IB 

Union Calendar No. 571 

114TH CONGRESS 

2D SESSION H. R. 3299 

[Report No. 114–735] 

To amend the Public Health Service Act to ensure preparedness for chemical, 

radiological, biological, and nuclear threats, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 29, 2015 

Mrs. BROOKS of Indiana (for herself and Ms. ESHOO) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

SEPTEMBER 9, 2016 

Additional sponsors: Mr. FLORES, Mrs. ELLMERS of North Carolina, Mrs. 

BLACKBURN, Mr. MULLIN, Mr. HUNTER, Mrs. MIMI WALTERS of California, Mr. BISHOP of Michigan, Mr. LONG, Mr. NUNES, Mr. TURNER, 

Mr. BURGESS, Mr. KNIGHT, Mr. CARTER of Georgia, Mr. BILIRAKIS, Mr. 

GARAMENDI, Mr. GRIFFITH, Mr. SWALWELL of California, Mr. COLLINS

of New York, Mr. LANCE, Mrs. COMSTOCK, Mr. GUTHRIE, Mr. HASTINGS, Mr. KINZINGER of Illinois, Mr. STEWART, Mr. VARGAS, Mr. 

BUCSHON, Mr. WALDEN, Mr. CRAMER, Mr. HUDSON, Mr. JOYCE, Mr. 

JOHNSON of Ohio, Mr. QUIGLEY, Mr. CRENSHAW, Mr. OLSON, Mr. 

DAVID SCOTT of Georgia, Mr. CA ́RDENAS, Mr. WITTMAN, Mr. DENHAM, 

Mr. MESSER, Mr. RUPPERSBERGER, Mr. RUSH, Ms. SPEIER, Mr. SHIMKUS, Mrs. MCMORRIS RODGERS, Mr. RODNEY DAVIS of Illinois, and Mr. 

PASCRELL

SEPTEMBER 9, 2016 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

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

[For text of introduced bill, see copy of bill as introduced on July 29, 2015] 

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A BILL 

To amend the Public Health Service Act to ensure preparedness for chemical, radiological, biological, and nuclear 

threats, and for other purposes. 

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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; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Strengthening Public Health Emergency Response Act of 

6 2016’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of this 

8 Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. GAO report on State, local, and hospital preparedness programs. 

Sec. 3. Strategic national stockpile. 

Sec. 4. Project Bioshield procurement process. 

Sec. 5. BARDA transaction authorities. 

Sec. 6. Public health emergency medical countermeasures enterprise strategy and 

implementation plan. 

Sec. 7. Priority review to encourage treatments for agents that present national 

security threats. 

9 SEC. 2. GAO REPORT ON STATE, LOCAL, AND HOSPITAL 

10 PREPAREDNESS PROGRAMS. 

11 (a) IN GENERAL.—Not later than 1 year after the date 

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

13 United States shall submit a report to the Congress on the 

14 programs for awarding cooperative agreements and grants 

15 under section 319C–1 of the Public Health Service Act (42 

16 U.S.C. 247d–3a; improving State and local public health 

17 security) and section 319C–2 of such Act (42 U.S.C. 247d– 

18 3b; partnerships for State and regional hospital prepared19 ness to improve surge capacity). 

20 (b) CONTENTS.—The report under subsection (a) shall 

21 address each of the following: 

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1 (1) The goals of the programs specified in sub2 section (a). 

3 (2) The extent to which such goals are being met, 

4 including performance metrics that could help to as5 sess whether such programs are succeeding at the coa6 lition and member level. 

7 (3) How such programs could be improved, in8 cluding how such programs could be modified to im9 prove the medical preparedness of hospitals, health 

10 care coalitions, and the continuity of health care de11 livery. 

12 (4) How such programs complement other pre13 paredness programs of the Department of Health and 

14 Human Services. 

15 (5) How funds awarded through such programs 

16 should be allocated and whether that allocation should 

17 be based on risk. 

18 (6) Progress made toward State and local pre19 paredness entities being self-sustaining. 

20 (7) Whether the level of funding for such pro21 grams is sufficient. 

22 (8) How funding for such programs is being used 

23 to ensure preparedness for at-risk populations includ24 ing children, pregnant women, senior citizens, and 

25 other individuals who may have unique needs in the 

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1 event of a public health emergency, such as individ2 uals with disabilities. 

3 (9)(A) How, and to what extent, entities are 

4 using the funds awarded to such entities through sec5 tion 319C–2 of the Public Health Service Act (42 

6 U.S.C. 247d–3b) to directly fund regional health care 

7 coalitions and members of such coalitions. 

8 (B) The amount each such entity retains for its 

9 own indirect and direct costs. 

10 (C) The purposes for which such retained funds 

11 are used and whether these uses provide value for the 

12 program under such section 319C–2, regional health 

13 care coalitions, and members of such coalitions. 

14 (10) The extent to which the funds awarded 

15 through the programs under sections 319C–1 and 

16 319C–2 of the Public Health Service Act (42 U.S.C. 

17 247d–3a, 247d–3b) have been used for overlapping 

18 purposes. 

19 SEC. 3. STRATEGIC NATIONAL STOCKPILE. 

20 Section 319F–2(a)(2) of the Public Health Service Act 

21 (42 U.S.C. 247d–6b(a)(2)) is amended— 

22 (1) in subparagraph (G), by striking ‘‘and’’ at 

23 the end; 

24 (2) in subparagraph (H), by striking the period 

25 at the end and inserting ‘‘; and’’; and 

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1 (3) by adding at the end the following: 

2 ‘‘(I) ensure procedures are in place to co3 ordinate the ongoing stockpiling by the Bio4 medical Advanced Research and Development 

5 Authority and Centers for Disease Control and 

6 Prevention of qualified countermeasures (as de7 fined in section 319F–1) for which funds have 

8 been made available under this part, security 

9 countermeasures (as defined in this section), and 

10 qualified pandemic or epidemic products (as de11 fined in section 319F–3) for which funds have 

12 been made available under section 319L in order 

13 to avoid any gaps in preparedness.’’. 

14 SEC. 4. PROJECT BIOSHIELD PROCUREMENT 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 ‘‘make available the special reserve fund 

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

23 countermeasure’’; 

24 (2) in paragraph (6)— 

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

2 and (E); and 

3 (B) by striking ‘‘(6) RECOMMENDATIONS

4 FOR PRESIDENT’S APPROVAL’’ and all that fol5 lows through ‘‘(D) SUBSEQUENT SPECIFIC COUN6 TERMEASURES.—’’ and inserting ‘‘(6) SUBSE7 QUENT SPECIFIC COUNTERMEASURES.—’’; and 

8 (3) in paragraph (7)— 

9 (A) by striking subparagraph (A); 

10 (B) by redesignating subparagraph (B) as 

11 subparagraph (A) and amending such subpara12 graph (A), as redesignated, to read as follows: 

13 ‘‘(A) PAYMENTS FROM SPECIAL RESERVE

14 FUND.—The special reserve fund as defined in 

15 subsection (h) shall be available for payments 

16 made by the Secretary to a vendor for procure17 ment of a security countermeasure in accordance 

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

19 (C) by redesignating subparagraph (C) as 

20 subparagraph (B). 

21 SEC. 5. BARDA TRANSACTION AUTHORITIES. 

22 Section 319L(c)(5) of the Public Health Service Act 

23 (42 U.S.C. 247d–7e(c)(5)) is amended by adding at the end 

24 the following: 

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1 ‘‘(H) CONTRACTING AUTHORITY CLARIFICA2 TION.—The Secretary shall delegate authority for 

3 negotiating and entering into any contracts, 

4 grants, or cooperative agreements under this sec5 tion to the Director.’’. 

6 SEC. 6. PUBLIC HEALTH EMERGENCY MEDICAL COUNTER7 MEASURES ENTERPRISE STRATEGY AND IM8 PLEMENTATION PLAN. 

9 Section 2811(d)(2) of the Public Health Service Act 

10 (42 U.S.C. 300hh–10(d)(2)) is amended— 

11 (1) in subparagraph (A), by inserting after ‘‘de12 scribe the chemical, biological, radiological, and nu13 clear agent or agents that may present a threat to the 

14 Nation’’ the following: ‘‘(which shall include pan15 demic influenza)’’; 

16 (2) by striking ‘‘and’’ at the end of subpara17 graph (J); 

18 (3) by redesignating subparagraph (K) as sub19 paragraph (L); and 

20 (4) by inserting after subparagraph (J) the fol21 lowing: 

22 ‘‘(K) report on the amount of time between 

23 the issuance of each request for a proposal or 

24 task order from the Biomedical Advanced Re25 search and Development Authority and the 

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1 award of a contract pursuant to such request for 

2 a proposal or task order; and’’. 

3 SEC. 7. PRIORITY REVIEW TO ENCOURAGE TREATMENTS 

4 FOR AGENTS THAT PRESENT NATIONAL SE5 CURITY THREATS. 

6 (a) IN GENERAL.—Subchapter E of chapter V of the 

7 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb 

8 et seq.) is amended by inserting after section 565 the fol9 lowing: 

10 ‘‘SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREAT11 MENTS FOR AGENTS THAT PRESENT NA12 TIONAL SECURITY THREATS. 

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

14 ‘‘(1) PRIORITY REVIEW.—The term ‘priority re15 view’, with respect to a human drug application as 

16 defined in section 735(1), means review and action by 

17 the Secretary on such application not later than 6 

18 months after receipt by the Secretary of such applica19 tion, as described in the manual of policies and proce20 dures of the Food and Drug Administration and goals 

21 identified in the letters described in section 101(b) of 

22 the Food and Drug Administration Safety and Inno23 vation Act (Public Law 112–144). 

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

25 ‘priority review voucher’ means a voucher issued by 

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1 the Secretary to the sponsor of a material threat med2 ical countermeasure application that entitles the hold3 er of such voucher to priority review of a single 

4 human drug application submitted under section 

5 505(b)(1) of this Act or section 351(a) of the Public 

6 Health Service Act after the date of approval of the 

7 material threat medical countermeasure application. 

8 ‘‘(3) MATERIAL THREAT MEDICAL COUNTER9 MEASURE APPLICATION.—The term ‘material threat 

10 medical countermeasure application’ means an appli11 cation that— 

12 ‘‘(A) is a human drug application as de13 fined in section 735(1) to prevent, or treat harm 

14 from, a biological, chemical, radiological, or nu15 clear agent identified as a material threat under 

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

17 Service Act; 

18 ‘‘(B) the Secretary deems eligible for pri19 ority review; 

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

21 of the Strengthening Public Health Emergency 

22 Response Act of 2016; and 

23 ‘‘(D) is for a human drug, no active ingre24 dient (including any ester or salt of the active 

25 ingredient) of which has been approved pursuant 

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1 to any other application under section 505(b)(1) 

2 of this Act or section 351(a) of the Public Health 

3 Service Act. 

4 ‘‘(b) PRIORITY REVIEW VOUCHER.— 

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

6 priority review voucher to the sponsor of a material 

7 threat medical countermeasure application upon ap8 proval by the Secretary of such application. 

9 ‘‘(2) TRANSFERABILITY.— 

10 ‘‘(A) IN GENERAL.—The sponsor of a mate11 rial threat medical countermeasure application 

12 that receives a priority review voucher under 

13 this section may transfer (including by sale) the 

14 entitlement to such voucher to a sponsor of a 

15 human drug for which an application under sec16 tion 505(b)(1) of this Act or section 351(a) of the 

17 Public Health Service Act will be submitted after 

18 the date of the approval of the material threat 

19 medical countermeasure application. There is no 

20 limit on the number of times a priority review 

21 voucher may be transferred before such voucher is 

22 used. 

23 ‘‘(B) NOTIFICATION OF TRANSFER.—Each 

24 person to whom a voucher is transferred shall 

25 notify the Secretary of such change in ownership 

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1 of the voucher not later than 30 days after the 

2 date of such transfer. 

3 ‘‘(3) NOTIFICATION.— 

4 ‘‘(A) IN GENERAL.—The sponsor of a 

5 human drug application shall notify the Sec6 retary not later than 90 calendar days prior to 

7 submission of the human drug application that 

8 is the subject of a priority review voucher of an 

9 intent to submit the human drug application, 

10 including the date on which the sponsor intends 

11 to submit the application. Such notification 

12 shall be a legally binding commitment to pay for 

13 the user fee to be assessed in accordance with this 

14 section. 

15 ‘‘(B) TRANSFER AFTER NOTICE.—The spon16 sor of a human drug application that provides 

17 notification of the intent of such sponsor to use 

18 the voucher for the human drug application 

19 under subparagraph (A) may transfer the vouch20 er after such notification is provided, if such 

21 sponsor has not yet submitted the human drug 

22 application described in the notification. 

23 ‘‘(c) PRIORITY REVIEW USER FEE.— 

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

25 a user fee program under which a sponsor of a 

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1 human drug application that is the subject of a pri2 ority review voucher shall pay to the Secretary a fee 

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

4 addition to any fee required to be submitted by the 

5 sponsor under chapter VII. 

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

7 review user fee shall be determined each fiscal year by 

8 the Secretary and based on the average cost incurred 

9 by the agency in the review of a human drug applica10 tion subject to priority review in the previous fiscal 

11 year. 

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

13 establish, before the beginning of each fiscal year be14 ginning after September 30, 2016, for that fiscal year, 

15 the amount of the priority review user fee. 

16 ‘‘(4) PAYMENT.— 

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

18 user fee required by this subsection shall be due 

19 upon the notification by a sponsor of the intent 

20 of such sponsor to use the voucher, as specified 

21 in subsection (b)(3)(A). All other user fees associ22 ated with the human drug application shall be 

23 due as required by the Secretary or under appli24 cable law. 

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

3 the sponsor requests the use of a priority review 

4 voucher shall be considered incomplete if the fee 

5 required by this subsection and all other applica6 ble user fees are not paid in accordance with the 

7 Secretary’s procedures for paying such fees. 

8 ‘‘(C) NO WAIVERS, EXEMPTIONS, REDUC9 TIONS, OR REFUNDS.—The Secretary may not 

10 grant a waiver, exemption, reduction, or refund 

11 of any fees due and payable under this section. 

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

13 pursuant to this subsection for any fiscal year— 

14 ‘‘(A) shall be deposited and credited as off15 setting collections to the account providing ap16 propriations to the Food and Drug Administra17 tion; and 

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

19 year except to the extent provided in advance in 

20 appropriation Acts. 

21 ‘‘(d) NOTICE OF ISSUANCE OF VOUCHER AND AP22 PROVAL OF PRODUCTS UNDER VOUCHER.—The Secretary 

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

24 public website of the Food and Drug Administration not 

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

2 the following: 

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

4 voucher under this section. 

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

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

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

8 for which the sponsor of the application used a pri9 ority review voucher under this section. 

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

11 in this section precludes a sponsor who seeks a priority re12 view voucher under this section from participating in any 

13 other incentive program, including under this Act, except 

14 that no sponsor of a material threat medical counter15 measure application may receive more than one priority 

16 review voucher issued under any section of this Act with 

17 respect to the drug that is the subject of such application. 

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. 

23 ‘‘(g) MEDICAL COUNTERMEASURE POSTAPPROVAL RE24 PORT.— 

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1 ‘‘(1) IN GENERAL.—Not later than 5 years after 

2 the date of approval of a material threat medical 

3 countermeasure application, the sponsor of such ap4 plication shall submit a report to the Secretary on 

5 such medical countermeasure. 

6 ‘‘(2) CONTENTS.—A report under paragraph (1) 

7 shall include, with respect to each of the first 2 years 

8 after approval of such material threat medical coun9 termeasure application, a description of— 

10 ‘‘(A) the sponsor’s activities with Federal 

11 agencies related to the procurement, including 

12 stockpiling, of the approved medical counter13 measure; 

14 ‘‘(B) the sponsor’s progress in fulfilling con15 tracts entered into with Federal agencies, includ16 ing the Biomedical Advanced Research and De17 velopment Authority, the Centers for Disease 

18 Control and Prevention, and the Department of 

19 Defense, related to such procurement; 

20 ‘‘(C) the extent to which the Federal Gov21 ernment has fulfilled its stated medical counter22 measure requirements for the threat intended to 

23 be treated by the approved medical counter24 measure; and 

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1 ‘‘(D) the sponsor’s plans, if any, to develop 

2 additional material threat medical counter3 measures. 

4 ‘‘(3) AVAILABILITY TO CONGRESSIONAL COMMIT5 TEES.—The Secretary shall make each report sub6 mitted under this subsection available to the Com7 mittee on Energy and Commerce of the House of Rep8 resentatives and the Committee on Health, Education, 

9 Labor, and Pensions of the Senate upon request by ei10 ther such Committee not later than 30 days after re11 ceipt of such request. 

12 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in this 

13 subsection shall be construed to permit the disclosure 

14 of confidential commercial or trade secret information 

15 or the disclosure of information that could com16 promise national security.’’. 

17 (b) GAO REPORT.— 

18 (1) STUDY.—The Comptroller General of the 

19 United States shall conduct a study on the effective20 ness of priority review vouchers under section 565A 

21 of the Federal Food, Drug, and Cosmetic Act, as 

22 added by subsection (a), in providing incentives for 

23 the development of material threat medical counter24 measure applications under such section 565A. In 

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1 conducting such study, the Comptroller General shall 

2 examine the following: 

3 (A) The impact of such priority review on 

4 the development of material threat medical coun5 termeasures and the impact of such investment, 

6 as applicable, on the development of such coun7 termeasures. 

8 (B) How the drugs for which such priority 

9 review vouchers were awarded— 

10 (i) addressed identified medical coun11 termeasure needs; and 

12 (ii) impacted United States prepared13 ness against chemical, biological, radio14 logical, and nuclear threats, including both 

15 identified threats and naturally occurring 

16 threats. 

17 (C) How many material threat medical 

18 countermeasures were licensed or approved, or 

19 otherwise significantly advanced in clinical de20 velopment, in the 15 years following the enact21 ment of such section 565A compared to the 15 

22 years prior to the enactment of such section, in23 cluding a comparative analysis of Federal ad24 vanced development and procurement dollars 

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1 available in the 15 years following such enact2 ment compared to the prior 15 years. 

3 (D) How material threat medical counter4 measures developed after the date of enactment of 

5 this Act impact— 

6 (i) the supply of products in the stra7 tegic national stockpile under section 319F– 

8 2 of the Public Health Service Act (42 

9 U.S.C. 247d–6b); and 

10 (ii) national preparedness. 

11 (E) How the Federal Government supported 

12 sponsors of material threat medical counter13 measures during the research, development, ap14 plication review, and production of such drugs, 

15 including the use of government research, provi16 sion of resources through contracts or grants, and 

17 use of federally funded research facilities. 

18 (F) An analysis of the drugs for which such 

19 priority review vouchers were used, which shall 

20 include— 

21 (i) the indications for which such 

22 drugs were approved under section 

23 505(b)(1) of the Federal Food, Drug, and 

24 Cosmetic Act (21 U.S.C. 355(b)(1)) or secmstockstill on DSK3G9T082PROD with BILLS

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1 tion 351(a) of the Public Health Service Act 

2 (42 U.S.C. 262(a)); 

3 (ii) whether unmet medical needs were 

4 addressed through the approval of such 

5 drugs, including, for each such drug— 

6 (I) if there was a currently mar7 keted therapy approved to prevent or 

8 treat the same indication in the same 

9 patient population at the time the ap10 plication was submitted to the Food 

11 and Drug Administration; and 

12 (II) if the drug provided a signifi13 cant benefit or improvement in safety 

14 and effectiveness compared to such cur15 rently marketed product; 

16 (iii) the price of the priority review 

17 voucher if transferred or sold prior to re18 demption; and 

19 (iv) the length of time between the date 

20 on which a priority review voucher was 

21 awarded and the date on which it was used. 

22 (G) With respect to the priority review 

23 voucher program under such section 565A— 

24 (i) how many priority review vouchers 

25 were awarded under such section 565A and 

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1 how many of such awarded vouchers were 

2 redeemed for priority review of a drug ap3 plication in the 15 years following the date 

4 of enactment of such section; 

5 (ii) the resources associated with the 

6 Food and Drug Administration implemen7 tation of such section 565A and review of 

8 applications for which a voucher awarded 

9 under such section 565A is redeemed for 

10 priority review and if implementation of 

11 such section 565A prohibited the Food and 

12 Drug Administration from meeting drug 

13 application review goals; 

14 (iii) recommendations on whether ap15 propriate Federal funding for advanced de16 velopment and research would necessitate 

17 the priority review voucher program for 

18 medical countermeasures; 

19 (iv) the degree to which this incentive 

20 program impacts other priority review 

21 voucher programs; and 

22 (v) the degree to which guaranteed 

23 Federal funding for advanced development 

24 and research is a greater incentive for new 

25 investment in research and the development 

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1 of medical countermeasures than the uncer2 tain values of vouchers. 

3 (2) CONSULTATIONS.—In conducting the study 

4 under subsection (a), the Comptroller General of the 

5 United States shall consult with— 

6 (A) drug manufacturers involved in the re7 search and development of medical counter8 measures to address biological, chemical, radio9 logical, and nuclear threats; 

10 (B) stakeholders involved in investing in the 

11 research and development of such medical coun12 termeasures, including venture capitalists; 

13 (C) the Federal Government agencies re14 sponsible for advancing, reviewing, and pro15 curing such medical countermeasures, includ16 ing— 

17 (i) the Department of Health and 

18 Human Services, including the Office of the 

19 Assistant Secretary for Preparedness and 

20 Response, the Biomedical Advanced Re21 search and Development Authority, and the 

22 Food and Drug Administration; and 

23 (ii) the Department of Defense; 

24 (D) biodefense stakeholders, as applicable; 

25 and 

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1 (E) drug manufacturers involved in the re2 search and development of therapies that ad3 dress— 

4 (i) tropical diseases (as defined in sec5 tion 524(a) of the Federal Food, Drug, and 

6 Cosmetic Act (21 U.S.C. 360n(a))); or 

7 (ii) rare pediatric diseases (as defined 

8 in section 529(a) of such Act (21 U.S.C. 

9 360ff(a))). 

10 (3) INITIAL ASSESSMENT.—Not later than 10 

11 years after the date of enactment of this Act, the 

12 Comptroller General of the United States shall submit 

13 to the Committee on Health, Education, Labor, and 

14 Pensions of the Senate and the Committee on Energy 

15 and Commerce of the House of Representatives an 

16 initial assessment of the effectiveness of the priority 

17 review voucher program set forth in section 565A of 

18 the Federal Food, Drug, and Cosmetic Act, as added 

19 by subsection (a). 

20 (4) REPORT.—Not later than 16 years after the 

21 date of enactment of this Act, the Comptroller General 

22 of the United States shall submit to the Committee on 

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

24 and the Committee on Energy and Commerce of the 

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1 House of Representatives a report containing the re2 sults of the study conducted under paragraph (1). 

3 (5) PROTECTION OF NATIONAL SECURITY.—The 

4 Comptroller General of the United States shall con5 duct the study under paragraph (1) and issue the as6 sessment and report under paragraphs (3) and (4) in 

7 a manner that does not compromise national security. 

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Union Calendar No. 571 

114TH CONGRESS 

2D SESSION H. R. 3299 

[Report No. 114–735] 

A BILL 

To amend the Public Health Service Act to ensure 

cal, and nuclear threats, and for other purposes. preparedness for chemical, radiological, biologiSEPTEMBER 9, 2016 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 

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