IB 

Union Calendar No. 189 

112TH CONGRESS 

1ST SESSION H. R. 2405 

[Report No. 112–286] 

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. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 28, 2011 

Mr. ROGERS of Michigan (for himself, Mrs. MYRICK, and Mr. GENE GREEN

of Texas) introduced the following bill; which was referred to the Committee on Energy and Commerce 

NOVEMBER 16, 2011 

Additional sponsors: Mr. BURGESS and Ms. ESHOO

NOVEMBER 16, 2011 

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 June 28, 2011] 


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A BILL 

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. 


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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 ‘‘Pandemic and All-Hazards Preparedness Reauthorization 

6 Act of 2011’’. 

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

8 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. 

9 SEC. 2. REAUTHORIZATION OF CERTAIN PROVISIONS RE10 LATING TO PUBLIC HEALTH PREPAREDNESS. 

11 (a) VACCINE TRACKING AND DISTRIBUTION.—Sub12 section (e) of section 319A of the Public Health Service Act 

13 (42 U.S.C. 247d–1) is amended by striking ‘‘such sums for 

14 each of fiscal years 2007 through 2011’’ and inserting 

15 ‘‘$30,800,000 for each of fiscal years 2012 through 2016’’. 

16 (b) IMPROVING STATE AND LOCAL PUBLIC HEALTH

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

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

19 amended— 

20 (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’’ at 

14 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 car24 rying out this section, there is authorized to be 


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1 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 U.S.C. 

10 247d–3b) is amended— 

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

12 capacity and preparedness to address the needs of pe13 diatric and other at-risk populations’’ before the pe14 riod 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 SE21 CURITY STRATEGY.—The Secretary shall implement 

22 objective, evidence-based metrics to ensure that enti23 ties receiving awards under this section are meeting, 

24 to the extent practicable, the goals of the National 

25 Health Security Strategy under section 2802.’’; and 


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

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

4 this section, there is authorized to be appropriated 

5 $378,000,000 for each of fiscal years 2012 through 

6 2016.’’. 

7 (d) CDC PROGRAMS FOR COMBATING PUBLIC HEALTH

8 THREATS.—Section 319D of the Public Health Service Act 

9 (42 U.S.C. 247d–4) is amended— 

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

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

12 may be necessary in each of fiscal years 2007 through 

13 2011’’ and inserting ‘‘$160,121,000 for each of fiscal 

14 years 2012 through 2016’’. 

15 (e) DENTAL EMERGENCY RESPONDERS: PUBLIC

16 HEALTH AND MEDICAL RESPONSE.— 

17 (1) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL

18 RESPONSE CURRICULA AND TRAINING.—Section 

19 319F(a)(5)(B) of the Public Health Service Act (42 

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

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

22 health, medical, or dental’’. 

23 (2) NATIONAL HEALTH SECURITY STRATEGY.— 

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

25 (42 U.S.C. 300hh–1(b)(3)) is amended— 


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1 (A) in the matter preceding subparagraph 

2 (A), by inserting ‘‘and which may include dental 

3 health facilities’’ after ‘‘mental health facilities’’; 

4 and 

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

6 ‘‘(which may include dental health assets)’’ after 

7 ‘‘medical assets’’. 

8 (f) PROCUREMENT OF COUNTERMEASURES.— 

9 (1) CONTRACT TERMS.—Subclause (IX) of sec10 tion 319F–2(c)(7)(C)(ii) of the Public Health Service 

11 Act (42 U.S.C. 247d–6b(c)(7)(C)(ii)) is amended to 

12 read as follows: 

13 ‘‘(IX) CONTRACT TERMS.—The 

14 Secretary, in any contract for procure15 ment under this section— 

16 ‘‘(aa) may specify— 

17 ‘‘(AA) the dosing and 

18 administration requirements 

19 for countermeasures to be de20 veloped and procured; 

21 ‘‘(BB) the amount of 

22 funding that will be dedi23 cated by the Secretary for de24 velopment and acquisition of 

25 the countermeasure; and 


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1 ‘‘(CC) the specifications 

2 the countermeasure must 

3 meet to qualify for procure4 ment under a contract under 

5 this section; and 

6 ‘‘(bb) shall provide a clear 

7 statement of defined Government 

8 purpose limited to uses related to 

9 a security countermeasure, as de10 fined in paragraph (1)(B).’’. 

11 (2) REAUTHORIZATION OF THE SPECIAL RE12 SERVE FUND.—Section 319F–2 of the Public Health 

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

14 (A) in subsection (c)— 

15 (i) by striking ‘‘special reserve fund 

16 under paragraph (10)’’ each place it ap17 pears and inserting ‘‘special reserve fund as 

18 defined in subsection (g)(5)’’; and 

19 (ii) by striking paragraphs (9) and 

20 (10); and 

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

22 ‘‘(g) SPECIAL RESERVE FUND.— 

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

24 addition to amounts appropriated to the special re25 serve fund prior to the date of the enactment of this 


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1 subsection, there is authorized to be appropriated, for 

2 the procurement of security countermeasures under 

3 subsection (c) and for carrying out section 319L (re4 lating to the Biomedical Advanced Research and De5 velopment Authority), $2,800,000,000 for the period 

6 of fiscal years 2014 through 2018. Amounts appro7 priated pursuant to the preceding sentence are au8 thorized to remain available until September 30, 

9 2019. 

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

11 later than 15 days after any date on which the Sec12 retary determines that the amount of funds in the 

13 special reserve fund available for procurement is less 

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

15 Committee on Energy and Commerce of the House of 

16 Representatives and the Committee on Health, Edu17 cation, Labor, and Pensions of the Senate a report de18 tailing the amount of such funds available for pro19 curement and the impact such funding will have— 

20 ‘‘(A) in meeting the security countermeasure 

21 needs identified under this section; and 

22 ‘‘(B) on the annual Countermeasure Imple23 mentation Plan under section 2811(d). 

24 ‘‘(3) USE OF SPECIAL RESERVE FUND FOR AD25 VANCED RESEARCH AND DEVELOPMENT.—The SecVerDate Mar 15 2010 21:08 Nov 16, 2011 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6203 E:\BILLS\H2405.RH H2405

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1 retary may utilize not more than 30 percent of the 

2 amounts authorized to be appropriated under para3 graph (1) to carry out section 319L (related to the 

4 Biomedical Advanced Research and Development Au5 thority). Amounts authorized to be appropriated 

6 under this subsection to carry out section 319L are in 

7 addition to amounts otherwise authorized to be ap8 propriated to carry out such section. 

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

10 Amounts in the special reserve fund shall not be used 

11 to pay— 

12 ‘‘(A) costs other than payments made by the 

13 Secretary to a vendor for advanced development 

14 (under section 319L) or for procurement of a se15 curity countermeasure under subsection (c)(7); 

16 and 

17 ‘‘(B) any administrative expenses, includ18 ing salaries. 

19 ‘‘(5) DEFINITION.—In this section, the term ‘spe20 cial reserve fund’ means the ‘Biodefense Counter21 measures’ appropriations account, any appropriation 

22 made available pursuant to section 521(a) of the 

23 Homeland Security Act of 2002, and any appropria24 tion made available pursuant to paragraph (1) of this 

25 paragraph.’’. 


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1 (g) EMERGENCY SYSTEM FOR ADVANCE REGISTRATION

2 OF VOLUNTEER HEALTH PROFESSIONALS.—Section 

3 319I(k) of the Public Health Service Act (42 U.S.C. 247d– 

4 7b(k)) is amended by striking ‘‘are authorized to be appro5 priated $2,000,000 for fiscal year 2002, and such sums as 

6 may be necessary for each of the fiscal years 2003 through 

7 2011’’ and inserting ‘‘is authorized to be appropriated 

8 $5,900,000 for each of fiscal years 2012 through 2016’’. 

9 (h) BIOMEDICAL ADVANCED RESEARCH AND DEVEL10 OPMENT AUTHORITY.— 

11 (1) TRANSACTION AUTHORITIES.—Section 

12 319L(c)(5) of the Public Health Service Act (42 

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

14 end the following: 

15 ‘‘(G) GOVERNMENT PURPOSE.—In award16 ing contracts, grants, and cooperative agreements 

17 under this section, the Secretary shall provide a 

18 clear statement of defined Government purpose 

19 related to activities included in subsection 

20 (a)(6)(B) for a qualified countermeasure or 

21 qualified pandemic or epidemic product.’’. 

22 (2) BIODEFENSE MEDICAL COUNTERMEASURE

23 DEVELOPMENT FUND.—Paragraph (2) of section 

24 319L(d) of the Public Health Service Act (42 U.S.C. 

25 247d–7e(d)) is amended to read as follows: 


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

2 this section, there is authorized to be appropriated to 

3 the Fund $415,000,000 for each of fiscal years 2012 

4 through 2016, the amounts to remain available until 

5 expended.’’. 

6 (3) CONTINUED INAPPLICABILITY OF CERTAIN

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

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

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

10 the date of enactment of the Pandemic and All-Haz11 ards Preparedness Act’’ and inserting ‘‘September 30, 

12 2016’’. 

13 (i) NATIONAL DISASTER MEDICAL SYSTEM.—Section 

14 2812 of the Public Health Service Act (42 U.S.C. 300hh– 

15 11) is amended— 

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

17 following: 

18 ‘‘(D) ADMINISTRATION.—The Secretary 

19 may determine and pay claims for reimburse20 ment for services under subparagraph (A) di21 rectly or by contract providing for payment in 

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

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

24 may be necessary for each of the fiscal years 2007 


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

2 fiscal years 2012 through 2016’’. 

3 (j) NATIONAL HEALTH SECURITY STRATEGY

4 TIMELINE.—Section 2802(a)(1) of the Public Health Serv5 ice Act (42 U.S.C. 300hh–1(a)(1)) is amended by striking 

6 ‘‘2009’’ and inserting ‘‘2014’’. 

7 (k) ENHANCING SURGE CAPACITY.—Section 2802(b) of 

8 the Public Health Service Act (42 U.S.C. 300hh–1(b)(3)) 

9 is amended— 

10 (1) in paragraph (1)(A), by inserting ‘‘, includ11 ing drills and exercises to ensure medical surge capac12 ity for events without notice’’ after ‘‘exercises’’; and 

13 (2) in paragraph (3)— 

14 (A) in the matter preceding subparagraph 

15 (A), as amended by subsection (e)(2) of this sec16 tion— 

17 (i) by inserting ‘‘availability, coordi18 nation, accessibility,’’ after ‘‘response capa19 bilities,’’; 

20 (ii) by striking ‘‘including mental 

21 health facilities’’ and inserting ‘‘including 

22 mental health and ambulatory care facili23 ties’’; and 

24 (iii) by striking ‘‘trauma care and 

25 emergency medical service systems’’ and inVerDate Mar 15 2010 21:08 Nov 16, 2011 Jkt 019200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6203 E:\BILLS\H2405.RH H2405

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1 serting ‘‘trauma care, critical care, and 

2 emergency medical service systems’’; and 

3 (B) in subparagraph (B), by striking ‘‘Med4 ical evacuation and fatality management’’ and 

5 inserting ‘‘Fatality management, and coordi6 nated medical triage and evacuation to the ap7 propriate medical institution based on patient 

8 medical need as part of regional systems’’. 

9 (l) VOLUNTEER MEDICAL RESERVE CORPS.—Section 

10 2813(i) of the Public Health Service Act (42 U.S.C. 300hh– 

11 15(i)) is amended by striking ‘‘$22,000,000 for fiscal year 

12 2007, and such sums as may be necessary for each of fiscal 

13 years 2008 through 2011’’ and inserting ‘‘$11,900,000 for 

14 each of fiscal years 2012 through 2016’’. 

15 (m) EXTENSION OF LIMITED ANTITRUST EXEMP16 TION.—Section 405(b) of the Pandemic and All-Hazard 

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

18 striking ‘‘at the end of the 6-year period that begins on the 

19 date of enactment of this Act’’ and inserting ‘‘on September 

20 30, 2016’’. 

21 SEC. 3. TEMPORARY REDEPLOYMENT OF PERSONNEL DUR22 ING A PUBLIC HEALTH EMERGENCY. 

23 Section 319 of the Public Health Service Act (42 

24 U.S.C. 247d) is amended by adding at the end the fol25 lowing: 


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1 ‘‘(e) TEMPORARY REDEPLOYMENT OF PERSONNEL

2 DURING A PUBLIC HEALTH EMERGENCY.— 

3 ‘‘(1) EMERGENCY REDEPLOYMENT OF FEDER4 ALLY FUNDED PERSONNEL.—Notwithstanding any 

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

6 upon a request that is from a State, locality, terri7 tory, tribe, or the Freely Associated States and that 

8 includes such information and assurances as the Sec9 retary may require, the Secretary may authorize the 

10 requesting entity to temporarily redeploy to imme11 diately address a public health emergency non-Fed12 eral personnel funded in whole or in part through— 

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

14 ‘‘(B) at the discretion of the Secretary, any 

15 other program funded in whole or in part by the 

16 Department of Health and Human Services. 

17 ‘‘(2) ACTIVATION OF EMERGENCY REDEPLOY18 MENT.— 

19 ‘‘(A) PUBLIC HEALTH EMERGENCY.—The 

20 Secretary may exercise the authority vested by 

21 paragraph (1) only during the period of a public 

22 health emergency determined pursuant to sub23 section (a). 


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

2 temporary redeployment under paragraph (1), 

3 the Secretary shall consider each of the following: 

4 ‘‘(i) The degree to which the emergency 

5 cannot be adequately and appropriately ad6 dressed by the public health workforce. 

7 ‘‘(ii) The degree to which the emer8 gency requires or would otherwise benefit 

9 from supplemental staffing from those fund10 ed through nonpreparedness Federal pro11 grams. 

12 ‘‘(iii) The degree to which such pro13 grams would be adversely affected by the re14 deployment. 

15 ‘‘(iv) Such other factors as the Sec16 retary may deem appropriate. 

17 ‘‘(C) TERMINATION AND EXTENSION.— 

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

19 authorize a temporary redeployment of per20 sonnel under paragraph (1) shall terminate 

21 upon the earlier of the following: 

22 ‘‘(I) The Secretary’s determina23 tion that the public health emergency 

24 no longer exists. 


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1 ‘‘(II) Subject to clause (ii), 30 

2 days after the activation of the Sec3 retary’s authority pursuant to sub4 paragraph (A). 

5 ‘‘(ii) EXTENSION AUTHORITY.—The 

6 Secretary may extend the authority to au7 thorize a temporary redeployment of per8 sonnel under paragraph (1) beyond the date 

9 otherwise applicable under clause (i)(II) if 

10 the public health emergency still exists, but 

11 only if— 

12 ‘‘(I) the extension is requested by 

13 the entity that requested authority to 

14 authorize a temporary redeployment; 

15 and 

16 ‘‘(II) the Secretary gives notice to 

17 the Congress in conjunction with the 

18 extension.’’. 

19 SEC. 4. COORDINATION BY ASSISTANT SECRETARY FOR 

20 PREPAREDNESS AND RESPONSE. 

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

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

23 (1) in subsection (b)(3)— 

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

25 before ‘‘and procurement’’; and 


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

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

3 countermeasures (as defined in section 319F–1)’’; 

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

5 following: 

6 ‘‘(D) IDENTIFICATION OF INEFFICIEN7 CIES.—Identify gaps, duplication, and other in8 efficiencies in public health preparedness activi9 ties and the actions necessary to overcome these 

10 obstacles. 

11 ‘‘(E) DEVELOPMENT OF COUNTERMEASURE

12 IMPLEMENTATION PLAN.—Lead the development 

13 of a coordinated Countermeasure Implementa14 tion Plan under subsection (d). 

15 ‘‘(F) COUNTERMEASURES BUDGET ANAL16 YSIS.—Oversee the development of a comprehen17 sive, cross-cutting 5-year budget analysis with 

18 respect to activities described in paragraph (3)— 

19 ‘‘(i) to inform prioritization of re20 sources; and 

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

22 activities are adequately addressed. 

23 ‘‘(G) GRANT PROGRAMS FOR MEDICAL AND

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1 retary of Homeland Security, grant programs of 

2 the Department of Health and Human Services 

3 relating to medical and public health prepared4 ness capabilities and the activities of local com5 munities to respond to public health emergencies, 

6 including the— 

7 ‘‘(i) coordination of relevant program 

8 requirements, timelines, and measurable 

9 goals of such grant programs; and 

10 ‘‘(ii) establishment of a system for 

11 gathering and disseminating best practices 

12 among grant recipients.’’; 

13 (3) by amending subsection (c) to read as fol14 lows: 

15 ‘‘(c) FUNCTIONS.—The Assistant Secretary for Pre16 paredness and Response shall— 

17 ‘‘(1) have lead responsibility within the Depart18 ment of Health and Human Services for emergency 

19 preparedness and response policy and coordination; 

20 ‘‘(2) have authority over and responsibility for— 

21 ‘‘(A) the National Disaster Medical System 

22 (in accordance with section 301 of the Pandemic 

23 and All-Hazards Preparedness Act); 

24 ‘‘(B) the Hospital Preparedness Cooperative 

25 Agreement Program pursuant to section 319C–2; 


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1 ‘‘(C) the Biomedical Advanced Research 

2 and Development Authority under section 319L; 

3 and 

4 ‘‘(D) the Emergency System for Advance 

5 Registration of Volunteer Health Professionals 

6 pursuant to section 319I; 

7 ‘‘(3) provide policy coordination and oversight 

8 of— 

9 ‘‘(A) the Strategic National Stockpile under 

10 section 319F–2; 

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

12 ‘‘(C) the Medical Reserve Corps pursuant to 

13 section 2813; and 

14 ‘‘(4) assume other duties as determined appro15 priate by the Secretary.’’; and 

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

17 ‘‘(d) COUNTERMEASURE IMPLEMENTATION PLAN.— 

18 Not later than 6 months after the date of enactment of this 

19 subsection, and annually thereafter, the Assistant Secretary 

20 for Preparedness and Response shall submit through the 

21 Secretary to the Committee on Energy and Commerce of 

22 the House of Representatives and the Committee on Health, 

23 Education, Labor, and Pensions of the Senate a Counter24 measure Implementation Plan that— 


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1 ‘‘(1) describes the chemical, biological, radio2 logical, and nuclear threats facing the Nation and the 

3 corresponding efforts to develop qualified counter4 measures (as defined in section 319F–1), security 

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

6 qualified pandemic or epidemic products (as defined 

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

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

9 respect to such countermeasures or products, includ10 ing research, advanced research, development, pro11 curement, stockpiling, deployment, and utilization; 

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

13 long-term needs with respect to such countermeasures 

14 or products to address chemical, biological, radio15 logical, and nuclear threats; 

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

17 threat, a summary of all advanced development and 

18 procurement awards, including— 

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

20 the initial solicitation or request for a proposal 

21 to the adjudication (such as the award, denial of 

22 award, or solicitation termination); 

23 ‘‘(B) projected timelines for development 

24 and procurement of such countermeasures or 

25 products; 


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1 ‘‘(C) clearly defined goals, benchmarks, and 

2 milestones for each such countermeasure or prod3 uct, including information on the number of 

4 doses required, the intended use of the counter5 measure or product, and the required counter6 measure or product characteristics; and 

7 ‘‘(D) projected needs with regard to the re8 plenishment of the Strategic National Stockpile; 

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

10 goals, benchmarks, and milestones identified under 

11 paragraph (4)(C); 

12 ‘‘(6) reports on the amount of funds available for 

13 procurement in the special reserve fund as defined in 

14 section 319F–2(g)(5) and the impact this funding 

15 will have on meeting the requirements under section 

16 319F–2; 

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

18 local, and tribal stakeholders; and 

19 ‘‘(8) addresses the needs of pediatric populations 

20 with respect to such countermeasures and products in 

21 the Strategic National Stockpile and includes— 

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

23 products necessary to address the needs of pedi24 atric populations; 


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1 ‘‘(B) a description of measures taken to co2 ordinate with Office of Pediatric Therapeutics of 

3 the Food and Drug Administration to maximize 

4 the labeling, dosages, and formulations of such 

5 countermeasures and products for pediatric pop6 ulations; 

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

8 Strategic National Stockpile and the develop9 ment of such countermeasures and products to 

10 address the needs of pediatric populations; and 

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

12 addressing gaps identified pursuant to subpara13 graph (C). 

14 Notwithstanding any other provision of this subsection, the 

15 Plan shall not include any confidential commercial infor16 mation, proprietary information, or information that could 

17 reveal vulnerabilities of the Nation in the preparation for 

18 or ability to respond to chemical, biological, radiological, 

19 or nuclear threats.’’. 

20 (b) CONSULTATION IN AUTHORIZING MEDICAL PROD21 UCTS FOR USE IN EMERGENCIES.—Subsection (c) of section 

22 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

23 360bbb–3) is amended by striking ‘‘consultation with the 

24 Director of the National Institutes of Health’’ and inserting 

25 ‘‘consultation with the Assistant Secretary for Preparedness 


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1 and Response, the Director of the National Institutes of 

2 Health,’’. 

3 (c) BIOSURVEILLANCE PLAN.—Not later than one year 

4 after the date of the enactment of this Act, the Secretary 

5 of Health and Human Services shall prepare and submit 

6 to the Committee on Energy and Commerce of the House 

7 of Representatives and the Committee on Health, Edu8 cation, Labor, and Pensions of the Senate a plan to improve 

9 information sharing, coordination, and communications 

10 among disparate biosurveillance systems supported by the 

11 Department of Health and Human Services. 

12 SEC. 5. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD 

13 REPORTS. 

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

15 U.S.C. 247d–6c) is repealed. 

16 SEC. 6. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE 

17 IN EMERGENCIES. 

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

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

20 (1) in subsection (a)— 

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

22 505, 510(k), and 515 of this Act’’ and inserting 

23 ‘‘any provision of this Act’’; 

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

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


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

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

3 section 351 of the Public Health Service Act’’; 

4 and 

5 (C) in paragraph (3), by striking ‘‘a provi6 sion of law referred to in such paragraph’’ and 

7 inserting ‘‘a provision of law referred to in para8 graph (2)(A)’’; 

9 (2) in subsection (b)— 

10 (A) in the subsection heading, by striking 

11 ‘‘DECLARATION OF EMERGENCY’’ and inserting 

12 ‘‘DECLARATION SUPPORTING EMERGENCY USE

13 AUTHORIZATION’’; 

14 (B) in paragraph (1)— 

15 (i) in the matter preceding subpara16 graph (A), by striking ‘‘an emergency justi17 fying’’ and inserting ‘‘that circumstances 

18 exist justifying’’; 

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

20 ‘‘specified’’; 

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

22 ‘‘specified’’; and 

23 (iv) by amending subparagraph (C) to 

24 read as follows: 


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

2 there is a public health emergency, or a signifi3 cant potential for a public health emergency, in4 volving a heightened risk to national security or 

5 the health and security of United States citizens 

6 abroad, and involving a biological, chemical, ra7 diological, or nuclear agent or agents, or a dis8 ease or condition that may be attributable to 

9 such agent or agents.’’; 

10 (C) in paragraph (2)— 

11 (i) by amending subparagraph (A) to 

12 read as follows: 

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

14 this subsection shall terminate upon a deter15 mination by the Secretary, in consultation with, 

16 as appropriate, the Secretary of Homeland Secu17 rity or the Secretary of Defense, that the cir18 cumstances described in paragraph (1) have 

19 ceased to exist.’’; 

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

21 (iii) by redesignating subparagraph 

22 (C) as subparagraph (B); and 

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

24 notice of termination, and renewal’’ and insert25 ing ‘‘and advance notice of termination’’; 


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

2 in’’ and insert ‘‘covered by’’; 

3 (4) in subsection (d)(3), by inserting ‘‘, to the ex4 tent practicable given the circumstances of the emer5 gency,’’ after ‘‘including’’; 

6 (5) in subsection (e)— 

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

8 clause (iii) to read as follows: 

9 ‘‘(iii) Appropriate conditions with re10 spect to the collection and analysis of infor11 mation concerning the safety and effective12 ness of the product with respect to the ac13 tual use of such product pursuant to an au14 thorization under this section.’’; 

15 (B) in paragraph (2)— 

16 (i) in subparagraph (A)— 

17 (I) by striking ‘‘manufacturer of 

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

19 and 

20 (II) by inserting ‘‘or in para21 graph (1)(B)’’ before the period at the 

22 end; 

23 (ii) in subparagraph (B)(i), by insert24 ing ‘‘, with the exception of extensions of a 

25 product’s expiration date authorized under 


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1 section 564A(b)’’ before the period at the 

2 end; and 

3 (iii) by amending subparagraph (C) to 

4 read as follows: 

5 ‘‘(C) In establishing conditions under this 

6 paragraph with respect to the distribution and 

7 administration of a product, the Secretary shall 

8 not impose conditions that would restrict dis9 tribution or administration of the product that 

10 is solely for the approved uses.’’; 

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

12 follows: 

13 ‘‘(3) GOOD MANUFACTURING PRACTICE; PRE14 SCRIPTION; PRACTITIONER’S AUTHORIZATION.—With 

15 respect to the emergency use of a product for which 

16 an authorization under this section is issued (whether 

17 for an unapproved product or an unapproved use of 

18 an approved product), the Secretary may waive or 

19 limit, to the extent appropriate given the cir20 cumstances of the emergency— 

21 ‘‘(A) requirements regarding current good 

22 manufacturing practice otherwise applicable to 

23 the manufacture, processing, packing, or holding 

24 of products subject to regulation under this Act, 

25 including such requirements established under 


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1 section 501 or 520(f)(1), and including relevant 

2 conditions prescribed with respect to the product 

3 by an order under section 520(f)(2); 

4 ‘‘(B) requirements established under section 

5 503(b); and 

6 ‘‘(C) requirements established under section 

7 520(e).’’; and 

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

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

10 section restricts any authority vested in the Secretary 

11 by any other provision of this Act or the Public 

12 Health Service Act for establishing conditions of au13 thorization for a product.’’; and 

14 (6) in subsection (g)— 

15 (A) in the heading, by striking ‘‘REVOCA16 TION OF AUTHORIZATION’’ and inserting ‘‘RE17 VIEW, MODIFICATION, AND REVOCATION OF AU18 THORIZATION’’; 

19 (B) in paragraph (1), by striking ‘‘periodi20 cally review’’ and inserting ‘‘review not less than 

21 every three years’’; and 

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

23 ‘‘(3) MODIFICATION.—The Secretary may modify 

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1 view of the authorization or new information that is 

2 otherwise obtained, including information obtained 

3 during an emergency.’’. 

4 SEC. 7. ADDITIONAL PROVISIONS RELATED TO MEDICAL 

5 PRODUCTS FOR EMERGENCY USE. 

6 (a) IN GENERAL.—The Federal Food, Drug, and Cos7 metic Act is amended by inserting after section 564 (21 

8 U.S.C. 360bbb–3) the following: 

9 ‘‘SEC. 564A. ADDITIONAL PROVISIONS RELATED TO MED10 ICAL PRODUCTS FOR EMERGENCY USE. 

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

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

13 biological product. 

14 ‘‘(2) The term ‘eligible product’ means a product 

15 that is— 

16 ‘‘(A) approved or cleared under this chapter 

17 or licensed under section 351 of the Public 

18 Health Service Act; and 

19 ‘‘(B) intended to be used to diagnose, pre20 vent, or treat a disease or condition involving a 

21 biological, chemical, radiological, or nuclear 

22 agent or agents during— 

23 ‘‘(i) a domestic emergency or military 

24 emergency involving heightened risk of at25 tack with such an agent or agents; or 


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1 ‘‘(ii) a public health emergency affect2 ing national security or the health and se3 curity of United States citizens abroad. 

4 ‘‘(b) EXPIRATION DATING.— 

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

6 the expiration date and authorize the introduction or 

7 delivery for introduction into interstate commerce of 

8 an eligible product after the expiration date provided 

9 by the manufacturer if— 

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

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

12 health emergency described in subsection 

13 (a)(2)(B); 

14 ‘‘(B) the expiration date extension is in15 tended to support the United States’ ability to 

16 protect— 

17 ‘‘(i) the public health; or 

18 ‘‘(ii) military preparedness and effec19 tiveness; and 

20 ‘‘(C) the expiration date extension is sup21 ported by an appropriate scientific evaluation 

22 that is conducted or accepted by the Secretary. 

23 ‘‘(2) REQUIREMENTS AND CONDITIONS.—Any ex24 tension of an expiration date under paragraph (1) 

25 shall, as part of the extension, identify— 


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

2 of the product for which extended expiration is 

3 authorized; 

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

5 ‘‘(C) any other requirements or conditions 

6 as the Secretary may deem appropriate for the 

7 protection of the public health, which may in8 clude requirements for, or conditions on, product 

9 sampling, storage, packaging or repackaging, 

10 transport, labeling, notice to product recipients, 

11 recordkeeping, periodic testing or retesting, or 

12 product disposition. 

13 ‘‘(3) EFFECT.—Notwithstanding any other pro14 vision of this Act or the Public Health Service Act, 

15 an eligible product shall not be considered an unap16 proved product (as defined in section 564(a)(2)(A)) 

17 and shall not be deemed adulterated or misbranded 

18 under this Act because, with respect to such product, 

19 the Secretary has, under paragraph (1), extended the 

20 expiration date and authorized the introduction or 

21 delivery for introduction into interstate commerce of 

22 such product after the expiration date provided by the 

23 manufacturer. 

24 ‘‘(c) CURRENT GOOD MANUFACTURING PRACTICES.— 


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

2 the circumstances of a domestic, military, or public 

3 health emergency described in subsection (a)(2)(B) so 

4 warrant, authorize, with respect to an eligible prod5 uct, deviations from current good manufacturing 

6 practice requirements otherwise applicable to the 

7 manufacture, processing, packing, or holding of prod8 ucts subject to regulation under this Act, including re9 quirements under section 501 or 520(f)(1) or applica10 ble conditions prescribed with respect to the eligible 

11 product by an order under section 520(f)(2). 

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

14 an eligible product shall not be considered an unap15 proved product (as defined in section 564(a)(2)(A)) 

16 and shall not be deemed adulterated or misbranded 

17 under this Act because, with respect to such product, 

18 the Secretary has authorized deviations from current 

19 good manufacturing practices under paragraph (1). 

20 ‘‘(d) MASS DISPENSING.—The requirements of section 

21 503(b) and 520(e) shall not apply to an eligible product, 

22 and the product shall not be considered an unapproved 

23 product (as defined in section 564(a)(2)(A)) and shall not 

24 be deemed adulterated or misbranded under this Act because 

25 it is dispensed without an individual prescription, if— 


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

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

3 ‘‘(2) such dispensing without an individual pre4 scription occurs— 

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

6 State in which the product is dispensed; or 

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

8 the Secretary. 

9 ‘‘(e) EMERGENCY USE INSTRUCTIONS.— 

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

11 through an appropriate official within the Depart12 ment of Health and Human Services, may create and 

13 issue emergency use instructions to inform health care 

14 providers or individuals to whom an eligible product 

15 is to be administered concerning such product’s ap16 proved, licensed, or cleared conditions of use. 

17 ‘‘(2) EFFECT.—Notwithstanding any other pro18 visions of this Act or the Public Health Service Act, 

19 a product shall not be considered an unapproved 

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

21 not be deemed adulterated or misbranded under this 

22 Act because of— 

23 ‘‘(A) the issuance of emergency use instruc24 tions under paragraph (1) with respect to such 

25 product; or 


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1 ‘‘(B) the introduction or delivery for intro2 duction of such product into interstate commerce 

3 accompanied by such instructions during an 

4 emergency response to an actual emergency de5 scribed in subsection (a)(2)(B).’’. 

6 (b) RISK EVALUATION AND MITIGATION STRATE7 GIES.—Section 505–1 of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 355-1), is amended— 

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

10 and 

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

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

13 The Secretary may waive any requirement of this section 

14 with respect to a qualified countermeasure (as defined in 

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

16 which a requirement under this section has been applied, 

17 if the Secretary determines that such waiver is required to 

18 mitigate the effects of, or reduce the severity of, an actual 

19 or potential domestic emergency or military emergency in20 volving heightened risk of attack with a biological, chemical, 

21 radiological, or nuclear agent, or an actual or potential 

22 public health emergency affecting national security or the 

23 health and security of United States citizens abroad.’’. 


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1 SEC. 8. PRODUCTS HELD FOR EMERGENCY USE. 

2 The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 301 et seq.) is amended by inserting after section 564A, as 

4 added by section 7, the following: 

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

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

7 the Public Health Service Act for a government entity (in8 cluding a Federal, State, local, and tribal government enti9 ty), or a person acting on behalf of such a government enti10 ty, to introduce into interstate commerce a product (as de11 fined in section 564(a)(4)) intended for emergency use, if 

12 that product— 

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

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

15 product— 

16 ‘‘(A) is approved, cleared, or licensed under 

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

18 351 of the Public Health Service Act; 

19 ‘‘(B) is authorized for investigational use 

20 under section 505 or 520 of this Act or section 

21 351 of the Public Health Service Act; or 

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

23 564.’’. 


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1 SEC. 9. ACCELERATE COUNTERMEASURE DEVELOPMENT BY 

2 STRENGTHENING FDA’S ROLE IN REVIEWING 

3 PRODUCTS FOR NATIONAL SECURITY PRIOR4 ITIES. 

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

6 Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) is amended 

7 to read as follows: 

8 ‘‘SEC. 565. COUNTERMEASURE DEVELOPMENT AND REVIEW. 

9 ‘‘(a) COUNTERMEASURES AND PRODUCTS.—The coun10 termeasures and products referred to in this subsection 

11 are— 

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

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

14 ‘‘(2) security countermeasures (as defined in sec15 tion 319F–2 of such Act); and 

16 ‘‘(3) qualified pandemic or epidemic products 

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

18 Secretary determines to be a priority. 

19 ‘‘(b) IN GENERAL.— 

20 ‘‘(1) INVOLVEMENT OF FDA PERSONNEL IN

21 INTERAGENCY ACTIVITIES.—For the purpose of accel22 erating the development, stockpiling, approval, clear23 ance, and licensure of countermeasures and products 

24 referred to in subsection (a), the Secretary shall ex25 pand the involvement of Food and Drug Administra26 tion personnel in interagency activities with the AsVerDate Mar 15 2010 21:08 Nov 16, 2011 Jkt 019200 PO 00000 Frm 00037 Fmt 6652 Sfmt 6203 E:\BILLS\H2405.RH H2405

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1 sistant Secretary for Preparedness and Response (in2 cluding the Biomedical Advanced Research and De3 velopment Authority), the Centers for Disease Control 

4 and Prevention, the National Institutes of Health, 

5 and the Department of Defense. 

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

7 shall establish within the Food and Drug Administra8 tion a team of experts on manufacturing and regu9 latory activities (including compliance with current 

10 Good Manufacturing Practices) to provide both off11 site and on-site technical assistance to the manufac12 turers of countermeasures and products referred to in 

13 subsection (a). On-site technical assistance shall be 

14 provided upon the request of the manufacturer and at 

15 the discretion of the Secretary if the Secretary deter16 mines that the provision of such assistance would ac17 celerate the development, manufacturing, or approval, 

18 clearance, or licensure of countermeasures and prod19 ucts referred to in subsection (a). 

20 ‘‘(c) AGENCY INTERACTION WITH SECURITY COUNTER21 MEASURE SPONSORS.— 

22 ‘‘(1) IN GENERAL.—For security counter23 measures (as defined in section 319F–2 of the Public 

24 Health Service Act) that are procured under such sec25 tion 319F–2— 


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

2 for frequent scientific feedback and interactions 

3 between the Food and Drug Administration and 

4 the security countermeasure sponsor (referred to 

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

6 facilitate the approval, clearance, and licensure 

7 of the security countermeasures; 

8 ‘‘(B) such feedback and interactions shall 

9 include meetings and, in accordance with sub10 section (b)(2), on-site technical assistance; and 

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

12 process under this paragraph shall include par13 ticipation by the Food and Drug Administration 

14 in meetings between the Biomedical Advanced 

15 Research and Development Authority and spon16 sors on the development of such countermeasures. 

17 ‘‘(2) REGULATORY MANAGEMENT PLAN.— 

18 ‘‘(A) IN GENERAL.—The process established 

19 under paragraph (1) shall allow for the develop20 ment of a written regulatory management plan 

21 (in this paragraph referred to as the ‘plan’) for 

22 a security countermeasure (as defined in para23 graph (1)) in accordance with this paragraph. 

24 ‘‘(B) PROPOSAL AND FINALIZATION OF

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1 graph (1), the Secretary shall direct the Food 

2 and Drug Administration, upon submission of a 

3 written request by the sponsor that includes a 

4 proposed plan and relevant data and future 

5 planning detail to support such a plan, to work 

6 with the sponsor to agree on a final plan within 

7 a reasonable time not to exceed 90 days. The 

8 basis for this agreement shall be the proposed 

9 plan submitted by the sponsor. Notwithstanding 

10 the preceding sentence, the Secretary shall retain 

11 full discretion to determine the contents of the 

12 final plan or to determine that no such plan can 

13 be agreed upon. If the Secretary determines that 

14 no final plan can be agreed upon, the Secretary 

15 shall provide to the sponsor, in writing, the sci16 entific or regulatory rationale why such agree17 ment cannot be reached. If a final plan is agreed 

18 upon, it shall be shared with the sponsor in writ19 ing. 

20 ‘‘(C) CONTENTS.—The plan shall include an 

21 agreement on the nature of, and timelines for, 

22 feedback and interactions between the sponsor 

23 and the Food and Drug Administration, shall 

24 provide reasonable flexibility in implementing 

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1 graph as warranted during the countermeasure 

2 development process, and shall identify— 

3 ‘‘(i) the current regulatory status of the 

4 countermeasure, an assessment of known 

5 scientific gaps relevant to approval, clear6 ance, or licensure of the countermeasure, 

7 and a proposed pathway to approval, clear8 ance, or licensure of the countermeasure; 

9 ‘‘(ii) developmental milestones whose 

10 completion will result in meetings to be 

11 scheduled within a reasonable time between 

12 the applicable review division of the Food 

13 and Drug Administration and the sponsor; 

14 ‘‘(iii) sponsor submissions that will re15 sult in written feedback from the review di16 vision within a reasonable time; 

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

18 Administration regarding the data required 

19 to support delivery of the countermeasure to 

20 the Strategic National Stockpile under sec21 tion 319F–2 of the Public Health Service 

22 Act; 

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

24 Administration regarding data required to 

25 support submission of a proposed agreement 


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1 on the design and size of clinical trials for 

2 review under section 505(b)(5)(B); and 

3 ‘‘(vi) other issues that have the poten4 tial to delay approval, clearance, or licen5 sure. 

6 ‘‘(D) CHANGES.—Changes to the plan shall 

7 be made by subsequent agreement between the 

8 Secretary and the sponsor. If after reasonable at9 tempts to negotiate changes to the plan the Sec10 retary and the sponsor are unable to finalize 

11 such changes, the Secretary shall provide to the 

12 sponsor, in writing, the scientific or regulatory 

13 rationale why such changes are required or can14 not be included in the plan. 

15 ‘‘(3) APPLICABILITY TO CERTAIN QUALIFIED

16 PANDEMIC OR EPIDEMIC PRODUCTS.—The Secretary 

17 may, with respect to qualified pandemic or epidemic 

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

19 Health Service Act) for which a contract for advanced 

20 research and development is entered into under sec21 tion 319L of such Act, choose to apply the provisions 

22 of paragraphs (1) and (2) to the same extent and in 

23 the same manner as such provisions apply with re24 spect to security countermeasures. 


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1 ‘‘(d) FINAL GUIDANCE ON DEVELOPMENT OF ANIMAL

2 MODELS.— 

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

4 the date of the enactment of the Pandemic and All5 Hazards Preparedness Reauthorization Act of 2011, 

6 the Secretary shall provide final guidance to industry 

7 regarding the development of animal models to sup8 port approval, clearance, or licensure of counter9 measures and products referred to in subsection (a) 

10 when human efficacy studies are not ethical or fea11 sible. 

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

13 Secretary may extend the deadline for providing final 

14 guidance under paragraph (1) by not more than 6 

15 months upon submission by the Secretary of a report 

16 on the status of such guidance to the Committee on 

17 Energy and Commerce of the House of Representa18 tives and the Committee on Health, Education, 

19 Labor, and Pensions of the Senate. 

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

21 2013, and every 2 years thereafter, the Secretary shall sub22 mit a report to the Committee on Energy and Commerce 

23 of the House of Representatives and the Committee on 

24 Health, Education, Labor, and Pensions of the Senate, that, 

25 with respect to the preceding 2 fiscal years, includes— 


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1 ‘‘(1) the number of full-time equivalent employ2 ees of the Food and Drug Administration who di3 rectly support the review of countermeasures and 

4 products referred to in subsection (a); 

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

6 and Drug Administration for review of such counter7 measures and products; 

8 ‘‘(3) the number of regulatory teams at the Food 

9 and Drug Administration specific to such counter10 measures and products and, for each such team, the 

11 assigned products, classes of products, or technologies; 

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

13 the sponsor of such a countermeasure or product for 

14 information and the provision of such information by 

15 the Food and Drug Administration; 

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

17 interactions between the Food and Drug Administra18 tion and— 

19 ‘‘(A) sponsors of a countermeasure or prod20 uct referred to in subsection (a); or 

21 ‘‘(B) another agency engaged in develop22 ment or management of portfolios for such coun23 termeasures or products, including the Centers 

24 for Disease Control and Prevention, the Bio25 medical Advanced Research and Development 


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1 Authority, the National Institutes of Health, and 

2 the appropriate agencies of the Department of 

3 Defense; 

4 ‘‘(6) a description of other measures that, as de5 termined by the Secretary, are appropriate to deter6 mine the efficiency of the regulatory teams described 

7 in paragraph (3); and 

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

9 to countermeasures or products referred to in sub10 section (a) and which the Food and Drug Adminis11 tration is addressing and the progress made on these 

12 priorities.’’. 

13 (b) SPECIAL PROTOCOL ASSESSMENT.—Subparagraph 

14 (B) of section 505(b)(5) of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 355(b)(5)) is amended to read as fol16 lows: 

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

18 investigation or an applicant for approval for a drug under 

19 this subsection or section 351 of the Public Health Service 

20 Act if the sponsor or applicant makes a reasonable written 

21 request for a meeting for the purpose of reaching agreement 

22 on the design and size of— 

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

24 basis of an effectiveness claim; or 


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

2 clinical trials that in combination are intended to 

3 form the primary basis of an effectiveness claim for 

4 a countermeasure or product referred to in section 

5 565(a) when human efficacy studies are not ethical or 

6 feasible. 

7 ‘‘(ii) The sponsor or applicant shall provide informa8 tion necessary for discussion and agreement on the design 

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

10 shall be prepared by the Secretary and made available to 

11 the sponsor or applicant upon request.’’. 


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Union Calendar No. 189 

112TH CONGRESS 

1ST SESSION H. R. 2405 

[Report No. 112–286] 

A BILL 

To reauthorize certain provisions of the Public 

for other purposes. paredness and countermeasure development, and and Cosmetic Act relating to public health preHealth Service Act and the Federal Food, Drug, 

NOVEMBER 16, 2011 

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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