I 

112TH CONGRESS 

1ST SESSION H. R. 2405 

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 

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. 

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 Reauthoriza6 tion Act of 2011’’. 

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

8 this Act is as follows: 


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Sec. 1. Short title; table of contents. 

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

Sec. 3. Coordination by Assistant Secretary for Preparedness and Response. 

Sec. 4. Eliminating duplicative Project Bioshield reports. 

Sec. 5. Accelerate countermeasure development by strengthening FDA’s role in 

reviewing products for national security priorities. 

1 SEC. 2. REAUTHORIZATION OF CERTAIN PROVISIONS RE2 LATING TO PUBLIC HEALTH PREPAREDNESS. 

3 (a) VACCINE TRACKING AND DISTRIBUTION.—Sub4 section (e) of section 319A of the Public Health Service 

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

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

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

8 through 2016’’. 

9 (b) IMPROVING STATE AND LOCAL PUBLIC HEALTH

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

11 1 of the Public Health Service Act (42 U.S.C. 247d–3a) 

12 is amended— 

13 (1) in subsection (f)— 

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

15 at the end; 

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

17 and inserting a period; and 

18 (C) by striking paragraph (4); 

19 (2) by striking subsection (h); and 

20 (3) in subsection (i)— 

21 (A) in paragraph (1)— 


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1 (i) by amending subparagraph (A) to 

2 read as follows: 

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

4 carrying out this section, there is authorized to 

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

6 years 2012 through 2016.’’; and 

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

8 (B) in subparagraphs (C) and (D) of para9 graph (3), by striking ‘‘(1)(A)(i)(I)’’ each place 

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

11 (c) PARTNERSHIPS FOR STATE AND REGIONAL HOS12 PITAL PREPAREDNESS TO IMPROVE SURGE CAPACITY.— 

13 Paragraph (1) of section 319C–2(j) of the Public Health 

14 Service Act (42 U.S.C. 247d–3b(j)) is amended to read 

15 as follows: 

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

17 out this section, there is authorized to be appro18 priated $378,000,000 for each of fiscal years 2012 

19 through 2016.’’. 

20 (d) CDC PROGRAMS FOR COMBATING PUBLIC

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

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

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

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

25 may be necessary in each of fiscal years 2007 


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

2 each of fiscal years 2012 through 2016’’. 

3 (e) DENTAL EMERGENCY RESPONDERS: PUBLIC

4 HEALTH AND MEDICAL RESPONSE.— 

5 (1) ALL-HAZARDS PUBLIC HEALTH AND MED6 ICAL RESPONSE CURRICULA AND TRAINING.—Sec7 tion 319F(a)(5)(B) of the Public Health Service Act 

8 (42 U.S.C. 247d–6(a)(5)(B)) is amended by striking 

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

10 health, medical, or dental’’. 

11 (2) NATIONAL HEALTH SECURITY STRATEGY.— 

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

13 (42 U.S.C. 300hh–1(b)(3)) is amended— 

14 (A) in the matter preceding subparagraph 

15 (A), by inserting ‘‘and which may include den16 tal health facilities’’ after ‘‘mental health facili17 ties’’; and 

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

19 ‘‘(which may include such dental health as20 sets)’’ after ‘‘medical assets’’. 

21 (f) PROCUREMENT OF COUNTERMEASURES.— 

22 (1) CONTRACT TERMS.—Clause (ii) of section 

23 319F–2(c)(7)(C) of the Public Health Service Act 

24 (42 U.S.C. 247d–6b(c)(7)(C)) is amended by adding 

25 at the end the following: 


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1 ‘‘(X) GOVERNMENT PURPOSE.— 

2 The contract shall provide a clear 

3 statement of defined Government pur4 pose limited to uses related to a secu5 rity countermeasure, as defined in 

6 paragraph (1)(B).’’. 

7 (2) REAUTHORIZATION OF THE SPECIAL RE8 SERVE FUND.—Section 319F–2 of the Public Health 

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

10 (A) in subsection (c)— 

11 (i) by striking ‘‘special reserve fund 

12 under paragraph (10)’’ each place it ap13 pears and inserting ‘‘special reserve fund 

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

15 (ii) by striking paragraphs (9) and 

16 (10); and 

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

18 ‘‘(g) SPECIAL RESERVE FUND.— 

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

20 addition to amounts appropriated to the special re21 serve fund prior to the date of the enactment of this 

22 subsection, there is authorized to be appropriated, 

23 for the procurement of security countermeasures 

24 under subsection (c) and for carrying out section 

25 319L (relating to the Biomedical Advanced Research 


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

2 period of fiscal years 2014 through 2018. Amounts 

3 appropriated pursuant to the preceding sentence are 

4 authorized to remain available until September 30, 

5 2019. 

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

7 later than 15 days after any date on which the Sec8 retary determines that the amount of funds in the 

9 special reserve fund available for procurement is less 

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

11 the relevant committees of Congress a report detail12 ing the amount of such funds available for procure13 ment and the impact such funding will have— 

14 ‘‘(A) in meeting the security counter15 measure needs identified under this section; and 

16 ‘‘(B) on the annual Public Health Emer17 gency Medical Countermeasure Enterprise Im18 plementation Plan under section 319F–5(b). 

19 ‘‘(3) USE OF SPECIAL RESERVE FUND FOR AD20 VANCED RESEARCH AND DEVELOPMENT.—The Sec21 retary, acting through the Director of the Bio22 medical Advanced Research and Development Au23 thority, may utilize not more than 30 percent of the 

24 amounts authorized to be appropriated under para25 graph (1) to carry out section 319L (related to the 


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1 Biomedical Advanced Research and Development 

2 Authority). Amounts authorized to be appropriated 

3 under this subsection to carry out section 319L are 

4 in addition to amounts otherwise authorized to be 

5 appropriated to carry out such section. 

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

7 Amounts in the special reserve fund shall not be 

8 used to pay— 

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

10 the Secretary to a vendor for advanced research 

11 and development or procurement of a security 

12 countermeasure under subsection (c)(7); and 

13 ‘‘(B) any administrative expenses, includ14 ing salaries. 

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

16 ‘special reserve fund’ means the ‘Biodefense Coun17 termeasures’ appropriations account, any appropria18 tion made available pursuant to section 521(a) of 

19 the Homeland Security Act of 2002, and any appro20 priation made available pursuant to paragraph (1) of 

21 this paragraph.’’. 

22 (g) BIOMEDICAL ADVANCED RESEARCH AND DEVEL23 OPMENT AUTHORITY.— 

24 (1) TRANSACTION AUTHORITIES.—Section 

25 319L(c)(5) of the Public Health Service Act (42 


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

2 end the following: 

3 ‘‘(G) GOVERNMENT PURPOSE.—In award4 ing contracts, grants, and cooperative agree5 ments under this section, the Secretary shall 

6 provide a clear statement of defined Govern7 ment purpose related to activities included in 

8 subsection (a)(6)(B) for a qualified counter9 measure or qualified pandemic or epidemic 

10 product.’’. 

11 (2) BIODEFENSE MEDICAL COUNTERMEASURE

12 DEVELOPMENT FUND.—Paragraph (2) of section 

13 319L(d) of the Public Health Service Act (42 U.S.C. 

14 247d–7e(d)) is amended to read as follows: 

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

16 this section, there is authorized to be appropriated 

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

18 2012 through 2016, the amounts to remain available 

19 until expended.’’. 

20 (3) CONTINUED INAPPLICABILITY OF CERTAIN

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

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

23 amended by striking ‘‘7 years’’ and inserting ‘‘10 

24 years’’. 


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1 (h) NATIONAL DISASTER MEDICAL SYSTEM.—Sec2 tion 2812 of the Public Health Service Act (42 U.S.C. 

3 300hh–11) is amended— 

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

5 the following: 

6 ‘‘(D) ADMINISTRATION.—The Secretary 

7 may determine and pay claims for reimburse8 ment for services under subparagraph (A) di9 rectly or by contract providing for payment in 

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

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

12 may be necessary for each of the fiscal years 2007 

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

14 of fiscal years 2012 through 2016’’. 

15 (i) 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 

18 by striking ‘‘6-year’’ and inserting ‘‘10-year’’. 

19 SEC. 3. 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– 

4 1)’’; 

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

6 the following: 

7 ‘‘(D) IDENTIFICATION OF INEFFICIEN8 CIES.—Identify gaps, duplication, and other in9 efficiencies in public health preparedness activi10 ties and the actions necessary to overcome these 

11 obstacles. 

12 ‘‘(E) DEVELOPMENT OF COUNTER13 MEASURE IMPLEMENTATION PLAN.—Lead the 

14 development of a coordinated Countermeasure 

15 Implementation Plan under subsection (d). 

16 ‘‘(F) COUNTERMEASURES BUDGET ANAL17 YSIS.—Oversee, in consultation with the Direc18 tor of the Office of Management and Budget, 

19 the development of a comprehensive, cross-cut20 ting 5-year budget analysis with respect to ac21 tivities described in paragraph (3)— 

22 ‘‘(i) to inform prioritization of re23 sources; and 

24 ‘‘(ii) to ensure that challenges are 

25 adequately addressed. 


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1 ‘‘(G) GRANT PROGRAMS FOR MEDICAL AND

2 PUBLIC HEALTH PREPAREDNESS CAPABILI3 TIES.—Coordinate, in consultation with the 

4 Secretary of Homeland Security, grant pro5 grams of the Department of Health and 

6 Human Services relating to medical and public 

7 health preparedness capabilities and the ability 

8 of local communities to respond to public health 

9 emergencies, including by— 

10 ‘‘(i) coordinating the program require11 ments, timelines, and measurable goals of 

12 such grant programs; and 

13 ‘‘(ii) establishing a system for gath14 ering and disseminating best practices 

15 among grant recipients.’’; 

16 (3) by amending subsection (c) to read as fol17 lows: 

18 ‘‘(c) FUNCTIONS.—The Assistant Secretary for Pre19 paredness and Response shall— 

20 ‘‘(1) have authority over and responsibility 

21 for— 

22 ‘‘(A) the National Disaster Medical System 

23 (in accordance with section 301 of the Pan24 demic and All-Hazards Preparedness Act); 


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1 ‘‘(B) the Hospital Preparedness Coopera2 tive Agreement Program pursuant to section 

3 319C–2; 

4 ‘‘(C) the Biomedical Advanced Research 

5 and Development Authority under section 

6 319L; 

7 ‘‘(D) the Medical Reserve Corps pursuant 

8 to section 2813; 

9 ‘‘(E) the Emergency System for Advance 

10 Registration of Volunteer Health Professionals 

11 pursuant to section 319I; 

12 ‘‘(F) the Strategic National Stockpile; and 

13 ‘‘(G) the Cities Readiness Initiative; and 

14 ‘‘(2) 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 

19 this subsection, and annually thereafter, the Assistant 

20 Secretary for Preparedness and Response shall submit to 

21 the Secretary and relevant congressional committees a 

22 Countermeasure Implementation Plan that— 

23 ‘‘(1) describes the chemical, biological, radio24 logical, and nuclear threats facing the Nation and 

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1 termeasures (as defined in section 319F–1), secured 

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

3 qualified pandemic or epidemic products (as defined 

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

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

6 respect to such countermeasures or products, includ7 ing research, advanced research, development, pro8 curement, stockpiling, deployment, and utilization; 

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

10 long-term needs with respect to such counter11 measures or products to address chemical, biological, 

12 radiological, and nuclear threats; 

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

14 threat, a summary of all advanced development and 

15 procurement awards, including the time elapsed 

16 from the issuance of the initial solicitation or re17 quest for a proposal to the adjudication (such as the 

18 award, denial of award, or solicitation termination), 

19 and including— 

20 ‘‘(A) projected timelines for development 

21 and procurement of such countermeasures or 

22 products; 

23 ‘‘(B) clearly defined goals, benchmarks, 

24 and milestones for each countermeasure or 

25 product, including information on the number 


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1 of doses required, the intended use of the coun2 termeasure or product, and the required coun3 termeasure or product characteristics; and 

4 ‘‘(C) projected needs with regard to the re5 plenishment of the Strategic National Stockpile; 

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

7 goals, benchmarks, and milestones identified under 

8 paragraph (4); 

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

10 for procurement in the special reserve fund as de11 fined in section 319F–2(g)(5) and the impact this 

12 funding will have on meeting the requirements under 

13 section 319F–2; and 

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

15 local, and tribal stakeholders.’’. 

16 (b) CONSULTATION IN AUTHORIZING MEDICAL

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

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

19 Act (21 U.S.C. 360bbb–3) is amended by striking ‘‘con20 sultation with the Director of the National Institutes of 

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

22 Secretary for Preparedness and Response, the Director of 

23 the National Institutes of Health,’’. 


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1 SEC. 4. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD 

2 REPORTS. 

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

4 U.S.C. 247d–6c) is repealed. 

5 SEC. 5. ACCELERATE COUNTERMEASURE DEVELOPMENT 

6 BY STRENGTHENING FDA’S ROLE IN REVIEW7 ING PRODUCTS FOR NATIONAL SECURITY 

8 PRIORITIES. 

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

10 Drug, and Cosmetic Act (21 U.S.C. 360bbb–4) is amend11 ed to read as follows: 

12 ‘‘SEC. 565. COUNTERMEASURE DEVELOPMENT AND RE13 VIEW. 

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

15 countermeasures and products referred to in this sub16 section are— 

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

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

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

20 section 319F–2 of such Act); and 

21 ‘‘(3) qualified pandemic or epidemic products 

22 (as defined in section 319F–3 of such Act). 

23 ‘‘(b) IN GENERAL.— 

24 ‘‘(1) INVOLVEMENT OF FDA PERSONNEL IN

25 INTERAGENCY ACTIVITIES.—The Secretary shall ac26 celerate the development, stockpiling, approval, and 


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1 licensure of countermeasures and products referred 

2 to in subsection (a) by expanding the involvement of 

3 Food and Drug Administration personnel in inter4 agency activities with the Biomedical Advanced Re5 search and Development Authority, the Centers for 

6 Disease Control and Prevention, the National Insti7 tutes of Health, and the Department of Defense. 

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

9 shall establish within the Food and Drug Adminis10 tration a team of experts on manufacturing and reg11 ulatory activities (including compliance with current 

12 Good Manufacturing Practice) to provide both off13 site and on-site technical assistance to the manufac14 turers of countermeasures and products referred to 

15 in subsection (a). 

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

18 ‘‘(1) COUNTERMEASURE DEVELOPMENT PRO19 GRAM.— 

20 ‘‘(A) IN GENERAL.—For each security 

21 countermeasure (as defined in section 319F–2 

22 of the Public Health Service Act) that is pro23 cured under such section 319F–2, the Secretary 

24 shall initiate, in consultation with the security 

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1 tion as the ‘countermeasure sponsor’), a pro2 gram of frequent scientific feedback and inter3 actions regarding the process of developing such 

4 countermeasure, including— 

5 ‘‘(i) regular meetings between appro6 priate Food and Drug Administration per7 sonnel and the countermeasure sponsor 

8 during the process of developing the coun9 termeasure, to be scheduled within 45 days 

10 after attainment of each milestone identi11 fied pursuant to subparagraph (B)(iv)(I) 

12 in the regulatory management plan for the 

13 countermeasure; 

14 ‘‘(ii) written feedback from the Food 

15 and Drug Administration within 30 days 

16 after submission of a request for feedback 

17 pursuant to subparagraph (B)(iv)(II) in 

18 the regulatory management plan for the 

19 countermeasure; 

20 ‘‘(iii) written feedback from the Food 

21 and Drug Administration within 30 days 

22 after submission by the countermeasure 

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1 graph (B)(iv)(III) in the regulatory man2 agement plan for the countermeasure; 

3 ‘‘(iv) at the request of the Director of 

4 the Biomedical Advanced Research and 

5 Development Authority, participation in 

6 meetings of such Authority on the develop7 ment of the countermeasure; and 

8 ‘‘(v) other meetings, including on-site 

9 meetings, as appropriate. 

10 ‘‘(B) REGULATORY MANAGEMENT PLAN.— 

11 In carrying out the program under subpara12 graph (A), the Secretary shall, in consultation 

13 with the countermeasure sponsor, develop a 

14 written regulatory management plan for each 

15 security countermeasure (as defined in section 

16 319F–2 of the Public Health Service Act) that 

17 is procured under such section 319F–2. The 

18 regulatory management plan shall be completed 

19 within 60 days of issuance of a contract for the 

20 countermeasure under such section 319F–2 or, 

21 for a countermeasure that was procured under 

22 such section 319F–2 before the date of the en23 actment of the Pandemic and All-Hazards Pre24 paredness Reauthorization Act of 2011, within 

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1 ulatory management plan for a security coun2 termeasure shall include— 

3 ‘‘(i) an assessment of the current reg4 ulatory status, an assessment of known 

5 scientific gaps, and a proposed pathway to 

6 approval or licensure of the counter7 measure; 

8 ‘‘(ii) guidance by the Food and Drug 

9 Administration regarding the data required 

10 to support delivery of the countermeasure 

11 to the Strategic National Stockpile; 

12 ‘‘(iii) guidance by the Food and Drug 

13 Administration regarding data required to 

14 support submission of a proposed agree15 ment on the design and size of clinical 

16 trials for review under section 

17 505(b)(5)(B); and 

18 ‘‘(iv) an agreement between the Food 

19 and Drug Administration and the counter20 measure sponsor to identify— 

21 ‘‘(I) developmental milestones 

22 that will trigger meetings between the 

23 Administration and the sponsor; 


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1 ‘‘(II) the process for requesting 

2 and receiving written or oral feedback 

3 from the Administration; and 

4 ‘‘(III) the type study reports that 

5 will be considered by the Administra6 tion to be complete. 

7 ‘‘(C) APPLICABILITY TO CERTAIN QUALI8 FIED PANDEMIC OR EPIDEMIC PRODUCTS.—The 

9 Secretary may, with respect to qualified pan10 demic or epidemic products (as defined in sec11 tion 319F–3 of the Public Health Service Act) 

12 for which a contract for advanced research and 

13 development is entered into under section 319L 

14 of such Act, choose to apply the provisions of 

15 subparagraphs (A) and (B) to the same extent 

16 and in the same manner as such provisions 

17 apply with respect to security countermeasures. 

18 ‘‘(d) FINAL GUIDANCE ON DEVELOPMENT OF ANI19 MAL MODELS.—Not later than 180 days after the date 

20 of the enactment of the Pandemic and All-Hazards Pre21 paredness Reauthorization Act of 2011, the Secretary 

22 shall provide final guidance to industry regarding the de23 velopment of animal models to support approval or licen24 sure of countermeasures and products referred to in subVerDate Mar 15 2010 23:34 Jul 01, 2011 Jkt 099200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H2405.IH H2405

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1 section (a) when human efficacy studies are not ethical 

2 or feasible. 

3 ‘‘(e) ANNUAL REPORT.—Not later than January 1, 

4 2012, and every January 1 thereafter, the Secretary shall 

5 submit a report to the Committee on Energy and Com6 merce of the House of Representatives and the Committee 

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

8 that, with respect to the preceding fiscal year, includes— 

9 ‘‘(1) the number of full-time equivalent employ10 ees of the Food and Drug Administration who di11 rectly support the review of countermeasures and 

12 products referred to in subsection (a); 

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

14 and Drug Administration for development of such 

15 countermeasures and products; 

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

17 Food and Drug Administration specific to such 

18 countermeasures and products and, for each such 

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

20 technologies; 

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

22 the sponsor of such a countermeasure or product for 

23 information and the provision of such information by 

24 the Food and Drug Administration; 


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

2 interactions between the Food and Drug Adminis3 tration and— 

4 ‘‘(A) sponsors of a countermeasure or 

5 product referred to in subsection (a); or 

6 ‘‘(B) another agency engaged in develop7 ment or management of portfolios for such 

8 countermeasures or products, including the 

9 Centers for Disease Control and Prevention, the 

10 Biomedical Advanced Research and Develop11 ment Authority, the National Institutes of 

12 Health, and the appropriate agencies of the De13 partment of Defense; 

14 ‘‘(6) any other measure to determine the effi15 ciency of the regulatory teams described in para16 graph (3); and 

17 ‘‘(7) the regulatory science priorities which the 

18 Food and Drug Administration is addressing and 

19 the progress made on these priorities.’’. 

20 (b) DISCUSSIONS BETWEEN FDA AND SPONSOR ON

21 DESIGN AND SIZE OF ANIMAL AND CLINICAL TRIALS IN22 TENDED TO FORM THE PRIMARY BASIS OF AN EFFEC23 TIVENESS CLAIM WHEN HUMAN EFFICACY STUDIES ARE

24 NOT ETHICAL OR FEASIBLE.—Subparagraph (B) of secVerDate Mar 15 2010 23:34 Jul 01, 2011 Jkt 099200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\H2405.IH H2405

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1 tion 505(b)(5) of the Federal Food, Drug, and Cosmetic 

2 Act (21 U.S.C. 355(b)(5)) is amended to read as follows: 

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

4 an investigation or an applicant for approval for a drug 

5 under this subsection or section 351 of the Public Health 

6 Service Act if the sponsor or applicant makes a reasonable 

7 written request for a meeting for the purpose of reaching 

8 agreement on the design and size of— 

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

10 basis of an effectiveness claim; or 

11 ‘‘(II) animal and clinical trials intended to form 

12 the primary basis of an effectiveness claim when 

13 human efficacy studies are not ethical or feasible. 

14 ‘‘(ii) The sponsor or applicant shall provide informa15 tion necessary for discussion and agreement on the design 

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

17 shall be prepared by the Secretary and made available to 

18 the sponsor or applicant upon request.’’. 

Æ 


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