendations from audits and investigations carried out by the Inspector General of the Department, the Medical Inspector of the Department, the Special Counsel, and the Comptroller General of the United States, including the imposition of disciplinary actions and other corrective actions contained in such recommendations.

“(G) Analyzing data from the Office and the Office of Inspector General telephone hotlines, other whistleblower disclosures, disaggregated by facility and area of health care if appropriate, and relevant audits and investigations to identify trends and issue reports to the Secretary based on analysis conducted under this subparagraph.

“(H) Receiving, reviewing, and investigating allegations of misconduct, retaliation, or poor performance involving—

“(i) an individual in a senior executive position (as defined in section 713(d) of this title) in the Department;

“(ii) an individual employed in a confidential, policy-making, policy-determining, or policy-advocating position in the Department; or

“(iii) a supervisory employee, if the allegation involves retaliation against an employee for making a whistleblower disclosure.

“(I) Making such recommendations to the Secretary for disciplinary action as the Assistant Secretary considers appropriate after substantiating any allegation of misconduct or poor performance pursuant to an investigation carried out as described in subparagraph (F) or (H).

“(2) In carrying out the functions of the Office, the Assistant Secretary shall ensure that the Office maintains a toll-free telephone number and Internet website to receive anonymous whistleblower disclosures.

“(3) In any case in which the Assistant Secretary receives a whistleblower disclosure from an employee of the Department under paragraph (1)(C), the Assistant Secretary may not disclose the identity of the employee without the consent of the employee, except in accordance with the provisions of section 552a of title 5, or as required by any other applicable provision of Federal law.

“(d) Staff And Resources.—The Secretary shall ensure that the Assistant Secretary has such staff, resources, and access to information as may be necessary to carry out the functions of the Office.

“(e) Relation To Office Of General Counsel.—The Office shall not be established as an element of the Office of the General Counsel and the Assistant Secretary may not report to the General Counsel.

“(f) Reports.—(1)(A) Not later than June 30 of each calendar year, beginning with June 30, 2017, the Assistant Secretary shall submit to the Committee on Veterans' Affairs of the Senate and the Committee on Veterans' Affairs of the House of Representatives a report on the activities of the Office during the calendar year in which the report is submitted.

“(B) Each report submitted under subparagraph (A) shall include, for the period covered by the report, the following:

“(i) A full and substantive analysis of the activities of the Office, including such statistical information as the Assistant Secretary considers appropriate.

“(ii) Identification of any issues reported to the Secretary under subsection (c)(1)(G), including such data as the Assistant Secretary considers relevant to such issues and any trends the Assistant Secretary may have identified with respect to such issues.

“(iii) Identification of such concerns as the Assistant Secretary may have regarding the size, staffing, and resources of the Office and such recommendations as the Assistant Secretary may have for legislative or administrative action to address such concerns.

“(iv) Such recommendations as the Assistant Secretary may have for legislative or administrative action to improve—

“(I) the process by which concerns are reported to the Office; and

“(II) the protection of whistleblowers within the Department.

“(v) Such other matters as the Assistant Secretary considers appropriate regarding the functions of the Office or other matters relating to the Office.

“(2) If the Secretary receives a recommendation for disciplinary action under subsection (c)(1)(I) and does not take or initiate the recommended disciplinary action before the date that is 60 days after the date on which the Secretary received the recommendation, the Secretary shall submit to the Committee on Veterans' Affairs of the Senate and the Committee on Veterans' Affairs of the House of Representatives a detailed justification for not taking or initiating such disciplinary action.

“(g) Definitions.—In this section:

“(1) The term ‘supervisory employee’ means an employee of the Department who is a supervisor as defined in section 7103(a) of title 5.

“(2) The term ‘whistleblower’ means one who makes a whistleblower disclosure.

“(3) The term ‘whistleblower disclosure’ means any disclosure of information by an employee of the Department or individual applying to become an employee of the Department which the employee or individual reasonably believes evidences—

“(A) a violation of a law, rule, or regulation; or

“(B) gross mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety.”.

(b) Conforming Amendment.—Section 308(b) of such title is amended by adding at the end the following new paragraph:

“(12) The functions set forth in section 323(c) of this title.”.

(c) Clerical Amendment.—The table of sections at the beginning of chapter 3 of such title is amended by adding at the end the following new item:


“323. Office of Accountability and Whistleblower Protection.”.

SEC. 102. PROTECTION OF WHISTLEBLOWERS IN DEPARTMENT OF VETERANS AFFAIRS.

(a) In General.—Subchapter II of chapter 7 of title 38, United States Code, is amended by—

(1) striking sections 731, 732, 734, 735, and 736;

(2) by redesignating section 733 as section 731; and

(3) by adding at the end the following new sections:

“§ 732. Protection of whistleblowers as criteria in evaluation of supervisors

“(a) Development And Use Of Criteria Required.—The Secretary, in consultation with the Assistant Secretary of Accountability and Whistleblower Protection, shall develop criteria that—

“(1) the Secretary shall use as a critical element in any evaluation of the performance of a supervisory employee; and

“(2) promotes the protection of whistleblowers.

“(b) Principles For Protection Of Whistleblowers.—The criteria required by subsection (a) shall include principles for the protection of whistleblowers, such as the degree to which supervisory employees respond constructively when employees of the Department report concerns, take responsible action to resolve such concerns, and foster an environment in which employees of the Department feel comfortable reporting concerns to supervisory employees or to the appropriate authorities.

“(c) Supervisory Employee And Whistleblower Defined.—In this section, the terms ‘supervisory employee’ and‘whistleblower’ have the meanings given such terms in section 323 of this title.

“§ 733. Training regarding whistleblower disclosures

“(a) Training.—Not less frequently than once every two years, the Secretary, in coordination with the Whistleblower Protection Ombudsman designated under section 3(d)(1)(C) of the Inspector General Act of 1978 (5 U.S.C. App.), shall provide to each employee of the Department training regarding whistleblower disclosures, including—

“(1) an explanation of each method established by law in which an employee may file a whistleblower disclosure;

“(2) the right of the employee to petition Congress regarding a whistleblower disclosure in accordance with section 7211 of title 5;

“(3) an explanation that the employee may not be prosecuted or reprised against for disclosing information to Congress, the Inspector General, or another investigatory agency in instances where such disclosure is permitted by law, including under sections 5701, 5705, and 7732 of this title, under section 552a of title 5 (commonly referred to as the Privacy Act), under chapter 93 of title 18, and pursuant to regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191);

“(4) an explanation of the language that is required to be included in all nondisclosure policies, forms, and agreements pursuant to section 115(a)(1) of the Whistleblower Protection Enhancement Act of 2012 (5 U.S.C. 2302 note); and

“(5) the right of contractors to be protected from reprisal for the disclosure of certain information under section 4705 or 4712 of title 41.

“(b) Manner Training Is Provided.—The Secretary shall ensure, to the maximum extent practicable, that training provided under subsection (a) is provided in person.

“(c) Certification.—Not less frequently than once every two years, the Secretary shall provide training on merit system protection in a manner that the Special Counsel certifies as being satisfactory.

“(d) Publication.—The Secretary shall publish on the Internet website of the Department, and display prominently at each facility of the Department, the rights of an employee to make a whistleblower disclosure, including the information described in paragraphs (1) through (5) of subsection (a).

“(e) Whistleblower Disclosure Defined.—In this section, the term ‘whistleblower disclosure’ has the meaning given such term in section 323 of this title.”.

(b) Clerical Amendments.—The table of sections at the beginning of such chapter is amended—

(1) by striking the items relating to sections 731 through 736; and

(2) by adding at the end the following new items:

“731. Adverse actions against supervisory employees who commit prohibited personnel actions relating to whistleblower complaints.
“732. Protection of whistleblowers as criteria in evaluation of supervisors.
“733. Training regarding whistleblower disclosures.”.

(c) Conforming Amendments.—Section 731 of such title, as redesignated by subsection (a)(2), is amended—

(1) in subsection (c)—

(A) in paragraph (1)—

(i) by striking subparagraphs (A) and (B) and inserting the following:

“(A) making a whistleblower disclosure to the Assistant Secretary for Accountability and Whistleblower Protection, the Inspector General of the Department, the Special Counsel, or Congress;”; and

(ii) by redesignating subparagraphs (C) through (F) as subparagraphs (B) through (E), respectively; and

(iii) in subparagraph (B), as redesignated by clause (ii), by striking “complaint in accordance with section 732 or with” and inserting “disclosure made to the Assistant Secretary for Accountability and Whistleblower Protection,”; and

(B) in paragraph (2), by striking “through (F)” and inserting “through (E)”; and

(2) by adding at the end the following new subsection:

“(d) Whistleblower Disclosure Defined.—In this section, the term ‘whistleblower disclosure’ has the meaning given such term in section 323(g) of this title.”.

SEC. 103. REPORT ON METHODS USED TO INVESTIGATE EMPLOYEES OF DEPARTMENT OF VETERANS AFFAIRS.

(a) Report Required.—Not later than 540 days after the date of the enactment of this Act, the Assistant Secretary for Accountability and Whistleblower Protection shall submit to the Secretary of Veterans Affairs, the Committee on Veterans' Affairs of the Senate, and the Committee on Veterans' Affairs of the House of Representatives a report on methods used to investigate employees of the Department of Veterans Affairs and whether such methods are used to retaliate against whistleblowers.

(b) Contents.—The report required by subsection (a) shall include the following:

(1) An assessment of the use of administrative investigation boards, peer review, searches of medical records, and other methods for investigating employees of the Department.

(2) A determination of whether and to what degree the methods described in paragraph (1) are being used to retaliate against whistleblowers.

(3) Recommendations for legislative or administrative action to implement safeguards to prevent the retaliation described in paragraph (2).

(c) Whistleblower Defined.—In this section, the term “whistleblower” has the meaning given such term in section 323 of title 38, United States Code, as added by section 101.

TITLE II—ACCOUNTABILITY OF SENIOR EXECUTIVES, SUPERVISORS, AND OTHER EMPLOYEES

SEC. 201. IMPROVED AUTHORITIES OF SECRETARY OF VETERANS AFFAIRS TO IMPROVE ACCOUNTABILITY OF SENIOR EXECUTIVES.

(a) In General.—Section 713 of title 38, United States Code, is amended to read as follows:

“§ 713. Senior executives: removal, demotion, or suspension based on performance or misconduct

“(a) Authority.—(1) The Secretary may, as provided in this section, reprimand or suspend, involuntarily reassign, demote, or remove a covered individual from a senior executive position at the Department if the Secretary determines that the misconduct or performance of the covered individual warrants such action.

“(2) If the Secretary so removes such an individual, the Secretary may remove the individual from the civil service (as defined in section 2101 of title 5).

“(b) Rights And Procedures.—(1) A covered individual who is the subject of an action under subsection (a) is entitled to—

“(A) advance notice of the action and a file containing all evidence in support of the proposed action;

“(B) be represented by an attorney or other representative of the covered individual’s choice; and

“(C) grieve the action in accordance with an internal grievance process that the Secretary, in consultation with the Assistant Secretary for Accountability and Whistleblower Protection, shall establish for purposes of this subsection.

“(2)(A) The aggregate period for notice, response, and decision on an action under subsection (a) may not exceed 15 business days.

“(B) The period for the response of a covered individual to a notice under paragraph (1)(A) of an action under subsection (a) shall be 7 business days.

“(C) A decision under this paragraph on an action under subsection (a) shall be issued not later than 15 business days after notice of the action is provided to the covered individual under paragraph (1)(A). The decision shall be in writing, and shall include the specific reasons therefor.

“(3) The Secretary shall ensure that the grievance process established under paragraph (1)(C) takes fewer than 21 days.

“(4) A decision under paragraph (2) that is not grieved, and a grievance decision under paragraph (3), shall be final and conclusive.

“(5) A covered individual adversely affected by a decision under paragraph (2) that is not grieved, or by a grievance decision under paragraph (3), may obtain judicial review of such decision.

“(6) In any case in which judicial review is sought under paragraph (5), the court shall review the record and may set aside any Department action found to be—

“(A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with a provision of law;

“(B) obtained without procedures required by a provision of law having been followed; or

“(C) unsupported by substantial evidence.

“(c) Relation To Other Provisions Of Law.—Section 3592(b)(1) of title 5 and the procedures under section 7543(b) of such title do not apply to an action under subsection (a).

“(d) Definitions.—In this section:

“(1) The term ‘covered individual’ means—

“(A) a career appointee (as that term is defined in section 3132(a)(4) of title 5); or

“(B) any individual who occupies an administrative or executive position and who was appointed under section 7306(a), section 7401(1), or section 7401(4) of this title.

“(2) The term ‘misconduct’ includes neglect of duty, malfeasance, or failure to accept a directed reassignment or to accompany a position in a transfer of function.

“(3) The term ‘senior executive position’ means—

“(A) with respect to a career appointee (as that term is defined in section 3132(a) of title 5), a Senior Executive Service position (as such term is defined in such section); and

“(B) with respect to a covered individual appointed under section 7306(a) or section 7401(1) of this title, an administrative or executive position.”.

(b) Conforming Amendment.—Section 7461(c)(1) of such title is amended by inserting “employees in senior executive positions (as defined in section 713(d) of this title) and” before “interns”.

(c) Clerical Amendment.—The table of sections at the beginning of chapter 7 of such title is amended by striking the item relating to section 713 and inserting the following new item:


“713. Senior executives: removal, demotion, or suspension based on performance or misconduct.”.

SEC. 202. IMPROVED AUTHORITIES OF SECRETARY OF VETERANS AFFAIRS TO IMPROVE ACCOUNTABILITY OF EMPLOYEES.

(a) In General.—Subchapter I of chapter 7 of title 38, United States Code, is amended by inserting after section 713 the following new section:

“§ 714. Employees: removal, demotion, or suspension based on performance or misconduct

“(a) In General.—(1) The Secretary may remove, demote, or suspend a covered individual who is an employee of the Department if the Secretary determines the performance or misconduct of the covered individual warrants such removal, demotion, or suspension.

“(2) If the Secretary so removes, demotes, or suspends such a covered individual, the Secretary may—

“(A) remove the covered individual from the civil service (as defined in section 2101 of title 5);

“(B) demote the covered individual by means of a reduction in grade for which the covered individual is qualified, that the Secretary determines is appropriate, and that reduces the annual rate of pay of the covered individual; or

“(C) suspend the covered individual.

“(b) Pay Of Certain Demoted Individuals.—(1) Notwithstanding any other provision of law, any covered individual subject to a demotion under subsection (a)(2) shall, beginning on the date of such demotion, receive the annual rate of pay applicable to such grade.

“(2)(A) A covered individual so demoted may not be placed on administrative leave during the period during which an appeal (if any) under this section is ongoing, and may only receive pay if the covered individual reports for duty or is approved to use accrued unused annual, sick, family medical, military, or court leave.

“(B) If a covered individual so demoted does not report for duty or receive approval to use accrued unused leave, such covered individual shall not receive pay or other benefits pursuant to subsection (d)(5).

“(c) Procedure.—(1)(A) The aggregate period for notice, response, and final decision in a removal, demotion, or suspension under this section may not exceed 15 business days.

“(B) The period for the response of a covered individual to a notice of a proposed removal, demotion, or suspension under this section shall be 7 business days.

“(C) Paragraph (3) of subsection (b) of section 7513 of title 5 shall apply with respect to a removal, demotion, or suspension under this section.

“(D) The procedures in this subsection shall supersede any collective bargaining agreement to the extent that such agreement is inconsistent with such procedures.

“(2) The Secretary shall issue a final decision with respect to a removal, demotion, or suspension under this section not later than 15 business days after the Secretary provides notice, including a file containing all the evidence in support of the proposed action, to the covered individual of the removal, demotion, or suspension. The decision shall be in writing and shall include the specific reasons therefor.

“(3) The procedures under chapter 43 of title 5 shall not apply to a removal, demotion, or suspension under this section.

“(4)(A) Subject to subparagraph (B) and subsection (d), any removal or demotion under this section, and any suspension of more than 14 days under this section, may be appealed to the Merit Systems Protection Board, which shall refer such appeal to an administrative judge pursuant to section 7701(b)(1) of title 5.

“(B) An appeal under subparagraph (A) of a removal, demotion, or suspension may only be made if such appeal is made not later than 10 business days after the date of such removal, demotion, or suspension.

“(d) Expedited Review.—(1) Upon receipt of an appeal under subsection (c)(4)(A), the administrative judge shall expedite any such appeal under section 7701(b)(1) of title 5 and, in any such case, shall issue a final and complete decision not later than 180 days after the date of the appeal.

“(2)(A) Notwithstanding section 7701(c)(1)(B) of title 5, the administrative judge shall uphold the decision of the Secretary to remove, demote, or suspend an employee under subsection (a) if the decision is supported by substantial evidence.

“(B) Notwithstanding title 5 or any other provision of law, if the decision of the Secretary is supported by substantial evidence, the administrative judge shall not mitigate the penalty prescribed by the Secretary.

“(3)(A) The decision of the administrative judge under paragraph (1) may be appealed to the Merit Systems Protection Board.

“(B) Notwithstanding section 7701(c)(1)(B) of title 5, the Merit Systems Protection Board shall uphold the decision of the Secretary to remove, demote, or suspend an employee under subsection (a) if the decision is supported by substantial evidence.

“(C) Notwithstanding title 5 or any other provision of law, if the decision of the Secretary is supported by substantial evidence, the Merit Systems Protection Board shall not mitigate the penalty prescribed by the Secretary.

“(4) In any case in which the administrative judge cannot issue a decision in accordance with the 180-day requirement under paragraph (1), the Merit Systems Protection Board shall, not later than 14 business days after the expiration of the 180-day period, submit to the Committee on Veterans' Affairs of the Senate and the Committee on Veterans' Affairs of the House of Representatives a report that explains the reasons why a decision was not issued in accordance with such requirement.

“(5)(A) A decision of the Merit Systems Protection Board under paragraph (3) may be appealed to the United States Court of Appeals for the Federal Circuit pursuant to section 7703 of title 5 or to any court of appeals of competent jurisdiction pursuant to subsection (b)(1)(B) of such section.

“(B) Any decision by such Court shall be in compliance with section 7462(f)(2) of this title.

“(6) The Merit Systems Protection Board may not stay any removal or demotion under this section, except as provided in section 1214(b) of title 5.

“(7) During the period beginning on the date on which a covered individual appeals a removal from the civil service under subsection (c) and ending on the date that the United States Court of Appeals for the Federal Circuit issues a final decision on such appeal, such covered individual may not receive any pay, awards, bonuses, incentives, allowances, differentials, student loan repayments, special payments, or benefits related to the employment of the individual by the Department.

“(8) To the maximum extent practicable, the Secretary shall provide to the Merit Systems Protection Board such information and assistance as may be necessary to ensure an appeal under this subsection is expedited.

“(9) If an employee prevails on appeal under this section, the employee shall be entitled to backpay (as provided in section 5596 of title 5).

“(10) If an employee who is subject to a collective bargaining agreement chooses to grieve an action taken under this section through a grievance procedure provided under the collective bargaining agreement, the timelines and procedures set forth in subsection (c) and this subsection shall apply.

“(e) Whistleblower Protection.—(1) In the case of a covered individual seeking corrective action (or on behalf of whom corrective action is sought) from the Office of Special Counsel based on an alleged prohibited personnel practice described in section 2302(b) of title 5, the Secretary may not remove, demote, or suspend such covered individual under subsection (a) without the approval of the Special Counsel under section 1214(f) of title 5.

“(2) In the case of a covered individual who has made a whistleblower disclosure to the Assistant Secretary for Accountability and Whistleblower Protection, the Secretary may not remove, demote, or suspend such covered individual under subsection (a) until—

“(A) in the case in which the Assistant Secretary determines to refer the whistleblower disclosure under section 323(c)(1)(D) of this title to an office or other investigative entity, a final decision with respect to the whistleblower disclosure has been made by such office or other investigative entity; or

“(B) in the case in which the Assistant Secretary determines not to the refer the whistleblower disclosure under such section, the Assistant Secretary makes such determination.

“(f) Termination Of Investigations By Office Of Special Counsel.—(1) Notwithstanding any other provision of law, the Special Counsel (established by section 1211 of title 5) may terminate an investigation of a prohibited personnel practice alleged by an employee or former employee of the Department after the Special Counsel provides to the employee or former employee a written statement of the reasons for the termination of the investigation.

“(2) Such statement may not be admissible as evidence in any judicial or administrative proceeding without the consent of such employee or former employee.

“(g) Vacancies.—In the case of a covered individual who is removed or demoted under subsection (a), to the maximum extent feasible, the Secretary shall fill the vacancy arising as a result of such removal or demotion.

“(h) Definitions.—In this section:

“(1) The term ‘covered individual’ means an individual occupying a position at the Department, but does not include—

“(A) an individual occupying a senior executive position (as defined in section 713(d) of this title);

“(B) an individual appointed pursuant to sections 7306, 7401(1), 7401(4), or 7405 of this title;

“(C) an individual who has not completed a probationary or trial period; or

“(D) a political appointee.

“(2) The term ‘suspend’ means the placing of an employee, for disciplinary reasons, in a temporary status without duties and pay for a period in excess of 14 days.

“(3) The term ‘grade’ has the meaning given such term in section 7511(a) of title 5.

“(4) The term ‘misconduct’ includes neglect of duty, malfeasance, or failure to accept a directed reassignment or to accompany a position in a transfer of function.

“(5) The term ‘political appointee’ means an individual who is—

“(A) employed in a position described under sections 5312 through 5316 of title 5 (relating to the Executive Schedule);

“(B) a limited term appointee, limited emergency appointee, or noncareer appointee in the Senior Executive Service, as defined under paragraphs (5), (6), and (7), respectively, of section 3132(a) of title 5; or

“(C) employed in a position of a confidential or policy-determining character under schedule C of subpart C of part 213 of title 5, Code of Federal Regulations, or successor regulation.

“(6) The term ‘whistleblower disclosure’ has the meaning given such term in section 323(g) of this title.”.

(b) Clerical And Conforming Amendments.—

(1) CLERICAL.—The table of sections at the beginning of chapter 7 of such title is amended by inserting after the item relating to section 713 the following new item:


“714. Employees: removal, demotion, or suspension based on performance or misconduct.”.

(2) CONFORMING.—Section 4303(f) of title 5, United States Code, is amended—

(A) in paragraph (2), by striking “or” at the end;

(B) in paragraph (3), by striking the period at the end and inserting “, or”; and

(C) by adding at the end the following:

“(4) any removal or demotion under section 714 of title 38.”.

SEC. 203. REDUCTION OF BENEFITS FOR DEPARTMENT OF VETERANS AFFAIRS EMPLOYEES CONVICTED OF CERTAIN CRIMES.

(a) Reduction Of Benefits.—

(1) IN GENERAL.—Subchapter I of chapter 7 of title 38, United States Code, is amended by adding at the end the following new section:

“§ 719. Reduction of benefits of employees convicted of certain crimes

“(a) Reduction Of Annuity For Removed Employee.—(1) The Secretary shall order that the covered service of an employee of the Department removed from a position for performance or misconduct under section 713, 714, or 7461 of this title or any other provision of law shall not be taken into account for purposes of calculating an annuity with respect to such individual under chapter 83 or chapter 84 of title 5, if—

“(A) the Secretary determines that the individual is convicted of a felony (and the conviction is final) that influenced the individual’s performance while employed in the position; and

“(B) before such order is made, the individual is afforded—

“(i) notice of the proposed order; and

“(ii) an opportunity to respond to the proposed order by not later than ten business days following receipt of such notice; and

“(C) the Secretary issues the order—

“(i) in the case of a proposed order to which an individual responds under subparagraph (B)(ii), not later than five business days after receiving the response of the individual; or

“(ii) in the case of a proposed order to which an individual does not respond, not later than 15 business days after the Secretary provides notice to the individual under subparagraph (B)(i).

“(2) Any individual with respect to whom an annuity is reduced under this subsection may appeal the reduction to the Director of the Office of Personnel Management pursuant to such regulations as the Director may prescribe for purposes of this subsection.

“(b) Reduction Of Annuity For Retired Employee.—(1) The Secretary may order that the covered service of an individual who the Secretary proposes to remove for performance or misconduct under section 713, 714, or 7461 of this title or any other provision of law but who leaves employment at the Department prior to the issuance of a final decision with respect to such action shall not be taken into account for purposes of calculating an annuity with respect to such individual under chapter 83 or chapter 84 of title 5, if—

“(A) the Secretary determines that individual is convicted of a felony (and the conviction is final) that influenced the individual’s performance while employed in the position; and

“(B) before such order is made, the individual is afforded—

“(i) notice of the proposed order;

“(ii) opportunity to respond to the proposed order by not later than ten business days following receipt of such notice; and

“(C) the Secretary issues the order—

“(i) in the case of a proposed order to which an individual responds under subparagraph (B)(ii), not later than five business days after receiving the response of the individual; or

“(ii) in the case of a proposed order to which an individual does not respond, not later than 15 business days after the Secretary provides notice to the individual under subparagraph (B)(i).

“(2) Upon the issuance of an order by the Secretary under paragraph (1), the individual shall have an opportunity to appeal the order to the Director of the Office of Personnel Management before the date that is seven business days after the date of such issuance.

“(3) The Director of the Office of Personnel Management shall make a final decision with respect to an appeal under paragraph (2) within 30 business days of receiving the appeal.

“(c) Administrative Requirements.—Not later than 37 business days after the Secretary issues a final order under subsection (a) or (b) with respect to an individual, the Director of the Office of Personnel Management shall recalculate the annuity of the individual.

“(d) Lump-Sum Annuity Credit.—Any individual with respect to whom an annuity is reduced under subsection (a) or (b) shall be entitled to be paid so much of such individual’s lump-sum credit as is attributable to the period of covered service.

“(e) Spouse Or Children Exception.—(1) The Secretary, in consultation with the Director of the Office of Personnel Management, shall prescribe regulations that may provide for the payment to the spouse or children of any individual referred to in subsection (a) or (b) of any amounts which (but for this subsection) would otherwise have been nonpayable by reason of such subsections.

“(2) Regulations prescribed under paragraph (1) shall be consistent with the requirements of section 8332(o)(5) and 8411(l)(5) of title 5, as the case may be.

“(f) Definitions.—In this section:

“(1) The term ‘covered service’ means, with respect to an individual subject to a removal for performance or misconduct under section 719 or 7461 of this title or any other provision of law, the period of service beginning on the date that the Secretary determines under such applicable provision that the individual engaged in activity that gave rise to such action and ending on the date that the individual is removed from or leaves a position of employment at the Department prior to the issuance of a final decision with respect to such action.

“(2) The term ‘lump-sum credit’ has the meaning given such term in section 8331(8) or section 8401(19) of title 5, as the case may be.

“(3) The term ‘service’ has the meaning given such term in section 8331(12) or section 8401(26) of title 5, as the case may be.”.

(2) CLERICAL AMENDMENT.—The table of sections at the beginning of chapter 7 of such title is amended by inserting after the item relating to section 717 the following new item:


“719. Reduction of benefits of employees convicted of certain crimes.”.

(b) Application.—Section 719 of title 38, United States Code, as added by subsection (a)(1), shall apply to any action of removal of an employee of the Department of Veterans Affairs under section 719 or 7461 of such title or any other provision of law, commencing on or after the date of the enactment of this Act.

SEC. 204. AUTHORITY TO RECOUP BONUSES OR AWARDS PAID TO EMPLOYEES OF DEPARTMENT OF VETERANS AFFAIRS.

(a) In General.—Subchapter I of chapter 7 of title 38, United States Code, as amended by section 203, is further amended by adding at the end the following new section:

“§ 721. Recoupment of bonuses or awards paid to employees of Department

“(a) In General.—Notwithstanding any other provision of law, the Secretary may issue an order directing an employee of the Department to repay the amount, or a portion of the amount, of any award or bonus paid to the employee under title 5, including under chapters 45 or 53 of such title, or this title if—

“(1) the Secretary determines that the individual engaged in misconduct or poor performance prior to payment of the award or bonus, and that such award or bonus would not have been paid, in whole or in part, had the misconduct or poor performance been known prior to payment; and

“(2) before such repayment, the employee is afforded—

“(A) notice of the proposed order; and

“(B) an opportunity to respond to the proposed order by not later than 10 business days after the receipt of such notice; and

“(3) the Secretary issues the order—

“(A) in the case of a proposed order to which an individual responds under paragraph (2)(B), not later than five business days after receiving the response of the individual; or

“(B) in the case of a proposed order to which an individual does not respond, not later than 15 business days after the Secretary provides notice to the individual under paragraph (2)(A).

“(b) Appeal Of Order Of Secretary.—(1) Upon the issuance of an order by the Secretary under subsection (a) with respect to an individual, the individual shall have an opportunity to appeal the order to the Director of the Office of Personnel Management before the date that is seven business days after the date of such issuance.

“(2) The Director shall make a final decision with respect to an appeal under paragraph (1) within 30 business days after receiving such appeal.”.

(b) Clerical Amendment.—The table of sections at the beginning of such chapter, as amended by section 203(a)(2), is further amended by inserting after the item relating to section 719 the following new item:


“721. Recoupment of bonuses or awards paid to employees of Department.”.

(c) Effective Date.—Section 721 of title 38, United States Code, as added by subsection (a), shall apply with respect to an award or bonus paid by the Secretary of Veterans Affairs to an employee of the Department of Veterans Affairs on or after the date of the enactment of this Act.

(d) Construction.—Nothing in this Act or the amendments made by this Act may be construed to modify the certification issued by the Office of Personnel Management and the Office of Management and Budget regarding the performance appraisal system of the Senior Executive Service of the Department of Veterans Affairs.

SEC. 205. AUTHORITY TO RECOUP RELOCATION EXPENSES PAID TO OR ON BEHALF OF EMPLOYEES OF DEPARTMENT OF VETERANS AFFAIRS.

(a) In General.—Subchapter I of chapter 7 of title 38, United States Code, as amended by section 204, is further amended by adding at the end the following new section:

“§ 723. Recoupment of relocation expenses paid on behalf of employees of Department

“(a) In General.—Notwithstanding any other provision of law, the Secretary may issue an order directing an employee of the Department to repay the amount, or a portion of the amount, paid to or on behalf of the employee under title 5 for relocation expenses, including any expenses under section 5724 or 5724a of such title, or this title if—

“(1) the Secretary determines that relocation expenses were paid following an act of fraud or malfeasance that influenced the authorization of the relocation expenses;

“(2) before such repayment, the employee is afforded—

“(A) notice of the proposed order; and

“(B) an opportunity to respond to the proposed order not later than ten business days following the receipt of such notice; and

“(3) the Secretary issues the order—

“(A) in the case of a proposed order to which an individual responds under paragraph (2)(B), not later than five business days after receiving the response of the individual; or

“(B) in the case of a proposed order to which an individual does not respond, not later than 15 business days after the Secretary provides notice to the individual under paragraph (2)(A).

“(b) Appeal Of Order Of Secretary.—(1) Upon the issuance of an order by the Secretary under subsection (a) with respect to an individual, the individual shall have an opportunity to appeal the order to the Director of the Office of Personnel Management before the date that is seven business days after the date of such issuance.

“(2) The Director shall make a final decision with respect to an appeal under paragraph (1) within 30 days after receiving such appeal.”.

(b) Clerical Amendment.—The table of sections at the beginning of such chapter is further amended by inserting after the item relating to section 721, as added by section 204(b), the following new item:


“723. Recoupment of relocation expenses paid on behalf of employees of Department.”.

(c) Effective Date.—Section 723 of title 38, United States Code, as added by subsection (a), shall apply with respect to an amount paid by the Secretary of Veterans Affairs to or on behalf of an employee of the Department of Veterans Affairs for relocation expenses on or after the date of the enactment of this Act.

SEC. 206. TIME PERIOD FOR RESPONSE TO NOTICE OF ADVERSE ACTIONS AGAINST SUPERVISORY EMPLOYEES WHO COMMIT PROHIBITED PERSONNEL ACTIONS.

Section 731(a)(2)(B) of title 38, United States Code, as redesignated by section 102(a)(2), is amended—

(1) in clause (i), by striking “14 days” and inserting “10 days”; and

(2) in clause (ii), by striking “14-day period” and inserting “10-day period”.

SEC. 207. DIRECT HIRING AUTHORITY FOR MEDICAL CENTER DIRECTORS AND VISN DIRECTORS.

(a) In General.—Section 7401 of title 38, United States Code, is amended by adding at the end the following new paragraph:

“(4) Directors of medical centers and directors of Veterans Integrated Service Networks with demonstrated ability in the medical profession, in health care administration, or in health care fiscal management.”.

(b) Conforming Amendments.—Section 7404(a)(1) of such title is amended—

(1) by inserting “(A)” before “The annual”; and

(2) in subparagraph (A), as designated by paragraph (1)—

(A) by inserting “and 7401(4)” after “7306”; and

(B) by adding at the end the following new subparagraph:

“(B) Section 5377 of title 5 shall apply to a position under section 7401(4) of this title as if such position were included in the definition of ‘position’ in section 5377(a) of title 5.”.

SEC. 208. TIME PERIODS FOR REVIEW OF ADVERSE ACTIONS WITH RESPECT TO CERTAIN EMPLOYEES.

(a) Physicians, Dentists, Podiatrists, Chiropractors, Optometrists, Registered Nurses, Physician Assistants, and Expanded-Function Dental Auxiliaries.—Paragraph (2) of section 7461(b) of title 38, United States Code, is amended to read as follows:

“(2) In any case other than a case described in paragraph (1) that involves or includes a question of professional conduct or competence in which a major adverse action was not taken, such an appeal shall be made through Department grievance procedures under section 7463 of this title.”.

(b) Major Adverse Actions Involving Professional Conduct Or Competence.—Section 7462(b) of such title is amended—

(1) in paragraph (1)—

(A) in the matter preceding subparagraph (A), by inserting “, within the aggregate time period specified in paragraph (5)(A),” after “is entitled”;

(B) in subparagraph (A)—

(i) by striking “At least 30 days advance written notice” and inserting “Advance written notice”;

(ii) by striking “and a statement” and inserting “a statement”; and

(iii) by inserting “and a file containing all the evidence in support of each charge,” after “with respect to each charge,”; and

(C) in subparagraph (B), by striking “A reasonable time, but not less than seven days” and inserting “The opportunity, within the time period provided for in paragraph (4)(A)”;

(2) by striking paragraph (3) and inserting the following new paragraph (3):

“(3) After considering the employee's answer, if any, and within the time period provided for in paragraph (5)(B), the deciding official shall render a decision on the charges. The decision shall be in writing and shall include the specific reasons therefor.”;

(3) in paragraph (4)—

(A) by striking subparagraph (A) and inserting the following new subparagraph (A):

“(A) The period for the response of an employee under paragraph (1)(B) to advance written under paragraph (1)(A) shall be seven business days.”; and

(B) in subparagraph (B), by striking “30 days” and inserting “seven business days”; and

(4) by adding at the end the following new paragraphs:

“(5)(A) The aggregate period for the resolution of charges against an employee under this subsection may not exceed 15 business days.

“(B) The deciding official shall render a decision under paragraph (3) on charges under this subsection not later than 15 business days after the Under Secretary provides notice on the charges for purposes of paragraph (1)(A).

“(6) The procedures in this subsection shall supersede any collective bargaining agreement to the extent that such agreement is inconsistent with such procedures.”.

(c) Other Adverse Actions.—Section 7463(c) of such title is amended—

(1) in paragraph (1), by striking “the same notice and opportunity to answer with respect to those charges as provided in subparagraphs (A) and (B) of section 7462(b)(1) of this title” and inserting “notice and an opportunity to answer with respect to those charges in accordance with subparagraphs (A) and (B) of section 7462(b)(1) of this title, but within the time periods specified in paragraph (3)”;

(2) in paragraph (2)—

(A) in the matter preceding subparagraph (A), by inserting “, within the aggregate time period specified in paragraph (3)(A),” after “is entitled”;

(B) in subparagraph (A), by striking “an advance written notice” and inserting “written notice”; and

(C) in subparagraph (B), by striking “a reasonable time” and inserting “time to answer”; and

(3) by adding at the end the following new paragraph (3):

“(3)(A) The aggregate period for the resolution of charges against an employee under paragraph (1) or (2) may not exceed 15 business days.

“(B) The period for the response of an employee under paragraph (1) or (2)(B) to written notice of charges under paragraph (1) or (2)(A), as applicable, shall be seven business days.

“(C) The deciding official shall render a decision on charges under paragraph (1) or (2) not later than 15 business days after notice is provided on the charges for purposes of paragraph (1) or (2)(A), as applicable.”.

SEC. 209. IMPROVEMENT OF TRAINING FOR SUPERVISORS.

(a) In General.—The Secretary of Veterans Affairs shall provide to each employee of the Department of Veterans Affairs who is employed as a supervisor periodic training on the following:

(1) The rights of whistleblowers and how to address a report by an employee of a hostile work environment, reprisal, or harassment.

(2) How to effectively motivate, manage, and reward the employees who report to the supervisor.

(3) How to effectively manage employees who are performing at an unacceptable level and access assistance from the human resources office of the Department and the Office of the General Counsel of the Department with respect to those employees.

(b) Definitions.—In this section:

(1) SUPERVISOR.—The term “supervisor” has the meaning given such term in section 7103(a) of title 5, United States Code.

(2) WHISTLEBLOWER.—The term “whistleblower” has the meaning given such term in section 323(g) of title 38, United States Code, as added by section 101.

SEC. 210. ASSESSMENT AND REPORT ON EFFECT ON SENIOR EXECUTIVES AT DEPARTMENT OF VETERANS AFFAIRS.

(a) In General.—Not later than two years after the date of the enactment of this Act, the Secretary of Veterans Affairs shall—

(1) measure and assess the effect of the enactment of this title on the morale, engagement, hiring, promotion, retention, discipline, and productivity of individuals in senior executive positions at the Department of Veterans Affairs; and

(2) submit to the Committee on Veterans' Affairs of the Senate and the Committee on Veterans' Affairs of the House of Representatives a report on the findings of the Secretary with respect to the measurement and assessment carried out under paragraph (1).

(b) Elements.—The assessment required by subsection (a)(1) shall include the following:

(1) With respect to engagement, trends in morale of individuals in senior executive positions and individuals aspiring to senior executive positions.

(2) With respect to promotions—

(A) whether the Department is experiencing an increase or decrease in the number of employees participating in leadership development and candidate development programs with the intention of becoming candidates for senior executive positions; and

(B) trends in applications to senior executive positions within the Department.

(3) With respect to retention—

(A) trends in retirement rates of individuals in senior executive positions at the Department;

(B) trends in quit rates of individuals in senior executive positions at the Department;

(C) rates of transfer of—

(i) individuals from other Federal agencies into senior executive positions at the Department; and

(ii) individuals from senior executive positions at the Department to other Federal agencies; and

(D) trends in total loss rates by job function.

(4) With respect to disciplinary processes—

(A) regarding individuals in senior executive positions at the Department who are the subject of disciplinary action—

(i) the length of the disciplinary process in days for such individuals both before the date of the enactment of this Act and under the provisions of this Act described in subsection (a)(1); and

(ii) the extent to which appeals by such individuals are upheld under such provisions as compared to before the date of the enactment of this Act;

(B) the components or offices of the Department which experience the greatest number of proposed adverse actions against individuals in senior executive positions and components and offices which experience the least relative to the size of the components or offices’ total number of senior executive positions;

(C) the tenure of individuals in senior executive positions who are the subject of disciplinary action;

(D) whether the individuals in senior executive positions who are the subject of disciplinary action have previously been disciplined; and

(E) the number of instances of disciplinary action taken by the Secretary against individuals in senior executive positions at the Department as compared to government wide discipline against individuals in Senior Executive Service positions (as defined in section 3132(a) of title 5, United States Code) as a percentage of the total number of individuals in senior executive positions at the Department and Senior Executive Service positions (as so defined).

(5) With respect to hiring—

(A) the degree to which the skills of newly hired individuals in senior executive positions at the Department are appropriate with respect to the needs of the Department;

(B) the types of senior executive positions at the Department most commonly filled under the authorities in the provisions described in subsection (a)(1);

(C) the number of senior executive positions at the Department filled by hires outside of the Department compared to hires from within the Department;

(D) the length of time to fill a senior executive position at the Department and for a new hire to begin working in a new senior executive position;

(E) the mission-critical deficiencies filled by newly hired individuals in senior executive positions and the connection between mission-critical deficiencies filled under the provisions described in subsection (a) and annual performance of the Department;

(F) the satisfaction of applicants for senior executive positions at the Department with the hiring process, including the clarity of job announcements, reasons for withdrawal of applications, communication regarding status of applications, and timeliness of hiring decision; and

(G) the satisfaction of newly hired individuals in senior executive positions at the Department with the hiring process and the process of joining and becoming oriented with the Department.

(c) Senior Executive Position Defined.—In this section, the term “senior executive position” has the meaning given such term in section 713 of title 38, United States Code.

SEC. 211. MEASUREMENT OF DEPARTMENT OF VETERANS AFFAIRS DISCIPLINARY PROCESS OUTCOMES AND EFFECTIVENESS.

(a) Measuring And Collecting.—

(1) IN GENERAL.—The Secretary of Veterans Affairs shall measure and collect information on the outcomes of disciplinary actions carried out by the Department of Veterans Affairs during the three-year period ending on the date of the enactment of this Act and the effectiveness of such actions.

(2) ELEMENTS.—In measuring and collecting pursuant to paragraph (1), the Secretary shall measure and collect information regarding the following:

(A) The average time from the initiation of an adverse action against an employee at the Department to the final resolution of that action.

(B) The number of distinct steps and levels of review within the Department involved in the disciplinary process and the average length of time required to complete these steps.

(C) The rate of use of alternate disciplinary procedures compared to traditional disciplinary procedures and the frequency with which employees who are subject to alternative disciplinary procedures commit additional offenses.

(D) The number of appeals from adverse actions filed against employees of the Department, the number of appeals upheld, and the reasons for which the appeals were upheld.

(E) The use of paid administrative leave during the disciplinary process and the length of such leave.

(b) Report.—

(1) IN GENERAL.—Not later than December 31, 2017, the Secretary shall submit to the appropriate committees of Congress a report on the disciplinary procedures and actions of the Department.

(2) CONTENTS.—The report submitted under paragraph (1) shall include the following:

(A) The information collected under subsection (a).

(B) The findings of the Secretary with respect to the measurement and collection carried out under subsection (a).

(C) An analysis of the disciplinary procedures and actions of the Department.

(D) Suggestions for improving the disciplinary procedures and actions of the Department.

(E) Such other matters as the Secretary considers appropriate.

(3) APPROPRIATE COMMITTEES OF CONGRESS.—In this subsection, the term “appropriate committees of Congress” means—

(A) the Committee on Appropriations and the Committee on Veterans' Affairs of the Senate; and

(B) the Committee on Appropriations and the Committee on Veterans' Affairs of the House of Representatives.

 

Speaker of the House of Representatives  

Vice President of the United States and President of the Senate

H.R. 657 - Follow the Rules Act

H.R.657

One Hundred Fifteenth Congress

of the

United States of America

AT THE FIRST SESSION

Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and seventeen

An Act

To amend title 5, United States Code, to extend certain protections against prohibited personnel practices, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “Follow the Rules Act”.

SEC. 2. PROHIBITED PERSONNEL ACTION BASED ON ORDERING INDIVIDUAL TO VIOLATE RULE OR REGULATION.

(a) In General.—Subparagraph (D) of section 2302(b)(9) of title 5, United States Code, is amended by inserting “, rule, or regulation” after “law”.

(b) Technical Correction.—Such subparagraph is further amended by striking “for”.

 

Speaker of the House of Representatives.  

 

Vice President of the United States and President of the Senate.

H.R. 375 - An Act to designate the Federal building and United States courthouse located at 719 Church Street in Nashville, Tennessee, as the “Fred D. Thompson Federal Building and United States Courthouse”.

One Hundred Fifteenth Congress
of the
Unites States of America

AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday, 
the third day of January, two thousand and seventeen

An Act

To designate the Federal building and United States courthouse located at 719 Church Street in Nashville, Tennessee, as the “Fred D. Thompson Federal Building and United States Courthouse”.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. DESIGNATION.

The Federal building and United States courthouse located at 719 Church Street in Nashville, Tennessee, shall be known and designated as the “Fred D. Thompson Federal Building and United States Courthouse”.

SEC. 2. REFERENCES.

Any reference in a law, map, regulation, document, paper, or other record of the United States to the Federal building and United Statescourthouse referred to in section 1 shall be deemed to be a reference to the “Fred D. Thompson Federal Building and United States Courthouse”.

Passed the House of Representatives March 7, 2017.

Attest:

Speaker of the House of Representatives.  

Attest:

Vice President of the United States and   
President of the Senate.

H.R. 366 - DHS Stop Asset and Vehicle Excess Act or the DHS SAVE Act

 

One Hundred Fifteenth Congress
of the
Unites States of America

AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday, 
the third day of January, two thousand and seventeen

An Act

To amend the Homeland Security Act of 2002 to direct the Under Secretary for Management of the Department of Homeland Security to make certain improvements in managing the Department’s vehicle fleet, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “DHS Stop Asset and Vehicle Excess Act” or the “DHS SAVE Act”.

SEC. 2. DHS VEHICLE FLEETS.

Section 701 of the Homeland Security Act of 2002 (6 U.S.C. 341) is amended—

(1) in subsection (a)(5), by inserting “vehicle fleets (under subsection (c)),” after “equipment,”;

(2) by redesignating subsections (c) and (d) as subsections (d) and (e), respectively; and

(3) by inserting after subsection (b) the following new subsection:

“(c) Vehicle Fleets.—

“(1) IN GENERAL.—In carrying out responsibilities regarding vehicle fleets pursuant to subsection (a)(5), the Under Secretary for Management shall be responsible for overseeing and managing vehicle fleets throughout the Department. The Under Secretary shall also be responsible for the following:

“(A) Ensuring that components are in compliance with Federal law, Federal regulations, executive branch guidance, and Department policy (including associated guidance) relating to fleet management and use of vehicles from home to work.

“(B) Developing and distributing a standardized vehicle allocation methodology and fleet management plan for components to use to determine optimal fleet size in accordance with paragraph (4).

“(C) Ensuring that components formally document fleet management decisions.

“(D) Approving component fleet management plans, vehicle leases, and vehicle acquisitions.

“(2) COMPONENT RESPONSIBILITIES.—

“(A) IN GENERAL.—Component heads—

“(i) shall—

“(I) comply with Federal law, Federal regulations, executive branch guidance, and Department policy (including associated guidance) relating to fleet management and use of vehicles from home to work;

“(II) ensure that data related to fleet management is accurate and reliable;

“(III) use such data to develop a vehicle allocation tool derived by using the standardized vehicle allocation methodology provided by the Under Secretary for Management to determine the optimal fleet size for the next fiscal year and a fleet management plan; and

“(IV) use vehicle allocation methodologies and fleet management plans to develop annual requests for funding to support vehicle fleets pursuant to paragraph (6); and

“(ii) may not, except as provided in subparagraph (B), lease or acquire new vehicles or replace existing vehicles without prior approval from the Under Secretary for Management pursuant to paragraph (5)(B).

“(B) EXCEPTION REGARDING CERTAIN LEASING AND ACQUISITIONS.—If exigent circumstances warrant such, a component head may lease or acquire a new vehicle or replace an existing vehicle without prior approval from the Under Secretary for Management. If under such exigent circumstances a component head so leases, acquires, or replaces a vehicle, such component head shall provide to the Under Secretary an explanation of such circumstances.

“(3) ONGOING OVERSIGHT.—

“(A) QUARTERLY MONITORING.—In accordance with paragraph (4), the Under Secretary for Management shall collect, on a quarterly basis, information regarding component vehicle fleets, including information on fleet size, composition, cost, and vehicle utilization.

“(B) AUTOMATED INFORMATION.—The Under Secretary for Management shall seek to achieve a capability to collect, on a quarterly basis, automated information regarding component vehicle fleets, including the number of trips, miles driven, hours and days used, and the associated costs of such mileage for leased vehicles.

“(C) MONITORING.—The Under Secretary for Management shall track and monitor component information provided pursuant to subparagraph (A) and, as appropriate, subparagraph (B), to ensure that component vehicle fleets are the optimal fleet size and cost effective. The Under Secretary shall use such information to inform the annual component fleet analyses referred to in paragraph (4).

“(4) ANNUAL REVIEW OF COMPONENT FLEET ANALYSES.—

“(A) IN GENERAL.—To determine the optimal fleet size and associated resources needed for each fiscal year beginning with fiscal year 2018, component heads shall annually submit to the Under Secretary for Management a vehicle allocation tool and fleet management plan using information described in paragraph (3)(A). Such tools and plans may be submitted in classified form if a component head determines that such is necessary to protect operations or mission requirements.

“(B) VEHICLE ALLOCATION TOOL.—Component heads shall develop a vehicle allocation tool in accordance with subclause (III) of paragraph (2)(A)(i) that includes an analysis of the following:

“(i) Vehicle utilization data, including the number of trips, miles driven, hours and days used, and the associated costs of such mileage for leased vehicles, in accordance with such paragraph.

“(ii) The role of vehicle fleets in supporting mission requirements for each component.

“(iii) Any other information determined relevant by such component heads.

“(C) FLEET MANAGEMENT PLANS.—Component heads shall use information described in subparagraph (B) to develop a fleet management plan for each such component. Such fleet management plans shall include the following:

“(i) A plan for how each such component may achieve optimal fleet size determined by the vehicle allocation tool required under such subparagraph, including the elimination of excess vehicles in accordance with paragraph (5), if applicable.

“(ii) A cost benefit analysis supporting such plan.

“(iii) A schedule each such component will follow to obtain optimal fleet size.

“(iv) Any other information determined relevant by component heads.

“(D) REVIEW.—The Under Secretary for Management shall review and make a determination on the results of each component’s vehicle allocation tool and fleet management plan under this paragraph to ensure each such component’s vehicle fleets are the optimal fleet size and that components are in compliance with applicable Federal law, Federal regulations, executive branch guidance, and Department policy (including associated guidance) pursuant to paragraph (2) relating to fleet management and use of vehicles from home to work. The Under Secretary shall use such tools and plans when reviewing annual component requests for vehicle fleet funding in accordance with paragraph (6).

“(5) GUIDANCE TO DEVELOP FLEET MANAGEMENT PLANS.—The Under Secretary for Management shall provide guidance, pursuant to paragraph (1)(B) on how component heads may achieve optimal fleet size in accordance with paragraph (4), including processes for the following:

“(A) Leasing or acquiring additional vehicles or replacing existing vehicles, if determined necessary.

“(B) Disposing of excess vehicles that the Under Secretary determines should not be reallocated under subparagraph (C).

“(C) Reallocating excess vehicles to other components that may need temporary or long-term use of additional vehicles.

“(6) ANNUAL REVIEW OF VEHICLE FLEET FUNDING REQUESTS.—As part of the annual budget process, the Under Secretary for Management shall review and make determinations regarding annual component requests for funding for vehicle fleets. If component heads have not taken steps in furtherance of achieving optimal fleet size in the prior fiscal year pursuant to paragraphs (4) and (5), the Under Secretary shall provide rescission recommendations to the Committee on Appropriations and the Committee on Homeland Security of the House of Representatives and the Committee on Appropriations and the Committee on Homeland Security and Governmental Affairs of the Senate regarding such component vehicle fleets.

“(7) ACCOUNTABILITY FOR VEHICLE FLEET MANAGEMENT.—

“(A) PROHIBITION ON CERTAIN NEW VEHICLE LEASES AND ACQUISITIONS.—The Under Secretary for Management and component heads may not approve in any fiscal year beginning with fiscal year 2019 a vehicle lease, acquisition, or replacement request if such component heads did not comply in the prior fiscal year with paragraph (4).

“(B) PROHIBITION ON CERTAIN PERFORMANCE COMPENSATION.—No Department official with vehicle fleet management responsibilities may receive annual performance compensation in pay in any fiscal year beginning with fiscal year 2019 if such official did not comply in the prior fiscal year with paragraph (4).

“(C) PROHIBITION ON CERTAIN CAR SERVICES.—Notwithstanding any other provision of law, no senior executive service official of the Department whose office has a vehicle fleet may receive access to a car service in any fiscal year beginning with fiscal year 2019 if such official did not comply in the prior fiscal year with paragraph (4).

“(8) MOTOR POOL.—

“(A) IN GENERAL.—The Under Secretary for Management may determine the feasibility of operating a vehicle motor pool to permit components to share vehicles as necessary to support mission requirements to reduce the number of excess vehicles in the Department.

“(B) REQUIREMENTS.—The determination of feasibility of operating a vehicle motor pool under subparagraph (A) shall—

“(i) include—

“(I) regions in the United States in which multiple components with vehicle fleets are located in proximity to one another, or a significant number of employees with authorization to use vehicles are located; and

“(II) law enforcement vehicles;

“(ii) cover the National Capital Region; and

“(iii) take into account different mission requirements.

“(C) REPORT.—The Secretary shall include in the Department’s next annual performance report required under current law the results of the determination under this paragraph.

“(9) DEFINITIONS.—In this subsection:

“(A) COMPONENT HEAD.—The term ‘component head’ means the head of any component of the Department with a vehicle fleet.

“(B) EXCESS VEHICLE.—The term ‘excess vehicle’ means any vehicle that is not essential to support mission requirements of a component.

“(C) OPTIMAL FLEET SIZE.—The term ‘optimal fleet size’ means, with respect to a particular component, the appropriate number of vehicles to support mission requirements of such component.

“(D) VEHICLE FLEET.—The term ‘vehicle fleet’ means all owned, commercially leased, or Government-leased vehicles of the Department or of a component of the Department, as the case may be, including vehicles used for law enforcement and other purposes.”.

SEC. 3. INSPECTOR GENERAL REVIEW.

The Inspector General of the Department of Homeland Security shall—

(1) conduct a review of the implementation of subsection (c)(4) of section 701 of the Homeland Security Act of 2002 (6 U.S.C. 341), as added by section 2 of this Act, for fiscal year 2019, which shall include analysis of the effectiveness of such subsection (c)(4) with respect to cost avoidance, savings realized, and component operations; and

(2) provide, upon request, to the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Homeland Security of the House of Representatives information regarding the review required under paragraph (1).

Attest:

Speaker of the House of Representatives.  

Attest:

Vice President of the United States and   
President of the Senate.

S. 583 - American Law Enforcement Heroes Act of 2017

S. 583

One Hundred Fifteenth Congress
of the
United States of America

AT THE FIRST SESSION

Begun and held at the City of Washington on Tuesday, 
the third day of January, two thousand and seventeen

An Act

To amend the Omnibus Crime Control and Safe Streets Act of 1968 to authorize COPS grantees to use grant funds to hire veterans as career law enforcement officers, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “American Law Enforcement Heroes Act of 2017”.

SEC. 2. PRIORITIZING HIRING AND TRAINING OF VETERANS.

Section 1701(b)(2) of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796dd(b)(2)) is amended by inserting “, including by prioritizing the hiring and training of veterans (as defined in section 101 of title 38, United States Code)” after “Nation”.

 

Speaker of the House of Representatives  

 

Vice President of the United States and President of the Senate  

S. 419 - Public Safety Officers’ Benefits Improvement Act of 2017

S.419

One Hundred Fifteenth Congress

of the

United States of America

AT THE FIRST SESSION

Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and seventeen

An Act

To require adequate reporting on the Public Safety Officers' Benefits program, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “Public Safety Officers’ Benefits Improvement Act of 2017”.

SEC. 2. REPORTS.

Section 1205 of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796c) is amended—

(1) in subsection (a), by inserting “Rules, regulations, and procedures issued under this part may include regulations based on standards developed by another Federal agency for programs related to public safety officer death or disability claims.” before the last sentence;

(2) in subsection (b)—

(A) by inserting “(1)” before “In making”; and

(B) by adding at the end the following:

“(2) In making a determination under section 1201, the Bureau shall give substantial weight to the evidence and all findings of fact presented by a State, local, or Federal administrative or investigative agency regarding eligibility for death or disability benefits.

“(3) If the head of a State, local, or Federal administrative or investigative agency, in consultation with the principal legal officer of the agency, provides a certification of facts regarding eligibility for death or disability benefits, the Bureau shall adopt the factual findings, if the factual findings are supported by substantial evidence.”; and

(3) by adding at the end the following:

“(e)(1)(A) Not later than 30 days after the date of enactment of this subsection, the Bureau shall make available on the public website of the Bureau information on all death, disability, and educational assistance claims submitted under this part that are pending as of the date on which the information is made available.

“(B) Not less frequently than once per week, the Bureau shall make available on the public website of the Bureau updated information with respect to all death, disability, and educational assistance claims submitted under this part that are pending as of the date on which the information is made available.

“(C) The information made available under this paragraph shall include—

“(i) for each pending claim—

“(I) the date on which the claim was submitted to the Bureau;

“(II) the State of residence of the claimant;

“(III) an anonymized, identifying claim number; and

“(IV) the nature of the claim; and

“(ii) the total number of pending claims that were submitted to the Bureau more than 1 year before the date on which the information is made available.

“(2) Not later than 180 days after the date of enactment of this subsection, the Bureau shall publish on the public website of the Bureau a report, and shall update such report on such website not less than once every 180 days thereafter, containing—

“(A) the total number of claims for which a final determination has been made during the 180-day period preceding the report;

“(B) the amount of time required to process each claim for which a final determination has been made during the 180-day period preceding the report;

“(C) as of the last day of the 180-day period preceding the report, the total number of claims submitted to the Bureau on or before that date for which a final determination has not been made;

“(D) as of the last day of the 180-day period preceding the report, the total number of claims submitted to the Bureau on or before the date that is 1 year before that date for which a final determination has not been made;

“(E) for each claim described in subparagraph (D), a detailed description of the basis for delay;

“(F) as of the last day of the 180-day period preceding the report, the total number of claims submitted to the Bureau on or before that date relating to exposure due to the September 11th, 2001, terrorism attacks for which a final determination has not been made;

“(G) as of the last day of the 180-day period preceding the report, the total number of claims submitted to the Bureau on or before the date that is 1 year before that date relating to exposure due to the September 11th, 2001, terrorism attacks for which a final determination has not been made;

“(H) for each claim described in subparagraph (G), a detailed description of the basis for delay;

“(I) the total number of claims submitted to the Bureau relating to exposure due to the September 11th, 2001, terrorism attacks for which a final determination was made during the 180-day period preceding the report, and the average award amount for any such claims that were approved;

“(J) the result of each claim for which a final determination was made during the 180-day period preceding the report, including the number of claims rejected and the basis for any denial of benefits;

“(K) the number of final determinations which were appealed during the 180-day period preceding the report, regardless of when the final determination was first made;

“(L) the average number of claims processed per reviewer of the Bureau during the 180-day period preceding the report;

“(M) for any claim submitted to the Bureau that required the submission of additional information from a public agency, and for which the public agency completed providing all of the required information during the 180-day period preceding the report, the average length of the period beginning on the date the public agency was contacted by the Bureau and ending on the date on which the public agency submitted all required information to the Bureau;

“(N) for any claim submitted to the Bureau for which the Bureau issued a subpoena to a public agency during the 180-day period preceding the report in order to obtain information or documentation necessary to determine the claim, the name of the public agency, the date on which the subpoena was issued, and the dates on which the public agency was contacted by the Bureau before the issuance of the subpoena; and

“(O) information on the compliance of the Bureau with the obligation to offset award amounts under section 1201(f)(3), including—

“(i) the number of claims that are eligible for compensation under both this part and the September 11th Victim Compensation Fund of 2001 (49 U.S.C. 40101 note; Public Law 107–42) (commonly referred to as the ‘VCF’);

“(ii) for each claim described in clause (i) for which compensation has been paid under the VCF, the amount of compensation paid under the VCF;

“(iii) the number of claims described in clause (i) for which the Bureau has made a final determination; and

“(iv) the number of claims described in clause (i) for which the Bureau has not made a final determination.

“(3) Not later than 2 years after the date of enactment of this subsection, and 2 years thereafter, the Comptroller General of the United States shall—

“(A) conduct a study on the compliance of the Bureau with the obligation to offset award amounts under section 1201(f)(3); and

“(B) submit to Congress a report on the study conducted under subparagraph (A) that includes an assessment of whether the Bureau has provided the information required under subparagraph (B)(ix) of paragraph (2) of this subsection in each report required under that paragraph.

“(4) In this subsection, the term ‘nature of the claim’ means whether the claim is a claim for—

“(A) benefits under this subpart with respect to the death of a public safety officer;

“(B) benefits under this subpart with respect to the disability of a public safety officer; or

“(C) education assistance under subpart 2.”.

SEC. 3. AGE LIMITATION FOR CHILDREN.

Section 1212(c) of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796d–1(c)) is amended—

(1) by striking “No child” and inserting the following:

“(1) IN GENERAL.—Subject to paragraph (2), no child”; and

(2) by adding at the end the following:

“(2) DELAYED APPROVALS.—

“(A) EDUCATIONAL ASSISTANCE APPLICATION.—If a claim for assistance under this subpart is approved more than 1 year after the date on which the application for such assistance is filed with the Attorney General, the age limitation under this subsection shall be extended by the length of the period—

“(i) beginning on the day after the date that is 1 year after the date on which the application is filed; and

“(ii) ending on the date on which the application is approved.

“(B) CLAIM FOR BENEFITS FOR DEATH OR PERMANENT AND TOTAL DISABILITY.—In addition to an extension under subparagraph (A), if any, for an application for assistance under this subpart that relates to a claim for benefits under subpart 1 that was approved more than 1 year after the date on which the claim was filed with the Attorney General, the age limitation under this subsection shall be extended by the length of the period—

“(i) beginning on the day after the date that is 1 year after the date on which the claim for benefits is submitted; and

“(ii) ending on the date on which the claim for benefits is approved.”.

SEC. 4. DUE DILIGENCE IN PAYING BENEFIT CLAIMS.

Subpart 1 of part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) is amended by adding at the end the following:

“SEC. 1206. DUE DILIGENCE IN PAYING BENEFIT CLAIMS.

“(a) In General.—The Bureau, with all due diligence, shall expeditiously attempt to obtain the information and documentation necessary to adjudicate a benefit claim filed under this part, including a claim for financial assistance under subpart 2.

“(b) Sufficient Information Unavailable.—If a benefit claim filed under this part, including a claim for financial assistance under subpart 2, is unable to be adjudicated by the Bureau because of a lack of information or documentation from a third party, such as a public agency, and such information is not readily available to the claimant, the Bureau may not abandon the benefit claim unless the Bureau has utilized the investigative tools available to the Bureau to obtain the necessary information or documentation, including subpoenas.”.

SEC. 5. PRESUMPTION THAT OFFICER ACTED PROPERLY.

Section 1202 of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796a) is amended—

(1) by striking “No benefit” and inserting the following:

“(a) In General.—No benefit”; and

(2) by adding at the end the following:

“(b) Presumption.—In determining whether a benefit is payable under this part, the Bureau—

“(1) shall presume that none of the limitations described in subsection (a) apply; and

“(2) shall not determine that a limitation described in subsection (a) applies, absent clear and convincing evidence.”.

SEC. 6. EFFECTIVE DATE; APPLICABILITY.

The amendments made by this Act shall—

(1) take effect on the date of enactment of this Act; and

(2) apply to any benefit claim or application under part L of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) that is—

(A) pending before the Bureau of Justice Assistance on the date of enactment; or

(B) received by the Bureau on or after the date of enactment of this Act.

 

Speaker of the House of Representatives  

 

Vice President of the United States and President of the Senate  
 

U.S. Wants to Compete for a World Expo Act

One Hundred Fifteenth Congress
Of the
United States of America

AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday, 
the third day of January, two thousand and seventeen

An Act

To require the Secretary of State to take such actions as may be necessary for the United States to rejoin the Bureau of International Expositions, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “U.S. Wants to Compete for a World Expo Act”.

SEC. 2. FINDINGS.

Congress finds the following:

(1) The Bureau of International Expositions (BIE) is the organization responsible for governing World Fairs and International Expositions.

(2) Section 1(a) of Public Law 91–269 (22 U.S.C. 2801(a)) found that “international expositions . . . have a significant impact on the economic growth of the region surrounding the exposition and . . . are important instruments of national policy”.

(3) The United States has not been an active member of the BIE since 2001.

(4) State and local governments and private entities in the United States have continued to participate in international expositions held in foreign countries as a means of promoting United States exports and creating jobs, but face significantly higher costs for such participation because the United States is not an active member.

(5) State and local governments and private entities in the United States have expressed interest in an international exposition being hosted in the United States, but the bid of a United States city, region, or State to host an international exposition is unlikely to be successful if the United States is not a member of the BIE.

SEC. 3. SENSE OF CONGRESS.

It is the sense of Congress that—

(1) the United States should rejoin the BIE immediately to promote domestic job creation, global branding, and tourism to the United States; and

(2) the Secretary of State, in partnership with the Secretary of Commerce, State and local governments, and private and non-profit entities, should take all necessary steps to facilitate the timely submission of a request to rejoin the BIE.

SEC. 4. AUTHORIZATION.

(a) In General.—The Secretary of State is authorized to take such actions as the Secretary determines necessary for the United States to rejoin and maintain membership in the BIE.

(b) Authorization To Accept Private Contributions.—In addition to funds otherwise available to the Secretary to carry out this section, the Secretary is authorized to accept contributions for such purpose.

(c) Notification.—The Secretary of State shall notify the Committees on Foreign Affairs and Appropriations of the House of Representatives and the Committees on Foreign Relations and Appropriations of the Senate upon taking any action under subsection (a).

SEC. 5. CONTINUATION OF PROHIBITION ON USE OF FEDERAL FUNDS FOR WORLD'S FAIR PAVILIONS AND EXHIBITS.

(a) Continuation Of Prohibition.—Nothing in this Act may be construed to authorize any obligation or expenditure prohibited by section 204 of the Admiral James W. Nance and Meg Donovan Foreign Relations Authorization Act, Fiscal Years 2000 and 2001 (22 U.S.C. 2452b) (relating to limitations on the obligation or expenditure of funds by the Department of State for a United States pavilion or exhibit at an international exposition or world’s fair registered by the BIE).

(b) Prohibition On Solicitation Of Funds.—Section 204(b)(1)(C) of the Admiral James W. Nance and Meg Donovan Foreign Relations Authorization Act, Fiscal Years 2000 and 2001 (22 U.S.C. 2452b(b)(1)(C)) is amended by inserting after “expositions” the following: “, except that no employees of the Department of State may, in their official capacity, solicit funds to pay expenses for a United States pavilion or other major exhibit at any international exposition or world’s fair registered by the Bureau of International Expositions”.

Attest:

Speaker of the House of Representatives.  

Attest:

Vice President of the United States and   
President of the Senate.

 

 

H.J.Res. 66 - Joint Resolution disapproving the rule submitted by the Department of Labor relating to savings arrangements established by States for non-governmental employees.

One Hundred Fifteenth Congress
Of the
United States of America

AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday, 
the third day of January, two thousand and seventeen

Joint Resolution

Disapproving the rule submitted by the Department of Labor relating to savings arrangements established by States for non-governmental employees.

Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That Congress disapproves the rule submitted by the Department of Labor relating to “Savings Arrangements Established by States for Non-Governmental Employees” (published at 81 Fed. Reg. 59464 (August 30, 2016)), and such rule shall have no force or effect.


Speaker of the House of Representatives.  
 

H.R. 274 - Modernizing Government Travel Act

H. R. 274

One Hundred Fifteenth Congress
of the
United States of America

AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and seventeen

An Act

To provide for reimbursement for the use of modern travel services by Federal employees traveling on official Government business, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “Modernizing Government Travel Act”.

SEC. 2. FEDERAL EMPLOYEE REIMBURSEMENT FOR USE OF MODERN TRAVEL SERVICES.

(a) In General.—Not later than 90 days after the date of enactment of this Act, the Administrator of General Services shall prescribe regulations under section 5707 of title 5, United States Code, to provide for the reimbursement for the use of a transportation network company or innovative mobility technology company by any Federal employee traveling on official business under subchapter I of chapter 57 of such title, except that the Director of the Administrative Office of the United States Courts shall prescribe such regulations with respect to employees of the judicial branch of the Government.

(b) Definitions.—In this section:

(1) INNOVATIVE MOBILITY TECHNOLOGY COMPANY.—The term “innovative mobility technology company” means an organization, including a corporation, limited liability company, partnership, sole proprietorship, or any other entity, that applies technology to expand and enhance available transportation choices, better manages demand for transportation services, or provides alternatives to driving alone.

(2) TRANSPORTATION NETWORK COMPANY.—The term “transportation network company”—

(A) means a corporation, partnership, sole proprietorship, or other entity, that uses a digital network to connect riders to drivers affiliated with the entity in order for the driver to transport the rider using a vehicle owned, leased, or otherwise authorized for use by the driver to a point chosen by the rider; and

(B) does not include a shared-expense carpool or vanpool arrangement that is not intended to generate profit for the driver.

SEC. 3. REPORT ON TRANSPORTATION COSTS.

Section 5707(c) of title 5, United States Code, is amended to read as follows:

“(c)(1) Not later than November 30 of each year, the head of each agency shall submit to the Administrator of General Services, in a format prescribed by the Administrator and approved by the Director of the Office of Management and Budget—

“(A) data on total agency payments for such items as travel and transportation of people, average costs and durations of trips, and purposes of official travel;

“(B) data on estimated total agency payments for employee relocation; and

“(C) an analysis of the total costs of transportation service by type, and the total number of trips utilizing each transportation type for purposes of official travel.

“(2) The Administrator of General Services shall make the data submitted pursuant to paragraph (1) publicly available upon receipt.

“(3) Not later than January 31 of each year, the Administrator of General Services shall submit to the Director of the Office of Management and Budget, the Committee on Oversight and Government Reform of the House of Representatives, and the Committee on Homeland Security and Governmental Affairs of the Senate—

“(A) an analysis of the data submitted pursuant to paragraph (1) for the agencies listed in section 901(b) of title 31 and a survey of such data for each other agency; and

“(B) a description of any new regulations promulgated or changes to existing regulations authorized under this section.”.

Attest:


Speaker of the House of Representatives.  

 

Attest:


Vice President of the United States and   
President of the Senate.

 

 

H.R. 244 - Consolidated Appropriations Act, 2017

One Hundred Fifteenth Congress
of the
United States of America

AT THE FIRST SESSION
Begun and held at the City of Washington on Tuesday,
the third day of January, two thousand and seventeen

An Act

In the House of Representatives, U. S.,

May 3, 2017.  

Resolved, That the House agree to the amendments numbered 2 and 3 of the Senate to the bill (H.R. 244) entitled “An Act to encourage effective, voluntary investments to recruit, employ, and retain men and women who have served in the United States military with annual Federal awards to employers recognizing such efforts, and for other purposes.”, and be it further

Resolved, That the House agree to the amendment numbered 1 of the Senate to the aforementioned bill, with the following

HOUSE AMENDMENT TO SENATE AMENDMENT:

In lieu of the matter proposed to be stricken by Senate amendment numbered 1, insert the following:

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the “Consolidated Appropriations Act, 2017”.

SEC. 2. TABLE OF CONTENTS.


Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References.
Sec. 4. Explanatory statement.
Sec. 5. Statement of appropriations.
Sec. 6. Availability of funds.
Sec. 7. Technical allowance for estimating differences.
Sec. 8. Correction.

DIVISION A—AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2017


Title I—Agricultural Programs
Title II—Conservation Programs
Title III—Rural Development Programs
Title IV—Domestic Food Programs
Title V—Foreign Assistance and Related Programs
Title VI—Related Agency and Food and Drug Administration
Title VII—General Provisions

DIVISION B—COMMERCE, JUSTICE, SCIENCE, AND RELATED AGENCIES APPROPRIATIONS ACT, 2017


Title I—Department of Commerce
Title II—Department of Justice
Title III—Science
Title IV—Related Agencies
Title V—General Provisions

DIVISION C—DEPARTMENT OF DEFENSE APPROPRIATIONS ACT, 2017


Title I—Military Personnel
Title II—Operation and Maintenance
Title III—Procurement
Title IV—Research, Development, Test and Evaluation
Title V—Revolving and Management Funds
Title VI—Other Department of Defense Programs
Title VII—Related Agencies
Title VIII—General Provisions
Title IX—Overseas Contingency Operations/Global War on Terrorism
Title X—Department of Defense—Additional Appropriations

DIVISION D—ENERGY AND WATER DEVELOPMENT AND RELATED AGENCIES APPROPRIATIONS ACT, 2017


Title I—Corps of Engineers—Civil
Title II—Department of the Interior
Title III—Department of Energy
Title IV—Independent Agencies
Title V—General Provisions

DIVISION E—FINANCIAL SERVICES AND GENERAL GOVERNMENT APPROPRIATIONS ACT, 2017


Title I—Department of the Treasury
Title II—Executive Office of the President and Funds Appropriated to the President
Title III—The Judiciary
Title IV—District of Columbia
Title V—Independent Agencies
Title VI—General Provisions—This Act
Title VII—General Provisions—Government-wide
Title VIII—General Provisions—District of Columbia
Title IX—SOAR Reauthorization

DIVISION F—DEPARTMENT OF HOMELAND SECURITY APPROPRIATIONS ACT, 2017


Title I—Departmental Management, Operations, Intelligence, and Oversight
Title II—Security, Enforcement, and Investigations
Title III—Protection, Preparedness, Response, and Recovery
Title IV—Research, Development, Training, and Services
Title V—General Provisions
Title VI—Department of Homeland Security—Additional Appropriations

DIVISION G—DEPARTMENT OF THE INTERIOR, ENVIRONMENT, AND RELATED AGENCIES APPROPRIATIONS ACT, 2017


Title I—Department of the Interior
Title II—Environmental Protection Agency
Title III—Related Agencies
Title IV—General Provisions

DIVISION H—DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2017


Title I—Department of Labor
Title II—Department of Health and Human Services
Title III—Department of Education
Title IV—Related Agencies
Title V—General Provisions

DIVISION I—LEGISLATIVE BRANCH APPROPRIATIONS ACT, 2017


Title I—Legislative Branch
Title II—General Provisions

DIVISION J—DEPARTMENT OF STATE, FOREIGN OPERATIONS, AND RELATED PROGRAMS APPROPRIATIONS ACT, 2017


Title I—Department of State and Related Agency
Title II—United States Agency for International Development
Title III—Bilateral Economic Assistance
Title IV—International Security Assistance
Title V—Multilateral Assistance
Title VI—Export and Investment Assistance
Title VII—General Provisions
Title VIII—Overseas Contingency Operations/Global War on Terrorism

DIVISION K—TRANSPORTATION, HOUSING AND URBAN DEVELOPMENT, AND RELATED AGENCIES APPROPRIATIONS ACT, 2017


Title I—Department of Transportation
Title II—Department of Housing and Urban Development
Title III—Related Agencies
Title IV—General Provisions—This Act

DIVISION L—MILITARY CONSTRUCTION AND VETERANS AFFAIRS—ADDITIONAL APPROPRIATIONS ACT, 2017


Title I—Overseas Contingency Operations
Title II—Department of Veterans Affairs
Title III—General Provision—This Division

DIVISION M—OTHER MATTERS


Title I—Health Benefits for Miners Act of 2017
Title II—Puerto Rico Section 1108(g) Amendment of 2017
Title III—General Provision

DIVISION N—HONORING INVESTMENTS IN RECRUITING AND EMPLOYING AMERICAN MILITARY VETERANS ACT OF 2017

SEC. 3. REFERENCES.

Except as expressly provided otherwise, any reference to “this Act” contained in any division of this Act shall be treated as referring only to the provisions of that division.

SEC. 4. EXPLANATORY STATEMENT.

The explanatory statement regarding this Act, printed in the House section of the Congressional Record on or about May 2, 2017, and submitted by the Chairman of the Committee on Appropriations of the House, shall have the same effect with respect to the allocation of funds and implementation of divisions A through L of this Act as if it were a joint explanatory statement of a committee of conference.

SEC. 5. STATEMENT OF APPROPRIATIONS.

The following sums in this Act are appropriated, out of any money in the Treasury not otherwise appropriated, for the fiscal year ending September 30, 2017.

SEC. 6. AVAILABILITY OF FUNDS.

(a) Each amount designated in this Act by the Congress as an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985 shall be available (or rescinded, if applicable) only if the President subsequently so designates all such amounts and transmits such designations to the Congress.

(b) Each amount designated in this Act by the Congress for Overseas Contingency Operations/Global War on Terrorism pursuant to section 251(b)(2)(A)(ii) of the Balanced Budget and Emergency Deficit Control Act of 1985 shall be available (or rescinded, if applicable) only if the President subsequently so designates all such amounts and transmits such designations to the Congress.

SEC. 7. TECHNICAL ALLOWANCE FOR ESTIMATING DIFFERENCES.

If, for fiscal year 2017, new budget authority provided in appropriations Acts exceeds the discretionary spending limit for any category set forth in section 251(c) of the Balanced Budget and Emergency Deficit Control Act of 1985 due to estimating differences with the Congressional Budget Office, an adjustment to the discretionary spending limit in such category for fiscal year 2017 shall be made by the Director of the Office of Management and Budget in the amount of the excess but the total of all such adjustments shall not exceed 0.2 percent of the sum of the adjusted discretionary spending limits for all categories for that fiscal year.

SEC. 8. CORRECTION.

The Further Continuing and Security Assistance Appropriations Act, 2017 (Public Law 114–254) is amended by changing the long title so as to read: “Making further continuing appropriations for the fiscal year ending September 30, 2017, and for other purposes.”.

DIVISION A—AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2017

TITLE I—AGRICULTURAL PROGRAMS

Production, Processing, And Marketing

Office Of The Secretary

(including transfers of funds)

For necessary expenses of the Office of the Secretary, $44,555,000, of which not to exceed $5,051,000 shall be available for the immediate Office of the Secretary; not to exceed $502,000 shall be available for the Office of Tribal Relations; not to exceed $1,496,000 shall be available for the Office of Homeland Security and Emergency Coordination; not to exceed $1,209,000 shall be available for the Office of Advocacy and Outreach; not to exceed $24,928,000 shall be available for the Office of the Assistant Secretary for Administration, of which $24,124,000 shall be available for Departmental Administration to provide for necessary expenses for management support services to offices of the Department and for general administration, security, repairs and alterations, and other miscellaneous supplies and expenses not otherwise provided for and necessary for the practical and efficient work of the Department; not to exceed $3,869,000 shall be available for the Office of Assistant Secretary for Congressional Relations to carry out the programs funded by this Act, including programs involving intergovernmental affairs and liaison within the executive branch; and not to exceed $7,500,000 shall be available for the Office of Communications: Provided, That the Secretary of Agriculture is authorized to transfer funds appropriated for any office of the Office of the Secretary to any other office of the Office of the Secretary: Provided further, That no appropriation for any office shall be increased or decreased by more than 5 percent: Provided further, That not to exceed $11,000 of the amount made available under this paragraph for the immediate Office of the Secretary shall be available for official reception and representation expenses, not otherwise provided for, as determined by the Secretary: Provided further, That the amount made available under this heading for Departmental Administration shall be reimbursed from applicable appropriations in this Act for travel expenses incident to the holding of hearings as required by 5 U.S.C. 551–558: Provided further, That funds made available under this heading for the Office of the Assistant Secretary for Congressional Relations may be transferred to agencies of the Department of Agriculture funded by this Act to maintain personnel at the agency level: Provided further, That no funds made available under this heading for the Office of Assistant Secretary for Congressional Relations may be obligated after 30 days from the date of enactment of this Act, unless the Secretary has notified the Committees on Appropriations of both Houses of Congress on the allocation of these funds by USDA agency.

Executive Operations

office of the chief economist

For necessary expenses of the Office of the Chief Economist, $18,917,000, of which $4,000,000 shall be for grants or cooperative agreements for policy research under 7 U.S.C. 3155; and of which $2,000,000, to remain available until September 30, 2018, shall be available for policy research and related activities in support of the forthcoming Farm Bill.

office of hearings and appeals

For necessary expenses of the Office of Hearings and Appeals, $13,399,000.

office of budget and program analysis

For necessary expenses of the Office of Budget and Program Analysis, $9,525,000.

Office Of The Chief Information Officer

For necessary expenses of the Office of the Chief Information Officer, $49,538,000, of which not less than $33,000,000 is for cybersecurity requirements of the Department.

Office Of The Chief Financial Officer

For necessary expenses of the Office of the Chief Financial Officer, $8,028,000.

Office Of The Assistant Secretary For Civil Rights

For necessary expenses of the Office of the Assistant Secretary for Civil Rights, $901,000.

Office Of Civil Rights

For necessary expenses of the Office of Civil Rights, $24,206,000.

Agriculture Buildings And Facilities

(including transfers of funds)

For payment of space rental and related costs pursuant to Public Law 92–313, including authorities pursuant to the 1984 delegation of authority from the Administrator of General Services to the Department of Agriculture under 40 U.S.C. 121, for programs and activities of the Department which are included in this Act, and for alterations and other actions needed for the Department and its agencies to consolidate unneeded space into configurations suitable for release to the Administrator of General Services, and for the operation, maintenance, improvement, and repair of Agriculture buildings and facilities, and for related costs, $84,189,000, to remain available until expended.

Hazardous Materials Management

(including transfers of funds)

For necessary expenses of the Department of Agriculture, to comply with the Comprehensive Environmental Response, Compensation, and Liability Act (42 U.S.C. 9601 et seq.) and the Resource Conservation and Recovery Act (42 U.S.C. 6901 et seq.), $3,633,000, to remain available until expended: Provided, That appropriations and funds available herein to the Department for Hazardous Materials Management may be transferred to any agency of the Department for its use in meeting all requirements pursuant to the above Acts on Federal and non-Federal lands.

Office Of Inspector General

For necessary expenses of the Office of Inspector General, including employment pursuant to the Inspector General Act of 1978, $98,208,000, including such sums as may be necessary for contracting and other arrangements with public agencies and private persons pursuant to section 6(a)(9) of the Inspector General Act of 1978, and including not to exceed $125,000 for certain confidential operational expenses, including the payment of informants, to be expended under the direction of the Inspector General pursuant to Public Law 95–452 and section 1337 of Public Law 97–98.

Office Of The General Counsel

For necessary expenses of the Office of the General Counsel, $44,697,000.

Office Of Ethics

For necessary expenses of the Office of Ethics, $4,136,000.

Office Of The Under Secretary For Research, Education, And Economics

For necessary expenses of the Office of the Under Secretary for Research, Education, and Economics, $893,000.

Economic Research Service

For necessary expenses of the Economic Research Service, $86,757,000.

National Agricultural Statistics Service

For necessary expenses of the National Agricultural Statistics Service, $171,239,000, of which up to $42,177,000 shall be available until expended for the Census of Agriculture: Provided, That amounts made available for the Census of Agriculture may be used to conduct Current Industrial Report surveys subject to 7 U.S.C. 2204g(d) and (f).

Agricultural Research Service

salaries and expenses

For necessary expenses of the Agricultural Research Service and for acquisition of lands by donation, exchange, or purchase at a nominal cost not to exceed $100, and for land exchanges where the lands exchanged shall be of equal value or shall be equalized by a payment of money to the grantor which shall not exceed 25 percent of the total value of the land or interests transferred out of Federal ownership, $1,170,235,000: Provided, That appropriations hereunder shall be available for the operation and maintenance of aircraft and the purchase of not to exceed one for replacement only: Provided further, That appropriations hereunder shall be available pursuant to 7 U.S.C. 2250 for the construction, alteration, and repair of buildings and improvements, but unless otherwise provided, the cost of constructing any one building shall not exceed $500,000, except for headhouses or greenhouses which shall each be limited to $1,800,000, except for 10 buildings to be constructed or improved at a cost not to exceed $1,100,000 each, and except for two buildings to be constructed at a cost not to exceed $3,000,000 each, and the cost of altering any one building during the fiscal year shall not exceed 10 percent of the current replacement value of the building or $500,000, whichever is greater: Provided further, That appropriations hereunder shall be available for entering into lease agreements at any Agricultural Research Service location for the construction of a research facility by a non-Federal entity for use by the Agricultural Research Service and a condition of the lease shall be that any facility shall be owned, operated, and maintained by the non-Federal entity and shall be removed upon the expiration or termination of the lease agreement: Provided further, That the limitations on alterations contained in this Act shall not apply to modernization or replacement of existing facilities at Beltsville, Maryland: Provided further, That appropriations hereunder shall be available for granting easements at the Beltsville Agricultural Research Center: Provided further, That the foregoing limitations shall not apply to replacement of buildings needed to carry out the Act of April 24, 1948 (21 U.S.C. 113a): Provided further, That appropriations hereunder shall be available for granting easements at any Agricultural Research Service location for the construction of a research facility by a non-Federal entity for use by, and acceptable to, the Agricultural Research Service and a condition of the easements shall be that upon completion the facility shall be accepted by the Secretary, subject to the availability of funds herein, if the Secretary finds that acceptance of the facility is in the interest of the United States: Provided further, That funds may be received from any State, other political subdivision, organization, or individual for the purpose of establishing or operating any research facility or research project of the Agricultural Research Service, as authorized by law.

buildings and facilities

For the acquisition of land, construction, repair, improvement, extension, alteration, and purchase of fixed equipment or facilities as necessary to carry out the agricultural research programs of the Department of Agriculture, where not otherwise provided, $99,600,000 to remain available until expended.

National Institute Of Food And Agriculture

research and education activities

For payments to agricultural experiment stations, for cooperative forestry and other research, for facilities, and for other expenses, $849,518,000, which shall be for the purposes, and in the amounts, specified in the table titled “National Institute of Food and Agriculture, Research and Education Activities” in the explanatory statement described in section 4 (in the matter preceding division A of this consolidated Act): Provided, That funds for research grants for 1994 institutions, education grants for 1890 institutions, capacity building for non-land-grant colleges of agriculture, the agriculture and food research initiative, veterinary medicine loan repayment, multicultural scholars, graduate fellowship and institution challenge grants, and grants management systems shall remain available until expended: Provided further, That each institution eligible to receive funds under the Evans-Allen program receives no less than $1,000,000: Provided further, That funds for education grants for Alaska Native and Native Hawaiian-serving institutions be made available to individual eligible institutions or consortia of eligible institutions with funds awarded equally to each of the States of Alaska and Hawaii: Provided further, That funds for education grants for 1890 institutions shall be made available to institutions eligible to receive funds under 7 U.S.C. 3221 and 3222: Provided further, That not more than 5 percent of the amounts made available by this or any other Act to carry out the Agriculture and Food Research Initiative under 7 U.S.C. 450i(b) may be retained by the Secretary of Agriculture to pay administrative costs incurred by the Secretary in carrying out that authority.

native american institutions endowment fund

For the Native American Institutions Endowment Fund authorized by Public Law 103–382 (7 U.S.C. 301 note), $11,880,000, to remain available until expended.

extension activities

For payments to States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, Micronesia, the Northern Marianas, and American Samoa, $477,391,000, which shall be for the purposes, and in the amounts, specified in the table titled “National Institute of Food and Agriculture, Extension Activities” in the explanatory statement described in section 4 (in the matter preceding division A of this consolidated Act): Provided, That funds for facility improvements at 1890 institutions shall remain available until expended: Provided further, That institutions eligible to receive funds under 7 U.S.C. 3221 for cooperative extension receive no less than $1,000,000: Provided further, That funds for cooperative extension under sections 3(b) and (c) of the Smith-Lever Act (7 U.S.C. 343(b) and (c)) and section 208(c) of Public Law 93–471 shall be available for retirement and employees’ compensation costs for extension agents.

integrated activities

For the integrated research, education, and extension grants programs, including necessary administrative expenses, $36,000,000, which shall be for the purposes, and in the amounts, specified in the table titled “National Institute of Food and Agriculture, Integrated Activities” in the explanatory statement described in section 4 (in the matter preceding division A of this consolidated Act): Provided, That funds for the Food and Agriculture Defense Initiative shall remain available until September 30, 2018: Provided further, That notwithstanding any other provision of law, indirect costs shall not be charged against any Extension Implementation Program Area grant awarded under the Crop Protection/Pest Management Program (7 U.S.C. 7626).

Office Of The Under Secretary For Marketing And Regulatory Programs

For necessary expenses of the Office of the Under Secretary for Marketing and Regulatory Programs, $901,000.

Animal And Plant Health Inspection Service

salaries and expenses

(including transfers of funds)

For necessary expenses of the Animal and Plant Health Inspection Service, including up to $30,000 for representation allowances and for expenses pursuant to the Foreign Service Act of 1980 (22 U.S.C. 4085), $946,212,000, of which $477,000, to remain available until expended, shall be available for the control of outbreaks of insects, plant diseases, animal diseases and for control of pest animals and birds (“contingency fund”) to the extent necessary to meet emergency conditions; of which $11,520,000, to remain available until expended, shall be used for the cotton pests program for cost share purposes or for debt retirement for active eradication zones; of which $37,857,000, to remain available until expended, shall be for Animal Health Technical Services; of which $697,000 shall be for activities under the authority of the Horse Protection Act of 1970, as amended (15 U.S.C. 1831); of which $55,340,000, to remain available until expended, shall be used to support avian health; of which $4,251,000, to remain available until expended, shall be for information technology infrastructure; of which $166,500,000, to remain available until expended, shall be for specialty crop pests; of which, $8,826,000, to remain available until expended, shall be for field crop and rangeland ecosystem pests; of which $16,523,000, to remain available until expended, shall be for zoonotic disease management; of which $40,966,000, to remain available until expended, shall be for emergency preparedness and response; of which $54,000,000, to remain available until expended, shall be for tree and wood pests; of which $5,723,000, to remain available until expended, shall be for the National Veterinary Stockpile; of which up to $1,500,000, to remain available until expended, shall be for the scrapie program for indemnities; of which $2,500,000, to remain available until expended, shall be for the wildlife damage management program for aviation safety: Provided, That of amounts available under this heading for wildlife services methods development, $1,000,000 shall remain available until expended: Provided further, That of amounts available under this heading for the screwworm program, $4,990,000 shall remain available until expended; of which $3,000,000, to remain available until expended, shall be for National Bio and Agro-Defense human capital development: Provided further, That no funds shall be used to formulate or administer a brucellosis eradication program for the current fiscal year that does not require minimum matching by the States of at least 40 percent: Provided further, That this appropriation shall be available for the operation and maintenance of aircraft and the purchase of not to exceed five, of which two shall be for replacement only: Provided further, That in addition, in emergencies which threaten any segment of the agricultural production industry of this country, the Secretary may transfer from other appropriations or funds available to the agencies or corporations of the Department such sums as may be deemed necessary, to be available only in such emergencies for the arrest and eradication of contagious or infectious disease or pests of animals, poultry, or plants, and for expenses in accordance with sections 10411 and 10417 of the Animal Health Protection Act (7 U.S.C. 8310 and 8316) and sections 431 and 442 of the Plant Protection Act (7 U.S.C. 7751 and 7772), and any unexpended balances of funds transferred for such emergency purposes in the preceding fiscal year shall be merged with such transferred amounts: Provided further, That appropriations hereunder shall be available pursuant to law (7 U.S.C. 2250) for the repair and alteration of leased buildings and improvements, but unless otherwise provided the cost of altering any one building during the fiscal year shall not exceed 10 percent of the current replacement value of the building.

In fiscal year 2017, the agency is authorized to collect fees to cover the total costs of providing technical assistance, goods, or services requested by States, other political subdivisions, domestic and international organizations, foreign governments, or individuals, provided that such fees are structured such that any entity's liability for such fees is reasonably based on the technical assistance, goods, or services provided to the entity by the agency, and such fees shall be reimbursed to this account, to remain available until expended, without further appropriation, for providing such assistance, goods, or services.

buildings and facilities

For plans, construction, repair, preventive maintenance, environmental support, improvement, extension, alteration, and purchase of fixed equipment or facilities, as authorized by 7 U.S.C. 2250, and acquisition of land as authorized by 7 U.S.C. 428a, $3,175,000, to remain available until expended.

Agricultural Marketing Service

marketing services

For necessary expenses of the Agricultural Marketing Service, $84,933,000, of which $1,000,000 shall be available for the purposes of section 12306 of Public Law 113–79: Provided, That of the funds provided herein, $1,000,000 shall be used for the transportation services division: Provided further, That of the amounts made available under this heading, no more than $1,000,000 shall be used for the purpose of Public Law 114–216: Provided further, That this appropriation shall be available pursuant to law (7 U.S.C. 2250) for the alteration and repair of buildings and improvements, but the cost of altering any one building during the fiscal year shall not exceed 10 percent of the current replacement value of the building.

Fees may be collected for the cost of standardization activities, as established by regulation pursuant to law (31 U.S.C. 9701).

limitation on administrative expenses

Not to exceed $61,227,000 (from fees collected) shall be obligated during the current fiscal year for administrative expenses: Provided, That if crop size is understated and/or other uncontrollable events occur, the agency may exceed this limitation by up to 10 percent with notification to the Committees on Appropriations of both Houses of Congress.

funds for strengthening markets, income, and supply (section 32)

(including transfers of funds)

Funds available under section 32 of the Act of August 24, 1935 (7 U.S.C. 612c), shall be used only for commodity program expenses as authorized therein, and other related operating expenses, except for: (1) transfers to the Department of Commerce as authorized by the Fish and Wildlife Act of August 8, 1956; (2) transfers otherwise provided in this Act; and (3) not more than $20,705,000 for formulation and administration of marketing agreements and orders pursuant to the Agricultural Marketing Agreement Act of 1937 and the Agricultural Act of 1961.

payments to states and possessions

For payments to departments of agriculture, bureaus and departments of markets, and similar agencies for marketing activities under section 204(b) of the Agricultural Marketing Act of 1946 (7 U.S.C. 1623(b)), $1,235,000.

Grain Inspection, Packers And Stockyards Administration

salaries and expenses

For necessary expenses of the Grain Inspection, Packers and Stockyards Administration, $43,482,000: Provided, That this appropriation shall be available pursuant to law (7 U.S.C. 2250) for the alteration and repair of buildings and improvements, but the cost of altering any one building during the fiscal year shall not exceed 10 percent of the current replacement value of the building.

limitation on inspection and weighing services expenses

Not to exceed $55,000,000 (from fees collected) shall be obligated during the current fiscal year for inspection and weighing services: Provided, That if grain export activities require additional supervision and oversight, or other uncontrollable factors occur, this limitation may be exceeded by up to 10 percent with notification to the Committees on Appropriations of both Houses of Congress.

Office Of The Under Secretary For Food Safety

For necessary expenses of the Office of the Under Secretary for Food Safety, $819,000.

Food Safety And Inspection Service

For necessary expenses to carry out services authorized by the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act, including not to exceed $50,000 for representation allowances and for expenses pursuant to section 8 of the Act approved August 3, 1956 (7 U.S.C. 1766), $1,032,062,000; and in addition, $1,000,000 may be credited to this account from fees collected for the cost of laboratory accreditation as authorized by section 1327 of the Food, Agriculture, Conservation and Trade Act of 1990 (7 U.S.C. 138f): Provided, That funds provided for the Public Health Data Communication Infrastructure system shall remain available until expended: Provided further, That no fewer than 148 full-time equivalent positions shall be employed during fiscal year 2017 for purposes dedicated solely to inspections and enforcement related to the Humane Methods of Slaughter Act: Provided further, That the Food Safety and Inspection Service shall continue implementation of section 11016 of Public Law 110–246 as further clarified by the amendments made in section 12106 of Public Law 113–79: Provided further, That this appropriation shall be available pursuant to law (7 U.S.C. 2250) for the alteration and repair of buildings and improvements, but the cost of altering any one building during the fiscal year shall not exceed 10 percent of the current replacement value of the building.

Office Of The Under Secretary For Farm And Foreign Agricultural Services

For necessary expenses of the Office of the Under Secretary for Farm and Foreign Agricultural Services, $901,000.

Farm Service Agency

salaries and expenses

(including transfers of funds)

For necessary expenses of the Farm Service Agency, $1,206,110,000: Provided, That not more than 50 percent of the $100,851,000 made available under this heading for information technology related to farm program delivery, including the Modernize and Innovate the Delivery of Agricultural Systems and other farm program delivery systems, may be obligated until the Secretary submits to the Committees on Appropriations of both Houses of Congress, and receives written or electronic notification of receipt from such Committees of, a plan for expenditure that (1) identifies for each project/investment over $25,000 (a) the functional and performance capabilities to be delivered and the mission benefits to be realized, (b) the estimated lifecycle cost, including estimates for development as well as maintenance and operations, and (c) key milestones to be met; (2) demonstrates that each project/investment is (a) consistent with the Farm Service Agency Information Technology Roadmap, (b) being managed in accordance with applicable lifecycle management policies and guidance, and (c) subject to the applicable Department’s capital planning and investment control requirements; and (3) has been reviewed by the Government Accountability Office and approved by the Committees on Appropriations of both Houses of Congress: Provided further, That the agency shall submit a report by the end of the fourth quarter of fiscal year 2017 to the Committees on Appropriations and the Government Accountability Office, that identifies for each project/investment that is operational (a) current performance against key indicators of customer satisfaction, (b) current performance of service level agreements or other technical metrics, (c) current performance against a pre-established cost baseline, (d) a detailed breakdown of current and planned spending on operational enhancements or upgrades, and (e) an assessment of whether the investment continues to meet business needs as intended as well as alternatives to the investment: Provided further, That the Secretary is authorized to use the services, facilities, and authorities (but not the funds) of the Commodity Credit Corporation to make program payments for all programs administered by the Agency: Provided further, That other funds made available to the Agency for authorized activities may be advanced to and merged with this account: Provided further, That funds made available to county committees shall remain available until expended: Provided further, That none of the funds available to the Farm Service Agency shall be used to close Farm Service Agency county offices: Provided further, That none of the funds available to the Farm Service Agency shall be used to permanently relocate county based employees that would result in an office with two or fewer employees without prior notification and approval of the Committees on Appropriations of both Houses of Congress.

state mediation grants

For grants pursuant to section 502(b) of the Agricultural Credit Act of 1987, as amended (7 U.S.C. 5101–5106), $3,904,000.

grassroots source water protection program

For necessary expenses to carry out wellhead or groundwater protection activities under section 1240O of the Food Security Act of 1985 (16 U.S.C. 3839bb–2), $6,500,000, to remain available until expended.

dairy indemnity program

(including transfer of funds)

For necessary expenses involved in making indemnity payments to dairy farmers and manufacturers of dairy products under a dairy indemnity program, such sums as may be necessary, to remain available until expended: Provided, That such program is carried out by the Secretary in the same manner as the dairy indemnity program described in the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001 (Public Law 106–387, 114 Stat. 1549A–12).

agricultural credit insurance fund program account

(including transfers of funds)

For gross obligations for the principal amount of direct and guaranteed farm ownership (7 U.S.C. 1922 et seq.) and operating (7 U.S.C. 1941 et seq.) loans, emergency loans (7 U.S.C. 1961 et seq.), Indian tribe land acquisition loans (25 U.S.C. 488), boll weevil loans (7 U.S.C. 1989), guaranteed conservation loans (7 U.S.C. 1924 et seq.), and Indian highly fractionated land loans (25 U.S.C. 488) to be available from funds in the Agricultural Credit Insurance Fund, as follows: $2,750,000,000 for guaranteed farm ownership loans and $1,500,000,000 for farm ownership direct loans; $1,960,000,000 for unsubsidized guaranteed operating loans and $1,530,000,000 for direct operating loans; emergency loans, $22,576,000; Indian tribe land acquisition loans, $20,000,000; guaranteed conservation loans, $150,000,000; Indian highly fractionated land loans, $10,000,000; and for boll weevil eradication program loans, $60,000,000: Provided, That the Secretary shall deem the pink bollworm to be a boll weevil for the purpose of boll weevil eradication program loans.

For the cost of direct and guaranteed loans and grants, including the cost of modifying loans as defined in section 502 of the Congressional Budget Act of 1974, as follows: farm operating loans, $65,178,000 for direct operating loans, $20,972,000 for unsubsidized guaranteed operating loans, emergency loans, $1,262,000, to remain available until expended; and $2,550,000 for Indian highly fractionated land loans.

In addition, for administrative expenses necessary to carry out the direct and guaranteed loan programs, $317,068,000, of which $306,998,000 shall be transferred to and merged with the appropriation for “Farm Service Agency, Salaries and Expenses”.

Funds appropriated by this Act to the Agricultural Credit Insurance Program Account for farm ownership, operating and conservation direct loans and guaranteed loans may be transferred among these programs: Provided, That the Committees on Appropriations of both Houses of Congress are notified at least 15 days in advance of any transfer.

Risk Management Agency

salaries and expenses

For necessary expenses of the Risk Management Agency, $74,829,000: Provided, That not to exceed $1,000 shall be available for official reception and representation expenses, as authorized by 7 U.S.C. 1506(i).

CORPORATIONS

The following corporations and agencies are hereby authorized to make expenditures, within the limits of funds and borrowing authority available to each such corporation or agency and in accord with law, and to make contracts and commitments without regard to fiscal year limitations as provided by section 104 of the Government Corporation Control Act as may be necessary in carrying out the programs set forth in the budget for the current fiscal year for such corporation or agency, except as hereinafter provided.

Federal Crop Insurance Corporation Fund

For payments as authorized by section 516 of the Federal Crop Insurance Act (7 U.S.C. 1516), such sums as may be necessary, to remain available until expended.

Commodity Credit Corporation Fund

reimbursement for net realized losses

(including transfers of funds)

For the current fiscal year, such sums as may be necessary to reimburse the Commodity Credit Corporation for net realized losses sustained, but not previously reimbursed, pursuant to section 2 of the Act of August 17, 1961 (15 U.S.C. 713a–11): Provided, That of the funds available to the Commodity Credit Corporation under section 11 of the Commodity Credit Corporation Charter Act (15 U.S.C. 714i) for the conduct of its business with the Foreign Agricultural Service, up to $5,000,000 may be transferred to and used by the Foreign Agricultural Service for information resource management activities of the Foreign Agricultural Service that are not related to Commodity Credit Corporation business.

hazardous waste management

(limitation on expenses)

For the current fiscal year, the Commodity Credit Corporation shall not expend more than $5,000,000 for site investigation and cleanup expenses, and operations and maintenance expenses to comply with the requirement of section 107(g) of the Comprehensive Environmental Response, Compensation, and Liability Act (42 U.S.C. 9607(g)), and section 6001 of the Resource Conservation and Recovery Act (42 U.S.C. 6961).

TITLE II

CONSERVATION PROGRAMS

Office Of The Under Secretary For Natural Resources And Environment

For necessary expenses of the Office of the Under Secretary for Natural Resources and Environment, $901,000.

Natural Resources Conservation Service

conservation operations

For necessary expenses for carrying out the provisions of the Act of April 27, 1935 (16 U.S.C. 590a–f), including preparation of conservation plans and establishment of measures to conserve soil and water (including farm irrigation and land drainage and such special measures for soil and water management as may be necessary to prevent floods and the siltation of reservoirs and to control agricultural related pollutants); operation of conservation plant materials centers; classification and mapping of soil; dissemination of information; acquisition of lands, water, and interests therein for use in the plant materials program by donation, exchange, or purchase at a nominal cost not to exceed $100 pursuant to the Act of August 3, 1956 (7 U.S.C. 428a); purchase and erection or alteration or improvement of permanent and temporary buildings; and operation and maintenance of aircraft, $864,474,000, to remain available until September 30, 2018: Provided, That appropriations hereunder shall be available pursuant to 7 U.S.C. 2250 for construction and improvement of buildings and public improvements at plant materials centers, except that the cost of alterations and improvements to other buildings and other public improvements shall not exceed $250,000: Provided further, That when buildings or other structures are erected on non-Federal land, that the right to use such land is obtained as provided in 7 U.S.C. 2250a: Provided further, That of the amounts made available under this heading, $5,600,000, shall remain available until expended for the authorities under 16 U.S.C. 1001–1005 and 1007–1009 for authorized ongoing watershed projects with a primary purpose of providing water to rural communities.

watershed and flood prevention operations

For necessary expenses to carry out preventive measures, including but not limited to surveys and investigations, engineering operations, works of improvement, and changes in use of land, in accordance with the Watershed Protection and Flood Prevention Act (16 U.S.C. 1001–1005 and 1007–1009) and in accordance with the provisions of laws relating to the activities of the Department, $150,000,000, to remain available until expended: Provided, That of the amounts made available under this heading, $50,000,000 shall be allocated to projects and activities that can commence promptly following enactment; that address regional priorities for flood prevention, agricultural water management, inefficient irrigation systems, fish and wildlife habitat, or watershed protection; or that address authorized ongoing projects under the authorities of section 13 of the Flood Control Act of December 22, 1944 (Public Law 78–534) with a primary purpose of watershed protection by preventing floodwater damage and stabilizing stream channels, tributaries, and banks to reduce erosion and sediment transport.

watershed rehabilitation program

Under the authorities of section 14 of the Watershed Protection and Flood Prevention Act, $12,000,000 is provided.

TITLE III

RURAL DEVELOPMENT PROGRAMS

Office Of The Under Secretary For Rural Development

For necessary expenses of the Office of the Under Secretary for Rural Development, $896,000.

Rural Development

salaries and expenses

(including transfers of funds)

For necessary expenses for carrying out the administration and implementation of programs in the Rural Development mission area, including activities with institutions concerning the development and operation of agricultural cooperatives; and for cooperative agreements; $225,835,000: Provided, That notwithstanding any other provision of law, funds appropriated under this heading may be used for advertising and promotional activities that support the Rural Development mission area: Provided further, That any balances available from prior years for the Rural Utilities Service, Rural Housing Service, and the Rural Business—Cooperative Service salaries and expenses accounts shall be transferred to and merged with this appropriation.

Rural Housing Service

rural housing insurance fund program account

(including transfers of funds)

For gross obligations for the principal amount of direct and guaranteed loans as authorized by title V of the Housing Act of 1949, to be available from funds in the rural housing insurance fund, as follows: $1,000,000,000 shall be for direct loans and $24,000,000,000 shall be for unsubsidized guaranteed loans; $26,278,000 for section 504 housing repair loans; $35,000,000 for section 515 rental housing; $230,000,000 for section 538 guaranteed multi-family housing loans; $10,000,000 for credit sales of single family housing acquired property; $5,000,000 for section 523 self-help housing land development loans; and $5,000,000 for section 524 site development loans.

For the cost of direct and guaranteed loans, including the cost of modifying loans, as defined in section 502 of the Congressional Budget Act of 1974, as follows: section 502 loans, $67,700,000 shall be for direct loans; section 504 housing repair loans, $3,663,000; section 523 self-help housing land development loans, $417,000; section 524 site development loans, $111,000; and repair, rehabilitation, and new construction of section 515 rental housing, $10,360,000: Provided, That to support the loan program level for section 538 guaranteed loans made available under this heading the Secretary may charge or adjust any fees to cover the projected cost of such loan guarantees pursuant to the provisions of the Credit Reform Act of 1990 (2 U.S.C. 661 et seq.), and the interest on such loans may not be subsidized: Provided further, That applicants in communities that have a current rural area waiver under section 541 of the Housing Act of 1949 (42 U.S.C. 1490q) shall be treated as living in a rural area for purposes of section 502 guaranteed loans provided under this heading: Provided further, That of the amounts available under this paragraph for section 502 direct loans, no less than $5,000,000 shall be available for direct loans for individuals whose homes will be built pursuant to a program funded with a mutual and self-help housing grant authorized by section 523 of the Housing Act of 1949 until June 1, 2017: Provided further, That the Secretary shall implement provisions to provide incentives to nonprofit organizations and public housing authorities to facilitate the acquisition of Rural Housing Service (RHS) multifamily housing properties by such nonprofit organizations and public housing authorities that commit to keep such properties in the RHS multifamily housing program for a period of time as determined by the Secretary, with such incentives to include, but not be limited to, the following: allow such nonprofit entities and public housing authorities to earn a Return on Investment (ROI) on their own resources to include proceeds from low income housing tax credit syndication, own contributions, grants, and developer loans at favorable rates and terms, invested in a deal; and allow reimbursement of organizational costs associated with owner’s oversight of asset referred to as “Asset Management Fee” (AMF) of up to $7,500 per property.

In addition, for the cost of direct loans, grants, and contracts, as authorized by 42 U.S.C. 1484 and 1486, $15,387,000, to remain available until expended, for direct farm labor housing loans and domestic farm labor housing grants and contracts: Provided, That any balances available for the Farm Labor Program Account shall be transferred to and merged with this account.

In addition, for administrative expenses necessary to carry out the direct and guaranteed loan programs, $412,254,000 shall be transferred to and merged with the appropriation for “Rural Development, Salaries and Expenses”.

rental assistance program

For rental assistance agreements entered into or renewed pursuant to the authority under section 521(a)(2) or agreements entered into in lieu of debt forgiveness or payments for eligible households as authorized by section 502(c)(5)(D) of the Housing Act of 1949, $1,405,033,000, of which $40,000,000 shall be available until September 30, 2018; and in addition such sums as may be necessary, as authorized by section 521(c) of the Act, to liquidate debt incurred prior to fiscal year 1992 to carry out the rental assistance program under section 521(a)(2) of the Act: Provided, That rental assistance agreements entered into or renewed during the current fiscal year shall be funded for a one-year period: Provided further, That any unexpended balances remaining at the end of such one-year agreements may be transferred and used for purposes of any debt reduction; maintenance, repair, or rehabilitation of any existing projects; preservation; and rental assistance activities authorized under title V of the Act: Provided further, That rental assistance provided under agreements entered into prior to fiscal year 2017 for a farm labor multi-family housing project financed under section 514 or 516 of the Act may not be recaptured for use in another project until such assistance has remained unused for a period of 12 consecutive months, if such project has a waiting list of tenants seeking such assistance or the project has rental assistance eligible tenants who are not receiving such assistance: Provided further, That such recaptured rental assistance shall, to the extent practicable, be applied to another farm labor multi-family housing project financed under section 514 or 516 of the Act: Provided further, That except as provided in the third proviso under this heading and notwithstanding any other provision of the Act, the Secretary may recapture rental assistance provided under agreements entered into prior to fiscal year 2017 for a project that the Secretary determines no longer needs rental assistance and use such recaptured funds for current needs.

multi-family housing revitalization program account

For the rural housing voucher program as authorized under section 542 of the Housing Act of 1949, but notwithstanding subsection (b) of such section, and for additional costs to conduct a demonstration program for the preservation and revitalization of multi-family rental housing properties described in this paragraph, $41,400,000, to remain available until expended: Provided, That of the funds made available under this heading, $19,400,000, shall be available for rural housing vouchers to any low-income household (including those not receiving rental assistance) residing in a property financed with a section 515 loan which has been prepaid after September 30, 2005: Provided further, That the amount of such voucher shall be the difference between comparable market rent for the section 515 unit and the tenant paid rent for such unit: Provided further, That funds made available for such vouchers shall be subject to the availability of annual appropriations: Provided further, That the Secretary shall, to the maximum extent practicable, administer such vouchers with current regulations and administrative guidance applicable to section 8 housing vouchers administered by the Secretary of the Department of Housing and Urban Development: Provided further, That if the Secretary determines that the amount made available for vouchers in this or any other Act is not needed for vouchers, the Secretary may use such funds for the demonstration program for the preservation and revitalization of multi-family rental housing properties described in this paragraph: Provided further, That of the funds made available under this heading, $22,000,000 shall be available for a demonstration program for the preservation and revitalization of the sections 514, 515, and 516 multi-family rental housing properties to restructure existing USDA multi-family housing loans, as the Secretary deems appropriate, expressly for the purposes of ensuring the project has sufficient resources to preserve the project for the purpose of providing safe and affordable housing for low-income residents and farm laborers including reducing or eliminating interest; deferring loan payments, subordinating, reducing or reamortizing loan debt; and other financial assistance including advances, payments and incentives (including the ability of owners to obtain reasonable returns on investment) required by the Secretary: Provided further, That the Secretary shall as part of the preservation and revitalization agreement obtain a restrictive use agreement consistent with the terms of the restructuring: Provided further, That if the Secretary determines that additional funds for vouchers described in this paragraph are needed, funds for the preservation and revitalization demonstration program may be used for such vouchers: Provided further, That if Congress enacts legislation to permanently authorize a multi-family rental housing loan restructuring program similar to the demonstration program described herein, the Secretary may use funds made available for the demonstration program under this heading to carry out such legislation with the prior approval of the Committees on Appropriations of both Houses of Congress: Provided further, That in addition to any other available funds, the Secretary may expend not more than $1,000,000 total, from the program funds made available under this heading, for administrative expenses for activities funded under this heading.

mutual and self-help housing grants

For grants and contracts pursuant to section 523(b)(1)(A) of the Housing Act of 1949 (42 U.S.C. 1490c), $30,000,000, to remain available until expended.

rural housing assistance grants

For grants for very low-income housing repair and rural housing preservation made by the Rural Housing Service, as authorized by 42 U.S.C. 1474, and 1490m, $33,701,000, to remain available until expended.

rural community facilities program account

(including transfers of funds)

For gross obligations for the principal amount of direct and guaranteed loans as authorized by section 306 and described in section 381E(d)(1) of the Consolidated Farm and Rural Development Act, $2,600,000,000 for direct loans and $148,305,000 for guaranteed loans.

For the cost of guaranteed loans, including the cost of modifying loans, as defined in section 502 of the Congressional Budget Act of 1974, $3,322,000, to remain available until expended.

For the cost of grants for rural community facilities programs as authorized by section 306 and described in section 381E(d)(1) of the Consolidated Farm and Rural Development Act, $43,778,000, to remain available until expended: Provided, That $4,000,000 of the amount appropriated under this heading shall be available for a Rural Community Development Initiative: Provided further, That such funds shall be used solely to develop the capacity and ability of private, nonprofit community-based housing and community development organizations, low-income rural communities, and Federally Recognized Native American Tribes to undertake projects to improve housing, community facilities, community and economic development projects in rural areas: Provided further, That such funds shall be made available to qualified private, nonprofit and public intermediary organizations proposing to carry out a program of financial and technical assistance: Provided further, That such intermediary organizations shall provide matching funds from other sources, including Federal funds for related activities, in an amount not less than funds provided: Provided further, That $5,778,000 of the amount appropriated under this heading shall be to provide grants for facilities in rural communities with extreme unemployment and severe economic depression (Public Law 106–387), with up to 5 percent for administration and capacity building in the State rural development offices: Provided further, That $4,000,000 of the amount appropriated under this heading shall be available for community facilities grants to tribal colleges, as authorized by section 306(a)(19) of such Act: Provided further, That sections 381E–H and 381N of the Consolidated Farm and Rural Development Act are not applicable to the funds made available under this heading.

Rural Business—Cooperative Service

rural business program account

(including transfers of funds)

For the cost of loan guarantees and grants, for the rural business development programs authorized by section 310B and described in subsections (a), (c), (f) and (g) of section 310B of the Consolidated Farm and Rural Development Act, $65,319,000, to remain available until expended: Provided, That of the amount appropriated under this heading, not to exceed $500,000 shall be made available for one grant to a qualified national organization to provide technical assistance for rural transportation in order to promote economic development and $6,000,000 shall be for grants to the Delta Regional Authority (7 U.S.C. 2009aa et seq.) and the Appalachian Regional Commission (40 U.S.C. 14101 et seq.) for any Rural Community Advancement Program purpose as described in section 381E(d) of the Consolidated Farm and Rural Development Act, of which not more than 5 percent may be used for administrative expenses: Provided further, That $4,000,000 of the amount appropriated under this heading shall be for business grants to benefit Federally Recognized Native American Tribes, including $250,000 for a grant to a qualified national organization to provide technical assistance for rural transportation in order to promote economic development: Provided further, That sections 381E–H and 381N of the Consolidated Farm and Rural Development Act are not applicable to funds made available under this heading.

intermediary relending program fund account

(including transfer of funds)

For the principal amount of direct loans, as authorized by the Intermediary Relending Program Fund Account (7 U.S.C. 1936b), $18,889,000.

For the cost of direct loans, $5,476,000, as authorized by the Intermediary Relending Program Fund Account (7 U.S.C. 1936b), of which $557,000 shall be available through June 30, 2017, for Federally Recognized Native American Tribes; and of which $1,072,000 shall be available through June 30, 2017, for Mississippi Delta Region counties (as determined in accordance with Public Law 100–460): Provided, That such costs, including the cost of modifying such loans, shall be as defined in section 502 of the Congressional Budget Act of 1974.

In addition, for administrative expenses to carry out the direct loan programs, $4,468,000 shall be transferred to and merged with the appropriation for “Rural Development, Salaries and Expenses”.

rural economic development loans program account

(including rescission of funds)

For the principal amount of direct loans, as authorized under section 313 of the Rural Electrification Act, for the purpose of promoting rural economic development and job creation projects, $42,213,000.

Of the funds derived from interest on the cushion of credit payments, as authorized by section 313 of the Rural Electrification Act of 1936, $132,000,000 shall not be obligated and $132,000,000 are rescinded.

The cost of grants authorized under section 313 of the Rural Electrification Act, for the purpose of promoting rural economic development and job creation projects shall not exceed $10,000,000.

rural cooperative development grants

For rural cooperative development grants authorized under section 310B(e) of the Consolidated Farm and Rural Development Act (7 U.S.C. 1932), $26,550,000, of which $2,750,000 shall be for cooperative agreements for the appropriate technology transfer for rural areas program: Provided, That not to exceed $3,000,000 shall be for grants for cooperative development centers, individual cooperatives, or groups of cooperatives that serve socially disadvantaged groups and a majority of the boards of directors or governing boards of which are comprised of individuals who are members of socially disadvantaged groups; and of which $15,000,000, to remain available until expended, shall be for value-added agricultural product market development grants, as authorized by section 231 of the Agricultural Risk Protection Act of 2000 (7 U.S.C. 1632a).

rural energy for america program

For the cost of a program of loan guarantees, under the same terms and conditions as authorized by section 9007 of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 8107), $352,000: Provided, That the cost of loan guarantees, including the cost of modifying such loans, shall be as defined in section 502 of the Congressional Budget Act of 1974.

Rural Utilities Service

rural water and waste disposal program account

(including transfers of funds)

For the cost of direct loans, loan guarantees, and grants for the rural water, waste water, waste disposal, and solid waste management programs authorized by sections 306, 306A, 306C, 306D, 306E, and 310B and described in sections 306C(a)(2), 306D, 306E, and 381E(d)(2) of the Consolidated Farm and Rural Development Act, $571,190,000, to remain available until expended, of which not to exceed $1,000,000 shall be available for the rural utilities program described in section 306(a)(2)(B) of such Act, and of which not to exceed $993,000 shall be available for the rural utilities program described in section 306E of such Act: Provided, That not to exceed $10,000,000 of the amount appropriated under this heading shall be for grants authorized by section 306A(i)(2) of the Consolidated Farm and Rural Development Act in addition to funding authorized by section 306A(i)(1) of such Act: Provided further, That $64,000,000 of the amount appropriated under this heading shall be for loans and grants including water and waste disposal systems grants authorized by section 306C(a)(2)(B) and section 306D of the Consolidated Farm and Rural Development Act, and Federally Recognized Native American Tribes authorized by 306C(a)(1) of such Act: Provided further, That funding provided for section 306D of the Consolidated Farm and Rural Development Act may be provided to a consortium formed pursuant to section 325 of Public Law 105–83: Provided further, That not more than 2 percent of the funding provided for section 306D of the Consolidated Farm and Rural Development Act may be used by the State of Alaska for training and technical assistance programs and not more than 2 percent of the funding provided for section 306D of the Consolidated Farm and Rural Development Act may be used by a consortium formed pursuant to section 325 of Public Law 105–83 for training and technical assistance programs: Provided further, That not to exceed $20,000,000 of the amount appropriated under this heading shall be for technical assistance grants for rural water and waste systems pursuant to section 306(a)(14) of such Act, unless the Secretary makes a determination of extreme need, of which $6,500,000 shall be made available for a grant to a qualified nonprofit multi-State regional technical assistance organization, with experience in working with small communities on water and waste water problems, the principal purpose of such grant shall be to assist rural communities with populations of 3,300 or less, in improving the planning, financing, development, operation, and management of water and waste water systems, and of which not less than $800,000 shall be for a qualified national Native American organization to provide technical assistance for rural water systems for tribal communities: Provided further, That not to exceed $16,897,000 of the amount appropriated under this heading shall be for contracting with qualified national organizations for a circuit rider program to provide technical assistance for rural water systems: Provided further, That not to exceed $4,000,000 shall be for solid waste management grants: Provided further, That $10,000,000 of the amount appropriated under this heading shall be transferred to, and merged with, the Rural Utilities Service, High Energy Cost Grants Account to provide grants authorized under section 19 of the Rural Electrification Act of 1936 (7 U.S.C. 918a): Provided further, That any prior year balances for high-energy cost grants authorized by section 19 of the Rural Electrification Act of 1936 (7 U.S.C. 918a) shall be transferred to and merged with the Rural Utilities Service, High Energy Cost Grants Account: Provided further, That sections 381E–H and 381N of the Consolidated Farm and Rural Development Act are not applicable to the funds made available under this heading.

rural electrification and telecommunications loans program account

(including transfer of funds)

The principal amount of direct and guaranteed loans as authorized by sections 305 and 306 of the Rural Electrification Act of 1936 (7 U.S.C. 935 and 936) shall be made as follows: loans made pursuant to section 306 of that Act, rural electric, $5,500,000,000; guaranteed underwriting loans pursuant to section 313A, $750,000,000; 5 percent rural telecommunications loans, cost of money rural telecommunications loans, and for loans made pursuant to section 306 of that Act, rural telecommunications loans, $690,000,000: Provided, That up to $2,000,000,000 shall be used for the construction, acquisition, or improvement of fossil-fueled electric generating plants (whether new or existing) that utilize carbon sequestration systems.

For the cost of direct loans as authorized by section 305 of the Rural Electrification Act of 1936 (7 U.S.C. 935), including the cost of modifying loans, as defined in section 502 of the Congressional Budget Act of 1974, cost of money rural telecommunications loans, $3,071,000.

In addition, for administrative expenses necessary to carry out the direct and guaranteed loan programs, $33,270,000, which shall be transferred to and merged with the appropriation for “Rural Development, Salaries and Expenses”.

distance learning, telemedicine, and broadband program

For the principal amount of broadband telecommunication loans, $27,043,000.

For grants for telemedicine and distance learning services in rural areas, as authorized by 7 U.S.C. 950aaa et seq., $26,600,000, to remain available until expended: Provided, That $3,000,000 shall be made available for grants authorized by 379G of the Consolidated Farm and Rural Development Act: Provided further, That funding provided under this heading for grants under 379G of the Consolidated Farm and Rural Development Act may only be provided to entities that meet all of the eligibility criteria for a consortium as established by this section.

For the cost of broadband loans, as authorized by section 601 of the Rural Electrification Act, $4,500,000, to remain available until expended: Provided, That the cost of direct loans shall be as defined in section 502 of the Congressional Budget Act of 1974.

In addition, $34,500,000, to remain available until expended, for a grant program to finance broadband transmission in rural areas eligible for Distance Learning and Telemedicine Program benefits authorized by 7 U.S.C. 950aaa.

TITLE IV

DOMESTIC FOOD PROGRAMS

Office Of The Under Secretary For Food, Nutrition, And Consumer Services

For necessary expenses of the Office of the Under Secretary for Food, Nutrition, and Consumer Services, $814,000.

Food And Nutrition Service

child nutrition programs

(including transfers of funds)

For necessary expenses to carry out the Richard B. Russell National School Lunch Act (42 U.S.C. 1751 et seq.), except section 21, and the Child Nutrition Act of 1966 (42 U.S.C. 1771 et seq.), except sections 17 and 21; $22,793,982,000 to remain available through September 30, 2018, of which such sums as are made available under section 14222(b)(1) of the Food, Conservation, and Energy Act of 2008 (Public Law 110–246), as amended by this Act, shall be merged with and available for the same time period and purposes as provided herein: Provided, That of the total amount available, $17,004,000 shall be available to carry out section 19 of the Child Nutrition Act of 1966 (42 U.S.C. 1771 et seq.): Provided further, That of the total amount available, $25,000,000 shall be available to provide competitive grants to State agencies for subgrants to local educational agencies and schools to purchase the equipment needed to serve healthier meals, improve food safety, and to help support the establishment, maintenance, or expansion of the school breakfast program: Provided further, That of the total amount available, $23,000,000 shall remain available until expended to carry out section 749(g) of the Agriculture Appropriations Act of 2010 (Public Law 111–80): Provided further, That section 26(d) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1769g(d)) is amended in the first sentence by striking “2010 through 2016” and inserting “2010 through 2017”: Provided further, That section 9(h)(3) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1758(h)(3)) is amended in the first sentence by striking “for each of fiscal years 2011 through 2015” and inserting “for fiscal year 2017”: Provided further, That section 9(h)(4) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1758(h)(4)) is amended in the first sentence by striking “for each of fiscal years 2011 through 2015” and inserting “for fiscal year 2017”.

special supplemental nutrition program for women, infants, and children (wic)

For necessary expenses to carry out the special supplemental nutrition program as authorized by section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786), $6,350,000,000, to remain available through September 30, 2018: Provided, That notwithstanding section 17(h)(10) of the Child Nutrition Act of 1966 (42 U.S.C. 1786(h)(10)), not less than $60,000,000 shall be used for breastfeeding peer counselors and other related activities, and $13,600,000 shall be used for infrastructure: Provided further, That none of the funds provided in this account shall be available for the purchase of infant formula except in accordance with the cost containment and competitive bidding requirements specified in section 17 of such Act: Provided further, That none of the funds provided shall be available for activities that are not fully reimbursed by other Federal Government departments or agencies unless authorized by section 17 of such Act: Provided further, That upon termination of a federally mandated vendor moratorium and subject to terms and conditions established by the Secretary, the Secretary may waive the requirement at 7 CFR 246.12(g)(6) at the request of a State agency.

supplemental nutrition assistance program

For necessary expenses to carry out the Food and Nutrition Act of 2008 (7 U.S.C. 2011 et seq.), $78,480,694,000, of which $3,000,000,000, to remain available through December 31, 2018, shall be placed in reserve for use only in such amounts and at such times as may become necessary to carry out program operations: Provided, That funds provided herein shall be expended in accordance with section 16 of the Food and Nutrition Act of 2008: Provided further, That of the funds made available under this heading, $998,000 may be used to provide nutrition education services to State agencies and Federally Recognized Tribes participating in the Food Distribution Program on Indian Reservations: Provided further, That this appropriation shall be subject to any work registration or workfare requirements as may be required by law: Provided further, That funds made available for Employment and Training under this heading shall remain available through September 30, 2018: Provided further, That funds made available under this heading for section 28(d)(1), section 4(b), and section 27(a) of the Food and Nutrition Act of 2008 shall remain available through September 30, 2018: Provided further, That none of the funds made available under this heading may be obligated or expended in contravention of section 213A of the Immigration and Nationality Act (8 U.S.C. 1183A): Provided further, That funds made available under this heading may be used to enter into contracts and employ staff to conduct studies, evaluations, or to conduct activities related to program integrity provided that such activities are authorized by the Food and Nutrition Act of 2008.

commodity assistance program

For necessary expenses to carry out disaster assistance and the Commodity Supplemental Food Program as authorized by section 4(a) of the Agriculture and Consumer Protection Act of 1973 (7 U.S.C. 612c note); the Emergency Food Assistance Act of 1983; special assistance for the nuclear affected islands, as authorized by section 103(f)(2) of the Compact of Free Association Amendments Act of 2003 (Public Law 108–188); and the Farmers' Market Nutrition Program, as authorized by section 17(m) of the Child Nutrition Act of 1966, $315,139,000, to remain available through September 30, 2018: Provided, That none of these funds shall be available to reimburse the Commodity Credit Corporation for commodities donated to the program: Provided further, That notwithstanding any other provision of law, effective with funds made available in fiscal year 2017 to support the Seniors Farmers' Market Nutrition Program, as authorized by section 4402 of the Farm Security and Rural Investment Act of 2002, such funds shall remain available through September 30, 2018: Provided further, That of the funds made available under section 27(a) of the Food and Nutrition Act of 2008 (7 U.S.C. 2036(a)), the Secretary may use up to 10 percent for costs associated with the distribution of commodities.

nutrition programs administration

For necessary administrative expenses of the Food and Nutrition Service for carrying out any domestic nutrition assistance program, $170,716,000: Provided, That of the funds provided herein, $17,700,000 shall be available until expended for relocation expenses and for the alteration and repair of buildings and improvements pursuant to 7 U.S.C. 2250: Provided further, That of the funds provided herein, $2,000,000 shall be used for the purposes of section 4404 of Public Law 107–171, as amended by section 4401 of Public Law 110–246: Provided further, That of the funds provided herein, $1,000,000 shall be used to contract for an independent study to identify the best means of consolidating and coordinating reporting requirements under Child Nutrition Programs to eliminate redundancy, increase efficiency, and reduce the reporting burden on school food authorities and State agencies.

TITLE V
FOREIGN ASSISTANCE AND RELATED PROGRAMS

Foreign Agricultural Service

salaries and expenses

(including transfers of funds)

For necessary expenses of the Foreign Agricultural Service, including not to exceed $250,000 for representation allowances and for expenses pursuant to section 8 of the Act approved August 3, 1956 (7 U.S.C. 1766), $196,571,000: Provided, That the Service may utilize advances of funds, or reimburse this appropriation for expenditures made on behalf of Federal agencies, public and private organizations and institutions under agreements executed pursuant to the agricultural food production assistance programs (7 U.S.C. 1737) and the foreign assistance programs of the United States Agency for International Development: Provided further, That funds made available for middle-income country training programs, funds made available for the Borlaug International Agricultural Science and Technology Fellowship program, and up to $2,000,000 of the Foreign Agricultural Service appropriation solely for the purpose of offsetting fluctuations in international currency exchange rates, subject to documentation by the Foreign Agricultural Service, shall remain available until expended.

food for peace title i direct credit and food for progress program account

(including transfer of funds)

For administrative expenses to carry out the credit program of title I, Food for Peace Act (Public Law 83–480) and the Food for Progress Act of 1985, $149,000, shall be transferred to and merged with the appropriation for “Farm Service Agency, Salaries and Expenses”.

food for peace title ii grants

For expenses during the current fiscal year, not otherwise recoverable, and unrecovered prior years' costs, including interest thereon, under the Food for Peace Act (Public Law 83–480), for commodities supplied in connection with dispositions abroad under title II of said Act, $1,466,000,000, to remain available until expended: Provided, That the Administrator of the United States Agency for International Development shall in each instance notify in writing the Committees on Appropriations of both Houses of Congress, the Committee on Agriculture of the House, and the Committee on Agriculture, Nutrition, and Forestry of the Senate and make publicly available online the amount and use of authority in section 202(a) of the Food for Peace Act (7 U.S.C. 1722(a)) to notwithstand the minimum level of nonemergency assistance required by section 412(e)(2) of the Food for Peace Act (7 U.S.C. 1736f(e)(2)) not later than 15 days after the date of such action.

mcgovern-dole international food for education and child nutrition program grants

For necessary expenses to carry out the provisions of section 3107 of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 1736o–1), $201,626,000, to remain available until expended: Provided, That the Commodity Credit Corporation is authorized to provide the services, facilities, and authorities for the purpose of implementing such section, subject to reimbursement from amounts provided herein: Provided further, That of the amount made available under this heading, $5,000,000, shall remain available until expended for necessary expenses to carry out the provisions of section 3207 of the Agricultural Act of 2014 (7 U.S.C. 1726c).

commodity credit corporation export (loans) credit guarantee program account

(including transfers of funds)

For administrative expenses to carry out the Commodity Credit Corporation's Export Guarantee Program, GSM 102 and GSM 103, $8,537,000; to cover common overhead expenses as permitted by section 11 of the Commodity Credit Corporation Charter Act and in conformity with the Federal Credit Reform Act of 1990, of which $6,074,000 shall be transferred to and merged with the appropriation for “Foreign Agricultural Service, Salaries and Expenses”, and of which $2,463,000 shall be transferred to and merged with the appropriation for “Farm Service Agency, Salaries and Expenses”.

TITLE VI
RELATED AGENCY AND FOOD AND DRUG ADMINISTRATION

Department Of Health And Human Services

food and drug administration

salaries and expenses

For necessary expenses of the Food and Drug Administration, including hire and purchase of passenger motor vehicles; for payment of space rental and related costs pursuant to Public Law 92–313 for programs and activities of the Food and Drug Administration which are included in this Act; for rental of special purpose space in the District of Columbia or elsewhere; for miscellaneous and emergency expenses of enforcement activities, authorized and approved by the Secretary and to be accounted for solely on the Secretary's certificate, not to exceed $25,000; and notwithstanding section 521 of Public Law 107–188; $4,655,089,000: Provided, That of the amount provided under this heading, $754,524,000 shall be derived from prescription drug user fees authorized by 21 U.S.C. 379h, and shall be credited to this account and remain available until expended; $126,083,000 shall be derived from medical device user fees authorized by 21 U.S.C. 379j, and shall be credited to this account and remain available until expended; $323,011,000 shall be derived from human generic drug user fees authorized by 21 U.S.C. 379j–42, and shall be credited to this account and remain available until expended; $22,079,000 shall be derived from biosimilar biological product user fees authorized by 21 U.S.C. 379j–52, and shall be credited to this account and remain available until expended; $23,673,000 shall be derived from animal drug user fees authorized by 21 U.S.C. 379j–12, and shall be credited to this account and remain available until expended; $11,341,000 shall be derived from animal generic drug user fees authorized by 21 U.S.C. 379j–21, and shall be credited to this account and remain available until expended; $635,000,000 shall be derived from tobacco product user fees authorized by 21 U.S.C. 387s, and shall be credited to this account and remain available until expended: Provided further, That in addition to and notwithstanding any other provision under this heading, amounts collected for prescription drug user fees, medical device user fees, human generic drug user fees, biosimilar biological product user fees, animal drug user fees, and animal generic drug user fees that exceed the respective fiscal year 2017 limitations are appropriated and shall be credited to this account and remain available until expended: Provided further, That fees derived from prescription drug, medical device, human generic drug, biosimilar biological product, animal drug, and animal generic drug assessments for fiscal year 2017, including any such fees collected prior to fiscal year 2017 but credited for fiscal year 2017, shall be subject to the fiscal year 2017 limitations: Provided further, That the Secretary may accept payment during fiscal year 2017 of user fees specified under this heading and authorized for fiscal year 2018, prior to the due date for such fees, and that amounts of such fees assessed for fiscal year 2018 for which the Secretary accepts payment in fiscal year 2017 shall not be included in amounts under this heading: Provided further, That none of these funds shall be used to develop, establish, or operate any program of user fees authorized by 31 U.S.C. 9701: Provided further, That of the total amount appropriated: (1) $1,025,503,000 shall be for the Center for Food Safety and Applied Nutrition and related field activities in the Office of Regulatory Affairs; (2) $1,329,328,000 shall be for the Center for Drug Evaluation and Research and related field activities in the Office of Regulatory Affairs; (3) $339,618,000 shall be for the Center for Biologics Evaluation and Research and for related field activities in the Office of Regulatory Affairs; (4) $194,252,000 shall be for the Center for Veterinary Medicine and for related field activities in the Office of Regulatory Affairs; (5) $427,928,000 shall be for the Center for Devices and Radiological Health and for related field activities in the Office of Regulatory Affairs; (6) $63,331,000 shall be for the National Center for Toxicological Research; (7) $596,338,000 shall be for the Center for Tobacco Products and for related field activities in the Office of Regulatory Affairs; (8) not to exceed $163,507,000 shall be for Rent and Related activities, of which $46,856,000 is for White Oak Consolidation, other than the amounts paid to the General Services Administration for rent; (9) not to exceed $231,293,000 shall be for payments to the General Services Administration for rent; and (10) $283,991,000 shall be for other activities, including the Office of the Commissioner of Food and Drugs, the Office of Foods and Veterinary Medicine, the Office of Medical and Tobacco Products, the Office of Global and Regulatory Policy, the Office of Operations, the Office of the Chief Scientist, and central services for these offices: Provided further, That not to exceed $25,000 of this amount shall be for official reception and representation expenses, not otherwise provided for, as determined by the Commissioner: Provided further, That any transfer of funds pursuant to section 770(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(n)) shall only be from amounts made available under this heading for other activities: Provided further, That of the amounts that are made available under this heading for “other activities”, and that are not derived from user fees, $1,500,000 shall be transferred to and merged with the appropriation for “Department of Health and Human Services—Office of Inspector General” for oversight of the programs and operations of the Food and Drug Administration and shall be in addition to funds otherwise made available for oversight of the Food and Drug Administration: Provided further, That of the total amount made available under this heading, $3,000,000 shall be used by the Commissioner of Food and Drugs, in coordination with the Secretary of Agriculture, for consumer outreach and education regarding agricultural biotechnology and biotechnology-derived food products and animal feed, including through publication and distribution of science-based educational information on the environmental, nutritional, food safety, economic, and humanitarian impacts of such biotechnology, food products, and feed: Provided further, That funds may be transferred from one specified activity to another with the prior approval of the Committees on Appropriations of both Houses of Congress.

In addition, mammography user fees authorized by 42 U.S.C. 263b, export certification user fees authorized by 21 U.S.C. 381, priority review user fees authorized by 21 U.S.C. 360n and 360ff, food and feed recall fees, food reinspection fees, and voluntary qualified importer program fees authorized by 21 U.S.C. 379j–31, outsourcing facility fees authorized by 21 U.S.C. 379j–62, prescription drug wholesale distributor licensing and inspection fees authorized by 21 U.S.C. 353(e)(3), third-party logistics provider licensing and inspection fees authorized by 21 U.S.C. 360eee–3(c)(1), third-party auditor fees authorized by 21 U.S.C. 384d(c)(8), and medical countermeasure priority review voucher user fees authorized by 21 U.S.C. 360bbb–4a, shall be credited to this account, to remain available until expended.

buildings and facilities

For plans, construction, repair, improvement, extension, alteration, demolition, and purchase of fixed equipment or facilities of or used by the Food and Drug Administration, where not otherwise provided, $11,788,000, to remain available until expended.

INDEPENDENT AGENCY

Farm Credit Administration

limitation on administrative expenses

Not to exceed $68,600,000 (from assessments collected from farm credit institutions, including the Federal Agricultural Mortgage Corporation) shall be obligated during the current fiscal year for administrative expenses as authorized under 12 U.S.C. 2249: Provided, That this limitation shall not apply to expenses associated with receiverships: Provided further, That the agency may exceed this limitation by up to 10 percent with notification to the Committees on Appropriations of both Houses of Congress.

TITLE VII

GENERAL PROVISIONS

(including rescissions and transfers of funds)

SEC. 701.

Within the unit limit of cost fixed by law, appropriations and authorizations made for the Department of Agriculture for the current fiscal year under this Act shall be available for the purchase, in addition to those specifically provided for, of not to exceed 52 passenger motor vehicles of which 52 shall be for replacement only, and for the hire of such vehicles: Provided, That notwithstanding this section, the only purchase of new passenger vehicles shall be for those determined by the Secretary to be necessary for transportation safety, to reduce operational costs, and for the protection of life, property, and public safety.

SEC. 702.

Notwithstanding any other provision of this Act, the Secretary of Agriculture may transfer unobligated balances of discretionary funds appropriated by this Act or any other available unobligated discretionary balances that are remaining available of the Department of Agriculture to the Working Capital Fund for the acquisition of plant and capital equipment necessary for the delivery of financial, administrative, and information technology services of primary benefit to the agencies of the Department of Agriculture, such transferred funds to remain available until expended: Provided, That none of the funds made available by this Act or any other Act shall be transferred to the Working Capital Fund without the prior approval of the agency administrator: Provided further, That none of the funds transferred to the Working Capital Fund pursuant to this section shall be available for obligation without written notification to and the prior approval of the Committees on Appropriations of both Houses of Congress: Provided further, That none of the funds appropriated by this Act or made available to the Department's Working Capital Fund shall be available for obligation or expenditure to make any changes to the Department's National Finance Center without written notification to and prior approval of the Committees on Appropriations of both Houses of Congress as required by section 717 of this Act: Provided further, That of annual income amounts in the Working Capital Fund of the Department of Agriculture allocated for the National Finance Center, the Secretary may reserve not more than 4 percent for the replacement or acquisition of capital equipment, including equipment for the improvement and implementation of a financial management plan, information technology, and other systems of the National Finance Center or to pay any unforeseen, extraordinary cost of the National Finance Center: Provided further, That none of the amounts reserved shall be available for obligation unless the Secretary submits written notification of the obligation to the Committees on Appropriations of both Houses of Congress: Provided further, That in addition to the funds appropriated or made available in this Act for the National Finance Center the Secretary shall make available $8,608,000 from unobligated balances of the Working Capital Fund and unobligated balances and reserves of the National Finance Center for travel, information technology, financial management systems, and related expenses incurred as a result of a February 2017 tornado: Provided further, That the limitations on the obligation of funds pending notification to Congressional Committees shall not apply to any obligation that, as determined by the Secretary, is necessary to respond to a declared state of emergency that significantly impacts the operations of the National Finance Center; or to evacuate employees of the National Finance Center to a safe haven to continue operations of the National Finance Center.

SEC. 703.

No part of any appropriation contained in this Act shall remain available for obligation beyond the current fiscal year unless expressly so provided herein.

SEC. 704.

No funds appropriated by this Act may be used to pay negotiated indirect cost rates on cooperative agreements or similar arrangements between the United States Department of Agriculture and nonprofit institutions in excess of 10 percent of the total direct cost of the agreement when the purpose of such cooperative arrangements is to carry out programs of mutual interest between the two parties. This does not preclude appropriate payment of indirect costs on grants and contracts with such institutions when such indirect costs are computed on a similar basis for all agencies for which appropriations are provided in this Act.

SEC. 705.

Appropriations to the Department of Agriculture for the cost of direct and guaranteed loans made available in the current fiscal year shall remain available until expended to disburse obligations made in the current fiscal year for the following accounts: the Rural Development Loan Fund program account, the Rural Electrification and Telecommunication Loans program account, and the Rural Housing Insurance Fund program account.

SEC. 706.

None of the funds made available to the Department of Agriculture by this Act may be used to acquire new information technology systems or significant upgrades, as determined by the Office of the Chief Information Officer, without the approval of the Chief Information Officer and the concurrence of the Executive Information Technology Investment Review Board: Provided, That notwithstanding any other provision of law, none of the funds appropriated or otherwise made available by this Act may be transferred to the Office of the Chief Information Officer without written notification to and the prior approval of the Committees on Appropriations of both Houses of Congress: Provided further, That, notwithstanding section 11319 of title 40, United States Code, none of the funds available to the Department of Agriculture for information technology shall be obligated for projects, contracts, or other agreements over $25,000 prior to receipt of written approval by the Chief Information Officer: Provided further, That the Chief Information Officer may authorize an agency to obligate funds without written approval from the Chief Information Officer for projects, contracts, or other agreements up to $250,000 based upon the performance of an agency measured against the performance plan requirements described in the explanatory statement accompanying Public Law 113–235.

SEC. 707.

Funds made available under section 524(b) of the Federal Crop Insurance Act (7 U.S.C. 1524(b)) in the current fiscal year shall remain available until expended to disburse obligations made in the current fiscal year.

SEC. 708.

Notwithstanding any other provision of law, any former RUS borrower that has repaid or prepaid an insured, direct or guaranteed loan under the Rural Electrification Act of 1936, or any not-for-profit utility that is eligible to receive an insured or direct loan under such Act, shall be eligible for assistance under section 313(b)(2)(B) of such Act in the same manner as a borrower under such Act.

SEC. 709.

Except as otherwise specifically provided by law, not more than $20,000,000 in unobligated balances from appropriations made available for salaries and expenses in this Act for the Farm Service Agency shall remain available through September 30, 2018, for information technology expenses: Provided, That except as otherwise specifically provided by law, unobligated balances from appropriations made available for salaries and expenses in this Act for the Rural Development mission area shall remain available through September 30, 2018, for information technology expenses.

SEC. 710.

None of the funds appropriated or otherwise made available by this Act may be used for first-class travel by the employees of agencies funded by this Act in contravention of sections 301–10.122 through 301–10.124 of title 41, Code of Federal Regulations.

SEC. 711.

In the case of each program established or amended by the Agricultural Act of 2014 (Public Law 113–79), other than by title I or subtitle A of title III of such Act, or programs for which indefinite amounts were provided in that Act, that is authorized or required to be carried out using funds of the Commodity Credit Corporation—

(1) such funds shall be available for salaries and related administrative expenses, including technical assistance, associated with the implementation of the program, without regard to the limitation on the total amount of allotments and fund transfers contained in section 11 of the Commodity Credit Corporation Charter Act (15 U.S.C. 714i); and

(2) the use of such funds for such purpose shall not be considered to be a fund transfer or allotment for purposes of applying the limitation on the total amount of allotments and fund transfers contained in such section.

SEC. 712.

Of the funds made available by this Act, not more than $2,000,000 shall be used to cover necessary expenses of activities related to all advisory committees, panels, commissions, and task forces of the Department of Agriculture, except for panels used to comply with negotiated rule makings and panels used to evaluate competitively awarded grants.

SEC. 713.

None of the funds in this Act shall be available to pay indirect costs charged against any agricultural research, education, or extension grant awards issued by the National Institute of Food and Agriculture that exceed 30 percent of total Federal funds provided under each award: Provided, That notwithstanding section 1462 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3310), funds provided by this Act for grants awarded competitively by the National Institute of Food and Agriculture shall be available to pay full allowable indirect costs for each grant awarded under section 9 of the Small Business Act (15 U.S.C. 638).

SEC. 714.

None of the funds appropriated or otherwise made available by this or any other Act shall be used to pay the salaries and expenses of personnel to carry out the following:

(1) The Watershed Rehabilitation program authorized by section 14(h)(1) of the Watershed Protection and Flood Prevention Act (16 U.S.C. 1012(h)(1)) in excess of $9,000,000;

(2) The Environmental Quality Incentives Program as authorized by sections 1240-1240H of the Food Security Act of 1985 (16 U.S.C. 3839aa–3839aa–8) in excess of $1,357,000,000: Provided, That this limitation shall apply only to funds provided by section 1241(a)(5)(D) of the Food Security Act of 1985 (16 U.S.C. 3841(a)(5)(D));

(3) The Biomass Crop Assistance Program authorized by section 9011 of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 8111) in excess of $3,000,000 in new obligational authority;

(4) The Biorefinery, Renewable Chemical and Biobased Product Manufacturing Assistance program as authorized by section 9003 of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 8103) in excess of $151,000,000 of the funding made available by subsection (g)(1)(A) of that section for all fiscal years; and

(5) A program authorized by section 524(b) of the Federal Crop Insurance Act, as amended (7 U.S.C. 1524(b)) in excess of $7,000,000 for fiscal year 2017: Provided, That notwithstanding section 524(b)(4)(C)(i) and 524(b)(4)(C)(iii) this limitation shall not apply to funds provided by section 524(b)(4)(C)(ii).

SEC. 715.

Notwithstanding subsection (b) of section 14222 of Public Law 110–246 (7 U.S.C. 612c–6; in this section referred to as ‘‘section 14222’’), none of the funds appropriated or otherwise made available by this or any other Act shall be used to pay the salaries and expenses of personnel to carry out a program under section 32 of the Act of August 24, 1935 (7 U.S.C. 612c; in this section referred to as ‘‘section 32’’) in excess of $886,000,000 (exclusive of carryover appropriations from prior fiscal years), as follows: Child Nutrition Programs Entitlement Commodities—$465,000,000; State Option Contracts— $5,000,000; Removal of Defective Commodities—$2,500,000; Administration of Section 32 Commodity Purchases—$35,440,000: Provided, That of the total funds made available in the matter preceding this proviso that remain unobligated on October 1, 2017, such unobligated balances shall carryover into the next fiscal year and shall remain available until expended for any of the three stated purposes of section 32, except that any such carryover funds used in accordance with clause (3) of section 32 may not exceed $75,000,000 and may not be obligated until the Secretary of Agriculture provides written notification of the expenditures to the Committees on Appropriations of both Houses of Congress at least two weeks in advance: Provided further, That none of the funds made available in this Act or any other Act shall be used for salaries and expenses to carry out in this fiscal year sub-section (i)(1)(E) of section 19 of the Richard B. Russell National School Lunch Act (42 U.S.C. 1769a), except in an amount that excludes the transfer of $125,000,000 of the funds to be transferred under subsection (c) of section 14222, until October 1, 2017: Provided further, That $125,000,000 made available on October 1, 2017, to carry out such section 19 shall be excluded from the limitation described in subsection (b)(2)(A)(x) of section 14222: Provided further, That, with the exception of any available carryover funds authorized in the first proviso of this section to be used for the purposes of clause (3) of section 32, none of the funds appropriated or otherwise made available by this or any other Act shall be used to pay the salaries or expenses of any employee of the Department of Agriculture or officer of the Commodity Credit Corporation to carry out clause (3) of section 32, or for any surplus removal activities or price support activities under section 5 of the Commodity Credit Corporation Charter Act (15 U.S.C. 714c): Provided further, That the available unobligated balances under (b)(2)(A)(ix) of section 14222 in excess of the limitation set forth in this section, excluding the carryover amounts authorized in the first proviso of this section for section 32 and the amounts to be transferred pursuant to the second proviso of this section, are hereby permanently rescinded.

SEC. 716.

None of the funds appropriated by this or any other Act shall be used to pay the salaries and expenses of personnel who prepare or submit appropriations language as part of the President's budget submission to the Congress for programs under the jurisdiction of the Appropriations Subcommittees on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies that assumes revenues or reflects a reduction from the previous year due to user fees proposals that have not been enacted into law prior to the submission of the budget unless such budget submission identifies which additional spending reductions should occur in the event the user fees proposals are not enacted prior to the date of the convening of a committee of conference for the fiscal year 2018 appropriations Act.

SEC. 717.

(a) None of the funds provided by this Act, or provided by previous appropriations Acts to the agencies funded by this Act that remain available for obligation or expenditure in the current fiscal year, or provided from any accounts in the Treasury derived by the collection of fees available to the agencies funded by this Act, shall be available for obligation or expenditure through a reprogramming, transfer of funds, or reimbursements as authorized by the Economy Act, or in the case of the Department of Agriculture, through use of the authority provided by section 702(b) of the Department of Agriculture Organic Act of 1944 (7 U.S.C. 2257) or section 8 of Public Law 89–106 (7 U.S.C. 2263), that—

(1) creates new programs;

(2) eliminates a program, project, or activity;

(3) increases funds or personnel by any means for any project or activity for which funds have been denied or restricted;

(4) relocates an office or employees;

(5) reorganizes offices, programs, or activities; or

(6) contracts out or privatizes any functions or activities presently performed by Federal employees;

unless the Secretary of Agriculture or the Secretary of Health and Human Services (as the case may be) notifies in writing and receives approval from the Committees on Appropriations of both Houses of Congress at least 30 days in advance of the reprogramming of such funds or the use of such authority.

(b) None of the funds provided by this Act, or provided by previous Appropriations Acts to the agencies funded by this Act that remain available for obligation or expenditure in the current fiscal year, or provided from any accounts in the Treasury derived by the collection of fees available to the agencies funded by this Act, shall be available for obligation or expenditure for activities, programs, or projects through a reprogramming or use of the authorities referred to in subsection (a) involving funds in excess of $500,000 or 10 percent, whichever is less, that—

(1) augments existing programs, projects, or activities;

(2) reduces by 10 percent funding for any existing program, project, or activity, or numbers of personnel by 10 percent as approved by Congress; or

(3) results from any general savings from a reduction in personnel which would result in a change in existing programs, activities, or projects as approved by Congress; unless the Secretary of Agriculture or the Secretary of Health and Human Services (as the case may be) notifies in writing and receives approval from the Committees on Appropriations of both Houses of Congress at least 30 days in advance of the reprogramming or transfer of such funds or the use of such authority.

(c) The Secretary of Agriculture or the Secretary of Health and Human Services shall notify in writing and receive approval from the Committees on Appropriations of both Houses of Congress before implementing any program or activity not carried out during the previous fiscal year unless the program or activity is funded by this Act or specifically funded by any other Act.

(d) None of the funds provided by this Act, or provided by previous Appropriations Acts to the agencies funded by this Act that remain available for obligation or expenditure in the current fiscal year, or provided from any accounts in the Treasury derived by the collection of fees available to the agencies funded by this Act, shall be available for—

(1) modifying major capital investments funding levels, including information technology systems, that involves increasing or decreasing funds in the current fiscal year for the individual investment in excess of $500,000 or 10 percent of the total cost, whichever is less;

(2) realigning or reorganizing new, current, or vacant positions or agency activities or functions to establish a center, office, branch, or similar entity with five or more personnel; or

(3) carrying out activities or functions that were not described in the budget request; unless the agencies funded by this Act notify, in writing, the Committees on Appropriations of both Houses of Congress at least 30 days in advance of using the funds for these purposes.

(e) As described in this section, no funds may be used for any activities unless the Secretary of Agriculture or the Secretary of Health and Human Services receives from the Committee on Appropriations of both Houses of Congress written or electronic mail confirmation of receipt of the notification as required in this section.

SEC. 718.

Notwithstanding section 310B(g)(5) of the Consolidated Farm and Rural Development Act (7 U.S.C. 1932(g)(5)), the Secretary may assess a one-time fee for any guaranteed business and industry loan in an amount that does not exceed 3 percent of the guaranteed principal portion of the loan.

SEC. 719.

None of the funds appropriated or otherwise made available to the Department of Agriculture, the Food and Drug Administration, or the Farm Credit Administration shall be used to transmit or otherwise make available reports, questions, or responses to questions that are a result of information requested for the appropriations hearing process to any non-Department of Agriculture, non-Department of Health and Human Services, or non-Farm Credit Administration employee.

SEC. 720.

Unless otherwise authorized by existing law, none of the funds provided in this Act, may be used by an executive branch agency to produce any prepackaged news story intended for broadcast or distribution in the United States unless the story includes a clear notification within the text or audio of the prepackaged news story that the prepackaged news story was prepared or funded by that executive branch agency.

SEC. 721.

No employee of the Department of Agriculture may be detailed or assigned from an agency or office funded by this Act or any other Act to any other agency or office of the Department for more than 60 days in a fiscal year unless the individual's employing agency or office is fully reimbursed by the receiving agency or office for the salary and expenses of the employee for the period of assignment.

SEC. 722.

In addition to amounts otherwise made available by this Act and notwithstanding the last sentence of 16 U.S.C. 1310, there is appropriated $4,000,000, to remain available until expended, to implement non-renewable agreements on eligible lands, including flooded agricultural lands, as determined by the Secretary, under the Water Bank Act (16 U.S.C. 1301–1311).

SEC. 723.

Not later than 30 days after the date of enactment of this Act, the Secretary of Agriculture, the Commissioner of the Food and Drug Administration, and the Chairman of the Farm Credit Administration shall submit to the Committees on Appropriations of both Houses of Congress a detailed spending plan by program, project, and activity for all the funds made available under this Act including appropriated user fees, as defined in the explanatory statement described in section 4 (in the matter preceding division A of this consolidated Act).

SEC. 724.

Funds made available under title II of the Food for Peace Act (7 U.S.C. 1721 et seq.) may only be used to provide assistance to recipient nations if adequate monitoring and controls, as determined by the Secretary, are in place to ensure that emergency food aid is received by the intended beneficiaries in areas affected by food shortages and not diverted for unauthorized or inappropriate purposes.

SEC. 725.

The Secretary shall establish an intermediary loan packaging program based on the pilot program in effect for fiscal year 2013 for packaging and reviewing section 502 single family direct loans. The Secretary shall enter into agreements with current intermediary organizations and with additional qualified intermediary organizations. The Secretary shall work with these organizations to increase effectiveness of the section 502 single family direct loan program in rural communities and shall set aside and make available from the national reserve section 502 loans an amount necessary to support the work of such intermediaries and provide a priority for review of such loans.

SEC. 726.

For loans and loan guarantees that do not require budget authority and the program level has been established in this Act, the Secretary of Agriculture may increase the program level for such loans and loan guarantees by not more than 25 percent: Provided, That prior to the Secretary implementing such an increase, the Secretary notifies, in writing, the Committees on Appropriations of both Houses of Congress at least 15 days in advance.

SEC. 727.

None of the credit card refunds or rebates transferred to the Working Capital Fund pursuant to section 729 of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2002 (7 U.S.C. 2235aPublic Law 107–76) shall be available for obligation without written notification to, and the prior approval of, the Committees on Appropriations of both Houses of Congress: Provided, That the refunds or rebates so transferred shall be available for obligation only for the acquisition of plant and capital equipment necessary for the delivery of financial, administrative, and information technology services of primary benefit to the agencies of the Department of Agriculture.

SEC. 728.

None of the funds made available by this Act may be used to procure processed poultry products imported into the United States from the People’s Republic of China for use in the school lunch program under the Richard B. Russell National School Lunch Act (42 U.S.C. 1751 et seq.), the Child and Adult Care Food Program under section 17 of such Act (42 U.S.C. 1766), the Summer Food Service Program for Children under section 13 of such Act (42 U.S.C. 1761), or the school breakfast program under the Child Nutrition Act of 1966 (42 U.S.C. 1771 et seq.).

SEC. 729.

In response to an eligible community where the drinking water supplies are inadequate due to a natural disaster, as determined by the Secretary, including drought or severe weather, the Secretary may provide potable water through the Emergency Community Water Assistance Grant Program for an additional period of time not to exceed 120 days beyond the established period provided under the Program in order to protect public health.

SEC. 730.

Funds provided by this or any prior Appropriations Act for the Agriculture and Food Research Initiative under 7 U.S.C. 450i(b) shall be made available without regard to section 7128 of the Agricultural Act of 2014 (7 U.S.C. 3371 note), under the matching requirements in laws in effect on the date before the date of enactment of such section: Provided, That the requirements of 7 U.S.C. 450i(b)(9) shall continue to apply.

SEC. 731.

There is hereby appropriated $1,996,000 to carry out section 1621 of Public Law 110–246.

SEC. 732.

None of the funds made available by this Act may be used by the Secretary of Agriculture, acting through the Food and Nutrition Service, to commence any new research and evaluation projects until the Secretary submits to the Committees on Appropriations of both Houses of Congress a research and evaluation plan for fiscal year 2017, prepared in coordination with the Research, Education, and Economics mission area of the Department of Agriculture, and a period of 30 days beginning on the date of the submission of the plan expires to permit Congressional review of the plan.

SEC. 733.

In carrying out subsection (h) of section 502 of the Housing Act of 1949 (42 U.S.C. 1472), the Secretary of Agriculture shall have the same authority with respect to loans guaranteed under such section and eligible lenders for such loans as the Secretary has under subsections (h) and (j) of section 538 of such Act (42 U.S.C. 1490p–2) with respect to loans guaranteed under such section 538 and eligible lenders for such loans.

SEC. 734.

None of the funds made available by this Act may be used to propose, promulgate, or implement any rule, or take any other action with respect to, allowing or requiring information intended for a prescribing health care professional, in the case of a drug or biological product subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)), to be distributed to such professional electronically (in lieu of in paper form) unless and until a Federal law is enacted to allow or require such distribution.

SEC. 735.

Any amounts transferred pursuant to section 149 of the Continuing Appropriations Act, 2017 (division C of Public Law 114–223), as amended by the Further Continuing and Security Assistance Appropriations Act, 2017 (Public Law 114–254), that the Secretary of Agriculture determines are not necessary for the cost of direct telecommunications loans authorized by section 305 of the Rural Electrification Act of 1936 (7 U.S.C. 935) shall be transferred back to the accounts to which they were originally appropriated and shall be available for the same purposes as originally appropriated.

SEC. 736.

None of the funds made available by this Act may be used to notify a sponsor or otherwise acknowledge receipt of a submission for an exemption for investigational use of a drug or biological product under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) or section 351(a)(3) of the Public Health Service Act (42 U.S.C. 262(a)(3)) in research in which a human embryo is intentionally created or modified to include a heritable genetic modification. Any such submission shall be deemed to have not been received by the Secretary, and the exemption may not go into effect.

SEC. 737.

None of the funds made available by this or any other Act may be used to carry out the final rule promulgated by the Food and Drug Administration and put into effect November 16, 2015, in regards to the hazard analysis and risk-based preventive control requirements of the current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals rule with respect to the regulation of the production, distribution, sale, or receipt of dried spent grain byproducts of the alcoholic beverage production process.

SEC. 738.

(a) The Secretary of Agriculture shall—

(1) conduct audits in a manner that evaluates the following factors in the country or region being audited, as applicable—

(A) veterinary control and oversight;

(B) disease history and vaccination practices;

(C) livestock demographics and traceability;

(D) epidemiological separation from potential sources of infection;

(E) surveillance practices;

(F) diagnostic laboratory capabilities; and

(G) emergency preparedness and response; and

(2) promptly make publicly available the final reports of any audits or reviews conducted pursuant to subsection (1).

(b) This section shall be applied in a manner consistent with United States obligations under its international trade agreements.

SEC. 739.

None of the funds made available by this Act may be used to carry out any activities or incur any expense related to the issuance of licenses under section 3 of the Animal Welfare Act (7 U.S.C. 2133), or the renewal of such licenses, to class B dealers who sell dogs and cats for use in research, experiments, teaching, or testing.

SEC. 740.

No partially hydrogenated oils as defined in the order published by the Food and Drug Administration in the Federal Register on June 17, 2015 (80 Fed. Reg. 34650 et seq.) shall be deemed unsafe within the meaning of section 409(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(a)) and no food that is introduced or delivered for introduction into interstate commerce that bears or contains a partially hydrogenated oil shall be deemed adulterated under sections 402(a)(1) or 402(a)(2)(C)(i) of this Act by virtue of bearing or containing a partially hydrogenated oil until the compliance date as specified in such order (June 18, 2018).

SEC. 741.

The Secretary may charge a fee for lenders to access Department loan guarantee systems in connection with such lenders’ participation in loan guarantee programs of the Rural Housing Service: Provided, That the funds collected from such fees shall be made available to the Secretary without further appropriation and such funds shall be deposited into the Rural Development Salaries and Expense Account and shall remain available until expended for obligation and expenditure by the Secretary for administrative expenses of the Rural Housing Service Loan Guarantee Program in addition to other available funds: Provided further, That such fees collected shall not exceed $50 per loan.

SEC. 742.

(a) None of the funds made available in this Act may be used to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

(b) Nothing in subsection (a) shall limit the use of funds necessary for any Federal, State, tribal, or local law enforcement agency or any other entity carrying out criminal investigations, prosecution, or adjudication activities.

SEC. 743.

In addition to amounts otherwise made available by this Act under the heading “Animal and Plant Health Inspection Service—Buildings and Facilities”, there is appropriated $47,000,000, to remain available until expended, for fruit fly rearing facilities.

SEC. 744.

Beginning on the date of enactment of this Act, in fiscal year 2017 and each fiscal year hereafter, notwithstanding any other provision of law, a household certified to participate in the Supplemental Nutrition Assistance Program is required to report in a manner prescribed by the Secretary if the household no longer resides in the State in which it is certified.

SEC. 745.

Of the unobligated balances from amounts made available for the special supplemental nutrition program as authorized by section 17 of the Child Nutrition Act of 1966 (42 U.S.C. 1786), $850,000,000 are rescinded.

SEC. 746.

(a)(1) No Federal funds made available for this fiscal year for the rural water, waste water, waste disposal, and solid waste management programs authorized by sections 306, 306A, 306C, 306D, 306E, and 310B of the Consolidated Farm and Rural Development Act (7 U.S.C. 1926 et seq.) shall be used for a project for the construction, alteration, maintenance, or repair of a public water or wastewater system unless all of the iron and steel products used in the project are produced in the United States.

(2) In this section, the term “iron and steel products” means the following products made primarily of iron or steel: lined or unlined pipes and fittings, manhole covers and other municipal castings, hydrants, tanks, flanges, pipe clamps and restraints, valves, structural steel, reinforced precast concrete, and construction materials.

(b) Subsection (a) shall not apply in any case or category of cases in which the Secretary of Agriculture (in this section referred to as the “Secretary”) or the designee of the Secretary finds that—

(1) applying subsection (a) would be inconsistent with the public interest;

(2) iron and steel products are not produced in the United States in sufficient and reasonably available quantities or of a satisfactory quality; or

(3) inclusion of iron and steel products produced in the United States will increase the cost of the overall project by more than 25 percent.

(c) If the Secretary or the designee receives a request for a waiver under this section, the Secretary or the designee shall make available to the public on an informal basis a copy of the request and information available to the Secretary or the designee concerning the request, and shall allow for informal public input on the request for at least 15 days prior to making a finding based on the request. The Secretary or the designee shall make the request and accompanying information available by electronic means, including on the official public Internet Web site of the Department.

(d) This section shall be applied in a manner consistent with United States obligations under international agreements.

(e) The Secretary may retain up to 0.25 percent of the funds appropriated in this Act for “Rural Utilities Service—Rural Water and Waste Disposal Program Account” for carrying out the provisions described in subsection (a)(1) for management and oversight of the requirements of this section.

(f) Subsection (a) shall not apply with respect to a project for which the engineering plans and specifications include use of iron and steel products otherwise prohibited by such subsection if the plans and specifications have received required approvals from State agencies prior to the date of enactment of this Act.

(g) For purposes of this section, the terms “United States” and “State” shall include each of the several States, the District of Columbia, and each federally recognized Indian tribe.

SEC. 747.

(a) For the period beginning on the date of enactment of this Act through school year 2017–2018, with respect to the school lunch program established under the Richard B. Russell National School Lunch Act (42 U.S.C. 1751 et seq.) or the school breakfast program established under the Child Nutrition Act of 1966 (42 U.S.C. 1771 et seq.) and final regulations published by the Department of Agriculture in the Federal Register on January 26, 2012 (77 Fed. Reg. 4088 et seq.), the Secretary of Agriculture shall allow States to grant an exemption from the whole grain requirements that took effect on or after July 1, 2014, and the States shall establish a process for evaluating and responding, in a reasonable amount of time, to requests for an exemption: Provided, That school food authorities demonstrate hardship, including financial hardship, in procuring specific whole grain products which are acceptable to the students and compliant with the whole grain-rich requirements: Provided further, That school food authorities shall comply with the applicable grain component or standard with respect to the school lunch or school breakfast program that was in effect prior to July 1, 2014.

(b) For the period beginning on the date of enactment of this Act through school year 2017–2018, none of the funds appropriated or otherwise made available by this or any other Act shall be used to pay the salaries and expenses of personnel to implement any regulations under the Richard B. Russell National School Lunch Act (42 U.S.C. 1751 et seq.), the Child Nutrition Act of 1966 (42 U.S.C. 1771 et seq.), the Healthy, Hunger-Free Kids Act of 2010 (Public Law 111–296), or any other law that would require a reduction in the quantity of sodium contained in federally reimbursed meals, foods, and snacks sold in schools below Target 1 (as described in section 220.8(f)(3) of title 7, Code of Federal Regulations (or successor regulations)).

(c) For the period beginning on the date of enactment of this Act through school year 2017-2018, notwithstanding any other provision of law, the Secretary shall allow States to grant special exemptions for the service of flavored, low-fat fluid milk in the school lunch program established under the Richard B. Russell National School Lunch Act (42 U.S.C. 1751 et seq.) and the school breakfast program established under the Child Nutrition Act of 1966 (42 U.S.C. 1771 et seq.), and as a competitive food available on campus during the school day, to schools which demonstrate a reduction in student milk consumption or an increase in school milk waste.

SEC. 748.

In addition to amounts otherwise made available under this Act to carry out section 27(a)(1) of the Food and Nutrition Act of 2008 (7 U.S.C. 2036(a)(1)) for fiscal year 2017, there is appropriated $19,000,000 to carry out such section.

SEC. 749.

(a) Subject to subsection (b), the Secretary of Agriculture may conduct a pilot program in accordance with this section that authorizes not more than $600,000,000 in funds from rural electrification loans made by the Federal Financing Bank that are guaranteed under section 306 of the Rural Electrification Act of 1936 to be used for refinancing debt pursuant to section 306C of such Act (including any associated prepayment penalties and prepayment or refinance premium), notwithstanding subsections (b) and (c)(4) of section 306C of such Act.

(b) The Secretary of Agriculture may not provide an authorization under subsection (a) to a borrower unless the Secretary determines that the refinancing involved will benefit the ratepayers of the borrower.

(c) The Federal Financing Bank shall make a new loan to each borrower refinancing a loan pursuant to this section and section 306 of the Rural Electrification Act of 1936, for the purpose of providing funds for the refinancing, which loan shall be obligated from amounts made available for rural electrification loans, and the Secretary of Agriculture shall guarantee the new loan pursuant to section 306 of the Rural Electrification Act of 1936.

(d) For the cost of refinancing a loan pursuant to this section for any borrower identified by the Federal Financing Bank as having opted since origination of the loan to pay an interest rate premium for the eligibility to prepay at par, including a borrower paying an interest rate premium in the near-term for the right to prepay at par starting in 2020, $13,800,000, to remain available until expended: Provided, That these funds shall also be available for refinancing a loan pursuant to any extension or expansion of this pilot program that is enacted subsequent to this Act for those same borrowers.

(e) The authority for the pilot program provided by this section shall remain in effect through September 30, 2019.

SEC. 750.

Of the total amounts made available by this Act for direct loans and grants in the following headings: “Rural Housing Service—Rural Housing Insurance Fund Program Account”; “Rural Housing Service—Mutual and Self-Help Housing Grants”; “Rural Housing Service—Rural Housing Assistance Grants”; “Rural Housing Service—Rural Community Facilities Program Account”; “Rural Business-Cooperative Service—Rural Business Program Account”; “Rural Business-Cooperative Service—Rural Economic Development Loans Program Account”; “Rural Business- Cooperative Service—Rural Cooperative Development Grants”; “Rural Utilities Service—Rural Water and Waste Disposal Program Account”; “Rural Utilities Service—Rural Electrification and Telecommunications Loans Program Account”; and “Rural Utilities Service—Distance Learning, Telemedicine, and Broadband Program”, to the maximum extent feasible, at least 10 percent of the new unobligated balances remaining upon enactment shall be allocated for assistance in persistent poverty counties under this section: Provided, That for purposes of this section, the term “persistent poverty counties” means any county that has had 20 percent or more of its population living in poverty over the past 30 years, as measured by the 1980, 1990, and 2000 decennial censuses, and 2007–2011 American Community Survey 5-year average: Provided further, That with respect to specific activities for which program levels have been made available by this Act that are not supported by budget authority, the requirements of this section shall be applied to such program level.

SEC. 751.

For the purposes of determining eligibility or level of program assistance for Rural Development mission area programs the Secretary shall not include incarcerated prison populations.

SEC. 752.

For an additional amount for “Food and Drug Administration—Salaries and Expenses” to prevent, prepare for, and respond to emerging health threats, including the Ebola and Zika viruses, domestically and internationally and to develop necessary medical countermeasures and vaccines, including the review, regulation, and post market surveillance of vaccines and therapies, and for related administrative activities, $10,000,000, to remain available until expended.

SEC. 753.

There is hereby appropriated for the “Emergency Conservation Program”, $28,651,000, to remain available until expended for emergencies not declared as a major disaster or emergency under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121 et seq.).

SEC. 754.

None of the funds appropriated by this Act may be used in any way, directly or indirectly, to influence congressional action on any legislation or appropriation matters pending before Congress, other than to communicate to Members of Congress as described in 18 U.S.C. 1913.

SEC. 755.

In addition to funds appropriated in this Act, there is hereby appropriated $134,000,000, to remain available until expended, under the heading “Food for Peace Title II Grants”: Provided, That the funds made available under this section shall be used for the purposes set forth in the Food for Peace Act for both emergency and non-emergency purposes.

SEC. 756.

The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final regulations revising the Federal drug regulations (as defined in section 1112(c) of such Act (21 U.S.C. 360dd note)) with respect to medical gases not later than July 15, 2017.

SEC. 757.

For an additional amount for “Animal and Plant Health Inspection Service—Salaries and Expenses”, $5,500,000, to remain available until September 30, 2018, for one-time control and management and associated activities directly related to the multiple-agency response to citrus greening.

SEC. 758.

The following unobligated balances identified by the following Treasury Appropriation Fund Symbols are hereby rescinded: 12X1951, $632,928.89; 12X1953, $2,420,129.91; 12X1902, $352,323.31; 12X1900, $16,452.44; and 12X1232, $529,310.95: Provided, That no amounts may be rescinded from amounts that were designated by the Congress as an emergency or disaster relief requirement pursuant to a concurrent resolution on the budget or the Balanced Budget and Emergency Deficit Control Act of 1985.

SEC. 759.

The unobligated balances resulting from offsetting collections identified by Treasury Appropriation Fund Symbols 12X1951, 12X2002, 12X2006, 12X1902, 12X1900, 12X1232, and 12X1980, respectively, are hereby rescinded: Provided, that no amounts may be rescinded from amounts that were designated by the Congress as an emergency or disaster relief requirement pursuant to a concurrent resolution on the budget or the Balanced Budget and Emergency Deficit Control Act of 1985.

SEC. 760.

There is hereby appropriated $5,000,000, to remain available until September 30, 2018, for a pilot program for the National Institute of Food and Agriculture to provide grants to nonprofit organizations for programs and services to establish and enhance farming and ranching opportunities for military veterans.

SEC. 761.

During fiscal year 2017, the Food and Drug Administration (FDA) shall not allow the introduction or delivery for introduction into interstate commerce of any food that contains genetically engineered salmon until FDA publishes final labeling guidelines for informing consumers of such content.

SEC. 762.

None of the funds made available in this Act may be used to pay the salary or expenses of personnel—

(1) to inspect horses under section 3 of the Federal Meat Inspection Act (21 U.S.C. 603);

(2) to inspect horses under section 903 of the Federal Agriculture Improvement and Reform Act of 1996 (7 U.S.C. 1901 note; Public Law 104–127); or

(3) to implement or enforce section 352.19 of title 9, Code of Federal Regulations (or a successor regulation).

SEC. 763.

The Secretary shall set aside for Rural Economic Area Partnership (REAP) Zones, until August 15, 2017, an amount of funds made available in title III under the headings of Rural Housing Insurance Fund Program Account, Mutual and Self-Help Housing Grants, Rural Housing Assistance Grants, Rural Community Facilities Program Account, Rural Business Program Account, Rural Development Loan Fund Program Account, and Rural Water and Waste Disposal Program Account, equal to the amount obligated in REAP Zones with respect to funds provided under such headings in the most recent fiscal year any such funds were obligated under such headings for REAP Zones.

SEC. 764.

There is hereby appropriated $600,000 for the purposes of section 727 of division A of Public Law 112–55.

SEC. 765.

None of the funds made available by this Act may be used to implement, administer, or enforce the “variety” requirements of the final rule entitled “Enhancing Retailer Standards in the Supplemental Nutrition Assistance Program (SNAP)” published by the Department of Agriculture in the Federal Register on December 15, 2016 (81 Fed. Reg. 90675) until the Secretary of Agriculture amends the definition of the term “variety” as de fined in section 278.1(b)(1)(ii)(C) of title 7, Code of Federal Regulations, and “variety” as applied in the definition of the term “staple food” as defined in section 271.2 of title 7, Code of Federal Regulations, to increase the number of items that qualify as acceptable varieties in each staple food category so that the total number of such items in each staple food category exceeds the number of such items in each staple food category included in the final rule as published on December 15, 2016: Provided, That until the Secretary promulgates such regulatory amendments, the Secretary shall apply the requirements regarding acceptable varieties and breadth of stock to Supplemental Nutrition Assistance Program retailers that were in effect on the day before the date of the enactment of the Agricultural Act of 2014 (Public Law 113–79).

SEC. 766.

None of the funds made available by this Act may be used by the Food and Drug Administration to develop, issue, promote, or advance any regulations applicable to food manufacturers for population-wide sodium reduction actions or to develop, issue, promote or advance final guidance applicable to food manufacturers for long term population-wide sodium reduction actions until the date on which a dietary reference intake report with respect to sodium is completed.

SEC. 767.

There is hereby appropriated $1,000,000, to remain available until September 30, 2018, for the cost of loans and grants that is consistent with section 4206 of the Agricultural Act of 2014, for necessary expenses of the Secretary to support projects that provide access to healthy food in underserved areas, to create and preserve quality jobs, and to revitalize low-income communities.

SEC. 768.

In addition to funds appropriated in this Act, there is hereby appropriated $500,000, to remain available until September 30, 2018, under the heading “Rural Development, Salaries and Expenses”, for development of an implementation plan for increasing access to education in the fields of science, technology, engineering, and mathematics in rural communities through the Distance Learning and Telemedicine program.

SEC. 769.

There is hereby appropriated $8,000,000, to remain available until September 30, 2018, to carry out section 6407 of the Farm Security and Rural Investment Act of 2002 (7 U.S.C. 8107a).

SEC. 770.

(a) Of the unobligated balances from amounts made available in fiscal year 2016 for the Comprehensive Loan Accounting System under the heading “Rural Development, Salaries and Expenses”, $8,900,000 are hereby rescinded.

(b) For an additional amount for “Rural Development, Salaries and Expenses”, $8,900,000, to remain available until September 30, 2018, is provided for Information Technology modernization activities.

SEC. 771.

The Secretary shall modify the pilot program initiated March 1, 2017, designed to preserve affordable rental housing through non-profit transfer or acquisition of Section 515 properties with expiring mortgages. The program will study effective means to transfer Section 515 properties exiting the program due to mortgage maturity to qualified nonprofit organizations to preserve the properties in the Rural Housing Service multi-family program. The Secretary shall—

(1) Conduct limited research under the authority found at section 506(b) of the Housing Act of 1949, as amended (41 U.S.C. §1476(b));

(2) Track the results and identify ways or incentives to create additional opportunities for nonprofits to participate in the preservation of properties;

(3) Work collaboratively with third-parties to address concerns identified on the Department issued guidance issued September 16, 2016 titled, “March 1, 2017, Pilot Program to Promote Non-Profit Participation in Transactions to Retain the Section 515 Portfolio” to maximize research benefits and potential application; and

(4) Conduct research for two years after the date of the enactment of this Act and report the findings to the Committees on Appropriations of both Houses of Congress:

Provided, That there is hereby appropriated $1,000,000, to remain available until September 30, 2018, to provide grants to qualified non-profit organizations and public housing authorities to provide technical assistance, including financial and legal services, to RHS multi-family housing borrowers to facilitate the acquisition of RHS multi-family housing properties in areas where the Secretary determines a risk of loss of affordable housing.

SEC. 772.

(a) The Secretary of Agriculture (referred to in this section as the “Secretary”) shall carry out a pilot program during fiscal year 2017 with respect to the 2016 crop year for county-level agriculture risk coverage payments under section 1117(b)(1) of the Agricultural Act of 2014 (7 U.S.C. 9017(b)(1)), that provides all or some of the State Farm Service Agency offices in each State the opportunity to provide agricultural producers in the State a supplemental payment described in subsection (c) based on the alternate calculation method described in subsection (b) for 1 or more counties in a State if the office for that State determines that the alternate calculation method is necessary to ensure that, to the maximum extent practicable, there are not significant yield calculation disparities between comparable counties in the State.

(b) The alternate calculation method referred to in subsection (a) is a method of calculating the actual yield for the 2016 crop year for county-level agriculture risk coverage payments under section 1117(b)(1) of the Agricultural Act of 2014 (7 U.S.C. 9017(b)(1)), under which—

(1) county data of the National Agricultural Statistics Service (referred to in this section as “NASS data”) is used for the calculations;

(2) if there is insufficient NASS data for a county (as determined under standards of the Secretary in effect as of the date of enactment of this Act) or the available NASS data produces a substantially disparate result, the calculation of the county yield is determined using comparable contiguous county NASS data as determined by the Farm Service Agency office in the applicable State; and

(3) if there is insufficient NASS data for a comparable contiguous county (as determined under standards of the Secretary in effect as of the date of enactment of this Act), the calculation of the county yield is determined using reliable yield data from other sources, such as Risk Management Agency data, National Agricultural Statistics Service district data, National Agricultural Statistics Service State yield data, or other data as determined by the Farm Service Agency office in the applicable State.

(c)(1) A supplemental payment made under the pilot program established under this section may be made to an agricultural producer who is subject to the alternate calculation method described in subsection (b) if that agricultural producer would otherwise receive a county-level agriculture risk coverage payment for the 2016 crop year in an amount that is less than the payment that the agricultural producer would receive under the alternate calculation method.

(2) The amount of a supplemental payment to an agricultural producer under this section may not exceed the difference between—

(A) the payment that the agricultural producer would have received without the alternate calculation method described in subsection (b); and

(B) the payment that the agricultural producer would receive using the alternate calculation method.

(d)(1) There is appropriated to the Secretary, out of funds of the Treasury not otherwise appropriated, $5,000,000, to remain available until September 30, 2018, to carry out the pilot program described in this section.

(2) Of the funds appropriated, the Secretary shall use not more than $5,000,000 to carry out the pilot program described in this section.

(e)(1) To the maximum extent practicable, the Secretary shall select States to participate in the pilot program under this section so the cost of the pilot program equals the amount provided under subsection (d).

(2) To the extent that the cost of the pilot program exceeds the amount made available, the Secretary shall reduce all payments under the pilot program on a pro rata basis.

(f) Nothing in this section affects the calculation of actual yield for purposes of county-level agriculture risk coverage payments under section 1117(b)(1) of the Agricultural Act of 2014 (7 U.S.C. 9017(b)(1)) other than payments made in accordance with the pilot program under this section.

(g) A calculation of actual yield made using the alternate calculation method described in subsection (b) shall not be used as a basis for any agriculture risk coverage payment determinations under section 1117 of the Agricultural Act of 2014 (7 U.S.C. 9017) other than for purposes of the pilot program under this section.

SEC. 773.

None of the funds made available by this Act or any other Act may be used—

(1) in contravention of section 7606 of the Agricultural Act of 2014 (7 U.S.C. 5940); or

(2) to prohibit the transportation, processing, sale, or use of industrial hemp that is grown or cultivated in accordance with section 7606 of the Agricultural Act of 2014, within or outside the State in which the industrial hemp is grown or cultivated.

SEC. 774.

Notwithstanding any other provision of law, for purposes of applying the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the acceptable market name of Lithodes aequispinus is “golden king crab.”

This division may be cited as the “Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2017”.

DIVISION B—COMMERCE, JUSTICE, SCIENCE, AND RELATED AGENCIES APPROPRIATIONS ACT, 2017

TITLE I

DEPARTMENT OF COMMERCE

International Trade Administration

operations and administration

For necessary expenses for international trade activities of the Department of Commerce provided for by law, and for engaging in trade promotional activities abroad, including expenses of grants and cooperative agreements for the purpose of promoting exports of United States firms, without regard to sections 3702 and 3703 of title 44, United States Code; full medical coverage for dependent members of immediate families of employees stationed overseas and employees temporarily posted overseas; travel and transportation of employees of the International Trade Administration between two points abroad, without regard to section 40118 of title 49, United States Code; employment of citizens of the United States and aliens by contract for services; rental of space abroad for periods not exceeding 10 years, and expenses of alteration, repair, or improvement; purchase or construction of temporary demountable exhibition structures for use abroad; payment of tort claims, in the manner authorized in the first paragraph of section 2672 of title 28, United States Code, when such claims arise in foreign countries; not to exceed $294,300 for official representation expenses abroad; purchase of passenger motor vehicles for official use abroad, not to exceed $45,000 per vehicle; obtaining insurance on official motor vehicles; and rental of tie lines, $495,000,000, to remain available until September 30, 2018, of which $12,000,000 is to be derived from fees to be retained and used by the International Trade Administration, notwithstanding section 3302 of title 31, United States Code: Provided, That, of amounts provided under this heading, not less than $16,400,000 shall be for China antidumping and countervailing duty enforcement and compliance activities: Provided further, That the provisions of the first sentence of section 105(f) and all of section 108(c) of the Mutual Educational and Cultural Exchange Act of 1961 (22 U.S.C. 2455(f) and 2458(c)) shall apply in carrying out these activities; and that for the purpose of this Act, contributions under the provisions of the Mutual Educational and Cultural Exchange Act of 1961 shall include payment for assessments for services provided as part of these activities.

Bureau Of Industry And Security

operations and administration

For necessary expenses for export administration and national security activities of the Department of Commerce, including costs associated with the performance of export administration field activities both domestically and abroad; full medical coverage for dependent members of immediate families of employees stationed overseas; employment of citizens of the United States and aliens by contract for services abroad; payment of tort claims, in the manner authorized in the first paragraph of section 2672 of title 28, United States Code, when such claims arise in foreign countries; not to exceed $13,500 for official representation expenses abroad; awards of compensation to informers under the Export Administration Act of 1979, and as authorized by section 1(b) of the Act of June 15, 1917 (40 Stat. 223; 22 U.S.C. 401(b)); and purchase of passenger motor vehicles for official use and motor vehicles for law enforcement use with special requirement vehicles eligible for purchase without regard to any price limitation otherwise established by law, $112,500,000, to remain available until expended: Provided, That the provisions of the first sentence of section 105(f) and all of section 108(c) of the Mutual Educational and Cultural Exchange Act of 1961 (22 U.S.C. 2455(f) and 2458(c)) shall apply in carrying out these activities: Provided further, That payments and contributions collected and accepted for materials or services provided as part of such activities may be retained for use in covering the cost of such activities, and for providing information to the public with respect to the export administration and national security activities of the Department of Commerce and other export control programs of the United States and other governments.

Economic Development Administration

economic development assistance programs

For grants for economic development assistance as provided by the Public Works and Economic Development Act of 1965, for trade adjustment assistance, and for grants authorized by section 27 of the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 3722), $237,000,000, to remain available until expended, of which $17,000,000 shall be for grants under such section 27.

salaries and expenses

For necessary expenses of administering the economic development assistance programs as provided for by law, $39,000,000: Provided, That these funds may be used to monitor projects approved pursuant to title I of the Public Works Employment Act of 1976, title II of the Trade Act of 1974, section 27 of the Stevenson-Wydler Technology Innovation Act of 1980 (15 U.S.C. 3722), and the Community Emergency Drought Relief Act of 1977.

Minority Business Development Agency

minority business development

For necessary expenses of the Department of Commerce in fostering, promoting, and developing minority business enterprise, including expenses of grants, contracts, and other agreements with public or private organizations, $34,000,000.

Economic And Statistical Analysis

salaries and expenses

For necessary expenses, as authorized by law, of economic and statistical analysis programs of the Department of Commerce, $107,300,000, to remain available until September 30, 2018.

Bureau Of The Census

current surveys and programs

For necessary expenses for collecting, compiling, analyzing, preparing and publishing statistics, provided for by law, $270,000,000: Provided, That, from amounts provided herein, funds may be used for promotion, outreach, and marketing activities: Provided further, That the Bureau of the Census shall collect and analyze data for the Annual Social and Economic Supplement to the Current Population Survey using the same health insurance questions included in previous years, in addition to the revised questions implemented in the Current Population Survey beginning in February 2014.

periodic censuses and programs

(including transfer of funds)

For necessary expenses for collecting, compiling, analyzing, preparing and publishing statistics for periodic censuses and programs provided for by law, $1,200,000,000, to remain available until September 30, 2018: Provided, That, from amounts provided herein, funds may be used for promotion, outreach, and marketing activities: Provided further, That within the amounts appropriated, $2,580,000 shall be transferred to the “Office of Inspector General” account for activities associated with carrying out investigations and audits related to the Bureau of the Census: Provided further, That not more than 50 percent of the amounts made available under this heading for information technology related to 2020 census delivery, including the Census Enterprise Data Collection and Processing (CEDCaP) program, may be obligated until the Secretary submits to the Committees on Appropriations of the House of Representatives and the Senate a plan for expenditure that: (1) identifies for each CEDCaP project/investment over $25,000: (A) the functional and performance capabilities to be delivered and the mission benefits to be realized; (B) the estimated lifecycle cost, including estimates for development as well as maintenance and operations; and (C) key milestones to be met; (2) details for each project/investment: (A) reasons for any cost and schedule variances; and (B) top risks and mitigation strategies; and (3) has been submitted to the Government Accountability Office.

National Telecommunications And Information Administration

salaries and expenses

For necessary expenses, as provided for by law, of the National Telecommunications and Information Administration (NTIA), $32,000,000, to remain available until September 30, 2018: Provided, That, notwithstanding 31 U.S.C. 1535(d), the Secretary of Commerce shall charge Federal agencies for costs incurred in spectrum management, analysis, operations, and related services, and such fees shall be retained and used as offsetting collections for costs of such spectrum services, to remain available until expended: Provided further, That the Secretary of Commerce is authorized to retain and use as offsetting collections all funds transferred, or previously transferred, from other Government agencies for all costs incurred in telecommunications research, engineering, and related activities by the Institute for Telecommunication Sciences of NTIA, in furtherance of its assigned functions under this paragraph, and such funds received from other Government agencies shall remain available until expended.

public telecommunications facilities, planning and construction

For the administration of prior-year grants, recoveries and unobligated balances of funds previously appropriated are available for the administration of all open grants until their expiration.

United States Patent And Trademark Office

salaries and expenses

(including transfers of funds)

For necessary expenses of the United States Patent and Trademark Office (USPTO) provided for by law, including defense of suits instituted against the Under Secretary of Commerce for Intellectual Property and Director of the USPTO, $3,230,000,000, to remain available until expended: Provided, That the sum herein appropriated from the general fund shall be reduced as offsetting collections of fees and surcharges assessed and collected by the USPTO under any law are received during fiscal year 2017, so as to result in a fiscal year 2017 appropriation from the general fund estimated at $0: Provided further, That during fiscal year 2017, should the total amount of such offsetting collections be less than $3,230,000,000 this amount shall be reduced accordingly: Provided further, That any amount received in excess of $3,230,000,000 in fiscal year 2017 and deposited in the Patent and Trademark Fee Reserve Fund shall remain available until expended: Provided further, That the Director of USPTO shall submit a spending plan to the Committees on Appropriations of the House of Representatives and the Senate for any amounts made available by the preceding proviso and such spending plan shall be treated as a reprogramming under section 505 of this Act and shall not be available for obligation or expenditure except in compliance with the procedures set forth in that section: Provided further, That any amounts reprogrammed in accordance with the preceding proviso shall be transferred to the United States Patent and Trademark Office “Salaries and Expenses” account: Provided further, That from amounts provided herein, not to exceed $900 shall be made available in fiscal year 2017 for official reception and representation expenses: Provided further, That in fiscal year 2017 from the amounts made available for “Salaries and Expenses” for the USPTO, the amounts necessary to pay (1) the difference between the percentage of basic pay contributed by the USPTO and employees under section 8334(a) of title 5, United States Code, and the normal cost percentage (as defined by section 8331(17) of that title) as provided by the Office of Personnel Management (OPM) for USPTO's specific use, of basic pay, of employees subject to subchapter III of chapter 83 of that title, and (2) the present value of the otherwise unfunded accruing costs, as determined by OPM for USPTO's specific use of post-retirement life insurance and post-retirement health benefits coverage for all USPTO employees who are enrolled in Federal Employees Health Benefits (FEHB) and Federal Employees Group Life Insurance (FEGLI), shall be transferred to the Civil Service Retirement and Disability Fund, the FEGLI Fund, and the FEHB Fund, as appropriate, and shall be available for the authorized purposes of those accounts: Provided further, That any differences between the present value factors published in OPM's yearly 300 series benefit letters and the factors that OPM provides for USPTO's specific use shall be recognized as an imputed cost on USPTO's financial statements, where applicable: Provided further, That, notwithstanding any other provision of law, all fees and surcharges assessed and collected by USPTO are available for USPTO only pursuant to section 42(c) of title 35, United States Code, as amended by section 22 of the Leahy-Smith America Invents Act (Public Law 112–29): Provided further, That within the amounts appropriated, $2,000,000 shall be transferred to the “Office of Inspector General” account for activities associated with carrying out investigations and audits related to the USPTO.

National Institute Of Standards And Technology

scientific and technical research and services

(including transfer of funds)

For necessary expenses of the National Institute of Standards and Technology (NIST), $690,000,000, to remain available until expended, of which not to exceed $9,000,000 may be transferred to the “Working Capital Fund”: Provided, That not to exceed $5,000 shall be for official reception and representation expenses: Provided further, That NIST may provide local transportation for summer undergraduate research fellowship program participants.

industrial technology services

For necessary expenses for industrial technology services, $155,000,000, to remain available until expended, of which $130,000,000 shall be for the Hollings Manufacturing Extension Partnership, and of which $25,000,000 shall be for the National Network for Manufacturing Innovation: Provided, That of the amount provided under this heading, $2,000,000 shall be derived from recoveries of prior year obligations.

construction of research facilities

For construction of new research facilities, including architectural and engineering design, and for renovation and maintenance of existing facilities, not otherwise provided for the National Institute of Standards and Technology, as authorized by sections 13 through 15 of the National Institute of Standards and Technology Act (15 U.S.C. 278c–278e), $109,000,000, to remain available until expended: Provided, That the Secretary of Commerce shall include in the budget justification materials that the Secretary submits to Congress in support of the Department of Commerce budget (as submitted with the budget of the President under section 1105(a) of title 31, United States Code) an estimate for each National Institute of Standards and Technology construction project having a total multi-year program cost of more than $5,000,000, and simultaneously the budget justification materials shall include an estimate of the budgetary requirements for each such project for each of the 5 subsequent fiscal years.

National Oceanic And Atmospheric Administration

operations, research, and facilities

(including transfer of funds)

For necessary expenses of activities authorized by law for the National Oceanic and Atmospheric Administration, including maintenance, operation, and hire of aircraft and vessels; grants, contracts, or other payments to nonprofit organizations for the purposes of conducting activities pursuant to cooperative agreements; and relocation of facilities, $3,367,875,000, to remain available until September 30, 2018, except that funds provided for cooperative enforcement shall remain available until September 30, 2019: Provided, That fees and donations received by the National Ocean Service for the management of national marine sanctuaries may be retained and used for the salaries and expenses associated with those activities, notwithstanding section 3302 of title 31, United States Code: Provided further, That in addition, $130,164,000 shall be derived by transfer from the fund entitled “Promote and Develop Fishery Products and Research Pertaining to American Fisheries”, which shall only be used for fishery activities related to the Saltonstall-Kennedy Grant Program, Cooperative Research, Annual Stock Assessments, Survey and Monitoring Projects, Interjurisdictional Fisheries Grants, and Fish Information Networks: Provided further, That of the $3,515,539,000 provided for in direct obligations under this heading, $3,367,875,000 is appropriated from the general fund, $130,164,000 is provided by transfer and $17,500,000 is derived from recoveries of prior year obligations: Provided further, That the total amount available for National Oceanic and Atmospheric Administration corporate services administrative support costs shall not exceed $228,440,000: Provided further, That any deviation from the amounts designated for specific activities in the explanatory statement described in section 4 (in the matter preceding division A of this consolidated Act), or any use of deobligated balances of funds provided under this heading in previous years, shall be subject to the procedures set forth in section 505 of this Act: Provided further, That in addition, for necessary retired pay expenses under the Retired Serviceman's Family Protection and Survivor Benefits Plan, and for payments for the medical care of retired personnel and their dependents under the Dependents' Medical Care Act (10 U.S.C. ch. 55), such sums as may be necessary.

procurement, acquisition and construction

(including transfer of funds)

For procurement, acquisition and construction of capital assets, including alteration and modification costs, of the National Oceanic and Atmospheric Administration, $2,242,610,000, to remain available until September 30, 2019, except that funds provided for acquisition and construction of vessels and construction of facilities shall remain available until expended: Provided, That of the $2,255,610,000 provided for in direct obligations under this heading, $2,242,610,000 is appropriated from the general fund and $13,000,000 is provided from recoveries of prior year obligations: Provided further, That any deviation from the amounts designated for specific activities in the explanatory statement described in section 4 (in the matter preceding division A of this consolidated Act), or any use of deobligated balances of funds provided under this heading in previous years, shall be subject to the procedures set forth in section 505 of this Act: Provided further, That the Secretary of Commerce shall include in budget justification materials that the Secretary submits to Congress in support of the Department of Commerce budget (as submitted with the budget of the President under section 1105(a) of title 31, United States Code) an estimate for each National Oceanic and Atmospheric Administration procurement, acquisition or construction project having a total of more than $5,000,000 and simultaneously the budget justification shall include an estimate of the budgetary requirements for each such project for each of the 5 subsequent fiscal years: Provided further, That, within the amounts appropriated, $1,302,000 shall be transferred to the “Office of Inspector General” account for activities associated with carrying out investigations and audits related to satellite procurement, acquisition and construction.

pacific coastal salmon recovery

For necessary expenses associated with the restoration of Pacific salmon populations, $65,000,000, to remain available until September 30, 2018: Provided, That, of the funds provided herein, the Secretary of Commerce may issue grants to the States of Washington, Oregon, Idaho, Nevada, California, and Alaska, and to the Federally recognized tribes of the Columbia River and Pacific Coast (including Alaska), for projects necessary for conservation of salmon and steelhead populations that are listed as threatened or endangered, or that are identified by a State as at-risk to be so listed, for maintaining populations necessary for exercise of tribal treaty fishing rights or native subsistence fishing, or for conservation of Pacific coastal salmon and steelhead habitat, based on guidelines to be developed by the Secretary of Commerce: Provided further, That all funds shall be allocated based on scientific and other merit principles and shall not be available for marketing activities: Provided further, That funds disbursed to States shall be subject to a matching requirement of funds or documented in-kind contributions of at least 33 percent of the Federal funds.

fishermen's contingency fund

For carrying out the provisions of title IV of Public Law 95–372, not to exceed $350,000, to be derived from receipts collected pursuant to that Act, to remain available until expended.

fisheries finance program account

Subject to section 502 of the Congressional Budget Act of 1974, during fiscal year 2017, obligations of direct loans may not exceed $24,000,000 for Individual Fishing Quota loans and not to exceed $100,000,000 for traditional direct loans as authorized by the Merchant Marine Act of 1936.

Departmental Management

salaries and expenses

For necessary expenses for the management of the Department of Commerce provided for by law, including not to exceed $4,500 for official reception and representation, $58,000,000: Provided, That within amounts provided, the Secretary of Commerce may use up to $2,500,000 to engage in activities to provide businesses and communities with information about and referrals to relevant Federal, State, and local government programs.

renovation and modernization

(including transfer of funds)

For necessary expenses for the renovation and modernization of the Herbert C. Hoover Building, including security-related costs, $4,000,000, to remain available until expended: Provided, That the Secretary of Commerce may transfer up to $8,224,000 to this account from funds available to the Department of Commerce: Provided further, That the transfer authority provided in the first proviso is in addition to any other transfer authority contained in this Act: Provided further, That any transfer pursuant to the authority provided under this heading shall be treated as a reprogramming under section 505 of this Act and shall not be available for obligation or expenditure except in compliance with the procedures set forth in that section.

office of inspector general

For necessary expenses of the Office of Inspector General in carrying out the provisions of the Inspector General Act of 1978 (5 U.S.C. App.), $32,744,000.

General Provisions—Department Of Commerce

(including transfer of funds)

SEC. 101.

During the current fiscal year, applicable appropriations and funds made available to the Department of Commerce by this Act shall be available for the activities specified in the Act of October 26, 1949 (15 U.S.C. 1514), to the extent and in the manner prescribed by the Act, and, notwithstanding 31 U.S.C. 3324, may be used for advanced payments not otherwise authorized only upon the certification of officials designated by the Secretary of Commerce that such payments are in the public interest.

SEC. 102.

During the current fiscal year, appropriations made available to the Department of Commerce by this Act for salaries and expenses shall be available for hire of passenger motor vehicles as authorized by 31 U.S.C. 1343 and 1344; services as authorized by 5 U.S.C. 3109; and uniforms or allowances therefor, as authorized by law (5 U.S.C. 5901–5902).

SEC. 103.

Not to exceed 5 percent of any appropriation made available for the current fiscal year for the Department of Commerce in this Act may be transferred between such appropriations, but no such appropriation shall be increased by more than 10 percent by any such transfers: Provided, That any transfer pursuant to this section shall be treated as a reprogramming of funds under section 505 of this Act and shall not be available for obligation or expenditure except in compliance with the procedures set forth in that section: Provided further, That the Secretary of Commerce shall notify the Committees on Appropriations at least 15 days in advance of the acquisition or disposal of any capital asset (including land, structures, and equipment) not specifically provided for in this Act or any other law appropriating funds for the Department of Commerce.

SEC. 104.

The requirements set forth by section 105 of the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2012 (Public Law 112–55), as amended by section 105 of title I of division B of Public Law 113–6, are hereby adopted by reference and made applicable with respect to fiscal year 2017: Provided, That the life cycle cost for the Joint Polar Satellite System is $11,322,125,000 and the life cycle cost for the Geostationary Operational Environmental Satellite R-Series Program is $10,828,059,000.

SEC. 105.

Notwithstanding any other provision of law, the Secretary may furnish services (including but not limited to utilities, telecommunications, and security services) necessary to support the operation, maintenance, and improvement of space that persons, firms, or organizations are authorized, pursuant to the Public Buildings Cooperative Use Act of 1976 or other authority, to use or occupy in the Herbert C. Hoover Building, Washington, DC, or other buildings, the maintenance, operation, and protection of which has been delegated to the Secretary from the Administrator of General Services pursuant to the Federal Property and Administrative Services Act of 1949 on a reimbursable or non-reimbursable basis. Amounts received as reimbursement for services provided under this section or the authority under which the use or occupancy of the space is authorized, up to $200,000, shall be credited to the appropriation or fund which initially bears the costs of such services.

SEC. 106.

Nothing in this title shall be construed to prevent a grant recipient from deterring child pornography, copyright infringement, or any other unlawful activity over its networks.

SEC. 107.

The Administrator of the National Oceanic and Atmospheric Administration is authorized to use, with their consent, with reimbursement and subject to the limits of available appropriations, the land, services, equipment, personnel, and facilities of any department, agency, or instrumentality of the United States, or of any State, local government, Indian tribal government, Territory, or possession, or of any political subdivision thereof, or of any foreign government or international organization, for purposes related to carrying out the responsibilities of any statute administered by the National Oceanic and Atmospheric Administration.

SEC. 108.

The National Technical Information Service shall not charge any customer for a copy of any report or document generated by the Legislative Branch unless the Service has provided information to the customer on how an electronic copy of such report or document may be accessed and downloaded for free online. Should a customer still require the Service to provide a printed or digital copy of the report or document, the charge shall be limited to recovering the Service's cost of processing, reproducing, and delivering such report or document.

SEC. 109.

The Secretary of Commerce may waive the requirement for bonds under 40 U.S.C. 3131 with respect to contracts for the construction, alteration, or repair of vessels, regardless of the terms of the contracts as to payment or title, when the contract is made under the Coast and Geodetic Survey Act of 1947 (33 U.S.C. 883a et seq.).

SEC. 110.

None of the funds appropriated or otherwise made available in this or any other Act, with respect to any fiscal year, may be used in contravention of section 110 of the Commerce, Justice, Science, and Related Agencies Appropriations Act, 2016 (Public Law 114–113).

SEC. 111.

To carry out the responsibilities of the National Oceanic and Atmospheric Administration (NOAA), the Administrator of NOAA is authorized to: (1) enter into grants and cooperative agreements with; (2) use on a non-reimbursable basis land, services, equipment, personnel, and facilities provided by; and (3) receive and expend funds made available on a consensual basis from: a Federal agency, State or subdivision thereof, local government, tribal government, territory, or possession or any subdivisions thereof: Provided, That funds received for permitting and related regulatory activities pursuant to this section shall be deposited under the heading “National Oceanic and Atmospheric Administration—Operations, Research, and Facilities” and shall remain available until September 30, 2019, for such purposes: Provided further, That all funds within this section and their corresponding uses are subject to section 505 of this Act.

SEC. 112.

Amounts provided by this Act or by any prior appropriations Act that remain available for obligation, for necessary expenses of the programs of the Economics and Statistics Administration of the Department of Commerce, including amounts provided for programs of the Bureau of Economic Analysis and the U.S. Census Bureau, shall be available for expenses of cooperative agreements with appropriate entities, including any Federal, State, or local governmental unit, or institution of higher education, to aid and promote statistical, research, and methodology activities which further the purposes for which such amounts have been made available.

SEC. 113.

For fiscal year 2017 and each fiscal year thereafter, no person shall conduct any research, exploration, salvage, or other activity that would physically alter or disturb the wreck or wreck site of the RMS Titanic unless authorized by the Secretary of Commerce per the provisions of the Agreement Concerning the Shipwrecked Vessel RMS Titanic. The Secretary of Commerce shall take appropriate actions to carry out this section consistent with the Agreement.

This title may be cited as the “Department of Commerce Appropriations Act, 2017”.

TITLE II—DEPARTMENT OF JUSTICE

General Administration

salaries and expenses

For expenses necessary for the administration of the Department of Justice, $114,124,000, of which not to exceed $4,000,000 for security and construction of Department of Justice facilities shall remain available until expended.

justice information sharing technology

(including transfer of funds)

For necessary expenses for information sharing technology, including planning, development, deployment and departmental direction, $31,000,000, to remain available until expended: Provided, That the Attorney General may transfer up to $35,400,000 to this account, from funds available to the Department of Justice for information technology, to remain available until expended, for enterprise-wide information technology initiatives: Provided further, That the transfer authority in the preceding proviso is in addition to any other transfer authority contained in this Act: Provided further, That any transfer pursuant to the first proviso shall be treated as a reprogramming under section 505 of this Act and shall not be available for obligation or expenditure except in compliance with the procedures set forth in that section.

executive office for immigration review

(including transfer of funds)

For expenses necessary for the administration of immigration-related activities of the Executive Office for Immigration Review, $440,000,000, of which $4,000,000 shall be derived by transfer from the Executive Office for Immigration Review fees deposited in the “Immigration Examinations Fee” account: Provided, That not to exceed $15,000,000 of the total amount made available under this heading shall remain available until expended: Provided further, That any unobligated balances available from funds appropriated for the Executive Office for Immigration Review under the heading “General Administration, Administrative Review and Appeals” shall be transferred to and merged with the appropriation under this heading.

office of inspector general

For necessary expenses of the Office of Inspector General, $95,583,000, including not to exceed $10,000 to meet unforeseen emergencies of a confidential character.

United States Parole Commission

salaries and expenses

For necessary expenses of the United States Parole Commission as authorized, $13,308,000: Provided, That, notwithstanding any other provision of law, upon the expiration of a term of office of a Commissioner, the Commissioner may continue to act until a successor has been appointed.

Legal Activities

salaries and expenses, general legal activities

For expenses necessary for the legal activities of the Department of Justice, not otherwise provided for, including not to exceed $20,000 for expenses of collecting evidence, to be expended under the direction of, and to be accounted for solely under the certificate of, the Attorney General; the administration of pardon and clemency petitions; and rent of private or Government-owned space in the District of Columbia, $897,500,000, of which not to exceed $20,000,000 for litigation support contracts shall remain available until expended: Provided, That of the amount provided for INTERPOL Washington dues payments, not to exceed $685,000 shall remain available until expended: Provided further, That of the total amount appropriated, not to exceed $9,000 shall be available to INTERPOL Washington for official reception and representation expenses: Provided further, That notwithstanding section 205 of this Act, upon a determination by the Attorney General that emergent circumstances require additional funding for litigation activities of the Civil Division, the Attorney General may transfer such amounts to “Salaries and Expenses, General Legal Activities” from available appropriations for the current fiscal year for the Department of Justice, as may be necessary to respond to such circumstances: Provided further, That any transfer pursuant to the preceding proviso shall be treated as a reprogramming under section 505 of this Act and shall not be available for obligation or expenditure except in compliance with the procedures set forth in that section: Provided further, That of the amount appropriated, such sums as may be necessary shall be available to the Civil Rights Division for salaries and expenses associated with the election monitoring program under section 8 of the Voting Rights Act of 1965 (52 U.S.C. 10305) and to reimburse the Office of Personnel Management for such salaries and expenses: Provided further, That of the amounts provided under this heading for the election monitoring program, $3,390,000 shall remain available until expended.

In addition, for reimbursement of expenses of the Department of Justice associated with processing cases under the National Childhood Vaccine Injury Act of 1986, not to exceed $10,000,000, to be appropriated from the Vaccine Injury Compensation Trust Fund.

salaries and expenses, antitrust division

For expenses necessary for the enforcement of antitrust and kindred laws, $164,977,000, to remain available until expended: Provided, That notwithstanding any other provision of law, fees collected for premerger notification filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (15 U.S.C. 18a), regardless of the year of collection (and estimated to be $125,000,000 in fiscal year 2017), shall be retained and used for necessary expenses in this appropriation, and shall remain available until expended: Provided further, That the sum herein appropriated from the general fund shall be reduced as such offsetting collections are received during fiscal year 2017, so as to result in a final fiscal year 2017 appropriation from the general fund estimated at $39,977,000.

salaries and expenses, united states attorneys

For necessary expenses of the Offices of the United States Attorneys, including inter-governmental and cooperative agreements, $2,035,000,000: Provided, That of the total amount appropriated, not to exceed $7,200 shall be available for official reception and representation expenses: Provided further, That not to exceed $25,000,000 shall remain available until expended: Provided further, That each United States Attorney shall establish or participate in a task force on human trafficking.

united states trustee system fund

For necessary expenses of the United States Trustee Program, as authorized, $225,908,000, to remain available until expended: Provided, That, notwithstanding any other provision of law, deposits to the United States Trustee System Fund and amounts herein appropriated shall be available in such amounts as may be necessary to pay refunds due depositors: Provided further, That, notwithstanding any other provision of law, fees collected pursuant to section 589a(b) of title 28, United States Code, shall be retained and used for necessary expenses in this appropriation and shall remain available until expended: Provided further, That to the extent that fees collected in fiscal year 2017, net of amounts necessary to pay refunds due depositors, exceed $225,908,000, those excess amounts shall be available in future fiscal years only to the extent provided in advance in appropriations Acts: Provided further, That the sum herein appropriated from the general fund shall be reduced (1) as such fees are received during fiscal year 2017, net of amounts necessary to pay refunds due depositors, (estimated at $163,000,000) and (2) to the extent that any remaining general fund appropriations can be derived from amounts deposited in the Fund in previous fiscal years that are not otherwise appropriated, so as to result in a final fiscal year 2017 appropriation from the general fund estimated at $62,908,000.

salaries and expenses, foreign claims settlement commission

For expenses necessary to carry out the activities of the Foreign Claims Settlement Commission, including services as authorized by section 3109 of title 5, United States Code, $2,374,000.

fees and expenses of witnesses

For fees and expenses of witnesses, for expenses of contracts for the procurement and supervision of expert witnesses, for private counsel expenses, including advances, and for expenses of foreign counsel, $270,000,000, to remain available until expended, of which not to exceed $16,000,000 is for construction of buildings for protected witness safesites; not to exceed $3,000,000 is for the purchase and maintenance of armored and other vehicles for witness security caravans; and not to exceed $13,000,000 is for the purchase, installation, maintenance, and upgrade of secure telecommunications equipment and a secure automated information network to store and retrieve the identities and locations of protected witnesses: Provided, That amounts made available under this heading may not be transferred pursuant to section 205 of this Act.

salaries and expenses, community relations service

(including transfer of funds)

For necessary expenses of the Community Relations Service, $15,500,000: Provided, That notwithstanding section 205 of this Act, upon a determination by the Attorney General that emergent circumstances require additional funding for conflict resolution and violence prevention activities of the Community Relations Service, the Attorney General may transfer such amounts to the Community Relations Service, from available appropriations for the current fiscal year for the Department of Justice, as may be necessary to respond to such circumstances: Provided further, That any transfer pursuant to the preceding proviso shall be treated as a reprogramming under section 505 of this Act and shall not be available for obligation or expenditure except in compliance with the procedures set forth in that section.

assets forfeiture fund

For expenses authorized by subparagraphs (B), (F), and (G) of section 524(c)(1) of title 28, United States Code, $20,514,000, to be derived from the Department of Justice Assets Forfeiture Fund.

United States Marshals Service

salaries and expenses

For necessary expenses of the United States Marshals Service, $1,249,040,000, of which not to exceed $6,000 shall be available for official reception and representation expenses, and not to exceed $15,000,000 shall remain available until expended.

construction

For construction in space controlled, occupied or utilized by the United States Marshals Service for prisoner holding and related support, $10,000,000, to remain available until expended.

federal prisoner detention

(including transfer of funds)

For necessary expenses related to United States prisoners in the custody of the United States Marshals Service as authorized by section 4013 of title 18, United States Code, $1,454,414,000, to remain available until expended: Provided, That not to exceed $20,000,000 shall be considered “funds appropriated for State and local law enforcement assistance” pursuant to section 4013(b) of title 18, United States Code: Provided further, That the United States Marshals Service shall be responsible for managing the Justice Prisoner and Alien Transportation System: Provided further, That any unobligated balances available from funds appropriated under the heading “General Administration, Detention Trustee” shall be transferred to and merged with the appropriation under this heading.

National Security Division

salaries and expenses

(including transfer of funds)

For expenses necessary to carry out the activities of the National Security Division, $96,000,000, of which not to exceed $5,000,000 for information technology systems shall remain available until expended: Provided, That notwithstanding section 205 of this Act, upon a determination by the Attorney General that emergent circumstances require additional funding for the activities of the National Security Division, the Attorney General may transfer such amounts to this heading from available appropriations for the current fiscal year for the Department of Justice, as may be necessary to respond to such circumstances: Provided further, That any transfer pursuant to the preceding proviso shall be treated as a reprogramming under section 505 of this Act and shall not be available for obligation or expenditure except in compliance with the procedures set forth in that section.

Interagency Law Enforcement

interagency crime and drug enforcement

For necessary expenses for the identification, investigation, and prosecution of individuals associated with the most significant drug trafficking organizations, transnational organized crime, and money laundering organizations not otherwise provided for, to include inter-governmental agreements with State and local law enforcement agencies engaged in the investigation and prosecution of individuals involved in transnational organized crime and drug trafficking, $517,000,000, of which $50,000,000 shall remain available until expended: Provided, That any amounts obligated from appropriations under this heading may be used under authorities available to the organizations reimbursed from this appropriation.

Federal Bureau Of Investigation

salaries and expenses

For necessary expenses of the Federal Bureau of Investigation for detection, investigation, and prosecution of crimes against the United States, $8,767,201,000, of which not to exceed $285,882,000 shall remain available until expended: Provided, That not to exceed $184,500 shall be available for official reception and representation expenses: Provided further, That in addition to other funds provided for Construction projects, the Federal Bureau of Investigation may use up to $68,982,000 under this heading for all costs related to construction, conversion, modification and extension of federally owned and leased space; preliminary planning and design of projects; and operation and maintenance of secure work environment facilities and secure networking capabilities.

construction

(including transfer of funds)

For necessary expenses, to include the cost of equipment, furniture, and information technology requirements, related to construction or acquisition of buildings, facilities and sites by purchase, or as otherwise authorized by law; conversion, modification and extension of federally owned buildings; preliminary planning and design of projects; and operation and maintenance of secure work environment facilities and secure networking capabilities; $420,178,000, to remain available until expended, of which $181,000,000 shall be derived by transfer from the Department of Justice’s Working Capital Fund: Provided, That $323,000,000 shall be for the new Federal Bureau of Investigation consolidated headquarters facility in the National Capital Region.

Drug Enforcement Administration

salaries and expenses

For necessary expenses of the Drug Enforcement Administration, including not to exceed $70,000 to meet unforeseen emergencies of a confidential character pursuant to section 530C of title 28, United States Code; and expenses for conducting drug education and training programs, including travel and related expenses for participants in such programs and the distribution of items of token value that promote the goals of such programs, $2,102,976,000, of which not to exceed $75,000,000 shall remain available until expended and not to exceed $90,000 shall be available for official reception and representation expenses.

Bureau Of Alcohol, Tobacco, Firearms And Explosives

salaries and expenses

For necessary expenses of the Bureau of Alcohol, Tobacco, Firearms and Explosives, for training of State and local law enforcement agencies with or without reimbursement, including training in connection with the training and acquisition of canines for explosives and fire accelerants detection; and for provision of laboratory assistance to State and local law enforcement agencies, with or without reimbursement, $1,258,600,000, of which not to exceed $36,000 shall be for official reception and representation expenses, not to exceed $1,000,000 shall be available for the payment of attorneys' fees as provided by section 924(d)(2) of title 18, United States Code, and not to exceed $20,000,000 shall remain available until expended: Provided, That none of the funds appropriated herein shall be available to investigate or act upon applications for relief from Federal firearms disabilities under section 925(c) of title 18, United States Code: Provided further, That such funds shall be available to investigate and act upon applications filed by corporations for relief from Federal firearms disabilities under section 925(c) of title 18, United States Code: Provided further, That no funds made available by this or any other Act may be used to transfer the functions, missions, or activities of the Bureau of Alcohol, Tobacco, Firearms and Explosives to other agencies or Departments.

Federal Prison System

salaries and expenses

(including transfer of funds)

For necessary expenses of the Federal Prison System for the administration, operation, and maintenance of Federal penal and correctional institutions, and for the provision of technical assistance and advice on corrections related issues to foreign governments, $7,008,800,000: Provided, That the Attorney General may transfer to the Department of Health and Human Services such amounts as may be necessary for direct expenditures by that Department for medical relief for inmates of Federal penal and correctional institutions: Provided further, That the Director of the Federal Prison System, where necessary, may enter into contracts with a fiscal agent or fiscal intermediary claims processor to determine the amounts payable to persons who, on behalf of the Federal Prison System, furnish health services to individuals committed to the custody of the Federal Prison System: Provided further, That not to exceed $5,400 shall be available for official reception and representation expenses: Provided further, That not to exceed $50,000,000 shall remain available for necessary operations until September 30, 2018: Provided further, That, of the amounts provided for contract confinement, not to exceed $20,000,000 shall remain available until expended to make payments in advance for grants, contracts and reimbursable agreements, and other expenses: Provided further, That the Director of the Federal Prison System may accept donated property and services relating to the operation of the prison card program from a not-for-profit entity which has operated such program in the past, notwithstanding the fact that such not-for-profit entity furnishes services under contracts to the Federal Prison System relating to the operation of pre-release services, halfway houses, or other custodial facilities.

buildings and facilities

For planning, acquisition of sites and construction of new facilities; purchase and acquisition of facilities and remodeling, and equipping of such facilities for penal and correctional use, including all necessary expenses incident thereto, by contract or force account; and constructing, remodeling, and equipping necessary buildings and facilities at existing penal and correctional institutions, including all necessary expenses incident thereto, by contract or force account, $130,000,000, to remain available until expended, of which $50,000,000 shall be available only for costs related to construction of new facilities: Provided, That labor of United States prisoners may be used for work performed under this appropriation.

federal prison industries, incorporated

The Federal Prison Industries, Incorporated, is hereby authorized to make such expenditures within the limits of funds and borrowing authority available, and in accord with the law, and to make such contracts and commitments without regard to fiscal year limitations as provided by section 9104 of title 31, United States Code, as may be necessary in carrying out the program set forth in the budget for the current fiscal year for such corporation.

limitation on administrative expenses, federal prison industries, incorporated

Not to exceed $2,700,000 of the funds of the Federal Prison Industries, Incorporated, shall be available for its administrative expenses, and for services as authorized by section 3109 of title 5, United States Code, to be computed on an accrual basis to be determined in accordance with the corporation's current prescribed accounting system, and such amounts shall be exclusive of depreciation, payment of claims, and expenditures which such accounting system requires to be capitalized or charged to cost of commodities acquired or produced, including selling and shipping expenses, and expenses in connection with acquisition, construction, operation, maintenance, improvement, protection, or disposition of facilities and other property belonging to the corporation or in which it has an interest.

State And Local Law Enforcement Activities

Office On Violence Against Women

violence against women prevention and prosecution programs

(including transfer of funds)

For grants, contracts, cooperative agreements, and other assistance for the prevention and prosecution of violence against women, as authorized by the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3711 et seq.) (“the 1968 Act”); the Violent Crime Control and Law Enforcement Act of 1994 (Public Law 103–322) (“the 1994 Act”); the Victims of Child Abuse Act of 1990 (Public Law 101–647) (“the 1990 Act”); the Prosecutorial Remedies and Other Tools to end the Exploitation of Children Today Act of 2003 (Public Law 108–21); the Juvenile Justice and Delinquency Prevention Act of 1974 (42 U.S.C. 5601 et seq.) (“the 1974 Act”); the Victims of Trafficking and Violence Protection Act of 2000 (Public Law 106–386) (“the 2000 Act”); the Violence Against Women and Department of Justice Reauthorization Act of 2005 (Public Law 109–162) (“the 2005 Act”); the Violence Against Women Reauthorization Act of 2013 (Public Law 113–4) (“the 2013 Act”); and the Rape Survivor Child Custody Act of 2015 (Public Law 114–22) (“the 2015 Act”); and for related victims services, $481,500,000, to remain available until expended, of which $326,000,000 shall be derived by transfer from amounts available for obligation in this Act from the Fund established by section 1402 of chapter XIV of title II of Public Law 98–473 (42 U.S.C. 10601), notwithstanding section 1402(d) of such Act of 1984, and merged with the amounts otherwise made available under this heading: Provided, That except as otherwise provided by law, not to exceed 5 percent of funds made available under this heading may be used for expenses related to evaluation, training, and technical assistance: Provided further, That of the amount provided—

(1) $215,000,000 is for grants to combat violence against women, as authorized by part T of the 1968 Act;

(2) $30,000,000 is for transitional housing assistance grants for victims of domestic violence, dating violence, stalking, or sexual assault as authorized by section 40299 of the 1994 Act;

(3) $3,000,000 is for the National Institute of Justice for research and evaluation of violence against women and related issues addressed by grant programs of the Office on Violence Against Women, which shall be transferred to “Research, Evaluation and Statistics” for administration by the Office of Justice Programs;

(4) $11,000,000 is for a grant program to provide services to advocate for and respond to youth victims of domestic violence, dating violence, sexual assault, and stalking; assistance to children and youth exposed to such violence; programs to engage men and youth in preventing such violence; and assistance to middle and high school students through education and other services related to such violence: Provided, That unobligated balances available for the programs authorized by sections 41201, 41204, 41303, and 41305 of the 1994 Act, prior to its amendment by the 2013 Act, shall be available for this program: Provided further, That 10 percent of the total amount available for this grant program shall be available for grants under the program authorized by section 2015 of the 1968 Act: Provided further, That the definitions and grant conditions in section 40002 of the 1994 Act shall apply to this program;

(5) $53,000,000 is for grants to encourage arrest policies as authorized by part U of the 1968 Act, of which $4,000,000 is for a homicide reduction initiative;

(6) $35,000,000 is for sexual assault victims assistance, as authorized by section 41601 of the 1994 Act;

(7) $35,000,000 is for rural domestic violence and child abuse enforcement assistance grants, as authorized by section 40295 of the 1994 Act;

(8) $20,000,000 is for grants to reduce violent crimes against women on campus, as authorized by section 304 of the 2005 Act;

(9) $45,000,000 is for legal assistance for victims, as authorized by section 1201 of the 2000 Act;

(10) $5,000,000 is for enhanced training and services to end violence against and abuse of women in later life, as authorized by section 40802 of the 1994 Act;

(11) $16,000,000 is for grants to support families in the justice system, as authorized by section 1301 of the 2000 Act: Provided, That unobligated balances available for the programs authorized by section 1301 of the 2000 Act and section 41002 of the 1994 Act, prior to their amendment by the 2013 Act, shall be available for this program;

(12) $6,000,000 is for education and training to end violence against and abuse of women with disabilities, as authorized by section 1402 of the 2000 Act;

(13) $500,000 is for the National Resource Center on Workplace Responses to assist victims of domestic violence, as authorized by section 41501 of the 1994 Act;

(14) $1,000,000 is for analysis and research on violence against Indian women, including as authorized by section 904 of the 2005 Act: Provided, That such funds may be transferred to “Research, Evaluation and Statistics” for administration by the Office of Justice Programs;

(15) $500,000 is for a national clearinghouse that provides training and technical assistance on issues relating to sexual assault of American Indian and Alaska Native women;

(16) $4,000,000 is for grants to assist tribal governments in exercising special domestic violence criminal jurisdiction, as authorized by section 904 of the 2013 Act: Provided, That the grant conditions in section 40002(b) of the 1994 Act shall apply to this program; and

(17) $1,500,000 for the purposes authorized under the 2015 Act.

Office Of Justice Programs

research, evaluation and statistics

(including transfer of funds)

For grants, contracts, cooperative agreements, and other assistance authorized by title I of the Omnibus Crime Control and Safe Streets Act of 1968 (“the 1968 Act”); the Juvenile Justice and Delinquency Prevention Act of 1974 (“the 1974 Act”); the Missing Children's Assistance Act (42 U.S.C. 5771 et seq.); the Prosecutorial Remedies and Other Tools to end the Exploitation of Children Today Act of 2003 (Public Law 108–21); the Justice for All Act of 2004 (Public Law 108–405); the Violence Against Women and Department of Justice Reauthorization Act of 2005 (Public Law 109–162) (“the 2005 Act”); the Victims of Child Abuse Act of 1990 (Public Law 101–647); the Second Chance Act of 2007 (Public Law 110–199); the Victims of Crime Act of 1984 (Public Law 98–473); the Adam Walsh Child Protection and Safety Act of 2006 (Public Law 109–248) (“the Adam Walsh Act”); the PROTECT Our Children Act of 2008 (Public Law 110–401); subtitle D of title II of the Homeland Security Act of 2002 (Public Law 107–296) (“the 2002 Act”); the NICS Improvement Amendments Act of 2007 (Public Law 110–180); the Violence Against Women Reauthorization Act of 2013 (Public Law 113–4) (“the 2013 Act”); and other programs, $89,000,000, to remain available until expended, of which—

(1) $45,500,000 is for criminal justice statistics programs, and other activities, as authorized by part C of title I of the 1968 Act, of which $5,000,000 is for a nationwide incident-based crime statistics program;

(2) $39,500,000 is for research, development, and evaluation programs, and other activities as authorized by part B of title I of the 1968 Act and subtitle D of title II of the 2002 Act, of which $4,000,000 is for research targeted toward developing a better understanding of the domestic radicalization phenomenon, and advancing evidence-based strategies for effective intervention and prevention; and

(3) $4,000,000 is for activities to strengthen and enhance the practice of forensic sciences, of which $3,000,000 is for transfer to the National Institute of Standards and Technology to support Scientific Area Committees.

state and local law enforcement assistance

(including transfer of funds)

For grants, contracts, cooperative agreements, and other assistance authorized by the Violent Crime Control and Law Enforcement Act of 1994 (Public Law 103–322) (“the 1994 Act”); the Omnibus Crime Control and Safe Streets Act of 1968 (“the 1968 Act”); the Justice for All Act of 2004 (Public Law 108–405); the Victims of Child Abuse Act of 1990 (Public Law 101–647) (“the 1990 Act”); the Trafficking Victims Protection Reauthorization Act of 2005 (Public Law 109–164); the Violence Against Women and Department of Justice Reauthorization Act of 2005 (Public Law 109–162) (“the 2005 Act”); the Adam Walsh Child Protection and Safety Act of 2006 (Public Law 109–248) (“the Adam Walsh Act”); the Victims of Trafficking and Violence Protection Act of 2000 (Public Law 106–386); the NICS Improvement Amendments Act of 2007 (Public Law 110–180); subtitle D of title II of the Homeland Security Act of 2002 (Public Law 107–296) (“the 2002 Act”); the Second Chance Act of 2007 (Public Law 110–199); the Prioritizing Resources and Organization for Intellectual Property Act of 2008 (Public Law 110–403); the Victims of Crime Act of 1984 (Public Law 98–473); the Mentally Ill Offender Treatment and Crime Reduction Reauthorization and Improvement Act of 2008 (Public Law 110–416); the Violence Against Women Reauthorization Act of 2013 (Public Law 113–4) (“the 2013 Act”); the Comprehensive Addiction and Recovery Act of 2016 (Public Law 114–198) (“CARA”); and other programs, $1,258,500,000, to remain available until expended as follows—

(1) $396,000,000 for the Edward Byrne Memorial Justice Assistance Grant program as authorized by subpart 1 of part E of title I of the 1968 Act (except that section 1001(c), and the special rules for Puerto Rico under section 505(g) of title I of the 1968 Act shall not apply for purposes of this Act), of which, notwithstanding such subpart 1, $7,500,000 is for the Officer Robert Wilson III Memorial Initiative on Preventing Violence Against Law Enforcement Officer Resilience and Survivability (VALOR), $5,000,000 is for an initiative to support evidence-based policing, $2,500,000 is for an initiative to enhance prosecutorial decision-making, $2,400,000 is for the operationalization, maintenance and expansion of the National Missing and Unidentified Persons System, $2,500,000 is for a national training initiative to improve police-based responses to people with mental illness or developmental disabilities, $6,500,000 is for competitive and evidence-based programs to reduce gun crime and gang violence, $2,000,000 is for a student loan repayment assistance program pursuant to section 952 of Public Law 110–315, $2,500,000 is for the Capital Litigation Improvement Grant Program, as authorized by section 426 of Public Law 108–405, and for grants for wrongful conviction review, $10,500,000 is for prison rape prevention and prosecution grants to States and units of local government, and other programs, as authorized by the Prison Rape Elimination Act of 2003 (Public Law 108–79), and $20,000,000 is for the sole purpose of providing reimbursement of extraordinary law enforcement and related costs directly associated with protection of the President-elect incurred from November 9, 2016 until the inauguration of the President-elect as President: Provided, That reimbursement under the foregoing shall be provided only for costs that a State or local agency can document as being over and above normal law enforcement operations and directly attributable to the provision of protection described herein: Provided further, That section 154 of the Continuing Appropriations Act, 2017 (division C of Public Law 114–223), as amended by the Further Continuing and Security Assistance Appropriations Act, 2017 (Public Law 114–254), is amended by inserting after “$7,000,000” the following: “, to remain available until September 30, 2017,”;

(2) $210,000,000 for the State Criminal Alien Assistance Program, as authorized by section 241(i)(5) of the Immigration and Nationality Act (8 U.S.C. 1231(i)(5)): Provided, That no jurisdiction shall request compensation for any cost greater than the actual cost for Federal immigration and other detainees housed in State and local detention facilities;

(3) $45,000,000 for victim services programs for victims of trafficking, as authorized by section 107(b)(2) of Public Law 106–386, for programs authorized under Public Law 109–164, or programs authorized under Public Law 113–4;

(4) $13,000,000 for economic, high technology, white collar and Internet crime prevention grants, including as authorized by section 401 of Public Law 110–403;

(5) $20,000,000 for sex offender management assistance, as authorized by the Adam Walsh Act, and related activities;

(6) $22,500,000 for the matching grant program for law enforcement armor vests, as authorized by section 2501 of title I of the 1968 Act: Provided, That $1,500,000 is transferred directly to the National Institute of Standards and Technology’s Office of Law Enforcement Standards for research, testing and evaluation programs;

(7) $1,000,000 for the National Sex Offender Public Website;

(8) $73,000,000 for grants to States to upgrade criminal and mental health records for the National Instant Criminal Background Check System, of which no less than $25,000,000 shall be for grants made under the authorities of the NICS Improvement Amendments Act of 2007 (Public Law 110–180);

(9) $13,000,000 for Paul Coverdell Forensic Sciences Improvement Grants under part BB of title I of the 1968 Act;

(10) $125,000,000 for DNA-related and forensic programs and activities, of which—

(A) $117,000,000 is for a DNA analysis and capacity enhancement program and for other local, State, and Federal forensic activities, including the purposes authorized under section 2 of the DNA Analysis Backlog Elimination Act of 2000 (Public Law 106–546) (the Debbie Smith DNA Backlog Grant Program): Provided, That up to 4 percent of funds made available under this paragraph may be used for the purposes described in the DNA Training and Education for Law Enforcement, Correctional Personnel, and Court Officers program (Public Law 108–405, section 303);

(B) $4,000,000 is for the purposes described in the Kirk Bloodsworth Post-Conviction DNA Testing Grant Program (Public Law 108–405, section 412); and

(C) $4,000,000 is for Sexual Assault Forensic Exam Program grants, including as authorized by section 304 of Public Law 108–405;

(11) $45,000,000 for a grant program for community-based sexual assault response reform;

(12) $9,000,000 for the court-appointed special advocate program, as authorized by section 217 of the 1990 Act;

(13) $68,000,000 for offender reentry programs and research, as authorized by the Second Chance Act of 2007 (Public Law 110–199), without regard to the time limitations specified at section 6(1) of such Act, of which not to exceed $6,000,000 is for a program to improve State, local, and tribal probation or parole supervision efforts and strategies, $5,000,000 is for Children of Incarcerated Parents Demonstrations to enhance and maintain parental and family relationships for incarcerated parents as a reentry or recidivism reduction strategy, and $4,000,000 is for additional replication sites employing the Project HOPE Opportunity Probation with Enforcement model implementing swift and certain sanctions in probation, and for a research project on the effectiveness of the model: Provided, That up to $7,500,000 of funds made available in this paragraph may be used for performance-based awards for Pay for Success projects, of which up to $5,000,000 shall be for Pay for Success programs implementing the Permanent Supportive Housing Model;

(14) $50,000,000 for the Comprehensive School Safety Initiative;

(15) $65,000,000 for initiatives to improve police-community relations, of which $22,500,000 is for a competitive matching grant program for purchases of body-worn cameras for State, local and tribal law enforcement, $25,000,000 is for a justice reinvestment initiative, for activities related to criminal justice reform and recidivism reduction, and $17,500,000 is for an Edward Byrne Memorial criminal justice innovation program; and

(16) $103,000,000 for comprehensive opioid abuse reduction activities, including as authorized by CARA, and for the following programs, which shall address opioid abuse reduction consistent with underlying program authorities—

(A) $43,000,000 for Drug Courts, as authorized by section 1001(a)(25)(A) of title I of the 1968 Act;

(B) $12,000,000 for mental health courts and adult and juvenile collaboration program grants, as authorized by parts V and HH of title I of the 1968 Act, and the Mentally Ill Offender Treatment and Crime Reduction Reauthorization and Improvement Act of 2008 (Public Law 110–416);

(C) $14,000,000 for grants for Residential Substance Abuse Treatment for State Prisoners, as authorized by part S of title I of the 1968 Act;

(D) $7,000,000 for a veterans treatment courts program; and

(E) $14,000,000 for a program to monitor prescription drugs and scheduled listed chemical products:

Provided, That, if a unit of local government uses any of the funds made available under this heading to increase the number of law enforcement officers, the unit of local government will achieve a net gain in the number of law enforcement officers who perform non-administrative public sector safety service.

juvenile justice programs

For grants, contracts, cooperative agreements, and other assistance authorized by the Juvenile Justice and Delinquency Prevention Act of 1974 (“the 1974 Act”); the Omnibus Crime Control and Safe Streets Act of 1968 (“the 1968 Act”); the Violence Against Women and Department of Justice Reauthorization Act of 2005 (Public Law 109–162) (“the 2005 Act”); the Missing Children's Assistance Act (42 U.S.C. 5771 et seq.); the Prosecutorial Remedies and Other Tools to end the Exploitation of Children Today Act of 2003 (Public Law 108–21); the Victims of Child Abuse Act of 1990 (Public Law 101–647) (“the 1990 Act”); the Adam Walsh Child Protection and Safety Act of 2006 (Public Law 109–248) (“the Adam Walsh Act”); the PROTECT Our Children Act of 2008 (Public Law 110–401); the Violence Against Women Reauthorization Act of 2013 (Public Law 113–4) (“the 2013 Act”); and other juvenile justice programs, $247,000,000, to remain available until expended as follows—

(1) $55,000,000 for programs authorized by section 221 of the 1974 Act, and for training and technical assistance to assist small, nonprofit organizations with the Federal grants process: Provided, That of the amounts provided under this paragraph, $500,000 shall be for a competitive demonstration grant program to support emergency planning among State, local and tribal juvenile justice residential facilities;

(2) $80,000,000 for youth mentoring grants;

(3) $14,500,000 for delinquency prevention, as authorized by section 505 of the 1974 Act, of which, pursuant to sections 261 and 262 thereof—

(A) $4,000,000 shall be for gang and youth violence education, prevention and intervention, and related activities;

(B) $500,000 shall be for an Internet site providing information and resources on children of incarcerated parents;

(C) $2,000,000 shall be for competitive grants focusing on girls in the juvenile justice system; and

(D) $8,000,000 shall be for community-based violence prevention initiatives, including for public health approaches to reducing shootings and violence;

(4) $21,000,000 for programs authorized by the Victims of Child Abuse Act of 1990;

(5) $72,500,000 for missing and exploited children programs, including as authorized by sections 404(b) and 405(a) of the 1974 Act (except that section 102(b)(4)(B) of the PROTECT Our Children Act of 2008 (Public Law 110–401) shall not apply for purposes of this Act);

(6) $2,000,000 for child abuse training programs for judicial personnel and practitioners, as authorized by section 222 of the 1990 Act; and

(7) $2,000,000 for a program to improve juvenile indigent defense:

Provided, That not more than 10 percent of each amount may be used for research, evaluation, and statistics activities designed to benefit the programs or activities authorized: Provided further, That not more than 2 percent of the amounts designated under paragraphs (1) through (4) and (6) may be used for training and technical assistance: Provided further, That the two preceding provisos shall not apply to grants and projects administered pursuant to sections 261 and 262 of the 1974 Act and to missing and exploited children programs.

public safety officer benefits

(including transfer of funds)

For payments and expenses authorized under section 1001(a)(4) of title I of the Omnibus Crime Control and Safe Streets Act of 1968, such sums as are necessary (including amounts for administrative costs), to remain available until expended; and $16,300,000 for payments authorized by section 1201(b) of such Act and for educational assistance authorized by section 1218 of such Act, to remain available until expended: Provided, That notwithstanding section 205 of this Act, upon a determination by the Attorney General that emergent circumstances require additional funding for such disability and education payments, the Attorney General may transfer such amounts to “Public Safety Officer Benefits” from available appropriations for the Department of Justice as may be necessary to respond to such circumstances: Provided further, That any transfer pursuant to the preceding proviso shall be treated as a reprogramming under section 505 of this Act and shall not be available for obligation or expenditure except in compliance with the procedures set forth in that section.

Community Oriented Policing Services

community oriented policing services programs

(including transfer of funds)

For activities authorized by the Violent Crime Control and Law Enforcement Act of 1994 (Public Law 103–322); the Omnibus Crime Control and Safe Streets Act of 1968 (“the 1968 Act”); and the Violence Against Women and Department of Justice Reauthorization Act of 2005 (Public Law 109–162) (“the 2005 Act”), $221,500,000, to remain available until expended: Provided, That any balances made available through prior year deobligations shall only be available in accordance with section 505 of this Act: Provided further, That of the amount provided under this heading—

(1) $10,000,000 is for anti-methamphetamine-related activities, which shall be transferred to the Drug Enforcement Administration upon enactment of this Act;

(2) $194,500,000 is for grants under section 1701 of title I of the 1968 Act (42 U.S.C. 3796dd) for the hiring and rehiring of additional career law enforcement officers under part Q of such title notwithstanding subsection (i) of such section: Provided, That, notwithstanding section 1704(c) of such title (42 U.S.C. 3796dd–3(c)), funding for hiring or rehiring a career law enforcement officer may not exceed $125,000 unless the Director of the Office of Community Oriented Policing Services grants a waiver from this limitation: Provided further, That of the amounts appropriated under this paragraph, $5,000,000 is for community policing development activities in furtherance of the purposes in section 1701: Provided further, That within the amounts appropriated under this paragraph, $10,000,000 is for the collaborative reform model of technical assistance in furtherance of the purposes in section 1701: Provided further, That of the amounts appropriated under this paragraph $35,000,000 is for regional information sharing activities, as authorized by part M of title I of the 1968 Act, which shall be transferred to and merged with “Research, Evaluation, and Statistics” for administration by the Office of Justice Programs: Provided further, That of the amounts appropriated under this paragraph, $7,500,000 is for activities authorized by the POLICE Act of 2016 (Public Law 114–199);

(3) $7,000,000 is for competitive grants to State law enforcement agencies in States with high seizures of precursor chemicals, finished methamphetamine, laboratories, and laboratory dump seizures: Provided, That funds appropriated under this paragraph shall be utilized for investigative purposes to locate or investigate illicit activities, including precursor diversion, laboratories, or methamphetamine traffickers; and

(4) $10,000,000 is for competitive grants to statewide law enforcement agencies in States with high rates of primary treatment admissions for heroin and other opioids: Provided, That these funds shall be utilized for investigative purposes to locate or investigate illicit activities, including activities related to the distribution of heroin or unlawful distribution of prescription opioids, or unlawful heroin and prescription opioid traffickers through statewide collaboration.

General Provisions—Department Of Justice

(including transfer of funds)

SEC. 201.

In addition to amounts otherwise made available in this title for official reception and representation expenses, a total of not to exceed $50,000 from funds appropriated to the Department of Justice in this title shall be available to the Attorney General for official reception and representation expenses.

SEC. 202.

None of the funds appropriated by this title shall be available to pay for an abortion, except where the life of the mother would be endangered if the fetus were carried to term, or in the case of rape or incest: Provided, That should this prohibition be declared unconstitutional by a court of competent jurisdiction, this section shall be null and void.

SEC. 203.

None of the funds appropriated under this title shall be used to require any person to perform, or facilitate in any way the performance of, any abortion.

SEC. 204.

Nothing in the preceding section shall remove the obligation of the Director of the Bureau of Prisons to provide escort services necessary for a female inmate to receive such service outside the Federal facility: Provided, That nothing in this section in any way diminishes the effect of section 203 intended to address the philosophical beliefs of individual employees of the Bureau of Prisons.

SEC. 205.

Not to exceed 5 percent of any appropriation made available for the current fiscal year for the Department of Justice in this Act may be transferred between such appropriations, but no such appropriation, except as otherwise specifically provided, shall be increased by more than 10 percent by any such transfers: Provided, That any transfer pursuant to this section shall be treated as a reprogramming of funds under section 505 of this Act and shall not be available for obligation except in compliance with the procedures set forth in that section.

SEC. 206.

None of the funds made available under this title may be used by the Federal Bureau of Prisons or the United States Marshals Service for the purpose of transporting an individual who is a prisoner pursuant to conviction for crime under State or Federal law and is classified as a maximum or high security prisoner, other than to a prison or other facility certified by the Federal Bureau of Prisons as appropriately secure for housing such a prisoner.

SEC. 207.

(a) None of the funds appropriated by this Act may be used by Federal prisons to purchase cable television services, or to rent or purchase audiovisual or electronic media or equipment used primarily for recreational purposes.

(b) Subsection (a) does not preclude the rental, maintenance, or purchase of audiovisual or electronic media or equipment for inmate training, religious, or educational programs.

SEC. 208.

None of the funds made available under this title shall be obligated or expended for any new or enhanced information technology program having total estimated development costs in excess of $100,000,000, unless the Deputy Attorney General and the investment review board certify to the Committees on Appropriations of the House of Representatives and the Senate that the information technology program has appropriate program management controls and contractor oversight mechanisms in place, and that the program is compatible with the enterprise architecture of the Department of Justice.

SEC. 209.

The notification thresholds and procedures set forth in section 505 of this Act shall apply to deviations from the amounts designated for specific activities in this Act and in the explanatory statement described in section 4 (in the matter preceding division A of this consolidated Act), and to any use of deobligated balances of funds provided under this title in previous years.

SEC. 210.

None of the funds appropriated by this Act may be used to plan for, begin, continue, finish, process, or approve a public-private competition under the Office of Management and Budget Circular A–76 or any successor administrative regulation, directive, or policy for work performed by employees of the Bureau of Prisons or of Federal Prison Industries, Incorporated.

SEC. 211.

Notwithstanding any other provision of law, no funds shall be available for the salary, benefits, or expenses of any United States Attorney assigned dual or additional responsibilities by the Attorney General or his designee that exempt that United States Attorney from the residency requirements of section 545 of title 28, United States Code.

SEC. 212.

At the discretion of the Attorney General, and in addition to any amounts that otherwise may be available (or authorized to be made available) by law, with respect to funds appropriated by this title under the headings “Research, Evaluation and Statistics”, “State and Local Law Enforcement Assistance”, and “Juvenile Justice Programs”—

(1) up to 3 percent of funds made available to the Office of Justice Programs for grant or reimbursement programs may be used by such Office to provide training and technical assistance; and

(2) up to 2 percent of funds made available for grant or reimbursement programs under such headings, except for amounts appropriated specifically for research, evaluation, or statistical programs administered by the National Institute of Justice and the Bureau of Justice Statistics, shall be transferred to and merged with funds provided to the National Institute of Justice and the Bureau of Justice Statistics, to be used by them for research, evaluation, or statistical purposes, without regard to the authorizations for such grant or reimbursement programs.

SEC. 213.

At the discretion of the Attorney General, and in addition to any amounts that otherwise may be available (or authorized to be made available) by law, up to 7 percent of funds made available for grant or reimbursement programs—

(1) under the heading “State and Local Law Enforcement Assistance” (except for funds made available under paragraphs (1), (2), and (16) under such heading); and

(2) under the headings “Juvenile Justice Programs” (except for funds made available under paragraph (5) under such heading) and “Community Oriented Policing Services Programs”, to be transferred to and merged with funds made available under the heading “State and Local Law Enforcement Assistance”,

shall be available for tribal criminal justice assistance without regard to the authorizations for such grant or reimbursement programs.

SEC. 214.

Upon request by a grantee for whom the Attorney General has determined there is a fiscal hardship, the Attorney General may, with respect to funds appropriated in this or any other Act making appropriations for fiscal years 2014 through 2017 for the following programs, waive the following requirements:

(1) For the adult and juvenile offender State and local reentry demonstration projects under part FF of title I of the Omnibus Crime Control and Safe Streets Act of 1968 (42 U.S.C. 3797w(g)(1)), the requirements under section 2976(g)(1) of such part.

(2) For State, Tribal, and local reentry courts under part FF of title I of such Act of 1968 (42 U.S.C. 3797w–2(e)(1) and (2)), the requirements under section 2978(e)(1) and (2) of such part.

(3) For the prosecution drug treatment alternatives to prison program under part CC of title I of such Act of 1968 (42 U.S.C. 3797q–3), the requirements under section 2904 of such part.

(4) For grants to protect inmates and safeguard communities as authorized by section 6 of the Prison Rape Elimination Act of 2003 (42 U.S.C. 15605(c)(3)), the requirements of section 6(c)(3) of such Act.

SEC. 215.

Notwithstanding any other provision of law, section 20109(a) of subtitle A of title II of the Violent Crime Control and Law Enforcemen