II 

Calendar No. 263 

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, Mr. ROBERTS, and Mr. BENNET) introduced the following bill; which was read 

twice and referred to the Committee on Health, Education, Labor, and 

Pensions 

DECEMBER 16, 2011 

Reported by Mr. HARKIN, with an amendment 

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

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, 


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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

3 ‘‘Pandemic and All-Hazards Preparedness Act Reauthor4 ization of 2011’’. 

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

6 this Act is as follows: 

Sec. 1. Short title; table of contents. 

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. 


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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)— 

12 (i) in the matter preceding subpara13 graph (A), by inserting ‘‘and which may 

14 include dental health facilities’’ after 

15 ‘‘mental health facilities’’; and 

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

17 ‘‘(which may include such dental health as18 sets)’’ after ‘‘medical assets’’; 

19 (B) in paragraph (4)— 

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

21 ‘‘, including the unique needs and consider22 ations of individuals with disabilities,’’ 

23 after ‘‘medical needs of at-risk individ24 uals’’; and 


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

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

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

4 ‘‘(7) COUNTERMEASURES.— 

5 ‘‘(A) Promoting strategic initiatives to ad6 vance countermeasures to diagnose, mitigate, 

7 prevent, or treat harm from any biological 

8 agent or toxin, chemical, radiological, or nuclear 

9 agent or agents. 

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

11 term ‘countermeasures’ has the same meaning 

12 as the terms ‘qualified countermeasures’ under 

13 section 319F–1, ‘qualified pandemic and epi14 demic products’ under section 319F–3, and ‘se15 curity countermeasures’ under section 319F–2. 

16 ‘‘(8) MEDICAL AND PUBLIC HEALTH COMMU17 NITY RESILIENCY.—Strengthening the ability of 

18 State and local communities to prepare for, respond 

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

20 emergencies, whether naturally occurring, uninten21 tional, or deliberate by— 

22 ‘‘(A) optimizing alignment and integration 

23 of medical and public health preparedness and 

24 response planning and capabilities with and into 

25 routine daily activities; and 


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1 ‘‘(B) promoting familiarity with local med2 ical and public health systems.’’. 

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

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

5 amended— 

6 (1) by striking paragraph (7); 

7 (2) by redesignating paragraphs (1) through 

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

9 respectively; 

10 (3) by inserting before paragraph (2) (as so re11 designated), the following: 

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

13 they relate to medical and public health prepared14 ness and response for at-risk individuals in the event 

15 of a public health emergency declared by the Sec16 retary under section 319;’’; and 

17 (4) by inserting after paragraph (7) (as so re18 designated), the following: 

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

20 novel and best practices of outreach to and care of 

21 at-risk individuals before, during, and following pub22 lic health emergencies in as timely a manner as is 

23 practicable, including from the time a public health 

24 threat is identified; 


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1 ‘‘(9) ensure that public health and medical in2 formation distributed by the Department of Health 

3 and Human Services during a public health emer4 gency is delivered in a manner that takes into ac5 count the range of communication needs of the in6 tended recipients, including at-risk individuals; and’’. 

7 SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

8 RESPONSE. 

9 Section 2811 of the Public Health Service Act (42 

10 U.S.C. 300hh–10) is amended— 

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

12 the following: 

13 ‘‘(D) POLICY COORDINATION AND STRA14 TEGIC DIRECTION.—Provide integrated policy 

15 coordination and strategic direction with re16 spect to all matters related to Federal public 

17 health and medical preparedness and execution 

18 and deployment of the Federal response for 

19 public health emergencies and incidents covered 

20 by the National Response Plan developed pur21 suant to section 502(6) of the Homeland Secu22 rity Act of 2002, or any successor plan, before, 

23 during, and following public health emer24 gencies.’’; 


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

2 following: 

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

5 ‘‘(1) have authority over and responsibility 

6 for— 

7 ‘‘(A) the National Disaster Medical System 

8 (in accordance with section 301 of the Pan9 demic and All-Hazards Preparedness Act); 

10 ‘‘(B) the Hospital Preparedness Coopera11 tive Agreement Program pursuant to section 

12 319C–2; 

13 ‘‘(C) the Medical Reserve Corps pursuant 

14 to section 2813; 

15 ‘‘(D) the Emergency System for Advance 

16 Registration of Volunteer Health Professionals 

17 pursuant to section 319I; and 

18 ‘‘(E) administering grants and related au19 thorities related to trauma care under parts A 

20 through C of title XII, such authority to be 

21 transferred by the Secretary from the Adminis22 trator of the Health Resources and Services Ad23 ministration to such Assistant Secretary; 


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1 ‘‘(2) exercise the responsibilities and authorities 

2 of the Secretary with respect to the coordination 

3 of— 

4 ‘‘(A) the Public Health Emergency Pre5 paredness Cooperative Agreement Program pur6 suant to section 319C–1; 

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

8 ‘‘(C) the Cities Readiness Initiative; 

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

10 health preparedness and response grants and cooper11 ative agreements authorized under this Act, to the 

12 extent possible, including program requirements, 

13 timelines, and measurable goals, and in coordination 

14 with the Secretary of Homeland Security, to— 

15 ‘‘(A) optimize and streamline medical and 

16 public health preparedness capabilities and the 

17 ability of local communities to respond to public 

18 health emergencies; 

19 ‘‘(B) minimize duplication of efforts with 

20 regard to medical and public health prepared21 ness and response programs; and 

22 ‘‘(C) gather and disseminate best practices 

23 among grant and cooperative agreement recipi24 ents, as appropriate; 


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

2 in coordination with the Department of Homeland 

3 Security, the Department of Defense, and other ap4 plicable Federal departments and agencies, as nec5 essary and appropriate, to identify, inform, and ad6 dress gaps in and policies related to all-hazards med7 ical and public health preparedness, including exer8 cises based on— 

9 ‘‘(A) identified threats for which counter10 measures are available and for which no coun11 termeasures are available; and 

12 ‘‘(B) unknown threats for which no coun13 termeasures are available; and 

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

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

17 ‘‘(d) NATIONAL SECURITY PRIORITY.—The Sec18 retary, acting through the Assistant Secretary for Pre19 paredness and Response, shall on a periodic basis conduct 

20 meetings, as applicable and appropriate, with the Assist21 ant to the President for National Security Affairs to pro22 vide an update on, and discuss, medical and public health 

23 preparedness and response activities pursuant to this Act 

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


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1 progress on the development, approval, clearance, and li2 censure of medical countermeasures. 

3 ‘‘(e) PUBLIC HEALTH EMERGENCY MEDICAL COUN4 TERMEASURES ENTERPRISE STRATEGY AND IMPLEMEN5 TATION PLAN.— 

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

7 after the date of enactment of this subsection, and 

8 every other year thereafter, the Secretary, acting 

9 through the Assistant Secretary for Preparedness 

10 and Response and in coordination with the Director 

11 of the Biomedical Advanced Research and Develop12 ment Authority, the Director of the National Insti13 tutes of Health, the Director of the Centers for Dis14 ease Control and Prevention, and the Commissioner 

15 of the Food and Drug Administration, shall develop 

16 and submit to the appropriate committees of Con17 gress a coordinated strategy and accompanying im18 plementation plan for medical countermeasures to 

19 address chemical, biological, radiological, and nu20 clear threats. Such strategy and plan shall be known 

21 as the ‘Public Health Emergency Medical Counter22 measures Enterprise Strategy and Implementation 

23 Plan’. 

24 ‘‘(2) REQUIREMENTS.—The plan under para25 graph (1) shall— 


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

2 of medical countermeasure-related activities, in3 cluding research, advanced research, develop4 ment, procurement, stockpiling, deployment, 

5 and distribution; 

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

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

8 security countermeasure (as defined in sections 

9 319F–1 and 319F–2) needs and goals of the 

10 Federal Government according to chemical, bio11 logical, radiological, and nuclear threat or 

12 threats; 

13 ‘‘(C) identify projected timelines, antici14 pated funding allocations, benchmarks, and 

15 milestones for each medical countermeasure pri16 ority under subparagraph (B), including pro17 jected needs with regard to replenishment of 

18 the Strategic National Stockpile; 

19 ‘‘(D) be informed by the recommendations 

20 of the National Biodefense Science Board pur21 suant to section 319M; 

22 ‘‘(E) report on advanced research and de23 velopment awards and the date of the issuance 

24 of contract awards, including awards made 


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1 through the special reserve fund (as defined in 

2 section 319F–2(c)(10)); 

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

4 goals, benchmarks, and milestones identified 

5 under subparagraph (C) in plans submitted 

6 subsequent to the initial plan; and 

7 ‘‘(G) be made publically available. 

8 ‘‘(3) GAO REPORT.— 

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

10 after the date on which a Public Health Emer11 gency Medical Countermeasures Enterprise 

12 Strategy and Implementation Plan under this 

13 subsection is issued by the Secretary, the Gov14 ernment Accountability Office shall conduct an 

15 independent evaluation and submit to the ap16 propriate committees of Congress a report con17 cerning such strategy and implementation plan. 

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

19 subparagraph (A) shall review and assess— 

20 ‘‘(i) the near-term, mid-term, and 

21 long-term medical countermeasure needs 

22 and identified priorities of the Federal 

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

24 ‘‘(ii) the activities of the Department 

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1 spect to advanced research and develop2 ment pursuant to section 319L; and 

3 ‘‘(iii) the progress made toward meet4 ing the goals, benchmarks, and milestones 

5 identified in the Public Health Emergency 

6 Medical Countermeasures Enterprise 

7 Strategy and Implementation Plan under 

8 this subsection. 

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

10 The Secretary shall develop, and update on an annual 

11 basis, a coordinated 5-year budget plan based on the med12 ical countermeasure priorities and goals described in sub13 section (e). Each such plan shall— 

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

15 countermeasures enterprise, including— 

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

17 development; 

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

19 authorized uses of products; and 

20 ‘‘(C) procurement, stockpiling, mainte21 nance, and replenishment of all products in the 

22 Strategic National Stockpile; 

23 ‘‘(2) include measurable outputs and outcomes 

24 to allow for the tracking of the progress made to25 ward identified goals; 


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

2 costs to inform planning, budgeting, and anticipated 

3 needs within the continuum of the medical counter4 measure enterprise consistent with section 319F–2; 

5 and 

6 ‘‘(4) be made available to the appropriate com7 mittees of Congress upon request. 

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

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

10 subsection, the Secretary, in coordination with the Sec11 retary of Defense, shall submit to the appropriate commit12 tees of Congress a report concerning the manner in which 

13 the Department of Health and Human Services is coordi14 nating with the Department of Defense regarding counter15 measure activities to address chemical, biological, radio16 logical, and nuclear threats. Such report shall include in17 formation with respect to— 

18 ‘‘(1) the research, advanced research, develop19 ment, procurement, stockpiling, and distribution of 

20 countermeasures to meet identified needs; and 

21 ‘‘(2) the coordination of efforts between the De22 partment of Health and Human Services and the 

23 Department of Defense to address countermeasure 

24 needs for various segments of the population. 


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1 ‘‘(h) PROTECTION OF NATIONAL SECURITY.—In car2 rying out subsections (e), (f), and (g), the Secretary shall 

3 ensure that information and items that could compromise 

4 national security are not disclosed.’’. 

5 SEC. 103. MODERNIZATION OF THE NATIONAL DISASTER 

6 MEDICAL SYSTEM. 

7 Section 2812 of the Public Health Service Act (42 

8 U.S.C. 300hh–11) is amended— 

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

10 the following: 

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

12 inserting ‘‘, including at-risk individuals as ap13 plicable’’ after ‘‘victims of a public health emer14 gency’’; 

15 (B) by redesignating subparagraph (C) as 

16 subparagraph (E); and 

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

18 the following: 

19 ‘‘(C) CONSIDERATIONS FOR AT-RISK POPU20 LATIONS.—The Secretary shall take steps to 

21 ensure that an appropriate specialized and fo22 cused range of public health and medical capa23 bilities are represented in the National Disaster 

24 Medical System, which take into account the 


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

2 public health emergency.’’. 

3 ‘‘(D) ADMINISTRATION.—The Secretary 

4 may determine and pay claims for reimburse5 ment for services under subparagraph (A) di6 rectly or through contracts that provide for 

7 payment in advance or by way of reimburse8 ment.’’; and 

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

10 may be necessary for each of the fiscal years 2007 

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

12 of fiscal years 2012 through 2016’’. 

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

14 VETERANS AFFAIRS. 

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

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

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

18 2011’’ and inserting ‘‘$156,500,000 for each of fiscal 

19 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 01:43 Dec 17, 2011 Jkt 019200 PO 00000 Frm 00051 Fmt 6652 Sfmt 6401 E:\BILLS\S1855.RS 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.’’. 

8 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

10 ‘‘Pandemic and All-Hazards Preparedness Act Reauthor11 ization of 2011’’. 

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

13 Act is as follows: 

Sec. 1. Short title; table of contents. 

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. National Advisory Committee on Children and Disasters. 

Sec. 104. Modernization of the National Disaster Medical System. 

Sec. 105. 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. Authorization of medical products for use in emergencies. 

Sec. 303. Definitions. 

Sec. 304. Enhancing medical countermeasure activities. 

Sec. 305. Regulatory management plans. 

Sec. 306. Report. 

Sec. 307. Pediatric medical countermeasures. 


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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)— 

12 (i) in the matter preceding subpara13 graph (A)— 

14 (I) by striking ‘‘facilities), and 

15 trauma care’’ and inserting ‘‘facilities 

16 and which may include dental health 

17 facilities), and trauma care, critical 

18 care,’’; and 

19 (II) by inserting ‘‘(including re20 lated availability, accessibility, and co21 ordination)’’ after ‘‘public health emer22 gencies’’; 


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1 (ii) in subparagraph (A), by inserting 

2 ‘‘and trauma’’ after ‘‘medical’’; 

3 (iii) in subparagraph (D), by inserting 

4 ‘‘(which may include such dental health as5 sets)’’ after ‘‘medical assets’’; 

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

7 ‘‘(F) Optimizing a coordinated and flexible 

8 approach to the medical surge capacity of hos9 pitals, other healthcare facilities, and trauma 

10 care (which may include trauma centers) and 

11 emergency medical systems.’’; 

12 (B) in paragraph (4)— 

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

14 ‘‘, including the unique needs and consider15 ations of individuals with disabilities,’’ 

16 after ‘‘medical needs of at-risk individuals’’; 

17 and 

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

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

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

21 ‘‘(7) COUNTERMEASURES.— 

22 ‘‘(A) Promoting strategic initiatives to ad23 vance countermeasures to diagnose, mitigate, 

24 prevent, or treat harm from any biological agent 

25 or toxin, chemical, radiological, or nuclear agent 


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1 or agents, whether naturally occurring, uninten2 tional, or deliberate. 

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

4 term ‘countermeasures’ has the same meaning as 

5 the terms ‘qualified countermeasures’ under sec6 tion 319F–1, ‘qualified pandemic and epidemic 

7 products’ under section 319F–3, and ‘security 

8 countermeasures’ under section 319F–2. 

9 ‘‘(8) MEDICAL AND PUBLIC HEALTH COMMUNITY

10 RESILIENCY.—Strengthening the ability of States, 

11 local communities, and tribal communities to prepare 

12 for, respond to, and be resilient in the event of public 

13 health emergencies, whether naturally occurring, un14 intentional, or deliberate by— 

15 ‘‘(A) optimizing alignment and integration 

16 of medical and public health preparedness and 

17 response planning and capabilities with and 

18 into routine daily activities; and 

19 ‘‘(B) promoting familiarity with local med20 ical and public health systems.’’. 

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

22 Health Service Act (42 U.S.C. 300hh–16) is amended— 

23 (1) by striking paragraphs (5), (7), and (8); 

24 (2) by redesignating paragraphs (1) through (4) 

25 as paragraphs (2) through (5), respectively; 


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1 (3) by inserting before paragraph (2) (as so re2 designated), the following: 

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

4 they relate to medical and public health preparedness 

5 and response for at-risk individuals in the event of a 

6 public health emergency declared by the Secretary 

7 under section 319;’’; 

8 (4) in paragraph (2) (as so redesignated), by 

9 striking ‘‘National Preparedness goal’’ and inserting 

10 ‘‘preparedness goals, as described in section 2802(b),’’; 

11 and 

12 (5) by inserting after paragraph (6), the fol13 lowing: 

14 ‘‘(7) disseminate and, as appropriate, update 

15 novel and best practices of outreach to and care of at16 risk individuals before, during, and following public 

17 health emergencies in as timely a manner as is prac18 ticable, including from the time a public health threat 

19 is identified; and 

20 ‘‘(8) ensure that public health and medical infor21 mation distributed by the Department of Health and 

22 Human Services during a public health emergency is 

23 delivered in a manner that takes into account the 

24 range of communication needs of the intended recipi25 ents, including at-risk individuals.’’. 


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1 SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

2 RESPONSE. 

3 Section 2811 of the Public Health Service Act (42 

4 U.S.C. 300hh–10) is amended— 

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

6 following: 

7 ‘‘(D) POLICY COORDINATION AND STRA8 TEGIC DIRECTION.—Provide integrated policy co9 ordination and strategic direction with respect to 

10 all matters related to Federal public health and 

11 medical preparedness and execution and deploy12 ment of the Federal response for public health 

13 emergencies and incidents covered by the Na14 tional Response Plan developed pursuant to sec15 tion 502(6) of the Homeland Security Act of 

16 2002, or any successor plan, before, during, and 

17 following public health emergencies.’’; 

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

19 following: 

20 ‘‘(c) FUNCTIONS.—The Assistant Secretary for Pre21 paredness and Response shall— 

22 ‘‘(1) have authority over and responsibility for— 

23 ‘‘(A) the National Disaster Medical System 

24 (in accordance with section 301 of the Pandemic 

25 and All-Hazards Preparedness Act); 


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1 ‘‘(B) the Hospital Preparedness Cooperative 

2 Agreement Program pursuant to section 319C–2; 

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

4 section 2813; 

5 ‘‘(D) the Emergency System for Advance 

6 Registration of Volunteer Health Professionals 

7 pursuant to section 319I; and 

8 ‘‘(E) administering grants and related au9 thorities related to trauma care under parts A 

10 through C of title XII, such authority to be 

11 transferred by the Secretary from the Adminis12 trator of the Health Resources and Services Ad13 ministration to such Assistant Secretary; 

14 ‘‘(2) exercise the responsibilities and authorities 

15 of the Secretary with respect to the coordination of— 

16 ‘‘(A) the Public Health Emergency Pre17 paredness Cooperative Agreement Program pur18 suant to section 319C–1; 

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

20 ‘‘(C) the Cities Readiness Initiative; 

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

22 health grants and cooperative agreements as applica23 ble to preparedness and response activities authorized 

24 under this Act, to the extent possible, including pro25 gram requirements, timelines, and measurable goals, 


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1 and in coordination with the Secretary of Homeland 

2 Security, to— 

3 ‘‘(A) optimize and streamline medical and 

4 public health preparedness capabilities and the 

5 ability of local communities to respond to public 

6 health emergencies; 

7 ‘‘(B) minimize duplication of efforts with 

8 regard to medical and public health preparedness 

9 and response programs; and 

10 ‘‘(C) gather and disseminate best practices 

11 among grant and cooperative agreement recipi12 ents, as appropriate; 

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

14 in coordination with the Department of Homeland 

15 Security, the Department of Defense, the Department 

16 of Veterans Affairs, and other applicable Federal de17 partments and agencies, as necessary and appro18 priate, to identify, inform, and address gaps in and 

19 policies related to all-hazards medical and public 

20 health preparedness, including exercises based on— 

21 ‘‘(A) identified threats for which counter22 measures are available and for which no counter23 measures are available; and 

24 ‘‘(B) unknown threats for which no counter25 measures are available; and 


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1 ‘‘(5) assume other duties as determined appro2 priate by the Secretary.’’; and 

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

4 ‘‘(d) NATIONAL SECURITY PRIORITY.—The Secretary, 

5 acting through the Assistant Secretary for Preparedness 

6 and Response, shall on a periodic basis conduct meetings, 

7 as applicable and appropriate, with the Assistant to the 

8 President for National Security Affairs to provide an up9 date on, and discuss, medical and public health prepared10 ness and response activities pursuant to this Act and the 

11 Federal Food, Drug, and Cosmetic Act, including progress 

12 on the development, approval, clearance, and licensure of 

13 medical countermeasures. 

14 ‘‘(e) PUBLIC HEALTH EMERGENCY MEDICAL COUN15 TERMEASURES ENTERPRISE STRATEGY AND IMPLEMENTA16 TION PLAN.— 

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

18 after the date of enactment of this subsection, and 

19 every other year thereafter, the Secretary, acting 

20 through the Assistant Secretary for Preparedness and 

21 Response and in consultation with the Director of the 

22 Biomedical Advanced Research and Development Au23 thority, the Director of the National Institutes of 

24 Health, the Director of the Centers for Disease Control 

25 and Prevention, and the Commissioner of the Food 


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1 and Drug Administration, shall develop and submit 

2 to the appropriate committees of Congress a coordi3 nated strategy and accompanying implementation 

4 plan for medical countermeasures to address chemical, 

5 biological, radiological, and nuclear threats. Such 

6 strategy and plan shall be known as the ‘Public 

7 Health Emergency Medical Countermeasures Enter8 prise Strategy and Implementation Plan’. 

9 ‘‘(2) REQUIREMENTS.—The plan under para10 graph (1) shall— 

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

12 of medical countermeasure-related activities, in13 cluding research, advanced research, develop14 ment, procurement, stockpiling, deployment, and 

15 distribution; 

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

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

18 security countermeasure (as defined in sections 

19 319F–1 and 319F–2) needs and goals of the Fed20 eral Government according to chemical, biologi21 cal, radiological, and nuclear threat or threats; 

22 ‘‘(C) identify projected timelines, antici23 pated funding allocations, benchmarks, and mile24 stones for each medical countermeasure priority 

25 under subparagraph (B), including projected 


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1 needs with regard to replenishment of the Stra2 tegic National Stockpile; 

3 ‘‘(D) be informed by the recommendations 

4 of the National Biodefense Science Board pursu5 ant to section 319M; 

6 ‘‘(E) report on advanced research and devel7 opment awards and the date of the issuance of 

8 contract awards, including awards made through 

9 the special reserve fund (as defined in section 

10 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 sub14 sequent to the initial plan; 

15 ‘‘(G) identify the progress made in meeting 

16 the medical countermeasure priorities for at-risk 

17 individuals, (as defined in 2802(b)(4)(B)), as 

18 applicable under subparagraph (B), including 

19 with regard to the projected needs for related 

20 stockpiling and replenishment of the Strategic 

21 National Stockpile; and 

22 ‘‘(H) be made publicly available. 

23 ‘‘(3) GAO REPORT.— 

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

25 after the date on which a Public Health EmerVerDate Mar 15 2010 01:43 Dec 17, 2011 Jkt 019200 PO 00000 Frm 00076 Fmt 6652 Sfmt 6203 E:\BILLS\S1855.RS S1855

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1 gency Medical Countermeasures Enterprise 

2 Strategy and Implementation Plan under this 

3 subsection is issued by the Secretary, the Govern4 ment Accountability Office shall conduct an 

5 independent evaluation and submit to the appro6 priate committees of Congress a report con7 cerning such strategy and implementation plan. 

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

9 subparagraph (A) shall review and assess— 

10 ‘‘(i) the near-term, mid-term, and 

11 long-term medical countermeasure needs 

12 and identified priorities of the Federal Gov13 ernment pursuant to subparagraphs (A) 

14 and (B) of paragraph (2); 

15 ‘‘(ii) the activities of the Department of 

16 Health and Human Services with respect to 

17 advanced research and development pursu18 ant to section 319L; and 

19 ‘‘(iii) the progress made toward meet20 ing the goals, benchmarks, and milestones 

21 identified in the Public Health Emergency 

22 Medical Countermeasures Enterprise Strat23 egy and Implementation Plan under this 

24 subsection. 


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1 ‘‘(f) INTERNAL MULTIYEAR PLANNING PROCESS.—The 

2 Secretary shall develop, and update on an annual basis, 

3 a coordinated 5-year budget plan based on the medical 

4 countermeasure priorities and goals described in subsection 

5 (e). Each such plan shall— 

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

7 countermeasures enterprise, including— 

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

9 development; 

10 ‘‘(B) approval, clearance, licensure, and au11 thorized uses of products; and 

12 ‘‘(C) procurement, stockpiling, maintenance, 

13 and replenishment of all products in the Stra14 tegic National Stockpile; 

15 ‘‘(2) include measurable outputs and outcomes to 

16 allow for the tracking of the progress made toward 

17 identified goals; 

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

19 costs to inform planning, budgeting, and anticipated 

20 needs within the continuum of the medical counter21 measure enterprise consistent with section 319F–2; 

22 and 

23 ‘‘(4) be made available to the appropriate com24 mittees of Congress upon request. 


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1 ‘‘(g) INTERAGENCY COORDINATION PLAN.—Not later 

2 than 1 year after the date of enactment of this subsection, 

3 the Secretary, in coordination with the Secretary of De4 fense, shall submit to the appropriate committees of Con5 gress a report concerning the manner in which the Depart6 ment of Health and Human Services is coordinating with 

7 the Department of Defense regarding countermeasure ac8 tivities to address chemical, biological, radiological, and 

9 nuclear threats. Such report shall include information with 

10 respect to— 

11 ‘‘(1) the research, advanced research, develop12 ment, procurement, stockpiling, and distribution of 

13 countermeasures to meet identified needs; and 

14 ‘‘(2) the coordination of efforts between the De15 partment of Health and Human Services and the De16 partment of Defense to address countermeasure needs 

17 for various segments of the population. 

18 ‘‘(h) PROTECTION OF NATIONAL SECURITY.—In car19 rying out subsections (e), (f), and (g), the Secretary shall 

20 ensure that information and items that could compromise 

21 national security are not disclosed.’’. 


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1 SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN 

2 AND DISASTERS. 

3 Subtitle B of title XXVIII of the Public Health Service 

4 Act (42 U.S.C. 300hh et seq.) is amended by inserting after 

5 section 2811 the end the following: 

6 ‘‘SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHIL7 DREN AND DISASTERS. 

8 ‘‘(a) ESTABLISHMENT.—The Secretary, in consulta9 tion with the Secretary of Homeland Security, shall estab10 lish an advisory committee to be known as the ‘National 

11 Advisory Committee on Children and Disasters’ (referred 

12 to in this section as the ‘Advisory Committee’). 

13 ‘‘(b) DUTIES.—The Advisory Committee shall— 

14 ‘‘(1) provide advice and consultation with re15 spect to the activities carried out pursuant to section 

16 2814, as applicable and appropriate; 

17 ‘‘(2) evaluate and provide input with respect to 

18 the needs of children as they relate to preparation for, 

19 response to, and recovery from all-hazards, including 

20 public health emergencies; and 

21 ‘‘(3) provide advice and consultation to States 

22 and territories with respect to State emergency pre23 paredness and response activities and children, in24 cluding related drills and exercises pursuant to the 

25 preparedness goals under section 2802(b). 


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1 ‘‘(c) ADDITIONAL DUTIES.—The Advisory Committee 

2 may provide advice and recommendations to the Secretary 

3 with respect to children and the medical and public health 

4 grants and cooperative agreements as applicable to pre5 paredness and response activities authorized under this title 

6 and title III. 

7 ‘‘(d) MEMBERSHIP.— 

8 ‘‘(1) IN GENERAL.—The Secretary, in consulta9 tion with such other Secretaries as may be appro10 priate, shall appoint not to exceed 15 members to the 

11 Advisory Committee. In appointing such members, 

12 the Secretary shall ensure that the total membership 

13 of the Advisory Committee is an odd number. 

14 ‘‘(2) REQUIRED MEMBERS.—The Secretary, in 

15 consultation with such other Secretaries as may be 

16 appropriate, may appoint to the Advisory Committee 

17 under paragraph (1) such individuals as may be ap18 propriate to perform the duties described in sub19 sections (b) and (c), which may include— 

20 ‘‘(A) the Assistant Secretary for Prepared21 ness and Response; 

22 ‘‘(B) the Director of the Biomedical Ad23 vanced Research and Development Authority; 

24 ‘‘(C) the Director of the Centers for Disease 

25 Control and Prevention; 


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1 ‘‘(D) the Commissioner of Food and Drugs; 

2 ‘‘(E) the Director of the National Institutes 

3 of Health; 

4 ‘‘(F) the Assistant Secretary of the Admin5 istration for Children and Families; 

6 ‘‘(G) at least two health care professionals 

7 with expertise in pediatric medical disaster 

8 planning, preparedness, response, or recovery; 

9 ‘‘(H) at least two representatives from 

10 State, local, territories, or tribal agencies with 

11 expertise in pediatric disaster planning, pre12 paredness, response, or recovery; and 

13 ‘‘(I) representatives from such Federal agen14 cies (such as the Department of Education and 

15 the Department of Homeland Security) as deter16 mined necessary to fulfill the duties of the Advi17 sory Committee, as established under subsections 

18 (b) and (c). 

19 ‘‘(e) MEETINGS.—The Advisory Committee shall meet 

20 not less than biannually. 

21 ‘‘(f) SUNSET.—The Advisory Committee shall termi22 nate on the date that is 5 years after the date of enactment 

23 of the Pandemic and All-Hazards Preparedness Act Reau24 thorization of 2011.’’. 


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1 SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER 

2 MEDICAL SYSTEM. 

3 Section 2812 of the Public Health Service Act (42 

4 U.S.C. 300hh–11) is amended— 

5 (1) in subsection (a)(3)— 

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

7 inserting ‘‘, including at-risk individuals as ap8 plicable’’ after ‘‘victims of a public health emer9 gency’’; 

10 (B) by redesignating subparagraph (C) as 

11 subparagraph (E); and 

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

13 the following: 

14 ‘‘(C) CONSIDERATIONS FOR AT-RISK POPU15 LATIONS.—The Secretary shall take steps to en16 sure that an appropriate specialized and focused 

17 range of public health and medical capabilities 

18 are represented in the National Disaster Medical 

19 System, which take into account the needs of at20 risk individuals, in the event of a public health 

21 emergency.’’. 

22 ‘‘(D) ADMINISTRATION.—The Secretary 

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1 ment in advance or by way of reimbursement.’’; 

2 and 

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

4 may be necessary for each of the fiscal years 2007 

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

6 fiscal years 2012 through 2016’’. 

7 SEC. 105. CONTINUING THE ROLE OF THE DEPARTMENT OF 

8 VETERANS AFFAIRS. 

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

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

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

12 2011’’ and inserting ‘‘$156,500,000 for each of fiscal years 

13 2012 through 2016 to carry out this section’’. 

14 TITLE II—OPTIMIZING STATE 

15 AND LOCAL ALL-HAZARDS 

16 PREPAREDNESS AND RE17 SPONSE 

18 SEC. 201. IMPROVING STATE AND LOCAL PUBLIC HEALTH 

19 SECURITY. 

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

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

22 amended— 

23 (1) in subsection (b)(2)— 

24 (A) in subparagraph (A)— 


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

2 inserting the following: 

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

4 entity will carry out under the agreement to 

5 meet the goals identified under section 2802, 

6 including with respect to chemical, biologi7 cal, radiological, or nuclear threats, whether 

8 naturally occurring, unintentional, or delib9 erate; 

10 ‘‘(ii) a description of the activities such 

11 entity will carry out with respect to pan12 demic influenza, as a component of the ac13 tivities carried out under clause (i), and 

14 consistent with the requirements of para15 graphs (2) and (5) of subsection (g);’’; 

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

17 the end; and 

18 (iii) by adding at the end the fol19 lowing: 

20 ‘‘(vi) a description of how, as appro21 priate, the entity may partner with relevant 

22 public and private stakeholders in public 

23 health emergency preparedness and re24 sponse; 


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1 ‘‘(vii) a description of how the entity, 

2 as applicable and appropriate, will coordi3 nate with State emergency preparedness 

4 and response plans in public health emer5 gency preparedness, including State edu6 cational agencies (as defined in section 

7 9101(41) of the Elementary and Secondary 

8 Education Act of 1965) and State child care 

9 lead agencies (as defined in section 658D of 

10 the Child Care and Development Block 

11 Grant Act); and 

12 ‘‘(viii) in the case of entities that oper13 ate on the United States-Mexico border or 

14 the United States-Canada border, a descrip15 tion of the activities such entity will carry 

16 out under the agreement that are specific to 

17 the border area including disease detection, 

18 identification, and investigation, and pre19 paredness and response activities related to 

20 emerging diseases and infectious disease 

21 outbreaks whether naturally-occurring or 

22 due to bioterrorism, consistent with the re23 quirements of this section;’’; and 


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

2 including addressing the needs of at-risk individ3 uals,’’ after ‘‘capabilities of such entity’’; 

4 (2) in subsection (g)— 

5 (A) in paragraph (1), by striking subpara6 graph (A) and inserting the following: 

7 ‘‘(A) include outcome goals representing 

8 operational achievements of the National Pre9 paredness Goals developed under section 2802(b) 

10 with respect to all-hazards, including chemical, 

11 biological, radiological, or nuclear threats; and’’; 

12 and 

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

14 end the following: ‘‘The Secretary shall periodi15 cally update, as necessary and appropriate, such 

16 pandemic influenza plan criteria and shall re17 quire the integration of such criteria into the 

18 benchmarks and standards described in para19 graph (1).’’; 

20 (3) in subsection (i)— 

21 (A) in paragraph (1)(A)— 

22 (i) by striking ‘‘$824,000,000 for fiscal 

23 year 2007’’ and inserting ‘‘$632,900,000 for 

24 fiscal year 2012’’; and 


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

2 necessary for each of fiscal years 2008 

3 through 2011’’ and inserting ‘‘$632,900,000 

4 for each of fiscal years 2013 through 2016’’; 

5 and 

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

7 ‘‘(7) AVAILABILITY OF COOPERATIVE AGREEMENT

8 FUNDS.— 

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

10 an eligible entity under a cooperative agreement 

11 under subsection (a) for a fiscal year and re12 maining unobligated at the end of such year 

13 shall remain available to such entity for the next 

14 fiscal year for the purposes for which such funds 

15 were provided. 

16 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

17 BENCHMARKS.—The continued availability of 

18 funds under subparagraph (A) with respect to an 

19 entity shall be contingent upon such entity 

20 achieving the benchmarks and submitting the 

21 pandemic influenza plan as described in sub22 section (g).’’; and 

23 (4) in subsection (j), by striking paragraph (3). 

24 (b) VACCINE TRACKING AND DISTRIBUTION.—Section 

25 319A(e) of the Public Health Service Act (42 U.S.C. 247d– 


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1 1(e)) is amended by striking ‘‘such sums for each of fiscal 

2 years 2007 through 2011’’ and inserting ‘‘$30,800,000 for 

3 each of fiscal years 2012 through 2016’’. 

4 (c) GAO REPORT.—Section 319C-1 of the Public 

5 Health Service Act (42 U.S.C. 247d–3a) is amended by 

6 adding at the end the following: 

7 ‘‘(l) GAO REPORT.— 

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

9 the date of enactment of the Pandemic and All-Haz10 ards Preparedness Act Reauthorization of 2011, the 

11 Government Accountability Office shall conduct an 

12 independent evaluation, and submit to the appro13 priate committees of Congress a report, concerning 

14 Federal programs at the Department of Health and 

15 Human Services that support medical and public 

16 health preparedness and response programs at the 

17 State and local levels. 

18 ‘‘(2) CONTENT.—The report described in para19 graph (1) shall review and assess— 

20 ‘‘(A) the extent to which grant and coopera21 tive agreement requirements and goals have been 

22 met by recipients; 

23 ‘‘(B) the extent to which such grants and 

24 cooperative agreements have supported medical 

25 and public health preparedness and response 


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1 goals pursuant to section 2802(b), as appro2 priate and applicable; 

3 ‘‘(C) whether recipients or the Department 

4 of Health and Human Services have identified 

5 any factors that may impede a recipient’s abil6 ity to achieve programmatic goals and require7 ments; and 

8 ‘‘(D) instances in which funds may not 

9 have been used appropriately, in accordance 

10 with grant and cooperative agreement require11 ments, and actions taken to address inappro12 priate expenditures.’’. 

13 SEC. 202. HOSPITAL PREPAREDNESS AND MEDICAL SURGE 

14 CAPACITY. 

15 (a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL

16 RESPONSE CURRICULA AND TRAINING.—Section 

17 319F(a)(5)(B) of the Public Health Service Act (42 U.S.C. 

18 247d–6(a)(5)(B)) is amended by striking ‘‘public health or 

19 medical’’ and inserting ‘‘public health, medical, or dental’’. 

20 (b) ENCOURAGING HEALTH PROFESSIONAL VOLUN21 TEERS.— 

22 (1) EMERGENCY SYSTEM FOR ADVANCE REG23 ISTRATION OF VOLUNTEER HEALTH PROFES24 SIONALS.—Section 319I(k) of the Public Health Serv25 ice Act (42 U.S.C. 247d–7b(k)) is amended by strikVerDate Mar 15 2010 01:43 Dec 17, 2011 Jkt 019200 PO 00000 Frm 00090 Fmt 6652 Sfmt 6203 E:\BILLS\S1855.RS S1855

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1 ing ‘‘$2,000,000 for fiscal year 2002, and such sums 

2 as may be necessary for each of the fiscal years 2003 

3 through 2011’’ and inserting ‘‘$5,900,000 for each of 

4 fiscal years 2012 through 2016’’. 

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

6 Health Service Act (42 U.S.C. 300hh–15) is amend7 ed— 

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

9 end the following: ‘‘Such training exercises shall, 

10 as appropriate and applicable, incorporate the 

11 needs of at-risk individuals in the event of a 

12 public health emergency.’’; and 

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

14 ‘‘$22,000,000 for fiscal year 2007, and such sums 

15 as may be necessary for each of fiscal years 2008 

16 through 2011’’ and inserting ‘‘$11,900,000 for 

17 each of fiscal years 2012 through 2016’’. 

18 (c) PARTNERSHIPS FOR STATE AND REGIONAL PRE19 PAREDNESS TO IMPROVE SURGE CAPACITY.—Section 

20 319C–2 of the Public Health Service Act (42 U.S.C. 247d– 

21 3b) is amended— 

22 (1) in subsection (b)(1)(A)(ii), by striking ‘‘cen23 ters, primary’’ and inserting ‘‘centers, community 

24 health centers, primary’’; 


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

2 following: 

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

4 shall be expended for activities to achieve the preparedness 

5 goals described under paragraphs (1), (3), (4), (5), and (6) 

6 of section 2802(b) with respect to all-hazards, including 

7 chemical, biological, radiological, or nuclear threats.’’; 

8 (3) by striking subsection (g) and inserting the 

9 following: 

10 ‘‘(g) COORDINATION.— 

11 ‘‘(1) LOCAL RESPONSE CAPABILITIES.—An eligi12 ble entity shall, to the extent practicable, ensure that 

13 activities carried out under an award under sub14 section (a) are coordinated with activities of relevant 

15 local Metropolitan Medical Response Systems, local 

16 Medical Reserve Corps, the local Cities Readiness Ini17 tiative, and local emergency plans. 

18 ‘‘(2) NATIONAL COLLABORATION.—Partnerships 

19 consisting of one or more eligible entities under this 

20 section may, to the extent practicable, collaborate 

21 with other partnerships consisting of one or more eli22 gible entities under this section for purposes of na23 tional coordination and collaboration with respect to 

24 activities to achieve the preparedness goals described 


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1 under paragraphs (1), (3), (4), (5), and (6) of section 

2 2802(b).’’; and 

3 (4) 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 years 

7 2008 through 2011’’ and inserting ‘‘$378,000,000 

8 for each of fiscal years 2012 through 2016’’; and 

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

10 ‘‘(4) AVAILABILITY OF COOPERATIVE AGREEMENT

11 FUNDS.— 

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

13 an eligible entity under a cooperative agreement 

14 under subsection (a) for a fiscal year and re15 maining unobligated at the end of such year 

16 shall remain available to such entity for the next 

17 fiscal year for the purposes for which such funds 

18 were provided. 

19 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

20 BENCHMARKS.—The continued availability of 

21 funds under subparagraph (A) with respect to an 

22 entity shall be contingent upon such entity 

23 achieving the benchmarks and submitting the 

24 pandemic influenza plan as required under sub25 section (i).’’. 


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1 SEC. 203. ENHANCING SITUATIONAL AWARENESS AND BIO2 SURVEILLANCE. 

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

4 U.S.C. 247d–4) is amended— 

5 (1) in subsection (b)— 

6 (A) in paragraph (1)(B), by inserting ‘‘poi7 son control centers,’’ after ‘‘hospitals,’’; 

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

9 the period the following: ‘‘, allowing for coordi10 nation to maximize all-hazards medical and 

11 public health preparedness and response and to 

12 minimize duplication of effort’’; and 

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

14 the period the following: ‘‘and update such 

15 standards as necessary’’; 

16 (2) in subsection (d)— 

17 (A) in the subsection heading, by striking 

18 ‘‘PUBLIC HEALTH SITUATIONAL AWARENESS’’ 

19 and inserting ‘‘MODERNIZING PUBLIC HEALTH

20 SITUATIONAL AWARENESS AND BIOSURVEIL21 LANCE’’; 

22 (B) in paragraph (1)— 

23 (i) by striking ‘‘Pandemic and All24 Hazards Preparedness Act’’ and inserting 

25 ‘‘Pandemic and All-Hazards Preparedness 

26 Act Reauthorization of 2011’’; and 


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1 (ii) by inserting ‘‘, novel emerging 

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

3 (C) by striking paragraph (2) and inserting 

4 the following: 

5 ‘‘(2) STRATEGY AND IMPLEMENTATION PLAN.— 

6 Not later than 180 days after the date of enactment 

7 of the Pandemic and All-Hazards Preparedness Act 

8 Reauthorization of 2011, the Secretary shall submit to 

9 the appropriate committees of Congress, a coordinated 

10 strategy and an accompanying implementation plan 

11 that identifies and demonstrates the measurable steps 

12 the Secretary will carry out to— 

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

14 network described in paragraph (1), utilizing the 

15 elements described in paragraph (3); and 

16 ‘‘(B) modernize and enhance biosurveillance 

17 activities.’’; 

18 (D) in paragraph (3)(D), by inserting 

19 ‘‘community health centers, health centers’’ after 

20 ‘‘poison control,’’; 

21 (E) in paragraph (5), by striking subpara22 graph (A) and inserting the following: 

23 ‘‘(A) utilize applicable interoperability 

24 standards as determined by the Secretary, and 

25 in consultation with the Office of the National 


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1 Coordinator for Health Information Technology, 

2 through a joint public and private sector proc3 ess;’’; and 

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

5 ‘‘(6) CONSULTATION WITH THE NATIONAL BIO6 DEFENSE SCIENCE BOARD.—In carrying out this sec7 tion consistent with section 319M, the National Bio8 defense Science Board shall provide expert advice and 

9 guidance, including recommendations, regarding the 

10 measurable steps the Secretary should take to mod11 ernize and enhance biosurveillance activities pursuant 

12 to the efforts of the Department of Health and Hu13 mans Services to ensure comprehensive, real-time all14 hazards biosurveillance capabilities. In complying 

15 with the preceding sentence, the National Biodefense 

16 Science Board shall— 

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

18 a national biosurveillance system for human 

19 health, with international connectivity, where 

20 appropriate, that is predicated on State, re21 gional, and community level capabilities and 

22 creates a networked system to allow for two-way 

23 information flow between and among Federal, 

24 State, and local government public health au25 thorities and clinical health care providers; 


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1 ‘‘(B) identify any duplicative surveillance 

2 programs under the authority of the Secretary, 

3 or changes that are necessary to existing pro4 grams, in order to enhance and modernize such 

5 activities, minimize duplication, strengthen and 

6 streamline such activities under the authority of 

7 the Secretary, and achieve real-time and appro8 priate data that relate to disease activity, both 

9 human and zoonotic; and 

10 ‘‘(C) coordinate with applicable existing ad11 visory committees of the Director of the Centers 

12 for Disease Control and Prevention, including 

13 such advisory committees consisting of represent14 atives from State, local, and tribal public health 

15 authorities and appropriate public and private 

16 sector health care entities and academic institu17 tions, in order to provide guidance on public 

18 health surveillance activities.’’; 

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

20 after the date of enactment of the Pandemic and All21 Hazards Preparedness Act’’ and inserting ‘‘3 years 

22 after the date of enactment of the Pandemic and All23 Hazards Preparedness Act Reauthorization of 2011’’; 

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

25 may be necessary in each of fiscal years 2007 through 


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1 2011’’ and inserting ‘‘$160,121,000 for each of fiscal 

2 years 2012 through 2016’’; and 

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

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

5 term ‘biosurveillance’ means the process of gathering near 

6 real-time, biological data that relates to disease activity and 

7 threats to human or zoonotic health, in order to achieve 

8 early warning and identification of such health threats, 

9 early detection and prompt ongoing tracking of health 

10 events, and overall situational awareness of disease activ11 ity.’’. 

12 TITLE III—ENHANCING MEDICAL 

13 COUNTERMEASURE REVIEW 

14 SEC. 301. SPECIAL PROTOCOL ASSESSMENT. 

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

16 Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by strik17 ing ‘‘size of clinical trials intended’’ and all that follows 

18 through ‘‘. The sponsor or applicant’’ and inserting the fol19 lowing: ‘‘size— 

20 ‘‘(i)(I) of clinical trials intended to form the pri21 mary basis of an effectiveness claim; or 

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

23 are not ethical or feasible, of animal and any associ24 ated clinical trials which, in combination, are inVerDate Mar 15 2010 01:43 Dec 17, 2011 Jkt 019200 PO 00000 Frm 00098 Fmt 6652 Sfmt 6203 E:\BILLS\S1855.RS S1855

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1 tended to form the primary basis of an effectiveness 

2 claim; or 

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

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

5 Public Health Service Act, of any necessary clinical 

6 study or studies. 

7 The sponsor or applicant’’. 

8 SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

9 USE IN EMERGENCIES. 

10 (a) IN GENERAL.—Section 564 of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amend12 ed— 

13 (1) in subsection (a)— 

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

15 505, 510(k), and 515 of this Act’’ and inserting 

16 ‘‘any provision of this Act’’; 

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

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

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

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

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

22 and 

23 (C) in paragraph (3), by striking ‘‘a provi24 sion of law referred to in such paragraph’’ and 


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1 inserting ‘‘a provision of law referred to in para2 graph (2)(A)’’; 

3 (2) in subsection (b)— 

4 (A) in the subsection heading, by striking 

5 ‘‘EMERGENCY’’ and inserting ‘‘EMERGENCY OR

6 THREAT JUSTIFYING EMERGENCY AUTHORIZED

7 USE’’; 

8 (B) in paragraph (1)— 

9 (i) in the matter preceding subpara10 graph (A), by striking ‘‘may declare an 

11 emergency’’ and inserting ‘‘may make a 

12 declaration that the circumstances exist’’; 

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

14 ‘‘specified’’; 

15 (iii) in subparagraph (B)— 

16 (I) by striking ‘‘specified’’; and 

17 (II) by striking ‘‘; or’’ and insert18 ing a semicolon; 

19 (iv) by amending subparagraph (C) to 

20 read as follows: 

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

22 there is a public health emergency, or a signifi23 cant potential for a public health emergency, 

24 that affects, or has a significant potential to af25 fect, national security or the health and security 


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1 of United States citizens abroad, and that in2 volves a biological, chemical, radiological, or nu3 clear agent or agents, or a disease or condition 

4 that may be attributable to such agent or agents; 

5 or’’; and 

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

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

8 pursuant to section 319F–2 of the Public Health 

9 Service Act sufficient to affect national security 

10 or the health and security of United States citi11 zens living abroad.’’; 

12 (C) in paragraph (2)(A)— 

13 (i) by amending clause (ii) to read as 

14 follows: 

15 ‘‘(ii) a change in the approval status of 

16 the product such that the circumstances de17 scribed in subsection (a)(2) have ceased to 

18 exist.’’; 

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

20 (iii) by redesignating subparagraph 

21 (C) as subparagraph (B); 

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

23 notice of termination, and renewal under this 

24 subsection.’’ and inserting ‘‘, and advance notice 

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1 retary shall make any renewal under this sub2 section available on the Internet Web site of the 

3 Food and Drug Administration.’’; and 

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

5 ‘‘(5) EXPLANATION BY SECRETARY.—If an au6 thorization under this section with respect to an un7 approved product has been in effect for more than 1 

8 year, the Secretary shall provide in writing to the 

9 sponsor of such product, an explanation of the sci10 entific, regulatory, or other obstacles to approval, li11 censure, or clearance of such product, including spe12 cific actions to be taken by the Secretary and the 

13 sponsor to overcome such obstacles.’’; 

14 (3) in subsection (c)— 

15 (A) in the matter preceding paragraph 

16 (1)— 

17 (i) by inserting ‘‘the Assistant Sec18 retary for Preparedness and Response,’’ 

19 after ‘‘consultation with’’; 

20 (ii) by striking ‘‘Health and’’ and in21 serting ‘‘Health, and’’; and 

22 (iii) by striking ‘‘circumstances of the 

23 emergency involved’’ and inserting ‘‘appli24 cable circumstances described in subsection 

25 (b)(1)’’; 


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1 (B) in paragraph (1), by striking ‘‘speci2 fied’’ and inserting ‘‘referred to’’; and 

3 (C) in paragraph (2)(B), by inserting ‘‘, 

4 taking into consideration the material threat 

5 posed by the agent or agents identified in a dec6 laration under subsection (b)(1)(D), if applica7 ble’’ after ‘‘risks of the product’’; 

8 (4) in subsection (d)(3), by inserting ‘‘, to the ex9 tent practicable given the circumstances of the emer10 gency,’’ after ‘‘including’’; 

11 (5) in subsection (e)— 

12 (A) in paragraph (1)(A), by striking ‘‘cir13 cumstances of the emergency’’ and inserting ‘‘ap14 plicable circumstances described in subsection 

15 (b)(1)’’; 

16 (B) in paragraph (2)— 

17 (i) in subparagraph (A)— 

18 (I) by striking ‘‘manufacturer of 

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

20 (II) by striking ‘‘circumstances of 

21 the emergency’’ and inserting ‘‘appli22 cable circumstances described in sub23 section (b)(1)’’; and 


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1 (III) by inserting at the end be2 fore the period ‘‘or in paragraph 

3 (1)(B)’’; 

4 (ii) in subparagraph (B)(i), by insert5 ing before the period at the end ‘‘, except as 

6 provided in section 564A with respect to au7 thorized changes to the product expiration 

8 date’’; and 

9 (iii) by amending subparagraph (C) to 

10 read as follows: 

11 ‘‘(C) In establishing conditions under this 

12 paragraph with respect to the distribution and 

13 administration of the product for the unap14 proved use, the Secretary shall not impose condi15 tions that would restrict distribution or adminis16 tration of the product when done solely for the 

17 approved use.’’; and 

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

19 follows: 

20 ‘‘(3) GOOD MANUFACTURING PRACTICE; PRE21 SCRIPTION.—With respect to the emergency use of a 

22 product for which an authorization under this section 

23 is issued (whether an unapproved product or an un24 approved use of an approved product), the Secretary 

25 may waive or limit, to the extent appropriate given 


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1 the applicable circumstances described in subsection 

2 (b)(1)— 

3 ‘‘(A) requirements regarding current good 

4 manufacturing practice otherwise applicable to 

5 the manufacture, processing, packing, or holding 

6 of products subject to regulation under this Act, 

7 including such requirements established under 

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

9 conditions prescribed with respect to the product 

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

11 ‘‘(B) requirements established under section 

12 503(b); and 

13 ‘‘(C) requirements established under section 

14 520(e).’’; 

15 (6) in subsection (g)— 

16 (A) in the subsection heading, by inserting 

17 ‘‘REVIEW AND’’ before ‘‘REVOCATION’’; 

18 (B) in paragraph (1), by inserting after the 

19 period at the end the following: ‘‘As part of such 

20 review, the Secretary shall regularly review the 

21 progress made with respect to the approval, li22 censure, or clearance of— 

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

24 authorization was issued under this section; or 


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

2 product for which an authorization was issued 

3 under this section.’’; and 

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

5 follows: 

6 ‘‘(2) REVISION AND REVOCATION.—The Secretary 

7 may revise or revoke an authorization under this sec8 tion if— 

9 ‘‘(A) the circumstances described under sub10 section (b)(1) no longer exist; 

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

12 issuance of such authorization are no longer met; 

13 or 

14 ‘‘(C) other circumstances make such revision 

15 or revocation appropriate to protect the public 

16 health or safety.’’; 

17 (7) in subsection (h)(1), by adding after the pe18 riod at the end the following: ‘‘The Secretary shall 

19 make any revisions to an authorization under this 

20 section available on the Internet Web site of the Food 

21 and Drug Administration.’’; and 

22 (8) by adding at the end of subsection (j) the fol23 lowing: 

24 ‘‘(4) Nothing in this section shall be construed as 

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1 ation by the Food and Drug Administration of any 

2 application pending before the Administration for a 

3 countermeasure or product referred to in subsection 

4 (a).’’. 

5 (b) EMERGENCY USE OF MEDICAL PRODUCTS.—Sub6 chapter E of chapter V of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 360bbb et seq.) is amended by insert8 ing after section 564 the following: 

9 ‘‘SEC. 564A. EMERGENCY USE OF MEDICAL PRODUCTS. 

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

11 ‘‘(1) ELIGIBLE PRODUCT.—The term ‘eligible 

12 product’ means a product that— 

13 ‘‘(A) is approved or cleared under this 

14 chapter or licensed under section 351 of the Pub15 lic Health Service Act; 

16 ‘‘(B)(i) is intended for use to prevent, diag17 nose, or treat a disease or condition involving a 

18 biological, chemical, radiological, or nuclear 

19 agent or agents, including a product intended to 

20 be used to prevent or treat pandemic influenza; 

21 or 

22 ‘‘(ii) is intended for use to prevent, diag23 nose, or treat a serious or life-threatening disease 

24 or condition caused by a product described in 

25 clause (i); and 


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1 ‘‘(C) is intended for use during the cir2 cumstances under which— 

3 ‘‘(i) a determination described in sub4 paragraph (A), (B), or (C) of section 

5 564(b)(1) has been made by the Secretary of 

6 Homeland Security, the Secretary of De7 fense, or the Secretary, respectively; or 

8 ‘‘(ii) the identification of a material 

9 threat described in subparagraph (D) of sec10 tion 564(b)(1) has been made pursuant to 

11 section 319F–2 of the Public Health Service 

12 Act. 

13 ‘‘(2) PRODUCT.—The term ‘product’ means a 

14 drug, device, or biological product. 

15 ‘‘(b) EXTENSION OF EXPIRATION DATE.— 

16 ‘‘(1) AUTHORITY TO EXTEND EXPIRATION

17 DATE.—The Secretary may extend the expiration date 

18 of an eligible product in accordance with this sub19 section. 

20 ‘‘(2) EXPIRATION DATE.—For purposes of this 

21 subsection, the term ‘expiration date’ means the date 

22 established through appropriate stability testing re23 quired by the regulations issued by the Secretary to 

24 ensure that the product meets applicable standards of 


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1 identity, strength, quality, and purity at the time of 

2 use. 

3 ‘‘(3) EFFECT OF EXTENSION.—Notwithstanding 

4 any other provision of this Act or the Public Health 

5 Service Act, if the expiration date of an eligible prod6 uct is extended in accordance with this section, the 

7 introduction or delivery for introduction into inter8 state commerce of such product after the expiration 

9 date provided by the manufacturer and within the 

10 duration of such extension shall not be deemed to 

11 render the product— 

12 ‘‘(A) an unapproved product; or 

13 ‘‘(B) adulterated or misbranded under this 

14 Act. 

15 ‘‘(4) DETERMINATIONS BY SECRETARY.—Before 

16 extending the expiration date of an eligible product 

17 under this subsection, the Secretary shall determine— 

18 ‘‘(A) that extension of the expiration date 

19 will help protect public health; 

20 ‘‘(B) that any extension of expiration is 

21 supported by scientific evaluation that is con22 ducted or accepted by the Secretary; 

23 ‘‘(C) what changes to the product labeling, 

24 if any, are required or permitted, including 

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1 municating the extension of the expiration date 

2 may alter or obscure the labeling provided by the 

3 manufacturer; and 

4 ‘‘(D) that any other conditions that the Sec5 retary deems appropriate have been met. 

6 ‘‘(5) SCOPE OF EXTENSION.—With respect to 

7 each extension of an expiration date granted under 

8 this subsection, the Secretary shall determine— 

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

10 extension shall apply; 

11 ‘‘(B) the duration of such extension; and 

12 ‘‘(C) any conditions to effectuate such exten13 sion that are necessary and appropriate to pro14 tect public health or safety. 

15 ‘‘(c) CURRENT GOOD MANUFACTURING PRACTICE.— 

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

17 the circumstances of a domestic, military, or public 

18 health emergency or material threat described in sub19 section (a)(1)(C) so warrant, authorize, with respect 

20 to an eligible product, deviations from current good 

21 manufacturing practice requirements otherwise appli22 cable to the manufacture, processing, packing, or 

23 holding of products subject to regulation under this 

24 Act, including requirements under section 501 or 

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1 spect to the eligible product by an order under section 

2 520(f)(2). 

3 ‘‘(2) EFFECT.—Notwithstanding any other pro4 vision of this Act or the Public Health Service Act, 

5 an eligible product shall not be considered an unap6 proved product and shall not be deemed adulterated 

7 or misbranded under this Act because, with respect to 

8 such product, the Secretary has authorized deviations 

9 from current good manufacturing practices under 

10 paragraph (1). 

11 ‘‘(d) EMERGENCY USE INSTRUCTIONS.— 

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

13 through an appropriate official within the Depart14 ment of Health and Human Services, may create and 

15 issue emergency use instructions to inform health care 

16 providers or individuals to whom an eligible product 

17 is to be administered concerning such product’s ap18 proved, licensed, or cleared conditions of use. 

19 ‘‘(2) EFFECT.—Notwithstanding any other pro20 visions of this Act or the Public Health Service Act, 

21 a product shall not be considered an unapproved 

22 product and shall not be deemed adulterated or mis23 branded under this Act because of the issuance of 

24 emergency use instructions under paragraph (1) with 

25 respect to such product or the introduction or delivery 


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1 for introduction of such product into interstate com2 merce accompanied by such instructions— 

3 ‘‘(A) during an emergency response to an 

4 actual emergency that is the basis for a deter5 mination described in subsection (a)(1)(C)(i); or 

6 ‘‘(B) by a government entity (including a 

7 Federal, State, local, and tribal government enti8 ty), or a person acting on behalf of such a gov9 ernment entity, in preparation for an emergency 

10 response.’’. 

11 (c) RISK EVALUATION AND MITIGATION STRATE12 GIES.—Section 505–1 of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 355–1), is amended— 

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

15 and 

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

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

18 The Secretary may waive any requirement of this section 

19 with respect to a qualified countermeasure (as defined in 

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

21 which a requirement under this section has been applied, 

22 if the Secretary determines that such waiver is required to 

23 mitigate the effects of, or reduce the severity of, the cir24 cumstances under which— 


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1 ‘‘(1) a determination described in subparagraph 

2 (A), (B), or (C) of section 564(b)(1) has been made 

3 by the Secretary of Homeland Security, the Secretary 

4 of Defense, or the Secretary, respectively; or 

5 ‘‘(2) the identification of a material threat de6 scribed in subparagraph (D) of section 564(b)(1) has 

7 been made pursuant to section 319F–2 of the Public 

8 Health Service Act.’’. 

9 (d) PRODUCTS HELD FOR EMERGENCY USE.—The 

10 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

11 seq.) is amended by inserting after section 564A, as added 

12 by subsection (b), the following: 

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

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

15 the Public Health Service Act for a government entity (in16 cluding a Federal, State, local, and tribal government enti17 ty), or a person acting on behalf of such a government enti18 ty, to introduce into interstate commerce a product (as de19 fined in section 564(a)(4)) intended for emergency use, if 

20 that product— 

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

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

23 product— 


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

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

3 351 of the Public Health Service Act; 

4 ‘‘(B) is authorized for investigational use 

5 under section 505 or 520 of this Act or section 

6 351 of the Public Health Service Act; or 

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

8 564.’’. 

9 SEC. 303. DEFINITIONS. 

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

11 Act (21 U.S.C. 360bbb–4) is amended by striking ‘‘The Sec12 retary, in consultation’’ and inserting the following: 

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

14 ‘‘(1) the term ‘countermeasure’ means a qualified 

15 countermeasure, a security countermeasure, and a 

16 qualified pandemic or epidemic product; 

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

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

19 Public Health Service Act; 

20 ‘‘(3) the term ‘security countermeasure’ has the 

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

22 Act; and 

23 ‘‘(4) the term ‘qualified pandemic or epidemic 

24 product’ means a product that meets the definition 


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1 given such term in section 319F–3 of the Public 

2 Health Service Act and— 

3 ‘‘(A) that has been identified by the Depart4 ment of Health and Human Services or the De5 partment of Defense as receiving funding directly 

6 related to addressing chemical, biological, radio7 logical or nuclear threats, including pandemic 

8 influenza; or 

9 ‘‘(B) is included under this paragraph pur10 suant to a determination by the Secretary. 

11 ‘‘(b) GENERAL DUTIES.—The Secretary, in consulta12 tion’’. 

13 SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVI14 TIES. 

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

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

17 further amended— 

18 (1) in the section heading, by striking ‘‘TECH19 NICAL ASSISTANCE’’ and inserting ‘‘COUNTER20 MEASURE DEVELOPMENT, REVIEW, AND TECH21 NICAL ASSISTANCE’’; 

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

23 heading and all that follows through ‘‘shall establish’’ 

24 and inserting the following: 


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1 ‘‘(b) GENERAL DUTIES.—In order to accelerate the de2 velopment, stockpiling, approval, licensure, and clearance 

3 of qualified countermeasures, security countermeasures, and 

4 qualified pandemic or epidemic products, the Secretary, in 

5 consultation with the Assistant Secretary for Preparedness 

6 and Response, shall— 

7 ‘‘(1) ensure the appropriate involvement of Food 

8 and Drug Administration personnel in interagency 

9 activities related to countermeasure advanced research 

10 and development, consistent with sections 319F, 

11 319F–1, 319F–2, 319F–3, and 319L of the Public 

12 Health Service Act; 

13 ‘‘(2) ensure the appropriate involvement and 

14 consultation of Food and Drug Administration per15 sonnel in any flexible manufacturing activities car16 ried out under section 319L of the Public Health 

17 Service Act, including with respect to meeting regu18 latory requirements set forth in this Act; 

19 ‘‘(3) promote countermeasure expertise within 

20 the Food and Drug Administration by— 

21 ‘‘(A) ensuring that Food and Drug Admin22 istration personnel involved in reviewing coun23 termeasures for approval, licensure, or clearance 

24 are informed by the Assistant Secretary for Pre25 paredness and Response on the material threat 


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1 assessment conducted under section 319F–2 of 

2 the Public Health Service Act for the agent or 

3 agents for which the countermeasure under re4 view is intended; 

5 ‘‘(B) training Food and Drug Administra6 tion personnel regarding review of counter7 measures for approval, licensure, or clearance; 

8 ‘‘(C) holding public meetings at least twice 

9 annually to encourage the exchange of scientific 

10 ideas; and 

11 ‘‘(D) establishing protocols to ensure that 

12 countermeasure reviewers have sufficient train13 ing or experience with countermeasures; 

14 ‘‘(4) maintain teams, composed of Food and 

15 Drug Administration personnel with expertise on 

16 countermeasures, including specific countermeasures, 

17 populations with special clinical needs (including 

18 children and pregnant women that may use counter19 measures, as applicable and appropriate), classes or 

20 groups of countermeasures, or other countermeasure21 related technologies and capabilities, that shall— 

22 ‘‘(A) consult with countermeasure experts, 

23 including countermeasure sponsors and appli24 cants, to identify and help resolve scientific 

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1 ance of countermeasures, through workshops or 

2 public meetings; 

3 ‘‘(B) improve and advance the science relat4 ing to the development of new tools, standards, 

5 and approaches to assessing and evaluating 

6 countermeasures— 

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

8 countermeasure approval, clearance, and li9 censure; and 

10 ‘‘(ii) with respect to the development of 

11 countermeasures for populations with spe12 cial clinical needs, including children and 

13 pregnant women, in order to meet the needs 

14 of such populations, as necessary and ap15 propriate; and 

16 ‘‘(5) establish’’; and 

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

18 ‘‘(c) DEVELOPMENT AND ANIMAL MODELING PROCE19 DURES.— 

20 ‘‘(1) AVAILABILITY OF ANIMAL MODEL MEET21 INGS.—To facilitate the timely development of animal 

22 models and support the development, stockpiling, li23 censure, approval, and clearance of countermeasures, 

24 the Secretary shall, not later than 180 days after the 

25 enactment of this subsection, establish a procedure by 


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1 which a sponsor or applicant that is developing a 

2 countermeasure for which human efficacy studies are 

3 not ethical or practicable, and that has an approved 

4 investigational new drug application or investiga5 tional device exemption, may request and receive— 

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

7 model development activities; and 

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

9 animal studies. 

10 ‘‘(2) PEDIATRIC MODELS.—To facilitate the de11 velopment and selection of animal models that could 

12 translate to pediatric studies, any meeting conducted 

13 under paragraph (1) shall include discussion of ani14 mal models for pediatric populations, as appropriate. 

15 ‘‘(d) REVIEW AND APPROVAL OF COUNTER16 MEASURES.— 

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

18 application or submission for approval, licensure, or 

19 clearance of a countermeasure, the Secretary shall 

20 take into account the material threat posed by the 

21 chemical, biological, radiological, or nuclear agent or 

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

23 Health Service Act for which the countermeasure 

24 under review is intended. 


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

2 and appropriate, teams of Food and Drug Adminis3 tration personnel reviewing applications or submis4 sions described under paragraph (1) shall include a 

5 reviewer with sufficient training or experience with 

6 countermeasures pursuant to the protocols established 

7 under subsection (b)(3)(D).’’. 

8 SEC. 305. REGULATORY MANAGEMENT PLANS. 

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

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

11 further amended by adding at the end the following: 

12 ‘‘(e) REGULATORY MANAGEMENT PLAN.— 

13 ‘‘(1) DEFINITION.—In this subsection, the term 

14 ‘eligible countermeasure’ means— 

15 ‘‘(A) a security countermeasure with respect 

16 to which the Secretary has entered into a pro17 curement contract under section 319F-2(c) of the 

18 Public Health Service Act; or 

19 ‘‘(B) a countermeasure with respect to 

20 which the Biomedical Advanced Research and 

21 Development Authority has provided funding 

22 under section 319L of the Public Health Service 

23 Act for advanced research and development. 

24 ‘‘(2) REGULATORY MANAGEMENT PLAN PROC25 ESS.—The Secretary, in consultation with the AssistVerDate Mar 15 2010 01:43 Dec 17, 2011 Jkt 019200 PO 00000 Frm 00120 Fmt 6652 Sfmt 6203 E:\BILLS\S1855.RS S1855

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1 ant Secretary for Preparedness and Response and the 

2 Director of the Biomedical Advanced Research and 

3 Development Authority, shall establish a formal proc4 ess for obtaining scientific feedback and interactions 

5 regarding the development and regulatory review of 

6 eligible countermeasures by facilitating the develop7 ment of written regulatory management plans in ac8 cordance with this subsection. 

9 ‘‘(3) SUBMISSION OF REQUEST AND PROPOSED

10 PLAN BY SPONSOR OR APPLICANT.— 

11 ‘‘(A) IN GENERAL.—A sponsor or applicant 

12 of an eligible countermeasure may initiate the 

13 process described under paragraph (2) upon sub14 mission of written request to the Secretary. Such 

15 request shall include a proposed regulatory man16 agement plan. 

17 ‘‘(B) TIMING OF SUBMISSION.—A sponsor 

18 or applicant may submit a written request 

19 under subparagraph (A) after the eligible coun20 termeasure has an investigational new drug or 

21 investigational device exemption in effect. 

22 ‘‘(C) RESPONSE BY SECRETARY.—The Sec23 retary shall direct the Food and Drug Adminis24 tration, upon submission of a written request by 

25 a sponsor or applicant under subparagraph (A), 


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1 to work with the sponsor or applicant to agree 

2 on a regulatory management plan within a rea3 sonable time not to exceed 90 days. If the Sec4 retary determines that no plan can be agreed 

5 upon, the Secretary shall provide to the sponsor 

6 or applicant, in writing, the scientific or regu7 latory rationale why such agreement cannot be 

8 reached. 

9 ‘‘(4) PLAN.—The content of a regulatory man10 agement plan agreed to by the Secretary and a spon11 sor or applicant shall include— 

12 ‘‘(A) an agreement between the Secretary 

13 and the sponsor or applicant regarding develop14 mental milestones that will trigger responses by 

15 the Secretary as described in subparagraph (B); 

16 ‘‘(B) performance targets and goals for 

17 timely and appropriate responses by the Sec18 retary to the triggers described under subpara19 graph (A), including meetings between the Sec20 retary and the sponsor or applicant, written 

21 feedback, decisions by the Secretary, and other 

22 activities carried out as part of the development 

23 and review process; and 

24 ‘‘(C) an agreement on how the plan shall be 

25 modified, if needed. 


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1 ‘‘(5) MILESTONES AND PERFORMANCE TAR2 GETS.—The developmental milestones described in 

3 paragraph (4)(A) and the performance targets and 

4 goals described in paragraph (4)(B) shall include— 

5 ‘‘(A) feedback from the Secretary regarding 

6 the data required to support the approval, clear7 ance, or licensure of the eligible countermeasure 

8 involved; 

9 ‘‘(B) feedback from the Secretary regarding 

10 the data necessary to inform any authorization 

11 under section 564; 

12 ‘‘(C) feedback from the Secretary regarding 

13 the data necessary to support the positioning 

14 and delivery of the eligible countermeasure, in15 cluding to the Strategic National Stockpile; 

16 ‘‘(D) feedback from the Secretary regarding 

17 the data necessary to support the submission of 

18 protocols for review under section 505(b)(5)(B); 

19 ‘‘(E) feedback from the Secretary regarding 

20 any gaps in scientific knowledge that will need 

21 resolution prior to approval, licensure, or clear22 ance of the eligible countermeasure, and plans 

23 for conducting the necessary scientific research; 

24 ‘‘(F) identification of the population for 

25 which the countermeasure sponsor or applicant 


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1 seeks approval, licensure, or clearance, and the 

2 population for which desired labeling would not 

3 be appropriate, if known; and 

4 ‘‘(G) as necessary and appropriate, and to 

5 the extent practicable, a plan for demonstrating 

6 safety and effectiveness in pediatric populations, 

7 and for developing pediatric dosing, formulation, 

8 and administration with respect to the eligible 

9 countermeasure, provided that such plan would 

10 not delay authorization under section 564, ap11 proval, licensure, or clearance for adults. 

12 ‘‘(6) PRIORITIZATION.—If the Commissioner of 

13 Food and Drugs determines that resources are not 

14 available to establish regulatory management plans 

15 under this section for all eligible countermeasures for 

16 which a request is submitted under paragraph (3)(A), 

17 the Director of the Biomedical Advanced Research 

18 and Development Authority, in consultation with the 

19 Commissioner of Food and Drugs, shall prioritize 

20 which eligible countermeasures may receive regulatory 

21 managements plans, and in doing so shall give pri22 ority to eligible countermeasures that are security 

23 countermeasures.’’. 


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1 SEC. 306. REPORT. 

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

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

4 further amended by adding at the end the following: 

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

6 the date of enactment of this subsection, and annually there7 after, the Secretary shall submit to the Committee on 

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

9 the Committee on Energy and Commerce of the House of 

10 Representatives a report that details the countermeasure de11 velopment and review activities of the Food and Drug Ad12 ministration, including— 

13 ‘‘(1) with respect to the development of new tools, 

14 standards, and approaches to assess and evaluate 

15 countermeasures— 

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

17 the Food and Drug Administration and the 

18 progress made on such priorities; and 

19 ‘‘(B) the identification of scientific gaps 

20 that impede the development or approval, licen21 sure, or clearance of countermeasures for popu22 lations with special clinical needs, including 

23 children and pregnant women, and the progress 

24 made on resolving these challenges; 

25 ‘‘(2) with respect to countermeasures for which a 

26 regulatory management plan has been agreed upon 


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1 under subsection (e), the extent to which the perform2 ance targets and goals set forth in subsection 

3 (e)(4)(B) and the regulatory management plan has 

4 been met, including, for each such countermeasure— 

5 ‘‘(A) whether the regulatory management 

6 plan was completed within the required time7 frame, and the length of time taken to complete 

8 such plan; 

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

10 timely and appropriate response times set forth 

11 in such plan; and 

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

13 such performance targets and goals; 

14 ‘‘(3) the number of regulatory teams established 

15 pursuant to subsection (b)(4), the number of products, 

16 classes of products, or technologies assigned to each 

17 such team, and the number of, type of, and any 

18 progress made as a result of consultations carried out 

19 under subsection (b)(4)(A); 

20 ‘‘(4) an estimate of resources obligated to coun21 termeasure development and regulatory assessment, 

22 including Center specific objectives and accomplish23 ments; 

24 ‘‘(5) the number of countermeasure applications 

25 submitted, the number of countermeasures approved, 


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1 licensed, or cleared, the status of remaining submitted 

2 applications, and the number of each type of author3 ization issued pursuant to section 564; and 

4 ‘‘(6) the number of written requests for a regu5 latory management plan submitted under subsection 

6 (e)(3)(A), the number of regulatory management 

7 plans developed, and the number of such plans devel8 oped for security countermeasures.’’. 

9 SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES. 

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

11 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) 

12 is amended— 

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

14 following: 

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

16 that is a qualified countermeasure (as defined in sec17 tion 319F–1 of the Public Health Service Act), a secu18 rity countermeasure (as defined in section 319F–2 of 

19 the Public Health Service Act), or a qualified pan20 demic or epidemic product (as defined in section 

21 319F–3 of the Public Health Service Act), the Sec22 retary shall solicit input from the Assistant Secretary 

23 for Preparedness and Response regarding the need for 

24 and, from the Director of the Biomedical Advanced 


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1 Research and Development Authority regarding the 

2 conduct of, pediatric studies under this section.’’; and 

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

4 following: 

5 ‘‘(C) For a drug that is a qualified counter6 measure (as defined in section 319F–1 of the 

7 Public Health Service Act), a security counter8 measure (as defined in section 319F–2 of the 

9 Public Health Service Act), or a qualified pan10 demic or epidemic product (as defined in section 

11 319F–3 of such Act), in addition to any action 

12 with respect to such drug under subparagraph 

13 (A) or (B), the Secretary shall notify the Assist14 ant Secretary for Preparedness and Response 

15 and the Director of the Biomedical Advanced Re16 search and Development Authority of all pedi17 atric studies in the written request issued by the 

18 Commissioner of Food and Drugs.’’. 

19 (b) ADDITION TO PRIORITY LIST CONSIDERATIONS.— 

20 Section 409I of the Public Health Service Act (42 U.S.C. 

21 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 that 

6 may include developmental pharmacology, 

7 pharmacogenetic determinants of drug re8 sponse, metabolism of drugs and biologics in 

9 children, and pediatric clinical trials; 

10 ‘‘(ii) particular pediatric diseases, dis11 orders or conditions where more complete 

12 knowledge and testing of therapeutics, in13 cluding drugs and biologics, may be bene14 ficial in pediatric populations; and 

15 ‘‘(iii) the adequacy of necessary infra16 structure to conduct pediatric pharma17 cological research, including research net18 works and trained pediatric investigators; 

19 and 

20 ‘‘(B) may consider the availability of quali21 fied countermeasures (as defined in section 

22 319F–1), security countermeasures (as defined in 

23 section 319F–2), and qualified pandemic or epi24 demic products (as defined in section 319F–3) to 

25 address the needs of pediatric populations, in 


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1 consultation with the Assistant Secretary for 

2 Preparedness and Response, consistent with the 

3 purposes of this section.’’; and 

4 (2) in subsection (b), by striking ‘‘subsection (a)’’ 

5 and inserting ‘‘paragraphs (1) and (2)(A) of sub6 section (a)’’. 

7 (c) ADVICE AND RECOMMENDATIONS OF THE PEDI8 ATRIC ADVISORY COMMITTEE REGARDING COUNTER9 MEASURES FOR PEDIATRIC POPULATIONS.—Subsection 

10 (b)(2) of section 14 of the Best Pharmaceuticals for Children 

11 Act (42 U.S.C. 284m note) is amended— 

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

13 and inserting ‘‘; and’’; and 

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

15 ‘‘(D) the development of countermeasures 

16 (as defined in section 565(a) of the Federal Food, 

17 Drug, and Cosmetic Act) for pediatric popu18 lations.’’. 

19 TITLE IV—ACCELERATING MED20 ICAL COUNTERMEASURE AD21 VANCED RESEARCH AND DE22 VELOPMENT 

23 SEC. 401. BIOSHIELD. 

24 (a) REAUTHORIZATION OF THE SPECIAL RESERVE

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


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1 (42 U.S.C. 247d-6b(c)) is amended by adding at the end 

2 the following: 

3 ‘‘(11) REAUTHORIZATION OF THE SPECIAL RE4 SERVE FUND.—In addition to amounts otherwise ap5 propriated, there are authorized to be appropriated 

6 for the special reserve fund, $2,800,000,000 for the fis7 cal years 2014 through 2018. 

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

9 any date on which the Secretary determines that the 

10 amount of funds in the special reserve fund available 

11 for procurement is less than $1,500,000,000, the Sec12 retary shall submit to the appropriate committees of 

13 Congress a report detailing the amount of such funds 

14 available for procurement and the impact such reduc15 tion in funding will have— 

16 ‘‘(A) in meeting the security countermeasure 

17 needs identified under this section; and 

18 ‘‘(B) on the biennial Public Health Emer19 gency Medical Countermeasures Enterprise and 

20 Strategy Implementation Plan (pursuant to sec21 tion 2811(d)).’’. 

22 (b) PROCUREMENT OF COUNTERMEASURES.—Section 

23 319F–2(c) of the Public Health Service Act (42 U.S.C. 

24 247d–6b(c)) is amended— 


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

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

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

4 years’’ and inserting ‘‘10 years’’; 

5 (3) in paragraph (7)(C)— 

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

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

8 may reasonably be required,’’; 

9 (B) in clause (ii)— 

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

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

12 (ii) by striking subclause (IX) and in13 serting the following: 

14 ‘‘(IX) CONTRACT TERMS.—The 

15 Secretary, in any contract for procure16 ment under this section— 

17 ‘‘(aa) may specify— 

18 ‘‘(AA) the dosing and 

19 administration requirements 

20 for the countermeasure to be 

21 developed and procured; 

22 ‘‘(BB) the amount of 

23 funding that will be dedi24 cated by the Secretary for 

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1 ment, and procurement of the 

2 countermeasure; and 

3 ‘‘(CC) the specifications 

4 the countermeasure must 

5 meet to qualify for procure6 ment under a contract under 

7 this section; and 

8 ‘‘(bb) shall provide a clear 

9 statement of defined Government 

10 purpose limited to uses related to 

11 a security countermeasure, as de12 fined in paragraph (1)(B).’’; and 

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

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

15 this section, the Secretary may, consistent 

16 with the applicable provisions of this sec17 tion, enter into contracts and other agree18 ments that are in the best interest of the 

19 Government in meeting identified security 

20 countermeasure needs, including with re21 spect to reimbursement of the cost of ad22 vanced research and development as a rea23 sonable, allowable, and allocable direct cost 

24 of the contract involved.’’; 


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

2 period the following: ‘‘, except that this subparagraph 

3 shall not be construed to prohibit the use of such 

4 amounts as otherwise authorized in this title’’; and 

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

6 following: 

7 ‘‘(C) ADVANCED RESEARCH AND DEVELOP8 MENT.—For purposes of this paragraph, the 

9 term ‘advanced research and development’ shall 

10 have the meaning given such term in section 

11 319L(a).’’. 

12 SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVEL13 OPMENT AUTHORITY. 

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

15 Service Act (42 U.S.C. 247d–7e(c)(4)) is amended— 

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

17 ‘‘(which may include advanced research and develop18 ment for purposes of fulfilling requirements under the 

19 Federal Food, Drug, and Cosmetic Act or section 351 

20 of this Act)’’ after ‘‘development’’; and 

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

22 vaccine manufacturing technologies’’ and inserting 

23 ‘‘vaccine manufacturing technologies, dose sparing 

24 technologies, efficacy increasing technologies, and 

25 platform technologies’’. 


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1 (b) STRATEGIC PUBLIC-PRIVATE PARTNERSHIP.—Sec2 tion 319L(c)(4) of the Public Health Service Act (42 U.S.C. 

3 247d-7e(c)(4)) is amended by adding at the end the fol4 lowing: 

5 ‘‘(E) STRATEGIC INVESTOR.— 

6 ‘‘(i) IN GENERAL.—To support the 

7 purposes described in paragraph (2), the 

8 Secretary, acting through the Director of 

9 BARDA, may enter into an agreement (in10 cluding through the use of grants, contracts, 

11 cooperative agreements, or other trans12 actions as described in paragraph (5)) with 

13 an independent, non-profit entity to— 

14 ‘‘(I) foster and accelerate the de15 velopment and innovation of medical 

16 countermeasures and technologies that 

17 may assist advanced research and de18 velopment of qualified countermeasures 

19 and qualified pandemic or epidemic 

20 products, including strategic invest21 ment through the use of venture capital 

22 practices and methods; 

23 ‘‘(II) promote the development of 

24 new and promising technologies that 


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1 address urgent medical countermeasure 

2 needs, as identified by the Secretary; 

3 ‘‘(III) address unmet public 

4 health needs that are directly related to 

5 medical countermeasure requirements, 

6 such as novel antimicrobials for 

7 multidrug resistant organisms and 

8 multiuse platform technologies for 

9 diagnostics, prophylaxis, vaccines, and 

10 therapeutics; and 

11 ‘‘(IV) provide expert consultation 

12 and advice to foster viable medical 

13 countermeasure innovators, including 

14 helping qualified countermeasure 

15 innovators navigate unique industry 

16 challenges with respect to developing 

17 chemical, biological, radiological, and 

18 nuclear countermeasure products. 

19 ‘‘(ii) ELIGIBILITY.— 

20 ‘‘(I) IN GENERAL.—To be eligible 

21 to enter into an agreement under 

22 clause (i) an entity shall— 

23 ‘‘(aa) be an independent, 

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1 filiated with the Department of 

2 Health and Human Services; 

3 ‘‘(bb) have a demonstrated 

4 record of being able to create link5 ages between innovators and in6 vestors and leverage such partner7 ships and resources for the pur8 pose of addressing identified stra9 tegic needs of the Federal Govern10 ment; 

11 ‘‘(cc) have experience in pro12 moting novel technology innova13 tion; 

14 ‘‘(dd) be problem driven and 

15 solution focused based on the 

16 needs, requirements, and problems 

17 identified by the Secretary under 

18 clause (iv); 

19 ‘‘(ee) demonstrate the ability, 

20 or the potential ability, to pro21 mote the development of medical 

22 countermeasure products; and 

23 ‘‘(ff) demonstrate expertise, 

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1 nical and regulatory consider2 ations with respect to medical 

3 countermeasures. 

4 ‘‘(II) PARTNERING EXPERI5 ENCE.—In selecting an entity with 

6 which to enter into an agreement 

7 under clause (i), the Secretary shall 

8 place a high value on the demonstrated 

9 experience of the entity in partnering 

10 with the Federal Government to meet 

11 identified strategic needs. 

12 ‘‘(iii) NOT AGENCY.—An entity that 

13 enters into an agreement under clause (i) 

14 shall not be deemed to be a Federal agency 

15 for any purpose, including for any purpose 

16 under title 5, United States Code. 

17 ‘‘(iv) DIRECTION.—Pursuant to an 

18 agreement entered into under this subpara19 graph, the Secretary, acting through the Di20 rector of BARDA, shall provide direction to 

21 the entity that enters into an agreement 

22 under clause (i). As part of this agreement 

23 the Director of BARDA shall— 

24 ‘‘(I) communicate the medical 

25 countermeasure needs, requirements, 


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1 and problems to be addressed by the 

2 entity under the agreement; 

3 ‘‘(II) develop a description of 

4 work to be performed by the entity 

5 under the agreement; 

6 ‘‘(III) provide technical feedback 

7 and appropriate oversight over work 

8 carried out by the entity under the 

9 agreement, including subsequent devel10 opment and partnerships consistent 

11 with the needs and requirements set 

12 forth in this subparagraph; 

13 ‘‘(IV) ensure fair consideration of 

14 products developed under the agree15 ment in order to maintain competition 

16 to the maximum practical extent, as 

17 applicable and appropriate under ap18 plicable provisions of this section; and 

19 ‘‘(V) ensure, as a condition of the 

20 agreement— 

21 ‘‘(aa) a comprehensive set of 

22 policies that demonstrate a com23 mitment to transparency and ac24 countability; 


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1 ‘‘(bb) protection against con2 flicts of interest through a com3 prehensive set of policies that ad4 dress potential conflicts of inter5 est, ethics, disclosure, and report6 ing requirements; 

7 ‘‘(cc) that the entity provides 

8 monthly accounting on the use of 

9 funds provided under such agree10 ment; and 

11 ‘‘(dd) that the entity provides 

12 on a quarterly basis, reports re13 garding the progress made toward 

14 meeting the identified needs set 

15 forth in the agreement. 

16 ‘‘(v) SUPPLEMENT NOT SUPPLANT.— 

17 Activities carried out under this subpara18 graph shall supplement, and not supplant, 

19 other activities carried out under this sec20 tion. 

21 ‘‘(vi) NO ESTABLISHMENT OF ENTI22 TY.—To prevent unnecessary duplication 

23 and target resources effectively, nothing in 

24 this subparagraph shall be construed to au25 thorize the Secretary to establish within the 


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1 Department of Health and Human Services 

2 a strategic investor entity. 

3 ‘‘(vii) TRANSPARENCY AND OVER4 SIGHT.—Upon request, the Secretary shall 

5 provide to Congress the information pro6 vided to the Secretary under clause 

7 (iv)(V)(dd). 

8 ‘‘(viii) INDEPENDENT EVALUATION.— 

9 Not later than 4 years after the date of en10 actment of this subparagraph, the Govern11 ment Accountability Office shall conduct an 

12 independent evaluation, and submit to the 

13 Secretary and the appropriate committees 

14 of Congress a report, concerning the activi15 ties conducted under this subparagraph. 

16 Such report shall include recommendations 

17 with respect to any agreement or activities 

18 carried out pursuant to this subparagraph. 

19 ‘‘(ix) SUNSET.—This subparagraph 

20 shall have no force or effect after September 

21 30, 2016.’’. 

22 (c) TRANSACTION AUTHORITIES.—Section 319L(c)(5) 

23 of the Public Health Service Act (42 U.S.C. 247d–7e(c)(5)) 

24 is amended by adding at the end the following: 


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1 ‘‘(G) GOVERNMENT PURPOSE.—In award2 ing contracts, grants, and cooperative agreements 

3 under this section, the Secretary shall provide a 

4 clear statement of defined Government purpose 

5 related to activities included in subsection 

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

7 qualified pandemic or epidemic product.’’. 

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

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

10 amended to read as follows: 

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

12 this section, there is authorized to be appropriated to 

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

14 through 2016, such amounts to remain available until 

15 expended.’’. 

16 (e) CONTINUED INAPPLICABILITY OF CERTAIN PROVI17 SIONS.—Section 319L(e)(1)(C) of the Public Health Service 

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

19 ‘‘7 years’’ and inserting ‘‘10 years’’. 

20 (f) EXTENSION OF LIMITED ANTITRUST EXEMP21 TION.—Section 405(b) of the Pandemic and All-Hazards 

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

23 striking ‘‘6-year’’ and inserting ‘‘10-year’’. 


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1 (g) INDEPENDENT EVALUATION.—Section 319L of the 

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

3 by adding at the end the following: 

4 ‘‘(f) INDEPENDENT EVALUATION.— 

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

6 after the date of enactment of this subsection, the Gov7 ernment Accountability Office shall conduct an inde8 pendent evaluation of the activities carried out to fa9 cilitate flexible manufacturing capacity pursuant to 

10 this section. 

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

12 date of enactment of this subsection, the Government 

13 Accountability Office shall submit to the appropriate 

14 committees of Congress a report concerning the results 

15 of the evaluation conducted under paragraph (1). 

16 Such report shall review and assess— 

17 ‘‘(A) the extent to which flexible manufac18 turing capacity under this section is dedicated to 

19 chemical, biological, radiological, and nuclear 

20 threats; 

21 ‘‘(B) the activities supported by flexible 

22 manufacturing initiatives; and 

23 ‘‘(C) the ability of flexible manufacturing 

24 activities carried out under this section to— 


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1 ‘‘(i) secure and leverage leading tech2 nical expertise with respect to counter3 measure advanced research, development, 

4 and manufacturing processes; and 

5 ‘‘(ii) meet the surge manufacturing ca6 pacity needs presented by novel and emerg7 ing threats, including chemical, biological, 

8 radiological and nuclear agents.’’. 

9 (h) DEFINITIONS.— 

10 (1) QUALIFIED COUNTERMEASURE.—Section 

11 319F–1(a)(2)(A) of the Public Health Service Act (42 

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

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

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

15 (B) in clause (i)— 

16 (i) by striking ‘‘diagnose’’ and insert17 ing ‘‘to diagnose’’; and 

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

19 semicolon; 

20 (C) in clause (ii)— 

21 (i) by striking ‘‘diagnose’’ and insert22 ing ‘‘to diagnose’’; and 

23 (ii) by striking the period at the end 

24 and inserting ‘‘; or’’; and 

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


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1 ‘‘(iii) is a product or technology in2 tended to enhance the use or effect of a drug, 

3 biological product, or device described in 

4 clause (i) or (ii).’’. 

5 (2) QUALIFIED PANDEMIC OR EPIDEMIC PROD6 UCT.—Section 319F–3(i)(7)(A) of the Public Health 

7 Service Act (42 U.S.C. 247d–6d(i)(7)(A)) is amend8 ed— 

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

10 inserting ‘‘;’’; 

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

12 inserting ‘‘; or’’; and 

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

14 ‘‘(iii) a product or technology intended 

15 to enhance the use or effect of a drug, bio16 logical product, or device described in clause 

17 (i) or (ii); and’’. 

18 (3) TECHNICAL AMENDMENTS.—Section 319F– 

19 3(i) of the Public Health Service Act (42 U.S.C. 

20 247d–6d(i)) is amended— 

21 (A) in paragraph (1)(C), by inserting ‘‘, 

22 564A, or 564B’’ after ‘‘564’’; and 

23 (B) in paragraph (7)(B)(iii), by inserting 

24 ‘‘, 564A, or 564B’’ after ‘‘564’’. 


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1 SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

2 (a) IN GENERAL.—Section 319F–2 of the Public 

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

4 (1) in subsection (a)— 

5 (A) in paragraph (1)— 

6 (i) by inserting ‘‘consistent with sec7 tion 2811’’ before ‘‘by the Secretary to be 

8 appropriate’’; and 

9 (ii) by inserting before the period at 

10 the end the following: ‘‘and shall submit 

11 such review annually to the appropriate 

12 Congressional committees of jurisdiction to 

13 the extent that disclosure of such informa14 tion does not compromise national secu15 rity’’; and 

16 (B) in paragraph (2)— 

17 (i) by redesignating subparagraphs (E) 

18 through (H) as subparagraphs (F) through 

19 (I), respectively; and 

20 (ii) by inserting after subparagraph 

21 (D), the following: 

22 ‘‘(E) identify and address the potential de23 pletion and ensure appropriate replenishment of 

24 medical countermeasures, including those cur25 rently in the stockpile;’’; and 


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

2 ‘‘$640,000,000 for fiscal year 2002, and such sums as 

3 may be necessary for each of fiscal years 2003 through 

4 2006’’ and inserting ‘‘$522,486,000 for each of fiscal 

5 years 2012 through 2016’’. 

6 (b) REPORT ON POTASSIUM IODIDE.—Not later than 

7 270 days after the date of enactment of this Act, the Sec8 retary of Health and Human Services shall submit to the 

9 appropriate Committees of Congress a report regarding the 

10 stockpiling of potassium iodide. Such report shall include— 

11 (1) an assessment of the availability of potas12 sium iodide at Federal, State, and local levels; and 

13 (2) a description of the extent to which such ac14 tivities and policies provide public health protection 

15 in the event of a nuclear incident, whether uninten16 tional or deliberate, including an act of terrorism. 

17 SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD. 

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

19 U.S.C. 247d–f(a)) is amended— 

20 (1) in paragraph (2)— 

21 (A) in subparagraph (D)— 

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

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

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

25 the end; 


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1 (iii) in clause (ii), by striking the pe2 riod and inserting a semicolon; and 

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

4 ‘‘(iii) one such member shall be an in5 dividual with pediatric subject matter ex6 pertise; and 

7 ‘‘(iv) one such member shall be a State, 

8 tribal, territorial, or local public health offi9 cial.’’; and 

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

11 sentence: 

12 ‘‘Nothing in this paragraph shall preclude a member 

13 of the Board from satisfying two or more of the re14 quirements described in subparagraph (D).’’; 

15 (2) in paragraph (5)— 

16 (A) in subparagraph (B), by striking ‘‘and’’ 

17 at the end; 

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

19 period and inserting ‘‘; and’’; and 

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

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

22 or report provided to the Secretary under this 

23 paragraph to the appropriate committees of Con24 gress.’’; and 


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

2 following: ‘‘Such chairperson shall serve as the decid3 ing vote in the event that a deciding vote is necessary 

4 with respect to voting by members of the Board.’’. 


smartinez on DSK6TPTVN1PROD with BILLS
Calendar No. 263 

112TH CONGRESS 

1ST SESSION S. 1855 

A BILL 

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

DECEMBER 16, 2011 

Reported with an amendment 


smartinez on DSK6TPTVN1PROD with BILLS