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White House Legislation - Signed

S.J.Res. 49 - Joint Resolution condemning the violence and domestic terrorist attack that took place during events between August 11 and August 12, 2017, in Charlottesville, Virginia, recognizing the first responders who lost their lives...

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

Condemning the violence and domestic terrorist attack that took place during events between August 11 and August 12, 2017, in Charlottesville, Virginia, recognizing the first responders who lost their lives while monitoring the events, offering deepest condolences to the families and friends of those individuals who were killed and deepest sympathies and support to those individuals who were injured by the violence, expressing support for the Charlottesville community, rejecting White nationalists, White supremacists, the Ku Klux Klan, neo-Nazis, and other hate groups, and urging the President and the President’s Cabinet to use all available resources to address the threats posed by those groups.

Whereas, on the night of Friday, August 11, 2017, a day before a White nationalist demonstration was scheduled to occur in Charlottesville, Virginia, hundreds of torch-bearing White nationalists, White supremacists, Klansmen, and neo-Nazis chanted racist, anti-Semitic, and anti-immigrant slogans and violently engaged with counter-demonstrators on and around the grounds of the University of Virginia in Charlottesville;

Whereas, on Saturday, August 12, 2017, ahead of the scheduled start time of the planned march, protestors and counter-demonstrators gathered at Emancipation Park in Charlottesville;

Whereas the extremist demonstration turned violent, culminating in the death of peaceful counter-demonstrator Heather Heyer and injuries to 19 other individuals after a neo-Nazi sympathizer allegedly drove a vehicle into a crowd, an act that resulted in a charge of second degree murder, 3 counts of malicious wounding, and 1 count of hit and run;

Whereas 2 Virginia State Police officers, Lieutenant H. Jay Cullen and Trooper Pilot Berke M.M. Bates, died in a helicopter crash as they patrolled the events occurring below them;

Whereas the Charlottesville community is engaged in a healing process following this horrific and violent display of bigotry; and

Whereas White nationalists, White supremacists, the Ku Klux Klan, neo-Nazis, and other hate groups reportedly are organizing similar events in other cities in the United States and communities everywhere are concerned about the growing and open display of hate and violence being perpetrated by those groups: Now, therefore, be it

Resolved by the Senate and House of Representatives of the United States of America in Congress assembled, That Congress—

(1) condemns the racist violence and domestic terrorist attack that took place between August 11 and August 12, 2017, in Charlottesville, Virginia;

(2) recognizes—

(A) Heather Heyer, who was killed, and 19 other individuals who were injured in the reported domestic terrorist attack; and

(B) several other individuals who were injured in separate attacks while standing up to hate and intolerance;

(3) recognizes the public service and heroism of Virginia State Police officers Lieutenant H. Jay Cullen and Trooper Pilot Berke M.M. Bates, who lost their lives while responding to the events from the air;

(4) offers—

(A) condolences to the families and friends of Heather Heyer, Lieutenant H. Jay Cullen, and Trooper Pilot Berke M.M. Bates; and

(B) sympathy and support to those individuals who are recovering from injuries sustained during the attacks;

(5) expresses support for the Charlottesville community as the community heals following this demonstration of violent bigotry;

(6) rejects White nationalism, White supremacy, and neo-Nazism as hateful expressions of intolerance that are contradictory to the values that define the people of the United States; and

(7) urges—

(A) the President and his administration to—

(i) speak out against hate groups that espouse racism, extremism, xenophobia, anti-Semitism, and White supremacy; and

(ii) use all resources available to the President and the President’s Cabinet to address the growing prevalence of those hate groups in the United States; and

(B) the Attorney General to work with—

(i) the Secretary of Homeland Security to investigate thoroughly all acts of violence, intimidation, and domestic terrorism by White supremacists, White nationalists, neo-Nazis, the Ku Klux Klan, and associated groups in order to determine if any criminal laws have been violated and to prevent those groups from fomenting and facilitating additional violence; and

(ii) the heads of other Federal agencies to improve the reporting of hate crimes and to emphasize the importance of the collection, and the reporting to the Federal Bureau of Investigation, of hate crime data by State and local agencies.


 

Speaker of the House of Representatives  


Vice President of the United States and President of the Senate  

S. 1616 - Bob Dole Congressional Gold Medal 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 award the Congressional Gold Medal to Bob Dole, in recognition for his service to the nation as a soldier, legislator, and statesman.

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 “Bob Dole Congressional Gold Medal Act”.

SEC. 2. FINDINGS.

Congress finds the following:

(1) Bob Dole was born on July 22, 1923, in Russell, Kansas.

(2) Growing up during the Great Depression, Bob Dole learned the values of hard work and discipline, and worked at a local drug store.

(3) In 1941, Bob Dole enrolled at the University of Kansas as a pre-medical student. During his time at KU he played for the basketball, football, and track teams, and joined the Kappa Sigma Fraternity, from which he would receive the “Man of the Year” award in 1970.

(4) Bob Dole’s collegiate studies were interrupted by WWII, and he enlisted in the United States Army. During a military offensive in Italy, he was seriously wounded while trying to save a fellow soldier. Despite his grave injuries, Dole recovered and was awarded two Purple Hearts and a Bronze Star with an Oak Cluster for his service. He also received an American Campaign Medal, a European-African-Middle Eastern Campaign Medal, and a World War II Victory Medal.

(5) While working on his law degree from Washburn University, Bob Dole was elected into the Kansas House of Representatives, serving from 1951–1953.

(6) Bob Dole was elected into the U.S. House of Representatives and served two Kansas districts from 1961–1969.

(7) In 1969, Bob Dole was elected into the U.S. Senate and served until 1996. Over the course of this period, he served as Chairman of the Republican National Committee, Chairman of the Finance Committee, Senate Minority Leader, and Senate Majority Leader.

(8) Bob Dole was known for his ability to work across the aisle and embrace practical bipartisanship on issues such as Social Security.

(9) Bob Dole has been a life-long advocate for the disabled and was a key figure in the passing of the Americans with Disabilities Act in 1990.

(10) After his appointment as Majority Leader, Bob Dole set the record as the nation’s longest-serving Republican Leader in the Senate.

(11) Several Presidents of the United States have specially honored Bob Dole for his hard work and leadership in the public sector. This recognition is exemplified by the following:

(A) President Reagan awarded Bob Dole the Presidential Citizens Medal in 1989 stating, “Whether on the battlefield or Capitol Hill, Senator Dole has served America heroically. Senate Majority Leader during one of the most productive Congresses of recent time, he has also been a friend to veterans, farmers, and Americans from every walk of life. Bob Dole has stood for integrity, straight talk and achievement throughout his years of distinguished public service.”.

(B) Upon awarding Bob Dole with the Presidential Medal of Freedom in 1997, President Clinton made the following comments, “Son of the soil, citizen, soldier and legislator, Bob Dole understands the American people, their struggles, their triumphs and their dreams … In times of conflict and crisis, he has worked to keep America united and strong … our country is better for his courage, his determination, and his willingness to go the long course to lead America.”.

(12) After his career in public office, Bob Dole became an active advocate for the public good. He served as National Chairman of the World War II Memorial Campaign, helping raise over $197 million to construct the National WWII Memorial, and as Co-Chair of the Families of Freedom Scholarship Fund, raising over $120 million for the educational needs of the families of victims of 9/11.

(13) From 1997–2001, Bob Dole served as chairman of the International Commission on Missing Persons in the Former Yugoslavia.

(14) In 2003, Bob Dole established The Robert J. Dole Institute of Politics at the University of Kansas to encourage bipartisanship in politics.

(15) Bob Dole is a strong proponent of international justice and, in 2004, received the Golden Medal of Freedom from the President of Kosovo for his support of democracy and freedom in Kosovo.

(16) In 2007, President George W. Bush appointed Bob Dole to co-chair the President's Commission on Care for America's Returning Wounded Warriors, which inspected the system of medical care received by U.S. soldiers returning from Iraq and Afghanistan.

(17) Bob Dole was the co-creator of the McGovern-Dole International Food for Education and Child Nutrition Program, helping combat child hunger and poverty. In 2008, he was co-awarded the World Food Prize for his work with this organization.

(18) Bob Dole is co-founder of the Bipartisan Policy Center which works to develop policies suitable for bipartisan support.

(19) Bob Dole is a strong advocate for veterans, having volunteered on a weekly basis for more than a decade on behalf of the Honor Flight Network.

(20) Bob Dole serves as Finance Chairman of the Campaign for the National Eisenhower Memorial, leading the private fundraising effort to memorialize President Dwight D. Eisenhower in Washington, DC.

(21) Bob Dole was acknowledged by many organizations for his achievements both inside and outside of politics, including being awarded the “U.S. Senator John Heinz Award for Outstanding Public Service By An Elected Official”, the Gold Good Citizenship Award, the American Patriot Award, the Survivor's Gratitude Award, the U.S. Association of Former Member of Congress Distinguished Service Award, a Distinguished Service Medal, the French Legion of Honor medal, the Horatio Alger Award, the U.S. Defense Department’s Distinguished Public Service Award, the National Collegiate Athletic Association’s Teddy Roosevelt Award, the Albert Schweitzer Medal “for outstanding contributions to animal welfare”, the 2004 Sylvanus Thayer Award, and honorary degrees from the University of Kansas, Fort Hays State University, and the University of New Hampshire School of Law.

(22) Throughout his life-long service to our country, Bob Dole has embodied the American spirit of leadership and determination, and serves as one of the most prolific role models both in and outside of politics.

SEC. 3. CONGRESSIONAL GOLD MEDAL.

(a) Award Authorized.—The Speaker of the House of Representatives and the President pro tempore of the Senate shall make appropriate arrangements for the award, on behalf of Congress, of a gold medal of appropriate design to Bob Dole, in recognition for his service to the nation as a soldier, legislator, and statesman.

(b) Design And Striking.—For the purpose of the award referred to in subsection (a), the Secretary of the Treasury (referred to in this Act as the “Secretary”) shall strike a gold medal with suitable emblems, devices, and inscriptions to be determined by the Secretary.

SEC. 4. DUPLICATE MEDALS.

The Secretary may strike and sell duplicates in bronze of the gold medal struck under section 3 under such regulations as the Secretary may prescribe, at a price sufficient to cover the cost thereof, including labor, materials, dies, use of machinery, and overhead expenses, and the cost of the gold medal.

SEC. 5. STATUS OF MEDALS.

(a) National Medals.—The medals struck under this Act are national medals for purposes of chapter 51 of title 31, United States Code.

(b) Numismatic Items.—For purposes of sections 5134 and 5136 of title 31, United States Code, all medals struck under this Act shall be considered to be numismatic items.



Speaker of the House of Representatives

 

Vice President of the United States and President of the Senate

H.R. 601 - Continuing Appropriations Act, 2018 and Supplemental Appropriations for Disaster Relief Requirements Act, 2017

In the House of Representatives, U. S.,

September 6, 2017.  

Resolved, That the House agree to the amendments numbered 1, 2, 3, 4, 5, 7, and 8 of the Senate to the bill (H.R. 601) entitled “An Act to enhance the transparency and accelerate the impact of assistance provided under the Foreign Assistance Act of 1961 to promote quality basic education in developing countries, to better enable such countries to achieve universal access to quality basic education and improved learning outcomes, to eliminate duplication and waste, and for other purposes.” and be it further

Resolved, That the House agree to the amendment numbered 6 of the Senate to the aforementioned bill, with the following

HOUSE AMENDMENT TO SENATE AMENDMENT:

In lieu of the matter proposed to be inserted by the amendment numbered 6 of the Senate, insert the following:

“(C) there is the greatest opportunity to reduce childhood and adolescence exposure to or engagement in violent extremism or extremist ideologies.”.

DIVISION B—DISASTER RELIEF APPROPRIATIONS ACT, 2017

The following sums are appropriated, out of any money in the Treasury not otherwise appropriated, for disaster relief for the fiscal year ending September 30, 2017, and for other purposes, namely:

DEPARTMENT OF HOMELAND SECURITY

FEDERAL EMERGENCY MANAGEMENT AGENCY

DISASTER RELIEF FUND

For an additional amount for “Disaster Relief Fund” for major disasters declared pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5121 et seq.), $7,400,000,000, to remain available until expended: Provided, That such amount is designated by the Congress as being for an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985: Provided further, That the amount designated under this heading 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 only if the President subsequently so designates such amount and transmits such designation to the Congress.

SMALL BUSINESS ADMINISTRATION

DISASTER LOANS PROGRAM ACCOUNT

(INCLUDING TRANSFER OF FUNDS)

For an additional amount for the “Disaster Loans Program Account” for the cost of direct loans authorized by section 7(b) of the Small Business Act, $450,000,000, to remain available until expended: Provided, That up to $225,000,000 may be transferred to and merged with “Salaries and Expenses” for administrative expenses to carry out the disaster loan program authorized by section 7(b) of the Small Business Act: Provided further, That none of the funds provided under this heading may be used for indirect administrative expenses: Provided further, That the amount provided under this heading is designated as an emergency requirement pursuant to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of 1985: Provided further, That the amount designated under this heading 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 only if the President subsequently so designates such amount and transmits such designation to the Congress.

This division may be cited as the “Disaster Relief Appropriations Act, 2017”.

Attest:

H.R. 339 - An Act to amend Public Law 94–241 with respect to the Northern Mariana Islands.

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 Public Law 94–241 with respect to the Northern Mariana Islands.

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 “Northern Mariana Islands Economic Expansion Act”.

SEC. 2. COMMONWEALTH OF THE NORTHERN MARIANA ISLANDS: TRANSITIONAL WORKERS.

Section 6 of Public Law 94–241 (48 U.S.C. 1806) is amended—

(1) in subsection (a)(6), by striking “$150” and inserting “$200”; and

(2) in subsection (d)(2)—

(A) by striking the period at the end of the first sentence and inserting “, except a permit for construction occupations (as that term is defined by the Department of Labor as Standard Occupational Classification Group 47–0000 or any successor provision) shall only be issued to extend a permit first issued before October 1, 2015.”; and

(B) by striking “ ‘ending on December 31, 2019’.” and inserting “ending on December 31, 2019, except that for fiscal year 2017 an additional 350 permits shall be made available for extension of existing permits, expiring after the date of enactment of the Northern Mariana Islands Economic Expansion Act through September 30, 2017, of which no fewer than 60 shall be reserved for healthcare practitioners and technical operations (as that term is defined by the Department of Labor as Standard Occupational Classification Group 29–0000 or any successor provision), and no fewer than 10 shall be reserved for plant and system operators (as that term is defined by the Department of Labor as Standard Occupational Classification Group 51–8000 or any successor provision).”.

Attest:

Speaker of the House of Representatives.  

Attest:

Vice President of the United States and   
President of the Senate.

H.R.2288 - Veterans Appeals Improvement and Modernization 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 title 38, United States Code, to reform the rights and processes relating to appeals of decisions regarding claims for benefits under the laws administered by the Secretary 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.

This Act may be cited as the “Veterans Appeals Improvement and Modernization Act of 2017”.

SEC. 2. REFORM OF RIGHTS AND PROCESSES RELATING TO APPEALS OF DECISIONS REGARDING CLAIMS FOR BENEFITS UNDER LAWS ADMINISTERED BY SECRETARY OF VETERANS AFFAIRS.

(a) Definitions.—Section 101 of title 38, United States Code, is amended by adding at the end the following new paragraphs:

“(34) The term ‘agency of original jurisdiction’ means the activity which entered the original determination with regard to a claim for benefits under laws administered by the Secretary.

“(35) The term ‘relevant evidence’ means evidence that tends to prove or disprove a matter in issue.

“(36) The term ‘supplemental claim’ means a claim for benefits under laws administered by the Secretary filed by a claimant who had previously filed a claim for the same or similar benefits on the same or similar basis.”.

(b) Notice Regarding Claims.—Section 5103(a) of such title is amended—

(1) in paragraph (1), in the first sentence, by striking “The” and inserting “Except as provided in paragraph (3), the”;

(2) in paragraph (2)(B)(i) by striking “, a claim for reopening a prior decision on a claim, or a claim for an increase in benefits;” and inserting “or a supplemental claim;”; and

(3) by adding at the end the following new paragraph:

“(3) The requirement to provide notice under paragraph (1) shall not apply with respect to a supplemental claim that is filed within the timeframe set forth in subparagraphs (B) and (D) of section 5110(a)(2) of this title.”.

(c) Modification Of Rule Regarding Disallowed Claims.—Section 5103A(f) of such title is amended—

(1) by striking “reopen” and inserting “readjudicate”; and

(2) by striking “material” and inserting “relevant”.

(d) Modification Of Duty To Assist Claimants.—Section 5103A of such title is amended—

(1) by redesignating subsections (e) through (g) as subsections (g) through (i), respectively; and

(2) by inserting after subsection (d) the following new subsections:

“(e) Applicability Of Duty To Assist.— (1) The Secretary’s duty to assist under this section shall apply only to a claim, or supplemental claim, for a benefit under a law administered by the Secretary until the time that a claimant is provided notice of the agency of original jurisdiction’s decision with respect to such claim, or supplemental claim, under section 5104 of this title.

“(2) The Secretary’s duty to assist under this section shall not apply to higher-level review by the agency of original jurisdiction, pursuant to section 5104B of this title, or to review on appeal by the Board of Veterans’ Appeals.

“(f) Correction Of Duty To Assist Errors.— (1) If, during review of the agency of original jurisdiction decision under section 5104B of this title, the higher-level adjudicator identifies or learns of an error on the part of the agency of original jurisdiction to satisfy its duties under this section, and that error occurred prior to the agency of original jurisdiction decision being reviewed, unless the Secretary may award the maximum benefit in accordance with this title based on the evidence of record, the higher-level adjudicator shall return the claim for correction of such error and readjudication.

“(2) (A) If the Board of Veterans’ Appeals, during review on appeal of an agency of original jurisdiction decision, identifies or learns of an error on the part of the agency of original jurisdiction to satisfy its duties under this section, and that error occurred prior to the agency of original jurisdiction decision on appeal, unless the Secretary may award the maximum benefit in accordance with this title based on the evidence of record, the Board shall remand the claim to the agency of original jurisdiction for correction of such error and readjudication.

“(B) Remand for correction of such error may include directing the agency of original jurisdiction to obtain an advisory medical opinion under section 5109 of this title.

“(3) Nothing in this subsection shall be construed to imply that the Secretary, during the consideration of a claim, does not have a duty to correct an error described in paragraph (1) or (2) that was erroneously not identified during higher-level review or during review on appeal with respect to the claim.”.

(e) Decisions And Notices Of Decisions.—Subsection (b) of section 5104 of such title is amended to read as follows:

“(b) Each notice provided under subsection (a) shall also include all of the following:

“(1) Identification of the issues adjudicated.

“(2) A summary of the evidence considered by the Secretary.

“(3) A summary of the applicable laws and regulations.

“(4) Identification of findings favorable to the claimant.

“(5) In the case of a denial, identification of elements not satisfied leading to the denial.

“(6) An explanation of how to obtain or access evidence used in making the decision.

“(7) If applicable, identification of the criteria that must be satisfied to grant service connection or the next higher level of compensation.”.

(f) Binding Nature Of Favorable Findings.—

(1) IN GENERAL.—Chapter 51 of such title is amended by inserting after section 5104 the following new section:

“§ 5104A. Binding nature of favorable findings

“Any finding favorable to the claimant as described in section 5104(b)(4) of this title shall be binding on all subsequent adjudicators within the Department, unless clear and convincing evidence is shown to the contrary to rebut such favorable finding.”.

(2) CLERICAL AMENDMENT.—The table of sections at the beginning of chapter 51 of such title is amended by inserting after the item relating to section 5104 the following new item:


“5104A. Binding nature of favorable findings.”.

(g) Higher-Level Review By Agency Of Original Jurisdiction.—

(1) IN GENERAL.—Chapter 51 of such title, as amended by subsection (f), is further amended by inserting after section 5104A, as added by such subsection, the following new section:

“§ 5104B. Higher-level review by the agency of original jurisdiction

“(a) In General.— (1) A claimant may request a review of the decision of the agency of original jurisdiction by a higher-level adjudicator within the agency of original jurisdiction.

“(2) The Secretary shall approve each request for review under paragraph (1).

“(b) Time And Manner Of Request.— (1) A request for higher-level review by the agency of original jurisdiction shall be—

“(A) in writing in such form as the Secretary may prescribe; and

“(B) made within one year of the notice of the agency of original jurisdiction’s decision.

“(2) Such request may specifically indicate whether such review is requested by a higher-level adjudicator at the same office within the agency of original jurisdiction or by an adjudicator at a different office of the agency of original jurisdiction. The Secretary shall not deny such request for review by an adjudicator at a different office of the agency of original jurisdiction without good cause.

“(c) Decision.—Notice of a higher-level review decision under this section shall be provided in writing and shall include a general statement—

“(1) reflecting whether evidence was not considered pursuant to subsection (d); and

“(2) noting the options available to the claimant to have the evidence described in paragraph (1), if any, considered by the Department.

“(d) Evidentiary Record For Review.—The evidentiary record before the higher-level adjudicator shall be limited to the evidence of record in the agency of original jurisdiction decision being reviewed.

“(e) De Novo Review.—A review of the decision of the agency of original jurisdiction by a higher-level adjudicator within the agency of original jurisdiction shall be de novo.”.

(2) CLERICAL AMENDMENT.—The table of sections at the beginning of chapter 51 of such title, as amended by subsection (f), is further amended by inserting after the item relating to section 5104A, as added by such subsection, the following new item:


“5104B. Higher-level review by the agency of original jurisdiction.”.

(h) Options Following Decision By Agency Of Original Jurisdiction.—

(1) IN GENERAL.—Chapter 51 of such title, as amended by subsection (g), is further amended by inserting after section 5104B, as added by such subsection, the following new section:

“§ 5104C. Options following decision by agency of original jurisdiction

“(a) Within One Year Of Decision.— (1) Subject to paragraph (2), in any case in which the Secretary renders a decision on a claim, the claimant may take any of the following actions on or before the date that is one year after the date on which the agency of original jurisdiction issues a decision with respect to that claim:

“(A) File a request for higher-level review under section 5104B of this title.

“(B) File a supplemental claim under section 5108 of this title.

“(C) File a notice of disagreement under section 7105 of this title.

“(2) (A) Once a claimant takes an action set forth in paragraph (1), the claimant may not take another action set forth in that paragraph with respect to the same claim or same issue contained within the claim until—

“(i) the higher-level review, supplemental claim, or notice of disagreement is adjudicated; or

“(ii) the request for higher-level review, supplemental claim, or notice of disagreement is withdrawn.

“(B) Nothing in this subsection shall prohibit a claimant from taking any of the actions set forth in paragraph (1) in succession with respect to a claim or an issue contained within the claim.

“(C) Nothing in this subsection shall prohibit a claimant from taking different actions set forth in paragraph (1) with respect to different claims or different issues contained within a claim.

“(D) The Secretary may, as the Secretary considers appropriate, develop and implement a policy for claimants who—

“(i) take an action under paragraph (1);

“(ii) wish to withdraw the action before the higher-level review, supplemental claim, or notice of disagreement is adjudicated; and

“(iii) in lieu of such action take a different action under paragraph (1).

“(b) More Than One Year After Decision.—In any case in which the Secretary renders a decision on a claim and more than one year has passed since the date on which the agency of original jurisdiction issues a decision with respect to that claim, the claimant may file a supplemental claim under section 5108 of this title.”.

(2) CLERICAL AMENDMENT.—The table of sections at the beginning of chapter 51 of such title, as amended by subsection (g), is further amended by inserting after the item relating to section 5104B, as added by such subsection, the following new item:


“5104C. Options following decision by agency of original jurisdiction.”.

(i) Supplemental Claims.—

(1) IN GENERAL.—Section 5108 of such title is amended to read as follows:

“§ 5108. Supplemental claims

“(a) In General.—If new and relevant evidence is presented or secured with respect to a supplemental claim, the Secretary shall readjudicate the claim taking into consideration all of the evidence of record.

“(b) Duty To Assist.— (1) If a claimant, in connection with a supplemental claim, reasonably identifies existing records, whether or not in the custody of a Federal department or agency, the Secretary shall assist the claimant in obtaining the records in accordance with section 5103A of this title.

“(2) Assistance under paragraph (1) shall not be predicated upon a finding that new and relevant evidence has been presented or secured.”.

(2) RULE OF CONSTRUCTION.—Section 5108 of such title, as amended by paragraph (1), shall not be construed to impose a higher evidentiary threshold than the new and material evidence standard that was in effect pursuant to such section on the day before the date of the enactment of this Act.

(3) CLERICAL AMENDMENT.—The table of sections at the beginning of chapter 51 of such title is amended by striking the item relating to section 5108 and inserting the following new item:


“5108. Supplemental claims.”.

(j) Remand To Obtain Advisory Medical Opinion.—Section 5109 of such title is amended by adding at the end the following new subsection:

“(d) (1) The Board of Veterans’ Appeals shall remand a claim to direct the agency of original jurisdiction to obtain an advisory medical opinion from an independent medical expert under this section if the Board finds that the Veterans Benefits Administration should have exercised its discretion to obtain such an opinion.

“(2) The Board’s remand instructions shall include the questions to be posed to the independent medical expert providing the advisory medical opinion.”.

(k) Restatement Of Requirement For Expedited Treatment Of Returned And Remanded Claims.—

(1) IN GENERAL.—Section 5109B of such title is amended to read as follows:

“§ 5109B. Expedited treatment of returned and remanded claims

“The Secretary shall take such actions as may be necessary to provide for the expeditious treatment by the Veterans Benefits Administration of any claim that is returned by a higher-level adjudicator under section 5104B of this title or remanded by the Board of Veterans' Appeals.”.

(2) CLERICAL AMENDMENT.—The table of sections at the beginning of chapter 51 of such title is amended by striking the item relating to section 5109B and inserting the following new item:


“5109B. Expedited treatment of returned and remanded claims.”.

(l) Effective Dates Of Awards.—Section 5110 of title 38, United States Code, is amended—

(1) by amending subsection (a) to read as follows:

“(a) (1) Unless specifically provided otherwise in this chapter, the effective date of an award based on an initial claim, or a supplemental claim, of compensation, dependency and indemnity compensation, or pension, shall be fixed in accordance with the facts found, but shall not be earlier than the date of receipt of application therefor.

“(2) For purposes of determining the effective date of an award under this section, the date of application shall be considered the date of the filing of the initial application for a benefit if the claim is continuously pursued by filing any of the following, either alone or in succession:

“(A) A request for higher-level review under section 5104B of this title on or before the date that is one year after the date on which the agency of original jurisdiction issues a decision.

“(B) A supplemental claim under section 5108 of this title on or before the date that is one year after the date on which the agency of original jurisdiction issues a decision.

“(C) A notice of disagreement on or before the date that is one year after the date on which the agency of original jurisdiction issues a decision.

“(D) A supplemental claim under section 5108 of this title on or before the date that is one year after the date on which the Board of Veterans’ Appeals issues a decision.

“(E) A supplemental claim under section 5108 of this title on or before the date that is one year after the date on which the Court of Appeals for Veterans Claims issues a decision.

“(3) Except as otherwise provided in this section, for supplemental claims received more than one year after the date on which the agency of original jurisdiction issued a decision or the Board of Veterans’ Appeals issued a decision, the effective date shall be fixed in accordance with the facts found, but shall not be earlier than the date of receipt of the supplemental claim.”; and

(2) in subsection (i), in the first sentence—

(A) by striking “reopened” and inserting “readjudicated”;

(B) by striking “material” and inserting “relevant”; and

(C) by striking “reopening” and inserting “readjudication”.

(m) Definition Of Award Or Increased Award For Purposes Of Provisions Relating To Commencement Of Period Of Payment.—Section 5111(d)(1) of such title is amended by striking “or reopened award” and inserting “award or award based on a supplemental claim”.

(n) Modification Of Limitation On Fees Allowable For Representation.—Section 5904(c) of such title is amended, in paragraphs (1) and (2), by striking “notice of disagreement is filed” both places it appears and inserting “claimant is provided notice of the agency of original jurisdiction’s initial decision under section 5104 of this title”.

(o) Clarification Of Board Of Veterans' Appeals Referral Requirements After Order For Reconsideration Of Decisions.—Section 7103(b)(1) of title 38, United States Code, is amended by striking “heard” both places it appears and inserting “decided”.

(p) Conforming Amendment Relating To Readjudication.—Section 7104(b) of such title is amended by striking “reopened” and inserting “readjudicated”.

(q) Modification Of Procedures For Appeals To Board Of Veterans' Appeals.—

(1) IN GENERAL.—Section 7105 of title 38, United States Code, is amended—

(A) in subsection (a), by striking the first sentence and inserting “Appellate review shall be initiated by the filing of a notice of disagreement in the form prescribed by the Secretary.”;

(B) by amending subsection (b) to read as follows:

“(b) (1) (A) Except in the case of simultaneously contested claims, a notice of disagreement shall be filed within one year from the date of the mailing of notice of the decision of the agency of original jurisdiction pursuant to section 5104, 5104B, or 5108 of this title.

“(B) A notice of disagreement postmarked before the expiration of the one-year period shall be accepted as timely filed.

“(C) A question as to timeliness or adequacy of the notice of disagreement shall be decided by the Board.

“(2) (A) Notices of disagreement shall be in writing, shall identify the specific determination with which the claimant disagrees, and may be filed by the claimant, the claimant's legal guardian, or such accredited representative, attorney, or authorized agent as may be selected by the claimant or legal guardian.

“(B) Not more than one recognized organization, attorney, or agent may be recognized at any one time in the prosecution of a claim.

“(C) Notices of disagreement shall be filed with the Board.

“(3) The notice of disagreement shall indicate whether the claimant requests—

“(A) a hearing before the Board, which shall include an opportunity to submit evidence in accordance with section 7113(b) of this title;

“(B) an opportunity to submit additional evidence without a hearing before the Board, which shall include an opportunity to submit evidence in accordance with section 7113(c) of this title; or

“(C) a review by the Board without a hearing or the submittal of additional evidence.

“(4) The Secretary shall develop a policy to permit a claimant to modify the information identified in the notice of disagreement after the notice of disagreement has been filed under this section pursuant to such requirements as the Secretary may prescribe.”;

(C) by amending subsection (c) to read as follows:

“(c) If no notice of disagreement is filed in accordance with this chapter within the prescribed period, the action or decision of the agency of original jurisdiction shall become final and the claim shall not thereafter be readjudicated or allowed, except—

“(1) in the case of a readjudication or allowance pursuant to a higher-level review that was requested in accordance with section 5104B of this title;

“(2) as may otherwise be provided by section 5108 of this title; or

“(3) as may otherwise be provided in such regulations as are consistent with this title.”;

(D) by striking subsection (d) and inserting the following new subsection (d):

“(d) The Board may dismiss any appeal which fails to identify the specific determination with which the claimant disagrees.”;

(E) by striking subsection (e); and

(F) in the section heading, by striking “notice of disagreement and”.

(2) CLERICAL AMENDMENT.—The table of sections at the beginning of chapter 71 of such title is amended by striking the item relating to section 7105 and inserting the following new item:


“7105. Filing of appeal.”.

(r) Modification Of Procedures And Requirements For Simultaneously Contested Claims.—Subsection (b) of section 7105A of such title is amended to read as follows:

“(b) (1) The substance of the notice of disagreement shall be communicated to the other party or parties in interest and a period of thirty days shall be allowed for filing a brief or argument in response thereto.

“(2) Such notice shall be forwarded to the last known address of record of the parties concerned, and such action shall constitute sufficient evidence of notice.”.

(s) Repeal Of Procedures For Administrative Appeals.—

(1) IN GENERAL.—Chapter 71 of such title is amended by striking section 7106.

(2) CLERICAL AMENDMENT.—The table of sections at the beginning of chapter 71 of such title is amended by striking the item relating to section 7106.

(t) Modifications Relating To Appeals: Dockets; Hearings.—Section 7107 of such title is amended to read as follows:

“§ 7107. Appeals: dockets; hearings

“(a) Dockets.— (1) Subject to paragraph (2), the Board shall maintain at least two separate dockets.

“(2) The Board may not maintain more than two separate dockets unless the Board notifies the Committee on Veterans' Affairs of the Senate and the Committee on Veterans' Affairs of the House of Representatives of any additional docket, including a justification for maintaining such additional docket.

“(3) (A) The Board may assign to each docket maintained under paragraph (1) such cases as the Board considers appropriate, except that cases described in clause (i) of subparagraph (B) may not be assigned to any docket to which cases described in clause (ii) of such paragraph are assigned.

“(B) Cases described in this paragraph are the following:

“(i) Cases in which no Board hearing is requested.

“(ii) Cases in which a Board hearing is requested in the notice of disagreement.

“(4) Except as provided in subsection (b), each case before the Board will be decided in regular order according to its respective place on the docket to which it is assigned by the Board.

“(b) Advancement On The Docket.— (1) A case on one of the dockets of the Board maintained under subsection (a) may, for cause shown, be advanced on motion for earlier consideration and determination.

“(2) Any such motion shall set forth succinctly the grounds upon which the motion is based.

“(3) Such a motion may be granted only—

“(A) if the case involves interpretation of law of general application affecting other claims;

“(B) if the appellant is seriously ill or is under severe financial hardship; or

“(C) for other sufficient cause shown.

“(c) Manner And Scheduling Of Hearings For Cases On A Docket That May Include A Hearing.— (1) For cases on a docket maintained by the Board under subsection (a) that may include a hearing, in which a hearing is requested in the notice of disagreement, the Board shall notify the appellant whether a Board hearing will be held—

“(A) at its principal location; or

“(B) by picture and voice transmission at a facility of the Department where the Secretary has provided suitable facilities and equipment to conduct such hearings.

“(2) (A) Upon notification of a Board hearing at the Board’s principal location as described in subparagraph (A) of paragraph (1), the appellant may alternatively request a hearing as described in subparagraph (B) of such paragraph. If so requested, the Board shall grant such request.

“(B) Upon notification of a Board hearing by picture and voice transmission as described in subparagraph (B) of paragraph (1), the appellant may alternatively request a hearing as described in subparagraph (A) of such paragraph. If so requested, the Board shall grant such request.

“(d) Screening Of Cases.—Nothing in this section shall be construed to preclude the screening of cases for purposes of—

“(1) determining the adequacy of the record for decisional purposes; or

“(2) the development, or attempted development, of a record found to be inadequate for decisional purposes.

“(e) Policy On Changing Dockets.—The Secretary shall develop and implement a policy allowing an appellant to move the appellant's case from one docket to another docket.”.

(u) Repeal Of Certain Authority For Independent Medical Opinions.—

(1) IN GENERAL.—Section 7109 of such title is repealed.

(2) CONFORMING AMENDMENT.—Section 5701(b)(1) of such title is amended by striking “or 7109”.

(3) CLERICAL AMENDMENT.—The table of sections at the beginning of chapter 71 of such title is amended by striking the item relating to section 7109.

(v) Clarification Of Procedures For Review Of Decisions On Grounds Of Clear And Unmistakable Error.—Section 7111(e) of such title is amended by striking “, without referral to any adjudicative or hearing official acting on behalf of the Secretary”.

(w) Evidentiary Record Before Board Of Veterans' Appeals.—

(1) IN GENERAL.—Chapter 71 of such title is amended by adding at the end the following new section:

“§ 7113. Evidentiary record before the Board of Veterans' Appeals

“(a) Cases With No Request For A Hearing Or Additional Evidence.—For cases in which a hearing before the Board of Veterans' Appeals is not requested in the notice of disagreement and no request was made to submit evidence, the evidentiary record before the Board shall be limited to the evidence of record at the time of the decision of the agency of original jurisdiction on appeal.

“(b) Cases With A Request For A Hearing.— (1) Except as provided in paragraph (2), for cases in which a hearing is requested in the notice of disagreement, the evidentiary record before the Board shall be limited to the evidence of record at the time of the decision of the agency of original jurisdiction on appeal.

“(2) The evidentiary record before the Board for cases described in paragraph (1) shall include each of the following, which the Board shall consider in the first instance:

“(A) Evidence submitted by the appellant and his or her representative, if any, at the Board hearing.

“(B) Evidence submitted by the appellant and his or her representative, if any, within 90 days following the Board hearing.

“(c) Cases With No Request For A Hearing And With A Request For Additional Evidence.— (1) Except as provided in paragraph (2), for cases in which a hearing is not requested in the notice of disagreement but an opportunity to submit evidence is requested, the evidentiary record before the Board shall be limited to the evidence considered by the agency of original jurisdiction in the decision on appeal.

“(2) The evidentiary record before the Board for cases described in paragraph (1) shall include each of the following, which the Board shall consider in the first instance:

“(A) Evidence submitted by the appellant and his or her representative, if any, with the notice of disagreement.

“(B) Evidence submitted by the appellant and his or her representative, if any, within 90 days following receipt of the notice of disagreement.”.

(2) NOTIFICATION WHEN EVIDENCE NOT CONSIDERED.—Section 7104(d) of such title is amended—

(A) in paragraph (1), by striking “; and” and inserting a semicolon;

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

(C) by inserting after paragraph (1) the following new paragraph (2):

“(2) a general statement—

“(A) reflecting whether evidence was not considered in making the decision because the evidence was received at a time when not permitted under section 7113 of this title; and

“(B) noting such options as may be available for having the evidence considered by the Department; and”.

(3) CLERICAL AMENDMENT.—The table of sections at the beginning of chapter 71 of such title is amended by inserting after the item relating to section 7112 the following new item:


“7113. Evidentiary record before the Board of Veterans' Appeals.”.

(x) Applicability.—

(1) IN GENERAL.—Except as otherwise provided in this subsection, the amendments made by this section shall apply to all claims for which notice of a decision under section 5104 of title 38, United States Code, is provided by the Secretary of Veterans Affairs on or after the later of—

(A) the date that is 540 days after the date of the enactment of this Act; and

(B) the date that is 30 days after the date on which the Secretary of Veterans Affairs submits to the appropriate committees of Congress—

(i) a certification that the Secretary confirms, without delegation, that the Department of Veterans Affairs has the resources, personnel, office space, procedures, and information technology required—

(I) to carry out the new appeals system;

(II) to timely address appeals under the new appeals system; and

(III) to timely address appeals of decisions on legacy claims; and

(ii) a summary of the expectations for performance outcomes that the Secretary used in making the certification under clause (i)(III) and a comparison of such expected performance outcomes with actual performance outcomes with respect to appeals of legacy claims before the effective date of the new appeals system.

(2) COLLABORATION.—In determining whether and when to make a certification under paragraph (1)(B), the Secretary shall collaborate with, partner with, and give weight to the advice of veterans service organizations and such other stakeholders as the Secretary considers appropriate.

(3) EARLY APPLICABILITY.—The Secretary may apply the new appeals system to a claim with respect to which the claimant—

(A) receives a notice of a decision under section 5104 of such title after the date of the enactment of this Act and before the applicability date set forth in paragraph (1); and

(B) elects to subject the claim to the new appeals system.

(4) PHASED ROLLOUT.—The Secretary may begin implementation of the new appeals system in phases, with the first phase of such phased implementation beginning on the applicability date set forth in paragraph (1).

(5) TREATMENT OF LEGACY CLAIMS.—With respect to legacy claims, upon the issuance to a claimant of a statement of the case or supplemental statement of the case occurring on or after the applicability date specified in paragraph (1), a claimant may elect to participate in the new appeals system.

(6) PUBLICATION OF APPLICABILITY DATE.—Not later than the date on which the new appeals system goes into effect (or the first phase of the new appeals system goes into effect under paragraph (4), as the case may be), the Secretary shall publish in the Federal Register such date.

(7) DEFINITIONS.—In this subsection:

(A) APPROPRIATE COMMITTEES OF CONGRESS.—The term “appropriate committees of Congress” means—

(i) the Committee on Veterans' Affairs and the Committee on Appropriations of the Senate; and

(ii) the Committee on Veterans' Affairs and the Committee on Appropriations of the House of Representatives.

(B) VETERANS SERVICE ORGANIZATION.—The term “veterans service organization” means any organization recognized by the Secretary for the representation of veterans under section 5902 of title 38, United States Code.

(y) Rule Of Construction.—Nothing in this section or any of the amendments made by this section shall be construed to limit the ability of a claimant to request a revision of a decision under section 5109A or 7111 of title 38, United States Code.

SEC. 3. COMPREHENSIVE PLAN FOR PROCESSING OF LEGACY APPEALS AND IMPLEMENTING NEW APPEALS SYSTEM.

(a) Plan Required.—Not later than 90 days after the date of the enactment of this Act, the Secretary of Veterans Affairs shall submit to the appropriate committees of Congress and the Comptroller General of the United States a comprehensive plan for—

(1) the processing of appeals of decisions on legacy claims that the Secretary considers pending;

(2) implementing the new appeals system;

(3) timely processing, under the new appeals system, of—

(A) supplemental claims under section 5108 of title 38, United States Code, as amended by section 2(i);

(B) requests for higher-level review under section 5104B of such title, as added by section 2(g); and

(C) appeals on any docket maintained under section 7107 of such title, as amended by section 2(t); and

(4) monitoring the implementation of the new appeals system, including metrics and goals—

(A) to track the progress of the implementation;

(B) to evaluate the efficiency and effectiveness of the implementation; and

(C) to identify potential issues relating to the implementation.

(b) Elements.—The plan required by subsection (a) shall include, at a minimum, the following:

(1) Delineation of the total resource requirements of the Veterans Benefits Administration and the Board of Veterans’ Appeals, disaggregated by resources required to implement and administer the new appeals system and resources required to address the appeals of decisions on legacy claims.

(2) Delineation of the personnel requirements of the Administration and the Board, including staffing levels during the—

(A) period in which the Administration and the Board are concurrently processing—

(i) appeals of decisions on legacy claims; and

(ii) appeals of decisions on non-legacy claims under the new appeals system; and

(B) the period during which the Administration and the Board are no longer processing any appeals of decisions on legacy claims.

(3) Identification of the legal authorities under which the Administration or the Board may—

(A) hire additional employees to conduct the concurrent processing described in paragraph (2)(A); and

(B) remove employees who are no longer required by the Administration or the Board once the Administration and the Board are no longer processing any appeals of decisions on legacy claims.

(4) An estimate of the amount of time the Administration and the Board will require to hire additional employees as described in paragraph (3)(A) once funding has been made available for such purpose, including a comparison of such estimate and the historical average time required by the Administration and the Board to hire additional employees.

(5) A description of the amount of training and experience that will be required of individuals conducting higher-level reviews under section 5104B of title 38, United States Code, as added by section 2(g).

(6) An estimate of the percentage of higher-level adjudicators who will be employees of the Department of Veterans Affairs who were Decision Review Officers on the day before the new appeals system takes effect or had experience, as of such date, comparable to that of one who was a Decision Review Officer.

(7) A description of the functions that will be performed after the date on which the new appeals system takes effect by Decision Review Officers who were Decision Review Officers on the day before the date the new appeals system takes effect.

(8) Identification of and a timeline for—

(A) any training that may be required as a result of hiring new employees to carry out the new appeals system or to process appeals of decisions on legacy claims; and

(B) any retraining of existing employees that may be required to carry out such system or to process such claims.

(9) Identification of the costs to the Department of Veterans Affairs of the training identified under paragraph (8) and any additional training staff and any additional training facilities that will be required to provide such training.

(10) A description of the modifications to the information technology systems of the Administration and the Board that the Administration and the Board require to carry out the new appeals system, including cost estimates and a timeline for making the modifications.

(11) An estimate of the office space the Administration and the Board will require during each of the periods described in paragraph (2), including—

(A) an estimate of the amount of time the Administration and the Board will require to acquire any additional office space to carry out processing of appeals of decisions on legacy claims and processing of appeals under the new appeals system;

(B) a comparison of the estimate under subparagraph (A) and the historical average time required by the Administration and the Board to acquire new office space; and

(C) a plan for using telework to accommodate staff exceeding available office space, including how the Administration and the Board will provide training and oversight with respect to such teleworking.

(12) Projections for the productivity of individual employees at the Administration and the Board in carrying out tasks relating to the processing of appeals of decisions on legacy claims and appeals under the new appeals system, taking into account the experience level of new employees and the enhanced notice requirements under section 5104(b) of title 38, United States Code, as amended by section 2(e).

(13) An outline of the outreach the Secretary expects to conduct to inform veterans, families of veterans, survivors of veterans, veterans service organizations, military service organizations, congressional caseworkers, advocates for veterans, and such other stakeholders as the Secretary considers appropriate about the new appeals system, including—

(A) a description of the resources required to conduct such outreach; and

(B) timelines for conducting such outreach.

(14) Timelines for updating any policy guidance, Internet websites, and official forms that may be necessary to carry out the new appeals system, including—

(A) identification of which offices and entities will be involved in efforts relating to such updating; and

(B) historical information about how long similar update efforts have taken.

(15) A timeline, including interim milestones, for promulgating such regulations as may be necessary to carry out the new appeals system and a comparison with historical averages for time required to promulgate regulations of similar complexity and scope.

(16) An outline of the circumstances under which claimants with pending appeals of decisions on legacy claims would be authorized to have their appeals reviewed under the new appeals system.

(17) A delineation of the key goals and milestones for reducing the number of pending appeals that are not processed under the new appeals system, including the expected number of appeals, remands, and hearing requests at the Administration and the Board each year, beginning with the one year period beginning on the date of the enactment of this Act, until there are no longer any appeals pending before the Administration or the Board for a decision on a legacy claim.

(18) A description of each risk factor associated with each element of the plan and a contingency plan to minimize each such risk.

(c) Review By Comptroller General Of The United States.—

(1) IN GENERAL.—Not later than 90 days after the Comptroller General of the United States receives the plan required by subsection (a), the Comptroller General shall—

(A) assess such plan; and

(B) notify the appropriate committees of Congress of the findings of the Comptroller General with respect to the assessment conducted under subparagraph (A).

(2) ELEMENTS.—The assessment conducted under paragraph (1)(A) shall include the following:

(A) An assessment of whether the plan comports with sound planning practices.

(B) Identification of any gaps in the plan.

(C) Formulation of such recommendations as the Comptroller General considers appropriate.

(d) Periodic Progress Reports.—Not later than 90 days after the date on which the Secretary submits the plan under subsection (a), not less frequently than once every 90 days thereafter until the applicability date set forth in section 2(x)(1), and not less frequently than once every 180 days thereafter for the seven-year period following such applicability date, the Secretary shall submit to the appropriate committees of Congress and the Comptroller General a report on the progress of the Secretary in carrying out the plan and what steps, if any, the Secretary has taken to address any recommendations formulated by the Comptroller General pursuant to subsection (c)(2)(C).

(e) Publication.—The Secretary shall make available to the public on an Internet website of the Department of Veterans Affairs—

(1) the plan required by subsection (a); and

(2) the periodic progress reports required by subsection (d).

(f) Appropriate Committees Of Congress Defined.—In this section, the term “appropriate committees of Congress” means—

(1) the Committee on Veterans' Affairs and the Committee on Appropriations of the Senate; and

(2) the Committee on Veterans' Affairs and the Committee on Appropriations of the House of Representatives.

SEC. 4. PROGRAMS TO TEST ASSUMPTIONS RELIED ON IN DEVELOPMENT OF COMPREHENSIVE PLAN FOR PROCESSING OF LEGACY APPEALS AND SUPPORTING NEW APPEALS SYSTEM.

(a) Authorization.—

(1) IN GENERAL.—The Secretary of Veterans Affairs may carry out such programs as the Secretary considers appropriate to test any assumptions relied upon in developing the comprehensive plan required by section 3(a) and to test the feasibility and advisability of any facet of the new appeals system.

(2) REPORTING REQUIRED.—Whenever the Secretary determines, based on the conduct of a program under paragraph (1), that legislative changes to the new appeals system are necessary, the Secretary shall submit to the Committee on Veterans' Affairs of the Senate and the Committee on Veterans' Affairs of the House of Representatives notice of such determination.

(b) Department Of Veterans Affairs Program On Fully Developed Appeals.—

(1) IN GENERAL.—The Secretary of Veterans Affairs may, under subsection (a)(1), carry out a program to provide the option of an alternative appeals process that shall more quickly determine such appeals in accordance with this subsection.

(2) ELECTION.—

(A) FILING.—In accordance with subparagraph (B), a claimant may elect to file a fully developed appeal under the program by filing with the Secretary all of the following:

(i) The notice of disagreement under chapter 71 of title 38, United States Code, along with the written election of the claimant to have the appeal determined under the program.

(ii) All evidence that the claimant believes is needed for the appeal as of the date of the filing.

(iii) A statement of the argument in support of the claim, if any.

(B) TIMING.—A claimant shall make an election under subparagraph (A) as part of the notice of disagreement filed by the claimant in accordance with subparagraph (A)(i).

(C) TRIAGE.—The Secretary shall, upon expiration of the period specified in paragraph (3)(C)(iii), ensure that an assessment is undertaken of whether an appeal filed under subparagraph (A) of this paragraph satisfies the requirements for appeal under the program and provide appropriate notification to the claimant of the results of that assessment.

(D) REVERSION.—

(i) ELECTED REVERSION.—At any time, a claimant who makes an election under subparagraph (A) may elect to revert to the standard appeals process. Such a reversion shall be final.

(ii) AUTOMATIC REVERSION.—A claimant described in clause (i), or a claimant who makes an election under subparagraph (A) but is later determined to be ineligible for the program under paragraph (1), shall revert to the standard appeals process without any penalty to the claimant other than the loss of the docket number associated with the fully developed appeal.

(E) OUTREACH.—In providing claimants with notices of the determination of a claim during the period in which the program under paragraph (1) is carried out, the Secretary shall conduct outreach as follows:

(i) The Secretary shall provide to the claimant (and to the representative of record of the claimant, if any) information regarding—

(I) the program, including the advantages and disadvantages of the program;

(II) how to make an election under subparagraph (A);

(III) the limitation on the use of new evidence described in subparagraph (C) of paragraph (3) and the development of information under subparagraph (D) of such paragraph;

(IV) the ability of the claimant to seek advice and education regarding such process from veterans service organizations, attorneys, and claims agents recognized under chapter 59 of title 38, United States Code; and

(V) the circumstances under which the appeal will automatically revert to the standard appeals process, including by making a request for a hearing.

(ii) The Secretary shall collaborate, partner with, and give weight to the advice of the three veterans service organizations with the most members and such other stakeholders as the Secretary considers appropriate to publish on the Internet website of the Department of Veterans Affairs an online tutorial explaining the advantages and disadvantages of the program.

(3) TREATMENT BY DEPARTMENT AND BOARD.—

(A) PROCESS.—Upon the election of a claimant to file a fully developed appeal pursuant to paragraph (2)(A), the Secretary shall—

(i) not provide the claimant with a statement of the case nor require the claimant to file a substantive appeal; and

(ii) transfer jurisdiction over the fully developed appeal directly to the Board of Veterans’ Appeals.

(B) DOCKET.—

(i) IN GENERAL.—The Board of Veterans’ Appeals shall—

(I) maintain fully developed appeals on a separate docket than standard appeals;

(II) decide fully developed appeals in the order that the fully developed appeals are received on the fully developed appeal docket;

(III) except as provided by clause (ii), decide not more than one fully developed appeal for each four standard appeals decided; and

(IV) to the extent practicable, decide each fully developed appeal by the date that is one year following the date on which the claimant files the notice of disagreement.

(ii) ADJUSTMENT.—Beginning one year after the date on which the program commences, the Board may adjust the number of standard appeals decided for each fully developed appeal under clause (i)(III) if the Board determines that such adjustment is fair for both standard appeals and fully developed appeals.

(C) LIMITATION ON USE OF NEW EVIDENCE.—

(i) IN GENERAL.—Except as provided by clauses (ii) and (iii)—

(I) a claimant may not submit or identify to the Board of Veterans’ Appeals any new evidence relating to a fully developed appeal after filing such appeal unless the claimant reverts to the standard appeals process pursuant to paragraph (2)(D); and

(II) if a claimant submits or identifies any such new evidence, such submission or identification shall be deemed to be an election to make such a reversion pursuant to paragraph (2)(D).

(ii) EVIDENCE GATHERED BY BOARD.—Clause (i) shall not apply to evidence developed pursuant to subparagraphs (D) and (E). The Board shall consider such evidence in the first instance without consideration by the Veterans Benefits Administration.

(iii) REPRESENTATIVE OF RECORD.—The representative of record of a claimant for appeals purposes, if any, shall be provided an opportunity to review the fully developed appeal of the claimant and submit any additional arguments or evidence that the representative determines necessary during a period specified by the Board for purposes of this subparagraph.

(D) PROHIBITION ON REMAND FOR ADDITIONAL DEVELOPMENT.—If the Board of Veterans’ Appeals determines that a fully developed appeal requires Federal records, independent medical opinions, or new medical examinations, the Board shall—

(i) in accordance with subparagraph (E), take such actions as may be necessary to develop such records, opinions, or examinations in accordance with section 5103A of title 38, United States Code;

(ii) retain jurisdiction of the fully developed appeal without requiring a determination by the Veterans Benefits Administration based on such records, opinions, or examinations;

(iii) ensure the claimant, and the representative of record of a claimant, if any, receives a copy of such records, opinions, or examinations; and

(iv) provide the claimant a period of 90 days after the date of mailing such records, opinions, or examinations during which the claimant may provide the Board any additional evidence without requiring the claimant to make a reversion pursuant to paragraph (2)(D).

(E) DEVELOPMENT UNIT.—

(i) ESTABLISHMENT.—The Board of Veterans’ Appeals shall establish an office to develop Federal records, independent medical opinions, and new medical examinations pursuant to subparagraph (D)(i) that the Board determines necessary to decide a fully developed appeal.

(ii) REQUIREMENTS.—The Secretary shall—

(I) ensure that the Veterans Benefits Administration cooperates with the Board of Veterans’ Appeals in carrying out clause (i); and

(II) transfer employees of the Veterans Benefits Administration who, prior to the enactment of this Act, were responsible for processing claims remanded by the Board of Veterans’ Appeals to positions within the office of the Board established under clause (i) in a number the Secretary determines sufficient to carry out such subparagraph.

(F) HEARINGS.—Notwithstanding section 7107 of title 38, United States Code, the Secretary may not provide hearings with respect to fully developed appeals under the program. If a claimant requests to hold a hearing pursuant to such section 7107, such request shall be deemed to be an election to revert to the standard appeals process pursuant to paragraph (2)(D).

(4) DURATION; APPLICABILITY.—

(A) DURATION.—Subject to subsection (c), the Secretary may carry out the program during such period as the Secretary considers appropriate.

(B) APPLICABILITY.—This section shall apply only to fully developed appeals that are filed during the period in which the program is carried out pursuant to subparagraph (A).

(5) DEFINITIONS.—In this subsection:

(A) COMPENSATION.—The term “compensation” has the meaning given that term in section 101 of title 38, United States Code.

(B) FULLY DEVELOPED APPEAL.—The term “fully developed appeal” means an appeal of a claim for disability compensation that is—

(i) filed by a claimant in accordance with paragraph (2)(A); and

(ii) considered in accordance with this subsection.

(C) STANDARD APPEAL.—The term “standard appeal” means an appeal of a claim for disability compensation that is not a fully developed appeal.

(c) Termination Of Authority.—The Secretary of Veterans Affairs may not carry out a program under this section after the applicability date set forth in section 2(x)(1).

SEC. 5. PERIODIC PUBLICATION OF METRICS RELATING TO PROCESSING OF APPEALS BY DEPARTMENT OF VETERANS AFFAIRS.

The Secretary of Veterans Affairs shall periodically publish on an Internet website of the Department of Veterans Affairs the following:

(1) With respect to the processing by the Secretary of appeals under the new appeals system of decisions regarding claims for benefits under laws administered by the Secretary, the following:

(A) For the Veterans Benefits Administration and, to the extent practicable, each regional office of the Department of Veterans Affairs, the number of—

(i) supplemental claims under section 5108 of title 38, United States Code, as amended by section 2(i), that are pending; and

(ii) requests for higher-level review under section 5104B of such title, as added by section 2(g), that are pending.

(B) The number of appeals on any docket maintained under section 7107 of such title, as amended by section 2(t), that are pending.

(C) The average duration for processing claims and supplemental claims, disaggregated by regional office.

(D) The average duration for processing requests for higher-level review under section 5104B of such title, as added by section 2(g), disaggregated by regional office.

(E) The average number of days that appeals are pending on a docket of the Board of Veterans' Appeals maintained pursuant to section 7107 of such title, as amended by section 2(t), disaggregated by—

(i) appeals that include a request for a hearing;

(ii) appeals that do not include a request for a hearing and do include submittal of evidence; and

(iii) appeals that do not include a request for a hearing and do not include submittal of evidence.

(F) With respect to the policy developed and implemented under section 7107(e) of such title, as amended by section 2(t)—

(i) the number of cases moved from one docket to another pursuant to such policy;

(ii) the average time cases were pending prior to moving from one docket to another; and

(iii) the average time to adjudicate the cases after so moving.

(G) The total number of remands to obtain advisory medical opinions under section 5109(d) of title 38, United States Code, as added by section 2(j).

(H) The average number of days between the date on which the Board remands a claim to obtain an advisory medical opinion under section 5109(d) of such title, as so added, and the date on which the advisory medical opinion is obtained.

(I) The average number of days between the date on which the Board remands a claim to obtain an advisory medical opinion under section 5109(d) of such title, as so added, and the date on which the agency of original jurisdiction issues a decision taking that advisory opinion into account.

(J) The number of appeals that are granted, the number of appeals that are remanded, and the number of appeals that are denied by the Board disaggregated by docket.

(K) The number of claimants each year that take action within the period set forth in section 5110(a)(2) of such title, as added by section 2(l), to protect their effective date under such section 5110(a)(2), disaggregated by the status of the claimants taking the actions, such as whether the claimant is represented by a veterans service organization, the claimant is represented by an attorney, or the claimant is taking such action pro se.

(L) The total number of times on average each claimant files under section 5110(a)(2) of such title, as so added, to protect their effective date under such section, disaggregated by the subparagraph of such section under which they file.

(M) The average duration, from the filing of an initial claim until the claim is resolved and claimants no longer take any action to protect their effective date under section 5110(a)(2) of such title, as so added—

(i) of claims under the new appeals system, excluding legacy claims that opt in to the new appeals system; and

(ii) of legacy claims that opt in to the new appeals system.

(N) How frequently an action taken within one year to protect an effective date under section 5110(a)(2) of such title, as so added, leads to additional grant of benefits, disaggregated by action taken.

(O) The average of how long it takes to complete each segment of the claims process while claimants are protecting the effective date under such section, disaggregated by the time waiting for the claimant to take an action and the time waiting for the Secretary to take an action.

(P) The number and the average amount of retroactive awards of benefits from the Secretary as a result of protected effective dates under such section, disaggregated by action taken.

(Q) The average number of times claimants submit to the Secretary different claims with respect to the same condition, such as an initial claim and a supplemental claim.

(R) The number of cases each year in which a claimant inappropriately tried to take simultaneous actions, such as filing a supplemental claim while a higher-level review is pending, what actions the Secretary took in response, and how long it took on average to take those actions.

(S) In the case that the Secretary develops and implements a policy under section 5104C(a)(2)(D) of such title, as amended by section 2(h)(1), the number of actions withdrawn and new actions taken pursuant to such policy.

(T) The number of times the Secretary received evidence relating to an appeal or higher-level review at a time not authorized under the new appeals system, disaggregated by actions taken by the Secretary to deal with the evidence and how long on average it took to take those actions.

(U) The number of errors committed by the Secretary in carrying out the Secretary's duty to assist under section 5103A of title 38, United States Code, that were identified by higher-level review and by the Board, disaggregated by type of error, such as errors relating to private records and inadequate examinations, and a comparison with errors committed by the Secretary in carrying out such duty with respect to appeals of decisions on legacy claims.

(V) An assessment of the productivity of employees at the regional offices and at the Board, disaggregated by level of experience of the employees.

(W) The percentage of cases that are decided within the goals established by the Secretary for deciding cases, disaggregated by cases that involve a supplemental claim, cases that involve higher-level review, and by docket maintained under section 7107(a) of such title, as amended by section 2(t), or in the case that the Secretary has not established goals for deciding cases, the percentage of cases which are decided within one year, two years, three years, and more than three years, disaggregated by docket.

(X) Of the cases that involve higher-level review, the percentage of decisions that are overturned in whole or in part by the higher-level adjudicator, that are upheld by the higher-level adjudicator, and that are returned for correction of an error.

(Y) The frequency by which the Secretary readjudicates a claim pursuant to section 5108 of such title, as amended by section 2(i), and the frequency by which readjudication pursuant to section 5108 of such title, as so amended, results in an award of benefits.

(Z) In any case in which the Board decides to screen cases for a purpose described in section 7107(d) of such title, as amended by section 2(t)(1)—

(i) a description of the way in which the cases are screened and the purposes for which they are screened;

(ii) a description of the effect such screening has had on—

(I) the timeliness of the issuance of decisions of the Board; and

(II) the inventory of cases before the Board; and

(iii) the type and frequency of development errors detected through such screening.

(2) With respect to the processing by the Secretary of appeals of decisions on legacy claims, the following:

(A) The average duration of each segment of the appeals process, disaggregated by periods in which the Secretary is waiting for a claimant to take an action and periods in which the claimant is waiting for the Secretary to take an action.

(B) The frequency by which appeals lead to additional grant of benefits by the Secretary, disaggregated by whether the additional benefits are a result of additional evidence added after the initial decision.

(C) The number and average amount of retroactive awards of benefits resulting from an appeal.

(D) The average duration from filing a legacy claim with the Secretary until all appeals and remands relating to such legacy claim are completed.

(E) The average number of times claimants submit to the Secretary different claims with respect to the same condition, such as an initial claim, new and material evidence, or a claim for an increase in benefits.

(F) An assessment of the productivity of employees at the regional offices and at the Board, disaggregated by level of experience of the employees.

(G) The average number of days the duration of an appeal is extended because the Secretary secured or attempted to secure an advisory medical opinion under section 5109 of title 38, United States Code, or section 7109 of such title (as in effect on the day before the date of the enactment of this Act).

(H) The frequency by which claims are reopened pursuant to section 5108 of such title and the frequency by which such reopening results in an award of benefits.

(3) With respect to the processing by the Secretary of appeals of decisions on legacy claims that opt in to the new appeals system, the following:

(A) The cumulative number of such legacy claims.

(B) The portion of work in the new appeals system attributable to appeals of decisions on such legacy claims.

(C) The average period such legacy claims were pending before opting in to the new appeals system and the average period required to adjudicate such legacy claims on average after opting in—

(i) with respect to claims at a regional office of the Department of Veterans Affairs, disaggregated by—

(I) supplemental claims under section 5108 of title 38, United States Code, as amended by section 2(i); and

(II) requests for higher-level review under section 5104B of such title, as added by section 2(g); and

(ii) with respect to appeals, disaggregated by docket of the Board maintained under section 7107 of such title, as amended by section 2(t).

SEC. 6. DEFINITIONS.

In this Act:

(1) CLAIMANT.—The term “claimant” has the meaning given such term in section 5100 of title 38, United States Code.

(2) LEGACY CLAIMS.—The term “legacy claim” means a claim—

(A) that was submitted to the Secretary of Veterans Affairs for a benefit under a law administered by the Secretary; and

(B) for which notice of a decision under section 5104 of title 38, United States Code, was provided by the Secretary before the date set forth in section 2(x).

(3) OPT IN.—The term “opt in” means, with respect to a legacy claim of a claimant, that the claimant elects to subject the claim to the new appeals system pursuant to—

(A) section 2(x)(3); or

(B) such other mechanism as the Secretary may prescribe for purposes of carrying out this Act and the amendments made by this Act.

(4) NEW APPEALS SYSTEM.—The term “new appeals system” means the set of processes and mechanisms by which the Secretary processes, pursuant to the authorities and requirements modified by section 2, claims for benefits under laws administered by the Secretary.

Attest:

Speaker of the House of Representatives.  

Attest:

Vice President of the United States and   
President of the Senate.

H.J.Res. 76 - Joint Resolution granting the consent and approval of Congress for the Commonwealth of Virginia, the State of Maryland, and the District of Columbia to a enter into a compact relating to the establishment of the Washington Metrorail...

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

Granting the consent and approval of Congress for the Commonwealth of Virginia, the State of Maryland, and the District of Columbia to enter into a compact relating to the establishment of the Washington Metrorail Safety Commission.

Whereas the Washington Metropolitan Area Transit Authority, an interstate compact agency of the District of Columbia, the Commonwealth of Virginia, and the State of Maryland, provides transportation services to millions of people each year, the safety of whom is paramount;

Whereas an effective and safe Washington Metropolitan Area Transit Authority system is essential to the commerce and prosperity of the National Capital region;

Whereas the Tri-State Oversight Committee, created by a memorandum of understanding amongst these 3 jurisdictions, has provided safety oversight of the Washington Metropolitan Area Transit Authority;

Whereas 49 U.S.C. 5329 requires the creation of a legally and financially independent state authority for safety oversight of all fixed rail transit facilities;

Whereas the District of Columbia, the Commonwealth of Virginia, and the State of Maryland intend to create a Washington Metrorail Safety Commission to act as the state safety oversight authority for the Washington Metropolitan Area Transit Authority system under 49 U.S.C. 5329; and

Whereas this compact is created for the benefit of the people of the District of Columbia, the Commonwealth of Virginia, and the State of Maryland and for the increase of their safety, commerce, and prosperity: Now, therefore, be it

Resolved by the Senate and House of Representatives of the United States of America in Congress assembled,

CONSENT AND APPROVAL OF CONGRESS

Section 1. The consent and approval of Congress is hereby given for the Commonwealth of Virginia, the State of Maryland, and the District of Columbia to enter into a compact for the safety oversight of the Washington Metropolitan Area Transit Authority Metrorail system (known as the Metrorail Safety Commission Interstate Compact), which has been negotiated by representatives of the State, the Commonwealth, and the District, substantially as follows:

ARTICLE I

Definitions

“1. As used in this MSC Compact, the following words and terms shall have the meanings set forth below, unless the context clearly requires a different meaning. Capitalized terms used herein, but not otherwise defined in this MSC Compact, shall have the definition set forth in regulations issued under 49 U.S.C. § 5329, as they may be revised from time to time.

“(a) ‘Alternate Member’ means an alternate member of the Board;

“(b) ‘Board’ means the board of directors of the Commission;

“(c) ‘Commission’ means the Washington Metrorail Safety Commission;

“(d) ‘Member’ means a member of the Board;

“(e) ‘MSC Compact’ means this Washington Metrorail Safety Commission Interstate Compact;

“(f) ‘Public Transportation Agency Safety Plan’ means the comprehensive agency safety plan for a rail transit agency required by 49 U.S.C. § 5329 and the regulations issued thereunder, as may be amended or revised from time to time;

“(g) ‘Public Transportation Safety Certification Training Program’ means the federal certification training program, as established and amended from time to time by applicable federal laws and regulations, for federal and state employees, or other designated personnel, who conduct safety audits and examinations of public transportation systems, and employees of public transportation agencies directly responsible for safety oversight;

“(h) ‘Safety Sensitive Position’ means any position held by a WMATA employee or contractor designated in the Public Transportation Agency Safety Plan for the WMATA Rail System and approved by the Commission as directly or indirectly affecting the safety of the passengers or employees of the WMATA Rail System;

“(i) ‘Signatory’ means the State of Maryland, the Commonwealth of Virginia, and the District of Columbia;

“(j) ‘State’, ‘state’, or ‘jurisdiction’ means the District of Columbia, the State of Maryland, or the Commonwealth of Virginia;

“(k) ‘Washington Metropolitan Area Transit Authority’ or ‘WMATA’ is the entity created by the WMATA Compact, which entity is responsible for providing certain rail fixed guideway public transportation system services;

“(l) ‘WMATA Compact’ means the Washington Metropolitan Area Transit Authority Compact, approved November 6, 1966 (80 Stat. 1324; D.C. Official Code § 9–1107.01 et seq.); and

“(m) ‘WMATA Rail System’ or ‘Metrorail’ means the rail fixed guideway public transportation system and all other real and personal property owned, leased, operated, or otherwise used by WMATA rail services and shall include WMATA rail projects under design or construction by owners other than WMATA.

ARTICLE II

Purpose And Functions

“2. The Signatories to the WMATA Compact hereby adopt this MSC Compact pursuant to 49 U.S.C. § 5329. The Commission created hereunder shall have safety regulatory and enforcement authority over the WMATA Rail System and shall act as the state safety oversight authority for WMATA under 49 U.S.C. § 5329, as may be amended from time to time. WMATA shall be subject to the Commission’s rules, regulations, actions, and orders.

“3. The purpose of this MSC Compact is to create a state safety oversight authority for the WMATA Rail System, pursuant to the mandate of federal law, as a common agency of each Signatory, empowered in the manner hereinafter set forth to review, approve, oversee, and enforce the safety of the WMATA Rail System, including, without limitation, to:

“(a) Have exclusive safety oversight authority and responsibility over the WMATA Rail System pursuant to federal law, including, without limitation, the power to restrict, suspend, or prohibit rail service on all or part of the WMATA Rail System as set forth in this MSC Compact;

“(b) Develop and adopt a written state safety oversight program standard;

“(c) Review and approve the WMATA Public Transportation Agency Safety Plan;

“(d) Investigate hazards, incidents, and accidents on the WMATA Rail System;

“(e) Require, review, approve, oversee, and enforce Corrective Action Plans developed by WMATA; and

“(f) Meet other requirements of federal and State law relating to safety oversight of the WMATA Rail System.

ARTICLE III

Establishment And Organization

“A. Washington Metrorail Safety Commission

“4. The Commission is hereby created as an instrumentality of each Signatory, which shall be a public body corporate and politic, and which shall have the powers and duties set forth in this MSC Compact.

“5. The Commission shall be financially and legally independent from WMATA.

“B. Board Membership

“6. The Commission shall be governed by a Board of 6 Members with 2 Members appointed or reappointed (including to fill an unexpired term) by each Signatory pursuant to the Signatory’s applicable laws.

“7. Each Signatory shall also appoint or reappoint (including to fill an unexpired term) one Alternate Member pursuant to the Signatory’s applicable laws.

“8. An Alternate Member shall participate and take action as a Member only in the absence of one or both Members appointed from the same jurisdiction as the Alternate Member’s appointing jurisdiction and, in such instances, may cast a single vote.

“9. Members and Alternate Members shall have backgrounds in transit safety, transportation, relevant engineering disciplines, or public finance.

“10. No Member or Alternate Member shall simultaneously hold an elected public office, serve on the WMATA board of directors, be employed by WMATA, or be a contractor to WMATA.

“11. Each Member and Alternate Member shall serve a 4-year term and may be reappointed for additional terms; except that, each Signatory shall make its initial appointments as follows:

“(a) One Member shall be appointed for a 4-year term;

“(b) One Member shall be appointed for a 2-year term; and

“(c) The Alternate Member shall be appointed for a 3-year term.

“12. Any person appointed to fill a vacancy shall serve for the unexpired term.

“13. Members and Alternate Members shall be entitled to reimbursement for reasonable and necessary expenses and shall be compensated for each day spent meeting on the business of the Commission at a rate of $200 per day or at such other rate as may be adjusted in appropriations approved by all of the Signatories.

“14. A Member or an Alternate Member may be removed or suspended from office only for cause in accordance with the laws of such Member’s or Alternate Member’s appointing jurisdiction.

“C. Quorum and Actions of the Board

“15. Four Members shall constitute a quorum, and the affirmative vote of 4 Members is required for action of the Board. Quorum and voting requirements under this paragraph may be met with one or more Alternate Members pursuant to section 8.

“16. The Commission action shall become effective upon enactment unless otherwise provided for by the Commission.

“D. Oath of Office

“17. Before entering office, each Member and Alternate Member shall take and subscribe to the following oath (or affirmation) of office or any such other oath or affirmation as the constitution or laws of the Signatory he or she represents shall provide:

  • “I, ___________, hereby solemnly swear (or affirm) that I will support and defend the Constitution and the laws of the United States as a Member (or Alternate Member) of the Board of the Washington Metrorail Safety Commission and will faithfully discharge the duties of the office upon which I am about to enter.

“E. Organization and Procedure

“18. The Board shall provide for its own organization and procedure. Meetings of the Board shall be held as frequently as the Board determines, but in no event less than quarterly. The Board shall keep minutes of its meetings and establish rules and regulations governing its transactions and internal affairs, including, without limitation, policies regarding records retention that are not in conflict with applicable federal record retention laws.

“19. The Commission shall keep commercially reasonable records of its financial transactions in accordance with accounting principles generally accepted in the United States of America.

“20. The Commission shall establish an office for the conduct of its affairs at a location to be determined by the Commission.

“21. The Commission shall adopt 5 U.S.C. § 552(a)–(d) and (g), and 5 U.S.C. § 552b, as both may be amended from time to time, as its freedom-of-information policy and open-meeting policy, respectively, and shall not be subject to the comparable laws or policies of any Signatory.

“22. Reports of investigations or inquiries adopted by the Board shall be made publicly available.

“23. The Commission shall adopt a policy on conflict of interest that shall be consistent with the regulations issued under 49 U.S.C. § 5329, as they may be revised from time to time, which, among other things, places appropriate separation between Members, officers, employees, contractors, and agents of the Commission and WMATA.

“24. The Commission shall adopt and utilize its own administrative procedure and procurement policies in conformance with applicable federal regulations and shall not be subject to the administrative procedure or procurement laws of any Signatory.

“F. Officers and Employees

“25. The Board shall elect a Chairman, Vice Chairman, Secretary, and Treasurer from among its Members, each for a 2-year term and shall prescribe their powers and duties.

“26. The Board shall appoint and fix the compensation and benefits of a chief executive officer who shall be the chief administrative officer of the Commission and who shall have expertise in transportation safety and one or more industry-recognized transportation safety certifications.

“27. Consistent with 49 U.S.C. § 5329, as may be amended from time to time, the Commission may employ, under the direction of the chief executive officer, such other technical, legal, clerical, and other employees on a regular, part-time, or as-needed basis as it determines necessary or desirable for the discharge of its duties.

“28. The Commission shall not be bound by any statute or regulation of any Signatory in the employment or discharge of any officer or employee of the Commission, but shall develop its own policies in compliance with federal law. The MSC shall, however, consider the laws of the Signatories in devising its employment and discharge policies, and when it deems it practical, devise policies consistent with the laws of the Signatories.

“29. The Board may fix and provide policies for the qualification, appointment, removal, term, tenure, compensation benefits, worker’s compensation, pension, and retirement rights of its employees subject to federal law. The Board may also establish a personnel system based on merit and fitness and, subject to eligibility, participate in the pension, retirement, and worker’s compensation plans of any Signatory or agency or political subdivision thereof.

ARTICLE IV

Powers

“A. Safety Oversight Powers

“30. In carrying out its purposes, the Commission, through its Board or designated employees or agents, shall, consistent with federal law:

“(a) Adopt, revise, and distribute a written State Safety Oversight Program;

“(b) Review, approve, oversee, and enforce the adoption and implementation of WMATA’s Public Transportation Agency Safety Plan;

“(c) Require, review, approve, oversee, and enforce the adoption and implementation of any Corrective Action Plans that the Commission deems appropriate;

“(d) Implement and enforce relevant federal and State laws and regulations relating to safety of the WMATA Rail System; and

“(e) Audit every 3 years the compliance of WMATA with WMATA’s Public Transportation Agency Safety Plan or conduct such an audit on an ongoing basis over a 3-year time frame.

“31. In performing its duties, the Commission, through its Board or designated employees or agents, may:

“(a) Conduct, or cause to be conducted, inspections, investigations, examinations, and testing of WMATA personnel and contractors, property, equipment, facilities, rolling stock, and operations of the WMATA Rail System, including, without limitation, electronic information and databases through reasonable means, which may include issuance of subpoenas;

“(b) Enter upon the WMATA Rail System and, upon reasonable notice and a finding by the chief executive officer that a need exists, upon any lands, waters, and premises adjacent to the WMATA Rail System, including, without limitation, property owned or occupied by the federal government, for the purpose of making inspections, investigations, examinations, and testing as the Commission may deem necessary to carry out the purposes of this MSC Compact, and such entry shall not be deemed a trespass. The Commission shall make reasonable reimbursement for any actual damage resulting to any such adjacent lands, waters, and premises as a result of such activities;

“(c) Compel WMATA’s compliance with any Corrective Action Plan or order of the Commission by such means as the Commission deems appropriate, including, without limitation, by:

“(1) Taking legal action in a court of competent jurisdiction;

“(2) Issuing citations or fines with funds going into an escrow account for spending by WMATA on Commission-directed safety measures;

“(3) Directing WMATA to prioritize spending on safety-critical items;

“(4) Removing a specific vehicle, infrastructure element, or hazard from the WMATA Rail System; and

“(5) Compelling WMATA to restrict, suspend, or prohibit rail service on all or part of the WMATA Rail System with an appropriate notice period dictated by the circumstances;

“(d) Direct WMATA to suspend or disqualify from performing in any Safety Sensitive Position an individual who is alleged to or has violated safety rules, regulations, policies, or laws;

“(e) Compel WMATA’s Office of the Inspector General, created under WMATA Board Resolution 2006–18, or any successor WMATA office or organization having similar duties, to conduct safety-related audits or investigations and to provide its findings to the Commission; and

“(f) Take such other actions as the Commission may deem appropriate consistent with its purpose and powers.

“32. Action by the Board under section 31(c)(5) shall require the unanimous vote of all Members present and voting. The Commission shall coordinate its enforcement activities with appropriate federal and State governmental authorities.

“B. General Powers

“33. In addition to the powers and duties set forth above, the Commission may:

“(a) Sue and be sued;

“(b) Adopt, amend, and repeal rules and regulations respecting the exercise of the powers conferred by this MSC Compact;

“(c) Create and abolish offices, employments, and positions (other than those specifically provided for in this MSC Compact) necessary or desirable for the purposes of the Commission;

“(d) Determine a staffing level for the Commission that is commensurate with the size and complexity of the WMATA Rail System, and require that employees and other designated personnel of the Commission, who are responsible for safety oversight, be qualified to perform such functions through appropriate training, including, without limitation, successful completion of the Public Transportation Safety Certification Training Program;

“(e) Contract for or employ consulting attorneys, inspectors, engineers, and such other experts necessary or desirable and, within the limitations prescribed in this MSC Compact, prescribe their powers and duties and fix their compensation;

“(f) Enter into and perform contracts, leases, and agreements necessary or desirable in the performance of its duties and in the execution of the powers granted under this MSC Compact;

“(g) Apply for, receive, and accept such payments, appropriations, grants, gifts, loans, advances, and other funds, properties, and services as may be transferred or made available to it by the United States government or any other public or private entity or individual, subject to the limitations specified in section 42;

“(h) Adopt an official seal and alter the same at its pleasure;

“(i) Adopt and amend by-laws, policies, and procedures governing the regulation of its affairs;

“(j) Appoint one or more advisory committees; and

“(k) Do such other acts necessary or desirable for the performance of its duties and the execution of its powers under this MSC Compact.

“34. Consistent with this MSC Compact, the Commission shall promulgate rules and regulations to carry out the purposes of this MSC Compact.

ARTICLE V

General Provisions

“A. Annual Safety Report

“35. The Commission shall make and publish annually a status report on the safety of the WMATA Rail System, which shall include, among other requirements established by the Commission and federal law, status updates of outstanding Corrective Action Plans, Commission directives, and on-going investigations. A copy of each such report shall be provided to:

“(a) The Administrator of the Federal Transit Administration;

“(b) The Governor of Virginia, the Governor of Maryland, and the Mayor of the District of Columbia;

“(c) The Chairman of the Council of the District of Columbia;

“(d) The President of the Maryland Senate and the Speaker of the Maryland House of Delegates;

“(e) The President of the Virginia Senate and the Speaker of the Virginia House of Delegates; and

“(f) The General Manager and each member of the board of directors of WMATA.

“36. The Commission may prepare, publish, and distribute such other safety reports that it deems necessary or desirable.

“B. Annual Report of Operations

“37. The Commission shall make and publish an annual report on its programs, operations, and finances, which shall be distributed in the same manner provided by section 35.

“38. The Commission may also prepare, publish, and distribute such other public reports and informational materials as it deems necessary or desirable.

“C. Annual Independent Audit

“39. An independent annual audit shall be made of the financial accounts of the Commission. The audit shall be made by qualified certified public accountants selected by the Board, who shall have no personal interest, direct or indirect, in the financial affairs of the Commission or any of its officers or employees. The report of audit shall be prepared in accordance with generally accepted auditing principles and shall be distributed in the same manner provided by section 35. Members, employees, agents, and contractors of the Commission shall provide access to information necessary or desirable for the conduct of the annual audit.

“D. Financing

“40. The Commission’s operations shall be funded, independently of WMATA, by the Signatory jurisdictions and, when available, by federal funds. The Commission shall have no authority to levy taxes.

“41. The Signatories shall unanimously agree on adequate funding levels for the Commission and make equal contributions of such funding, subject to annual appropriation, to cover the portion of Commission operations not funded by federal funds.

“42. The Commission may borrow up to 5% of its last annual appropriations budget in anticipation of receipts, or as otherwise set forth in the appropriations budget approved by all of the Signatories, from any lawful lending institution for any purpose of this MSC Compact, including, without limitation, for administrative expenses. Such loans shall be for a term not to exceed 2 years, or at such longer term approved by each Signatory pursuant to its laws as evidenced by the written authorization by the Mayor of the District of Columbia and the Governors of Maryland and Virginia, and at such rates of interest as shall be acceptable to the Commission.

“43. With respect to the District of Columbia, the commitment or obligation to render financial assistance to the Commission shall be created, by appropriation or in such other manner, or by such other legislation, as the District of Columbia shall determine; provided, that any such commitment or obligation shall be approved by Congress pursuant to the District of Columbia Home Rule Act, approved December 24, 1973 (87 Stat. 774; D.C. Official Code § 1–201.01 et seq.).

“44. Pursuant to the requirements of 31 U.S.C. §§ 1341, 1342, 1349 to 1351, and 1511 to 1519, and D.C. Official Code §§ 47–105 and 47–355.01 to 355.08 (collectively, the ‘Anti-Deficiency Acts’), the District cannot obligate itself to any financial commitment in any present or future year unless the necessary funds to pay that commitment have been appropriated and are lawfully available for the purpose committed. Thus, pursuant to the Anti-Deficiency Acts, nothing in the MSC Compact creates an obligation of the District in anticipation of an appropriation for such purpose, and the District’s legal liability for the payment of any amount under this MSC Compact does not and may not arise or obtain in advance of the lawful availability of appropriated funds for the applicable fiscal year.

“E. Tax Exemption

“45. The exercise of the powers granted by this MSC Compact shall in all respects be for the benefit of the people of the District of Columbia, the Commonwealth of Virginia, and the State of Maryland and for the increase of their safety, commerce, and prosperity, and as the activities associated with this MSC Compact shall constitute the performance of essential governmental functions, the Commission shall not be required to pay any taxes or assessments upon the services or any property acquired or used by the Commission under the provisions of this MSC Compact or upon the income therefrom, and shall at all times be free from taxation within the District of Columbia, the Commonwealth of Virginia, and the State of Maryland.

“F. Reconsideration of Commission Orders

“46. WMATA shall have the right to petition the Commission for reconsideration of an order based on rules and procedures developed by the Commission.

“47. Consistent with section 16, the filing of a petition for reconsideration shall not act as a stay upon the execution of a Commission order, or any part of it, unless the Commission orders otherwise. WMATA may appeal any adverse action on a petition for reconsideration as set forth in section 48.

“G. Judicial Matters

“48. The United States District Court for the Eastern District of Virginia, Alexandria Division, the United States District Court for the District of Maryland, Southern Division, and the United States District Court for the District of Columbia shall have exclusive and original jurisdiction of all actions brought by or against the Commission and to enforce subpoenas under this MSC Compact.

“49. The commencement of a judicial proceeding shall not operate as a stay of a Commission order unless specifically ordered by the court.

“H. Liability and Indemnification

“50. The Commission and its Members, Alternate Members, officers, agents, employees, or representatives shall not be liable for suit or action or for any judgment or decree for damages, loss, or injury resulting from action taken within the scope of their employment or duties under this MSC Compact, nor required in any case arising or any appeal taken under this MSC Compact to give a supersedeas bond or security for damages. Nothing in this paragraph shall be construed to protect such person from suit or liability for damage, loss, injury, or liability caused by the intentional or willful and wanton misconduct of such person.

“51. The Commission shall be liable for its contracts and for its torts and those of its Members, Alternate Members, officers, agents, employees, and representatives committed in the conduct of any proprietary function, in accordance with the law of the applicable Signatory (including, without limitation, rules on conflict of laws) but shall not be liable for any torts occurring in the performance of a governmental function. The exclusive remedy for such breach of contract or tort for which the Commission shall be liable, as herein provided, shall be by suit against the Commission. Nothing contained in this MSC Compact shall be construed as a waiver by the District of Columbia, the Commonwealth of Virginia, or the State of Maryland of any immunity from suit.

“I. Commitment of Parties

“52. Each of the Signatories pledges to each other faithful cooperation in providing safety oversight for the WMATA Rail System, and, to affect such purposes, agrees to consider in good faith and request any necessary legislation to achieve the objectives of this MSC Compact.

“J. Amendments and Supplements

“53. Amendments and supplements to this MSC Compact shall be adopted by legislative action of each of the Signatories and the consent of Congress. When one Signatory adopts an amendment or supplement to an existing section of this MSC Compact, that amendment or supplement shall not be immediately effective, and the previously enacted provision or provisions shall remain in effect in each jurisdiction until the amendment or supplement is approved by the other Signatories and is consented to by Congress.

“K. Withdrawal and Termination

“54. Any Signatory may withdraw from this MSC Compact, which action shall constitute a termination of this MSC Compact.

“55. Withdrawal from this MSC Compact shall be by a Signatory’s repeal of this MSC Compact from its laws, but such repeal shall not take effect until 2 years after the effective date of the repealed statute and written notice of the withdrawal being given by the withdrawing Signatory to the governors or mayor, as appropriate, of the other Signatories.

“56. Prior to termination of this MSC Compact, the Commission shall provide each Signatory:

“(a) A mechanism for concluding the operations of the Commission;

“(b) A proposal to maintain state safety oversight of the WMATA Rail System in compliance with applicable federal law;

“(c) A plan to hold surplus funds in a trust for a successor regulatory entity for 4 years after the termination of this MSC Compact; and

“(d) A plan to return any surplus funds that remain 4 years after the creation of the trust.

“L. Construction and Severability

“57. This MSC Compact shall be liberally construed to effectuate the purposes for which it is created.

“58. If any part or provision of this MSC Compact or the application thereof to any person or circumstances be adjudged invalid by any court of competent jurisdiction, such judgment shall be confined in its operation to the part, provision, or application directly involved in the controversy in which such judgment shall have been rendered and shall not affect or impair the validity of the remainder of this MSC Compact or the application thereof to other persons or circumstances, and the Signatories hereby declare that they would have entered into this MSC Compact or the remainder thereof had the invalidity of such provision or application thereof been apparent.

“M. Adoption; Effective Date

“59. This MSC Compact shall be adopted by the Signatories in the manner provided by law therefor and shall be signed and sealed in 4 duplicate original copies. One such copy shall be filed with the Secretary of State of the State of Maryland, the Secretary of the Commonwealth of Virginia, and the Secretary of the District of Columbia in accordance with the laws of each jurisdiction. One copy shall be filed and retained in the archives of the Commission upon its organization. This MSC Compact shall become effective upon the enactment of concurring legislation by the District of Columbia, the Commonwealth of Virginia, and the State of Maryland, and consent thereto by Congress and when all other acts or actions have been taken, including, without limitation, the signing and execution of this MSC Compact by the Governors of Maryland and Virginia and the Mayor of the District of Columbia.

“N. Conflict of Laws

“60. Any conflict between any authority granted herein, or the exercise of such authority, and the provisions of the WMATA Compact shall be resolved in favor of the exercise of such authority by the Commission.

“61. All other general or special laws inconsistent with this MSC Compact are hereby declared to be inapplicable to the Commission or its activities.”.

RIGHT TO ALTER, AMEND, OR REPEAL

Sec. 2. The right to alter, amend, or repeal this joint resolution is expressly reserved. The consent granted by this joint resolution shall not be construed as impairing or in any manner affecting any right or jurisdiction of the United States in and over the region that forms the subject of the Compact.

CONSTRUCTION AND SEVERABILITY

Sec. 3. It is intended that the provisions of this Compact shall be reasonably and liberally construed to effectuate the purposes thereof. If any part or application of this Compact, or legislation enabling the Compact, is held invalid, the remainder of the Compact or its application to other situations or persons shall not be affected.

INCONSISTENCY OF LANGUAGE

Sec. 4. The validity of this Compact shall not be affected by any insubstantial differences in its form or language as adopted by the State of Maryland, the Commonwealth of Virginia, and the District of Columbia.

EFFECTIVE DATE

Sec. 5. This joint resolution shall take effect on the date of enactment of this joint resolution.



Speaker of the House of Representatives.  


Vice President of the United States and   
President of the Senate.

H.R. 3218 - Harry W. Colmery Veterans Educational Assistance 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 title 38, United States Code, to make certain improvements in the laws administered by the Secretary 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 “Harry W. Colmery Veterans Educational Assistance Act of 2017”.

(b) Table Of Contents.—The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. References to title 38, United States Code.

TITLE I—POST-9/11 EDUCATIONAL ASSISTANCE PROGRAM

Sec. 101. Consideration of certain time spent receiving medical care from Secretary of Defense as active duty for purposes of eligibility for Post-9/11 Educational Assistance.
Sec. 102. Educational assistance under Post-9/11 Educational Assistance Program for members of the Armed Forces awarded the Purple Heart.
Sec. 103. Inclusion of Fry Scholarship recipients and Purple Heart recipients in Yellow Ribbon G.I. Education Enhancement Program.
Sec. 104. Inclusion of certain members of the Armed Forces serving on active duty in Yellow Ribbon G.I. Education Enhancement Program.
Sec. 105. Consolidation of certain eligibility tiers under Post-9/11 Educational Assistance Program of the Department of Veterans Affairs.
Sec. 106. Eligibility for Post-9/11 Educational Assistance for certain members of reserve components of Armed Forces who lost entitlement to educational assistance under Reserve Educational Assistance Program.
Sec. 107. Calculation of monthly housing stipend under Post-9/11 Educational Assistance Program based on location of campus where classes are attended.
Sec. 108. Charge to entitlement for certain licensure and certification tests and national tests under Department of Veterans Affairs Post-9/11 Educational Assistance Program.
Sec. 109. Restoration of entitlement to educational assistance and other relief for veterans affected by school closure or disapproval.
Sec. 110. Additional authorized transfer of unused Post-9/11 Educational Assistance benefits to dependents upon death of originally designated dependent.
Sec. 111. Edith Nourse Rogers STEM Scholarship.
Sec. 112. Honoring the national service of members of the Armed Forces by elimination of time limitation for use of entitlement.
Sec. 113. Monthly stipend for certain members of the reserve components of the Armed Forces receiving Post-9/11 Educational Assistance.
Sec. 114. Annual reports to Congress on information on student progress submitted by educational institutions.
Sec. 115. Improvement of information technology of the veterans benefits administration of the Department of Veterans Affairs.
Sec. 116. Department of Veterans Affairs high technology pilot program.

TITLE II—OTHER EDUCATIONAL ASSISTANCE PROGRAMS

Sec. 201. Work-study allowance.
Sec. 202. Duration of educational assistance under Survivors’ and Dependents’ Educational Assistance Program.
Sec. 203. Olin E. Teague increase in amounts of educational assistance payable under Survivors’ and Dependents’ Educational Assistance Program.

TITLE III—ADMINISTRATION OF EDUCATIONAL ASSISTANCE PROGRAMS

Sec. 301. State approving agency funding.
Sec. 302. Authorization for use of Post-9/11 Educational Assistance to pursue independent study programs at certain educational institutions that are not institutions of higher learning.
Sec. 303. Provision of information on priority enrollment for veterans in certain courses of education.
Sec. 304. Limitation on use of reporting fees payable to educational institutions and sponsors of programs of apprenticeship.
Sec. 305. Training for school certifying officials.
Sec. 306. Extension of authority for Advisory Committee on Education.
Sec. 307. Department of Veterans Affairs provision of on-campus educational and vocational counseling for veterans.
Sec. 308. Provision of information regarding veteran entitlement to educational assistance.
Sec. 309. Treatment, for purposes of educational assistance administered by the Secretary of Veterans Affairs, of educational courses that begin seven or fewer days after the first day of an academic term.
Sec. 310. Inclusion of risk-based reviews in State approving agency oversight activities.
Sec. 311. Comptroller General study of State approving agency performance.

TITLE IV—RESERVE COMPONENT BENEFITS

Sec. 401. Eligibility of reserve component members for Post-9/11 Educational Assistance.
Sec. 402. Time limitation for training and rehabilitation for veterans with service-connected disabilities.

TITLE V—OTHER MATTERS

Sec. 501. Repeal inapplicability of modification of basic allowance for housing to benefits under laws administered by Secretary of Veterans Affairs.
Sec. 502. Reconsideration of previously denied claims for disability compensation for veterans who allege full-body exposure to nitrogen mustard gas, sulfur mustard gas, or Lewisite during World War II.

SEC. 2. REFERENCES TO TITLE 38, UNITED STATES CODE.

Except as otherwise expressly provided, whenever in this Act an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of title 38, United States Code.

 

TITLE I—POST-9/11 EDUCATIONAL ASSISTANCE PROGRAM

SEC. 101. CONSIDERATION OF CERTAIN TIME SPENT RECEIVING MEDICAL CARE FROM SECRETARY OF DEFENSE AS ACTIVE DUTY FOR PURPOSES OF ELIGIBILITY FOR POST-9/11 EDUCATIONAL ASSISTANCE.

(a) In General.—Section 3301(1)(B) is amended by inserting “12301(h),” after “12301(g),”.

(b) Retroactive Application.—The amendment made by subsection (a) shall apply with respect to service in the Armed Forces occurring on or after September 11, 2001.

(c) Application With Respect To Use Of Entitlement.—An individual who is entitled to educational assistance by reason of the amendment made by subsection (a) may use such entitlement to pursue a course of education beginning on or after August 1, 2018.

 

SEC. 102. EDUCATIONAL ASSISTANCE UNDER POST-9/11 EDUCATIONAL ASSISTANCE PROGRAM FOR MEMBERS OF THE ARMED FORCES AWARDED THE PURPLE HEART.

(a) Eligibility.— Section 3311(b) is amended by adding at the end the following new paragraph:

“(10) An individual who is awarded the Purple Heart for service in the Armed Forces occurring on or after September 11, 2001, and continues to serve on active duty in the Armed Forces or is discharged or released from active duty as described in subsection (c).”.

(b) Amount Of Assistance.—Section 3313(c)(1) is amended by striking “or (9)” and inserting “(9), or (10)”.

(c) Effective Date.—The amendments made by this section shall take effect on August 1, 2018.

 

SEC. 103. INCLUSION OF FRY SCHOLARSHIP RECIPIENTS AND PURPLE HEART RECIPIENTS IN YELLOW RIBBON G.I. EDUCATION ENHANCEMENT PROGRAM.

(a) In General.—Section 3317(a) is amended, in the second sentence, by striking “paragraphs (1) and (2)” and inserting “paragraphs (1), (2), (9), and (10)”.

(b) Effective Date.—The amendment made by subsection (a) shall take effect on August 1, 2018.

 

SEC. 104. INCLUSION OF CERTAIN MEMBERS OF THE ARMED FORCES SERVING ON ACTIVE DUTY IN YELLOW RIBBON G.I. EDUCATION ENHANCEMENT PROGRAM.

(a) In General.—Section 3317(a) is amended, in the first sentence, by striking “section 3313(c)(1)(A)” and inserting “subsection (c)(1)(A) or (e)(2)(A) of section 3313 of this title”.

(b) Effective Date.—The amendment made by subsection (a) shall take effect on August 1, 2022.

 

SEC. 105. CONSOLIDATION OF CERTAIN ELIGIBILITY TIERS UNDER POST-9/11 EDUCATIONAL ASSISTANCE PROGRAM OF THE DEPARTMENT OF VETERANS AFFAIRS.

(a) Entitlement.—Section 3311(b), as amended by section 102, is further amended—

(1) in paragraph (6)(A), by striking “12 months” and inserting “6 months”;

(2) by striking paragraph (7); and

(3) by redesignating paragraphs (8), (9), and (10) as paragraphs (7), (8), and (9), respectively.

(b) Amount Of Educational Assistance.—Section 3313(c) is amended by striking paragraph (7).

(c) Conforming Amendments.—Chapter 33 is further amended as follows:

(1) In section 3311(f), by striking “paragraph (9)” each place it appears and inserting “paragraph (8)”.

(2) In section 3313, as amended by section 102—

(A) in subsection (c)(1), by striking “(9), or (10)” and inserting “(8), or (9)”;

(B) in subsection (d), by striking “paragraphs (2) through (7)” each place it appears and inserting “paragraphs (2) through (6)”;

(C) in subsection (e)(2)(C)—

(i) by striking “paragraphs (3) through (8)” and inserting “paragraphs (3) through (7)”; and

(ii) by striking “paragraphs (2) through (7)” and inserting “paragraphs (2) through (6)”;

(D) in subsection (f)(2)(A)(ii), by striking “paragraphs (2) through (7)” and inserting “paragraphs (2) through (6)”;

(E) in subsection (g)(3)—

(i) in subparagraph (A)(iv)—

(I) by striking “paragraphs (3) through (8)” and inserting “paragraphs (3) through (7)”; and

(II) by striking “paragraphs (2) through (7)” and inserting “paragraphs (2) through (6)”;

(ii) in subparagraph (B)(iii)—

(I) by striking “paragraphs (3) through (8)” and inserting “paragraphs (3) through (7)”; and

(II) by striking “paragraphs (2) through (7)” and inserting “paragraphs (2) through (6)”;

(iii) in subparagraph (C)(ii)—

(I) in subclause (I), by striking “(9)” and inserting “(8)”; and

(II) in subclause (II)—

(aa) by striking “paragraphs (3) through (8)” and inserting “paragraphs (3) through (7)”; and

(bb) by striking “paragraphs (2) through (7)” and inserting “paragraphs (2) through (6)”; and

(iv) in subparagraph (D)(ii)—

(I) in subclause (I), by striking “(9)” and inserting “(8)”; and

(II) in subclause (II)—

(aa) by striking “paragraphs (3) through (8)” and inserting “paragraphs (3) through (7)”; and

(bb) by striking “paragraphs (2) through (7)” and inserting “paragraphs (2) through (6)”; and

(F) in subsection (h), by striking “paragraphs (2) through (7)” and inserting “paragraphs (2) through (6)”;

(3) In section 3316—

(A) in subsection (a)(1), by striking “paragraphs (2) through (7)” and inserting “paragraphs (2) through (6)”; and

(B) in subsection (b)(1), by striking “paragraphs (2) through (7)” and inserting “paragraphs (2) through (6)”.

(4) In section 3317(a), in the second sentence, as amended by section 103, by striking “paragraphs (1), (2), (9), and (10)” and inserting “paragraphs (1), (2), (8), and (9)”.

(5) In section 3321(b)(4), as amended by section 112, by striking “section 3311(b)(9)” and inserting “section 3311(b)(8)”.

(6) In section 3322—

(A) in subsection (e), by striking “3311(b)(9)” and inserting “3311(b)(8)”;

(B) in subsection (f), by striking “3311(b)(9)” and inserting “3311(b)(8)”; and

(C) in subsection (h)(2), by striking “3311(b)(9)” and inserting “3311(b)(8)”.

(7) In section 3679(c)(2)(B), by striking “3311(b)(9)” and inserting “3311(b)(8)”.

(d) Effective Date.—The amendments made by this section shall take effect on August 1, 2020.

SEC. 106. ELIGIBILITY FOR POST-9/11 EDUCATIONAL ASSISTANCE FOR CERTAIN MEMBERS OF RESERVE COMPONENTS OF ARMED FORCES WHO LOST ENTITLEMENT TO EDUCATIONAL ASSISTANCE UNDER RESERVE EDUCATIONAL ASSISTANCE PROGRAM.

(a) Election.—Section 16167 of title 10, United States Code, is amended by adding at the end the following new subsection:

“(c) Eligibility For Post-9/11 Educational Assistance.—A member who loses eligibility for benefits under this chapter pursuant to subsection (b) shall be allowed to elect (in such form and manner as the Secretary of Veterans Affairs may prescribe) to have such service previously credited toward this chapter credited towards establishing eligibility for educational assistance under chapter 33 of title 38, notwithstanding the provisions of section 16163(e) of this title or section 3322(h)(1) of title 38.”.

(b) Qualification Of Service.—Section 3301(1) of title 38, United States Code, shall be construed to include, in the case of a member of a reserve component of the Armed Forces who, before November 25, 2015, established eligibility for educational assistance under chapter 1607 of title 10, United States Code, pursuant to section 16163(a)(1) of such title, but lost eligibility for such educational assistance pursuant to section 16167(b) of such title, service on active duty (as defined in section 101 of such title) that satisfies the requirements of section 16163(a)(1) of such title.

(c) Entitlement.—Section 3311(b)(6) of title 38, United States Code, shall be construed to include an individual who, before November 25, 2015, established eligibility for educational assistance under chapter 1607 of title 10, United States Code, pursuant to section 16163(b) of such title, but lost such eligibility pursuant to section 16167(b) of such title.

(d) Duration.—Notwithstanding section 3312 of title 38, United States Code, an individual who establishes eligibility for educational assistance under chapter 33 of such title by crediting towards such chapter service previously credited towards chapter 1607 of title 10, United States Code, is only entitled to a number of months of educational assistance under section 3313 of title 38, United States Code, equal to the number of months of entitlement remaining under chapter 1607 of title 10, United States Code, at the time of conversion to chapter 33 of title 38, United States Code.

 

SEC. 107. CALCULATION OF MONTHLY HOUSING STIPEND UNDER POST-9/11 EDUCATIONAL ASSISTANCE PROGRAM BASED ON LOCATION OF CAMPUS WHERE CLASSES ARE ATTENDED.

(a) In General.—Section 3313(c)(1)(B)(i)(I) is amended by striking “the institution of higher learning at which the individual is enrolled” and inserting “the campus of the institution of higher learning where the individual physically participates in a majority of classes”.

(b) Effective Date.—The amendment made by subsection (a) shall apply with respect to initial enrollment in a program of education on or after August 1, 2018.

 

SEC. 108. CHARGE TO ENTITLEMENT FOR CERTAIN LICENSURE AND CERTIFICATION TESTS AND NATIONAL TESTS UNDER DEPARTMENT OF VETERANS AFFAIRS POST-9/11 EDUCATIONAL ASSISTANCE PROGRAM.

(a) Licensure And Certification Tests.—Subsection (c) of section 3315 is amended—

(1) by striking “shall be determined at the rate of one month (rounded to the nearest whole month)” and inserting “shall be pro-rated based on the actual amount of the fee charged for the test relative to the rate for 1 month”; and

(2) by striking “for each amount paid that equals” and inserting “payable”.

(b) National Tests.—Section 3315A is amended—

(1) in subsection (a), by adding at the end the following new paragraph:

“(3) A national test that evaluates prior learning and knowledge and provides an opportunity for course credit at an institution of higher learning as so described.”; and

(2) in subsection (c)—

(A) by striking “shall be determined at the rate of one month (rounded to the nearest whole month)” and inserting “shall be pro-rated based on the actual amount of the fee charged for the test relative to the rate for 1 month”; and

(B) by striking “for each amount paid that equals” and inserting “payable”.

(c) Tests Included.—Section 3452(b) is amended in the last sentence—

(1) by striking “and national tests providing” and inserting “, national tests providing”; and

(2) by inserting before the period at the end the following: “, and national tests that evaluate prior learning and knowledge and provides an opportunity for course credit at an institution of higher learning”.

(d) Effective Date.—The amendments made by this Act shall apply to a test taken on or after August 1, 2018.

SEC. 109. RESTORATION OF ENTITLEMENT TO EDUCATIONAL ASSISTANCE AND OTHER RELIEF FOR VETERANS AFFECTED BY SCHOOL CLOSURE OR DISAPPROVAL.

(a) School Closure Or Disapproval.—

(1) RESTORATION OF ENTITLEMENT.—Chapter 36 is amended by adding at the end the following new section:

Ҥ 3699. Effects of closure or disapproval of educational institution

“(a) Closure Or Disapproval.—Any payment of educational assistance described in subsection (b) shall not—

“(1) be charged against any entitlement to educational assistance of the individual concerned; or

“(2) be counted against the aggregate period for which section 3695 of this title limits the receipt of educational assistance by such individual.

“(b) Educational Assistance Described.—Subject to subsection (c), the payment of educational assistance described in this paragraph is the payment of such assistance to an individual for pursuit of a course or program of education at an educational institution under chapter 30, 32, 33, or 35 of this title, or chapter 1606 or 1607 of title 10, if the Secretary determines that the individual—

“(1) was unable to complete such course or program as a result of—

“(A) the closure of the educational institution; or

“(B) the disapproval of the course or a course that is a necessary part of that program under this chapter by reason of—

“(i) a provision of law enacted after the date on which the individual enrolls at such institution affecting the approval or disapproval of courses under this chapter; or

“(ii) after the date on which the individual enrolls at such institution, the Secretary prescribing or modifying regulations or policies of the Department affecting such approval or disapproval; and

“(2) did not receive credit or lost training time, toward completion of the program of education being so pursued.

“(c) Period Not Charged.—The period for which, by reason of this subsection, educational assistance is not charged against entitlement or counted toward the applicable aggregate period under section 3695 of this title shall not exceed the aggregate of—

“(1) the portion of the period of enrollment in the course from which the individual did not receive credit or with respect to which the individual lost training time, as determined under subsection (b)(2); and

“(2) the period by which a monthly stipend is extended under section 3680(a)(2)(B) of this title.

“(d) Continuing Pursuit Of Disapproved Courses.— (1) The Secretary may treat a course of education that is disapproved under this chapter as being approved under this chapter with respect to an individual described in paragraph (2) if the Secretary determines, on a case-by-case basis, that—

“(A) such disapproval is the result of an action described in clause (i) or (ii) of subsection (b)(1)(B); and

“(B) continuing pursuing such course is in the best interest of the individual.

“(2) An individual described in this paragraph is an individual who is pursuing a course of education at an educational institution under chapter 30, 32, 33, or 35 of this title, or chapter 1606 or 1607 of title 10, as of the date on which the course is disapproved under this chapter.

“(e) Notice Of Closures.—Not later than 5 business days after the date on which the Secretary receives notice that an educational institution will close or is closed, the Secretary shall provide to each individual who is enrolled in a course or program or education at such educational institution using entitlement to educational assistance under chapter 30, 32, 33, or 35 of this title, or chapter 1606 or 1607 of title 10, notice of—

“(1) such closure and the date of such closure; and

“(2) the effect of such closure on the individual’s entitlement to educational assistance pursuant to this section.”.

(2) CLERICAL AMENDMENT.—The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 3698 the following new item:


“3699. Effects of closure or disapproval of educational institution.”.

(b) Monthly Housing Stipend.—

(1) IN GENERAL.—Subsection (a) section 3680 is amended—

(A) by striking the matter after paragraph (3)(B);

(B) in paragraph (3), by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively;

(C) by redesignating paragraphs (1) through (3) as subparagraphs (A) through (C), respectively;

(D) in the matter preceding subparagraph (A), as redesignated, in the first sentence, by striking “Payment of” and inserting “(1) Except as provided in paragraph (2), payment of”; and

(E) by adding at the end the following new paragraph (2):

“(2) Notwithstanding paragraph (1), the Secretary may, pursuant to such regulations as the Secretary shall prescribe, continue to pay allowances to eligible veterans and eligible persons enrolled in courses set forth in paragraph (1)(A)—

“(A) during periods when educational institutions are temporarily closed under an established policy based on an Executive order of the President or due to an emergency situation, except that the total number of weeks for which allowances may continue to be so payable in any 12-month period may not exceed 4 weeks; or

“(B) solely for the purpose of awarding a monthly housing stipend described in section 3313 of this title, during periods following a permanent closure of an educational institution, or following the disapproval of a course of study described in section 3699(b)(1)(B) of this title, except that payment of such a stipend may only be continued until the earlier of—

“(i) the date of the end of the term, quarter, or semester during which the closure or disapproval occurred; and

“(ii) the date that is 120 days after the date of the closure or disapproval.”.

(2) CONFORMING AMENDMENT.—Paragraph (1)(C)(ii) of such subsection, as redesignated, is amended by striking “described in subclause (A) of this clause” and inserting “described in clause (i)”.

(c) Applicability.—

(1) SCHOOL CLOSURE OR DISAPPROVAL.—

(A) IN GENERAL.—The amendments made by subsection (a) shall take effect on the date that is 90 days after the date of the enactment of this Act, and shall apply with respect to courses and programs of education discontinued as described in section 3699 of title 38, United States Code, as added by subsection (a)(1), after January 1, 2015.

(B) SPECIAL APPLICATION.—With respect to courses and programs of education discontinued as described in section 3699 of title 38, United States Code, as added by subsection (a)(1), during the period beginning January 1, 2015, and ending on the date of the enactment of this Act, an individual who does not transfer credits from such program of education shall be deemed to be an individual who did not receive such credits, as described in subsection (b)(2) of such section, except that the period for which the individual’s entitlement is not charged shall be the entire period of the individual’s enrollment in the program of education. In carrying out this paragraph, the Secretary of Veterans Affairs, in consultation with the Secretary of Education, shall establish procedures to determine whether the individual transferred credits to a comparable course or program of education.

(2) MONTHLY HOUSING STIPEND.—The amendments made by subsection (b) shall take effect on August 1, 2018, and shall apply with respect to courses and programs of education discontinued as described in section 3699 of title 38, United States Code, as added by such subsection, on or after the date of the enactment of this Act.

SEC. 110. ADDITIONAL AUTHORIZED TRANSFER OF UNUSED POST-9/11 EDUCATIONAL ASSISTANCE BENEFITS TO DEPENDENTS UPON DEATH OF ORIGINALLY DESIGNATED DEPENDENT.

(a) Transfer Upon Death Of Dependent.—Section 3319 is amended—

(1) in subsection (f)(1), by inserting after “section 3321” the following: “, and except as provided in subsection (k) or (l),”; and

(2) by adding at the end the following new subsection:

“(k) Additional Transfer Upon Death Of Dependent.—In the case of a dependent to whom entitlement to educational assistance is transferred under this section who dies before using all of such entitlement, the individual who transferred the entitlement to the dependent may transfer any remaining entitlement to a different eligible dependent, notwithstanding whether the individual is serving as a member of the Armed Forces when such transfer is executed.

“(l) Transfer By Dependent.—In the case of an individual who transfers entitlement to educational assistance under this section who dies before the dependent to whom entitlement to educational assistance is so transferred has used all of such entitlement, such dependent may transfer such entitlement to another eligible dependent in accordance with the provisions of this section.”.

(b) Effective Dates.—

(1) ELIGIBLE DEATHS.—The amendments made by this section shall apply with respect to deaths occurring on or after August 1, 2009.

(2) USE OF ENTITLEMENT.—A dependent to whom entitlement to educational assistance is transferred under subsection (k) or (l) of section 3319 of title 38, United States Code, as added by subsection (a), may use such entitlement to pursue a course of education beginning on or after August 1, 2018.

SEC. 111. EDITH NOURSE ROGERS STEM SCHOLARSHIP.

(a) In General.—Subchapter II of chapter 33 is amended by adding at the end the following new section:

Ҥ 3320. Edith Nourse Rogers STEM Scholarship

“(a) In General.—Subject to the limitation under subsection (f), the Secretary shall provide additional benefits to eligible individuals selected by the Secretary under this section. Such benefits shall be known as the ‘Edith Nourse Rogers STEM Scholarship’.

“(b) Eligibility.—For purposes of this section, an eligible individual is an individual—

“(1) who is or was entitled to educational assistance under section 3311 of this title;

“(2) who has used all of the educational assistance to which the individual is entitled under this chapter or will, based on the individual’s rate of usage, use all of such assistance within 180 days of applying for benefits under this section;

“(3) who applies for assistance under this section; and

“(4) who—

“(A) is an individual who—

“(i) is enrolled in a program of education leading to a post-secondary degree that, in accordance with the guidelines of the applicable regional or national accrediting agency, requires more than the standard 128 semester (or 192 quarter) credit hours for completion in a standard, undergraduate college degree in—

“(I) biological or biomedical science;

“(II) physical science;

“(III) science technologies or technicians;

“(IV) computer and information science and support services;

“(V) mathematics or statistics;

“(VI) engineering;

“(VII) engineering technologies or an engineering-related field;

“(VIII) a health profession or related program;

“(IX) a medical residency program;

“(X) an agriculture science program or a natural resources science program; or

“(XI) other subjects and fields identified by the Secretary as meeting national needs;

“(ii) has completed at least 60 standard semester (or 90 quarter) credit hours in a field referred to in clause (i); or

“(B) is an individual who has earned a post-secondary degree in a field referred to in subparagraph (A)(i) and is enrolled in a program of education leading to a teaching certification.

“(c) Priority.—In selecting eligible individuals to receive additional benefits under this section, the Secretary shall give priority to the following individuals:

“(1) Individuals who require the most credit hours described in subsection (b)(4).

“(2) Individuals who are entitled to educational assistance under this chapter by reason of paragraph (1), (2), (8), or (9) of section 3311(b) of this title.

“(d) Amount Of Assistance.— (1) The Secretary shall pay to each eligible individual who receives additional benefits under this section the monthly amount payable under section 3313 of this title for not more than 9 months of the program of education in which the individual is enrolled (adjusted with respect to the individual pursuant to section 3313(c), as appropriate), except that the aggregate amount paid to an individual under this section may not exceed $30,000.

“(2) The Secretary may not pay to such an individual an amount in addition to the amount payable under paragraph (1) by reason of section 3317 of this title.

“(3) An individual who receives additional benefits under this section may also receive amounts payable by a college or university pursuant to section 3317 of this title.

“(e) Prohibition On Transfer.—An individual who receives additional benefits under this section may not transfer any amount of such additional benefits under section 3319 of this title.

“(f) Maximum Amount Of Total Assistance.—The total amount of benefits paid to all eligible individuals under this section may not exceed—

“(1) $25,000,000 for fiscal year 2019;

“(2) $75,000,000 for each of fiscal years 2020 through 2022; and

“(3) $100,000,000 for fiscal year 2023 and each subsequent fiscal year.

“(g) Congressional Notice.—If the Secretary identifies a new subject or field pursuant to subsection (b)(4)(A)(i)(XI) as meeting a national need, the Secretary shall submit to Congress notice of such identification at least 90 days before conferring eligibility on any individual for purposes of this section on the basis of such identification, including any analysis of labor market supply and demand used in identifying the new subject or field, as applicable.”.

(b) Clerical Amendment.—The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 3319 the following new item:


“3320. Edith Nourse Rogers STEM Scholarship.”.

(c) Effective Date.—Section 3320 of title 38, United States Code, shall take effect on August 1, 2019.

(d) Comptroller General Report.—

(1) INTERIM REPORT.—Not later than August 1, 2022, the Comptroller General of the United States shall submit to Congress a report containing the results of an interim assessment of the Comptroller General of the Edith Nourse Rogers STEM Scholarship program under section 3320 of title 38, United States Code, as added by subsection (a). Such report shall include the recommendations of the Comptroller General for improving the scholarship program and an assessment of each of the following, using rigorous, systematic, and objective methodology, and including comparisons to eligible veterans who did not participate in the program:

(A) An explanation of the identification of the Secretary of Veterans Affairs of subjects and fields meeting national needs under subsection (b)(4)(A)(i)(XI) of such section, including any analysis of labor market supply and demand, as applicable.

(B) An evaluation of the types of educational institutions and programs where beneficiaries use the educational assistance provided under the scholarship program.

(C) The completion rate of students participating in the program.

(D) The job placement rate for individuals who completed a program of education using educational assistance provided under the scholarship program in the field of study of the program of education.

(E) The median annual earnings of individuals who completed a program of education using educational assistance provided under the scholarship program.

(F) The average age of the individuals who received educational assistance under the scholarship program.

(G) An assessment of the extent to which any educational institutions made changes to degrees or programs of education offered by the institution for which the scholarship program may be used after the date of the enactment of this Act.

(2) FINAL REPORT.—Not later than August 1, 2024, the Comptroller General shall submit to Congress an assessment of such scholarship program that includes each of the following:

(A) Each item described in subparagraph (A) through (G) of paragraph (1).

(B) The percentage of individuals who completed a program of education using educational assistance provided under the scholarship program who were subsequently employed for a period of 6 months or longer in the field of study of the program of education.

(C) The percentage of individuals who completed a program of education using educational assistance provided under the scholarship program who were subsequently employed for a period of less than 6 months in the field of study of the program of education.

SEC. 112. HONORING THE NATIONAL SERVICE OF MEMBERS OF THE ARMED FORCES BY ELIMINATION OF TIME LIMITATION FOR USE OF ENTITLEMENT.

(a) In General.—Subsection (a) of section 3321 is amended—

(1) by striking “individual’s entitlement” and all that follows through the period and inserting “individual’s entitlement—”; and

(2) by adding at the end the following new paragraphs:

“(1) in the case of an individual whose last discharge or release from active duty is before January, 1, 2013, expires at the end of the 15-year period beginning on the date of such discharge or release; or

“(2) in the case of an individual whose last discharge or release from active duty is on or after January 1, 2013, shall not expire.”.

(b) Children Of Deceased Members.—Subsection (b)(4) of such section is amended—

(1) by inserting “of this title” after “3311(b)(9)”;

(2) by striking “child’s entitlement” and all that follows through the period and inserting “child’s entitlement—”; and

(3) by adding at the end the following new subparagraphs:

“(A) in the case of a child who first becomes entitled to such entitlement before January 1, 2013, expires at the end of the 15-year period beginning on the date of such child’s eighteenth birthday; or

“(B) in the case of a child who first becomes entitled to such entitlement on or after January 1, 2013, shall not expire.”.

(c) Spouses Of Deceased Members.—Subsection (b) of such section is further amended by adding at the end the following new paragraph:

“(5) APPLICABILITY TO SPOUSES OF DECEASED MEMBERS.—The period during which a spouse entitled to educational assistance by reason of section 3311(b)(9) may use such spouse’s entitlement—

“(A) in the case of a spouse who first becomes entitled to such entitlement before January 1, 2013, expires at the end of the 15-year period beginning on the date on which the spouse first becomes entitled to such entitlement; or

“(B) in the case of a spouse who first becomes entitled to such entitlement on or after January 1, 2013, shall not expire.”.

SEC. 113. MONTHLY STIPEND FOR CERTAIN MEMBERS OF THE RESERVE COMPONENTS OF THE ARMED FORCES RECEIVING POST-9/11 EDUCATIONAL ASSISTANCE.

(a) In General.—Section 3313 is further amended by adding at the end the following new subsection:

“(j) Determination Of Monthly Stipends During Certain Active Duty Service.—

“(1) PRO RATA BASIS.—In any month in which an individual described in paragraph (2) is performing active duty service described in section 3301(1)(B) of this title, the Secretary shall determine the amount of monthly stipends payable under this section for such month on a pro rata basis for the period of such month in which the covered individual is not performing such active duty service.

“(2) INDIVIDUAL DESCRIBED.—An individual described in this paragraph is an individual who is—

“(A) a member of the reserve components of the Armed Forces; and

“(B) pursuing a program of education using educational assistance under this chapter.”.

(b) Application.—The amendment made by subsection (a) shall apply with respect to a quarter, semester, or term, as applicable, commencing on or after August 1, 2018.

SEC. 114. ANNUAL REPORTS TO CONGRESS ON INFORMATION ON STUDENT PROGRESS SUBMITTED BY EDUCATIONAL INSTITUTIONS.

Section 3326 is amended—

(1) by striking “As a condition” and inserting “(a) Submittal Of Information By Educational Institutions.—As a condition”; and

(2) by adding at the end the following new subsection:

“(b) Reports To Congress.—Not later than March 1 of each year, the Secretary shall submit to Congress a report that includes a summary of the information provided by educational institutions under subsection (a) for the calendar year preceding the year during which such report is submitted.”.

SEC. 115. IMPROVEMENT OF INFORMATION TECHNOLOGY OF THE VETERANS BENEFITS ADMINISTRATION OF THE DEPARTMENT OF VETERANS AFFAIRS.

(a) Processing Of Certain Educational Assistance Claims.—The Secretary of Veterans Affairs shall, to the maximum extent possible, make such changes and improvements to the information technology system of the Veterans Benefits Administration of the Department of Veterans Affairs to ensure that—

(1) to the maximum extent possible, all original and supplemental claims for educational assistance under chapter 33 of title 38, United States Code, are adjudicated electronically; and

(2) rules-based processing is used to make decisions with respect to such claims with little human intervention.

(b) Implementation Plan.—Not later than 180 days after the date of the enactment of this Act, the Secretary of Veterans Affairs shall submit to Congress a plan to implement the changes and improvements described in subsection (a).

(c) Report.—Not later than 1 year after the date of the enactment of this Act, the Secretary of Veterans Affairs shall submit to Congress a report on the implementation of the changes and improvements described in subsection (a).

(d) Authorization Of Appropriations.—There is authorized to be appropriated to the Secretary of Veterans Affairs $30,000,000 to carry out this section during fiscal years 2018 and 2019.

SEC. 116. DEPARTMENT OF VETERANS AFFAIRS HIGH TECHNOLOGY PILOT PROGRAM.

(a) Pilot Program.—The Secretary of Veterans Affairs shall carry out a pilot program under which the Secretary shall provide eligible veterans with the opportunity to enroll in high technology programs of education that the Secretary determines provide training or skills sought by employers in a relevant field or industry.

(b) Eligibility.—For purposes of the pilot program under this section, an eligible veteran is a veteran who is entitled to educational assistance under chapter 30, 32, 33, 34, or 35 of title 38, United States Code, or chapter 1606 or 1607 of title 10, United States Code.

(c) Contracts.—

(1) IN GENERAL.—For purposes of carrying out subsection (a), by not later than 180 days after August 1, 2018, the Secretary shall seek to enter into contracts with any number of qualified providers of high technology programs of education for the provision of such programs to eligible veterans under the pilot program. Each such contract shall provide for the conditions under which the Secretary may terminate the contract with the provider and the procedures for providing for the completion of the instruction of students who were enrolled in a program provided by such provider in the case of such a termination.

(2) PAYMENT OF CONTRACTORS.—A contract under this subsection shall provide that the Secretary shall pay to a provider—

(A) upon the enrollment of an eligible veteran in the program, 25 percent of the cost of the tuition and other fees for the program of education for the veteran;

(B) upon the completion of the program by the veteran, 25 percent of such cost; and

(C) upon the employment of the veteran in the field of study of the program following completion of the program, 50 percent of such cost.

(3) QUALIFIED PROVIDERS.—For purposes of the pilot program, a provider of a high technology program of education is qualified if—

(A) the provider has been operational for at least 2 years;

(B) the provider has successfully provided the high technology program for at least 1 year; and

(C) the provider meets the approval criteria developed by the Secretary under paragraph (4).

(4) APPROVAL CRITERIA.—The Secretary shall develop criteria for approving providers for purposes of the pilot program. In developing such criteria, the Secretary may consult with State approving agencies. Such criteria is not required to meet the requirements of section 3672 of title 38, United States Code.

(5) TUITION REIMBURSEMENT.—In entering into contracts to carry out the pilot program, the Secretary shall give preference to a qualified provider that offers tuition reimbursement for any student who—

(A) completes a program of education offered by the provider; and

(B) does not find full-time meaningful employment in the field of study of the program within the 180-day period beginning on the date the student completes the program.

(d) Housing Stipend.—The Secretary shall pay to each eligible veteran who is enrolled in a high technology program of education under the pilot program on a full-time basis a monthly housing stipend equal to the product—

(1) of—

(A) in the case of a veteran pursuing resident training, the monthly amount of the basic allowance for housing payable under section 403 of title 37, United States Code, for a member with dependents in pay grade E–5 residing in the military housing area that encompasses all or the majority portion of the ZIP code area in which is located the institution at which the individual is enrolled; or

(B) in the case of a veteran pursuing a program of education through distance learning, a monthly amount equal to 50 percent of the amount payable under subparagraph (A), multiplied by

(2) the lesser of—

(A) 1.0; or

(B) the number of course hours borne by the individual in pursuit of the program of education involved, divided by the minimum number of course hours required for full-time pursuit of such program of education, rounded to the nearest multiple of 10.

(e) High Technology Program Of Education Defined.—In this section, the term “high technology program of education” means a program of education that—

(1) is offered by an entity other than an institution of higher learning;

(2) does not lead to a degree; and

(3) provides instruction in computer programming, computer software, media application, data processing, or information sciences.

(f) Reports.—

(1) SECRETARY OF VETERANS AFFAIRS.—Not later than 1 year after the date of the enactment of this Act, and annually thereafter, the Secretary shall submit to Congress a report on the pilot program under this section.

(2) COMPTROLLER GENERAL.—

(A) INTERIM REPORT.—Not later than 3 years after the date on which the Secretary first enters into a contract under this section, the Comptroller General of the United States shall submit to Congress a report containing the results of the interim assessment of the Comptroller General. Such report shall include the recommendations of the Comptroller General for improving the pilot program and an assessment of each of the following:

(i) The technology experience of the directors and instructors of the providers of high technology programs of education under the pilot program.

(ii) Whether the providers cooperated with the technology industry to create the curriculum for the program of education.

(iii) Whether the providers use an open source curriculum for the program of education.

(iv) The admittance rate into the pilot program.

(v) The job placement and retention rate for veterans who completed a program of education under the pilot program in the field of study of the program.

(vi) The percentage of veterans who completed a program of education under the pilot program who were subsequently employed for a period of 6 months or longer in a field of study of the program.

(vii) The percentage of veterans who completed a program of education under the pilot program who were subsequently employed for a period of less than 6 months in a field of study of the program.

(viii) The median annual salary of veterans who completed a program of education under the pilot program and were subsequently employed.

(ix) As applicable, the transfer rates to other academic or vocational programs and certifications and licensure exam passage rates.

(x) The average age of veterans who participated in the pilot program.

(B) FINAL REPORT.—Not later than 5 years after the date on which the Secretary first enters into a contract under this section, the Comptroller General shall submit to Congress a final report on the pilot program. Such report shall include the recommendation of the Comptroller General with respect to whether the program should be extended and an assessment of each item described in clauses (i) through (x) of subparagraph (A).

(g) Authorization Of Appropriations.—For each fiscal year during which the Secretary carries out a pilot program under this section, $15,000,000 shall be made available for such purpose from funds appropriated to, or otherwise made available to, the Department for the payment of readjustment benefits.

(h) Termination.—The authority to carry out a pilot program under this section shall terminate on the date that is 5 years after the date on which the Secretary first enters into a contract under this section.

 

TITLE II—OTHER EDUCATIONAL ASSISTANCE PROGRAMS

SEC. 201. WORK-STUDY ALLOWANCE.

Section 3485(a)(4) is amended by striking “the period beginning on June 30, 2017, and ending on June 30, 2022,” each place it appears and inserting “any time on or after June 30, 2017,”.

SEC. 202. DURATION OF EDUCATIONAL ASSISTANCE UNDER SURVIVORS’ AND DEPENDENTS’ EDUCATIONAL ASSISTANCE PROGRAM.

Section 3511(a)(1) is amended—

(1) by striking “chapter for” and all that follows through the period and inserting “chapter—”; and

(2) by adding at the end the following new subparagraphs:

“(A) in the case of a person who first enrolls in a program of education using such entitlement before August 1, 2018, for an aggregate period not in excess of 45 months (or to the equivalent thereof in part-time training); or

“(B) in the case of a person who first enrolls in a program of education using such entitlement on or after August 1, 2018, for an aggregate period not in excess of 36 months (or to the equivalent thereof in part-time training).”.

SEC. 203. OLIN E. TEAGUE INCREASE IN AMOUNTS OF EDUCATIONAL ASSISTANCE PAYABLE UNDER SURVIVORS’ AND DEPENDENTS’ EDUCATIONAL ASSISTANCE PROGRAM.

(a) Increase.—Section 3532 is amended—

(1) in subsection (a)—

(A) in paragraph (1)—

(i) by striking “$788” and inserting “$1,224”;

(ii) by striking “$592” and inserting “$967”; and

(iii) by striking “$394” and inserting “$710”; and

(B) in paragraph (2)(B), by striking “$788” and inserting “$1,224”; and

(2) in subsection (b), by striking “$788” and inserting “$1,224”.

(b) Effective Date.—The amendments made by subsection (a) shall apply with respect to a month that begins on or after October 1, 2018.

 

TITLE III—ADMINISTRATION OF EDUCATIONAL ASSISTANCE PROGRAMS

SEC. 301. STATE APPROVING AGENCY FUNDING.

(a) Increase.—Section 3674(a) of title 38, United States Code, is amended—

(1) in paragraph (2)(A), by striking “out of amounts available for the payment of readjustment benefits” and inserting “out of amounts in the Department of Veterans Affairs readjustment benefits account and amounts appropriated to the Secretary”;

(2) by redesignating paragraph (4) as paragraph (5);

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

“(4) In addition to amounts made available under paragraph (5), there is authorized to be appropriated to carry out this section $3,000,000 for fiscal year 2019 and each subsequent fiscal year.”; and

(4) in paragraph (5), as so redesignated—

(A) by striking “The total” and inserting “(A) The total”;

(B) by striking “for any fiscal year shall be $19,000,000” and inserting “for fiscal year 2018 shall be $21,000,000 and for fiscal year 2019 and thereafter shall be $23,000,000”; and

(C) by adding at the end the following new subparagraph:

“(B) Beginning in fiscal year 2019, whenever there is an increase in benefit amounts payable under title II of the Social Security Act (42 U.S.C. 401 et seq.) as a result of a determination made under section 215(i) of such Act (42 U.S.C. 415(i)), the Secretary shall, effective on the date of such increase in benefit amounts, increase the amount in effect under subparagraph (A), as in effect immediately prior to the date of such increase in benefit amounts payable under title II of the Social Security Act, by the same percentage as the percentage by which such benefit amounts are increased.”.

SEC. 302. AUTHORIZATION FOR USE OF POST-9/11 EDUCATIONAL ASSISTANCE TO PURSUE INDEPENDENT STUDY PROGRAMS AT CERTAIN EDUCATIONAL INSTITUTIONS THAT ARE NOT INSTITUTIONS OF HIGHER LEARNING.

Section 3680A is amended—

(1) in subsection (a)—

(A) in the matter preceding paragraph (1), by striking “in—” and inserting “in any of the following:”;

(B) in paragraph (1)—

(i) by striking “any” and inserting “Any”; and

(ii) by striking the semicolon at the end and inserting a period;

(C) in paragraph (2)—

(i) by striking “any” and inserting “Any”; and

(ii) by striking the semicolon at the end and inserting a period;

(D) in paragraph (3)—

(i) by striking “any” and inserting “Any”; and

(ii) by striking “; or” and inserting a period; and

(E) by striking paragraph (4) and inserting the following new paragraph (4):

“(4) Any independent study program except an independent study program (including such a program taken over open circuit television) that—

“(A) is accredited by an accrediting agency or association recognized by the Secretary of Education under subpart 2 of part H of title IV of the Higher Education Act of 1965 (20 U.S.C. 1099b);

“(B) leads to—

“(i) a standard college degree;

“(ii) a certificate that reflects educational attainment offered by an institution of higher learning; or

“(iii) a certificate that reflects completion of a course of study offered by—

“(I) an area career and technical education school (as defined in subparagraphs (C) and (D) of section 3(3) of the Carl D. Perkins Career and Technical Education Act of 2006 (20 U.S.C. 2302(3))) that provides education at the postsecondary level; or

“(II) a postsecondary vocational institution (as defined in section 102(c) of the Higher Education Act of 1965 (20 U.S.C. 1002(c))) that provides education at the postsecondary level; and

“(C) in the case of a program described in subparagraph (B)(iii)—

“(i) provides training aligned with the requirements of employers in the State or local area where the program is located, which may include in-demand industry sectors or occupations; and

“(ii) provides a student, upon completion of the program, with a recognized postsecondary credential that is recognized by employers in the relevant industry, which may include a credential recognized by industry or sector partnerships in the State or local area where the industry is located; and

“(iii) meets such content and instructional standards as may be required to comply with the criteria under section 3676(c)(14) and(15) of this title.”; and

(2) by adding at the end the following new subsection:

“(h) In this section, the terms ‘State or local area’, ‘recognized postsecondary credential’, ‘industry or sector partnership’, and ‘in-demand industry sector or occupation’ have the meaning given such terms in section 3 of the Workforce Innovation and Opportunity Act (29 U.S.C. 3102).”.

SEC. 303. PROVISION OF INFORMATION ON PRIORITY ENROLLMENT FOR VETERANS IN CERTAIN COURSES OF EDUCATION.

Section 3698(c)(1)(C) is amended—

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

(2) in clause (x), by striking the period and inserting “; and”; and

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

“(xi) information on whether the institution administers a priority enrollment system that allows certain student veterans to enroll in courses earlier than other students.”.

SEC. 304. LIMITATION ON USE OF REPORTING FEES PAYABLE TO EDUCATIONAL INSTITUTIONS AND SPONSORS OF PROGRAMS OF APPRENTICESHIP.

(a) In General.—Subsection (c) of section 3684 is amended to read as follows:

“(c) (1) The Secretary may pay to any educational institution, or to the sponsor of a program of apprenticeship, furnishing education or training under either this chapter or chapter 31, 34, or 35 of this title, a reporting fee which will be in lieu of any other compensation or reimbursement for reports or certifications which such educational institution or sponsor of a program of apprenticeship is required to submit to the Secretary by law or regulation.

“(2) Such reporting fee shall be computed for each calendar year by multiplying $16 by the number of eligible veterans or eligible persons enrolled under this chapter or chapter 31, 34, or 35 of this title. The reporting fee shall be paid to such educational institution or sponsor of a program of apprenticeship as soon as feasible after the end of the calendar year for which it is applicable.

“(3) No reporting fee payable to an educational institution under this subsection shall be subject to offset by the Secretary against any liability of such institution for any overpayment for which such institution may be administratively determined to be liable under section 3685 of this title unless such liability is not contested by such institution or has been upheld by a final decree of a court of appropriate jurisdiction.

“(4) Any reporting fee paid to an educational institution or sponsor of a program of apprenticeship after the date of the enactment of the Post-9/11 Veterans Educational Assistance Improvements Act of 2011 (Public Law 111–377)—

“(A) shall be utilized by such institution or sponsor solely for the making of certifications required under this chapter or chapter 31, 34, or 35 of this title or for otherwise supporting programs for veterans; and

“(B) with respect to an institution that has 100 or more enrollees described in paragraph (2) may not be used for or merged with amounts available for the general fund of the educational institution or sponsor of a program of apprenticeship.

“(5) The reporting fee payable under this subsection shall be paid from amounts appropriated for readjustment benefits.”.

(b) Effective Date.—The amendment made by subsection (a) shall take effect on August 1, 2018.

SEC. 305. TRAINING FOR SCHOOL CERTIFYING OFFICIALS.

(a) Training Requirement.—The Secretary of Veterans Affairs shall, in consultation with the State approving agencies, set forth requirements relating to training for school certifying officials employed by covered educational institutions offering courses of education approved under chapter 36 of title 38, United States Code. If a covered educational institution does not ensure that a school certifying official employed by the educational institution meets such requirements, the Secretary may disapprove any course of education offered by such educational institution.

(b) Definitions.—In this section:

(1) The term “covered educational institution” means an educational institution that has enrolled 20 or more individuals using educational assistance under title 38, United States Code.

(2) The term “school certifying official” means an employee of an educational institution with primary responsibility for certifying veteran enrollment at the educational institution.

(3) The term “State approving agency” means a department or agency of a State designated under section 3671 of title 38, United States Code.

(c) Effective Date.—This section shall take effect on August 1, 2018.

SEC. 306. EXTENSION OF AUTHORITY FOR ADVISORY COMMITTEE ON EDUCATION.

Section 3692 is amended by striking “December 31, 2017” and inserting “December 31, 2022”.

SEC. 307. DEPARTMENT OF VETERANS AFFAIRS PROVISION OF ON-CAMPUS EDUCATIONAL AND VOCATIONAL COUNSELING FOR VETERANS.

(a) In General.—Chapter 36 is amended by inserting after section 3697A the following new section:

Ҥ 3697B. On-campus educational and vocational counseling

“(a) In General.—The Secretary shall provide educational and vocational counseling services for individuals described in section 3697A(b) of this title at locations on the campuses of institutions of higher learning selected by the Secretary. Such counseling services shall be provided by employees of the Department who provide such services under section 3697A of this title.

“(b) Selection Of Locations.— (1) To be selected by the Secretary under this section, an institution of higher learning shall provide an appropriate space on the campus of the institution where counseling services can be provided under this section.

“(2) In selecting locations for the provision of counseling services under this section, the Secretary shall seek to select locations where the maximum number of veterans would have access to such services.

“(c) Annual Report.—Not later than 180 days after the date of the enactment of this section, and each year thereafter, the Secretary shall submit to Congress a report on the counseling services provided under this section. Such report shall include, for the year covered by the report—

“(1) the average ratio of counselors providing such services to individuals who received such services at each location where such services were provided;

“(2) a description of such services provided;

“(3) the recommendations of the Secretary for improving the provision of such services; and

“(4) any other matters the Secretary determines appropriate.”.

(b) Clerical Amendment.—The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 3697A the following new item:


“3697B. On-campus educational and vocational counseling.”.

SEC. 308. PROVISION OF INFORMATION REGARDING VETERAN ENTITLEMENT TO EDUCATIONAL ASSISTANCE.

(a) In General.—Subchapter II of chapter 36 is further amended by adding at the end the following new section:

Ҥ 3699A. Provision of certain information to educational institutions

“(a) In General.—For each veteran or other individual pursuing a course of education that has been approved under this chapter using educational assistance to which the veteran or other individual is entitled under chapter 30, 32, 33, or 35 of this title, the Secretary shall make available to the educational institution offering the course information about the amount of such educational assistance to which the veteran or other individual is entitled. Such information shall be provided to such educational institution through a secure information technology system accessible by the educational institution and shall be regularly updated to reflect any amounts used by the veteran or other individual.

“(b) Election.—A veteran or other individual pursuing a course of education described in subsection (a) may elect not to provide the information described in such subsection to an educational institution in a manner prescribed by the Secretary.”.

(b) Clerical Amendment.—The table of sections at the beginning of such chapter is further amended by inserting after the item relating to section 3699 the following new item:


“3699A. Provision of certain information to educational institutions.”.

(c) Effective Date.—Section 3699A of title 38, United States Code, as added by this section, shall take effect on August 1, 2018.

SEC. 309. TREATMENT, FOR PURPOSES OF EDUCATIONAL ASSISTANCE ADMINISTERED BY THE SECRETARY OF VETERANS AFFAIRS, OF EDUCATIONAL COURSES THAT BEGIN SEVEN OR FEWER DAYS AFTER THE FIRST DAY OF AN ACADEMIC TERM.

Section 3684(a) is amended—

(1) by redesignating paragraph (4) as paragraph (5); and

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

“(4) A course offered by an educational institution that does not begin on the first day of an academic term, but does begin seven or fewer days after such day, shall be treated as beginning on such day for purposes of this section.”.

SEC. 310. INCLUSION OF RISK-BASED SURVEYS IN STATE APPROVING AGENCY OVERSIGHT ACTIVITIES.

Section 3673(d) is amended—

(1) in the subsection heading, by striking “Compliance And” ;

(2) by striking “such compliance and oversight” and inserting “conducting risk-based surveys and other such oversight”; and

(3) by inserting “, in consultation with the State approving agencies,” after “as the Secretary”.

SEC. 311. COMPTROLLER GENERAL STUDY OF STATE APPROVING AGENCY PERFORMANCE.

(a) Study Required.—The Comptroller General of the United States shall carry out a study on the performance of State approving agencies. Such study shall include each of the following:

(1) An analysis of the effectiveness of the cooperation between the Secretary of Veterans Affairs and State approving agencies regarding the execution of shared compliance and oversight responsibilities under chapter 36 of title 38, United States Code.

(2) An analysis of the resources necessary for State approving agencies to fulfill the responsibilities of such agencies under such title, including an analysis of whether Congress has appropriated sufficient funds for State approving agencies to fulfill such responsibilities and the historic effect of funding on the ability of such agencies to fulfill such responsibilities.

(3) An evaluation of the use by State approving agencies of risk-based methods of review for identifying violations of established standards under such chapter.

(4) An examination of how State approving agencies use risk factors, including rapid increases in veteran enrollment, increases in the amount of benefits per capita, volume of student complaints, rates of Federal student loan defaults of veterans, veteran completion rates, deficiencies identified by accreditors and other State agencies, and deficiencies in Department of Veterans Affairs program administration compliance, in their oversight and compliance responsibilities and in selecting educational institutions for review of eligibility.

(5) Recommendations on how the Secretary and State approving agencies can better use data to evaluate, approve, or disapprove educational institutions under such chapter.

(b) Report To Congress.—Not later than 1 year after the date of the enactment of this Act, the Comptroller General 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 the study required under subsection (a) and the findings and recommendations of the Comptroller General with respect to such study.

 

TITLE IV—RESERVE COMPONENT BENEFITS

SEC. 401. ELIGIBILITY OF RESERVE COMPONENT MEMBERS FOR POST-9/11 EDUCATIONAL ASSISTANCE.

(a) In General.—Section 3301(1)(B) is amended by striking “or 12304” and inserting “12304, 12304a, or 12304b”.

(b) Retroactive Application.—The amendment made by subsection (a) shall apply with respect to service in the Armed Forces occurring on or after the date of the enactment of the Post-9/11 Veterans Educational Assistance Act of 2008 (Public Law 110–252).

(c) Application With Respect To Use Of Entitlement.—An individual who is entitled to educational assistance by reason of the amendment made by subsection (a) may use such entitlement to pursue a course of education beginning on or after August 1, 2018.

SEC. 402. TIME LIMITATION FOR TRAINING AND REHABILITATION FOR VETERANS WITH SERVICE-CONNECTED DISABILITIES.

Section 3103(f) is amended by striking “or 12304” and inserting “12304, 12304a, or 12304b”.

 

TITLE V—OTHER MATTERS

SEC. 501. REPEAL INAPPLICABILITY OF MODIFICATION OF BASIC ALLOWANCE FOR HOUSING TO BENEFITS UNDER LAWS ADMINISTERED BY SECRETARY OF VETERANS AFFAIRS.

(a) Repeal.—Subsection (b) of section 604 of the Carl Levin and Howard P. “Buck” McKeon National Defense Authorization Act for Fiscal Year 2015 (Public Law 113–291; 37 U.S.C. 403 note) is repealed.

(b) Effective Date.—The amendment made by subsection (a) shall take effect on January 1, 2018, and shall apply with respect to individuals who first use their entitlement to educational assistance under chapter 33 of title 38, United States Code, on or after such date.

SEC. 502. RECONSIDERATION OF PREVIOUSLY DENIED CLAIMS FOR DISABILITY COMPENSATION FOR VETERANS WHO ALLEGE FULL-BODY EXPOSURE TO NITROGEN MUSTARD GAS, SULFUR MUSTARD GAS, OR LEWISITE DURING WORLD WAR II.

(a) In General.—

(1) RECONSIDERATION REQUIRED.—The Secretary of Veterans Affairs shall reconsider all claims for compensation described in paragraph (2) and make a new determination regarding each such claim.

(2) CLAIMS FOR COMPENSATION DESCRIBED.—A claim for compensation described in this paragraph is a claim for compensation under chapter 11 of title 38, United States Code, that the Secretary determines—

(A) arose from the alleged full-body exposure of a veteran to a covered substance—

(i) during active military, naval, or air service during World War II; and

(ii) at a site listed in paragraph (3); and

(B) was denied before the date of the enactment of this Act.

(3) SITES.—The sites listed in this paragraph are the following:

(A) Camp Siebert, Alabama.

(B) Fort McClellan, Alabama.

(C) Huntsville Arsenal, Alabama.

(D) Rocky Mountain Arsenal, Colorado.

(E) Naval Research Laboratory, D.C.

(F) Bushnell Field, Florida.

(G) Great Lakes Naval Training Center, Illinois.

(H) Edgewood Arsenal, Maryland.

(I) Fort Detrick, Maryland.

(J) Naval Research Laboratory, Maryland.

(K) Naval Training Center, Bainbridge, Maryland.

(L) Horn Island Installation, Mississippi.

(M) Camp Crowder, Missouri.

(N) Hart’s Island, New York.

(O) Camp Lejeune, North Carolina.

(P) Charleston, South Carolina.

(Q) Dugway Proving Ground, Utah.

(R) Toole Army Depot, Utah.

(S) Naval Research Laboratory, Virginia.

(T) U.S.S. Eagle Boat No. 58.

(U) Ondal, India.

(V) Fort Clayton, San Jose Island, Panama.

(W) Any site the Secretary of Veterans Affairs determines is appropriate.

(4) FACTORS OF CONSIDERATION.—In making a determination under paragraph (1), the Secretary—

(A) shall consider—

(i) that contemporaneous records of testing of full-body exposure to a covered substance frequently may be unavailable because such tests were classified or such records were lost or destroyed;

(ii) that many veterans were sworn to secrecy following testing described in clause (i);

(iii) each statement based on personal knowledge of a veteran who served at a site listed in paragraph (3);

(iv) information in the report from the Secretary of Defense under subsection (b)(2); and

(v) any evidence the Secretary considers relevant; and

(B) may not determine that testing of full-body exposure to a covered substance did not occur at a site based solely on—

(i) information contained in the Department of Defense and Department of Veterans Affairs Chemical Biological Warfare Database; or

(ii) any list of known sites of testing of full-body exposure to a covered substance maintained by the Department of Veterans Affairs or the Department of Defense.

(5) PRESUMPTION OF EXPOSURE.—In carrying out paragraph (1), when the Secretary of Veterans Affairs makes a determination regarding whether a veteran experienced full-body exposure to a covered substance, the Secretary—

(A) shall presume, unless there is affirmative evidence to establish otherwise, that the veteran experienced such exposure by reason of the service of the veteran in World War II—

(i) based on the locations listed in paragraph (3); and

(ii) consistent with the places, types, and circumstances of service of the veteran in accordance with section 1154 of title 38; and

(B) shall resolve each reasonable doubt in favor of the veteran.

(6) EFFECTIVE DATE OF AWARD.—The effective date of any award of disability compensation resulting from reconsideration of a claim under paragraph (1) shall be fixed in accordance with the facts found, but shall not be earlier than the date of the receipt of the claim for compensation described in paragraph (2).

(b) Investigation And Report By The Secretary Of Defense.—Not later than 180 days after the date of the enactment of this Act, the Secretary of Defense shall—

(1) investigate and assess each site—

(A) where the Army Corps of Engineers has uncovered evidence of testing conducted by the Department of Defense during World War II to assess the effects of full-body exposure to a covered substance on humans; or

(B) with regards to which more than two veterans have been denied claims for compensation under chapter 11 of title 38, United States Code, in connection with exposure to a covered substance at such site; and

(2) submit to the appropriate congressional committees and the Secretary of Veterans Affairs a report on testing described in paragraph (1)(A), including—

(A) a list of each location where such testing occurred, including locations investigated and assessed under paragraph (1);

(B) the dates of each such testing; and

(C) the number of members of the Armed Forces who experienced full-body exposure to a covered substance in each such testing.

(c) Investigation And Report By Secretary Of Veterans Affairs.—Not later than 180 days after the date of the enactment of this Act, the Secretary of Veterans Affairs shall—

(1) investigate and assess—

(A) the actions taken by the Secretary to contact individuals who experienced full-body exposure to a covered substance in the course of testing described in subsection (b)(1)(A);

(B) the number of claims filed with the Secretary for disability compensation under chapter 11 of title 38, United States Code, arising from testing described in subsection (b)(1)(A); and

(C) the percentage of claims described in subparagraph (B) that the Secretary denied.

(2) submit to the appropriate congressional committees and the Secretary of Defense a report regarding the investigations and assessments carried out under paragraph (1).

(d) Definitions.—In this section:

(1) The terms “active military, naval, or air service”, “veteran”, and “World War II” have the meanings given such terms in section 101 of title 38, United States Code.

(2) The term “appropriate congressional committees” means—

(A) the Committees on Armed Services of the House of Representatives and the Senate; and

(B) the Committees on Veterans’ Affairs of the House of Representatives and the Senate.

(3) The term “covered substance” means—

(A) nitrogen mustard gas;

(B) sulfur mustard gas; or

(C) Lewisite.

(4) The term “full-body exposure”, with respect to a covered substance, has the meaning given that term by the Secretary of Defense.

 

Speaker of the House of Representatives.



Vice President of the United States and
President of the Senate

 

 

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. 2210 - An Act to designate the community living center of the Department of Veterans Affairs in Butler Township, Butler County, Pennsylvania, as the “Sergeant Joseph George Kusick VA Community Living Center”.

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 designate the community living center of the Department of Veterans Affairs in Butler Township, Butler County, Pennsylvania, as the “Sergeant Joseph George Kusick VA Community Living Center”.

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

SECTION 1. FINDINGS.

Congress finds the following:

(1) Sergeant Joseph George Kusick of Bruin, Pennsylvania, was assigned to the command and control detachment of the 5th Special Forces Group (Airborne) of the Army during the Vietnam War.

(2) On November 8, 1967, Kusick distinguished himself by exceptionally valorous actions while serving as a radio operator of a special forces reconnaissance team on a combat mission deep in hostile territory.

(3) During an enemy ambush, Kusick, though seriously wounded, refused aid and radioed the forward air controller to advise him of the critical situation.

(4) While the team leader led a withdrawal to a landing zone, Kusick maintained contact with the controller and requested emergency extraction.

(5) Realizing the importance of having a radio operator on the ground to direct landings, Kusick refused evacuation by the first helicopter.

(6) After the second helicopter was shot down, and in the midst of enemy fire, Kusick continued to maintain radio contact and called for a hoist extraction of the men still remaining on the ground.

(7) The last helicopter, which Kusick boarded, was shot down by intense Viet Cong fire and crashed in flames, resulting in Kusick’s death.

(8) On December 22, 1967, Kusick was posthumously awarded the Silver Star Medal for gallantry in action.

(9) The citation to accompany the award of the Silver Star Medal stated that “Kusick’s gallantry in action, at the cost of his life, was in keeping with the highest traditions of the military service and reflects great credit upon himself, his unit, and the United States Army”.

SEC. 2. SERGEANT JOSEPH GEORGE KUSICK VA COMMUNITY LIVING CENTER.

(a) Designation.—The community living center of the Department of Veterans Affairs in Butler Township, Butler County, Pennsylvania, shall after the date of the enactment of this Act be known and designated as the “Sergeant Joseph George Kusick VA Community Living Center”.

(b) References.—Any reference in any law, regulation, map, document, paper, or other record of the United States to the community living center referred to in subsection (a) shall be deemed to be a reference to the “Sergeant Joseph George Kusick VA Community Living Center”.

 

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.

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