II 

112TH CONGRESS 

1ST SESSION S. 1855 

To amend the Public Health Service Act to reauthorize various programs 

under the Pandemic and All-Hazards Preparedness Act. 

IN THE SENATE OF THE UNITED STATES 

NOVEMBER 10, 2011 

Mr. BURR (for himself, Mr. HARKIN, Mr. ENZI, Mr. CASEY, Ms. MIKULSKI, 

Mr. ALEXANDER, Mr. LIEBERMAN, Ms. COLLINS, Mrs. HAGAN, and Mr. 

ROBERTS) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Public Health Service Act to reauthorize various programs under the Pandemic and All-Hazards Preparedness Act. 

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 Act Reauthor6 ization of 2011’’. 

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

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 


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TITLE I—STRENGTHENING NATIONAL PREPAREDNESS AND 

RESPONSE FOR PUBLIC HEALTH EMERGENCIES 

Sec. 101. National Health Security Strategy. 

Sec. 102. Assistant Secretary for Preparedness and Response. 

Sec. 103. Modernization of the National Disaster Medical System. 

Sec. 104. Continuing the role of the Department of Veterans Affairs. 

TITLE II—OPTIMIZING STATE AND LOCAL ALL-HAZARDS 

PREPAREDNESS AND RESPONSE 

Sec. 201. Improving State and local public health security. 

Sec. 202. Hospital preparedness and medical surge capacity. 

Sec. 203. Enhancing situational awareness and biosurveillance. 

TITLE III—ENHANCING MEDICAL COUNTERMEASURE REVIEW 

Sec. 301. Special protocol assessment. 

Sec. 302. Authorized use for medical products. 

Sec. 303. Definitions. 

Sec. 304. Enhancing medical countermeasure activities. 

Sec. 305. Regulatory management plans. 

Sec. 306. Report. 

Sec. 307. Pediatric medical countermeasures. 

Sec. 308. Technical and conforming amendments. 

TITLE IV—ACCELERATING MEDICAL COUNTERMEASURE 

ADVANCED RESEARCH AND DEVELOPMENT 

Sec. 401. BioShield. 

Sec. 402. Biomedical Advanced Research and Development Authority. 

Sec. 403. Strategic National Stockpile. 

Sec. 404. National Biodefense Science Board. 

1 TITLE I—STRENGTHENING NA2 TIONAL PREPAREDNESS AND 

3 RESPONSE FOR PUBLIC 

4 HEALTH EMERGENCIES 

5 SEC. 101. NATIONAL HEALTH SECURITY STRATEGY. 

6 (a) IN GENERAL.—Section 2802 of the Public Health 

7 Service Act (42 U.S.C. 300hh–1) is amended— 

8 (1) in subsection (a)(1), by striking ‘‘2009’’ and 

9 inserting ‘‘2014’’; and 

10 (2) in subsection (b)— 

11 (A) in paragraph (3)— 


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1 (i) in the matter preceding subpara2 graph (A), by inserting ‘‘and which may 

3 include dental health facilities’’ after 

4 ‘‘mental health facilities’’; and 

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

6 ‘‘(which may include such dental health as7 sets)’’ after ‘‘medical assets’’; 

8 (B) in paragraph (4)— 

9 (i) in subparagraph (A), by inserting 

10 ‘‘, including the unique needs and consider11 ations of individuals with disabilities,’’ 

12 after ‘‘medical needs of at-risk individ13 uals’’; and 

14 (ii) in subparagraph (B), by inserting 

15 ‘‘the’’ before ‘‘purpose of this section’’; and 

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

17 ‘‘(7) COUNTERMEASURES.— 

18 ‘‘(A) Promoting strategic initiatives to ad19 vance countermeasures to diagnose, mitigate, 

20 prevent, or treat harm from any biological 

21 agent or toxin, chemical, radiological, or nuclear 

22 agent or agents. 

23 ‘‘(B) For purposes of this paragraph the 

24 term ‘countermeasures’ has the same meaning 

25 as the terms ‘qualified countermeasures’ under 


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1 section 319F–1, ‘qualified pandemic and epi2 demic products’ under section 319F–3, and ‘se3 curity countermeasures’ under section 319F–2. 

4 ‘‘(8) MEDICAL AND PUBLIC HEALTH COMMU5 NITY RESILIENCY.—Strengthening the ability of 

6 State and local communities to prepare for, respond 

7 to, and ensure resiliency in the event of public health 

8 emergencies, whether naturally occurring, uninten9 tional, or deliberate by— 

10 ‘‘(A) optimizing alignment and integration 

11 of medical and public health preparedness and 

12 response planning and capabilities with and into 

13 routine daily activities; and 

14 ‘‘(B) promoting familiarity with local med15 ical and public health systems.’’. 

16 (b) AT-RISK INDIVIDUALS.—Section 2814 of the 

17 Public Health Service Act (42 U.S.C. 300hh–16) is 

18 amended— 

19 (1) by striking paragraph (7); 

20 (2) by redesignating paragraphs (1) through 

21 (6) and (8) as paragraphs (2) through (7) and (10), 

22 respectively; 

23 (3) by inserting before paragraph (2) (as so re24 designated), the following: 


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1 ‘‘(1) monitor emerging issues and concerns as 

2 they relate to medical and public health prepared3 ness and response for at-risk individuals in the event 

4 of a public health emergency declared by the Sec5 retary under section 319;’’; and 

6 (4) by inserting after paragraph (7) (as so re7 designated), the following: 

8 ‘‘(8) disseminate and, as appropriate, update 

9 novel and best practices of outreach to and care of 

10 at-risk individuals before, during, and following pub11 lic health emergencies in as timely a manner as is 

12 practicable, including from the time a public health 

13 threat is identified; 

14 ‘‘(9) ensure that public health and medical in15 formation distributed by the Department of Health 

16 and Human Services during a public health emer17 gency is delivered in a manner that takes into ac18 count the range of communication needs of the in19 tended recipients, including at-risk individuals; and’’. 

20 SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

21 RESPONSE. 

22 Section 2811 of the Public Health Service Act (42 

23 U.S.C. 300hh–10) is amended— 

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

25 the following: 


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1 ‘‘(D) POLICY COORDINATION AND STRA2 TEGIC DIRECTION.—Provide integrated policy 

3 coordination and strategic direction with re4 spect to all matters related to Federal public 

5 health and medical preparedness and execution 

6 and deployment of the Federal response for 

7 public health emergencies and incidents covered 

8 by the National Response Plan developed pur9 suant to section 502(6) of the Homeland Secu10 rity Act of 2002, or any successor plan, before, 

11 during, and following public health emer12 gencies.’’; 

13 (2) by striking subsection (c) and inserting the 

14 following: 

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

17 ‘‘(1) have authority over and responsibility 

18 for— 

19 ‘‘(A) the National Disaster Medical System 

20 (in accordance with section 301 of the Pan21 demic and All-Hazards Preparedness Act); 

22 ‘‘(B) the Hospital Preparedness Coopera23 tive Agreement Program pursuant to section 

24 319C–2; 


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1 ‘‘(C) the Medical Reserve Corps pursuant 

2 to section 2813; 

3 ‘‘(D) the Emergency System for Advance 

4 Registration of Volunteer Health Professionals 

5 pursuant to section 319I; and 

6 ‘‘(E) administering grants and related au7 thorities related to trauma care under parts A 

8 through C of title XII, such authority to be 

9 transferred by the Secretary from the Adminis10 trator of the Health Resources and Services Ad11 ministration to such Assistant Secretary; 

12 ‘‘(2) exercise the responsibilities and authorities 

13 of the Secretary with respect to the coordination 

14 of— 

15 ‘‘(A) the Public Health Emergency Pre16 paredness Cooperative Agreement Program pur17 suant to section 319C–1; 

18 ‘‘(B) the Strategic National Stockpile; and 

19 ‘‘(C) the Cities Readiness Initiative; 

20 ‘‘(3) align and coordinate medical and public 

21 health preparedness and response grants and cooper22 ative agreements authorized under this Act, to the 

23 extent possible, including program requirements, 

24 timelines, and measurable goals, and in coordination 

25 with the Secretary of Homeland Security, to— 


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1 ‘‘(A) optimize and streamline medical and 

2 public health preparedness capabilities and the 

3 ability of local communities to respond to public 

4 health emergencies; 

5 ‘‘(B) minimize duplication of efforts with 

6 regard to medical and public health prepared7 ness and response programs; and 

8 ‘‘(C) gather and disseminate best practices 

9 among grant and cooperative agreement recipi10 ents, as appropriate; 

11 ‘‘(4) carry out drills and operational exercises, 

12 in coordination with the Department of Homeland 

13 Security, the Department of Defense, and other ap14 plicable Federal departments and agencies, as nec15 essary and appropriate, to identify, inform, and ad16 dress gaps in and policies related to all-hazards med17 ical and public health preparedness, including exer18 cises based on— 

19 ‘‘(A) identified threats for which counter20 measures are available and for which no coun21 termeasures are available; and 

22 ‘‘(B) unknown threats for which no coun23 termeasures are available; and 

24 ‘‘(5) assume other duties as determined appro25 priate by the Secretary.’’; and 


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

2 ‘‘(d) NATIONAL SECURITY PRIORITY.—The Sec3 retary, acting through the Assistant Secretary for Pre4 paredness and Response, shall on a periodic basis conduct 

5 meetings, as applicable and appropriate, with the Assist6 ant to the President for National Security Affairs to pro7 vide an update on, and discuss, medical and public health 

8 preparedness and response activities pursuant to this Act 

9 and the Federal Food, Drug, and Cosmetic Act, including 

10 progress on the development, approval, clearance, and li11 censure of medical countermeasures. 

12 ‘‘(e) PUBLIC HEALTH EMERGENCY MEDICAL COUN13 TERMEASURES ENTERPRISE STRATEGY AND IMPLEMEN14 TATION PLAN.— 

15 ‘‘(1) IN GENERAL.—Not later than 180 days 

16 after the date of enactment of this subsection, and 

17 every other year thereafter, the Secretary, acting 

18 through the Assistant Secretary for Preparedness 

19 and Response and in coordination with the Director 

20 of the Biomedical Advanced Research and Develop21 ment Authority, the Director of the National Insti22 tutes of Health, the Director of the Centers for Dis23 ease Control and Prevention, and the Commissioner 

24 of the Food and Drug Administration, shall develop 

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1 gress a coordinated strategy and accompanying im2 plementation plan for medical countermeasures to 

3 address chemical, biological, radiological, and nu4 clear threats. Such strategy and plan shall be known 

5 as the ‘Public Health Emergency Medical Counter6 measures Enterprise Strategy and Implementation 

7 Plan’. 

8 ‘‘(2) REQUIREMENTS.—The plan under para9 graph (1) shall— 

10 ‘‘(A) consider and reflect the full spectrum 

11 of medical countermeasure-related activities, in12 cluding research, advanced research, develop13 ment, procurement, stockpiling, deployment, 

14 and distribution; 

15 ‘‘(B) identify and prioritize near-term, 

16 mid-term, and long-term priority qualified and 

17 security countermeasure (as defined in sections 

18 319F–1 and 319F–2) needs and goals of the 

19 Federal Government according to chemical, bio20 logical, radiological, and nuclear threat or 

21 threats; 

22 ‘‘(C) identify projected timelines, antici23 pated funding allocations, benchmarks, and 

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1 jected needs with regard to replenishment of 

2 the Strategic National Stockpile; 

3 ‘‘(D) be informed by the recommendations 

4 of the National Biodefense Science Board pur5 suant to section 319M; 

6 ‘‘(E) report on advanced research and de7 velopment awards and the date of the issuance 

8 of contract awards, including awards made 

9 through the special reserve fund (as defined in 

10 section 319F–2(c)(10)); 

11 ‘‘(F) identify progress made in meeting the 

12 goals, benchmarks, and milestones identified 

13 under subparagraph (C) in plans submitted 

14 subsequent to the initial plan; and 

15 ‘‘(G) be made publically available. 

16 ‘‘(3) GAO REPORT.— 

17 ‘‘(A) IN GENERAL.—Not later than 1 year 

18 after the date on which a Public Health Emer19 gency Medical Countermeasures Enterprise 

20 Strategy and Implementation Plan under this 

21 subsection is issued by the Secretary, the Gov22 ernment Accountability Office shall conduct an 

23 independent evaluation and submit to the ap24 propriate committees of Congress a report con25 cerning such strategy and implementation plan. 


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1 ‘‘(B) CONTENT.—The report described in 

2 subparagraph (A) shall review and assess— 

3 ‘‘(i) the near-term, mid-term, and 

4 long-term medical countermeasure needs 

5 and identified priorities of the Federal 

6 Government pursuant to paragraph (2)(B); 

7 ‘‘(ii) the activities of the Department 

8 of Health and Human Services with re9 spect to advanced research and develop10 ment pursuant to section 319L; and 

11 ‘‘(iii) the progress made toward meet12 ing the goals, benchmarks, and milestones 

13 identified in the Public Health Emergency 

14 Medical Countermeasures Enterprise 

15 Strategy and Implementation Plan under 

16 this subsection. 

17 ‘‘(f) INTERNAL MULTIYEAR PLANNING PROCESS.— 

18 The Secretary shall develop, and update on an annual 

19 basis, a coordinated 5-year budget plan based on the med20 ical countermeasure priorities and goals described in sub21 section (e). Each such plan shall— 

22 ‘‘(1) include consideration of the entire medical 

23 countermeasures enterprise, including— 

24 ‘‘(A) basic research, advanced research and 

25 development; 


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1 ‘‘(B) approval, clearance, licensure, and 

2 authorized uses of products; and 

3 ‘‘(C) procurement, stockpiling, mainte4 nance, and replenishment of all products in the 

5 Strategic National Stockpile; 

6 ‘‘(2) include measurable outputs and outcomes 

7 to allow for the tracking of the progress made to8 ward identified goals; 

9 ‘‘(3) identify medical countermeasure life-cycle 

10 costs to inform planning, budgeting, and anticipated 

11 needs within the continuum of the medical counter12 measure enterprise consistent with section 319F–2; 

13 and 

14 ‘‘(4) be made available to the appropriate com15 mittees of Congress upon request. 

16 ‘‘(g) INTERAGENCY COORDINATION PLAN.—Not 

17 later than one year after the date of enactment of this 

18 subsection, the Secretary, in coordination with the Sec19 retary of Defense, shall submit to the appropriate commit20 tees of Congress a report concerning the manner in which 

21 the Department of Health and Human Services is coordi22 nating with the Department of Defense regarding counter23 measure activities to address chemical, biological, radio24 logical, and nuclear threats. Such report shall include in25 formation with respect to— 


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1 ‘‘(1) the research, advanced research, develop2 ment, procurement, stockpiling, and distribution of 

3 countermeasures to meet identified needs; and 

4 ‘‘(2) the coordination of efforts between the De5 partment of Health and Human Services and the 

6 Department of Defense to address countermeasure 

7 needs for various segments of the population. 

8 ‘‘(h) PROTECTION OF NATIONAL SECURITY.—In car9 rying out subsections (e), (f), and (g), the Secretary shall 

10 ensure that information and items that could compromise 

11 national security are not disclosed.’’. 

12 SEC. 103. MODERNIZATION OF THE NATIONAL DISASTER 

13 MEDICAL SYSTEM. 

14 Section 2812 of the Public Health Service Act (42 

15 U.S.C. 300hh–11) is amended— 

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

17 the following: 

18 (A) in subparagraph (A), in clause (i) by 

19 inserting ‘‘, including at-risk individuals as ap20 plicable’’ after ‘‘victims of a public health emer21 gency’’; 

22 (B) by redesignating subparagraph (C) as 

23 subparagraph (E); and 

24 (C) by inserting after subparagraph (B), 

25 the following: 


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1 ‘‘(C) CONSIDERATIONS FOR AT-RISK POPU2 LATIONS.—The Secretary shall take steps to 

3 ensure that an appropriate specialized and fo4 cused range of public health and medical capa5 bilities are represented in the National Disaster 

6 Medical System, which take into account the 

7 needs of at-risk individuals, in the event of a 

8 public health emergency.’’. 

9 ‘‘(D) ADMINISTRATION.—The Secretary 

10 may determine and pay claims for reimburse11 ment for services under subparagraph (A) di12 rectly or through contracts that provide for 

13 payment in advance or by way of reimburse14 ment.’’; and 

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

16 may be necessary for each of the fiscal years 2007 

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

18 of fiscal years 2012 through 2016’’. 

19 SEC. 104. CONTINUING THE ROLE OF THE DEPARTMENT OF 

20 VETERANS AFFAIRS. 

21 Section 8117(g) of title 38, United States Code, is 

22 amended by striking ‘‘such sums as may be necessary to 

23 carry out this section for each of fiscal years 2007 through 

24 2011’’ and inserting ‘‘$156,500,000 for each of fiscal 

25 years 2012 through 2016 to carry out this section’’. 


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1 TITLE II—OPTIMIZING STATE 

2 AND LOCAL ALL-HAZARDS 

3 PREPAREDNESS AND RE4 SPONSE 

5 SEC. 201. IMPROVING STATE AND LOCAL PUBLIC HEALTH 

6 SECURITY. 

7 (a) COOPERATIVE AGREEMENTS.—Section 319C–1 

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

9 amended— 

10 (1) in subsection (b)(2)— 

11 (A) in subparagraph (A)— 

12 (i) by striking clauses (i) and (ii) and 

13 inserting the following: 

14 ‘‘(i) a description of the activities such 

15 entity will carry out under the agreement 

16 to meet the goals identified under section 

17 2802, including with respect to chemical, 

18 biological, radiological, or nuclear threats; 

19 ‘‘(ii) a description of the activities 

20 such entity will carry out with respect to 

21 pandemic influenza, as a component of the 

22 activities carried out under clause (i), and 

23 consistent with the requirements of para24 graphs (2) and (5) of subsection (g);’’; 


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

2 the end; 

3 (iii) in clause (v), by adding ‘‘and’’ 

4 after the semicolon; and 

5 (iv) by adding at the end the fol6 lowing: 

7 ‘‘(vi) a description of how, as appro8 priate, the entity may partner with rel9 evant public and private stakeholders in 

10 public health emergency preparedness and 

11 response’’; and 

12 (B) in subparagraph (C), by inserting ‘‘, 

13 including addressing the needs of at-risk indi14 viduals,’’ after ‘‘capabilities of such entity’’; 

15 (2) in subsection (g)— 

16 (A) in paragraph (1), by striking subpara17 graph (A) and inserting the following: 

18 ‘‘(A) include outcome goals representing 

19 operational achievements of the National Pre20 paredness Goals developed under section 

21 2802(b) with respect to all-hazards, including 

22 chemical, biological, radiological, or nuclear 

23 threats’’; and 

24 (B) in paragraph (2)(A), by adding at the 

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1 cally update, as necessary and appropriate, 

2 such pandemic influenza plan criteria and shall 

3 require the integration of such criteria into the 

4 benchmarks and standards described in para5 graph (1).’’; and 

6 (3) in subsection (i)— 

7 (A) in paragraph (1)(A)— 

8 (i) by striking ‘‘$824,000,000 for fis9 cal year 2007’’ and inserting 

10 ‘‘$632,900,000 for fiscal year 2012’’; and 

11 (ii) by striking ‘‘such sums as may be 

12 necessary for each of fiscal years 2008 

13 through 2011’’ and inserting 

14 ‘‘$632,900,000 for each of fiscal years 

15 2013 through 2016’’; and 

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

17 ‘‘(7) AVAILABILITY OF COOPERATIVE AGREE18 MENT FUNDS.— 

19 ‘‘(A) IN GENERAL.—Amounts provided to 

20 an eligible entity under a cooperative agreement 

21 under subsection (a) for a fiscal year and re22 maining unobligated at the end of such year 

23 shall remain available to such entity for the 

24 next fiscal year for the purposes for which such 

25 funds were provided. 


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1 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

2 BENCHMARKS.—The continued availability of 

3 funds under subparagraph (A) with respect to 

4 an entity shall be contingent upon such entity 

5 achieving the benchmarks and submitting the 

6 pandemic influenza plan as described in sub7 section (g).’’. 

8 (b) VACCINE TRACKING AND DISTRIBUTION.—Sec9 tion 319A(e) of the Public Health Service Act (42 U.S.C. 

10 247d–1(e)) is amended by striking ‘‘such sums for each 

11 of fiscal years 2007 through 2011’’ and inserting 

12 ‘‘$30,800,000 for each of fiscal years 2012 through 

13 2016’’. 

14 SEC. 202. HOSPITAL PREPAREDNESS AND MEDICAL SURGE 

15 CAPACITY. 

16 (a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL

17 RESPONSE CURRICULA AND TRAINING.—Section 

18 319F(a)(5)(B) of the Public Health Service Act (42 

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

20 health or medical’’ and inserting ‘‘public health, medical, 

21 or dental’’. 

22 (b) ENCOURAGING HEALTH PROFESSIONAL VOLUN23 TEERS.— 

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1 SIONALS.—Section 319I(k) of the Public Health 

2 Service Act (42 U.S.C. 247d–7b(k)) is amended by 

3 striking ‘‘$2,000,000 for fiscal year 2002, and such 

4 sums as may be necessary for each of the fiscal 

5 years 2003 through 2011’’ and inserting 

6 ‘‘$5,900,000 for each of fiscal years 2012 through 

7 2016’’. 

8 (2) VOLUNTEERS.—Section 2813 of the Public 

9 Health Service Act (42 U.S.C. 300hh–15) is amend10 ed— 

11 (A) in subsection (d)(2), by adding at the 

12 end the following: ‘‘Such training exercises 

13 shall, as appropriate and applicable, incorporate 

14 the needs of at-risk individuals in the event of 

15 a public health emergency.’’; and 

16 (B) in subsection (i), by striking 

17 ‘‘$22,000,000 for fiscal year 2007, and such 

18 sums as may be necessary for each of fiscal 

19 years 2008 through 2011’’ and inserting 

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

21 through 2016’’. 

22 (c) PARTNERSHIPS FOR STATE AND REGIONAL PRE23 PAREDNESS TO IMPROVE SURGE CAPACITY.—Section 

24 319C–2 of the Public Health Service Act (42 U.S.C. 

25 247d–3b) is amended— 


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1 (1) by striking subsection (c) and inserting the 

2 following: 

3 ‘‘(c) USE OF FUNDS.—An award under subsection 

4 (a) shall be expended for activities to achieve the prepared5 ness goals described under paragraphs (1), (3), (4), (5), 

6 and (6) of section 2802(b) with respect to all-hazards, in7 cluding chemical, biological, radiological, or nuclear 

8 threats.’’; 

9 (2) by striking subsection (g) and inserting the 

10 following: 

11 ‘‘(g) COORDINATION.— 

12 ‘‘(1) LOCAL RESPONSE CAPABILITIES.—An eli13 gible entity shall, to the extent practicable, ensure 

14 that activities carried out under an award under 

15 subsection (a) are coordinated with activities of rel16 evant local Metropolitan Medical Response Systems, 

17 local Medical Reserve Corps, the local Cities Readi18 ness Initiative, and local emergency plans. 

19 ‘‘(2) NATIONAL COLLABORATION.—Partner20 ships consisting of one or more eligible entities 

21 under this section may, to the extent practicable, 

22 collaborate with other partnerships consisting of one 

23 or more eligible entities under this section for pur24 poses of national coordination and collaboration with 

25 respect to activities to achieve the preparedness 


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1 goals described under paragraphs (1), (3), (4), (5), 

2 and (6) of section 2802(b).’’; and 

3 (3) in subsection (j)— 

4 (A) in paragraph (1), by striking 

5 ‘‘$474,000,000 for fiscal year 2007, and such 

6 sums as may be necessary for each of fiscal 

7 years 2008 through 2011’’ and inserting 

8 ‘‘$378,000,000 for each of fiscal years 2012 

9 through 2016’’; and 

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

11 ‘‘(4) AVAILABILITY OF COOPERATIVE AGREE12 MENT FUNDS.— 

13 ‘‘(A) IN GENERAL.—Amounts provided to 

14 an eligible entity under a cooperative agreement 

15 under subsection (a) for a fiscal year and re16 maining unobligated at the end of such year 

17 shall remain available to such entity for the 

18 next fiscal year for the purposes for which such 

19 funds were provided. 

20 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

21 BENCHMARKS.—The continued availability of 

22 funds under subparagraph (A) with respect to 

23 an entity shall be contingent upon such entity 

24 achieving the benchmarks and submitting the 


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1 pandemic influenza plan as required under sub2 section (i).’’. 

3 SEC. 203. ENHANCING SITUATIONAL AWARENESS AND BIO4 SURVEILLANCE. 

5 Section 319D of the Public Health Service Act (42 

6 U.S.C. 247d–4) is amended— 

7 (1) in subsection (b)— 

8 (A) in paragraph (1)(B), by inserting ‘‘poi9 son control centers,’’ after ‘‘hospitals,’’; 

10 (B) in paragraph (2), by inserting before 

11 the period the following: ‘‘, allowing for coordi12 nation to maximize all-hazards medical and 

13 public health preparedness and response and to 

14 minimize duplication of effort’’; and 

15 (C) in paragraph (3), by inserting before 

16 the period the following: ‘‘and update such 

17 standards as necessary’’; 

18 (2) in subsection (d)— 

19 (A) in the subsection heading, by striking 

20 ‘‘PUBLIC HEALTH SITUATIONAL AWARENESS’’ 

21 and inserting ‘‘MODERNIZING PUBLIC HEALTH

22 SITUATIONAL AWARENESS AND BIOSURVEIL23 LANCE’’; 

24 (B) in paragraph (1)— 


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1 (i) by striking ‘‘Pandemic and All2 Hazards Preparedness Act’’ and inserting 

3 ‘‘Pandemic and All-Hazards Preparedness 

4 Act Reauthorization of 2011’’; and 

5 (ii) by inserting ‘‘, novel emerging 

6 threats,’’ after ‘‘disease outbreaks’’; 

7 (C) by striking paragraph (2) and insert8 ing the following: 

9 ‘‘(2) STRATEGY AND IMPLEMENTATION

10 PLAN.—Not later than 180 days after the date of 

11 enactment of the Pandemic and All-Hazards Pre12 paredness Act Reauthorization of 2011, the Sec13 retary shall submit to the appropriate committees of 

14 Congress, a coordinated strategy and an accom15 panying implementation plan that identifies and 

16 demonstrates the measurable steps the Secretary will 

17 carry out to— 

18 ‘‘(A) develop, implement, and evaluate the 

19 network described in paragraph (1), utilizing 

20 the elements described in paragraph (3); and 

21 ‘‘(B) modernize and enhance biosurveil22 lance activities.’’; 

23 (D) in paragraph (5), by striking subpara24 graph (A) and inserting the following: 


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1 ‘‘(A) utilize applicable interoperability 

2 standards as determined by the Secretary, and 

3 in coordination with the Office of the National 

4 Coordinator for Health Information Tech5 nology, through a joint public and private sec6 tor process;’’; and 

7 (E) by adding at the end the following: 

8 ‘‘(6) CONSULTATION WITH THE NATIONAL BIO9 DEFENSE SCIENCE BOARD.—In carrying out this 

10 section consistent with section 319M, the National 

11 Biodefense Science Board shall provide expert advice 

12 and guidance, including recommendations, regarding 

13 the measurable steps the Secretary should take to 

14 modernize and enhance biosurveillance activities pur15 suant to the efforts of the Department of Health 

16 and Humans Services to ensure comprehensive, real17 time all-hazards biosurveillance capabilities. In com18 plying with the preceding sentence, the National 

19 Biodefense Science Board shall— 

20 ‘‘(A) identify the steps necessary to achieve 

21 a national biosurveillance system for human 

22 health, with international connectivity, where 

23 appropriate, that is predicated on State, re24 gional, and community level capabilities and 

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1 way information flow between and among Fed2 eral, State, and local government public health 

3 authorities and clinical health care providers; 

4 and 

5 ‘‘(B) identify any duplicative surveillance 

6 programs under the authority of the Secretary, 

7 or changes that are necessary to existing pro8 grams, in order to enhance and modernize such 

9 activities, minimize duplication, strengthen and 

10 streamline such activities under the authority of 

11 the Secretary, and achieve real-time and appro12 priate data that relate to disease activity, both 

13 human and zoonotic.’’; 

14 (3) in subsection (e)(5), by striking ‘‘4 years 

15 after the date of enactment of the Pandemic and 

16 All-Hazards Preparedness Act, the Government Ac17 countability Office’’ and inserting ‘‘3 years after the 

18 date of enactment of the Pandemic and All-Hazards 

19 Preparedness Act Reauthorization of 2011’’; 

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

21 may be necessary in each of fiscal years 2007 

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

23 each of fiscal years 2012 through 2016’’; and 

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


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1 ‘‘(h) DEFINITION.—For purposes of this section the 

2 term ‘biosurveillance’ means the process of gathering near 

3 real-time, biological data that relates to disease activity 

4 and threats to human or zoonotic health, in order to 

5 achieve early warning of such health threats, early detec6 tion of health events, and overall situational awareness of 

7 disease activity.’’. 

8 TITLE III—ENHANCING MEDICAL 

9 COUNTERMEASURE REVIEW 

10 SEC. 301. SPECIAL PROTOCOL ASSESSMENT. 

11 Section 505(b)(5)(B) of the Federal Food, Drug, and 

12 Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by 

13 striking ‘‘size of clinical trials intended’’ and all that fol14 lows through ‘‘. The sponsor or applicant’’ and inserting 

15 the following: ‘‘size— 

16 ‘‘(i)(I) of clinical trials intended to form the 

17 primary basis of an effectiveness claim; or 

18 ‘‘(II) in the case where human efficacy studies 

19 are not ethical or practicable, of animal and clinical 

20 trials which, in combination, are intended to form 

21 the primary basis of an effectiveness claim; or 

22 ‘‘(ii) with respect to an application for approval 

23 of a biological product under section 351(k) of the 

24 Public Health Service Act, of any necessary clinical 

25 study or studies. 


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1 The sponsor or applicant’’. 

2 SEC. 302. AUTHORIZED USE FOR MEDICAL PRODUCTS. 

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

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

5 (1) in the section heading, by striking ‘‘FOR

6 USE IN EMERGENCIES’’ and inserting ‘‘FOR USE

7 IN RESPONSE TO DECLARED EMERGENCY OR

8 IDENTIFIED MATERIAL THREAT’’; 

9 (2) in subsection (a)— 

10 (A) in paragraph (1)— 

11 (i) in the paragraph heading, by strik12 ing ‘‘EMERGENCY’’ and inserting ‘‘AU13 THORIZED’’; and 

14 (ii) by striking ‘‘(referred to in this 

15 section as an ‘emergency use’)’’ and insert16 ing ‘‘or with respect to a material threat 

17 (referred to in this section as an ‘author18 ized use’)’’; 

19 (B) in paragraph (2), by striking ‘‘an 

20 emergency use’’ and inserting ‘‘the use’’; 

21 (C) in paragraph (3), by striking ‘‘An 

22 emergency use authorized’’ and inserting ‘‘An 

23 authorized use’’; 

24 (D) by redesignating paragraph (4) as 

25 paragraph (5); 


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1 (E) by inserting after paragraph (3) the 

2 following: 

3 ‘‘(4) EXTENSION OF EXPIRATION DATE.— 

4 ‘‘(A) AUTHORITY TO EXTEND EXPIRATION

5 DATE.—The Secretary may extend the expira6 tion date of an approved product in accordance 

7 with this paragraph. 

8 ‘‘(B) EXPIRATION DATE.—For purposes of 

9 this paragraph, the term ‘expiration date’ 

10 means the date that appears on the label of an 

11 approved product to reflect the results of sta12 bility testing and to ensure that the product 

13 meets applicable standards of identity, strength, 

14 quality, and purity at the time of use. 

15 ‘‘(C) EFFECT OF EXTENSION.—If the expi16 ration date of an approved product is extended 

17 by the Secretary under this paragraph, then, 

18 notwithstanding any other provision of this Act, 

19 the extended expiration date shall not affect the 

20 approval status of the product or the authoriza21 tion of the product under this section. 

22 ‘‘(D) ELIGIBILITY.—A product shall be eli23 gible for extension of the expiration date of 

24 such product if— 


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1 ‘‘(i)(I) the product is intended for use 

2 to prevent, diagnose, or treat a disease or 

3 condition involving a biological, chemical, 

4 radiological, or nuclear agent or agents, in5 cluding a product intended to be used to 

6 prevent or treat pandemic influenza; or 

7 ‘‘(II) the product is intended for use 

8 to prevent, diagnose, or treat a serious or 

9 life-threatening disease or condition caused 

10 by a product described in subclause (I); 

11 and 

12 ‘‘(ii) the product is intended for use 

13 during the circumstances of an emergency 

14 or a material threat described in sub15 section (b)(1). 

16 ‘‘(E) DETERMINATIONS BY SECRETARY.— 

17 Before extending the expiration date of an ap18 proved product under this paragraph, the Sec19 retary shall determine— 

20 ‘‘(i) that extension of the expiration 

21 date will help protect public health; 

22 ‘‘(ii) that any extension of expiration 

23 is supported by scientific evaluation; and 

24 ‘‘(iii) what changes to the product la25 beling, if any, are required or permitted, 


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1 including whether and how any additional 

2 labeling communicating the extension of 

3 the expiration date may alter or obscure 

4 the labeling provided by the manufacturer. 

5 ‘‘(F) SCOPE OF EXTENSION.—With respect 

6 to each extension of an expiration date granted 

7 under this paragraph, the Secretary shall deter8 mine— 

9 ‘‘(i) the batch, lot, or unit to which 

10 such extension shall apply; 

11 ‘‘(ii) the duration of such extension; 

12 and 

13 ‘‘(iii) any conditions to effectuate such 

14 extension that are necessary and appro15 priate to protect public health or safety.’’; 

16 and 

17 (F) in paragraph (5)(B), as so redesig18 nated, by striking ‘‘emergency use’’ and insert19 ing ‘‘authorized use’’; 

20 (3) in subsection (b)— 

21 (A) in the subsection heading, by striking 

22 ‘‘EMERGENCY’’ and inserting ‘‘EMERGENCY OR

23 THREAT JUSTIFYING AUTHORIZED USE’’; 

24 (B) in paragraph (1)— 


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1 (i) in the matter preceding subpara2 graph (A), by striking ‘‘may declare an 

3 emergency’’ and inserting ‘‘may make a 

4 declaration that the circumstances exist’’; 

5 (ii) in subparagraph (B), by striking 

6 ‘‘; or’’ and inserting a semicolon; 

7 (iii) in subparagraph (C), by striking 

8 ‘‘national security’’ and all that follows 

9 through the period and inserting ‘‘national 

10 security, or the health and security of 

11 United States citizens living abroad, and 

12 that involves a specified biological, chem13 ical, radiological, or nuclear agent or 

14 agents, or a specified disease or condition 

15 that may be attributable to such agent or 

16 agents; or’’; and 

17 (iv) by adding at the end the fol18 lowing: 

19 ‘‘(D) the identification of a material threat 

20 pursuant to section 319F–2 of the Public 

21 Health Service Act sufficient to affect national 

22 security or the health and security of United 

23 States citizens living abroad.’’; 

24 (C) in paragraph (2)(A)— 


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1 (i) in clause (i), by striking ‘‘; or’’ and 

2 inserting a semicolon; 

3 (ii) by redesignating clause (ii) as 

4 clause (iii); and 

5 (iii) by inserting after clause (i) the 

6 following: 

7 ‘‘(ii) a change in the regulatory status 

8 of the product such that the circumstances 

9 described in subsection (a)(2) have ceased 

10 to exist; or’’; and 

11 (D) in paragraph (3)(B), by striking 

12 ‘‘emergency use’’ and inserting ‘‘authorized 

13 use’’; 

14 (4) in subsection (c)— 

15 (A) in the matter preceding paragraph 

16 (1)— 

17 (i) by striking ‘‘emergency use’’ and 

18 inserting ‘‘authorized use’’; 

19 (ii) by inserting ‘‘the Assistant Sec20 retary for Preparedness and Response,’’ 

21 after ‘‘consultation with’’; 

22 (iii) by striking ‘‘Health and’’ and in23 serting ‘‘Health, and’’; and 

24 (iv) by striking ‘‘circumstances of the 

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1 cable circumstances described in subsection 

2 (b)(1)’’; and 

3 (B) in paragraph (2)— 

4 (i) in the matter preceding subpara5 graph (A), by inserting ‘‘and the material 

6 threat posed by the agent or agents identi7 fied in a declaration under subsection 

8 (b)(1)(D), if applicable’’ after ‘‘if avail9 able,’’; and 

10 (ii) in subparagraph (B), by inserting 

11 ‘‘taking into consideration the material 

12 threat posed by the agent or agents identi13 fied in a declaration under subsection 

14 (b)(1)(D), if applicable’’ after ‘‘risks of the 

15 product,’’; 

16 (5) in subsection (e)(1)— 

17 (A) in subparagraph (A), in the matter 

18 preceding clause (i)— 

19 (i) by striking ‘‘emergency use’’ and 

20 inserting ‘‘authorized use’’; and 

21 (ii) by striking ‘‘circumstances of the 

22 emergency’’ and inserting ‘‘applicable cir23 cumstances described in subsection 

24 (b)(1)’’; 

25 (B) in subparagraph (A)(i)— 


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1 (i) in subclause (I), by striking ‘‘has 

2 authorized the emergency use’’ and insert3 ing ‘‘has authorized under this section the 

4 use’’; and 

5 (ii) in subclause (II), by striking 

6 ‘‘emergency use’’ and inserting ‘‘authorized 

7 use’’; 

8 (C) in subparagraph (A)(ii)(I), by striking 

9 ‘‘authorized the emergency use’’ and inserting 

10 ‘‘has authorized under this section the use’’; 

11 (D) in clauses (iii) and (iv) of subpara12 graph (A), by striking ‘‘emergency use’’ each 

13 place such term appears and inserting ‘‘author14 ized use’’; 

15 (E) in subparagraph (A), by adding at the 

16 end the following: 

17 ‘‘(v) Appropriate conditions with re18 spect to the collection and analysis of safe19 ty and effectiveness information useful to 

20 inform the approval, licensure, or clearance 

21 of the product, especially for a product for 

22 which human efficacy studies are not eth23 ical or practicable.’’; 

24 (F) in subparagraph (B)— 


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1 (i) by striking ‘‘emergency use’’ each 

2 place such term appears and inserting ‘‘au3 thorized use’’; 

4 (ii) by striking clause (iii); and 

5 (iii) by redesignating clause (iv) as 

6 clause (iii); 

7 (6) in subsection (e)— 

8 (A) in paragraph (2)— 

9 (i) by striking ‘‘emergency use’’ each 

10 place such term appears and inserting ‘‘au11 thorized use’’; and 

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

13 ‘‘circumstances of the emergency’’ and in14 serting ‘‘applicable circumstances described 

15 in subsection (b)(1)’’; 

16 (B) in paragraph (3)— 

17 (i) by striking ‘‘emergency use’’ and 

18 inserting ‘‘use’’; and 

19 (ii) by striking ‘‘circumstances of the 

20 emergency’’ and inserting ‘‘applicable cir21 cumstances described in subsection 

22 (b)(1)’’; and 

23 (C) in paragraph (4), by striking ‘‘emer24 gency use’’ and inserting ‘‘use’’; 

25 (7) in subsection (g)— 


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1 (A) in the subsection heading, by inserting 

2 ‘‘REVIEW AND’’ before ‘‘REVOCATION’’; 

3 (B) in paragraph (1), by inserting after 

4 the period at the end the following: ‘‘As part of 

5 such review, the Secretary shall regularly review 

6 the progress made with respect to the approval, 

7 licensure, or clearance of— 

8 ‘‘(A) an unapproved product for which an 

9 authorization was issued under this section; or 

10 ‘‘(B) an unapproved use of an approved 

11 product for which an authorization was issued 

12 under this section.’’; and 

13 (C) by amending paragraph (2) to read as 

14 follows: 

15 ‘‘(2) REVISION AND REVOCATION.—The Sec16 retary may revise or revoke an authorization under 

17 this section if— 

18 ‘‘(A) the circumstances described under 

19 subsection (b)(1) no longer exist; 

20 ‘‘(B) the criteria under subsection (c) for 

21 issuance of such authorization are no longer 

22 met; or 

23 ‘‘(C) other circumstances make such revi24 sion or revocation appropriate to protect the 

25 public health or safety.’’; and 


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1 (8) in subsection (h)(1), by inserting ‘‘, revi2 sion,’’ after ‘‘termination’’. 

3 SEC. 303. DEFINITIONS. 

4 Section 565 of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 360bbb–4) is amended by striking ‘‘The 

6 Secretary, in consultation’’ and inserting the following: 

7 ‘‘(a) DEFINITIONS.—In this section— 

8 ‘‘(1) the term ‘countermeasure’ means a quali9 fied countermeasure, a security countermeasure, and 

10 a qualified pandemic or epidemic product; 

11 ‘‘(2) the term ‘qualified countermeasure’ has 

12 the meaning given such term in section 319F–1 of 

13 the Public Health Service Act; 

14 ‘‘(3) the term ‘qualified pandemic or epidemic 

15 product’ has the meaning given such term in section 

16 319F–3 of such Act; and 

17 ‘‘(4) the term ‘security countermeasure’ has the 

18 meaning given such term in section 319F–2 of such 

19 Act. 

20 ‘‘(b) GENERAL DUTIES.—The Secretary, in consulta21 tion’’. 


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1 SEC. 304. ENHANCING MEDICAL COUNTERMEASURE AC2 TIVITIES. 

3 Section 565 of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 360bbb–4), as amended by section 303, 

5 is further amended— 

6 (1) in the section heading, by striking ‘‘TECH7 NICAL ASSISTANCE’’ and inserting ‘‘COUNTER8 MEASURE DEVELOPMENT, REVIEW, AND TECH9 NICAL ASSISTANCE’’; 

10 (2) in subsection (b), by striking the subsection 

11 heading and all that follows through ‘‘shall estab12 lish’’ and inserting the following: 

13 ‘‘(b) GENERAL DUTIES.—The Secretary, in consulta14 tion with the Assistant Secretary for Preparedness and 

15 Response, shall accelerate the development, stockpiling, 

16 approval, licensure, and clearance of qualified counter17 measures, security countermeasures, and qualified pan18 demic or epidemic products— 

19 ‘‘(1) by ensuring the appropriate involvement of 

20 Food and Drug Administration personnel in inter21 agency activities related to countermeasure advanced 

22 research and development, consistent with sections 

23 319F, 319F–1, 319F–2, 319F–3, and 319L of the 

24 Public Health Service Act; 

25 ‘‘(2) by ensuring the appropriate involvement 

26 and consultation of Food and Drug Administration 


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1 personnel in any flexible manufacturing activities 

2 carried out under section 319L of the Public Health 

3 Service Act, including with respect to meeting regu4 latory requirements set forth in this Act; 

5 ‘‘(3) by promoting countermeasure expertise 

6 within the Food and Drug Administration by— 

7 ‘‘(A) ensuring that Food and Drug Admin8 istration personnel involved in reviewing coun9 termeasures for approval, licensure, or clear10 ance are informed by the Assistant Secretary 

11 for Preparedness and Response on the material 

12 threat assessment conducted under section 

13 319F–2 of the Public Health Service Act for 

14 the agent or agents for which the counter15 measure under review is intended; 

16 ‘‘(B) training Food and Drug Administra17 tion personnel regarding review of counter18 measures for approval, licensure, or clearance; 

19 and 

20 ‘‘(C) establishing protocols to ensure that 

21 countermeasure reviewers have sufficient train22 ing or experience with countermeasures; 

23 ‘‘(4) by maintaining teams, composed of Food 

24 and Drug Administration personnel with expertise 

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1 measures, classes or groups of countermeasures, or 

2 other countermeasure-related technologies and capa3 bilities), that shall— 

4 ‘‘(A) work with countermeasure sponsors 

5 and applicants to identify and help resolve sci6 entific issues related to the approval, licensure, 

7 or clearance of countermeasures; 

8 ‘‘(B) encourage the exchange of scientific 

9 ideas by holding public meetings at least twice 

10 annually; and 

11 ‘‘(C) improve and advance the science re12 lating to the development of new tools, stand13 ards, and approaches to assessing and evalu14 ating countermeasures— 

15 ‘‘(i) in order to inform the process for 

16 countermeasure approval, clearance, and li17 censure; and 

18 ‘‘(ii) with respect to the development 

19 of countermeasures for populations with 

20 special clinical needs, including children 

21 and pregnant women, in order to meet the 

22 needs of such populations, as necessary 

23 and appropriate; and 

24 ‘‘(5) by establishing’’; and 

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


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1 ‘‘(c) DEVELOPMENT AND ANIMAL MODELING PRO2 CEDURES.— 

3 ‘‘(1) AVAILABILITY OF ANIMAL MODEL MEET4 INGS.—To facilitate the timely development of ani5 mal models and support the development, stock6 piling, licensure, approval, and clearance of counter7 measures, the Secretary shall, not later than 180 

8 days after the enactment of this subsection, establish 

9 a procedure by which a sponsor or applicant that is 

10 developing a countermeasure for which human effi11 cacy studies are not ethical or practicable, and that 

12 has an approved investigational new drug application 

13 or investigational device exemption, may request and 

14 receive— 

15 ‘‘(A) a meeting to discuss proposed animal 

16 model development activities; and 

17 ‘‘(B) a meeting prior to initiating pivotal 

18 animal studies. 

19 ‘‘(2) JUVENILE MODELS.—To facilitate the de20 velopment and selection of animal models that could 

21 translate to juvenile studies, any meeting conducted 

22 under paragraph (1) shall include discussion of juve23 nile animal models, as appropriate. 

24 ‘‘(d) REVIEW AND APPROVAL OF COUNTER25 MEASURES.— 


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1 ‘‘(1) MATERIAL THREAT.—When evaluating an 

2 application or submission for approval, licensure, or 

3 clearance of a countermeasure, the Secretary shall 

4 take into account the material threat posed by the 

5 chemical, biological, radiological, or nuclear agent or 

6 agents identified under section 319F–2 of the Public 

7 Health Service Act for which the countermeasure 

8 under review is intended. 

9 ‘‘(2) REVIEW EXPERTISE.—When practicable 

10 and appropriate, teams of Food and Drug Adminis11 tration personnel reviewing applications or submis12 sions described under paragraph (1) shall include a 

13 reviewer with sufficient training or experience with 

14 countermeasures pursuant to the protocols estab15 lished under subsection (b)(3)(C).’’. 

16 SEC. 305. REGULATORY MANAGEMENT PLANS. 

17 Section 565 of the Federal Food, Drug, and Cosmetic 

18 Act (21 U.S.C. 360bbb–4), as amended by section 304, 

19 is further amended by adding at the end the following: 

20 ‘‘(e) REGULATORY MANAGEMENT PLAN.— 

21 ‘‘(1) IN GENERAL.— 

22 ‘‘(A) INITIATION OF PROCESS.—The Sec23 retary, in consultation with the Assistant Sec24 retary for Preparedness and Response and the 

25 product sponsor or applicant, shall initiate a 


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1 formal process for obtaining scientific feedback 

2 and interactions regarding the development and 

3 regulatory review of any countermeasure. 

4 ‘‘(B) CONTENT.— 

5 ‘‘(i) IN GENERAL.—The process initi6 ated under subparagraph (A) shall include 

7 the development of a written regulatory 

8 management plan that shall be made part 

9 of the administrative record. Except as 

10 provided in paragraph (2), such plan shall 

11 be completed not later than 45 days after 

12 the date on which an investigational new 

13 drug application or investigational device 

14 exemption is approved with respect to the 

15 countermeasure involved. 

16 ‘‘(ii) CONTENT OF PLAN.—The con17 tent of a regulatory management plan 

18 under clause (i) shall be consistent with 

19 sections 319L and 319F–2 of the Public 

20 Health Service Act. Such plan shall in21 clude— 

22 ‘‘(I) guidance from the Secretary 

23 regarding the data required to sup24 port the approval, clearance, or licen25 sure of the countermeasure involved; 


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1 ‘‘(II) guidance from the Sec2 retary regarding the data necessary to 

3 inform any authorization under sec4 tion 564; 

5 ‘‘(III) guidance from the Sec6 retary regarding the data necessary to 

7 support the positioning and delivery of 

8 countermeasures, including to the 

9 Strategic National Stockpile; 

10 ‘‘(IV) guidance from the Sec11 retary regarding the data necessary to 

12 support the submission of protocols 

13 for review under section 505(b)(5)(B); 

14 ‘‘(V) an agreement between the 

15 Secretary and the countermeasure 

16 sponsor or applicant regarding devel17 opmental milestones that will trigger 

18 responses by the Secretary as de19 scribed in subclause (VI); 

20 ‘‘(VI) performance targets and 

21 goals for timely and appropriate re22 sponses by the Secretary to the trig23 gers described under subclause (V), 

24 including meetings between the Sec25 retary and the sponsor or applicant, 


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1 written feedback, decisions by the Sec2 retary, and other activities carried out 

3 as part of the development and review 

4 process; 

5 ‘‘(VII) guidance from the Sec6 retary regarding any gaps in scientific 

7 knowledge that will need resolution 

8 prior to countermeasure approval, li9 censure, or clearance, and plans for 

10 conducting the necessary scientific re11 search; 

12 ‘‘(VIII) identification of the pop13 ulation for which the countermeasure 

14 sponsor or applicant seeks approval, 

15 licensure, or clearance, and the popu16 lation for which desired labeling would 

17 not be appropriate, if known; and 

18 ‘‘(IX) as necessary and appro19 priate, and to the extent practicable, a 

20 plan for developing pediatric dosing 

21 and administration with respect to the 

22 countermeasure. 

23 ‘‘(iii) MODIFICATION OF PLAN.—Not 

24 later than 45 days after the Secretary be25 comes aware of a new substantial scientific 


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1 issue essential to the review of a counter2 measure, the Secretary shall— 

3 ‘‘(I) determine, in consultation 

4 with the countermeasure sponsor or 

5 applicant, if such issue necessitates a 

6 modification to the regulatory man7 agement plan; and 

8 ‘‘(II) if the Secretary so deter9 mines, make such modification. 

10 ‘‘(2) COUNTERMEASURES UNDER REVIEW.— 

11 ‘‘(A) IN GENERAL.—Not later than 45 

12 days after the date of enactment of this sub13 section, the Secretary shall establish a proce14 dure for developing regulatory management 

15 plans for countermeasures that are under re16 view by the Food and Drug Administration as 

17 of the date of enactment of this subsection. 

18 Subject to subparagraph (B), the regulatory 

19 management plans for all such countermeasures 

20 shall be developed not later than 274 days after 

21 the date of enactment of this subsection. 

22 ‘‘(B) EXCEPTION.—The sponsor or appli23 cant with respect to a countermeasure described 

24 subparagraph (A) may elect not to establish a 

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1 section. Such sponsor or applicant shall notify 

2 the Secretary of such an election not later than 

3 30 days after the Secretary makes the proce4 dures established under subparagraph (A) pub5 licly available. If notification of such an election 

6 is not received by the Secretary by such date, 

7 the procedures established under subparagraph 

8 (A) shall apply to the countermeasure.’’. 

9 SEC. 306. REPORT. 

10 Section 565 of the Federal Food, Drug, and Cosmetic 

11 Act (21 U.S.C. 360bbb–4), as amended by section 305, 

12 is further amended by adding at the end the following: 

13 ‘‘(f) ANNUAL REPORT.—Not later than 180 days 

14 after the date of enactment of this subsection, and annu15 ally thereafter, the Secretary shall submit to the Com16 mittee on Health, Education, Labor, and Pensions of the 

17 Senate and the Committee on Energy and Commerce of 

18 the House of Representatives a report that details the 

19 countermeasure development and review activities of the 

20 Food and Drug Administration, including— 

21 ‘‘(1) with respect to the development of new 

22 tools, standards, and approaches to assess and 

23 evaluate countermeasures— 


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1 ‘‘(A) the identification of the priorities of 

2 the Food and Drug Administration and the 

3 progress made on such priorities; and 

4 ‘‘(B) the identification of scientific gaps 

5 that impede the development or approval, licen6 sure, or clearance of countermeasures for popu7 lations with special clinical needs, including 

8 children and pregnant women, and the progress 

9 made on resolving these challenges; 

10 ‘‘(2) the extent to which the performance tar11 gets and goals set forth in subsection (e)(1)(B) and 

12 the regulatory management plans established under 

13 such subsection have been met, including, for each 

14 countermeasure reviewed— 

15 ‘‘(A) whether the regulatory management 

16 plan was completed within the required time17 frame, and the length of time taken to complete 

18 such plan; 

19 ‘‘(B) whether the Secretary adhered to the 

20 timely and appropriate response times set forth 

21 in such plan; and 

22 ‘‘(C) explanations for any failure to meet 

23 such performance targets and goals; 

24 ‘‘(3) the number of regulatory teams estab25 lished pursuant to subsection (b)(4) and the number 


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1 of products, classes of products, or technologies as2 signed to each such team; 

3 ‘‘(4) an estimate of resources obligated to coun4 termeasure development and regulatory assessment, 

5 including Center specific objectives and accomplish6 ments; and 

7 ‘‘(5) the number of countermeasure applications 

8 submitted, the number of countermeasures approved, 

9 licensed, or cleared, the status of remaining sub10 mitted applications, and the number of each type of 

11 authorization issued pursuant to section 564.’’. 

12 SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES. 

13 (a) PEDIATRIC STUDIES OF DRUGS.—Section 505A 

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

15 355a) is amended— 

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

17 following: 

18 ‘‘(5) CONSULTATION.—With respect to a drug 

19 that is a qualified countermeasure (as defined in sec20 tion 319F–1 of the Public Health Service Act), a se21 curity countermeasure (as defined in section 319F– 

22 2 of the Public Health Service Act), or a qualified 

23 pandemic or epidemic product (as defined in section 

24 319F–3 of the Public Health Service Act), the Sec25 retary shall solicit input from the Assistant SecVerDate Mar 15 2010 04:25 Nov 15, 2011 Jkt 019200 PO 00000 Frm 00050 Fmt 6652 Sfmt 6201 E:\BILLS\S1855.IS S1855

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1 retary for Preparedness and Response regarding the 

2 need for and conduct of pediatric studies under this 

3 section.’’; and 

4 (2) in subsection (n)(1), by adding at the end 

5 the following: 

6 ‘‘(C) For a drug that is a qualified coun7 termeasure (as defined in section 319F–1 of the 

8 Public Health Service Act), a security counter9 measure (as defined in section 319F–2 of the 

10 Public Health Service Act), or a qualified pan11 demic or epidemic product (as defined in sec12 tion 319F–3 of such Act), prior to any action 

13 with respect to such drug under subparagraph 

14 (A) or (B), the Secretary shall refer all pedi15 atric studies in the written request to the As16 sistant Secretary for Preparedness and Re17 sponse and the Director of the Biomedical Ad18 vanced Research and Development Authority.’’. 

19 (b) ADDITION TO PRIORITY LIST CONSIDER20 ATIONS.—Section 409I of the Public Health Service Act 

21 (42 U.S.C. 284m) is amended— 

22 (1) by striking subsection (a)(2) and inserting 

23 the following: 


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1 ‘‘(2) CONSIDERATION OF AVAILABLE INFORMA2 TION.—In developing and prioritizing the list under 

3 paragraph (1), the Secretary— 

4 ‘‘(A) shall consider— 

5 ‘‘(i) therapeutic gaps in pediatrics 

6 that may include developmental pharma7 cology, pharmacogenetic determinants of 

8 drug response, metabolism of drugs and 

9 biologics in children, and pediatric clinical 

10 trials; 

11 ‘‘(ii) particular pediatric diseases, dis12 orders or conditions where more complete 

13 knowledge and testing of therapeutics, in14 cluding drugs and biologics, may be bene15 ficial in pediatric populations; and 

16 ‘‘(iii) the adequacy of necessary infra17 structure to conduct pediatric pharma18 cological research, including research net19 works and trained pediatric investigators; 

20 and 

21 ‘‘(B) may consider the availability of quali22 fied countermeasures (as defined in section 

23 319F–1), security countermeasures (as defined 

24 in section 319F–2), and qualified pandemic or 

25 epidemic products (as defined in section 319F– 


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1 3) to address the needs of pediatric populations, 

2 in consultation with the Assistant Secretary for 

3 Preparedness and Response, consistent with the 

4 purposes of this section.’’; and 

5 (2) in subsection (b), by striking ‘‘subsection 

6 (a)’’ and inserting ‘‘paragraphs (1) and (2)(A) of 

7 subsection (a)’’. 

8 (c) ADVICE AND RECOMMENDATIONS OF THE PEDI9 ATRIC ADVISORY COMMITTEE REGARDING COUNTER10 MEASURES FOR PEDIATRIC POPULATIONS.—Subsection 

11 (b)(2) of section 14 of the Best Pharmaceuticals for Chil12 dren Act (42 U.S.C. 284m note) is amended— 

13 (1) in subparagraph (C), by striking the period 

14 and inserting ‘‘; and’’; and 

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

16 ‘‘(D) the development of countermeasures 

17 (as defined in section 565(a) of the Federal 

18 Food, Drug, and Cosmetic Act) for pediatric 

19 populations.’’. 

20 SEC. 308. TECHNICAL AND CONFORMING AMENDMENTS. 

21 (a) Section 319F–2(c)(1)(B)(ii) of the Public Health 

22 Service Act (42 U.S.C. 247d–6b(c)(1)(B)(ii)) is amended 

23 by striking ‘‘emergency’’. 

24 (b) Section 319F–3(i) of such Act (42 U.S.C. 247d– 

25 6d(i)) is amended— 


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1 (1) in paragraph (1)(C), by striking ‘‘emer2 gency’’; and 

3 (2) in paragraph (7)(B)(iii), by striking ‘‘emer4 gency’’. 

5 TITLE IV—ACCELERATING MED6 ICAL COUNTERMEASURE AD7 VANCED RESEARCH AND DE8 VELOPMENT 

9 SEC. 401. BIOSHIELD. 

10 (a) REAUTHORIZATION OF THE SPECIAL RESERVE

11 FUND.—Section 319F–2(c) of the Public Health Service 

12 Act (42 U.S.C. 247d-6b(c)) is amended by adding at the 

13 end the following: 

14 ‘‘(11) REAUTHORIZATION OF THE SPECIAL RE15 SERVE FUND.—In addition to amounts otherwise ap16 propriated, there are authorized to be appropriated 

17 for the special reserve fund, $2,800,000,000 for the 

18 fiscal years 2014 through 2018. 

19 ‘‘(12) REPORT.—Not later than 30 days after 

20 any date on which the Secretary determines that the 

21 amount of funds in the special reserve fund available 

22 for procurement is less than $1,500,000,000, the 

23 Secretary shall submit to the appropriate committees 

24 of Congress a report detailing the amount of such 


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1 funds available for procurement and the impact such 

2 reduction in funding will have— 

3 ‘‘(A) in meeting the security counter4 measure needs identified under this section; and 

5 ‘‘(B) on the annual Public Health Emer6 gency Medical Countermeasures Enterprise and 

7 Strategy Implementation Plan (pursuant to sec8 tion 2811(d)).’’. 

9 (b) PROCUREMENT OF COUNTERMEASURES.—Sec10 tion 319F–2(c) of the Public Health Service Act (42 

11 U.S.C. 247d–6b(c)) is amended— 

12 (1) in paragraph (1)(B)(i)(III)(bb), by striking 

13 ‘‘eight years’’ and inserting ‘‘10 years’’; 

14 (2) in paragraph (5)(B)(ii), by striking ‘‘eight 

15 years’’ and inserting ‘‘10 years’’; 

16 (3) in paragraph (7)(C)— 

17 (A) in clause (i)(I), by inserting ‘‘including 

18 advanced research and development,’’ after ‘‘as 

19 may reasonably be required,’’; 

20 (B) in clause (ii)— 

21 (i) in subclause (III), by striking 

22 ‘‘eight years’’ and inserting ‘‘10 years’’; 

23 and 

24 (ii) by striking subclause (IX) and in25 serting the following: 


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1 ‘‘(IX) CONTRACT TERMS.—The 

2 Secretary, in any contract for procure3 ment under this section— 

4 ‘‘(aa) may specify— 

5 ‘‘(AA) the dosing and 

6 administration requirements 

7 for the countermeasure to be 

8 developed and procured; 

9 ‘‘(BB) the amount of 

10 funding that will be dedi11 cated by the Secretary for 

12 advanced research, develop13 ment, and procurement of 

14 the countermeasure; and 

15 ‘‘(CC) the specifications 

16 the countermeasure must 

17 meet to qualify for procure18 ment under a contract under 

19 this section; and 

20 ‘‘(bb) shall provide a clear 

21 statement of defined Government 

22 purpose limited to uses related to 

23 a security countermeasure, as de24 fined in paragraph (1)(B).’’; and 

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


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1 ‘‘(viii) FLEXIBILITY.—In carrying out 

2 this section, the Secretary may, consistent 

3 with the applicable provisions of this sec4 tion, enter into contracts and other agree5 ments that are in the best interest of the 

6 Government in meeting identified security 

7 countermeasure needs, including with re8 spect to reimbursement of the cost of ad9 vanced research and development as an al10 lowable and allocable direct cost of the 

11 contract involved.’’; 

12 (4) in paragraph (9)(B), by inserting before the 

13 period the following: ‘‘, except that this subpara14 graph shall not be construed to prohibit the use of 

15 such amounts as otherwise authorized in this title’’; 

16 and 

17 (5) in paragraph (10), by adding at the end the 

18 following: 

19 ‘‘(C) ADVANCED RESEARCH AND DEVELOP20 MENT.—For purposes of this paragraph, the 

21 term ‘advanced research and development’ shall 

22 have the meaning given such term in section 

23 319L(a).’’. 


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1 SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVEL2 OPMENT AUTHORITY. 

3 (a) DUTIES.—Section 319L(c)(4) of the Public 

4 Health Service Act (42 U.S.C. 247d–7e(c)(4)) is amend5 ed— 

6 (1) in subparagraph (B)(iii), by inserting 

7 ‘‘(which may include advanced research and develop8 ment for purposes of fulfilling requirements under 

9 the Federal Food, Drug, and Cosmetic Act or sec10 tion 351 of this Act)’’ after ‘‘development’’; and 

11 (2) in subparagraph (D)(iii), by striking ‘‘and 

12 vaccine manufacturing technologies’’ and inserting 

13 ‘‘vaccine manufacturing technologies, dose sparing 

14 technologies, efficacy increasing technologies, and 

15 platform technologies’’. 

16 (b) TRANSACTION AUTHORITIES.—Section 

17 319L(c)(5) of the Public Health Service Act (42 U.S.C. 

18 247d–7e(c)(5)) is amended by adding at the end the fol19 lowing: 

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 (c) FUND.—Paragraph (2) of section 319L(d) of the 

4 Public Health Service Act (42 U.S.C. 247d–7e(d)(2)) is 

5 amended to read as follows: 

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

7 this section, there is authorized to be appropriated 

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

9 2012 through 2016, such amounts to remain avail10 able until expended.’’. 

11 (d) CONTINUED INAPPLICABILITY OF CERTAIN PRO12 VISIONS.—Section 319L(e)(1)(C) of the Public Health 

13 Service Act (42 U.S.C. 247d–7e(e)(1)(C)) is amended by 

14 striking ‘‘7 years’’ and inserting ‘‘10 years’’. 

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

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

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

19 (f) INDEPENDENT EVALUATION.—Section 319L of 

20 the Public Health Service Act (42 U.S.C. 247d–7e) is 

21 amended by adding at the end the following: 

22 ‘‘(f) INDEPENDENT EVALUATION.— 

23 ‘‘(1) IN GENERAL.—Not later than 180 days 

24 after the date of enactment of this subsection, the 

25 Government Accountability Office shall conduct an 


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1 independent evaluation of the activities carried out 

2 to facilitate flexible manufacturing capacity pursu3 ant to this section. 

4 ‘‘(2) REPORT.—Not later than 1 year after the 

5 date of enactment of this subsection, the Govern6 ment Accountability Office shall submit to the ap7 propriate committees of Congress a report con8 cerning the results of the evaluation conducted 

9 under paragraph (1). Such report shall review and 

10 assess— 

11 ‘‘(A) the extent to which flexible manufac12 turing capacity under this section is dedicated 

13 to chemical, biological, radiological, and nuclear 

14 threats; 

15 ‘‘(B) the activities supported by flexible 

16 manufacturing initiatives; and 

17 ‘‘(C) the ability of flexible manufacturing 

18 activities carried out under this section to— 

19 ‘‘(i) secure and leverage leading tech20 nical expertise with respect to counter21 measure advanced research, development, 

22 and manufacturing processes; and 

23 ‘‘(ii) meet the surge manufacturing 

24 capacity needs presented by novel and 


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1 emerging threats, including chemical, bio2 logical, radiological and nuclear agents.’’. 

3 (g) DEFINITIONS.— 

4 (1) QUALIFIED COUNTERMEASURE.—Section 

5 319F–1(a)(2)(A) of the Public Health Service Act 

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

7 (A) in the matter preceding clause (i), by 

8 striking ‘‘to—’’ and inserting ‘‘—’’; 

9 (B) in clause (i)— 

10 (i) by striking ‘‘diagnose’’ and insert11 ing ‘‘to diagnose’’; and 

12 (ii) by striking ‘‘; or’’ and inserting a 

13 semicolon; 

14 (C) in clause (ii)— 

15 (i) by striking ‘‘diagnose’’ and insert16 ing ‘‘to diagnose’’; and 

17 (ii) by striking the period at the end 

18 and inserting ‘‘; or’’; and 

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

20 ‘‘(iii) is a product or technology in21 tended to enhance the purpose of a drug, 

22 biological product, or device described in 

23 clause (i) or (ii).’’. 

24 (2) QUALIFIED PANDEMIC OR EPIDEMIC PROD25 UCT.—Section 319F–3(i)(7)(A) of the Public Health 


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1 Service Act (42 U.S.C. 247d–6d(i)(7)(A)) is amend2 ed— 

3 (A) in clause (i)(II), by striking ‘‘; or’’ and 

4 inserting ‘‘;’’; 

5 (B) in clause (ii), by striking ‘‘; and’’ and 

6 inserting ‘‘; or’’; and 

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

8 ‘‘(B) a product or technology intended to 

9 enhance the purpose of a drug, biological prod10 uct, or device described in clause (i) or (ii); 

11 and’’. 

12 SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

13 Section 319F–2 of the Public Health Service Act (42 

14 U.S.C. 247d–6b) is amended— 

15 (1) in subsection (a)— 

16 (A) in paragraph (1)— 

17 (i) by inserting ‘‘consistent with sec18 tion 2811’’ before ‘‘by the Secretary to be 

19 appropriate’’; and 

20 (ii) by inserting before the period at 

21 the end the following: ‘‘and shall submit 

22 such review annually to the appropriate 

23 Congressional committees of jurisdiction to 

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1 tion does not compromise national secu2 rity’’; and 

3 (B) in paragraph (2)— 

4 (i) by redesignating subparagraphs 

5 (E) through (H) as subparagraphs (F) 

6 through (I), respectively; and 

7 (ii) by inserting after subparagraph 

8 (D), the following: 

9 ‘‘(E) identify and address the potential de10 pletion and ensure appropriate replenishment of 

11 medical countermeasures, including those cur12 rently in the stockpile;’’; and 

13 (2) in subsection (f)(1), by striking 

14 ‘‘$640,000,000 for fiscal year 2002, and such sums 

15 as may be necessary for each of fiscal years 2003 

16 through 2006’’ and inserting ‘‘$522,486,000 for 

17 each of fiscal years 2012 through 2016’’. 

18 SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD. 

19 Section 319M(a) of the Public Health Service Act (42 

20 U.S.C. 247d–f(a)) is amended— 

21 (1) in paragraph (2)— 

22 (A) in subparagraph (D)— 

23 (i) in the matter preceding clause (i), 

24 by striking ‘‘five’’ and inserting ‘‘six’’; 


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1 (ii) in clause (i), by striking ‘‘and’’ at 

2 the end; 

3 (iii) in clause (ii), by striking the pe4 riod and inserting a semicolon; and 

5 (iv) by adding at the end the fol6 lowing: 

7 ‘‘(iii) one such member shall be an in8 dividual with pediatric subject matter ex9 pertise; and 

10 ‘‘(iv) one such member shall be a 

11 State, tribal, territorial, or local public 

12 health official.’’; and 

13 (B) by adding at the end the following 

14 flush sentence: 

15 ‘‘Nothing in this paragraph shall preclude a member 

16 of the Board from satisfying two or more of the re17 quirements described in subparagraph (D).’’; 

18 (2) in paragraph (5)— 

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

20 ‘‘and’’ at the end; 

21 (B) in subparagraph (C), by striking the 

22 period and inserting ‘‘; and’’; and 

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

24 ‘‘(D) provide any recommendation, finding, 

25 or report provided to the Secretary under this 


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1 paragraph to the appropriate committees of 

2 Congress.’’; and 

3 (3) in paragraph (8), by adding at the end the 

4 following: ‘‘Such chairperson shall serve as the de5 ciding vote in the event that a deciding vote is nec6 essary with respect to voting by members of the 

7 Board.’’. 

Æ 


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