IIB 

112TH CONGRESS 

1ST SESSION H. R. 2405 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 7, 2011 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

To reauthorize certain provisions of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act 

relating to public health preparedness and countermeasure development, and for other purposes. 

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


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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

3 ‘‘Pandemic and All-Hazards Preparedness Reauthoriza4 tion Act of 2011’’. 

5 (b) TABLE OF CONTENTS.—The table of contents for 

6 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Reauthorization of certain provisions relating to public health preparedness. 

Sec. 3. Temporary redeployment of personnel during a public health emergency. 

Sec. 4. Coordination by Assistant Secretary for Preparedness and Response. 

Sec. 5. Eliminating duplicative Project Bioshield reports. 

Sec. 6. Authorization for medical products for use in emergencies. 

Sec. 7. Additional provisions related to medical products for emergency use. 

Sec. 8. Products held for emergency use. 

Sec. 9. Accelerate countermeasure development by strengthening FDA’s role in 

reviewing products for national security priorities. 

7 SEC. 2. REAUTHORIZATION OF CERTAIN PROVISIONS RE8 LATING TO PUBLIC HEALTH PREPAREDNESS. 

9 (a) VACCINE TRACKING AND DISTRIBUTION.—Sub10 section (e) of section 319A of the Public Health Service 

11 Act (42 U.S.C. 247d–1) is amended by striking ‘‘such 

12 sums for each of fiscal years 2007 through 2011’’ and 

13 inserting ‘‘$30,800,000 for each of fiscal years 2012 

14 through 2016’’. 

15 (b) IMPROVING STATE AND LOCAL PUBLIC HEALTH

16 SECURITY.—Effective on October 1, 2011, section 319C– 

17 1 of the Public Health Service Act (42 U.S.C. 247d–3a) 

18 is amended— 

19 (1) in subsection (b)(2)(A)— 


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1 (A) in clause (iv), by striking ‘‘and’’ at the 

2 end; 

3 (B) in clause (v), by adding ‘‘and’’ at the 

4 end; and 

5 (C) by adding at the end the following: 

6 ‘‘(vi) a description of any activities 

7 that such entity will use to analyze real8 time clinical specimens for pathogens of 

9 public health or bioterrorism significance, 

10 including any utilization of poison control 

11 centers;’’; 

12 (2) in subsection (f)— 

13 (A) in paragraph (2), by inserting ‘‘and’’ 

14 at the end; 

15 (B) in paragraph (3), by striking ‘‘; and’’ 

16 and inserting a period; and 

17 (C) by striking paragraph (4); 

18 (3) by striking subsection (h); and 

19 (4) in subsection (i)— 

20 (A) in paragraph (1)— 

21 (i) by amending subparagraph (A) to 

22 read as follows: 

23 ‘‘(A) IN GENERAL.—For the purpose of 

24 carrying out this section, there is authorized to 


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1 be appropriated $632,900,000 for each of fiscal 

2 years 2012 through 2016.’’; and 

3 (ii) by striking subparagraph (B); and 

4 (B) in subparagraphs (C) and (D) of para5 graph (3), by striking ‘‘(1)(A)(i)(I)’’ each place 

6 it appears and inserting ‘‘(1)(A)’’. 

7 (c) PARTNERSHIPS FOR STATE AND REGIONAL HOS8 PITAL PREPAREDNESS TO IMPROVE SURGE CAPACITY.— 

9 Section 319C–2 of the Public Health Service Act (42 

10 U.S.C. 247d–3b) is amended— 

11 (1) in subsection (a), by inserting ‘‘, including 

12 capacity and preparedness to address the needs of 

13 pediatric and other at-risk populations’’ before the 

14 period at the end; 

15 (2) in subsection (i)— 

16 (A) by striking ‘‘The requirements of’’ and 

17 inserting the following: 

18 ‘‘(1) IN GENERAL.—The requirements of’’; and 

19 (B) by adding at the end the following: 

20 ‘‘(2) MEETING GOALS OF NATIONAL HEALTH

21 SECURITY STRATEGY.—The Secretary shall imple22 ment objective, evidence-based metrics to ensure that 

23 entities receiving awards under this section are 

24 meeting, to the extent practicable, the goals of the 


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1 National Health Security Strategy under section 

2 2802.’’; and 

3 (3) by amending subsection (j)(1) to read as 

4 follows: 

5 ‘‘(1) IN GENERAL.—For purposes of carrying 

6 out this section, there is authorized to be appro7 priated $378,000,000 for each of fiscal years 2012 

8 through 2016.’’. 

9 (d) CDC PROGRAMS FOR COMBATING PUBLIC

10 HEALTH THREATS.—Section 319D of the Public Health 

11 Service Act (42 U.S.C. 247d–4) is amended— 

12 (1) by striking subsection (c); and 

13 (2) in subsection (g), by striking ‘‘such sums as 

14 may be necessary in each of fiscal years 2007 

15 through 2011’’ and inserting ‘‘$160,121,000 for 

16 each of fiscal years 2012 through 2016’’. 

17 (e) DENTAL EMERGENCY RESPONDERS: PUBLIC

18 HEALTH AND MEDICAL RESPONSE.— 

19 (1) ALL-HAZARDS PUBLIC HEALTH AND MED20 ICAL RESPONSE CURRICULA AND TRAINING.—Sec21 tion 319F(a)(5)(B) of the Public Health Service Act 

22 (42 U.S.C. 247d–6(a)(5)(B)) is amended by striking 

23 ‘‘public health or medical’’ and inserting ‘‘public 

24 health, medical, or dental’’. 


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1 (2) NATIONAL HEALTH SECURITY STRATEGY.— 

2 Section 2802(b)(3) of the Public Health Service Act 

3 (42 U.S.C. 300hh–1(b)(3)) is amended— 

4 (A) in the matter preceding subparagraph 

5 (A), by inserting ‘‘and which may include den6 tal health facilities’’ after ‘‘mental health facili7 ties’’; and 

8 (B) in subparagraph (D), by inserting 

9 ‘‘(which may include dental health assets)’’ 

10 after ‘‘medical assets’’. 

11 (f) PROCUREMENT OF COUNTERMEASURES.— 

12 (1) CONTRACT TERMS.—Subclause (IX) of sec13 tion 319F–2(c)(7)(C)(ii) of the Public Health Serv14 ice Act (42 U.S.C. 247d–6b(c)(7)(C)(ii)) is amended 

15 to read as follows: 

16 ‘‘(IX) CONTRACT TERMS.—The 

17 Secretary, in any contract for procure18 ment under this section— 

19 ‘‘(aa) may specify— 

20 ‘‘(AA) the dosing and 

21 administration requirements 

22 for countermeasures to be 

23 developed and procured; 

24 ‘‘(BB) the amount of 

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1 cated by the Secretary for 

2 development and acquisition 

3 of the countermeasure; and 

4 ‘‘(CC) the specifications 

5 the countermeasure must 

6 meet to qualify for procure7 ment under a contract under 

8 this section; and 

9 ‘‘(bb) shall provide a clear 

10 statement of defined Government 

11 purpose limited to uses related to 

12 a security countermeasure, as de13 fined in paragraph (1)(B).’’. 

14 (2) REAUTHORIZATION OF THE SPECIAL RE15 SERVE FUND.—Section 319F–2 of the Public Health 

16 Service Act (42 U.S.C. 247d–6b) is amended— 

17 (A) in subsection (c)— 

18 (i) by striking ‘‘special reserve fund 

19 under paragraph (10)’’ each place it ap20 pears and inserting ‘‘special reserve fund 

21 as defined in subsection (g)(5)’’; and 

22 (ii) by striking paragraphs (9) and 

23 (10); and 

24 (B) by adding at the end the following: 

25 ‘‘(g) SPECIAL RESERVE FUND.— 


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1 ‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—In 

2 addition to amounts appropriated to the special re3 serve fund prior to the date of the enactment of this 

4 subsection, there is authorized to be appropriated, 

5 for the procurement of security countermeasures 

6 under subsection (c) and for carrying out section 

7 319L (relating to the Biomedical Advanced Research 

8 and Development Authority), $2,800,000,000 for the 

9 period of fiscal years 2014 through 2018. Amounts 

10 appropriated pursuant to the preceding sentence are 

11 authorized to remain available until September 30, 

12 2019. 

13 ‘‘(2) NOTICE OF INSUFFICIENT FUNDS.—Not 

14 later than 15 days after any date on which the Sec15 retary determines that the amount of funds in the 

16 special reserve fund available for procurement is less 

17 than $1,500,000,000, the Secretary shall submit to 

18 the Committee on Energy and Commerce of the 

19 House of Representatives and the Committee on 

20 Health, Education, Labor, and Pensions of the Sen21 ate a report detailing the amount of such funds 

22 available for procurement and the impact such fund23 ing will have— 

24 ‘‘(A) in meeting the security counter25 measure needs identified under this section; and 


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1 ‘‘(B) on the annual Countermeasure Imple2 mentation Plan under section 2811(d). 

3 ‘‘(3) USE OF SPECIAL RESERVE FUND FOR AD4 VANCED RESEARCH AND DEVELOPMENT.—The Sec5 retary may utilize not more than 30 percent of the 

6 amounts authorized to be appropriated under para7 graph (1) to carry out section 319L (related to the 

8 Biomedical Advanced Research and Development 

9 Authority). Amounts authorized to be appropriated 

10 under this subsection to carry out section 319L are 

11 in addition to amounts otherwise authorized to be 

12 appropriated to carry out such section. 

13 ‘‘(4) RESTRICTIONS ON USE OF FUNDS.— 

14 Amounts in the special reserve fund shall not be 

15 used to pay— 

16 ‘‘(A) costs other than payments made by 

17 the Secretary to a vendor for advanced develop18 ment (under section 319L) or for procurement 

19 of a security countermeasure under subsection 

20 (c)(7); and 

21 ‘‘(B) any administrative expenses, includ22 ing salaries. 

23 ‘‘(5) DEFINITION.—In this section, the term 

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1 tion made available pursuant to section 521(a) of 

2 the Homeland Security Act of 2002, and any appro3 priation made available pursuant to paragraph (1) of 

4 this paragraph.’’. 

5 (g) EMERGENCY SYSTEM FOR ADVANCE REGISTRA6 TION OF VOLUNTEER HEALTH PROFESSIONALS.—Section 

7 319I(k) of the Public Health Service Act (42 U.S.C. 

8 247d–7b(k)) is amended by striking ‘‘are authorized to be 

9 appropriated $2,000,000 for fiscal year 2002, and such 

10 sums as may be necessary for each of the fiscal years 2003 

11 through 2011’’ and inserting ‘‘is authorized to be appro12 priated $5,900,000 for each of fiscal years 2012 through 

13 2016’’. 

14 (h) BIOMEDICAL ADVANCED RESEARCH AND DEVEL15 OPMENT AUTHORITY.— 

16 (1) TRANSACTION AUTHORITIES.—Section 

17 319L(c)(5) of the Public Health Service Act (42 

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

19 end the following: 

20 ‘‘(G) GOVERNMENT PURPOSE.—In award21 ing contracts, grants, and cooperative agree22 ments under this section, the Secretary shall 

23 provide a clear statement of defined Govern24 ment purpose related to activities included in 

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1 measure or qualified pandemic or epidemic 

2 product.’’. 

3 (2) BIODEFENSE MEDICAL COUNTERMEASURE

4 DEVELOPMENT FUND.—Paragraph (2) of section 

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

6 247d–7e(d)) is amended to read as follows: 

7 ‘‘(2) FUNDING.—To carry out the purposes of 

8 this section, there is authorized to be appropriated 

9 to the Fund $415,000,000 for each of fiscal years 

10 2012 through 2016, the amounts to remain available 

11 until expended.’’. 

12 (3) CONTINUED INAPPLICABILITY OF CERTAIN

13 PROVISIONS.—Section 319L(e)(1)(C) of the Public 

14 Health Service Act (42 U.S.C. 247d–7e(e)(1)(C)) is 

15 amended by striking ‘‘the date that is 7 years after 

16 the date of enactment of the Pandemic and All-Haz17 ards Preparedness Act’’ and inserting ‘‘September 

18 30, 2016’’. 

19 (i) NATIONAL DISASTER MEDICAL SYSTEM.—Section 

20 2812 of the Public Health Service Act (42 U.S.C. 300hh– 

21 11) is amended— 

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

23 the following: 

24 ‘‘(D) ADMINISTRATION.—The Secretary 

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1 ment for services under subparagraph (A) di2 rectly or by contract providing for payment in 

3 advance or by way of reimbursement.’’; and 

4 (2) in subsection (g), by striking ‘‘such sums as 

5 may be necessary for each of the fiscal years 2007 

6 through 2011’’ and inserting ‘‘$56,000,000 for each 

7 of fiscal years 2012 through 2016’’. 

8 (j) NATIONAL HEALTH SECURITY STRATEGY

9 TIMELINE.—Section 2802(a)(1) of the Public Health 

10 Service Act (42 U.S.C. 300hh–1(a)(1)) is amended by 

11 striking ‘‘2009’’ and inserting ‘‘2014’’. 

12 (k) ENHANCING SURGE CAPACITY.—Section 2802(b) 

13 of the Public Health Service Act (42 U.S.C. 300hh– 

14 1(b)(3)) is amended— 

15 (1) in paragraph (1)(A), by inserting ‘‘, includ16 ing drills and exercises to ensure medical surge ca17 pacity for events without notice’’ after ‘‘exercises’’; 

18 and 

19 (2) in paragraph (3)— 

20 (A) in the matter preceding subparagraph 

21 (A), as amended by subsection (e)(2) of this 

22 section— 

23 (i) by inserting ‘‘availability, coordina24 tion, accessibility,’’ after ‘‘response capa25 bilities,’’; 


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1 (ii) by striking ‘‘including mental 

2 health facilities’’ and inserting ‘‘including 

3 mental health and ambulatory care facili4 ties’’; and 

5 (iii) by striking ‘‘trauma care and 

6 emergency medical service systems’’ and 

7 inserting ‘‘trauma care, critical care, and 

8 emergency medical service systems’’; and 

9 (B) in subparagraph (B), by striking 

10 ‘‘Medical evacuation and fatality management’’ 

11 and inserting ‘‘Fatality management, and co12 ordinated medical triage and evacuation to the 

13 appropriate medical institution based on patient 

14 medical need as part of regional systems’’. 

15 (l) VOLUNTEER MEDICAL RESERVE CORPS.—Section 

16 2813(i) of the Public Health Service Act (42 U.S.C. 

17 300hh–15(i)) is amended by striking ‘‘$22,000,000 for fis18 cal year 2007, and such sums as may be necessary for 

19 each of fiscal years 2008 through 2011’’ and inserting 

20 ‘‘$11,900,000 for each of fiscal years 2012 through 

21 2016’’. 

22 (m) EXTENSION OF LIMITED ANTITRUST EXEMP23 TION.—Section 405(b) of the Pandemic and All-Hazard 

24 Preparedness Act (42 U.S.C. 247d–6a note) is amended 

25 by striking ‘‘at the end of the 6-year period that begins 


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1 on the date of enactment of this Act’’ and inserting ‘‘on 

2 September 30, 2016’’. 

3 SEC. 3. TEMPORARY REDEPLOYMENT OF PERSONNEL DUR4 ING A PUBLIC HEALTH EMERGENCY. 

5 Section 319 of the Public Health Service Act (42 

6 U.S.C. 247d) is amended by adding at the end the fol7 lowing: 

8 ‘‘(e) TEMPORARY REDEPLOYMENT OF PERSONNEL

9 DURING A PUBLIC HEALTH EMERGENCY.— 

10 ‘‘(1) EMERGENCY REDEPLOYMENT OF FEDER11 ALLY FUNDED PERSONNEL.—Notwithstanding any 

12 other provision of law, and subject to paragraph (2), 

13 upon a request that is from a State, locality, terri14 tory, tribe, or the Freely Associated States and that 

15 includes such information and assurances as the 

16 Secretary may require, the Secretary may authorize 

17 the requesting entity to temporarily redeploy to im18 mediately address a public health emergency non19 Federal personnel funded in whole or in part 

20 through— 

21 ‘‘(A) any program under this Act; or 

22 ‘‘(B) at the discretion of the Secretary, 

23 any other program funded in whole or in part 

24 by the Department of Health and Human Serv25 ices. 


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1 ‘‘(2) ACTIVATION OF EMERGENCY REDEPLOY2 MENT.— 

3 ‘‘(A) PUBLIC HEALTH EMERGENCY.—The 

4 Secretary may exercise the authority vested by 

5 paragraph (1) only during the period of a pub6 lic health emergency determined pursuant to 

7 subsection (a). 

8 ‘‘(B) CONSIDERATIONS.—In authorizing a 

9 temporary redeployment under paragraph (1), 

10 the Secretary shall consider each of the fol11 lowing: 

12 ‘‘(i) The degree to which the emer13 gency cannot be adequately and appro14 priately addressed by the public health 

15 workforce. 

16 ‘‘(ii) The degree to which the emer17 gency requires or would otherwise benefit 

18 from supplemental staffing from those 

19 funded through nonpreparedness Federal 

20 programs. 

21 ‘‘(iii) The degree to which such pro22 grams would be adversely affected by the 

23 redeployment. 

24 ‘‘(iv) Such other factors as the Sec25 retary may deem appropriate. 


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1 ‘‘(C) TERMINATION AND EXTENSION.— 

2 ‘‘(i) TERMINATION.—The authority to 

3 authorize a temporary redeployment of 

4 personnel under paragraph (1) shall termi5 nate upon the earlier of the following: 

6 ‘‘(I) The Secretary’s determina7 tion that the public health emergency 

8 no longer exists. 

9 ‘‘(II) Subject to clause (ii), 30 

10 days after the activation of the Sec11 retary’s authority pursuant to sub12 paragraph (A). 

13 ‘‘(ii) EXTENSION AUTHORITY.—The 

14 Secretary may extend the authority to au15 thorize a temporary redeployment of per16 sonnel under paragraph (1) beyond the 

17 date otherwise applicable under clause 

18 (i)(II) if the public health emergency still 

19 exists, but only if— 

20 ‘‘(I) the extension is requested by 

21 the entity that requested authority to 

22 authorize a temporary redeployment; 

23 and 


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1 ‘‘(II) the Secretary gives notice 

2 to the Congress in conjunction with 

3 the extension.’’. 

4 SEC. 4. COORDINATION BY ASSISTANT SECRETARY FOR 

5 PREPAREDNESS AND RESPONSE. 

6 (a) IN GENERAL.—Section 2811 of the Public Health 

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

8 (1) in subsection (b)(3)— 

9 (A) by inserting ‘‘stockpiling, distribution,’’ 

10 before ‘‘and procurement’’; and 

11 (B) by inserting ‘‘, security measures (as 

12 defined in section 319F–2,’’ after ‘‘qualified 

13 countermeasures (as defined in section 319F– 

14 1)’’; 

15 (2) in subsection (b)(4), by adding at the end 

16 the following: 

17 ‘‘(D) IDENTIFICATION OF INEFFICIEN18 CIES.—Identify gaps, duplication, and other in19 efficiencies in public health preparedness activi20 ties and the actions necessary to overcome these 

21 obstacles. 

22 ‘‘(E) DEVELOPMENT OF COUNTER23 MEASURE IMPLEMENTATION PLAN.—Lead the 

24 development of a coordinated Countermeasure 

25 Implementation Plan under subsection (d). 


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1 ‘‘(F) COUNTERMEASURES BUDGET ANAL2 YSIS.—Oversee the development of a com3 prehensive, cross-cutting 5-year budget analysis 

4 with respect to activities described in paragraph 

5 (3)— 

6 ‘‘(i) to inform prioritization of re7 sources; and 

8 ‘‘(ii) to ensure that challenges to such 

9 activities are adequately addressed. 

10 ‘‘(G) GRANT PROGRAMS FOR MEDICAL AND

11 PUBLIC HEALTH PREPAREDNESS CAPABILI12 TIES.—Coordinate, in consultation with the 

13 Secretary of Homeland Security, grant pro14 grams of the Department of Health and 

15 Human Services relating to medical and public 

16 health preparedness capabilities and the activi17 ties of local communities to respond to public 

18 health emergencies, including the— 

19 ‘‘(i) coordination of relevant program 

20 requirements, timelines, and measurable 

21 goals of such grant programs; and 

22 ‘‘(ii) establishment of a system for 

23 gathering and disseminating best practices 

24 among grant recipients.’’; 


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1 (3) by amending subsection (c) to read as fol2 lows: 

3 ‘‘(c) FUNCTIONS.—The Assistant Secretary for Pre4 paredness and Response shall— 

5 ‘‘(1) have lead responsibility within the Depart6 ment of Health and Human Services for emergency 

7 preparedness and response policy and coordination; 

8 ‘‘(2) have authority over and responsibility 

9 for— 

10 ‘‘(A) the National Disaster Medical System 

11 (in accordance with section 301 of the Pan12 demic and All-Hazards Preparedness Act); 

13 ‘‘(B) the Hospital Preparedness Coopera14 tive Agreement Program pursuant to section 

15 319C–2; 

16 ‘‘(C) the Biomedical Advanced Research 

17 and Development Authority under section 

18 319L; and 

19 ‘‘(D) the Emergency System for Advance 

20 Registration of Volunteer Health Professionals 

21 pursuant to section 319I; 

22 ‘‘(3) provide policy coordination and oversight 

23 of— 

24 ‘‘(A) the Strategic National Stockpile 

25 under section 319F–2; 


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1 ‘‘(B) the Cities Readiness Initiative; and 

2 ‘‘(C) the Medical Reserve Corps pursuant 

3 to section 2813; and 

4 ‘‘(4) assume other duties as determined appro5 priate by the Secretary.’’; and 

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

7 ‘‘(d) COUNTERMEASURE IMPLEMENTATION PLAN.— 

8 Not later than 6 months after the date of enactment of 

9 this subsection, and annually thereafter, the Assistant 

10 Secretary for Preparedness and Response shall submit 

11 through the Secretary to the Committee on Energy and 

12 Commerce of the House of Representatives and the Com13 mittee on Health, Education, Labor, and Pensions of the 

14 Senate a Countermeasure Implementation Plan that— 

15 ‘‘(1) describes the chemical, biological, radio16 logical, and nuclear threats facing the Nation and 

17 the corresponding efforts to develop qualified coun18 termeasures (as defined in section 319F–1), security 

19 countermeasures (as defined in section 319F–2), or 

20 qualified pandemic or epidemic products (as defined 

21 in section 319F–3) for each threat; 

22 ‘‘(2) evaluates the progress of all activities with 

23 respect to such countermeasures or products, includ24 ing research, advanced research, development, pro25 curement, stockpiling, deployment, and utilization; 


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1 ‘‘(3) identifies and prioritizes near-, mid-, and 

2 long-term needs with respect to such counter3 measures or products to address chemical, biological, 

4 radiological, and nuclear threats; 

5 ‘‘(4) identifies, with respect to each category of 

6 threat, a summary of all advanced development and 

7 procurement awards, including— 

8 ‘‘(A) the time elapsed from the issuance of 

9 the initial solicitation or request for a proposal 

10 to the adjudication (such as the award, denial 

11 of award, or solicitation termination); 

12 ‘‘(B) projected timelines for development 

13 and procurement of such countermeasures or 

14 products; 

15 ‘‘(C) clearly defined goals, benchmarks, 

16 and milestones for each such countermeasure or 

17 product, including information on the number 

18 of doses required, the intended use of the coun19 termeasure or product, and the required coun20 termeasure or product characteristics; and 

21 ‘‘(D) projected needs with regard to the re22 plenishment of the Strategic National Stockpile; 

23 ‘‘(5) evaluates progress made in meeting the 

24 goals, benchmarks, and milestones identified under 

25 paragraph (4)(C); 


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1 ‘‘(6) reports on the amount of funds available 

2 for procurement in the special reserve fund as de3 fined in section 319F–2(g)(5) and the impact this 

4 funding will have on meeting the requirements under 

5 section 319F–2; 

6 ‘‘(7) incorporates input from Federal, State, 

7 local, and tribal stakeholders; and 

8 ‘‘(8) addresses the needs of pediatric popu9 lations with respect to such countermeasures and 

10 products in the Strategic National Stockpile and in11 cludes— 

12 ‘‘(A) a list of such countermeasures and 

13 products necessary to address the needs of pedi14 atric populations; 

15 ‘‘(B) a description of measures taken to 

16 coordinate with Office of Pediatric Therapeutics 

17 of the Food and Drug Administration to maxi18 mize the labeling, dosages, and formulations of 

19 such countermeasures and products for pedi20 atric populations; 

21 ‘‘(C) a description of existing gaps in the 

22 Strategic National Stockpile and the develop23 ment of such countermeasures and products to 

24 address the needs of pediatric populations; and 


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1 ‘‘(D) an evaluation of the progress made in 

2 addressing gaps identified pursuant to subpara3 graph (C). 

4 Notwithstanding any other provision of this subsection, 

5 the Plan shall not include any confidential commercial in6 formation, proprietary information, or information that 

7 could reveal vulnerabilities of the Nation in the prepara8 tion for or ability to respond to chemical, biological, radio9 logical, or nuclear threats.’’. 

10 (b) CONSULTATION IN AUTHORIZING MEDICAL

11 PRODUCTS FOR USE IN EMERGENCIES.—Subsection (c) 

12 of section 564 of the Federal Food, Drug, and Cosmetic 

13 Act (21 U.S.C. 360bbb–3) is amended by striking ‘‘con14 sultation with the Director of the National Institutes of 

15 Health’’ and inserting ‘‘consultation with the Assistant 

16 Secretary for Preparedness and Response, the Director of 

17 the National Institutes of Health,’’. 

18 (c) BIOSURVEILLANCE PLAN.—Not later than one 

19 year after the date of the enactment of this Act, the Sec20 retary of Health and Human Services shall prepare and 

21 submit to the Committee on Energy and Commerce of the 

22 House of Representatives and the Committee on Health, 

23 Education, Labor, and Pensions of the Senate a plan to 

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1 nications among disparate biosurveillance systems sup2 ported by the Department of Health and Human Services. 

3 SEC. 5. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD 

4 REPORTS. 

5 Section 5 of the Project Bioshield Act of 2004 (42 

6 U.S.C. 247d–6c) is repealed. 

7 SEC. 6. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

8 USE IN EMERGENCIES. 

9 Section 564 of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 360bbb–3) is amended— 

11 (1) in subsection (a)— 

12 (A) in paragraph (1), by striking ‘‘sections 

13 505, 510(k), and 515 of this Act’’ and inserting 

14 ‘‘any provision of this Act’’; 

15 (B) in paragraph (2)(A), by striking 

16 ‘‘under a provision of law referred to in such 

17 paragraph’’ and inserting ‘‘under a provision of 

18 law in section 505, 510(k), or 515 of this Act 

19 or section 351 of the Public Health Service 

20 Act’’; and 

21 (C) in paragraph (3), by striking ‘‘a provi22 sion of law referred to in such paragraph’’ and 

23 inserting ‘‘a provision of law referred to in 

24 paragraph (2)(A)’’; 

25 (2) in subsection (b)— 


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1 (A) in the subsection heading, by striking 

2 ‘‘DECLARATION OF EMERGENCY’’ and inserting 

3 ‘‘DECLARATION SUPPORTING EMERGENCY USE

4 AUTHORIZATION’’; 

5 (B) in paragraph (1)— 

6 (i) in the matter preceding subpara7 graph (A), by striking ‘‘an emergency jus8 tifying’’ and inserting ‘‘that circumstances 

9 exist justifying’’; 

10 (ii) in subparagraph (A), by striking 

11 ‘‘specified’’; 

12 (iii) in subparagraph (B), by striking 

13 ‘‘specified’’; and 

14 (iv) by amending subparagraph (C) to 

15 read as follows: 

16 ‘‘(C) a determination by the Secretary that 

17 there is a public health emergency, or a signifi18 cant potential for a public health emergency, in19 volving a heightened risk to national security or 

20 the health and security of United States citi21 zens abroad, and involving a biological, chem22 ical, radiological, or nuclear agent or agents, or 

23 a disease or condition that may be attributable 

24 to such agent or agents.’’; 

25 (C) in paragraph (2)— 


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1 (i) by amending subparagraph (A) to 

2 read as follows: 

3 ‘‘(A) IN GENERAL.—A declaration under 

4 this subsection shall terminate upon a deter5 mination by the Secretary, in consultation with, 

6 as appropriate, the Secretary of Homeland Se7 curity or the Secretary of Defense, that the cir8 cumstances described in paragraph (1) have 

9 ceased to exist.’’; 

10 (ii) by striking subparagraph (B); and 

11 (iii) by redesignating subparagraph 

12 (C) as subparagraph (B); and 

13 (D) in paragraph (4), by striking ‘‘advance 

14 notice of termination, and renewal’’ and insert15 ing ‘‘and advance notice of termination’’; 

16 (3) in subsection (c)(1), by striking ‘‘specified 

17 in’’ and insert ‘‘covered by’’; 

18 (4) in subsection (d)(3), by inserting ‘‘, to the 

19 extent practicable given the circumstances of the 

20 emergency,’’ after ‘‘including’’; 

21 (5) in subsection (e)— 

22 (A) in paragraph (1)(B), by amending 

23 clause (iii) to read as follows: 

24 ‘‘(iii) Appropriate conditions with re25 spect to the collection and analysis of inVerDate Mar 15 2010 23:41 Dec 07, 2011 Jkt 019200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6201 E:\BILLS\H2405.RFS H2405

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1 formation concerning the safety and effec2 tiveness of the product with respect to the 

3 actual use of such product pursuant to an 

4 authorization under this section.’’; 

5 (B) in paragraph (2)— 

6 (i) in subparagraph (A)— 

7 (I) by striking ‘‘manufacturer of 

8 the product’’ and inserting ‘‘person’’; 

9 and 

10 (II) by inserting ‘‘or in para11 graph (1)(B)’’ before the period at the 

12 end; 

13 (ii) in subparagraph (B)(i), by insert14 ing ‘‘, with the exception of extensions of 

15 a product’s expiration date authorized 

16 under section 564A(b)’’ before the period 

17 at the end; and 

18 (iii) by amending subparagraph (C) to 

19 read as follows: 

20 ‘‘(C) In establishing conditions under this 

21 paragraph with respect to the distribution and 

22 administration of a product, the Secretary shall 

23 not impose conditions that would restrict dis24 tribution or administration of the product that 

25 is solely for the approved uses.’’; 


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1 (C) by amending paragraph (3) to read as 

2 follows: 

3 ‘‘(3) GOOD MANUFACTURING PRACTICE; PRE4 SCRIPTION; PRACTITIONER’S AUTHORIZATION.—With 

5 respect to the emergency use of a product for which 

6 an authorization under this section is issued (wheth7 er for an unapproved product or an unapproved use 

8 of an approved product), the Secretary may waive or 

9 limit, to the extent appropriate given the cir10 cumstances of the emergency— 

11 ‘‘(A) requirements regarding current good 

12 manufacturing practice otherwise applicable to 

13 the manufacture, processing, packing, or hold14 ing of products subject to regulation under this 

15 Act, including such requirements established 

16 under section 501 or 520(f)(1), and including 

17 relevant conditions prescribed with respect to 

18 the product by an order under section 

19 520(f)(2); 

20 ‘‘(B) requirements established under sec21 tion 503(b); and 

22 ‘‘(C) requirements established under sec23 tion 520(e).’’; and 

24 (D) by adding at the end the following: 


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1 ‘‘(5) EXISTING AUTHORITIES.—Nothing in this 

2 section restricts any authority vested in the Sec3 retary by any other provision of this Act or the Pub4 lic Health Service Act for establishing conditions of 

5 authorization for a product.’’; and 

6 (6) in subsection (g)— 

7 (A) in the heading, by striking ‘‘REVOCA8 TION OF AUTHORIZATION’’ and inserting ‘‘RE9 VIEW, MODIFICATION, AND REVOCATION OF

10 AUTHORIZATION’’; 

11 (B) in paragraph (1), by striking ‘‘periodi12 cally review’’ and inserting ‘‘review not less 

13 than every three years’’; and 

14 (C) by adding at the end the following: 

15 ‘‘(3) MODIFICATION.—The Secretary may mod16 ify an authorization under this section or the condi17 tions of such an authorization, at any time, based on 

18 a review of the authorization or new information 

19 that is otherwise obtained, including information ob20 tained during an emergency.’’. 

21 SEC. 7. ADDITIONAL PROVISIONS RELATED TO MEDICAL 

22 PRODUCTS FOR EMERGENCY USE. 

23 (a) IN GENERAL.—The Federal Food, Drug, and 

24 Cosmetic Act is amended by inserting after section 564 

25 (21 U.S.C. 360bbb–3) the following: 


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1 ‘‘SEC. 564A. ADDITIONAL PROVISIONS RELATED TO MED2 ICAL PRODUCTS FOR EMERGENCY USE. 

3 ‘‘(a) DEFINITIONS.—For purposes of this section: 

4 ‘‘(1) The term ‘product’ means a drug, device, 

5 or biological product. 

6 ‘‘(2) The term ‘eligible product’ means a prod7 uct that is— 

8 ‘‘(A) approved or cleared under this chap9 ter or licensed under section 351 of the Public 

10 Health Service Act; and 

11 ‘‘(B) intended to be used to diagnose, pre12 vent, or treat a disease or condition involving a 

13 biological, chemical, radiological, or nuclear 

14 agent or agents during— 

15 ‘‘(i) a domestic emergency or military 

16 emergency involving heightened risk of at17 tack with such an agent or agents; or 

18 ‘‘(ii) a public health emergency affect19 ing national security or the health and se20 curity of United States citizens abroad. 

21 ‘‘(b) EXPIRATION DATING.— 

22 ‘‘(1) IN GENERAL.—The Secretary may extend 

23 the expiration date and authorize the introduction or 

24 delivery for introduction into interstate commerce of 

25 an eligible product after the expiration date provided 

26 by the manufacturer if— 


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1 ‘‘(A) the eligible product is intended to be 

2 held for use for a domestic, military, or public 

3 health emergency described in subsection 

4 (a)(2)(B); 

5 ‘‘(B) the expiration date extension is in6 tended to support the United States’ ability to 

7 protect— 

8 ‘‘(i) the public health; or 

9 ‘‘(ii) military preparedness and effec10 tiveness; and 

11 ‘‘(C) the expiration date extension is sup12 ported by an appropriate scientific evaluation 

13 that is conducted or accepted by the Secretary. 

14 ‘‘(2) REQUIREMENTS AND CONDITIONS.—Any 

15 extension of an expiration date under paragraph (1) 

16 shall, as part of the extension, identify— 

17 ‘‘(A) each specific lot, batch, or other unit 

18 of the product for which extended expiration is 

19 authorized; 

20 ‘‘(B) the duration of the extension; and 

21 ‘‘(C) any other requirements or conditions 

22 as the Secretary may deem appropriate for the 

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1 aging, transport, labeling, notice to product re2 cipients, recordkeeping, periodic testing or re3 testing, or product disposition. 

4 ‘‘(3) EFFECT.—Notwithstanding any other pro5 vision of this Act or the Public Health Service Act, 

6 an eligible product shall not be considered an unap7 proved product (as defined in section 564(a)(2)(A)) 

8 and shall not be deemed adulterated or misbranded 

9 under this Act because, with respect to such prod10 uct, the Secretary has, under paragraph (1), ex11 tended the expiration date and authorized the intro12 duction or delivery for introduction into interstate 

13 commerce of such product after the expiration date 

14 provided by the manufacturer. 

15 ‘‘(c) CURRENT GOOD MANUFACTURING PRAC16 TICES.— 

17 ‘‘(1) IN GENERAL.—The Secretary may, when 

18 the circumstances of a domestic, military, or public 

19 health emergency described in subsection (a)(2)(B) 

20 so warrant, authorize, with respect to an eligible 

21 product, deviations from current good manufac22 turing practice requirements otherwise applicable to 

23 the manufacture, processing, packing, or holding of 

24 products subject to regulation under this Act, in25 cluding requirements under section 501 or 520(f)(1) 


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1 or applicable conditions prescribed with respect to 

2 the eligible product by an order under section 

3 520(f)(2). 

4 ‘‘(2) EFFECT.—Notwithstanding any other pro5 vision of this Act or the Public Health Service Act, 

6 an eligible product shall not be considered an unap7 proved product (as defined in section 564(a)(2)(A)) 

8 and shall not be deemed adulterated or misbranded 

9 under this Act because, with respect to such prod10 uct, the Secretary has authorized deviations from 

11 current good manufacturing practices under para12 graph (1). 

13 ‘‘(d) MASS DISPENSING.—The requirements of sec14 tion 503(b) and 520(e) shall not apply to an eligible prod15 uct, and the product shall not be considered an unap16 proved product (as defined in section 564(a)(2)(A)) and 

17 shall not be deemed adulterated or misbranded under this 

18 Act because it is dispensed without an individual prescrip19 tion, if— 

20 ‘‘(1) the product is dispensed during an actual 

21 emergency described in subsection (a)(2)(B); and 

22 ‘‘(2) such dispensing without an individual pre23 scription occurs— 

24 ‘‘(A) as permitted under the law of the 

25 State in which the product is dispensed; or 


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1 ‘‘(B) in accordance with an order issued by 

2 the Secretary. 

3 ‘‘(e) EMERGENCY USE INSTRUCTIONS.— 

4 ‘‘(1) IN GENERAL.—The Secretary, acting 

5 through an appropriate official within the Depart6 ment of Health and Human Services, may create 

7 and issue emergency use instructions to inform 

8 health care providers or individuals to whom an eli9 gible product is to be administered concerning such 

10 product’s approved, licensed, or cleared conditions of 

11 use. 

12 ‘‘(2) EFFECT.—Notwithstanding any other pro13 visions of this Act or the Public Health Service Act, 

14 a product shall not be considered an unapproved 

15 product (as defined in section 564(a)(2)(A)) and 

16 shall not be deemed adulterated or misbranded 

17 under this Act because of— 

18 ‘‘(A) the issuance of emergency use in19 structions under paragraph (1) with respect to 

20 such product; or 

21 ‘‘(B) the introduction or delivery for intro22 duction of such product into interstate com23 merce accompanied by such instructions during 

24 an emergency response to an actual emergency 

25 described in subsection (a)(2)(B).’’. 


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1 (b) RISK EVALUATION AND MITIGATION STRATE2 GIES.—Section 505–1 of the Federal Food, Drug, and 

3 Cosmetic Act (21 U.S.C. 355–1), is amended— 

4 (1) in subsection (f), by striking paragraph (7); 

5 and 

6 (2) by adding at the end the following: 

7 ‘‘(k) WAIVER IN PUBLIC HEALTH EMERGENCIES.— 

8 The Secretary may waive any requirement of this section 

9 with respect to a qualified countermeasure (as defined in 

10 section 319F–1(a)(2) of the Public Health Service Act) 

11 to which a requirement under this section has been ap12 plied, if the Secretary determines that such waiver is re13 quired to mitigate the effects of, or reduce the severity 

14 of, an actual or potential domestic emergency or military 

15 emergency involving heightened risk of attack with a bio16 logical, chemical, radiological, or nuclear agent, or an ac17 tual or potential public health emergency affecting na18 tional security or the health and security of United States 

19 citizens abroad.’’. 

20 SEC. 8. PRODUCTS HELD FOR EMERGENCY USE. 

21 The Federal Food, Drug, and Cosmetic Act (21 

22 U.S.C. 301 et seq.) is amended by inserting after section 

23 564A, as added by section 7, the following: 


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1 ‘‘SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE. 

2 ‘‘It is not a violation of any section of this Act or 

3 of the Public Health Service Act for a government entity 

4 (including a Federal, State, local, and tribal government 

5 entity), or a person acting on behalf of such a government 

6 entity, to introduce into interstate commerce a product (as 

7 defined in section 564(a)(4)) intended for emergency use, 

8 if that product— 

9 ‘‘(1) is intended to be held and not used; and 

10 ‘‘(2) is held and not used, unless and until that 

11 product— 

12 ‘‘(A) is approved, cleared, or licensed 

13 under section 505, 510(k), or 515 of this Act 

14 or section 351 of the Public Health Service Act; 

15 ‘‘(B) is authorized for investigational use 

16 under section 505 or 520 of this Act or section 

17 351 of the Public Health Service Act; or 

18 ‘‘(C) is authorized for use under section 

19 564.’’. 

20 SEC. 9. ACCELERATE COUNTERMEASURE DEVELOPMENT 

21 BY STRENGTHENING FDA’S ROLE IN REVIEW22 ING PRODUCTS FOR NATIONAL SECURITY 

23 PRIORITIES. 

24 (a) IN GENERAL.—Section 565 of the Federal Food, 

25 Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) is amend26 ed to read as follows: 


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1 ‘‘SEC. 565. COUNTERMEASURE DEVELOPMENT AND RE2 VIEW. 

3 ‘‘(a) COUNTERMEASURES AND PRODUCTS.—The 

4 countermeasures and products referred to in this sub5 section are— 

6 ‘‘(1) qualified countermeasures (as defined in 

7 section 319F–1 of the Public Health Service Act); 

8 ‘‘(2) security countermeasures (as defined in 

9 section 319F–2 of such Act); and 

10 ‘‘(3) qualified pandemic or epidemic products 

11 (as defined in section 319F–3 of such Act) that the 

12 Secretary determines to be a priority. 

13 ‘‘(b) IN GENERAL.— 

14 ‘‘(1) INVOLVEMENT OF FDA PERSONNEL IN

15 INTERAGENCY ACTIVITIES.—For the purpose of ac16 celerating the development, stockpiling, approval, 

17 clearance, and licensure of countermeasures and 

18 products referred to in subsection (a), the Secretary 

19 shall expand the involvement of Food and Drug Ad20 ministration personnel in interagency activities with 

21 the Assistant Secretary for Preparedness and Re22 sponse (including the Biomedical Advanced Research 

23 and Development Authority), the Centers for Dis24 ease Control and Prevention, the National Institutes 

25 of Health, and the Department of Defense. 


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1 ‘‘(2) TECHNICAL ASSISTANCE.—The Secretary 

2 shall establish within the Food and Drug Adminis3 tration a team of experts on manufacturing and reg4 ulatory activities (including compliance with current 

5 Good Manufacturing Practices) to provide both off6 site and on-site technical assistance to the manufac7 turers of countermeasures and products referred to 

8 in subsection (a). On-site technical assistance shall 

9 be provided upon the request of the manufacturer 

10 and at the discretion of the Secretary if the Sec11 retary determines that the provision of such assist12 ance would accelerate the development, manufac13 turing, or approval, clearance, or licensure of coun14 termeasures and products referred to in subsection 

15 (a). 

16 ‘‘(c) AGENCY INTERACTION WITH SECURITY COUN17 TERMEASURE SPONSORS.— 

18 ‘‘(1) IN GENERAL.—For security counter19 measures (as defined in section 319F–2 of the Pub20 lic Health Service Act) that are procured under such 

21 section 319F–2— 

22 ‘‘(A) the Secretary shall establish a process 

23 for frequent scientific feedback and interactions 

24 between the Food and Drug Administration and 

25 the security countermeasure sponsor (referred 


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1 to in this subsection as the ‘sponsor’), designed 

2 to facilitate the approval, clearance, and licen3 sure of the security countermeasures; 

4 ‘‘(B) such feedback and interactions shall 

5 include meetings and, in accordance with sub6 section (b)(2), on-site technical assistance; and 

7 ‘‘(C) at the request of the Secretary, the 

8 process under this paragraph shall include par9 ticipation by the Food and Drug Administration 

10 in meetings between the Biomedical Advanced 

11 Research and Development Authority and spon12 sors on the development of such counter13 measures. 

14 ‘‘(2) REGULATORY MANAGEMENT PLAN.— 

15 ‘‘(A) IN GENERAL.—The process estab16 lished under paragraph (1) shall allow for the 

17 development of a written regulatory manage18 ment plan (in this paragraph referred to as the 

19 ‘plan’) for a security countermeasure (as de20 fined in paragraph (1)) in accordance with this 

21 paragraph. 

22 ‘‘(B) PROPOSAL AND FINALIZATION OF

23 PLAN.—In carrying out the process under para24 graph (1), the Secretary shall direct the Food 

25 and Drug Administration, upon submission of a 


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1 written request by the sponsor that includes a 

2 proposed plan and relevant data and future 

3 planning detail to support such a plan, to work 

4 with the sponsor to agree on a final plan within 

5 a reasonable time not to exceed 90 days. The 

6 basis for this agreement shall be the proposed 

7 plan submitted by the sponsor. Notwithstanding 

8 the preceding sentence, the Secretary shall re9 tain full discretion to determine the contents of 

10 the final plan or to determine that no such plan 

11 can be agreed upon. If the Secretary determines 

12 that no final plan can be agreed upon, the Sec13 retary shall provide to the sponsor, in writing, 

14 the scientific or regulatory rationale why such 

15 agreement cannot be reached. If a final plan is 

16 agreed upon, it shall be shared with the sponsor 

17 in writing. 

18 ‘‘(C) CONTENTS.—The plan shall include 

19 an agreement on the nature of, and timelines 

20 for, feedback and interactions between the 

21 sponsor and the Food and Drug Administra22 tion, shall provide reasonable flexibility in im23 plementing and adjusting the agreement under 

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1 termeasure development process, and shall iden2 tify— 

3 ‘‘(i) the current regulatory status of 

4 the countermeasure, an assessment of 

5 known scientific gaps relevant to approval, 

6 clearance, or licensure of the counter7 measure, and a proposed pathway to ap8 proval, clearance, or licensure of the coun9 termeasure; 

10 ‘‘(ii) developmental milestones whose 

11 completion will result in meetings to be 

12 scheduled within a reasonable time be13 tween the applicable review division of the 

14 Food and Drug Administration and the 

15 sponsor; 

16 ‘‘(iii) sponsor submissions that will re17 sult in written feedback from the review di18 vision within a reasonable time; 

19 ‘‘(iv) feedback by the Food and Drug 

20 Administration regarding the data required 

21 to support delivery of the countermeasure 

22 to the Strategic National Stockpile under 

23 section 319F–2 of the Public Health Serv24 ice Act; 


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1 ‘‘(v) feedback by the Food and Drug 

2 Administration regarding data required to 

3 support submission of a proposed agree4 ment on the design and size of clinical 

5 trials for review under section 

6 505(b)(5)(B); and 

7 ‘‘(vi) other issues that have the poten8 tial to delay approval, clearance, or licen9 sure. 

10 ‘‘(D) CHANGES.—Changes to the plan 

11 shall be made by subsequent agreement between 

12 the Secretary and the sponsor. If after reason13 able attempts to negotiate changes to the plan 

14 the Secretary and the sponsor are unable to fi15 nalize such changes, the Secretary shall provide 

16 to the sponsor, in writing, the scientific or regu17 latory rationale why such changes are required 

18 or cannot be included in the plan. 

19 ‘‘(3) APPLICABILITY TO CERTAIN QUALIFIED

20 PANDEMIC OR EPIDEMIC PRODUCTS.—The Secretary 

21 may, with respect to qualified pandemic or epidemic 

22 products (as defined in section 319F–3 of the Public 

23 Health Service Act) for which a contract for ad24 vanced research and development is entered into 

25 under section 319L of such Act, choose to apply the 


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1 provisions of paragraphs (1) and (2) to the same ex2 tent and in the same manner as such provisions 

3 apply with respect to security countermeasures. 

4 ‘‘(d) FINAL GUIDANCE ON DEVELOPMENT OF ANI5 MAL MODELS.— 

6 ‘‘(1) IN GENERAL.—Not later than 1 year after 

7 the date of the enactment of the Pandemic and All8 Hazards Preparedness Reauthorization Act of 2011, 

9 the Secretary shall provide final guidance to indus10 try regarding the development of animal models to 

11 support approval, clearance, or licensure of counter12 measures and products referred to in subsection (a) 

13 when human efficacy studies are not ethical or fea14 sible. 

15 ‘‘(2) AUTHORITY TO EXTEND DEADLINE.—The 

16 Secretary may extend the deadline for providing 

17 final guidance under paragraph (1) by not more 

18 than 6 months upon submission by the Secretary of 

19 a report on the status of such guidance to the Com20 mittee on Energy and Commerce of the House of 

21 Representatives and the Committee on Health, Edu22 cation, Labor, and Pensions of the Senate. 

23 ‘‘(e) BIENNIAL REPORT.—Not later than January 1, 

24 2013, and every 2 years thereafter, the Secretary shall 

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1 merce of the House of Representatives and the Committee 

2 on Health, Education, Labor, and Pensions of the Senate, 

3 that, with respect to the preceding 2 fiscal years, in4 cludes— 

5 ‘‘(1) the number of full-time equivalent employ6 ees of the Food and Drug Administration who di7 rectly support the review of countermeasures and 

8 products referred to in subsection (a); 

9 ‘‘(2) estimates of funds obligated by the Food 

10 and Drug Administration for review of such counter11 measures and products; 

12 ‘‘(3) the number of regulatory teams at the 

13 Food and Drug Administration specific to such 

14 countermeasures and products and, for each such 

15 team, the assigned products, classes of products, or 

16 technologies; 

17 ‘‘(4) the length of time between each request by 

18 the sponsor of such a countermeasure or product for 

19 information and the provision of such information by 

20 the Food and Drug Administration; 

21 ‘‘(5) the number, type, and frequency of official 

22 interactions between the Food and Drug Adminis23 tration and— 

24 ‘‘(A) sponsors of a countermeasure or 

25 product referred to in subsection (a); or 


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1 ‘‘(B) another agency engaged in develop2 ment or management of portfolios for such 

3 countermeasures or products, including the 

4 Centers for Disease Control and Prevention, the 

5 Biomedical Advanced Research and Develop6 ment Authority, the National Institutes of 

7 Health, and the appropriate agencies of the De8 partment of Defense; 

9 ‘‘(6) a description of other measures that, as 

10 determined by the Secretary, are appropriate to de11 termine the efficiency of the regulatory teams de12 scribed in paragraph (3); and 

13 ‘‘(7) the regulatory science priorities that relate 

14 to countermeasures or products referred to in sub15 section (a) and which the Food and Drug Adminis16 tration is addressing and the progress made on these 

17 priorities.’’. 

18 (b) SPECIAL PROTOCOL ASSESSMENT.—Subpara19 graph (B) of section 505(b)(5) of the Federal Food, Drug, 

20 and Cosmetic Act (21 U.S.C. 355(b)(5)) is amended to 

21 read as follows: 

22 ‘‘(B)(i) The Secretary shall meet with a sponsor of 

23 an investigation or an applicant for approval for a drug 

24 under this subsection or section 351 of the Public Health 

25 Service Act if the sponsor or applicant makes a reasonable 


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1 written request for a meeting for the purpose of reaching 

2 agreement on the design and size of— 

3 ‘‘(I) clinical trials intended to form the primary 

4 basis of an effectiveness claim; or 

5 ‘‘(II) animal efficacy trials and any associated 

6 clinical trials that in combination are intended to 

7 form the primary basis of an effectiveness claim for 

8 a countermeasure or product referred to in section 

9 565(a) when human efficacy studies are not ethical 

10 or feasible. 

11 ‘‘(ii) The sponsor or applicant shall provide informa12 tion necessary for discussion and agreement on the design 

13 and size of the clinical trials. Minutes of any such meeting 

14 shall be prepared by the Secretary and made available to 

15 the sponsor or applicant upon request.’’. 

Passed the House of Representatives December 6, 

2011. 

Attest: KAREN L. HAAS, 

Clerk. 


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