II 

114TH CONGRESS 

1ST 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 and Mr. CASEY) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

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’’. 

6 SEC. 2. MEDICAL COUNTERMEASURE GUIDELINES. 

7 (a) STRATEGIC NATIONAL STOCKPILE AND SECU8 RITY COUNTERMEASURE PROCUREMENTS.—Section 


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1 319F–2 of the Public Health Service Act (42 U.S.C. 

2 247d–6b) is amended— 

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

4 following: 

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

6 shall ensure timely and accurate recommended utili7 zation guidelines for qualified countermeasures (as 

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

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

10 and security countermeasures (as defined in sub11 section (c)), including for such products in the 

12 stockpile.’’; and 

13 (2) in subsection (g)— 

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

15 follows: 

16 ‘‘(4) REPORT ON SECURITY COUNTERMEASURE

17 PROCUREMENT.—Not later than March 1 of each 

18 year in which the Secretary determines that the 

19 amount of funds available for procurement of secu20 rity countermeasures is less than $1,500,000,000, 

21 the Secretary shall submit to the Committee on Ap22 propriations and the Committee on Health, Edu23 cation, Labor, and Pensions of the Senate and the 

24 Committee on Appropriations and the Committee on 

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1 tives a report detailing the amount of such funds 

2 available for procurement and the impact such 

3 amount of funding will have— 

4 ‘‘(A) in meeting the security counter5 measure needs identified under this section; and 

6 ‘‘(B) on the annual Public Health Emer7 gency Medical Countermeasures Enterprise and 

8 Strategy Implementation Plan (pursuant to sec9 tion 2811(d)).’’. 

10 SEC. 3. CLARIFICATION ON BARDA CONTRACTING AUTHOR11 ITY. 

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

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

14 by adding at the end the following: 

15 ‘‘(5) CLARIFICATION ON CONTRACTING AU16 THORITY.—The Secretary, acting through the Direc17 tor of the Biomedical Advanced Research and Devel18 opment Authority, shall carry out the programs 

19 funded by the special reserve fund (for the procure20 ment of security countermeasures under subsection 

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

22 execution of procurement contracts, grants, and co23 operative agreements pursuant to this section and 

24 section 319L.’’. 


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1 (b) BARDA CONTRACTING AUTHORITY.—Section 

2 319L(c)(3) of the Public Health Service Act (42 U.S.C. 

3 247d–7c) is amended by inserting ‘‘, including the execu4 tion of procurement contracts, grants, and cooperative 

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

6 SEC. 4. COUNTERMEASURES BUDGET PLAN. 

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

8 (42 U.S.C. 300hh–10(b)(7)) is amended— 

9 (1) by striking the first sentence and inserting 

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

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

12 on the medical countermeasure priorities described 

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

14 biological, radiological, and nuclear agent or agents 

15 that may present a threat to the Nation, including 

16 such agents that are novel or emerging infectious 

17 diseases, and the corresponding efforts to develop 

18 qualified countermeasures (as defined in section 

19 319F–1), security countermeasures (as defined in 

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

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

22 such threat.’’; 

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

24 and inserting a semicolon; 


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

2 appropriate committees of Congress upon request.’’ 

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

4 year, to the Committee on Appropriations and the 

5 Committee on Health, Education, Labor, and Pen6 sions of the Senate and the Committee on Appro7 priations and the Committee on Energy and Com8 merce of the House of Representatives; and’’; and 

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

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

11 be made publicly available.’’. 

12 SEC. 5. PRIORITIZING THE ANIMAL RULE GUIDANCE. 

13 Section 565(c) of the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 360bbb–4(c)) is amended by adding 

15 at the end the following: 

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

17 shall provide to the Committee on Health, Edu18 cation, Labor, and Pensions of the Senate and the 

19 Committee on Energy and Commerce of the House 

20 of Representatives a written explanation, not later 

21 than the last day of each month after the date of en22 actment of the Medical Countermeasure Innovation 

23 Act of 2015 in which the Secretary fails to finalize 

24 such guidance, for why the Secretary has failed to 


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1 finalize the guidance as required by this sub2 section.’’. 

3 SEC. 6. STREAMLINING THE PROJECT BIOSHIELD PRO4 CUREMENT PROCESS. 

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

6 (42 U.S.C. 247d–6b(c)) is amended— 

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

8 a recommendation under paragraph (6) that the spe9 cial reserve fund as defined in subsection (h) be 

10 made available for the procurement of such counter11 measure’’ and inserting ‘‘make available the special 

12 reserve fund as defined in subsection (h) for pro13 curement of such countermeasure, as applicable’’; 

14 (2) in paragraph (6)— 

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

16 and (E); 

17 (B) by redesignating subparagraphs (C) 

18 and (D) as subparagraphs (A) and (B), respec19 tively; 

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

21 redesignated, to read as follows: 

22 ‘‘(A) NOTICE TO APPROPRIATE CONGRES23 SIONAL COMMITTEES.—The Secretary shall no24 tify the Committee on Appropriations and the 

25 Committee on Health, Education, Labor, and 


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1 Pensions of the Senate and the Committee on 

2 Appropriations and the Committee on Energy 

3 and Commerce of the House of Representatives 

4 of each decision to make available the special 

5 reserve fund as defined in subsection (h) for 

6 procurement of a security countermeasure, in7 cluding, where available, the number of, the na8 ture of, and other information concerning po9 tential suppliers of such countermeasure, and 

10 whether other potential suppliers of the same or 

11 similar countermeasures were considered and 

12 rejected for procurement under this section and 

13 the reasons therefore.’’; and 

14 (D) in the heading, by striking ‘‘REC15 OMMENDATION FOR PRESIDENT’S APPROVAL’’ 

16 and inserting ‘‘RECOMMENDATIONS FOR PRO17 CUREMENT’’; and 

18 (3) in paragraph (7)— 

19 (A) by striking subparagraph (A); 

20 (B) by striking subparagraph (B) and in21 serting the following: 

22 ‘‘(A) PAYMENTS FROM SPECIAL RESERVE

23 FUND.—The special reserve fund as defined in 

24 subsection (h) shall be available for payments 

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1 ment of a security countermeasure in accord2 ance with the provisions of this paragraph.’’; 

3 and 

4 (C) by redesignating subparagraph (C) as 

5 subparagraph (B). 

6 SEC. 7. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 

7 FOR AGENTS THAT PRESENT NATIONAL SE8 CURITY THREATS. 

9 Subchapter E of chapter V of the Federal Food, 

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

11 amended by inserting after section 565 the following: 

12 ‘‘SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREAT13 MENTS FOR AGENTS THAT PRESENT NA14 TIONAL SECURITY THREATS. 

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

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

17 a human drug application as defined in section 

18 735(1), means review and action by the Secretary on 

19 such application not later than 6 months after re20 ceipt by the Secretary of such application, as de21 scribed in the Manual of Policies and Procedures in 

22 the Food and Drug Administration and goals identi23 fied in the letters described in section 101(b) of the 

24 Food and Drug Administration Safety and Innova25 tion Act. 


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

2 ‘priority review voucher’ means a voucher issued by 

3 the Secretary to the sponsor of a material threat 

4 medical countermeasure application that entitles the 

5 holder of such voucher to priority review of a single 

6 human drug application submitted under section 

7 505(b)(1) or section 351 of the Public Health Serv8 ice Act after the date of approval of the material 

9 threat medical countermeasure application. 

10 ‘‘(3) MATERIAL THREAT MEDICAL COUNTER11 MEASURE APPLICATION.—The term ‘material threat 

12 medical countermeasure application’ means an appli13 cation that— 

14 ‘‘(A) is a human drug application as de15 fined in section 735(1)— 

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

17 biological, chemical, radiological, or nuclear 

18 agent identified as a material threat under 

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

20 Health Service Act, or 

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

22 harm from a condition that may result in 

23 adverse health consequences or death and 

24 may be caused by administering a drug, or 

25 biological product against such agent; 


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1 ‘‘(B) the Secretary deems eligible for pri2 ority review; 

3 ‘‘(C) is approved after the date of enact4 ment of the Medical Countermeasure Innova5 tion Act of 2015; and 

6 ‘‘(D) is for a human drug, no active ingre7 dient (including any ester or salt of the active 

8 ingredient) of which has been approved in any 

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

10 section 351 of the Public Health Service Act. 

11 ‘‘(b) PRIORITY REVIEW VOUCHER.— 

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

13 a priority review voucher to the sponsor of a mate14 rial threat medical countermeasure application upon 

15 approval by the Secretary of such material threat 

16 medical countermeasure application. 

17 ‘‘(2) TRANSFERABILITY.—The sponsor of a ma18 terial threat medical countermeasure application 

19 that receives a priority review voucher under this 

20 section may transfer (including by sale) the entitle21 ment to such voucher to a sponsor of a human drug 

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

23 section 351 of the Public Health Service Act will be 

24 submitted after the date of the approval of the mate25 rial threat medical countermeasure application. 


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

2 review voucher may be transferred before such 

3 voucher is used. 

4 ‘‘(3) NOTIFICATION.— 

5 ‘‘(A) IN GENERAL.—The sponsor of a 

6 human drug application shall notify the Sec7 retary not later than 90 calendar days prior to 

8 submission of the human drug application that 

9 is the subject of a priority review voucher of an 

10 intent to submit the human drug application, 

11 including the date on which the sponsor intends 

12 to submit the application. Such notification 

13 shall be a legally binding commitment to pay 

14 for the user fee to be assessed in accordance 

15 with this section. 

16 ‘‘(B) TRANSFER AFTER NOTICE.—The 

17 sponsor of a human drug application that pro18 vides notification of the intent of such sponsor 

19 to use the voucher for the human drug applica20 tion under subparagraph (A) may transfer the 

21 voucher after such notification is provided, if 

22 such sponsor has not yet submitted the human 

23 drug application described in the notification. 

24 ‘‘(c) PRIORITY REVIEW USER FEE.— 


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1 ‘‘(1) IN GENERAL.—The Secretary shall estab2 lish a user fee program under which a sponsor of a 

3 human drug application that is the subject of a pri4 ority review voucher shall pay to the Secretary a fee 

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

6 in addition to any fee required to be submitted by 

7 the sponsor under chapter VII. 

8 ‘‘(2) FEE AMOUNT.—The amount of the pri9 ority review user fee shall be determined each fiscal 

10 year by the Secretary and based on the average cost 

11 incurred by the agency in the review of a human 

12 drug application subject to priority review in the 

13 previous fiscal year. 

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

15 shall establish, before the beginning of each fiscal 

16 year beginning after September 30, 2015, for that 

17 fiscal year, the amount of the priority review user 

18 fee. 

19 ‘‘(4) PAYMENT.— 

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

21 user fee required by this subsection shall be due 

22 upon the submission of a human drug applica23 tion under section 505(b)(1) or section 351 of 

24 the Public Health Service Act for which the pri25 ority review voucher is used. 


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1 ‘‘(B) COMPLETE APPLICATION.—An appli2 cation described under subparagraph (A) for 

3 which the sponsor requests the use of a priority 

4 review voucher shall be considered incomplete if 

5 the fee required by this subsection and all other 

6 applicable user fees are not paid in accordance 

7 with the Secretary’s procedures for paying such 

8 fees. 

9 ‘‘(C) NO WAIVERS, EXEMPTIONS, REDUC10 TIONS, OR REFUNDS.—The Secretary may not 

11 grant a waiver, exemption, reduction, or refund 

12 of any fees due and payable under this section. 

13 ‘‘(5) OFFSETTING COLLECTIONS.—Fees col14 lected pursuant to this subsection for any fiscal 

15 year— 

16 ‘‘(A) shall be deposited and credited as off17 setting collections to the account providing ap18 propriations to the Food and Drug Administra19 tion; and 

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

21 year except to the extent provided in advance in 

22 appropriation Acts. 

23 ‘‘(d) NOTICE OF ISSUANCE OF VOUCHER AND AP24 PROVAL OF PRODUCTS UNDER VOUCHER.—The Secretary 

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


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1 Internet Website of the Food and Drug Administration 

2 not later than 30 calendar days after the occurrence of 

3 each of the following: 

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

5 voucher under this section. 

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

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

8 this Act or section 351(a) of the Public Health Serv9 ice Act for which the sponsor of the application used 

10 a priority review voucher under this section. 

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

12 in this section precludes a sponsor who seeks a priority 

13 review voucher under this section from participating in 

14 any other incentive program, including under this Act, ex15 cept that no sponsor of a material threat medical counter16 measure application may receive more than one priority 

17 review voucher with respect to such drug. 

18 ‘‘(f) RELATION TO OTHER PROVISIONS.—The provi19 sions of this section shall supplement, not supplant, any 

20 other provisions of this Act or the Public Health Service 

21 Act that encourage the development of medical counter22 measures.’’. 

Æ 


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