112TH CONGRESS 

2D SESSION S. 1855 

AN ACT 

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. 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. 

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)— 

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 

22 emergencies’’; 

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

24 ‘‘and trauma’’ after ‘‘medical’’; 
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1 (iii) in subparagraph (D), by inserting 

2 ‘‘(which may include such dental health as3 sets)’’ after ‘‘medical assets’’; 

4 (iv) by adding at the end the fol5 lowing: 

6 ‘‘(F) Optimizing a coordinated and flexible 

7 approach to the medical surge capacity of hos8 pitals, other healthcare facilities, and trauma 

9 care (which may include trauma centers) and 

10 emergency medical systems.’’; 

11 (B) in paragraph (4)— 

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

13 ‘‘, including the unique needs and consider14 ations of individuals with disabilities,’’ 

15 after ‘‘medical needs of at-risk individ16 uals’’; and 

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

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

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

20 ‘‘(7) COUNTERMEASURES.— 

21 ‘‘(A) Promoting strategic initiatives to ad22 vance countermeasures to diagnose, mitigate, 

23 prevent, or treat harm from any biological 

24 agent or toxin, chemical, radiological, or nuclear 
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1 agent or agents, whether naturally occurring, 

2 unintentional, or deliberate. 

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

4 term ‘countermeasures’ has the same meaning 

5 as the terms ‘qualified countermeasures’ under 

6 section 319F–1, ‘qualified pandemic and epi7 demic products’ under section 319F–3, and ‘se8 curity countermeasures’ under section 319F–2. 

9 ‘‘(8) MEDICAL AND PUBLIC HEALTH COMMU10 NITY RESILIENCY.—Strengthening the ability of 

11 States, local communities, and tribal communities to 

12 prepare for, respond to, and be resilient in the event 

13 of public health emergencies, whether naturally oc14 curring, unintentional, or deliberate by— 

15 ‘‘(A) optimizing alignment and integration 

16 of medical and public health preparedness and 

17 response planning and capabilities with and into 

18 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 

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

23 amended— 

24 (1) by striking paragraphs (5), (7), and (8); 
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1 (2) by redesignating paragraphs (1) through 

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

3 (3) by inserting before paragraph (2) (as so re4 designated), the following: 

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

6 they relate to medical and public health prepared7 ness and response for at-risk individuals in the event 

8 of a public health emergency declared by the Sec9 retary under section 319;’’; 

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

11 striking ‘‘National Preparedness goal’’ and inserting 

12 ‘‘preparedness goals, as described in section 

13 2802(b),’’; and 

14 (5) by inserting after paragraph (6), the fol15 lowing: 

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

17 novel and best practices of outreach to and care of 

18 at-risk individuals before, during, and following pub19 lic health emergencies in as timely a manner as is 

20 practicable, including from the time a public health 

21 threat is identified; and 

22 ‘‘(8) ensure that public health and medical in23 formation distributed by the Department of Health 

24 and Human Services during a public health emer25 gency is delivered in a manner that takes into ac-
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1 count the range of communication needs of the in2 tended recipients, including at-risk individuals.’’. 

3 SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND 

4 RESPONSE. 

5 Section 2811 of the Public Health Service Act (42 

6 U.S.C. 300hh–10) is amended— 

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

8 the following: 

9 ‘‘(D) POLICY COORDINATION AND STRA10 TEGIC DIRECTION.—Provide integrated policy 

11 coordination and strategic direction with re12 spect to all matters related to Federal public 

13 health and medical preparedness and execution 

14 and deployment of the Federal response for 

15 public health emergencies and incidents covered 

16 by the National Response Plan developed pur17 suant to section 502(6) of the Homeland Secu18 rity Act of 2002, or any successor plan, before, 

19 during, and following public health emer20 gencies.’’; 

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

22 following: 

23 ‘‘(c) FUNCTIONS.—The Assistant Secretary for Pre24 paredness and Response shall— 
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1 ‘‘(1) have authority over and responsibility 

2 for— 

3 ‘‘(A) the National Disaster Medical System 

4 (in accordance with section 301 of the Pan5 demic and All-Hazards Preparedness Act); 

6 ‘‘(B) the Hospital Preparedness Coopera7 tive Agreement Program pursuant to section 

8 319C–2; 

9 ‘‘(C) the Medical Reserve Corps pursuant 

10 to section 2813; 

11 ‘‘(D) the Emergency System for Advance 

12 Registration of Volunteer Health Professionals 

13 pursuant to section 319I; and 

14 ‘‘(E) administering grants and related au15 thorities related to trauma care under parts A 

16 through C of title XII, such authority to be 

17 transferred by the Secretary from the Adminis18 trator of the Health Resources and Services Ad19 ministration to such Assistant Secretary; 

20 ‘‘(2) exercise the responsibilities and authorities 

21 of the Secretary with respect to the coordination 

22 of— 

23 ‘‘(A) the Public Health Emergency Pre24 paredness Cooperative Agreement Program pur25 suant to section 319C–1; 
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1 ‘‘(B) the Strategic National Stockpile; and 

2 ‘‘(C) the Cities Readiness Initiative; 

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

4 health grants and cooperative agreements as applica5 ble to preparedness and response activities author6 ized under this Act, to the extent possible, including 

7 program requirements, timelines, and measurable 

8 goals, and in coordination with the Secretary of 

9 Homeland Security, to— 

10 ‘‘(A) optimize and streamline medical and 

11 public health preparedness capabilities and the 

12 ability of local communities to respond to public 

13 health emergencies; 

14 ‘‘(B) minimize duplication of efforts with 

15 regard to medical and public health prepared16 ness and response programs; and 

17 ‘‘(C) gather and disseminate best practices 

18 among grant and cooperative agreement recipi19 ents, as appropriate; 

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

21 in coordination with the Department of Homeland 

22 Security, the Department of Defense, the Depart23 ment of Veterans Affairs, and other applicable Fed24 eral departments and agencies, as necessary and ap25 propriate, to identify, inform, and address gaps in 
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1 and policies related to all-hazards medical and public 

2 health preparedness, including exercises based on— 

3 ‘‘(A) identified threats for which counter4 measures are available and for which no coun5 termeasures are available; and 

6 ‘‘(B) unknown threats for which no coun7 termeasures are available; and 

8 ‘‘(5) assume other duties as determined appro9 priate by the Secretary.’’; and 

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

11 ‘‘(d) NATIONAL SECURITY PRIORITY.—The Sec12 retary, acting through the Assistant Secretary for Pre13 paredness and Response, shall on a periodic basis conduct 

14 meetings, as applicable and appropriate, with the Assist15 ant to the President for National Security Affairs to pro16 vide an update on, and discuss, medical and public health 

17 preparedness and response activities pursuant to this Act 

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

19 progress on the development, approval, clearance, and li20 censure of medical countermeasures. 

21 ‘‘(e) PUBLIC HEALTH EMERGENCY MEDICAL COUN22 TERMEASURES ENTERPRISE STRATEGY AND IMPLEMEN23 TATION PLAN.— 

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

25 after the date of enactment of this subsection, and 
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1 every other year thereafter, the Secretary, acting 

2 through the Assistant Secretary for Preparedness 

3 and Response and in consultation with the Director 

4 of the Biomedical Advanced Research and Develop5 ment Authority, the Director of the National Insti6 tutes of Health, the Director of the Centers for Dis7 ease Control and Prevention, and the Commissioner 

8 of the Food and Drug Administration, shall develop 

9 and submit to the appropriate committees of Con10 gress a coordinated strategy and accompanying im11 plementation plan for medical countermeasures to 

12 address chemical, biological, radiological, and nu13 clear threats. Such strategy and plan shall be known 

14 as the ‘Public Health Emergency Medical Counter15 measures Enterprise Strategy and Implementation 

16 Plan’. 

17 ‘‘(2) REQUIREMENTS.—The plan under para18 graph (1) shall— 

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

20 of medical countermeasure-related activities, in21 cluding research, advanced research, develop22 ment, procurement, stockpiling, deployment, 

23 and distribution; 

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

25 mid-term, and long-term priority qualified and 
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1 security countermeasure (as defined in sections 

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

3 Federal Government according to chemical, bio4 logical, radiological, and nuclear threat or 

5 threats; 

6 ‘‘(C) identify projected timelines, antici7 pated funding allocations, benchmarks, and 

8 milestones for each medical countermeasure pri9 ority under subparagraph (B), including pro10 jected needs with regard to replenishment of 

11 the Strategic National Stockpile; 

12 ‘‘(D) be informed by the recommendations 

13 of the National Biodefense Science Board pur14 suant to section 319M; 

15 ‘‘(E) report on advanced research and de16 velopment awards and the date of the issuance 

17 of contract awards, including awards made 

18 through the special reserve fund (as defined in 

19 section 319F–2(c)(10)); 

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

21 goals, benchmarks, and milestones identified 

22 under subparagraph (C) in plans submitted 

23 subsequent to the initial plan; 

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

25 the medical countermeasure priorities for at- 
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1 risk individuals, (as defined in 2802(b)(4)(B)), 

2 as applicable under subparagraph (B), includ3 ing with regard to the projected needs for re4 lated stockpiling and replenishment of the Stra5 tegic National Stockpile; and 

6 ‘‘(H) be made publicly available. 

7 ‘‘(3) GAO REPORT.— 

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

9 after the date on which a Public Health Emer10 gency Medical Countermeasures Enterprise 

11 Strategy and Implementation Plan under this 

12 subsection is issued by the Secretary, the Gov13 ernment Accountability Office shall conduct an 

14 independent evaluation and submit to the ap15 propriate committees of Congress a report con16 cerning such strategy and implementation plan. 

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

18 subparagraph (A) shall review and assess— 

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

20 long-term medical countermeasure needs 

21 and identified priorities of the Federal 

22 Government pursuant to subparagraphs 

23 (A) and (B) of paragraph (2); 

24 ‘‘(ii) the activities of the Department 

25 of Health and Human Services with re-
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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 1 year after the date of enactment of this sub10 section, the Secretary, in coordination with the Secretary 

11 of Defense, shall submit to the appropriate committees of 

12 Congress a report concerning the manner in which the De13 partment of Health and Human Services is coordinating 

14 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. NATIONAL ADVISORY COMMITTEE ON CHILDREN 

6 AND DISASTERS. 

7 Subtitle B of title XXVIII of the Public Health Serv8 ice Act (42 U.S.C. 300hh et seq.) is amended by inserting 

9 after section 2811 the end the following: 

10 ‘‘SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHIL11 DREN AND DISASTERS. 

12 ‘‘(a) ESTABLISHMENT.—The Secretary, in consulta13 tion with the Secretary of Homeland Security, shall estab14 lish an advisory committee to be known as the ‘National 

15 Advisory Committee on Children and Disasters’ (referred 

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

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

18 ‘‘(1) provide advice and consultation with re19 spect to the activities carried out pursuant to section 

20 2814, as applicable and appropriate; 

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

22 the medical and public health needs of children as 

23 they relate to preparation for, response to, and re24 covery from all-hazards; and 
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1 ‘‘(3) provide advice and consultation to States 

2 and territories with respect to State emergency pre3 paredness and response activities and children, in4 cluding related drills and exercises pursuant to the 

5 preparedness goals under section 2802(b). 

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

7 may provide advice and recommendations to the Secretary 

8 with respect to children and the medical and public health 

9 grants and cooperative agreements as applicable to pre10 paredness and response activities authorized under this 

11 title and title III. 

12 ‘‘(d) MEMBERSHIP.— 

13 ‘‘(1) IN GENERAL.—The Secretary, in consulta14 tion with such other Secretaries as may be appro15 priate, shall appoint not to exceed 15 members to 

16 the Advisory Committee. In appointing such mem17 bers, the Secretary shall ensure that the total mem18 bership of the Advisory Committee is an odd num19 ber. 

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

21 consultation with such other Secretaries as may be 

22 appropriate, may appoint to the Advisory Committee 

23 under paragraph (1) such individuals as may be ap24 propriate to perform the duties described in sub25 sections (b) and (c), which may include— 
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1 ‘‘(A) the Assistant Secretary for Prepared2 ness and Response; 

3 ‘‘(B) the Director of the Biomedical Ad4 vanced Research and Development Authority; 

5 ‘‘(C) the Director of the Centers for Dis6 ease Control and Prevention; 

7 ‘‘(D) the Commissioner of Food and 

8 Drugs; 

9 ‘‘(E) the Director of the National Insti10 tutes of Health; 

11 ‘‘(F) the Assistant Secretary of the Admin12 istration for Children and Families; 

13 ‘‘(G) the Administrator of the Federal 

14 Emergency Management Agency; 

15 ‘‘(H) at least two non-Federal health care 

16 professionals with expertise in pediatric medical 

17 disaster planning, preparedness, response, or 

18 recovery; 

19 ‘‘(I) at least two representatives from 

20 State, local, territories, or tribal agencies with 

21 expertise in pediatric disaster planning, pre22 paredness, response, or recovery; and 

23 ‘‘(J) representatives from such Federal 

24 agencies (such as the Department of Education 

25 and the Department of Homeland Security) as 
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1 determined necessary to fulfill the duties of the 

2 Advisory Committee, as established under sub3 sections (b) and (c). 

4 ‘‘(e) MEETINGS.—The Advisory Committee shall 

5 meet not less than biannually. 

6 ‘‘(f) SUNSET.—The Advisory Committee shall termi7 nate on the date that is 5 years after the date of enact8 ment of the Pandemic and All-Hazards Preparedness Act 

9 Reauthorization of 2011.’’. 

10 SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER 

11 MEDICAL SYSTEM. 

12 Section 2812 of the Public Health Service Act (42 

13 U.S.C. 300hh–11) is amended— 

14 (1) in subsection (a)(3)— 

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

16 inserting ‘‘, including at-risk individuals as ap17 plicable’’ after ‘‘victims of a public health emer18 gency’’; 

19 (B) by redesignating subparagraph (C) as 

20 subparagraph (E); and 

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

22 the following: 

23 ‘‘(C) CONSIDERATIONS FOR AT-RISK POPU24 LATIONS.—The Secretary shall take steps to 

25 ensure that an appropriate specialized and fo-
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1 cused range of public health and medical capa2 bilities are represented in the National Disaster 

3 Medical System, which take into account the 

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

5 public health emergency.’’. 

6 ‘‘(D) ADMINISTRATION.—The Secretary 

7 may determine and pay claims for reimburse8 ment for services under subparagraph (A) di9 rectly or through contracts that provide for 

10 payment in advance or by way of reimburse11 ment.’’; and 

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

13 may be necessary for each of the fiscal years 2007 

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

15 of fiscal years 2012 through 2016’’. 

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

17 VETERANS AFFAIRS. 

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

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

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

21 2011’’ and inserting ‘‘$156,500,000 for each of fiscal 

22 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 whether naturally occurring, unintentional, 

20 or deliberate; 

21 ‘‘(ii) a description of the activities 

22 such entity will carry out with respect to 

23 pandemic influenza, as a component of the 

24 activities carried out under clause (i), and 
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1 consistent with the requirements of para2 graphs (2) and (5) of subsection (g);’’; 

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

4 the end; and 

5 (iii) 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; 

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

13 as applicable and appropriate, will coordi14 nate with State emergency preparedness 

15 and response plans in public health emer16 gency preparedness, including State edu17 cational agencies (as defined in section 

18 9101(41) of the Elementary and Sec19 ondary Education Act of 1965) and State 

20 child care lead agencies (as defined in sec21 tion 658D of the Child Care and Develop22 ment Block Grant Act); and 

23 ‘‘(viii) in the case of entities that op24 erate on the United States-Mexico border 

25 or the United States-Canada border, a de-
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1 scription of the activities such entity will 

2 carry out under the agreement that are 

3 specific to the border area including dis4 ease detection, identification, and inves5 tigation, and preparedness and response 

6 activities related to emerging diseases and 

7 infectious disease outbreaks whether natu8 rally-occurring or due to bioterrorism, con9 sistent with the requirements of this sec10 tion;’’; and 

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

12 including addressing the needs of at-risk indi13 viduals,’’ after ‘‘capabilities of such entity’’; 

14 (2) in subsection (g)— 

15 (A) in paragraph (1), by striking subpara16 graph (A) and inserting the following: 

17 ‘‘(A) include outcome goals representing 

18 operational achievements of the National Pre19 paredness Goals developed under section 

20 2802(b) with respect to all-hazards, including 

21 chemical, biological, radiological, or nuclear 

22 threats; and’’; and 

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

24 end the following: ‘‘The Secretary shall periodi25 cally update, as necessary and appropriate, 
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1 such pandemic influenza plan criteria and shall 

2 require the integration of such criteria into the 

3 benchmarks and standards described in para4 graph (1).’’; 

5 (3) in subsection (i)— 

6 (A) in paragraph (1)(A)— 

7 (i) by striking ‘‘$824,000,000 for fis8 cal year 2007’’ and inserting 

9 ‘‘$632,900,000 for fiscal year 2012’’; and 

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

11 necessary for each of fiscal years 2008 

12 through 2011’’ and inserting 

13 ‘‘$632,900,000 for each of fiscal years 

14 2013 through 2016’’; and 

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

16 ‘‘(7) AVAILABILITY OF COOPERATIVE AGREE17 MENT FUNDS.— 

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

19 an eligible entity under a cooperative agreement 

20 under subsection (a) for a fiscal year and re21 maining unobligated at the end of such year 

22 shall remain available to such entity for the 

23 next fiscal year for the purposes for which such 

24 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).’’; and 

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

9 (b) VACCINE TRACKING AND DISTRIBUTION.—Sec10 tion 319A(e) of the Public Health Service Act (42 U.S.C. 

11 247d–1(e)) is amended by striking ‘‘such sums for each 

12 of fiscal years 2007 through 2011’’ and inserting 

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

14 2016’’. 

15 (c) GAO REPORT.—Section 319C–1 of the Public 

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

17 adding at the end the following: 

18 ‘‘(l) GAO REPORT.— 

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

20 the date of enactment of the Pandemic and All-Haz21 ards Preparedness Act Reauthorization of 2011, the 

22 Government Accountability Office shall conduct an 

23 independent evaluation, and submit to the appro24 priate committees of Congress a report, concerning 

25 Federal programs at the Department of Health and 
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1 Human Services that support medical and public 

2 health preparedness and response programs at the 

3 State and local levels. 

4 ‘‘(2) CONTENT.—The report described in para5 graph (1) shall review and assess— 

6 ‘‘(A) the extent to which grant and cooper7 ative agreement requirements and goals have 

8 been met by recipients; 

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

10 cooperative agreements have supported medical 

11 and public health preparedness and response 

12 goals pursuant to section 2802(b), as appro13 priate and applicable; 

14 ‘‘(C) whether recipients or the Department 

15 of Health and Human Services have identified 

16 any factors that may impede a recipient’s abil17 ity to achieve programmatic goals and require18 ments; and 

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

20 have been used appropriately, in accordance 

21 with grant and cooperative agreement require22 ments, and actions taken to address inappro23 priate expenditures.’’. 
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1 SEC. 202. HOSPITAL PREPAREDNESS AND MEDICAL SURGE 

2 CAPACITY. 

3 (a) ALL-HAZARDS PUBLIC HEALTH AND MEDICAL

4 RESPONSE CURRICULA AND TRAINING.—Section 

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

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

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

8 or dental’’. 

9 (b) ENCOURAGING HEALTH PROFESSIONAL VOLUN10 TEERS.— 

11 (1) EMERGENCY SYSTEM FOR ADVANCE REG12 ISTRATION OF VOLUNTEER HEALTH PROFES13 SIONALS.—Section 319I(k) of the Public Health 

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

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

16 sums as may be necessary for each of the fiscal 

17 years 2003 through 2011’’ and inserting 

18 ‘‘$5,900,000 for each of fiscal years 2012 through 

19 2016’’. 

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

21 Health Service Act (42 U.S.C. 300hh–15) is amend22 ed— 

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

24 end the following: ‘‘Such training exercises 

25 shall, as appropriate and applicable, incorporate 
28 

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

2 a public health emergency.’’; and 

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

4 ‘‘$22,000,000 for fiscal year 2007, and such 

5 sums as may be necessary for each of fiscal 

6 years 2008 through 2011’’ and inserting 

7 ‘‘$11,900,000 for each of fiscal years 2012 

8 through 2016’’. 

9 (c) PARTNERSHIPS FOR STATE AND REGIONAL PRE10 PAREDNESS TO IMPROVE SURGE CAPACITY.—Section 

11 319C–2 of the Public Health Service Act (42 U.S.C. 

12 247d–3b) is amended— 

13 (1) in subsection (b)(1)(A)(ii), by striking ‘‘cen14 ters, primary’’ and inserting ‘‘centers, community 

15 health centers, primary’’; 

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

17 following: 

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

19 (a) shall be expended for activities to achieve the prepared20 ness goals described under paragraphs (1), (3), (4), (5), 

21 and (6) of section 2802(b) with respect to all-hazards, in22 cluding chemical, biological, radiological, or nuclear 

23 threats.’’; 

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

25 following: 
29 

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1 ‘‘(g) COORDINATION.— 

2 ‘‘(1) LOCAL RESPONSE CAPABILITIES.—An eli3 gible entity shall, to the extent practicable, ensure 

4 that activities carried out under an award under 

5 subsection (a) are coordinated with activities of rel6 evant local Metropolitan Medical Response Systems, 

7 local Medical Reserve Corps, the local Cities Readi8 ness Initiative, and local emergency plans. 

9 ‘‘(2) NATIONAL COLLABORATION.—Partner10 ships consisting of one or more eligible entities 

11 under this section may, to the extent practicable, 

12 collaborate with other partnerships consisting of one 

13 or more eligible entities under this section for pur14 poses of national coordination and collaboration with 

15 respect to activities to achieve the preparedness 

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

17 and (6) of section 2802(b).’’; and 

18 (4) in subsection (j)— 

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

20 ‘‘$474,000,000 for fiscal year 2007, and such 

21 sums as may be necessary for each of fiscal 

22 years 2008 through 2011’’ and inserting 

23 ‘‘$378,000,000 for each of fiscal years 2012 

24 through 2016’’; and 

25 (B) by adding at the end the following: 
30 

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1 ‘‘(4) AVAILABILITY OF COOPERATIVE AGREE2 MENT FUNDS.— 

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

4 an eligible entity under a cooperative agreement 

5 under subsection (a) for a fiscal year and re6 maining unobligated at the end of such year 

7 shall remain available to such entity for the 

8 next fiscal year for the purposes for which such 

9 funds were provided. 

10 ‘‘(B) FUNDS CONTINGENT ON ACHIEVING

11 BENCHMARKS.—The continued availability of 

12 funds under subparagraph (A) with respect to 

13 an entity shall be contingent upon such entity 

14 achieving the benchmarks and submitting the 

15 pandemic influenza plan as required under sub16 section (i).’’. 

17 SEC. 203. ENHANCING SITUATIONAL AWARENESS AND BIO18 SURVEILLANCE. 

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

20 U.S.C. 247d–4) is amended— 

21 (1) in subsection (b)— 

22 (A) in paragraph (1)(B), by inserting ‘‘poi23 son control centers,’’ after ‘‘hospitals,’’; 

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

25 the period the following: ‘‘, allowing for coordi-
31 

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1 nation to maximize all-hazards medical and 

2 public health preparedness and response and to 

3 minimize duplication of effort’’; and 

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

5 the period the following: ‘‘and update such 

6 standards as necessary’’; 

7 (2) in subsection (d)— 

8 (A) in the subsection heading, by striking 

9 ‘‘PUBLIC HEALTH SITUATIONAL AWARENESS’’ 

10 and inserting ‘‘MODERNIZING PUBLIC HEALTH

11 SITUATIONAL AWARENESS AND BIOSURVEIL12 LANCE’’; 

13 (B) in paragraph (1)— 

14 (i) by striking ‘‘Pandemic and All15 Hazards Preparedness Act’’ and inserting 

16 ‘‘Pandemic and All-Hazards Preparedness 

17 Act Reauthorization of 2011’’; and 

18 (ii) by inserting ‘‘, novel emerging 

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

20 (C) by striking paragraph (2) and insert21 ing the following: 

22 ‘‘(2) STRATEGY AND IMPLEMENTATION

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

24 enactment of the Pandemic and All-Hazards Pre25 paredness Act Reauthorization of 2011, the Sec-
32 

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1 retary shall submit to the appropriate committees of 

2 Congress, a coordinated strategy and an accom3 panying implementation plan that identifies and 

4 demonstrates the measurable steps the Secretary will 

5 carry out to— 

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

7 network described in paragraph (1), utilizing 

8 the elements described in paragraph (3); and 

9 ‘‘(B) modernize and enhance biosurveil10 lance activities.’’; 

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

12 ‘‘community health centers, health centers’’ 

13 after ‘‘poison control,’’; 

14 (E) in paragraph (5), by striking subpara15 graph (A) and inserting the following: 

16 ‘‘(A) utilize applicable interoperability 

17 standards as determined by the Secretary, and 

18 in consultation with the Office of the National 

19 Coordinator for Health Information Tech20 nology, through a joint public and private sec21 tor process;’’; and 

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

23 ‘‘(6) CONSULTATION WITH THE NATIONAL BIO24 DEFENSE SCIENCE BOARD.—In carrying out this 

25 section consistent with section 319M, the National 
33 

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1 Biodefense Science Board shall provide expert advice 

2 and guidance, including recommendations, regarding 

3 the measurable steps the Secretary should take to 

4 modernize and enhance biosurveillance activities pur5 suant to the efforts of the Department of Health 

6 and Humans Services to ensure comprehensive, real7 time all-hazards biosurveillance capabilities. In com8 plying with the preceding sentence, the National 

9 Biodefense Science Board shall— 

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

11 a national biosurveillance system for human 

12 health, with international connectivity, where 

13 appropriate, that is predicated on State, re14 gional, and community level capabilities and 

15 creates a networked system to allow for two16 way information flow between and among Fed17 eral, State, and local government public health 

18 authorities and clinical health care providers; 

19 ‘‘(B) identify any duplicative surveillance 

20 programs under the authority of the Secretary, 

21 or changes that are necessary to existing pro22 grams, in order to enhance and modernize such 

23 activities, minimize duplication, strengthen and 

24 streamline such activities under the authority of 

25 the Secretary, and achieve real-time and appro-
34 

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1 priate data that relate to disease activity, both 

2 human and zoonotic; and 

3 ‘‘(C) coordinate with applicable existing 

4 advisory committees of the Director of the Cen5 ters for Disease Control and Prevention, includ6 ing such advisory committees consisting of rep7 resentatives from State, local, and tribal public 

8 health authorities and appropriate public and 

9 private sector health care entities and academic 

10 institutions, in order to provide guidance on 

11 public health surveillance activities.’’; 

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

13 after the date of enactment of the Pandemic and 

14 All-Hazards Preparedness Act’’ and inserting ‘‘3 

15 years after the date of enactment of the Pandemic 

16 and All-Hazards Preparedness Act Reauthorization 

17 of 2011’’; 

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

19 may be necessary in each of fiscal years 2007 

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

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

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

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

24 term ‘biosurveillance’ means the process of gathering near 

25 real-time, biological data that relates to disease activity 
35 

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

2 achieve early warning and identification of such health 

3 threats, early detection and prompt ongoing tracking of 

4 health events, and overall situational awareness of disease 

5 activity.’’. 

6 TITLE III—ENHANCING MEDICAL 

7 COUNTERMEASURE REVIEW 

8 SEC. 301. SPECIAL PROTOCOL ASSESSMENT. 

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

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

11 striking ‘‘size of clinical trials intended’’ and all that fol12 lows through ‘‘. The sponsor or applicant’’ and inserting 

13 the following: ‘‘size— 

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

15 primary basis of an effectiveness claim; or 

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

17 are not ethical or feasible, of animal and any associ18 ated clinical trials which, in combination, are in19 tended to form the primary basis of an effectiveness 

20 claim; or 

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

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

23 Public Health Service Act, of any necessary clinical 

24 study or studies. 

25 The sponsor or applicant’’. 
36 

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1 SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR 

2 USE IN EMERGENCIES. 

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

4 Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amend5 ed— 

6 (1) in subsection (a)— 

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

8 505, 510(k), and 515 of this Act’’ and inserting 

9 ‘‘any provision of this Act’’; 

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

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

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

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

14 or section 351 of the Public Health Service 

15 Act’’; and 

16 (C) in paragraph (3), by striking ‘‘a provi17 sion of law referred to in such paragraph’’ and 

18 inserting ‘‘a provision of law referred to in 

19 paragraph (2)(A)’’; 

20 (2) in subsection (b)— 

21 (A) in the subsection heading, by striking 

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

23 THREAT JUSTIFYING EMERGENCY AUTHOR24 IZED USE’’; 

25 (B) in paragraph (1)— 
37 

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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 (A), by striking 

6 ‘‘specified’’; 

7 (iii) in subparagraph (B)— 

8 (I) by striking ‘‘specified’’; and 

9 (II) by striking ‘‘; or’’ and insert10 ing a semicolon; 

11 (iv) by amending subparagraph (C) to 

12 read as follows: 

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

14 there is a public health emergency, or a signifi15 cant potential for a public health emergency, 

16 that affects, or has a significant potential to af17 fect, national security or the health and security 

18 of United States citizens abroad, and that in19 volves a biological, chemical, radiological, or nu20 clear agent or agents, or a disease or condition 

21 that may be attributable to such agent or 

22 agents; or’’; and 

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

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

25 pursuant to section 319F–2 of the Public 
38 

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1 Health Service Act sufficient to affect national 

2 security or the health and security of United 

3 States citizens living abroad.’’; 

4 (C) in paragraph (2)(A)— 

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

6 follows: 

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

8 of the product such that the circumstances 

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

10 to exist.’’; 

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

12 (iii) by redesignating subparagraph 

13 (C) as subparagraph (B); 

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

15 notice of termination, and renewal under this 

16 subsection.’’ and inserting ‘‘, and advance no17 tice of termination under this subsection. The 

18 Secretary shall make any renewal under this 

19 subsection available on the Internet Web site of 

20 the Food and Drug Administration.’’; and 

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

22 ‘‘(5) EXPLANATION BY SECRETARY.—If an au23 thorization under this section with respect to an un24 approved product has been in effect for more than 

25 1 year, the Secretary shall provide in writing to the 
39 

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1 sponsor of such product, an explanation of the sci2 entific, regulatory, or other obstacles to approval, li3 censure, or clearance of such product, including spe4 cific actions to be taken by the Secretary and the 

5 sponsor to overcome such obstacles.’’; 

6 (3) in subsection (c)— 

7 (A) in the matter preceding paragraph 

8 (1)— 

9 (i) by inserting ‘‘the Assistant Sec10 retary for Preparedness and Response,’’ 

11 after ‘‘consultation with’’; 

12 (ii) by striking ‘‘Health and’’ and in13 serting ‘‘Health, and’’; and 

14 (iii) by striking ‘‘circumstances of the 

15 emergency involved’’ and inserting ‘‘appli16 cable circumstances described in subsection 

17 (b)(1)’’; 

18 (B) in paragraph (1), by striking ‘‘speci19 fied’’ and inserting ‘‘referred to’’; and 

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

21 taking into consideration the material threat 

22 posed by the agent or agents identified in a dec23 laration under subsection (b)(1)(D), if applica24 ble’’ after ‘‘risks of the product’’; 
40 

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

2 extent practicable given the circumstances of the 

3 emergency,’’ after ‘‘including’’; 

4 (5) in subsection (e)— 

5 (A) in paragraph (1)(A), by striking ‘‘cir6 cumstances of the emergency’’ and inserting 

7 ‘‘applicable circumstances described in sub8 section (b)(1)’’; 

9 (B) in paragraph (2)— 

10 (i) in subparagraph (A)— 

11 (I) by striking ‘‘manufacturer of 

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

13 (II) by striking ‘‘circumstances of 

14 the emergency’’ and inserting ‘‘appli15 cable circumstances described in sub16 section (b)(1)’’; and 

17 (III) by inserting at the end be18 fore the period ‘‘or in paragraph 

19 (1)(B)’’; 

20 (ii) in subparagraph (B)(i), by insert21 ing before the period at the end ‘‘, except 

22 as provided in section 564A with respect to 

23 authorized changes to the product expira24 tion date’’; and 
41 

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1 (iii) by amending subparagraph (C) to 

2 read as follows: 

3 ‘‘(C) In establishing conditions under this 

4 paragraph with respect to the distribution and 

5 administration of the product for the unap6 proved use, the Secretary shall not impose con7 ditions that would restrict distribution or ad8 ministration of the product when done solely for 

9 the approved use.’’; and 

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

11 follows: 

12 ‘‘(3) GOOD MANUFACTURING PRACTICE; PRE13 SCRIPTION.—With respect to the emergency use of a 

14 product for which an authorization under this sec15 tion is issued (whether an unapproved product or an 

16 unapproved use of an approved product), the Sec17 retary may waive or limit, to the extent appropriate 

18 given the applicable circumstances described in sub19 section (b)(1)— 

20 ‘‘(A) requirements regarding current good 

21 manufacturing practice otherwise applicable to 

22 the manufacture, processing, packing, or hold23 ing of products subject to regulation under this 

24 Act, including such requirements established 

25 under section 501 or 520(f)(1), and including 
42 

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1 relevant conditions prescribed with respect to 

2 the product by an order under section 

3 520(f)(2); 

4 ‘‘(B) requirements established under sec5 tion 503(b); and 

6 ‘‘(C) requirements established under sec7 tion 520(e).’’; 

8 (6) in subsection (g)— 

9 (A) in the subsection heading, by inserting 

10 ‘‘REVIEW AND’’ before ‘‘REVOCATION’’; 

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

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

13 such review, the Secretary shall regularly review 

14 the progress made with respect to the approval, 

15 licensure, or clearance of— 

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

17 authorization was issued under this section; or 

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

19 product for which an authorization was issued 

20 under this section.’’; and 

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

22 follows: 

23 ‘‘(2) REVISION AND REVOCATION.—The Sec24 retary may revise or revoke an authorization under 

25 this section if— 
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1 ‘‘(A) the circumstances described under 

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

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

4 issuance of such authorization are no longer 

5 met; or 

6 ‘‘(C) other circumstances make such revi7 sion or revocation appropriate to protect the 

8 public health or safety.’’; 

9 (7) in subsection (h)(1), by adding after the pe10 riod at the end the following: ‘‘The Secretary shall 

11 make any revisions to an authorization under this 

12 section available on the Internet Web site of the 

13 Food and Drug Administration.’’; and 

14 (8) by adding at the end of subsection (j) the 

15 following: 

16 ‘‘(4) Nothing in this section shall be construed 

17 as authorizing a delay in the review or other consid18 eration by the Food and Drug Administration of any 

19 application pending before the Administration for a 

20 countermeasure or product referred to in subsection 

21 (a).’’. 

22 (b) EMERGENCY USE OF MEDICAL PRODUCTS.— 

23 Subchapter E of chapter V of the Federal Food, Drug, 

24 and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended 

25 by inserting after section 564 the following: 
44 

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

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

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

4 product’ means a product that— 

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

6 chapter or licensed under section 351 of the 

7 Public Health Service Act; 

8 ‘‘(B)(i) is intended for use to prevent, di9 agnose, or treat a disease or condition involving 

10 a biological, chemical, radiological, or nuclear 

11 agent or agents, including a product intended 

12 to be used to prevent or treat pandemic influ13 enza; or 

14 ‘‘(ii) is intended for use to prevent, diag15 nose, or treat a serious or life-threatening dis16 ease or condition caused by a product described 

17 in clause (i); and 

18 ‘‘(C) is intended for use during the cir19 cumstances under which— 

20 ‘‘(i) a determination described in sub21 paragraph (A), (B), or (C) of section 

22 564(b)(1) has been made by the Secretary 

23 of Homeland Security, the Secretary of 

24 Defense, or the Secretary, respectively; or 

25 ‘‘(ii) the identification of a material 

26 threat described in subparagraph (D) of 
45 

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1 section 564(b)(1) has been made pursuant 

2 to section 319F–2 of the Public Health 

3 Service Act. 

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

5 drug, device, or biological product. 

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

7 ‘‘(1) AUTHORITY TO EXTEND EXPIRATION

8 DATE.—The Secretary may extend the expiration 

9 date of an eligible product in accordance with this 

10 subsection. 

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

12 subsection, the term ‘expiration date’ means the 

13 date established through appropriate stability testing 

14 required by the regulations issued by the Secretary 

15 to ensure that the product meets applicable stand16 ards of identity, strength, quality, and purity at the 

17 time of use. 

18 ‘‘(3) EFFECT OF EXTENSION.—Notwith19 standing any other provision of this Act or the Pub20 lic Health Service Act, if the expiration date of an 

21 eligible product is extended in accordance with this 

22 section, the introduction or delivery for introduction 

23 into interstate commerce of such product after the 

24 expiration date provided by the manufacturer and 
46 

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1 within the duration of such extension shall not be 

2 deemed to render the product— 

3 ‘‘(A) an unapproved product; or 

4 ‘‘(B) adulterated or misbranded under this 

5 Act. 

6 ‘‘(4) DETERMINATIONS BY SECRETARY.—Be7 fore extending the expiration date of an eligible 

8 product under this subsection, the Secretary shall 

9 determine— 

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

11 will help protect public health; 

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

13 supported by scientific evaluation that is con14 ducted or accepted by the Secretary; 

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

16 if any, are required or permitted, including 

17 whether and how any additional labeling com18 municating the extension of the expiration date 

19 may alter or obscure the labeling provided by 

20 the manufacturer; and 

21 ‘‘(D) that any other conditions that the 

22 Secretary deems appropriate have been met. 

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

24 each extension of an expiration date granted under 

25 this subsection, the Secretary shall determine— 
47 

†S 1855 ES

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

2 extension shall apply; 

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

4 ‘‘(C) any conditions to effectuate such ex5 tension that are necessary and appropriate to 

6 protect public health or safety. 

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

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

9 the circumstances of a domestic, military, or public 

10 health emergency or material threat described in 

11 subsection (a)(1)(C) so warrant, authorize, with re12 spect to an eligible product, deviations from current 

13 good manufacturing practice requirements otherwise 

14 applicable to the manufacture, processing, packing, 

15 or holding of products subject to regulation under 

16 this Act, including requirements under section 501 

17 or 520(f)(1) or applicable conditions prescribed with 

18 respect to the eligible product by an order under sec19 tion 520(f)(2). 

20 ‘‘(2) EFFECT.—Notwithstanding any other pro21 vision of this Act or the Public Health Service Act, 

22 an eligible product shall not be considered an unap23 proved product and shall not be deemed adulterated 

24 or misbranded under this Act because, with respect 

25 to such product, the Secretary has authorized devi-
48 

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1 ations from current good manufacturing practices 

2 under paragraph (1). 

3 ‘‘(d) EMERGENCY USE INSTRUCTIONS.— 

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

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

7 and issue emergency use instructions to inform 

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

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

11 use. 

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

14 a product shall not be considered an unapproved 

15 product and shall not be deemed adulterated or mis16 branded under this Act because of the issuance of 

17 emergency use instructions under paragraph (1) 

18 with respect to such product or the introduction or 

19 delivery for introduction of such product into inter20 state commerce accompanied by such instructions— 

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

22 actual emergency that is the basis for a deter23 mination described in subsection (a)(1)(C)(i); or 

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

25 Federal, State, local, and tribal government en-
49 

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1 tity), or a person acting on behalf of such a 

2 government entity, in preparation for an emer3 gency response.’’. 

4 (c) RISK EVALUATION AND MITIGATION STRATE5 GIES.—Section 505–1 of the Federal Food, Drug, and 

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

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

8 and 

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

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

11 The Secretary may waive any requirement of this section 

12 with respect to a qualified countermeasure (as defined in 

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

14 to which a requirement under this section has been ap15 plied, if the Secretary determines that such waiver is re16 quired to mitigate the effects of, or reduce the severity 

17 of, the circumstances under which— 

18 ‘‘(1) a determination described in subparagraph 

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

20 by the Secretary of Homeland Security, the Sec21 retary of Defense, or the Secretary, respectively; or 

22 ‘‘(2) the identification of a material threat de23 scribed in subparagraph (D) of section 564(b)(1) 

24 has been made pursuant to section 319F–2 of the 

25 Public Health Service Act.’’. 
50 

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

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

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

4 added by subsection (b), the following: 

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

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

7 of the Public Health Service Act for a government entity 

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

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

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

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

12 if that product— 

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

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

15 product— 

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

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

18 or section 351 of the Public Health Service Act; 

19 ‘‘(B) is authorized for investigational use 

20 under section 505 or 520 of this Act or section 

21 351 of the Public Health Service Act; or 

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

23 564.’’. 
51 

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1 SEC. 303. DEFINITIONS. 

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

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

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

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

6 ‘‘(1) the term ‘countermeasure’ means a quali7 fied countermeasure, a security countermeasure, and 

8 a qualified pandemic or epidemic product; 

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

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

11 the Public Health Service Act; 

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

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

14 Act; and 

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

16 product’ means a product that meets the definition 

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

18 Health Service Act and— 

19 ‘‘(A) that has been identified by the De20 partment of Health and Human Services or the 

21 Department of Defense as receiving funding di22 rectly related to addressing chemical, biological, 

23 radiological or nuclear threats, including pan24 demic influenza; or 

25 ‘‘(B) is included under this paragraph pur26 suant to a determination by the Secretary. 
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1 ‘‘(b) GENERAL DUTIES.—The Secretary, in consulta2 tion’’. 

3 SEC. 304. ENHANCING MEDICAL COUNTERMEASURE AC4 TIVITIES. 

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

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

7 is further amended— 

8 (1) in the section heading, by striking ‘‘TECH9 NICAL ASSISTANCE’’ and inserting ‘‘COUNTER10 MEASURE DEVELOPMENT, REVIEW, AND TECH11 NICAL ASSISTANCE’’; 

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

13 heading and all that follows through ‘‘shall estab14 lish’’ and inserting the following: 

15 ‘‘(b) GENERAL DUTIES.—In order to accelerate the 

16 development, stockpiling, approval, licensure, and clear17 ance of qualified countermeasures, security counter18 measures, and qualified pandemic or epidemic products, 

19 the Secretary, in consultation with the Assistant Secretary 

20 for Preparedness and Response, shall— 

21 ‘‘(1) ensure the appropriate involvement of 

22 Food and Drug Administration personnel in inter23 agency activities related to countermeasure advanced 

24 research and development, consistent with sections 
53 

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

2 Public Health Service Act; 

3 ‘‘(2) ensure the appropriate involvement and 

4 consultation of Food and Drug Administration per5 sonnel in any flexible manufacturing activities car6 ried out under section 319L of the Public Health 

7 Service Act, including with respect to meeting regu8 latory requirements set forth in this Act; 

9 ‘‘(3) promote countermeasure expertise within 

10 the Food and Drug Administration by— 

11 ‘‘(A) ensuring that Food and Drug Admin12 istration personnel involved in reviewing coun13 termeasures for approval, licensure, or clear14 ance are informed by the Assistant Secretary 

15 for Preparedness and Response on the material 

16 threat assessment conducted under section 

17 319F–2 of the Public Health Service Act for 

18 the agent or agents for which the counter19 measure under review is intended; 

20 ‘‘(B) training Food and Drug Administra21 tion personnel regarding review of counter22 measures for approval, licensure, or clearance; 

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

24 annually to encourage the exchange of scientific 

25 ideas; and 
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1 ‘‘(D) establishing protocols to ensure that 

2 countermeasure reviewers have sufficient train3 ing or experience with countermeasures; 

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

5 Drug Administration personnel with expertise on 

6 countermeasures, including specific counter7 measures, populations with special clinical needs (in8 cluding children and pregnant women that may use 

9 countermeasures, as applicable and appropriate), 

10 classes or groups of countermeasures, or other coun11 termeasure-related technologies and capabilities, that 

12 shall— 

13 ‘‘(A) consult with countermeasure experts, 

14 including countermeasure sponsors and appli15 cants, to identify and help resolve scientific 

16 issues related to the approval, licensure, or 

17 clearance of countermeasures, through work18 shops or public meetings; 

19 ‘‘(B) improve and advance the science re20 lating to the development of new tools, stand21 ards, and approaches to assessing and evalu22 ating countermeasures— 

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

24 countermeasure approval, clearance, and li25 censure; and 
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1 ‘‘(ii) with respect to the development 

2 of countermeasures for populations with 

3 special clinical needs, including children 

4 and pregnant women, in order to meet the 

5 needs of such populations, as necessary 

6 and appropriate; and 

7 ‘‘(5) establish’’; and 

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

9 ‘‘(c) DEVELOPMENT AND ANIMAL MODELING PRO10 CEDURES.— 

11 ‘‘(1) AVAILABILITY OF ANIMAL MODEL MEET12 INGS.—To facilitate the timely development of ani13 mal models and support the development, stock14 piling, licensure, approval, and clearance of counter15 measures, the Secretary shall, not later than 180 

16 days after the enactment of this subsection, establish 

17 a procedure by which a sponsor or applicant that is 

18 developing a countermeasure for which human effi19 cacy studies are not ethical or practicable, and that 

20 has an approved investigational new drug application 

21 or investigational device exemption, may request and 

22 receive— 

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

24 model development activities; and 
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1 ‘‘(B) a meeting prior to initiating pivotal 

2 animal studies. 

3 ‘‘(2) PEDIATRIC MODELS.—To facilitate the de4 velopment and selection of animal models that could 

5 translate to pediatric studies, any meeting conducted 

6 under paragraph (1) shall include discussion of ani7 mal models for pediatric populations, as appropriate. 

8 ‘‘(d) REVIEW AND APPROVAL OF COUNTER9 MEASURES.— 

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

11 application or submission for approval, licensure, or 

12 clearance of a countermeasure, the Secretary shall 

13 take into account the material threat posed by the 

14 chemical, biological, radiological, or nuclear agent or 

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

16 Health Service Act for which the countermeasure 

17 under review is intended. 

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

19 and appropriate, teams of Food and Drug Adminis20 tration personnel reviewing applications or submis21 sions described under paragraph (1) shall include a 

22 reviewer with sufficient training or experience with 

23 countermeasures pursuant to the protocols estab24 lished under subsection (b)(3)(D).’’. 
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1 SEC. 305. REGULATORY MANAGEMENT PLANS. 

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

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

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

5 ‘‘(e) REGULATORY MANAGEMENT PLAN.— 

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

7 ‘eligible countermeasure’ means— 

8 ‘‘(A) a security countermeasure with re9 spect to which the Secretary has entered into a 

10 procurement contract under section 319F–2(c) 

11 of the Public Health Service Act; or 

12 ‘‘(B) a countermeasure with respect to 

13 which the Biomedical Advanced Research and 

14 Development Authority has provided funding 

15 under section 319L of the Public Health Serv16 ice Act for advanced research and development. 

17 ‘‘(2) REGULATORY MANAGEMENT PLAN PROC18 ESS.—The Secretary, in consultation with the As19 sistant Secretary for Preparedness and Response 

20 and the Director of the Biomedical Advanced Re21 search and Development Authority, shall establish a 

22 formal process for obtaining scientific feedback and 

23 interactions regarding the development and regu24 latory review of eligible countermeasures by facili25 tating the development of written regulatory man26 agement plans in accordance with this subsection. 
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1 ‘‘(3) SUBMISSION OF REQUEST AND PROPOSED

2 PLAN BY SPONSOR OR APPLICANT.— 

3 ‘‘(A) IN GENERAL.—A sponsor or appli4 cant of an eligible countermeasure may initiate 

5 the process described under paragraph (2) upon 

6 submission of written request to the Secretary. 

7 Such request shall include a proposed regu8 latory management plan. 

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

10 or applicant may submit a written request 

11 under subparagraph (A) after the eligible coun12 termeasure has an investigational new drug or 

13 investigational device exemption in effect. 

14 ‘‘(C) RESPONSE BY SECRETARY.—The 

15 Secretary shall direct the Food and Drug Ad16 ministration, upon submission of a written re17 quest by a sponsor or applicant under subpara18 graph (A), to work with the sponsor or appli19 cant to agree on a regulatory management plan 

20 within a reasonable time not to exceed 90 days. 

21 If the Secretary determines that no plan can be 

22 agreed upon, the Secretary shall provide to the 

23 sponsor or applicant, in writing, the scientific 

24 or regulatory rationale why such agreement 

25 cannot be reached. 
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1 ‘‘(4) PLAN.—The content of a regulatory man2 agement plan agreed to by the Secretary and a spon3 sor or applicant shall include— 

4 ‘‘(A) an agreement between the Secretary 

5 and the sponsor or applicant regarding develop6 mental milestones that will trigger responses by 

7 the Secretary as described in subparagraph (B); 

8 ‘‘(B) performance targets and goals for 

9 timely and appropriate responses by the Sec10 retary to the triggers described under subpara11 graph (A), including meetings between the Sec12 retary and the sponsor or applicant, written 

13 feedback, decisions by the Secretary, and other 

14 activities carried out as part of the development 

15 and review process; and 

16 ‘‘(C) an agreement on how the plan shall 

17 be modified, if needed. 

18 ‘‘(5) MILESTONES AND PERFORMANCE TAR19 GETS.—The developmental milestones described in 

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

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

22 ‘‘(A) feedback from the Secretary regard23 ing the data required to support the approval, 

24 clearance, or licensure of the eligible counter25 measure involved; 
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1 ‘‘(B) feedback from the Secretary regard2 ing the data necessary to inform any authoriza3 tion under section 564; 

4 ‘‘(C) feedback from the Secretary regard5 ing the data necessary to support the posi6 tioning and delivery of the eligible counter7 measure, including to the Strategic National 

8 Stockpile; 

9 ‘‘(D) feedback from the Secretary regard10 ing the data necessary to support the submis11 sion of protocols for review under section 

12 505(b)(5)(B); 

13 ‘‘(E) feedback from the Secretary regard14 ing any gaps in scientific knowledge that will 

15 need resolution prior to approval, licensure, or 

16 clearance of the eligible countermeasure, and 

17 plans for conducting the necessary scientific re18 search; 

19 ‘‘(F) identification of the population for 

20 which the countermeasure sponsor or applicant 

21 seeks approval, licensure, or clearance, and the 

22 population for which desired labeling would not 

23 be appropriate, if known; and 

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

25 the extent practicable, a plan for demonstrating 
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1 safety and effectiveness in pediatric popu2 lations, and for developing pediatric dosing, for3 mulation, and administration with respect to 

4 the eligible countermeasure, provided that such 

5 plan would not delay authorization under sec6 tion 564, approval, licensure, or clearance for 

7 adults. 

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

9 Food and Drugs determines that resources are not 

10 available to establish regulatory management plans 

11 under this section for all eligible countermeasures 

12 for which a request is submitted under paragraph 

13 (3)(A), the Director of the Biomedical Advanced Re14 search and Development Authority, in consultation 

15 with the Commissioner of Food and Drugs, shall 

16 prioritize which eligible countermeasures may receive 

17 regulatory managements plans, and in doing so shall 

18 give priority to eligible countermeasures that are se19 curity countermeasures.’’. 

20 SEC. 306. REPORT. 

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

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

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

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

25 after the date of enactment of this subsection, and annu-
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1 ally thereafter, the Secretary shall submit to the Com2 mittee on Health, Education, Labor, and Pensions of the 

3 Senate and the Committee on Energy and Commerce of 

4 the House of Representatives a report that details the 

5 countermeasure development and review activities of the 

6 Food and Drug Administration, including— 

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

8 tools, standards, and approaches to assess and 

9 evaluate countermeasures— 

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

11 the Food and Drug Administration and the 

12 progress made on such priorities; and 

13 ‘‘(B) the identification of scientific gaps 

14 that impede the development or approval, licen15 sure, or clearance of countermeasures for popu16 lations with special clinical needs, including 

17 children and pregnant women, and the progress 

18 made on resolving these challenges; 

19 ‘‘(2) with respect to countermeasures for which 

20 a regulatory management plan has been agreed upon 

21 under subsection (e), the extent to which the per22 formance targets and goals set forth in subsection 

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

24 been met, including, for each such countermeasure— 
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1 ‘‘(A) whether the regulatory management 

2 plan was completed within the required time3 frame, and the length of time taken to complete 

4 such plan; 

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

6 timely and appropriate response times set forth 

7 in such plan; and 

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

9 such performance targets and goals; 

10 ‘‘(3) the number of regulatory teams estab11 lished pursuant to subsection (b)(4), the number of 

12 products, classes of products, or technologies as13 signed to each such team, and the number of, type 

14 of, and any progress made as a result of consulta15 tions carried out under subsection (b)(4)(A); 

16 ‘‘(4) an estimate of resources obligated to coun17 termeasure development and regulatory assessment, 

18 including Center specific objectives and accomplish19 ments; 

20 ‘‘(5) the number of countermeasure applications 

21 submitted, the number of countermeasures approved, 

22 licensed, or cleared, the status of remaining sub23 mitted applications, and the number of each type of 

24 authorization issued pursuant to section 564; and 
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1 ‘‘(6) the number of written requests for a regu2 latory management plan submitted under subsection 

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

4 plans developed, and the number of such plans de5 veloped for security countermeasures.’’. 

6 SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES. 

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

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

9 355a) is amended— 

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

11 following: 

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

13 that is a qualified countermeasure (as defined in sec14 tion 319F–1 of the Public Health Service Act), a se15 curity countermeasure (as defined in section 319F– 

16 2 of the Public Health Service Act), or a qualified 

17 pandemic or epidemic product (as defined in section 

18 319F–3 of the Public Health Service Act), the Sec19 retary shall solicit input from the Assistant Sec20 retary for Preparedness and Response regarding the 

21 need for and, from the Director of the Biomedical 

22 Advanced Research and Development Authority re23 garding the conduct of, pediatric studies under this 

24 section.’’; and 
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1 (2) in subsection (n)(1), by adding at the end 

2 the following: 

3 ‘‘(C) For a drug that is a qualified coun4 termeasure (as defined in section 319F–1 of the 

5 Public Health Service Act), a security counter6 measure (as defined in section 319F–2 of the 

7 Public Health Service Act), or a qualified pan8 demic or epidemic product (as defined in sec9 tion 319F–3 of such Act), in addition to any 

10 action with respect to such drug under subpara11 graph (A) or (B), the Secretary shall notify the 

12 Assistant Secretary for Preparedness and Re13 sponse and the Director of the Biomedical Ad14 vanced Research and Development Authority of 

15 all pediatric studies in the written request 

16 issued by the Commissioner of Food and 

17 Drugs.’’. 

18 (b) ADDITION TO PRIORITY LIST CONSIDER19 ATIONS.—Section 409I of the Public Health Service Act 

20 (42 U.S.C. 284m) is amended— 

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

22 the following: 

23 ‘‘(2) CONSIDERATION OF AVAILABLE INFORMA24 TION.—In developing and prioritizing the list under 

25 paragraph (1), the Secretary— 
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1 ‘‘(A) shall consider— 

2 ‘‘(i) therapeutic gaps in pediatrics 

3 that may include developmental pharma4 cology, pharmacogenetic determinants of 

5 drug response, metabolism of drugs and 

6 biologics in children, and pediatric clinical 

7 trials; 

8 ‘‘(ii) particular pediatric diseases, dis9 orders or conditions where more complete 

10 knowledge and testing of therapeutics, in11 cluding drugs and biologics, may be bene12 ficial in pediatric populations; and 

13 ‘‘(iii) the adequacy of necessary infra14 structure to conduct pediatric pharma15 cological research, including research net16 works and trained pediatric investigators; 

17 and 

18 ‘‘(B) may consider the availability of quali19 fied countermeasures (as defined in section 

20 319F–1), security countermeasures (as defined 

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

22 epidemic products (as defined in section 319F– 

23 3) to address the needs of pediatric populations, 

24 in consultation with the Assistant Secretary for 
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1 Preparedness and Response, consistent with the 

2 purposes of this section.’’; and 

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

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

5 subsection (a)’’. 

6 (c) ADVICE AND RECOMMENDATIONS OF THE PEDI7 ATRIC ADVISORY COMMITTEE REGARDING COUNTER8 MEASURES FOR PEDIATRIC POPULATIONS.—Subsection 

9 (b)(2) of section 14 of the Best Pharmaceuticals for Chil10 dren Act (42 U.S.C. 284m note) is amended— 

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

12 and inserting ‘‘; and’’; and 

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

14 ‘‘(D) the development of countermeasures 

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

16 Food, Drug, and Cosmetic Act) for pediatric 

17 populations.’’. 

18 TITLE IV—ACCELERATING MED19 ICAL COUNTERMEASURE AD20 VANCED RESEARCH AND DE21 VELOPMENT 

22 SEC. 401. BIOSHIELD. 

23 (a) REAUTHORIZATION OF THE SPECIAL RESERVE

24 FUND.—Section 319F–2(c) of the Public Health Service 
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1 Act (42 U.S.C. 247d–6b(c)) is amended by adding at the 

2 end 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 

7 fiscal 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 

12 Secretary shall submit to the appropriate committees 

13 of Congress a report detailing the amount of such 

14 funds available for procurement and the impact such 

15 reduction in funding will have— 

16 ‘‘(A) in meeting the security counter17 measure 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.—Sec23 tion 319F–2(c) of the Public Health Service Act (42 

24 U.S.C. 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’’; 

12 and 

13 (ii) by striking subclause (IX) and in14 serting the following: 

15 ‘‘(IX) CONTRACT TERMS.—The 

16 Secretary, in any contract for procure17 ment under this section— 

18 ‘‘(aa) may specify— 

19 ‘‘(AA) the dosing and 

20 administration requirements 

21 for the countermeasure to be 

22 developed and procured; 

23 ‘‘(BB) the amount of 

24 funding that will be dedi25 cated by the Secretary for 
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1 advanced research, develop2 ment, and procurement of 

3 the countermeasure; and 

4 ‘‘(CC) the specifications 

5 the countermeasure must 

6 meet to qualify for procure7 ment under a contract under 

8 this section; and 

9 ‘‘(bb) shall provide a clear 

10 statement of defined Government 

11 purpose limited to uses related to 

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

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

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

16 this section, the Secretary may, consistent 

17 with the applicable provisions of this sec18 tion, enter into contracts and other agree19 ments that are in the best interest of the 

20 Government in meeting identified security 

21 countermeasure needs, including with re22 spect to reimbursement of the cost of ad23 vanced research and development as a rea24 sonable, allowable, and allocable direct cost 

25 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 subpara3 graph shall not be construed to prohibit the use of 

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

5 and 

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

7 following: 

8 ‘‘(C) ADVANCED RESEARCH AND DEVELOP9 MENT.—For purposes of this paragraph, the 

10 term ‘advanced research and development’ shall 

11 have the meaning given such term in section 

12 319L(a).’’. 

13 SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVEL14 OPMENT AUTHORITY. 

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

16 Health Service Act (42 U.S.C. 247d–7e(c)(4)) is amend17 ed— 

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

19 ‘‘(which may include advanced research and develop20 ment for purposes of fulfilling requirements under 

21 the Federal Food, Drug, and Cosmetic Act or sec22 tion 351 of this Act)’’ after ‘‘development’’; and 

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

24 vaccine manufacturing technologies’’ and inserting 

25 ‘‘vaccine manufacturing technologies, dose sparing 
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1 technologies, efficacy increasing technologies, and 

2 platform technologies’’. 

3 (b) STRATEGIC PUBLIC-PRIVATE PARTNERSHIP.— 

4 Section 319L(c)(4) of the Public Health Service Act (42 

5 U.S.C. 247d–7e(c)(4)) is amended by adding at the end 

6 the following: 

7 ‘‘(E) STRATEGIC INVESTOR.— 

8 ‘‘(i) IN GENERAL.—To support the 

9 purposes described in paragraph (2), the 

10 Secretary, acting through the Director of 

11 BARDA, may enter into an agreement (in12 cluding through the use of grants, con13 tracts, cooperative agreements, or other 

14 transactions as described in paragraph (5)) 

15 with an independent, non-profit entity to— 

16 ‘‘(I) foster and accelerate the de17 velopment and innovation of medical 

18 countermeasures and technologies 

19 that may assist advanced research 

20 and development of qualified counter21 measures and qualified pandemic or 

22 epidemic products, including strategic 

23 investment through the use of venture 

24 capital practices and methods; 
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1 ‘‘(II) promote the development of 

2 new and promising technologies that 

3 address urgent medical counter4 measure needs, as identified by the 

5 Secretary; 

6 ‘‘(III) address unmet public 

7 health needs that are directly related 

8 to medical countermeasure require9 ments, such as novel antimicrobials 

10 for multidrug resistant organisms and 

11 multiuse platform technologies for 

12 diagnostics, prophylaxis, vaccines, and 

13 therapeutics; and 

14 ‘‘(IV) provide expert consultation 

15 and advice to foster viable medical 

16 countermeasure innovators, including 

17 helping qualified countermeasure 

18 innovators navigate unique industry 

19 challenges with respect to developing 

20 chemical, biological, radiological, and 

21 nuclear countermeasure products. 

22 ‘‘(ii) ELIGIBILITY.— 

23 ‘‘(I) IN GENERAL.—To be eligible 

24 to enter into an agreement under 

25 clause (i) an entity shall— 
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1 ‘‘(aa) be an independent, 

2 non-profit entity not otherwise 

3 affiliated with the Department of 

4 Health and Human Services; 

5 ‘‘(bb) have a demonstrated 

6 record of being able to create 

7 linkages between innovators and 

8 investors and leverage such part9 nerships and resources for the 

10 purpose of addressing identified 

11 strategic needs of the Federal 

12 Government; 

13 ‘‘(cc) have experience in pro14 moting novel technology innova15 tion; 

16 ‘‘(dd) be problem driven and 

17 solution focused based on the 

18 needs, requirements, and prob19 lems identified by the Secretary 

20 under clause (iv); 

21 ‘‘(ee) demonstrate the abil22 ity, or the potential ability, to 

23 promote the development of med24 ical countermeasure products; 

25 and 
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1 ‘‘(ff) demonstrate expertise, 

2 or the capacity to develop or ac3 quire expertise, related to tech4 nical and regulatory consider5 ations with respect to medical 

6 countermeasures. 

7 ‘‘(II) PARTNERING EXPERI8 ENCE.—In selecting an entity with 

9 which to enter into an agreement 

10 under clause (i), the Secretary shall 

11 place a high value on the dem12 onstrated experience of the entity in 

13 partnering with the Federal Govern14 ment to meet identified strategic 

15 needs. 

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

17 enters into an agreement under clause (i) 

18 shall not be deemed to be a Federal agency 

19 for any purpose, including for any purpose 

20 under title 5, United States Code. 

21 ‘‘(iv) DIRECTION.—Pursuant to an 

22 agreement entered into under this subpara23 graph, the Secretary, acting through the 

24 Director of BARDA, shall provide direc25 tion to the entity that enters into an agree-
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1 ment under clause (i). As part of this 

2 agreement the Director of BARDA shall— 

3 ‘‘(I) communicate the medical 

4 countermeasure needs, requirements, 

5 and problems to be addressed by the 

6 entity under the agreement; 

7 ‘‘(II) develop a description of 

8 work to be performed by the entity 

9 under the agreement; 

10 ‘‘(III) provide technical feedback 

11 and appropriate oversight over work 

12 carried out by the entity under the 

13 agreement, including subsequent de14 velopment and partnerships consistent 

15 with the needs and requirements set 

16 forth in this subparagraph; 

17 ‘‘(IV) ensure fair consideration of 

18 products developed under the agree19 ment in order to maintain competition 

20 to the maximum practical extent, as 

21 applicable and appropriate under ap22 plicable provisions of this section; and 

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

24 agreement— 
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1 ‘‘(aa) a comprehensive set of 

2 policies that demonstrate a com3 mitment to transparency and ac4 countability; 

5 ‘‘(bb) protection against con6 flicts of interest through a com7 prehensive set of policies that ad8 dress potential conflicts of inter9 est, ethics, disclosure, and report10 ing requirements; 

11 ‘‘(cc) that the entity pro12 vides monthly accounting on the 

13 use of funds provided under such 

14 agreement; and 

15 ‘‘(dd) that the entity pro16 vides on a quarterly basis, re17 ports regarding the progress 

18 made toward meeting the identi19 fied needs set forth in the agree20 ment. 

21 ‘‘(v) SUPPLEMENT NOT SUPPLANT.— 

22 Activities carried out under this subpara23 graph shall supplement, and not supplant, 

24 other activities carried out under this sec25 tion. 
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1 ‘‘(vi) NO ESTABLISHMENT OF ENTI2 TY.—To prevent unnecessary duplication 

3 and target resources effectively, nothing in 

4 this subparagraph shall be construed to 

5 authorize the Secretary to establish within 

6 the Department of Health and Human 

7 Services a strategic investor entity. 

8 ‘‘(vii) TRANSPARENCY AND OVER9 SIGHT.—Upon request, the Secretary shall 

10 provide to Congress the information pro11 vided to the Secretary under clause 

12 (iv)(V)(dd). 

13 ‘‘(viii) INDEPENDENT EVALUATION.— 

14 Not later than 4 years after the date of en15 actment of this subparagraph, the Govern16 ment Accountability Office shall conduct 

17 an independent evaluation, and submit to 

18 the Secretary and the appropriate commit19 tees of Congress a report, concerning the 

20 activities conducted under this subpara21 graph. Such report shall include rec22 ommendations with respect to any agree23 ment or activities carried out pursuant to 

24 this subparagraph. 
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1 ‘‘(ix) SUNSET.—This subparagraph 

2 shall have no force or effect after Sep3 tember 30, 2016.’’. 

4 (c) TRANSACTION AUTHORITIES.—Section 

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

6 247d–7e(c)(5)) is amended by adding at the end the fol7 lowing: 

8 ‘‘(G) GOVERNMENT PURPOSE.—In award9 ing contracts, grants, and cooperative agree10 ments under this section, the Secretary shall 

11 provide a clear statement of defined Govern12 ment purpose related to activities included in 

13 subsection (a)(6)(B) for a qualified counter14 measure or qualified pandemic or epidemic 

15 product.’’. 

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

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

18 amended to read as follows: 

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

20 this section, there is authorized to be appropriated 

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

22 2012 through 2016, such amounts to remain avail23 able until expended.’’. 

24 (e) CONTINUED INAPPLICABILITY OF CERTAIN PRO25 VISIONS.—Section 319L(e)(1)(C) of the Public Health 
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1 Service Act (42 U.S.C. 247d–7e(e)(1)(C)) is amended by 

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

3 (f) EXTENSION OF LIMITED ANTITRUST EXEMP4 TION.—Section 405(b) of the Pandemic and All-Hazards 

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

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

7 (g) INDEPENDENT EVALUATION.—Section 319L of 

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

9 amended by adding at the end the following: 

10 ‘‘(f) INDEPENDENT EVALUATION.— 

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

12 after the date of enactment of this subsection, the 

13 Government Accountability Office shall conduct an 

14 independent evaluation of the activities carried out 

15 to facilitate flexible manufacturing capacity pursu16 ant to this section. 

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

18 date of enactment of this subsection, the Govern19 ment Accountability Office shall submit to the ap20 propriate committees of Congress a report con21 cerning the results of the evaluation conducted 

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

23 assess— 

24 ‘‘(A) the extent to which flexible manufac25 turing capacity under this section is dedicated 
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1 to chemical, biological, radiological, and nuclear 

2 threats; 

3 ‘‘(B) the activities supported by flexible 

4 manufacturing initiatives; and 

5 ‘‘(C) the ability of flexible manufacturing 

6 activities carried out under this section to— 

7 ‘‘(i) secure and leverage leading tech8 nical expertise with respect to counter9 measure advanced research, development, 

10 and manufacturing processes; and 

11 ‘‘(ii) meet the surge manufacturing 

12 capacity needs presented by novel and 

13 emerging threats, including chemical, bio14 logical, radiological and nuclear agents.’’. 

15 (h) DEFINITIONS.— 

16 (1) QUALIFIED COUNTERMEASURE.—Section 

17 319F–1(a)(2)(A) of the Public Health Service Act 

18 (42 U.S.C. 247d–6a(a)(2)(A)) is amended— 

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

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

21 (B) in clause (i)— 

22 (i) by striking ‘‘diagnose’’ and insert23 ing ‘‘to diagnose’’; and 

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

25 semicolon; 
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1 (C) in clause (ii)— 

2 (i) by striking ‘‘diagnose’’ and insert3 ing ‘‘to diagnose’’; and 

4 (ii) by striking the period at the end 

5 and inserting ‘‘; or’’; and 

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

7 ‘‘(iii) is a product or technology in8 tended to enhance the use or effect of a 

9 drug, biological product, or device de10 scribed in clause (i) or (ii).’’. 

11 (2) QUALIFIED PANDEMIC OR EPIDEMIC PROD12 UCT.—Section 319F–3(i)(7)(A) of the Public Health 

13 Service Act (42 U.S.C. 247d–6d(i)(7)(A)) is amend14 ed— 

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

16 inserting ‘‘;’’; 

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

18 inserting ‘‘; or’’; and 

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

20 ‘‘(iii) a product or technology intended 

21 to enhance the use or effect of a drug, bio22 logical product, or device described in 

23 clause (i) or (ii); and’’. 
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1 (3) TECHNICAL AMENDMENTS.—Section 319F– 

2 3(i) of the Public Health Service Act (42 U.S.C. 

3 247d–6d(i)) is amended— 

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

5 564A, or 564B’’ after ‘‘564’’; and 

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

7 ‘‘, 564A, or 564B’’ after ‘‘564’’. 

8 SEC. 403. STRATEGIC NATIONAL STOCKPILE. 

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

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

11 (1) in subsection (a)— 

12 (A) in paragraph (1)— 

13 (i) by inserting ‘‘consistent with sec14 tion 2811’’ before ‘‘by the Secretary to be 

15 appropriate’’; and 

16 (ii) by inserting before the period at 

17 the end the following: ‘‘and shall submit 

18 such review annually to the appropriate 

19 Congressional committees of jurisdiction to 

20 the extent that disclosure of such informa21 tion does not compromise national secu22 rity’’; and 

23 (B) in paragraph (2)— 
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1 (i) by redesignating subparagraphs 

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

3 through (I), respectively; and 

4 (ii) by inserting after subparagraph 

5 (D), the following: 

6 ‘‘(E) identify and address the potential de7 pletion and ensure appropriate replenishment of 

8 medical countermeasures, including those cur9 rently in the stockpile;’’; and 

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

11 ‘‘$640,000,000 for fiscal year 2002, and such sums 

12 as may be necessary for each of fiscal years 2003 

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

14 each of fiscal years 2012 through 2016’’. 

15 (b) REPORT ON POTASSIUM IODIDE.—Not later than 

16 270 days after the date of enactment of this Act, the Sec17 retary of Health and Human Services shall submit to the 

18 appropriate Committees of Congress a report regarding 

19 the stockpiling of potassium iodide. Such report shall in20 clude— 

21 (1) an assessment of the availability of potas22 sium iodide at Federal, State, and local levels; and 

23 (2) a description of the extent to which such ac24 tivities and policies provide public health protection 
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1 in the event of a nuclear incident, whether uninten2 tional or deliberate, including an act of terrorism. 

3 SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD. 

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

5 U.S.C. 247d–f(a)) is amended— 

6 (1) in paragraph (2)— 

7 (A) in subparagraph (D)— 

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

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

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

11 the end; 

12 (iii) in clause (ii), by striking the pe13 riod and inserting a semicolon; and 

14 (iv) by adding at the end the fol15 lowing: 

16 ‘‘(iii) one such member shall be an in17 dividual with pediatric subject matter ex18 pertise; and 

19 ‘‘(iv) one such member shall be a 

20 State, tribal, territorial, or local public 

21 health official.’’; and 

22 (B) by adding at the end the following 

23 flush sentence: 
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1 ‘‘Nothing in this paragraph shall preclude a member 

2 of the Board from satisfying two or more of the re3 quirements described in subparagraph (D).’’; 

4 (2) in paragraph (5)— 

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

6 ‘‘and’’ at the end; 

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

8 period and inserting ‘‘; and’’; and 

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

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

11 or report provided to the Secretary under this 

12 paragraph to the appropriate committees of 

13 Congress.’’; and 

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

15 following: ‘‘Such chairperson shall serve as the de16 ciding vote in the event that a deciding vote is nec17 essary with respect to voting by members of the 

18 Board.’’. 

Passed the Senate March 7, 2012. 

Attest: 

Secretary. 

112TH CONGRESS 

2D SESSION S. 1855 

AN ACT 

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