II 

Calendar No. 388 

114TH CONGRESS 

2D SESSION S. 2055 

To amend the Public Health Service Act and the Federal Food, Drug, 

and Cosmetic Act with respect to national health security. 

IN THE SENATE OF THE UNITED STATES 

SEPTEMBER 17, 2015 

Mr. BURR (for himself, Mr. CASEY, Mr. ISAKSON, and Mr. ROBERTS) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

MARCH 14, 2016 

Reported by Mr. ALEXANDER, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

To amend the Public Health Service Act and the Federal 

Food, Drug, and Cosmetic Act with respect to national 

health security. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Counter5 measure Innovation Act of 2015’’. 


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1 SEC. 2. MEDICAL COUNTERMEASURE GUIDELINES. 

2 (a) STRATEGIC NATIONAL STOCKPILE AND SECU3 RITY COUNTERMEASURE PROCUREMENTS.—Section 

4 319F–2 of the Public Health Service Act (42 U.S.C. 

5 247d–6b) is amended— 

6 (1) in subsection (a), by adding at the end the 

7 following: 

8 ‘‘(3) UTILIZATION GUIDELINES.—The Secretary 

9 shall ensure timely and accurate recommended utili10 zation guidelines for qualified countermeasures (as 

11 defined in section 319F–1), qualified pandemic and 

12 epidemic products (as defined in section 319F–3), 

13 and security countermeasures (as defined in sub14 section (c)), including for such products in the 

15 stockpile.’’; and 

16 (2) in subsection (g)— 

17 (A) by amending paragraph (4) to read as 

18 follows: 

19 ‘‘(4) REPORT ON SECURITY COUNTERMEASURE

20 PROCUREMENT.—Not later than March 1 of each 

21 year in which the Secretary determines that the 

22 amount of funds available for procurement of secu23 rity countermeasures is less than $1,500,000,000, 

24 the Secretary shall submit to the Committee on Ap25 propriations and the Committee on Health, Edu26 cation, Labor, and Pensions of the Senate and the 


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1 Committee on Appropriations and the Committee on 

2 Energy and Commerce of the House of Representa3 tives a report detailing the amount of such funds 

4 available for procurement and the impact such 

5 amount of funding will have— 

6 ‘‘(A) in meeting the security counter7 measure needs identified under this section; and 

8 ‘‘(B) on the annual Public Health Emer9 gency Medical Countermeasures Enterprise and 

10 Strategy Implementation Plan (pursuant to sec11 tion 2811(d)).’’. 

12 SEC. 3. CLARIFICATION ON BARDA CONTRACTING AUTHOR13 ITY. 

14 (a) IN GENERAL.—Section 319F–2(g) of the Public 

15 Health Service Act (42 U.S.C. 247d–6b(g)) is amended 

16 by adding at the end the following: 

17 ‘‘(5) CLARIFICATION ON CONTRACTING AU18 THORITY.—The Secretary, acting through the Direc19 tor of the Biomedical Advanced Research and Devel20 opment Authority, shall carry out the programs 

21 funded by the special reserve fund (for the procure22 ment of security countermeasures under subsection 

23 (c) and for carrying out section 319L), including the 

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1 operative agreements pursuant to this section and 

2 section 319L.’’. 

3 (b) BARDA CONTRACTING AUTHORITY.—Section 

4 319L(c)(3) of the Public Health Service Act (42 U.S.C. 

5 247d–7c) is amended by inserting ‘‘, including the execu6 tion of procurement contracts, grants, and cooperative 

7 agreements pursuant to this section’’ before the period. 

8 SEC. 4. COUNTERMEASURES BUDGET PLAN. 

9 Section 2811(b)(7) of the Public Health Service Act 

10 (42 U.S.C. 300hh–10(b)(7)) is amended— 

11 (1) by striking the first sentence and inserting 

12 ‘‘Develop, and update not later than March 1 of 

13 each year, a coordinated 5-year budget plan based 

14 on the medical countermeasure priorities described 

15 in subsection (d), including with respect to chemical, 

16 biological, radiological, and nuclear agent or agents 

17 that may present a threat to the Nation, including 

18 such agents that are novel or emerging infectious 

19 diseases, and the corresponding efforts to develop 

20 qualified countermeasures (as defined in section 

21 319F–1), security countermeasures (as defined in 

22 section 319F–2), and qualified pandemic or epidemic 

23 products (as defined in section 319F–3) for each 

24 such threat.’’; 


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1 (2) in subparagraph (C), by striking ‘‘; and’’ 

2 and inserting a semicolon; 

3 (3) in subparagraph (D), by striking ‘‘to the 

4 appropriate committees of Congress upon request.’’ 

5 and inserting ‘‘, not later than March 15 of each 

6 year, to the Committee on Appropriations and the 

7 Committee on Health, Education, Labor, and Pen8 sions of the Senate and the Committee on Appro9 priations and the Committee on Energy and Com10 merce of the House of Representatives; and’’; and 

11 (4) by adding at the end the following: 

12 ‘‘(E) not later than March 15 of each year, 

13 be made publicly available.’’. 

14 SEC. 5. PRIORITIZING THE ANIMAL RULE GUIDANCE. 

15 Section 565(c) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 360bbb–4(c)) is amended by adding 

17 at the end the following: 

18 ‘‘(3) WRITTEN EXPLANATION.—The Secretary 

19 shall provide to the Committee on Health, Edu20 cation, Labor, and Pensions of the Senate and the 

21 Committee on Energy and Commerce of the House 

22 of Representatives a written explanation, not later 

23 than the last day of each month after the date of en24 actment of the Medical Countermeasure Innovation 

25 Act of 2015 in which the Secretary fails to finalize 


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1 such guidance, for why the Secretary has failed to 

2 finalize the guidance as required by this sub3 section.’’. 

4 SEC. 6. STREAMLINING THE PROJECT BIOSHIELD PRO5 CUREMENT PROCESS. 

6 Section 319F–2(c) of the Public Health Service Act 

7 (42 U.S.C. 247d–6b(c)) is amended— 

8 (1) in paragraph (4)(A)(ii), by striking ‘‘make 

9 a recommendation under paragraph (6) that the spe10 cial reserve fund as defined in subsection (h) be 

11 made available for the procurement of such counter12 measure’’ and inserting ‘‘make available the special 

13 reserve fund as defined in subsection (h) for pro14 curement of such countermeasure, as applicable’’; 

15 (2) in paragraph (6)— 

16 (A) by striking subparagraphs (A), (B), 

17 and (E); 

18 (B) by redesignating subparagraphs (C) 

19 and (D) as subparagraphs (A) and (B), respec20 tively; 

21 (C) by amending subparagraph (A), as so 

22 redesignated, to read as follows: 

23 ‘‘(A) NOTICE TO APPROPRIATE CONGRES24 SIONAL COMMITTEES.—The Secretary shall no25 tify the Committee on Appropriations and the 


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1 Committee on Health, Education, Labor, and 

2 Pensions of the Senate and the Committee on 

3 Appropriations and the Committee on Energy 

4 and Commerce of the House of Representatives 

5 of each decision to make available the special 

6 reserve fund as defined in subsection (h) for 

7 procurement of a security countermeasure, in8 cluding, where available, the number of, the na9 ture of, and other information concerning po10 tential suppliers of such countermeasure, and 

11 whether other potential suppliers of the same or 

12 similar countermeasures were considered and 

13 rejected for procurement under this section and 

14 the reasons therefore.’’; and 

15 (D) in the heading, by striking ‘‘REC16 OMMENDATION FOR PRESIDENT’S APPROVAL’’ 

17 and inserting ‘‘RECOMMENDATIONS FOR PRO18 CUREMENT’’; and 

19 (3) in paragraph (7)— 

20 (A) by striking subparagraph (A); 

21 (B) by striking subparagraph (B) and in22 serting the following: 

23 ‘‘(A) PAYMENTS FROM SPECIAL RESERVE

24 FUND.—The special reserve fund as defined in 

25 subsection (h) shall be available for payments 


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1 made by the Secretary to a vendor for procure2 ment of a security countermeasure in accord3 ance with the provisions of this paragraph.’’; 

4 and 

5 (C) by redesignating subparagraph (C) as 

6 subparagraph (B). 

7 SEC. 7. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 

8 FOR AGENTS THAT PRESENT NATIONAL SE9 CURITY THREATS. 

10 Subchapter E of chapter V of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is 

12 amended by inserting after section 565 the following: 

13 ‘‘SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREAT14 MENTS FOR AGENTS THAT PRESENT NA15 TIONAL SECURITY THREATS. 

16 ‘‘(a) DEFINITIONS.—In this section: 

17 ‘‘(1) The term ‘priority review’ with respect to 

18 a human drug application as defined in section 

19 735(1), means review and action by the Secretary on 

20 such application not later than 6 months after re21 ceipt by the Secretary of such application, as de22 scribed in the Manual of Policies and Procedures in 

23 the Food and Drug Administration and goals identi24 fied in the letters described in section 101(b) of the 


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1 Food and Drug Administration Safety and Innova2 tion Act. 

3 ‘‘(2) PRIORITY REVIEW VOUCHER.—The term 

4 ‘priority review voucher’ means a voucher issued by 

5 the Secretary to the sponsor of a material threat 

6 medical countermeasure application that entitles the 

7 holder of such voucher to priority review of a single 

8 human drug application submitted under section 

9 505(b)(1) or section 351 of the Public Health Serv10 ice Act after the date of approval of the material 

11 threat medical countermeasure application. 

12 ‘‘(3) MATERIAL THREAT MEDICAL COUNTER13 MEASURE APPLICATION.—The term ‘material threat 

14 medical countermeasure application’ means an appli15 cation that— 

16 ‘‘(A) is a human drug application as de17 fined in section 735(1)— 

18 ‘‘(i) to prevent, or treat harm from a 

19 biological, chemical, radiological, or nuclear 

20 agent identified as a material threat under 

21 section 319F–2(c)(2)(A)(ii) of the Public 

22 Health Service Act, or 

23 ‘‘(ii) to mitigate, prevent, or treat 

24 harm from a condition that may result in 

25 adverse health consequences or death and 


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1 may be caused by administering a drug, or 

2 biological product against such agent; 

3 ‘‘(B) the Secretary deems eligible for pri4 ority review; 

5 ‘‘(C) is approved after the date of enact6 ment of the Medical Countermeasure Innova7 tion Act of 2015; and 

8 ‘‘(D) is for a human drug, no active ingre9 dient (including any ester or salt of the active 

10 ingredient) of which has been approved in any 

11 other application under section 505(b)(1) or 

12 section 351 of the Public Health Service Act. 

13 ‘‘(b) PRIORITY REVIEW VOUCHER.— 

14 ‘‘(1) IN GENERAL.—The Secretary shall award 

15 a priority review voucher to the sponsor of a mate16 rial threat medical countermeasure application upon 

17 approval by the Secretary of such material threat 

18 medical countermeasure application. 

19 ‘‘(2) TRANSFERABILITY.—The sponsor of a ma20 terial threat medical countermeasure application 

21 that receives a priority review voucher under this 

22 section may transfer (including by sale) the entitle23 ment to such voucher to a sponsor of a human drug 

24 for which an application under section 505(b)(1) or 

25 section 351 of the Public Health Service Act will be 


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1 submitted after the date of the approval of the mate2 rial threat medical countermeasure application. 

3 There is no limit on the number of times a priority 

4 review voucher may be transferred before such 

5 voucher is used. 

6 ‘‘(3) NOTIFICATION.— 

7 ‘‘(A) IN GENERAL.—The sponsor of a 

8 human drug application shall notify the Sec9 retary not later than 90 calendar days prior to 

10 submission of the human drug application that 

11 is the subject of a priority review voucher of an 

12 intent to submit the human drug application, 

13 including the date on which the sponsor intends 

14 to submit the application. Such notification 

15 shall be a legally binding commitment to pay 

16 for the user fee to be assessed in accordance 

17 with this section. 

18 ‘‘(B) TRANSFER AFTER NOTICE.—The 

19 sponsor of a human drug application that pro20 vides notification of the intent of such sponsor 

21 to use the voucher for the human drug applica22 tion under subparagraph (A) may transfer the 

23 voucher after such notification is provided, if 

24 such sponsor has not yet submitted the human 

25 drug application described in the notification. 


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1 ‘‘(c) PRIORITY REVIEW USER FEE.— 

2 ‘‘(1) IN GENERAL.—The Secretary shall estab3 lish a user fee program under which a sponsor of a 

4 human drug application that is the subject of a pri5 ority review voucher shall pay to the Secretary a fee 

6 determined under paragraph (2). Such fee shall be 

7 in addition to any fee required to be submitted by 

8 the sponsor under chapter VII. 

9 ‘‘(2) FEE AMOUNT.—The amount of the pri10 ority review user fee shall be determined each fiscal 

11 year by the Secretary and based on the average cost 

12 incurred by the agency in the review of a human 

13 drug application subject to priority review in the 

14 previous fiscal year. 

15 ‘‘(3) ANNUAL FEE SETTING.—The Secretary 

16 shall establish, before the beginning of each fiscal 

17 year beginning after September 30, 2015, for that 

18 fiscal year, the amount of the priority review user 

19 fee. 

20 ‘‘(4) PAYMENT.— 

21 ‘‘(A) IN GENERAL.—The priority review 

22 user fee required by this subsection shall be due 

23 upon the submission of a human drug applica24 tion under section 505(b)(1) or section 351 of 


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1 the Public Health Service Act for which the pri2 ority review voucher is used. 

3 ‘‘(B) COMPLETE APPLICATION.—An appli4 cation described under subparagraph (A) for 

5 which the sponsor requests the use of a priority 

6 review voucher shall be considered incomplete if 

7 the fee required by this subsection and all other 

8 applicable user fees are not paid in accordance 

9 with the Secretary’s procedures for paying such 

10 fees. 

11 ‘‘(C) NO WAIVERS, EXEMPTIONS, REDUC12 TIONS, OR REFUNDS.—The Secretary may not 

13 grant a waiver, exemption, reduction, or refund 

14 of any fees due and payable under this section. 

15 ‘‘(5) OFFSETTING COLLECTIONS.—Fees col16 lected pursuant to this subsection for any fiscal 

17 year— 

18 ‘‘(A) shall be deposited and credited as off19 setting collections to the account providing ap20 propriations to the Food and Drug Administra21 tion; and 

22 ‘‘(B) shall not be collected for any fiscal 

23 year except to the extent provided in advance in 

24 appropriation Acts. 


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1 ‘‘(d) NOTICE OF ISSUANCE OF VOUCHER AND AP2 PROVAL OF PRODUCTS UNDER VOUCHER.—The Secretary 

3 shall publish a notice in the Federal Register and on the 

4 Internet Website of the Food and Drug Administration 

5 not later than 30 calendar days after the occurrence of 

6 each of the following: 

7 ‘‘(1) The Secretary issues a priority review 

8 voucher under this section. 

9 ‘‘(2) The Secretary approves a drug pursuant 

10 to an application submitted under section 505(b) of 

11 this Act or section 351(a) of the Public Health Serv12 ice Act for which the sponsor of the application used 

13 a priority review voucher under this section. 

14 ‘‘(e) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing 

15 in this section precludes a sponsor who seeks a priority 

16 review voucher under this section from participating in 

17 any other incentive program, including under this Act, ex18 cept that no sponsor of a material threat medical counter19 measure application may receive more than one priority 

20 review voucher with respect to such drug. 

21 ‘‘(f) RELATION TO OTHER PROVISIONS.—The provi22 sions of this section shall supplement, not supplant, any 

23 other provisions of this Act or the Public Health Service 

24 Act that encourage the development of medical counter25 measures.’’. 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Medical Countermeasure 

3 Innovation Act of 2016’’. 

4 SEC. 2. MEDICAL COUNTERMEASURE GUIDELINES. 

5 (a) STRATEGIC NATIONAL STOCKPILE AND SECURITY

6 COUNTERMEASURE PROCUREMENTS.—Section 319F–2 of 

7 the Public Health Service Act (42 U.S.C. 247d–6b) is 

8 amended— 

9 (1) in subsection (a), by adding at the end the 

10 following: 

11 ‘‘(3) UTILIZATION GUIDELINES.—The Secretary 

12 shall ensure timely and accurate recommended utili13 zation guidelines for qualified countermeasures (as 

14 defined in section 319F–1), qualified pandemic and 

15 epidemic products (as defined in section 319F–3), 

16 and security countermeasures (as defined in sub17 section (c)), including for such products in the stock18 pile.’’; and 

19 (2) in subsection (g)— 

20 (A) by amending paragraph (4) to read as 

21 follows: 

22 ‘‘(4) REPORT ON SECURITY COUNTERMEASURE

23 PROCUREMENT.—Not later than March 1 of each year 

24 in which the Secretary determines that the amount of 

25 funds available for procurement of security counter26 measures is less than $1,500,000,000, the Secretary 


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1 shall submit to the Committee on Appropriations and 

2 the Committee on Health, Education, Labor, and 

3 Pensions of the Senate and the Committee on Appro4 priations and the Committee on Energy and Com5 merce of the House of Representatives a report detail6 ing the amount of such funds available for procure7 ment and the impact such amount of funding will 

8 have— 

9 ‘‘(A) in meeting the security countermeasure 

10 needs identified under this section; and 

11 ‘‘(B) on the annual Public Health Emer12 gency Medical Countermeasures Enterprise and 

13 Strategy Implementation Plan (pursuant to sec14 tion 2811(d)).’’; and 

15 SEC. 3. CLARIFICATION ON BARDA CONTRACTING AUTHOR16 ITY. 

17 (a) IN GENERAL.—Section 319F–2(g) of the Public 

18 Health Service Act (42 U.S.C. 247d–6b(g)) is amended by 

19 adding at the end the following: 

20 ‘‘(5) CLARIFICATION ON CONTRACTING AUTHOR21 ITY.—The Secretary, acting through the Director of 

22 the Biomedical Advanced Research and Development 

23 Authority, shall carry out the programs funded by the 

24 special reserve fund (for the procurement of security 

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1 rying out section 319L), including the execution of 

2 procurement contracts, grants, and cooperative agree3 ments pursuant to this section and section 319L.’’. 

4 (b) BARDA CONTRACTING AUTHORITY.—Section 

5 319L(c)(3) of the Public Health Service Act (42 U.S.C. 

6 247d-7c) is amended by inserting ‘‘, including the execution 

7 of procurement contracts, grants, and cooperative agree8 ments pursuant to this section’’ before the period. 

9 SEC. 4. COUNTERMEASURES BUDGET PLAN. 

10 Section 2811(b)(7) of the Public Health Service Act 

11 (42 U.S.C. 300hh–10(b)(7)) is amended— 

12 (1) by striking the first sentence and inserting 

13 ‘‘Develop, and update not later than March 1 of each 

14 year, a coordinated 5-year budget plan based on the 

15 medical countermeasure priorities described in sub16 section (d), including with respect to chemical, bio17 logical, radiological, and nuclear agent or agents that 

18 may present a threat to the Nation, including such 

19 agents that are novel or emerging infectious diseases, 

20 and the corresponding efforts to develop qualified 

21 countermeasures (as defined in section 319F–1), secu22 rity countermeasures (as defined in section 319F–2), 

23 and qualified pandemic or epidemic products (as de24 fined in section 319F–3) for each such threat.’’; 


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1 (2) in subparagraph (C), by striking ‘‘; and’’ 

2 and inserting a semicolon; 

3 (3) in subparagraph (D), by striking ‘‘to the ap4 propriate committees of Congress upon request.’’ and 

5 inserting ‘‘, not later than March 15 of each year, to 

6 the Committee on Appropriations and the Committee 

7 on Health, Education, Labor, and Pensions of the 

8 Senate and the Committee on Appropriations and the 

9 Committee on Energy and Commerce of the House of 

10 Representatives; and’’; and 

11 (4) by adding at the end the following: 

12 ‘‘(E) not later than March 15 of each year, 

13 be made publicly available in a manner that 

14 does not compromise national security.’’. 

15 SEC. 5. MEDICAL COUNTERMEASURES INNOVATION. 

16 Section 319L(c)(4) of the Public Health Service Act 

17 (42 U.S.C. 247d–7e(c)(4)) is amended by adding at the end 

18 the following: 

19 ‘‘(E) MEDICAL COUNTERMEASURES INNOVA20 TION PARTNER.— 

21 ‘‘(i) IN GENERAL.—To support the 

22 purposes described in paragraph (2), the 

23 Secretary, acting through the Director of 

24 BARDA, may enter into an agreement (in25 cluding through the use of grants, contracts, 


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1 cooperative agreements, or other trans2 actions as described in paragraph (5)) with 

3 an independent, non-profit entity to— 

4 ‘‘(I) foster and accelerate the de5 velopment and innovation of medical 

6 countermeasures and technologies that 

7 may assist advanced research and de8 velopment of qualified countermeasures 

9 and qualified pandemic or epidemic 

10 products, including through the use of 

11 strategic venture capital practices and 

12 methods; 

13 ‘‘(II) promote the development of 

14 new and promising technologies that 

15 address urgent medical countermeasure 

16 needs, as identified by the Secretary; 

17 ‘‘(III) address unmet public 

18 health needs that are directly related to 

19 medical countermeasure requirements, 

20 such as novel antimicrobials for 

21 multidrug resistant organisms and 

22 multiuse platform technologies for 

23 diagnostics, prophylaxis, vaccines, and 

24 therapeutics; and 


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1 ‘‘(IV) provide expert consultation 

2 and advice to foster viable medical 

3 countermeasure innovators, including 

4 helping qualified countermeasure 

5 innovators navigate unique industry 

6 challenges with respect to developing 

7 chemical, biological, radiological, and 

8 nuclear countermeasure products. 

9 ‘‘(ii) ELIGIBILITY.— 

10 ‘‘(I) IN GENERAL.—To be eligible 

11 to enter into an agreement under 

12 clause (i) an entity shall— 

13 ‘‘(aa) be an independent, 

14 non-profit entity; 

15 ‘‘(bb) have a demonstrated 

16 record of being able to create link17 ages between innovators and in18 vestors and leverage such partner19 ships and resources for the pur20 pose of addressing identified stra21 tegic needs of the Federal Govern22 ment; 

23 ‘‘(cc) have experience in pro24 moting novel technology innova25 tion; 


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1 ‘‘(dd) be problem driven and 

2 solution focused based on the 

3 needs, requirements, and problems 

4 identified by the Secretary under 

5 clause (iv); 

6 ‘‘(ee) demonstrate the ability, 

7 or the potential ability, to pro8 mote the development of medical 

9 countermeasure products; 

10 ‘‘(ff) demonstrate expertise, 

11 or the capacity to develop or ac12 quire expertise, related to tech13 nical and regulatory consider14 ations with respect to medical 

15 countermeasures; and 

16 ‘‘(gg) not be within the De17 partment of Health and Human 

18 Services. 

19 ‘‘(II) PARTNERING EXPERI20 ENCE.—In selecting an entity with 

21 which to enter into an agreement 

22 under clause (i), the Secretary shall 

23 place a high value on the demonstrated 

24 experience of the entity in partnering 


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1 with the Federal Government to meet 

2 identified strategic needs. 

3 ‘‘(iii) NOT AGENCY.—An entity that 

4 enters into an agreement under clause (i) 

5 shall not be deemed to be a Federal agency 

6 for any purpose, including for any purpose 

7 under title 5, United States Code. 

8 ‘‘(iv) DIRECTION.—Pursuant to an 

9 agreement entered into under this subpara10 graph, the Secretary, acting through the Di11 rector of BARDA, shall provide direction to 

12 the entity that enters into an agreement 

13 under clause (i). As part of this agreement 

14 the Director of BARDA shall— 

15 ‘‘(I) communicate the medical 

16 countermeasure needs, requirements, 

17 and problems to be addressed by the 

18 entity under the agreement; 

19 ‘‘(II) develop a description of 

20 work to be performed by the entity 

21 under the agreement; 

22 ‘‘(III) provide technical feedback 

23 and appropriate oversight over work 

24 carried out by the entity under the 

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1 opment and partnerships consistent 

2 with the needs and requirements set 

3 forth in this subparagraph; 

4 ‘‘(IV) ensure fair consideration of 

5 products developed under the agree6 ment in order to maintain competition 

7 to the maximum practical extent, as 

8 applicable and appropriate under ap9 plicable provisions of this section; and 

10 ‘‘(V) ensure, as a condition of the 

11 agreement— 

12 ‘‘(aa) a comprehensive set of 

13 policies that demonstrate a com14 mitment to transparency and ac15 countability; 

16 ‘‘(bb) protection against con17 flicts of interest through a com18 prehensive set of policies that ad19 dress potential conflicts of inter20 est, ethics, disclosure, and report21 ing requirements; 

22 ‘‘(cc) that the entity provides 

23 monthly accounting on the use of 

24 funds provided under such agree25 ment; and 


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1 ‘‘(dd) that the entity provides 

2 on a quarterly basis, reports re3 garding the progress made toward 

4 meeting the identified needs set 

5 forth in the agreement. 

6 ‘‘(v) SUPPLEMENT NOT SUPPLANT.— 

7 Activities carried out under this subpara8 graph shall supplement, and not supplant, 

9 other activities carried out under this sec10 tion. 

11 ‘‘(vi) NO ESTABLISHMENT OF ENTI12 TY.—To prevent unnecessary duplication 

13 and target resources effectively, nothing in 

14 this subparagraph shall be construed to au15 thorize the Secretary to establish within the 

16 Department of Health and Human Services 

17 an entity for the purposes of carrying out 

18 this subparagraph. 

19 ‘‘(vii) TRANSPARENCY AND OVER20 SIGHT.—Upon request, the Secretary shall 

21 provide to Congress the information pro22 vided to the Secretary under clause 

23 (iv)(V)(dd). 

24 ‘‘(viii) INDEPENDENT EVALUATION.— 

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1 actment of this subparagraph, the Govern2 ment Accountability Office shall conduct an 

3 independent evaluation, and submit to the 

4 Secretary and the appropriate committees 

5 of Congress a report, concerning the activi6 ties conducted under this subparagraph. 

7 Such report shall include recommendations 

8 with respect to any agreement or activities 

9 carried out pursuant to this subparagraph. 

10 ‘‘(ix) SUNSET.—This subparagraph 

11 shall have no force or effect after September 

12 30, 2022.’’. 

13 SEC. 6. STREAMLINING THE PROJECT BIOSHIELD PRO14 CUREMENT PROCESS. 

15 Section 319F–2(c) of the Public Health Service Act (42 

16 U.S.C. 247d–6b(c)) is amended— 

17 (1) in paragraph (4)(A)(ii), by striking ‘‘make a 

18 recommendation under paragraph (6) that the special 

19 reserve fund as defined in subsection (h) be made 

20 available for the procurement of such countermeasure’’ 

21 and inserting ‘‘and subject to the availability of ap22 propriations, make available the special reserve fund 

23 as defined in subsection (h) for procurement of such 

24 countermeasure, as applicable’’; 

25 (2) in paragraph (6)— 


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1 (A) by striking subparagraphs (A), (B), and 

2 (E); 

3 (B) by redesignating subparagraphs (C) 

4 and (D) as subparagraphs (A) and (B), respec5 tively; 

6 (C) by amending subparagraph (A), as so 

7 redesignated, to read as follows: 

8 ‘‘(A) NOTICE TO APPROPRIATE CONGRES9 SIONAL COMMITTEES.—The Secretary shall no10 tify the Committee on Appropriations and the 

11 Committee on Health, Education, Labor, and 

12 Pensions of the Senate and the Committee on 

13 Appropriations and the Committee on Energy 

14 and Commerce of the House of Representatives of 

15 each decision to make available the special re16 serve fund as defined in subsection (h) for pro17 curement of a security countermeasure, includ18 ing, where available, the number of, the nature 

19 of, and other information concerning potential 

20 suppliers of such countermeasure, and whether 

21 other potential suppliers of the same or similar 

22 countermeasures were considered and rejected for 

23 procurement under this section and the reasons 

24 therefore.’’; and 


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1 (D) in the heading, by striking ‘‘REC2 OMMENDATION FOR PRESIDENT’S APPROVAL’’ 

3 and inserting ‘‘RECOMMENDATIONS FOR PRO4 CUREMENT’’; and 

5 (3) in paragraph (7)— 

6 (A) by striking subparagraph (A); 

7 (B) by striking subparagraph (B) and in8 serting the following: 

9 ‘‘(A) PAYMENTS FROM SPECIAL RESERVE

10 FUND.—The special reserve fund as defined in 

11 subsection (h) shall be available for payments 

12 made by the Secretary to a vendor for procure13 ment of a security countermeasure in accordance 

14 with the provisions of this paragraph.’’; and 

15 (C) by redesignating subparagraph (C) as 

16 subparagraph (B). 

17 SEC. 7. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 

18 FOR AGENTS THAT PRESENT NATIONAL SE19 CURITY THREATS. 

20 Subchapter E of chapter V of the Federal Food, Drug, 

21 and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended 

22 by inserting after section 565 the following: 


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1 ‘‘SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREAT2 MENTS FOR AGENTS THAT PRESENT NA3 TIONAL SECURITY THREATS. 

4 ‘‘(a) DEFINITIONS.—In this section: 

5 ‘‘(1) The term ‘priority review’ with respect to a 

6 human drug application as defined in section 735(1), 

7 means review and action by the Secretary on such 

8 application not later than 6 months after receipt by 

9 the Secretary of such application, as described in the 

10 Manual of Policies and Procedures in the Food and 

11 Drug Administration and goals identified in the let12 ters described in section 101(b) of the Food and Drug 

13 Administration Safety and Innovation Act. 

14 ‘‘(2) PRIORITY REVIEW VOUCHER.—The term 

15 ‘priority review voucher’ means a voucher issued by 

16 the Secretary to the sponsor of a material threat med17 ical countermeasure application that entitles the hold18 er of such voucher to priority review of a single 

19 human drug application submitted under section 

20 505(b)(1) or section 351(a) of the Public Health Serv21 ice Act after the date of approval of the material 

22 threat medical countermeasure application. 

23 ‘‘(3) MATERIAL THREAT MEDICAL COUNTER24 MEASURE APPLICATION.—The term ‘material threat 

25 medical countermeasure application’ means an appli26 cation that— 


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1 ‘‘(A) is a human drug application as de2 fined in section 735(1)— 

3 ‘‘(i) to prevent, or treat harm from a 

4 biological, chemical, radiological, or nuclear 

5 agent identified as a material threat under 

6 section 319F–2(c)(2)(A)(ii) of the Public 

7 Health Service Act, or 

8 ‘‘(ii) to mitigate, prevent, or treat 

9 harm from a condition that may result in 

10 adverse health consequences or death and 

11 may be caused by administering a drug, or 

12 biological product against such agent; and 

13 ‘‘(B) the Secretary deems eligible for pri14 ority review; 

15 ‘‘(C) is approved after the date of enactment 

16 of the Medical Countermeasure Innovation Act of 

17 2016; and 

18 ‘‘(D) is for a human drug, no active ingre19 dient (including any ester or salt of the active 

20 ingredient) of which has been approved in any 

21 other application under section 505(b)(1) or sec22 tion 351(a) of the Public Health Service Act. 

23 ‘‘(b) PRIORITY REVIEW VOUCHER.— 

24 ‘‘(1) IN GENERAL.—The Secretary shall award a 

25 priority review voucher to the sponsor of a material 


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1 threat medical countermeasure application upon ap2 proval by the Secretary of such material threat med3 ical countermeasure application. 

4 ‘‘(2) TRANSFERABILITY.—The sponsor of a mate5 rial threat medical countermeasure application that 

6 receives a priority review voucher under this section 

7 may transfer (including by sale) the entitlement to 

8 such voucher to a sponsor of a human drug for which 

9 an application under section 505(b)(1) or section 

10 351(a) of the Public Health Service Act will be sub11 mitted after the date of the approval of the material 

12 threat medical countermeasure application. There is 

13 no limit on the number of times a priority review 

14 voucher may be transferred before such voucher is 

15 used. 

16 ‘‘(3) NOTIFICATION.— 

17 ‘‘(A) IN GENERAL.—The sponsor of a 

18 human drug application shall notify the Sec19 retary not later than 90 calendar days prior to 

20 submission of the human drug application that 

21 is the subject of a priority review voucher of an 

22 intent to submit the human drug application, 

23 including the date on which the sponsor intends 

24 to submit the application. Such notification 

25 shall be a legally binding commitment to pay for 


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1 the user fee to be assessed in accordance with this 

2 section. 

3 ‘‘(B) TRANSFER AFTER NOTICE.—The spon4 sor of a human drug application that provides 

5 notification of the intent of such sponsor to use 

6 the voucher for the human drug application 

7 under subparagraph (A) may transfer the vouch8 er after such notification is provided, if such 

9 sponsor has not yet submitted the human drug 

10 application described in the notification. 

11 ‘‘(c) PRIORITY REVIEW USER FEE.— 

12 ‘‘(1) IN GENERAL.—The Secretary shall establish 

13 a user fee program under which a sponsor of a 

14 human drug application that is the subject of a pri15 ority review voucher shall pay to the Secretary a fee 

16 determined under paragraph (2). Such fee shall be in 

17 addition to any fee required to be submitted by the 

18 sponsor under chapter VII. 

19 ‘‘(2) FEE AMOUNT.—The amount of the priority 

20 review user fee shall be determined each fiscal year by 

21 the Secretary and based on the average cost incurred 

22 by the agency in the review of a human drug applica23 tion subject to priority review in the previous fiscal 

24 year. 


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1 ‘‘(3) ANNUAL FEE SETTING.—The Secretary shall 

2 establish, before the beginning of each fiscal year be3 ginning after September 30, 2015, for that fiscal year, 

4 the amount of the priority review user fee. 

5 ‘‘(4) PAYMENT.— 

6 ‘‘(A) IN GENERAL.—The priority review 

7 user fee required by this subsection shall be due 

8 upon the submission of a human drug applica9 tion under section 505(b)(1) or section 351(a) of 

10 the Public Health Services Act for which the pri11 ority review voucher is used. 

12 ‘‘(B) COMPLETE APPLICATION.—An appli13 cation described under subparagraph (A) for 

14 which the sponsor requests the use of a priority 

15 review voucher shall be considered incomplete if 

16 the fee required by this subsection and all other 

17 applicable user fees are not paid in accordance 

18 with the Secretary’s procedures for paying such 

19 fees. 

20 ‘‘(C) NO WAIVERS, EXEMPTIONS, REDUC21 TIONS, OR REFUNDS.—The Secretary may not 

22 grant a waiver, exemption, reduction, or refund 

23 of any fees due and payable under this section. 

24 ‘‘(5) OFFSETTING COLLECTIONS.—Fees collected 

25 pursuant to this subsection for any fiscal year— 


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1 ‘‘(A) shall be deposited and credited as off2 setting collections to the account providing ap3 propriations to the Food and Drug Administra4 tion; and 

5 ‘‘(6) shall not be collected for any fiscal year ex6 cept to the extent provided in advance in appropria7 tion Acts. 

8 ‘‘(d) NOTICE OF ISSUANCE OF VOUCHER AND AP9 PROVAL OF PRODUCTS UNDER VOUCHER.—The Secretary 

10 shall publish a notice in the Federal Register and on the 

11 Internet Website of the Food and Drug Administration not 

12 later than 30 calendar days after the occurrence of each of 

13 the following: 

14 ‘‘(1) The Secretary issues a priority review 

15 voucher under this section. 

16 ‘‘(2) The Secretary approves a drug pursuant to 

17 an application submitted under section 505(b) of this 

18 Act or section 351(a) of the Public Health Service Act 

19 for which the sponsor of the application used a pri20 ority review voucher under this section. 

21 ‘‘(e) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing 

22 in this section precludes a sponsor who seeks a priority re23 view voucher under this section from participating in any 

24 other incentive program, including under this Act, except 

25 that no sponsor of a material threat medical counterVerDate Sep 11 2014 23:46 Mar 14, 2016 Jkt 059200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6203 E:\BILLS\S2055.RS S2055

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1 measure application may receive more than one priority 

2 review voucher issued under any section of this Act with 

3 respect to such drug. 

4 ‘‘(f) RELATION TO OTHER PROVISIONS.—The provi5 sions of this section shall supplement, not supplant, any 

6 other provisions of this Act or the Public Health Service 

7 Act that encourage the development of medical counter8 measures.’’. 

9 SEC. 8. GAO REPORT. 

10 (a) STUDY.—The Comptroller General of the United 

11 States shall conduct a study on the effectiveness of priority 

12 review vouchers under section 565A of the Federal Food, 

13 Drug, and Cosmetic Act (as added by section 7) in pro14 viding incentives for the development of material threat 

15 medical countermeasures applications under such section 

16 565A. In conducting such study, the Comptroller General 

17 shall examine the following: 

18 (1) The impact of the priority review voucher in 

19 attracting investment into the development of mate20 rial threat medical countermeasures and the impact 

21 of such investment, as applicable, on the development 

22 of such countermeasures. 

23 (2) How the drugs for which priority review 

24 vouchers were awarded under such section 565A— 


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1 (A) addressed identified medical counter2 measure needs; and 

3 (B) impacted United States preparedness 

4 against chemical, biological, radiological, and 

5 nuclear threats, including both identified threats 

6 and naturally-occurring threats. 

7 (3) How many material threat medical counter8 measures were licensed or approved, or otherwise sig9 nificantly advanced in clinical development, in the 10 

10 years following the enactment of such section 565A 

11 compared to the 10 years prior to the enactment of 

12 such section. 

13 (4) An analysis of the drugs for which such pri14 ority review vouchers were used, which shall in15 clude— 

16 (A) the indications for which such drugs 

17 were approved under section 505(b)(1) of the 

18 Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 355) or section 351(a) of the Public 

20 Health Service Act (42 U.S.C. 262); 

21 (B) whether unmet medical needs were ad22 dressed through the approval of such drugs, in23 cluding, for each such drug— 


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1 (i) if an alternative therapy was pre2 viously available to treat the indication; 

3 and 

4 (ii) if the drug provided a benefit or 

5 advantage over another available therapy; 

6 (C) the value of the priority review voucher 

7 if transferred; and 

8 (D) the length of time between the date on 

9 which a priority review voucher was awarded 

10 and the date on which it was used. 

11 (5) With respect to the priority review voucher 

12 program under such section 565A— 

13 (A) how many priority review vouchers 

14 were awarded under such section 565A and how 

15 many of such awarded vouchers were redeemed 

16 for priority review of a drug application in the 

17 10 years following the date of enactment of such 

18 section; 

19 (B) the resources associated with the Food 

20 and Drug Administration implementation of 

21 such section 565A and review of applications for 

22 which a voucher awarded under such section 

23 565A is redeemed for priority review; and 

24 (C) recommendations, if any, with respect 

25 to how such section 565A could be improved to 


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1 better achieve the objective of incentivizing the 

2 timely development of medical countermeasures 

3 to address identified chemical, biological, radio4 logical, and nuclear threats, including for med5 ical countermeasures that might otherwise not be 

6 developed, potentially eligible for an emergency 

7 use authorization, licensed, or approved. 

8 (b) CONSULTATIONS.—In conducting the study under 

9 subsection (a), the Comptroller General of the United States 

10 shall consult with— 

11 (1) drug manufacturers involved in the research 

12 and development of medical countermeasures to ad13 dress biological, chemical, radiological, and nuclear 

14 threats; 

15 (2) stakeholders involved in investing in the re16 search and development of medical countermeasures, 

17 including venture capitalists; 

18 (3) the Federal Government agencies responsible 

19 for advancing, reviewing, and procuring medical 

20 countermeasures, including— 

21 (A) the Department of Health and Human 

22 Services, including the Office of the Assistant 

23 Secretary for Preparedness and Response, the 

24 Biomedical Advanced Research and Development 


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1 Authority, and the Food and Drug Administra2 tion; and 

3 (B) the Department of Defense; and 

4 (4) biodefense stakeholders, as applicable. 

5 (c) INITIAL ASSESSMENT.—Not later than 7 years 

6 after the date of enactment of this Act, the Comptroller Gen7 eral of the United States shall submit to the Committee on 

8 Health, Education, Labor, and Pensions of the Senate and 

9 the Committee on Energy and Commerce of the House of 

10 Representatives an initial assessment of the effectiveness of 

11 the priority review voucher program set forth in section 

12 565A of the Federal Food, Drug, and Cosmetic Act (as 

13 added by section 7). 

14 (d) REPORT.—Not later than 12 years after the date 

15 of enactment of this Act, the Comptroller General of the 

16 United States shall submit to the Committee on Health, 

17 Education, Labor, and Pensions of the Senate and the Com18 mittee on Energy and Commerce of the House of Represent19 atives a report containing the results of the study conducted 

20 under subsection (a). 

21 (e) PROTECTION OF NATIONAL SECURITY.—The Comp22 troller General of the United States shall conduct the study 

23 and issue the assessment and report under this section in 

24 a manner that does not compromise national security. 


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Calendar No. 388 

114TH CONGRESS 

2D SESSION S. 2055 

A BILL 

To amend the Public Health Service Act and the 

spect to national health security. Federal Food, Drug, and Cosmetic Act with reMARCH 14, 2016 

Reported with an amendment 


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