[Congressional Record (Bound Edition), Volume 158 (2012), Part 3]
[Senate]
[Pages 3127-3144]
[From the U.S. Government Publishing Office, www.gpo.gov]




   PANDEMIC AND ALL-HAZARDS PREPAREDNESS ACT REAUTHORIZATION OF 2011

  Mr. REID. Mr. President, I ask unanimous consent that the Senate 
proceed to the consideration of Calendar No. 263.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The clerk will state the bill by title.
  The assistant legislative clerk read as follows:

       A bill (S. 1855) to amend the Public Health Service Act to 
     reauthorize various programs under the Pandemic and All-
     Hazards Preparedness Act.

  There being no objection, the Senate proceeded to consider the bill, 
which had been reported from the Committee on Health, Education, Labor, 
and Pensions, with an amendment to strike all after the enacting clause 
and insert in lieu thereof the following:

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Pandemic 
     and All-Hazards Preparedness Act Reauthorization of 2011''.
       (b) Table of Contents.--The table of contents of 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.

 TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC 
                           HEALTH EMERGENCIES

     SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

       (a) In General.--Section 2802 of the Public Health Service 
     Act (42 U.S.C. 300hh-1) is amended--
       (1) in subsection (a)(1), by striking ``2009'' and 
     inserting ``2014''; and
       (2) in subsection (b)--
       (A) in paragraph (3)--
       (i) in the matter preceding subparagraph (A)--

       (I) by striking ``facilities), and trauma care'' and 
     inserting ``facilities and which may include dental health 
     facilities), and trauma care, critical care,''; and
       (II) by inserting ``(including related availability, 
     accessibility, and coordination)'' after ``public health 
     emergencies'';

       (ii) in subparagraph (A), by inserting ``and trauma'' after 
     ``medical'';
       (iii) in subparagraph (D), by inserting ``(which may 
     include such dental health assets)'' after ``medical 
     assets'';
       (iv) by adding at the end the following:
       ``(F) Optimizing a coordinated and flexible approach to the 
     medical surge capacity of hospitals, other healthcare 
     facilities, and trauma care (which may include trauma 
     centers) and emergency medical systems.'';
       (B) in paragraph (4)--
       (i) in subparagraph (A), by inserting ``, including the 
     unique needs and considerations of individuals with 
     disabilities,'' after ``medical needs of at-risk 
     individuals''; and
       (ii) in subparagraph (B), by inserting ``the'' before 
     ``purpose of this section''; and
       (C) by adding at the end the following:
       ``(7) Countermeasures.--
       ``(A) Promoting strategic initiatives to advance 
     countermeasures to diagnose, mitigate, prevent, or treat harm 
     from any biological agent or toxin, chemical, radiological, 
     or nuclear agent or agents, whether naturally occurring, 
     unintentional, or deliberate.
       ``(B) For purposes of this paragraph the term 
     `countermeasures' has the same meaning as the terms 
     `qualified countermeasures' under section 319F-1, `qualified 
     pandemic and epidemic products' under section 319F-3, and 
     `security countermeasures' under section 319F-2.
       ``(8) Medical and public health community resiliency.--
     Strengthening the ability of States, local communities, and 
     tribal communities to prepare for, respond to, and be 
     resilient in the event of public health emergencies, whether 
     naturally occurring, unintentional, or deliberate by--
       ``(A) optimizing alignment and integration of medical and 
     public health preparedness and response planning and 
     capabilities with and into routine daily activities; and
       ``(B) promoting familiarity with local medical and public 
     health systems.''.
       (b) At-Risk Individuals.--Section 2814 of the Public Health 
     Service Act (42 U.S.C. 300hh-16) is amended--
       (1) by striking paragraphs (5), (7), and (8);
       (2) by redesignating paragraphs (1) through (4) as 
     paragraphs (2) through (5), respectively;
       (3) by inserting before paragraph (2) (as so redesignated), 
     the following:
       ``(1) monitor emerging issues and concerns as they relate 
     to medical and public health preparedness and response for 
     at-risk individuals in the event of a public health emergency 
     declared by the Secretary under section 319;'';
       (4) in paragraph (2) (as so redesignated), by striking 
     ``National Preparedness goal'' and inserting ``preparedness 
     goals, as described in section 2802(b),''; and
       (5) by inserting after paragraph (6), the following:
       ``(7) disseminate and, as appropriate, update novel and 
     best practices of outreach to and care of at-risk individuals 
     before, during, and following public health emergencies in as 
     timely a manner as is practicable, including from the time a 
     public health threat is identified; and
       ``(8) ensure that public health and medical information 
     distributed by the Department of Health and Human Services 
     during a public health emergency is delivered in a manner 
     that takes into account the range of communication needs of 
     the intended recipients, including at-risk individuals.''.

     SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

       Section 2811 of the Public Health Service Act (42 U.S.C. 
     300hh-10) is amended--
       (1) in subsection (b)(4), by adding at the end the 
     following:
       ``(D) Policy coordination and strategic direction.--Provide 
     integrated policy coordination and strategic direction with 
     respect to all matters related to Federal public health and 
     medical preparedness and execution and deployment of the 
     Federal response for public health emergencies and incidents 
     covered by the National Response Plan developed pursuant to 
     section 502(6) of the Homeland Security Act of 2002, or any 
     successor plan, before, during, and following public health 
     emergencies.'';
       (2) by striking subsection (c) and inserting the following:
       ``(c) Functions.--The Assistant Secretary for Preparedness 
     and Response shall--
       ``(1) have authority over and responsibility for--
       ``(A) the National Disaster Medical System (in accordance 
     with section 301 of the Pandemic and All-Hazards Preparedness 
     Act);
       ``(B) the Hospital Preparedness Cooperative Agreement 
     Program pursuant to section 319C-2;
       ``(C) the Medical Reserve Corps pursuant to section 2813;
       ``(D) the Emergency System for Advance Registration of 
     Volunteer Health Professionals pursuant to section 319I; and
       ``(E) administering grants and related authorities related 
     to trauma care under parts A through C of title XII, such 
     authority to be transferred by the Secretary from the 
     Administrator of the Health Resources and Services 
     Administration to such Assistant Secretary;
       ``(2) exercise the responsibilities and authorities of the 
     Secretary with respect to the coordination of--
       ``(A) the Public Health Emergency Preparedness Cooperative 
     Agreement Program pursuant to section 319C-1;
       ``(B) the Strategic National Stockpile; and
       ``(C) the Cities Readiness Initiative;
       ``(3) align and coordinate medical and public health grants 
     and cooperative agreements as applicable to preparedness and 
     response activities authorized under this Act, to the extent 
     possible, including program requirements, timelines, and 
     measurable goals, and in coordination with the Secretary of 
     Homeland Security, to--
       ``(A) optimize and streamline medical and public health 
     preparedness capabilities and the ability of local 
     communities to respond to public health emergencies;
       ``(B) minimize duplication of efforts with regard to 
     medical and public health preparedness and response programs; 
     and
       ``(C) gather and disseminate best practices among grant and 
     cooperative agreement recipients, as appropriate;
       ``(4) carry out drills and operational exercises, in 
     coordination with the Department of Homeland Security, the 
     Department of Defense, the

[[Page 3128]]

     Department of Veterans Affairs, and other applicable Federal 
     departments and agencies, as necessary and appropriate, to 
     identify, inform, and address gaps in and policies related to 
     all-hazards medical and public health preparedness, including 
     exercises based on--
       ``(A) identified threats for which countermeasures are 
     available and for which no countermeasures are available; and
       ``(B) unknown threats for which no countermeasures are 
     available; and
       ``(5) assume other duties as determined appropriate by the 
     Secretary.''; and
       (3) by adding at the end the following:
       ``(d) National Security Priority.--The Secretary, acting 
     through the Assistant Secretary for Preparedness and 
     Response, shall on a periodic basis conduct meetings, as 
     applicable and appropriate, with the Assistant to the 
     President for National Security Affairs to provide an update 
     on, and discuss, medical and public health preparedness and 
     response activities pursuant to this Act and the Federal 
     Food, Drug, and Cosmetic Act, including progress on the 
     development, approval, clearance, and licensure of medical 
     countermeasures.
       ``(e) Public Health Emergency Medical Countermeasures 
     Enterprise Strategy and Implementation Plan.--
       ``(1) In general.--Not later than 180 days after the date 
     of enactment of this subsection, and every other year 
     thereafter, the Secretary, acting through the Assistant 
     Secretary for Preparedness and Response and in consultation 
     with the Director of the Biomedical Advanced Research and 
     Development Authority, the Director of the National 
     Institutes of Health, the Director of the Centers for Disease 
     Control and Prevention, and the Commissioner of the Food and 
     Drug Administration, shall develop and submit to the 
     appropriate committees of Congress a coordinated strategy and 
     accompanying implementation plan for medical countermeasures 
     to address chemical, biological, radiological, and nuclear 
     threats. Such strategy and plan shall be known as the `Public 
     Health Emergency Medical Countermeasures Enterprise Strategy 
     and Implementation Plan'.
       ``(2) Requirements.--The plan under paragraph (1) shall--
       ``(A) consider and reflect the full spectrum of medical 
     countermeasure-related activities, including research, 
     advanced research, development, procurement, stockpiling, 
     deployment, and distribution;
       ``(B) identify and prioritize near-term, mid-term, and 
     long-term priority qualified and security countermeasure (as 
     defined in sections 319F-1 and 319F-2) needs and goals of the 
     Federal Government according to chemical, biological, 
     radiological, and nuclear threat or threats;
       ``(C) identify projected timelines, anticipated funding 
     allocations, benchmarks, and milestones for each medical 
     countermeasure priority under subparagraph (B), including 
     projected needs with regard to replenishment of the Strategic 
     National Stockpile;
       ``(D) be informed by the recommendations of the National 
     Biodefense Science Board pursuant to section 319M;
       ``(E) report on advanced research and development awards 
     and the date of the issuance of contract awards, including 
     awards made through the special reserve fund (as defined in 
     section 319F-2(c)(10));
       ``(F) identify progress made in meeting the goals, 
     benchmarks, and milestones identified under subparagraph (C) 
     in plans submitted subsequent to the initial plan;
       ``(G) identify the progress made in meeting the medical 
     countermeasure priorities for at-risk individuals, (as 
     defined in 2802(b)(4)(B)), as applicable under subparagraph 
     (B), including with regard to the projected needs for related 
     stockpiling and replenishment of the Strategic National 
     Stockpile; and
       ``(H) be made publicly available.
       ``(3) GAO report.--
       ``(A) In general.--Not later than 1 year after the date on 
     which a Public Health Emergency Medical Countermeasures 
     Enterprise Strategy and Implementation Plan under this 
     subsection is issued by the Secretary, the Government 
     Accountability Office shall conduct an independent evaluation 
     and submit to the appropriate committees of Congress a report 
     concerning such strategy and implementation plan.
       ``(B) Content.--The report described in subparagraph (A) 
     shall review and assess--
       ``(i) the near-term, mid-term, and long-term medical 
     countermeasure needs and identified priorities of the Federal 
     Government pursuant to subparagraphs (A) and (B) of paragraph 
     (2);
       ``(ii) the activities of the Department of Health and Human 
     Services with respect to advanced research and development 
     pursuant to section 319L; and
       ``(iii) the progress made toward meeting the goals, 
     benchmarks, and milestones identified in the Public Health 
     Emergency Medical Countermeasures Enterprise Strategy and 
     Implementation Plan under this subsection.
       ``(f) Internal Multiyear Planning Process.--The Secretary 
     shall develop, and update on an annual basis, a coordinated 
     5-year budget plan based on the medical countermeasure 
     priorities and goals described in subsection (e). Each such 
     plan shall--
       ``(1) include consideration of the entire medical 
     countermeasures enterprise, including--
       ``(A) basic research, advanced research and development;
       ``(B) approval, clearance, licensure, and authorized uses 
     of products; and
       ``(C) procurement, stockpiling, maintenance, and 
     replenishment of all products in the Strategic National 
     Stockpile;
       ``(2) include measurable outputs and outcomes to allow for 
     the tracking of the progress made toward identified goals;
       ``(3) identify medical countermeasure life-cycle costs to 
     inform planning, budgeting, and anticipated needs within the 
     continuum of the medical countermeasure enterprise consistent 
     with section 319F-2; and
       ``(4) be made available to the appropriate committees of 
     Congress upon request.
       ``(g) Interagency Coordination Plan.--Not later than 1 year 
     after the date of enactment of this subsection, the 
     Secretary, in coordination with the Secretary of Defense, 
     shall submit to the appropriate committees of Congress a 
     report concerning the manner in which the Department of 
     Health and Human Services is coordinating with the Department 
     of Defense regarding countermeasure activities to address 
     chemical, biological, radiological, and nuclear threats. Such 
     report shall include information with respect to--
       ``(1) the research, advanced research, development, 
     procurement, stockpiling, and distribution of countermeasures 
     to meet identified needs; and
       ``(2) the coordination of efforts between the Department of 
     Health and Human Services and the Department of Defense to 
     address countermeasure needs for various segments of the 
     population.
       ``(h) Protection of National Security.--In carrying out 
     subsections (e), (f), and (g), the Secretary shall ensure 
     that information and items that could compromise national 
     security are not disclosed.''.

     SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND 
                   DISASTERS.

       Subtitle B of title XXVIII of the Public Health Service Act 
     (42 U.S.C. 300hh et seq.) is amended by inserting after 
     section 2811 the end the following:

     ``SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND 
                   DISASTERS.

       ``(a) Establishment.--The Secretary, in consultation with 
     the Secretary of Homeland Security, shall establish an 
     advisory committee to be known as the `National Advisory 
     Committee on Children and Disasters' (referred to in this 
     section as the `Advisory Committee').
       ``(b) Duties.--The Advisory Committee shall--
       ``(1) provide advice and consultation with respect to the 
     activities carried out pursuant to section 2814, as 
     applicable and appropriate;
       ``(2) evaluate and provide input with respect to the needs 
     of children as they relate to preparation for, response to, 
     and recovery from all-hazards, including public health 
     emergencies; and
       ``(3) provide advice and consultation to States and 
     territories with respect to State emergency preparedness and 
     response activities and children, including related drills 
     and exercises pursuant to the preparedness goals under 
     section 2802(b).
       ``(c) Additional Duties.--The Advisory Committee may 
     provide advice and recommendations to the Secretary with 
     respect to children and the medical and public health grants 
     and cooperative agreements as applicable to preparedness and 
     response activities authorized under this title and title 
     III.
       ``(d) Membership.--
       ``(1) In general.--The Secretary, in consultation with such 
     other Secretaries as may be appropriate, shall appoint not to 
     exceed 15 members to the Advisory Committee. In appointing 
     such members, the Secretary shall ensure that the total 
     membership of the Advisory Committee is an odd number.
       ``(2) Required members.--The Secretary, in consultation 
     with such other Secretaries as may be appropriate, may 
     appoint to the Advisory Committee under paragraph (1) such 
     individuals as may be appropriate to perform the duties 
     described in subsections (b) and (c), which may include--
       ``(A) the Assistant Secretary for Preparedness and 
     Response;
       ``(B) the Director of the Biomedical Advanced Research and 
     Development Authority;
       ``(C) the Director of the Centers for Disease Control and 
     Prevention;
       ``(D) the Commissioner of Food and Drugs;
       ``(E) the Director of the National Institutes of Health;
       ``(F) the Assistant Secretary of the Administration for 
     Children and Families;
       ``(G) at least two health care professionals with expertise 
     in pediatric medical disaster planning, preparedness, 
     response, or recovery;
       ``(H) at least two representatives from State, local, 
     territories, or tribal agencies with expertise in pediatric 
     disaster planning, preparedness, response, or recovery; and
       ``(I) representatives from such Federal agencies (such as 
     the Department of Education and the Department of Homeland 
     Security) as determined necessary to fulfill the duties of 
     the Advisory Committee, as established under subsections (b) 
     and (c).
       ``(e) Meetings.--The Advisory Committee shall meet not less 
     than biannually.
       ``(f) Sunset.--The Advisory Committee shall terminate on 
     the date that is 5 years after the date of enactment of the 
     Pandemic and All-Hazards Preparedness Act Reauthorization of 
     2011.''.

     SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER MEDICAL 
                   SYSTEM.

       Section 2812 of the Public Health Service Act (42 U.S.C. 
     300hh-11) is amended--
       (1) in subsection (a)(3)--
       (A) in subparagraph (A), in clause (i) by inserting ``, 
     including at-risk individuals as applicable'' after ``victims 
     of a public health emergency'';

[[Page 3129]]

       (B) by redesignating subparagraph (C) as subparagraph (E); 
     and
       (C) by inserting after subparagraph (B), the following:
       ``(C) Considerations for at-risk populations.--The 
     Secretary shall take steps to ensure that an appropriate 
     specialized and focused range of public health and medical 
     capabilities are represented in the National Disaster Medical 
     System, which take into account the needs of at-risk 
     individuals, in the event of a public health emergency.''.
       ``(D) Administration.--The Secretary may determine and pay 
     claims for reimbursement for services under subparagraph (A) 
     directly or through contracts that provide for payment in 
     advance or by way of reimbursement.''; and
       (2) in subsection (g), by striking ``such sums as may be 
     necessary for each of the fiscal years 2007 through 2011'' 
     and inserting ``$56,000,000 for each of fiscal years 2012 
     through 2016''.

     SEC. 105. CONTINUING THE ROLE OF THE DEPARTMENT OF VETERANS 
                   AFFAIRS.

       Section 8117(g) of title 38, United States Code, is amended 
     by striking ``such sums as may be necessary to carry out this 
     section for each of fiscal years 2007 through 2011'' and 
     inserting ``$156,500,000 for each of fiscal years 2012 
     through 2016 to carry out this section''.

   TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND 
                                RESPONSE

     SEC. 201. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.

       (a) Cooperative Agreements.--Section 319C 1 of the Public 
     Health Service Act (42 U.S.C. 247d-3a) is amended--
       (1) in subsection (b)(2)--
       (A) in subparagraph (A)--
       (i) by striking clauses (i) and (ii) and inserting the 
     following:
       ``(i) a description of the activities such entity will 
     carry out under the agreement to meet the goals identified 
     under section 2802, including with respect to chemical, 
     biological, radiological, or nuclear threats, whether 
     naturally occurring, unintentional, or deliberate;
       ``(ii) a description of the activities such entity will 
     carry out with respect to pandemic influenza, as a component 
     of the activities carried out under clause (i), and 
     consistent with the requirements of paragraphs (2) and (5) of 
     subsection (g);'';
       (ii) in clause (iv), by striking ``and'' at the end; and
       (iii) by adding at the end the following:
       ``(vi) a description of how, as appropriate, the entity may 
     partner with relevant public and private stakeholders in 
     public health emergency preparedness and response;
       ``(vii) a description of how the entity, as applicable and 
     appropriate, will coordinate with State emergency 
     preparedness and response plans in public health emergency 
     preparedness, including State educational agencies (as 
     defined in section 9101(41) of the Elementary and Secondary 
     Education Act of 1965) and State child care lead agencies (as 
     defined in section 658D of the Child Care and Development 
     Block Grant Act); and
       ``(viii) in the case of entities that operate on the United 
     States-Mexico border or the United States-Canada border, a 
     description of the activities such entity will carry out 
     under the agreement that are specific to the border area 
     including disease detection, identification, and 
     investigation, and preparedness and response activities 
     related to emerging diseases and infectious disease outbreaks 
     whether naturally-occurring or due to bioterrorism, 
     consistent with the requirements of this section;''; and
       (B) in subparagraph (C), by inserting ``, including 
     addressing the needs of at-risk individuals,'' after 
     ``capabilities of such entity'';
       (2) in subsection (g)--
       (A) in paragraph (1), by striking subparagraph (A) and 
     inserting the following:
       ``(A) include outcome goals representing operational 
     achievements of the National Preparedness Goals developed 
     under section 2802(b) with respect to all-hazards, including 
     chemical, biological, radiological, or nuclear threats; 
     and''; and
       (B) in paragraph (2)(A), by adding at the end the 
     following: ``The Secretary shall periodically update, as 
     necessary and appropriate, such pandemic influenza plan 
     criteria and shall require the integration of such criteria 
     into the benchmarks and standards described in paragraph 
     (1).'';
       (3) in subsection (i)--
       (A) in paragraph (1)(A)--
       (i) by striking ``$824,000,000 for fiscal year 2007'' and 
     inserting ``$632,900,000 for fiscal year 2012''; and
       (ii) by striking ``such sums as may be necessary for each 
     of fiscal years 2008 through 2011'' and inserting 
     ``$632,900,000 for each of fiscal years 2013 through 2016''; 
     and
       (B) by adding at the end the following:
       ``(7) Availability of cooperative agreement funds.--
       ``(A) In general.--Amounts provided to an eligible entity 
     under a cooperative agreement under subsection (a) for a 
     fiscal year and remaining unobligated at the end of such year 
     shall remain available to such entity for the next fiscal 
     year for the purposes for which such funds were provided.
       ``(B) Funds contingent on achieving benchmarks.--The 
     continued availability of funds under subparagraph (A) with 
     respect to an entity shall be contingent upon such entity 
     achieving the benchmarks and submitting the pandemic 
     influenza plan as described in subsection (g).''; and
       (4) in subsection (j), by striking paragraph (3).
       (b) Vaccine Tracking and Distribution.--Section 319A(e) of 
     the Public Health Service Act (42 U.S.C. 247d-1(e)) is 
     amended by striking ``such sums for each of fiscal years 2007 
     through 2011'' and inserting ``$30,800,000 for each of fiscal 
     years 2012 through 2016''.
       (c) GAO Report.--Section 319C-1 of the Public Health 
     Service Act (42 U.S.C. 247d-3a) is amended by adding at the 
     end the following:
       ``(l) GAO Report.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of the Pandemic and All-Hazards Preparedness Act 
     Reauthorization of 2011, the Government Accountability Office 
     shall conduct an independent evaluation, and submit to the 
     appropriate committees of Congress a report, concerning 
     Federal programs at the Department of Health and Human 
     Services that support medical and public health preparedness 
     and response programs at the State and local levels.
       ``(2) Content.--The report described in paragraph (1) shall 
     review and assess--
       ``(A) the extent to which grant and cooperative agreement 
     requirements and goals have been met by recipients;
       ``(B) the extent to which such grants and cooperative 
     agreements have supported medical and public health 
     preparedness and response goals pursuant to section 2802(b), 
     as appropriate and applicable;
       ``(C) whether recipients or the Department of Health and 
     Human Services have identified any factors that may impede a 
     recipient's ability to achieve programmatic goals and 
     requirements; and
       ``(D) instances in which funds may not have been used 
     appropriately, in accordance with grant and cooperative 
     agreement requirements, and actions taken to address 
     inappropriate expenditures.''.

     SEC. 202. HOSPITAL PREPAREDNESS AND MEDICAL SURGE CAPACITY.

       (a) All-Hazards Public Health and Medical Response 
     Curricula and Training.--Section 319F(a)(5)(B) of the Public 
     Health Service Act (42 U.S.C. 247d-6(a)(5)(B)) is amended by 
     striking ``public health or medical'' and inserting ``public 
     health, medical, or dental''.
       (b) Encouraging Health Professional Volunteers.--
       (1) Emergency system for advance registration of volunteer 
     health professionals.--Section 319I(k) of the Public Health 
     Service Act (42 U.S.C. 247d-7b(k)) is amended by striking 
     ``$2,000,000 for fiscal year 2002, and such sums as may be 
     necessary for each of the fiscal years 2003 through 2011'' 
     and inserting ``$5,900,000 for each of fiscal years 2012 
     through 2016''.
       (2) Volunteers.--Section 2813 of the Public Health Service 
     Act (42 U.S.C. 300hh-15) is amended--
       (A) in subsection (d)(2), by adding at the end the 
     following: ``Such training exercises shall, as appropriate 
     and applicable, incorporate the needs of at-risk individuals 
     in the event of a public health emergency.''; and
       (B) in subsection (i), by striking ``$22,000,000 for fiscal 
     year 2007, and such sums as may be necessary for each of 
     fiscal years 2008 through 2011'' and inserting ``$11,900,000 
     for each of fiscal years 2012 through 2016''.
       (c) Partnerships for State and Regional Preparedness To 
     Improve Surge Capacity.--Section 319C-2 of the Public Health 
     Service Act (42 U.S.C. 247d-3b) is amended--
       (1) in subsection (b)(1)(A)(ii), by striking ``centers, 
     primary'' and inserting ``centers, community health centers, 
     primary'';
       (2) by striking subsection (c) and inserting the following:
       ``(c) Use of Funds.--An award under subsection (a) shall be 
     expended for activities to achieve the preparedness goals 
     described under paragraphs (1), (3), (4), (5), and (6) of 
     section 2802(b) with respect to all-hazards, including 
     chemical, biological, radiological, or nuclear threats.'';
       (3) by striking subsection (g) and inserting the following:
       ``(g) Coordination.--
       ``(1) Local response capabilities.--An eligible entity 
     shall, to the extent practicable, ensure that activities 
     carried out under an award under subsection (a) are 
     coordinated with activities of relevant local Metropolitan 
     Medical Response Systems, local Medical Reserve Corps, the 
     local Cities Readiness Initiative, and local emergency plans.
       ``(2) National collaboration.--Partnerships consisting of 
     one or more eligible entities under this section may, to the 
     extent practicable, collaborate with other partnerships 
     consisting of one or more eligible entities under this 
     section for purposes of national coordination and 
     collaboration with respect to activities to achieve the 
     preparedness goals described under paragraphs (1), (3), (4), 
     (5), and (6) of section 2802(b).''; and
       (4) in subsection (j)--
       (A) in paragraph (1), by striking ``$474,000,000 for fiscal 
     year 2007, and such sums as may be necessary for each of 
     fiscal years 2008 through 2011'' and inserting ``$378,000,000 
     for each of fiscal years 2012 through 2016''; and
       (B) by adding at the end the following:
       ``(4) Availability of cooperative agreement funds.--
       ``(A) In general.--Amounts provided to an eligible entity 
     under a cooperative agreement under subsection (a) for a 
     fiscal year and remaining unobligated at the end of such year 
     shall remain available to such entity for the next fiscal 
     year for the purposes for which such funds were provided.

[[Page 3130]]

       ``(B) Funds contingent on achieving benchmarks.--The 
     continued availability of funds under subparagraph (A) with 
     respect to an entity shall be contingent upon such entity 
     achieving the benchmarks and submitting the pandemic 
     influenza plan as required under subsection (i).''.

     SEC. 203. ENHANCING SITUATIONAL AWARENESS AND 
                   BIOSURVEILLANCE.

       Section 319D of the Public Health Service Act (42 U.S.C. 
     247d-4) is amended--
       (1) in subsection (b)--
       (A) in paragraph (1)(B), by inserting ``poison control 
     centers,'' after ``hospitals,'';
       (B) in paragraph (2), by inserting before the period the 
     following: ``, allowing for coordination to maximize all-
     hazards medical and public health preparedness and response 
     and to minimize duplication of effort''; and
       (C) in paragraph (3), by inserting before the period the 
     following: ``and update such standards as necessary'';
       (2) in subsection (d)--
       (A) in the subsection heading, by striking ``Public Health 
     Situational Awareness'' and inserting ``Modernizing Public 
     Health Situational Awareness and BioSurveillance'';
       (B) in paragraph (1)--
       (i) by striking ``Pandemic and All-Hazards Preparedness 
     Act'' and inserting ``Pandemic and All-Hazards Preparedness 
     Act Reauthorization of 2011''; and
       (ii) by inserting ``, novel emerging threats,'' after 
     ``disease outbreaks'';
       (C) by striking paragraph (2) and inserting the following:
       ``(2) Strategy and implementation plan.--Not later than 180 
     days after the date of enactment of the Pandemic and All-
     Hazards Preparedness Act Reauthorization of 2011, the 
     Secretary shall submit to the appropriate committees of 
     Congress, a coordinated strategy and an accompanying 
     implementation plan that identifies and demonstrates the 
     measurable steps the Secretary will carry out to--
       ``(A) develop, implement, and evaluate the network 
     described in paragraph (1), utilizing the elements described 
     in paragraph (3); and
       ``(B) modernize and enhance biosurveillance activities.'';
       (D) in paragraph (3)(D), by inserting ``community health 
     centers, health centers'' after ``poison control,'';
       (E) in paragraph (5), by striking subparagraph (A) and 
     inserting the following:
       ``(A) utilize applicable interoperability standards as 
     determined by the Secretary, and in consultation with the 
     Office of the National Coordinator for Health Information 
     Technology, through a joint public and private sector 
     process;''; and
       (F) by adding at the end the following:
       ``(6) Consultation with the national biodefense science 
     board.--In carrying out this section consistent with section 
     319M, the National Biodefense Science Board shall provide 
     expert advice and guidance, including recommendations, 
     regarding the measurable steps the Secretary should take to 
     modernize and enhance biosurveillance activities pursuant to 
     the efforts of the Department of Health and Humans Services 
     to ensure comprehensive, real-time all-hazards 
     biosurveillance capabilities. In complying with the preceding 
     sentence, the National Biodefense Science Board shall--
       ``(A) identify the steps necessary to achieve a national 
     biosurveillance system for human health, with international 
     connectivity, where appropriate, that is predicated on State, 
     regional, and community level capabilities and creates a 
     networked system to allow for two-way information flow 
     between and among Federal, State, and local government public 
     health authorities and clinical health care providers;
       ``(B) identify any duplicative surveillance programs under 
     the authority of the Secretary, or changes that are necessary 
     to existing programs, in order to enhance and modernize such 
     activities, minimize duplication, strengthen and streamline 
     such activities under the authority of the Secretary, and 
     achieve real-time and appropriate data that relate to disease 
     activity, both human and zoonotic; and
       ``(C) coordinate with applicable existing advisory 
     committees of the Director of the Centers for Disease Control 
     and Prevention, including such advisory committees consisting 
     of representatives from State, local, and tribal public 
     health authorities and appropriate public and private sector 
     health care entities and academic institutions, in order to 
     provide guidance on public health surveillance activities.'';
       (3) in subsection (e)(5), by striking ``4 years after the 
     date of enactment of the Pandemic and All-Hazards 
     Preparedness Act'' and inserting ``3 years after the date of 
     enactment of the Pandemic and All-Hazards Preparedness Act 
     Reauthorization of 2011'';
       (4) in subsection (g), by striking ``such sums as may be 
     necessary in each of fiscal years 2007 through 2011'' and 
     inserting ``$160,121,000 for each of fiscal years 2012 
     through 2016''; and
       (5) by adding at the end the following:
       ``(h) Definition.--For purposes of this section the term 
     `biosurveillance' means the process of gathering near real-
     time, biological data that relates to disease activity and 
     threats to human or zoonotic health, in order to achieve 
     early warning and identification of such health threats, 
     early detection and prompt ongoing tracking of health events, 
     and overall situational awareness of disease activity.''.

           TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW

     SEC. 301. SPECIAL PROTOCOL ASSESSMENT.

       Section 505(b)(5)(B) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by striking 
     ``size of clinical trials intended'' and all that follows 
     through ``. The sponsor or applicant'' and inserting the 
     following: ``size--
       ``(i)(I) of clinical trials intended to form the primary 
     basis of an effectiveness claim; or
       ``(II) in the case where human efficacy studies are not 
     ethical or feasible, of animal and any associated clinical 
     trials which, in combination, are intended to form the 
     primary basis of an effectiveness claim; or
       ``(ii) with respect to an application for approval of a 
     biological product under section 351(k) of the Public Health 
     Service Act, of any necessary clinical study or studies.
     The sponsor or applicant''.

     SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN 
                   EMERGENCIES.

       (a) In General.--Section 564 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1), by striking ``sections 505, 510(k), 
     and 515 of this Act'' and inserting ``any provision of this 
     Act'';
       (B) in paragraph (2)(A), by striking ``under a provision of 
     law referred to in such paragraph'' and inserting ``under a 
     provision of law in section 505, 510(k), or 515 of this Act 
     or section 351 of the Public Health Service Act''; and
       (C) in paragraph (3), by striking ``a provision of law 
     referred to in such paragraph'' and inserting ``a provision 
     of law referred to in paragraph (2)(A)'';
       (2) in subsection (b)--
       (A) in the subsection heading, by striking ``Emergency'' 
     and inserting ``Emergency or Threat Justifying Emergency 
     Authorized Use'';
       (B) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``may declare an emergency'' and inserting ``may make a 
     declaration that the circumstances exist'';
       (ii) in subparagraph (A), by striking ``specified'';
       (iii) in subparagraph (B)--

       (I) by striking ``specified''; and
       (II) by striking ``; or'' and inserting a semicolon;

       (iv) by amending subparagraph (C) to read as follows:
       ``(C) a determination by the Secretary that there is a 
     public health emergency, or a significant potential for a 
     public health emergency, that affects, or has a significant 
     potential to affect, national security or the health and 
     security of United States citizens abroad, and that involves 
     a biological, chemical, radiological, or nuclear agent or 
     agents, or a disease or condition that may be attributable to 
     such agent or agents; or''; and
       (v) by adding at the end the following:
       ``(D) the identification of a material threat pursuant to 
     section 319F-2 of the Public Health Service Act sufficient to 
     affect national security or the health and security of United 
     States citizens living abroad.'';
       (C) in paragraph (2)(A)--
       (i) by amending clause (ii) to read as follows:
       ``(ii) a change in the approval status of the product such 
     that the circumstances described in subsection (a)(2) have 
     ceased to exist.'';
       (ii) by striking subparagraph (B); and
       (iii) by redesignating subparagraph (C) as subparagraph 
     (B);
       (D) in paragraph (4), by striking ``advance notice of 
     termination, and renewal under this subsection.'' and 
     inserting ``, and advance notice of termination under this 
     subsection. The Secretary shall make any renewal under this 
     subsection available on the Internet Web site of the Food and 
     Drug Administration.''; and
       (E) by adding at the end the following:
       ``(5) Explanation by secretary.--If an authorization under 
     this section with respect to an unapproved product has been 
     in effect for more than 1 year, the Secretary shall provide 
     in writing to the sponsor of such product, an explanation of 
     the scientific, regulatory, or other obstacles to approval, 
     licensure, or clearance of such product, including specific 
     actions to be taken by the Secretary and the sponsor to 
     overcome such obstacles.'';
       (3) in subsection (c)--
       (A) in the matter preceding paragraph (1)--
       (i) by inserting ``the Assistant Secretary for Preparedness 
     and Response,'' after ``consultation with'';
       (ii) by striking ``Health and'' and inserting ``Health, 
     and''; and
       (iii) by striking ``circumstances of the emergency 
     involved'' and inserting ``applicable circumstances described 
     in subsection (b)(1)'';
       (B) in paragraph (1), by striking ``specified'' and 
     inserting ``referred to''; and
       (C) in paragraph (2)(B), by inserting ``, taking into 
     consideration the material threat posed by the agent or 
     agents identified in a declaration under subsection 
     (b)(1)(D), if applicable'' after ``risks of the product'';
       (4) in subsection (d)(3), by inserting ``, to the extent 
     practicable given the circumstances of the emergency,'' after 
     ``including'';
       (5) in subsection (e)--
       (A) in paragraph (1)(A), by striking ``circumstances of the 
     emergency'' and inserting ``applicable circumstances 
     described in subsection (b)(1)'';
       (B) in paragraph (2)--
       (i) in subparagraph (A)--

       (I) by striking ``manufacturer of the product'' and 
     inserting ``person'';
       (II) by striking ``circumstances of the emergency'' and 
     inserting ``applicable circumstances described in subsection 
     (b)(1)''; and

[[Page 3131]]

       (III) by inserting at the end before the period ``or in 
     paragraph (1)(B)'';

       (ii) in subparagraph (B)(i), by inserting before the period 
     at the end ``, except as provided in section 564A with 
     respect to authorized changes to the product expiration 
     date''; and
       (iii) by amending subparagraph (C) to read as follows:
       ``(C) In establishing conditions under this paragraph with 
     respect to the distribution and administration of the product 
     for the unapproved use, the Secretary shall not impose 
     conditions that would restrict distribution or administration 
     of the product when done solely for the approved use.''; and
       (C) by amending paragraph (3) to read as follows:
       ``(3) Good manufacturing practice; prescription.--With 
     respect to the emergency use of a product for which an 
     authorization under this section is issued (whether an 
     unapproved product or an unapproved use of an approved 
     product), the Secretary may waive or limit, to the extent 
     appropriate given the applicable circumstances described in 
     subsection (b)(1)--
       ``(A) requirements regarding current good manufacturing 
     practice otherwise applicable to the manufacture, processing, 
     packing, or holding of products subject to regulation under 
     this Act, including such requirements established under 
     section 501 or 520(f)(1), and including relevant conditions 
     prescribed with respect to the product by an order under 
     section 520(f)(2);
       ``(B) requirements established under section 503(b); and
       ``(C) requirements established under section 520(e).'';
       (6) in subsection (g)--
       (A) in the subsection heading, by inserting ``Review and'' 
     before ``Revocation'';
       (B) in paragraph (1), by inserting after the period at the 
     end the following: ``As part of such review, the Secretary 
     shall regularly review the progress made with respect to the 
     approval, licensure, or clearance of--
       ``(A) an unapproved product for which an authorization was 
     issued under this section; or
       ``(B) an unapproved use of an approved product for which an 
     authorization was issued under this section.''; and
       (C) by amending paragraph (2) to read as follows:
       ``(2) Revision and revocation.--The Secretary may revise or 
     revoke an authorization under this section if--
       ``(A) the circumstances described under subsection (b)(1) 
     no longer exist;
       ``(B) the criteria under subsection (c) for issuance of 
     such authorization are no longer met; or
       ``(C) other circumstances make such revision or revocation 
     appropriate to protect the public health or safety.'';
       (7) in subsection (h)(1), by adding after the period at the 
     end the following: ``The Secretary shall make any revisions 
     to an authorization under this section available on the 
     Internet Web site of the Food and Drug Administration.''; and
       (8) by adding at the end of subsection (j) the following:
       ``(4) Nothing in this section shall be construed as 
     authorizing a delay in the review or other consideration by 
     the Food and Drug Administration of any application pending 
     before the Administration for a countermeasure or product 
     referred to in subsection (a).''.
       (b) Emergency Use of Medical Products.--Subchapter E of 
     chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb et seq.) is amended by inserting after section 
     564 the following:

     ``SEC. 564A. EMERGENCY USE OF MEDICAL PRODUCTS.

       ``(a) Definitions.--In this section:
       ``(1) Eligible product.--The term `eligible product' means 
     a product that--
       ``(A) is approved or cleared under this chapter or licensed 
     under section 351 of the Public Health Service Act;
       ``(B)(i) is intended for use to prevent, diagnose, or treat 
     a disease or condition involving a biological, chemical, 
     radiological, or nuclear agent or agents, including a product 
     intended to be used to prevent or treat pandemic influenza; 
     or
       ``(ii) is intended for use to prevent, diagnose, or treat a 
     serious or life-threatening disease or condition caused by a 
     product described in clause (i); and
       ``(C) is intended for use during the circumstances under 
     which--
       ``(i) a determination described in subparagraph (A), (B), 
     or (C) of section 564(b)(1) has been made by the Secretary of 
     Homeland Security, the Secretary of Defense, or the 
     Secretary, respectively; or
       ``(ii) the identification of a material threat described in 
     subparagraph (D) of section 564(b)(1) has been made pursuant 
     to section 319F-2 of the Public Health Service Act.
       ``(2) Product.--The term `product' means a drug, device, or 
     biological product.
       ``(b) Extension of Expiration Date.--
       ``(1) Authority to extend expiration date.--The Secretary 
     may extend the expiration date of an eligible product in 
     accordance with this subsection.
       ``(2) Expiration date.--For purposes of this subsection, 
     the term `expiration date' means the date established through 
     appropriate stability testing required by the regulations 
     issued by the Secretary to ensure that the product meets 
     applicable standards of identity, strength, quality, and 
     purity at the time of use.
       ``(3) Effect of extension.--Notwithstanding any other 
     provision of this Act or the Public Health Service Act, if 
     the expiration date of an eligible product is extended in 
     accordance with this section, the introduction or delivery 
     for introduction into interstate commerce of such product 
     after the expiration date provided by the manufacturer and 
     within the duration of such extension shall not be deemed to 
     render the product--
       ``(A) an unapproved product; or
       ``(B) adulterated or misbranded under this Act.
       ``(4) Determinations by secretary.--Before extending the 
     expiration date of an eligible product under this subsection, 
     the Secretary shall determine--
       ``(A) that extension of the expiration date will help 
     protect public health;
       ``(B) that any extension of expiration is supported by 
     scientific evaluation that is conducted or accepted by the 
     Secretary;
       ``(C) what changes to the product labeling, if any, are 
     required or permitted, including whether and how any 
     additional labeling communicating the extension of the 
     expiration date may alter or obscure the labeling provided by 
     the manufacturer; and
       ``(D) that any other conditions that the Secretary deems 
     appropriate have been met.
       ``(5) Scope of extension.--With respect to each extension 
     of an expiration date granted under this subsection, the 
     Secretary shall determine--
       ``(A) the batch, lot, or unit to which such extension shall 
     apply;
       ``(B) the duration of such extension; and
       ``(C) any conditions to effectuate such extension that are 
     necessary and appropriate to protect public health or safety.
       ``(c) Current Good Manufacturing Practice.--
       ``(1) In general.--The Secretary may, when the 
     circumstances of a domestic, military, or public health 
     emergency or material threat described in subsection 
     (a)(1)(C) so warrant, authorize, with respect to an eligible 
     product, deviations from current good manufacturing practice 
     requirements otherwise applicable to the manufacture, 
     processing, packing, or holding of products subject to 
     regulation under this Act, including requirements under 
     section 501 or 520(f)(1) or applicable conditions prescribed 
     with respect to the eligible product by an order under 
     section 520(f)(2).
       ``(2) Effect.--Notwithstanding any other provision of this 
     Act or the Public Health Service Act, an eligible product 
     shall not be considered an unapproved product and shall not 
     be deemed adulterated or misbranded under this Act because, 
     with respect to such product, the Secretary has authorized 
     deviations from current good manufacturing practices under 
     paragraph (1).
       ``(d) Emergency Use Instructions.--
       ``(1) In general.--The Secretary, acting through an 
     appropriate official within the Department of Health and 
     Human Services, may create and issue emergency use 
     instructions to inform health care providers or individuals 
     to whom an eligible product is to be administered concerning 
     such product's approved, licensed, or cleared conditions of 
     use.
       ``(2) Effect.--Notwithstanding any other provisions of this 
     Act or the Public Health Service Act, a product shall not be 
     considered an unapproved product and shall not be deemed 
     adulterated or misbranded under this Act because of the 
     issuance of emergency use instructions under paragraph (1) 
     with respect to such product or the introduction or delivery 
     for introduction of such product into interstate commerce 
     accompanied by such instructions--
       ``(A) during an emergency response to an actual emergency 
     that is the basis for a determination described in subsection 
     (a)(1)(C)(i); or
       ``(B) by a government entity (including a Federal, State, 
     local, and tribal government entity), or a person acting on 
     behalf of such a government entity, in preparation for an 
     emergency response.''.
       (c) Risk Evaluation and Mitigation Strategies.--Section 505 
     1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-
     1), is amended--
       (1) in subsection (f), by striking paragraph (7); and
       (2) by adding at the end the following:
       ``(k) Waiver in Public Health Emergencies.--The Secretary 
     may waive any requirement of this section with respect to a 
     qualified countermeasure (as defined in section 319F-1(a)(2) 
     of the Public Health Service Act) to which a requirement 
     under this section has been applied, if the Secretary 
     determines that such waiver is required to mitigate the 
     effects of, or reduce the severity of, the circumstances 
     under which--
       ``(1) a determination described in subparagraph (A), (B), 
     or (C) of section 564(b)(1) has been made by the Secretary of 
     Homeland Security, the Secretary of Defense, or the 
     Secretary, respectively; or
       ``(2) the identification of a material threat described in 
     subparagraph (D) of section 564(b)(1) has been made pursuant 
     to section 319F-2 of the Public Health Service Act.''.
       (d) Products Held for Emergency Use.--The Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by 
     inserting after section 564A, as added by subsection (b), the 
     following:

     ``SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.

       ``It is not a violation of any section of this Act or of 
     the Public Health Service Act for a government entity 
     (including a Federal, State, local, and tribal government 
     entity), or a person acting on behalf of such a government 
     entity, to introduce into interstate commerce a product (as

[[Page 3132]]

     defined in section 564(a)(4)) intended for emergency use, if 
     that product--
       ``(1) is intended to be held and not used; and
       ``(2) is held and not used, unless and until that product--
       ``(A) is approved, cleared, or licensed under section 505, 
     510(k), or 515 of this Act or section 351 of the Public 
     Health Service Act;
       ``(B) is authorized for investigational use under section 
     505 or 520 of this Act or section 351 of the Public Health 
     Service Act; or
       ``(C) is authorized for use under section 564.''.

     SEC. 303. DEFINITIONS.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4) is amended by striking ``The Secretary, in 
     consultation'' and inserting the following:
       ``(a) Definitions.--In this section--
       ``(1) the term `countermeasure' means a qualified 
     countermeasure, a security countermeasure, and a qualified 
     pandemic or epidemic product;
       ``(2) the term `qualified countermeasure' has the meaning 
     given such term in section 319F-1 of the Public Health 
     Service Act;
       ``(3) the term `security countermeasure' has the meaning 
     given such term in section 319F-2 of such Act; and
       ``(4) the term `qualified pandemic or epidemic product' 
     means a product that meets the definition given such term in 
     section 319F-3 of the Public Health Service Act and--
       ``(A) that has been identified by the Department of Health 
     and Human Services or the Department of Defense as receiving 
     funding directly related to addressing chemical, biological, 
     radiological or nuclear threats, including pandemic 
     influenza; or
       ``(B) is included under this paragraph pursuant to a 
     determination by the Secretary.
       ``(b) General Duties.--The Secretary, in consultation''.

     SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVITIES.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4), as amended by section 303, is further 
     amended--
       (1) in the section heading, by striking ``technical 
     assistance'' and inserting ``countermeasure development, 
     review, and technical assistance'';
       (2) in subsection (b), by striking the subsection heading 
     and all that follows through ``shall establish'' and 
     inserting the following:
       ``(b) General Duties.--In order to accelerate the 
     development, stockpiling, approval, licensure, and clearance 
     of qualified countermeasures, security countermeasures, and 
     qualified pandemic or epidemic products, the Secretary, in 
     consultation with the Assistant Secretary for Preparedness 
     and Response, shall--
       ``(1) ensure the appropriate involvement of Food and Drug 
     Administration personnel in interagency activities related to 
     countermeasure advanced research and development, consistent 
     with sections 319F, 319F-1, 319F-2, 319F-3, and 319L of the 
     Public Health Service Act;
       ``(2) ensure the appropriate involvement and consultation 
     of Food and Drug Administration personnel in any flexible 
     manufacturing activities carried out under section 319L of 
     the Public Health Service Act, including with respect to 
     meeting regulatory requirements set forth in this Act;
       ``(3) promote countermeasure expertise within the Food and 
     Drug Administration by--
       ``(A) ensuring that Food and Drug Administration personnel 
     involved in reviewing countermeasures for approval, 
     licensure, or clearance are informed by the Assistant 
     Secretary for Preparedness and Response on the material 
     threat assessment conducted under section 319F-2 of the 
     Public Health Service Act for the agent or agents for which 
     the countermeasure under review is intended;
       ``(B) training Food and Drug Administration personnel 
     regarding review of countermeasures for approval, licensure, 
     or clearance;
       ``(C) holding public meetings at least twice annually to 
     encourage the exchange of scientific ideas; and
       ``(D) establishing protocols to ensure that countermeasure 
     reviewers have sufficient training or experience with 
     countermeasures;
       ``(4) maintain teams, composed of Food and Drug 
     Administration personnel with expertise on countermeasures, 
     including specific countermeasures, populations with special 
     clinical needs (including children and pregnant women that 
     may use countermeasures, as applicable and appropriate), 
     classes or groups of countermeasures, or other 
     countermeasure-related technologies and capabilities, that 
     shall--
       ``(A) consult with countermeasure experts, including 
     countermeasure sponsors and applicants, to identify and help 
     resolve scientific issues related to the approval, licensure, 
     or clearance of countermeasures, through workshops or public 
     meetings;
       ``(B) improve and advance the science relating to the 
     development of new tools, standards, and approaches to 
     assessing and evaluating countermeasures--
       ``(i) in order to inform the process for countermeasure 
     approval, clearance, and licensure; and
       ``(ii) with respect to the development of countermeasures 
     for populations with special clinical needs, including 
     children and pregnant women, in order to meet the needs of 
     such populations, as necessary and appropriate; and
       ``(5) establish''; and
       (3) by adding at the end the following:
       ``(c) Development and Animal Modeling Procedures.--
       ``(1) Availability of animal model meetings.--To facilitate 
     the timely development of animal models and support the 
     development, stockpiling, licensure, approval, and clearance 
     of countermeasures, the Secretary shall, not later than 180 
     days after the enactment of this subsection, establish a 
     procedure by which a sponsor or applicant that is developing 
     a countermeasure for which human efficacy studies are not 
     ethical or practicable, and that has an approved 
     investigational new drug application or investigational 
     device exemption, may request and receive--
       ``(A) a meeting to discuss proposed animal model 
     development activities; and
       ``(B) a meeting prior to initiating pivotal animal studies.
       ``(2) Pediatric models.--To facilitate the development and 
     selection of animal models that could translate to pediatric 
     studies, any meeting conducted under paragraph (1) shall 
     include discussion of animal models for pediatric 
     populations, as appropriate.
       ``(d) Review and Approval of Countermeasures.--
       ``(1) Material threat.--When evaluating an application or 
     submission for approval, licensure, or clearance of a 
     countermeasure, the Secretary shall take into account the 
     material threat posed by the chemical, biological, 
     radiological, or nuclear agent or agents identified under 
     section 319F-2 of the Public Health Service Act for which the 
     countermeasure under review is intended.
       ``(2) Review expertise.--When practicable and appropriate, 
     teams of Food and Drug Administration personnel reviewing 
     applications or submissions described under paragraph (1) 
     shall include a reviewer with sufficient training or 
     experience with countermeasures pursuant to the protocols 
     established under subsection (b)(3)(D).''.

     SEC. 305. REGULATORY MANAGEMENT PLANS.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4), as amended by section 304, is further 
     amended by adding at the end the following:
       ``(e) Regulatory Management Plan.--
       ``(1) Definition.--In this subsection, the term `eligible 
     countermeasure' means--
       ``(A) a security countermeasure with respect to which the 
     Secretary has entered into a procurement contract under 
     section 319F-2(c) of the Public Health Service Act; or
       ``(B) a countermeasure with respect to which the Biomedical 
     Advanced Research and Development Authority has provided 
     funding under section 319L of the Public Health Service Act 
     for advanced research and development.
       ``(2) Regulatory management plan process.--The Secretary, 
     in consultation with the Assistant Secretary for Preparedness 
     and Response and the Director of the Biomedical Advanced 
     Research and Development Authority, shall establish a formal 
     process for obtaining scientific feedback and interactions 
     regarding the development and regulatory review of eligible 
     countermeasures by facilitating the development of written 
     regulatory management plans in accordance with this 
     subsection.
       ``(3) Submission of request and proposed plan by sponsor or 
     applicant.--
       ``(A) In general.--A sponsor or applicant of an eligible 
     countermeasure may initiate the process described under 
     paragraph (2) upon submission of written request to the 
     Secretary. Such request shall include a proposed regulatory 
     management plan.
       ``(B) Timing of submission.--A sponsor or applicant may 
     submit a written request under subparagraph (A) after the 
     eligible countermeasure has an investigational new drug or 
     investigational device exemption in effect.
       ``(C) Response by secretary.--The Secretary shall direct 
     the Food and Drug Administration, upon submission of a 
     written request by a sponsor or applicant under subparagraph 
     (A), to work with the sponsor or applicant to agree on a 
     regulatory management plan within a reasonable time not to 
     exceed 90 days. If the Secretary determines that no plan can 
     be agreed upon, the Secretary shall provide to the sponsor or 
     applicant, in writing, the scientific or regulatory rationale 
     why such agreement cannot be reached.
       ``(4) Plan.--The content of a regulatory management plan 
     agreed to by the Secretary and a sponsor or applicant shall 
     include--
       ``(A) an agreement between the Secretary and the sponsor or 
     applicant regarding developmental milestones that will 
     trigger responses by the Secretary as described in 
     subparagraph (B);
       ``(B) performance targets and goals for timely and 
     appropriate responses by the Secretary to the triggers 
     described under subparagraph (A), including meetings between 
     the Secretary and the sponsor or applicant, written feedback, 
     decisions by the Secretary, and other activities carried out 
     as part of the development and review process; and
       ``(C) an agreement on how the plan shall be modified, if 
     needed.
       ``(5) Milestones and performance targets.--The 
     developmental milestones described in paragraph (4)(A) and 
     the performance targets and goals described in paragraph 
     (4)(B) shall include--
       ``(A) feedback from the Secretary regarding the data 
     required to support the approval, clearance, or licensure of 
     the eligible countermeasure involved;
       ``(B) feedback from the Secretary regarding the data 
     necessary to inform any authorization under section 564;
       ``(C) feedback from the Secretary regarding the data 
     necessary to support the positioning and delivery of the 
     eligible countermeasure, including to the Strategic National 
     Stockpile;
       ``(D) feedback from the Secretary regarding the data 
     necessary to support the submission of protocols for review 
     under section 505(b)(5)(B);

[[Page 3133]]

       ``(E) feedback from the Secretary regarding any gaps in 
     scientific knowledge that will need resolution prior to 
     approval, licensure, or clearance of the eligible 
     countermeasure, and plans for conducting the necessary 
     scientific research;
       ``(F) identification of the population for which the 
     countermeasure sponsor or applicant seeks approval, 
     licensure, or clearance, and the population for which desired 
     labeling would not be appropriate, if known; and
       ``(G) as necessary and appropriate, and to the extent 
     practicable, a plan for demonstrating safety and 
     effectiveness in pediatric populations, and for developing 
     pediatric dosing, formulation, and administration with 
     respect to the eligible countermeasure, provided that such 
     plan would not delay authorization under section 564, 
     approval, licensure, or clearance for adults.
       ``(6) Prioritization.--If the Commissioner of Food and 
     Drugs determines that resources are not available to 
     establish regulatory management plans under this section for 
     all eligible countermeasures for which a request is submitted 
     under paragraph (3)(A), the Director of the Biomedical 
     Advanced Research and Development Authority, in consultation 
     with the Commissioner of Food and Drugs, shall prioritize 
     which eligible countermeasures may receive regulatory 
     managements plans, and in doing so shall give priority to 
     eligible countermeasures that are security 
     countermeasures.''.

     SEC. 306. REPORT.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4), as amended by section 305, is further 
     amended by adding at the end the following:
       ``(f) Annual Report.--Not later than 180 days after the 
     date of enactment of this subsection, and annually 
     thereafter, the Secretary shall submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report that details the countermeasure 
     development and review activities of the Food and Drug 
     Administration, including--
       ``(1) with respect to the development of new tools, 
     standards, and approaches to assess and evaluate 
     countermeasures--
       ``(A) the identification of the priorities of the Food and 
     Drug Administration and the progress made on such priorities; 
     and
       ``(B) the identification of scientific gaps that impede the 
     development or approval, licensure, or clearance of 
     countermeasures for populations with special clinical needs, 
     including children and pregnant women, and the progress made 
     on resolving these challenges;
       ``(2) with respect to countermeasures for which a 
     regulatory management plan has been agreed upon under 
     subsection (e), the extent to which the performance targets 
     and goals set forth in subsection (e)(4)(B) and the 
     regulatory management plan has been met, including, for each 
     such countermeasure--
       ``(A) whether the regulatory management plan was completed 
     within the required timeframe, and the length of time taken 
     to complete such plan;
       ``(B) whether the Secretary adhered to the timely and 
     appropriate response times set forth in such plan; and
       ``(C) explanations for any failure to meet such performance 
     targets and goals;
       ``(3) the number of regulatory teams established pursuant 
     to subsection (b)(4), the number of products, classes of 
     products, or technologies assigned to each such team, and the 
     number of, type of, and any progress made as a result of 
     consultations carried out under subsection (b)(4)(A);
       ``(4) an estimate of resources obligated to countermeasure 
     development and regulatory assessment, including Center 
     specific objectives and accomplishments;
       ``(5) the number of countermeasure applications submitted, 
     the number of countermeasures approved, licensed, or cleared, 
     the status of remaining submitted applications, and the 
     number of each type of authorization issued pursuant to 
     section 564; and
       ``(6) the number of written requests for a regulatory 
     management plan submitted under subsection (e)(3)(A), the 
     number of regulatory management plans developed, and the 
     number of such plans developed for security 
     countermeasures.''.

     SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES.

       (a) Pediatric Studies of Drugs.--Section 505A of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 
     amended--
       (1) in subsection (d), by adding at the end the following:
       ``(5) Consultation.--With respect to a drug that is a 
     qualified countermeasure (as defined in section 319F-1 of the 
     Public Health Service Act), a security countermeasure (as 
     defined in section 319F-2 of the Public Health Service Act), 
     or a qualified pandemic or epidemic product (as defined in 
     section 319F-3 of the Public Health Service Act), the 
     Secretary shall solicit input from the Assistant Secretary 
     for Preparedness and Response regarding the need for and, 
     from the Director of the Biomedical Advanced Research and 
     Development Authority regarding the conduct of, pediatric 
     studies under this section.''; and
       (2) in subsection (n)(1), by adding at the end the 
     following:
       ``(C) For a drug that is a qualified countermeasure (as 
     defined in section 319F-1 of the Public Health Service Act), 
     a security countermeasure (as defined in section 319F-2 of 
     the Public Health Service Act), or a qualified pandemic or 
     epidemic product (as defined in section 319F-3 of such Act), 
     in addition to any action with respect to such drug under 
     subparagraph (A) or (B), the Secretary shall notify the 
     Assistant Secretary for Preparedness and Response and the 
     Director of the Biomedical Advanced Research and Development 
     Authority of all pediatric studies in the written request 
     issued by the Commissioner of Food and Drugs.''.
       (b) Addition to Priority List Considerations.--Section 409I 
     of the Public Health Service Act (42 U.S.C. 284m) is 
     amended--
       (1) by striking subsection (a)(2) and inserting the 
     following:
       ``(2) Consideration of available information.--In 
     developing and prioritizing the list under paragraph (1), the 
     Secretary--
       ``(A) shall consider--
       ``(i) therapeutic gaps in pediatrics that may include 
     developmental pharmacology, pharmacogenetic determinants of 
     drug response, metabolism of drugs and biologics in children, 
     and pediatric clinical trials;
       ``(ii) particular pediatric diseases, disorders or 
     conditions where more complete knowledge and testing of 
     therapeutics, including drugs and biologics, may be 
     beneficial in pediatric populations; and
       ``(iii) the adequacy of necessary infrastructure to conduct 
     pediatric pharmacological research, including research 
     networks and trained pediatric investigators; and
       ``(B) may consider the availability of qualified 
     countermeasures (as defined in section 319F-1), security 
     countermeasures (as defined in section 319F-2), and qualified 
     pandemic or epidemic products (as defined in section 319F-3) 
     to address the needs of pediatric populations, in 
     consultation with the Assistant Secretary for Preparedness 
     and Response, consistent with the purposes of this 
     section.''; and
       (2) in subsection (b), by striking ``subsection (a)'' and 
     inserting ``paragraphs (1) and (2)(A) of subsection (a)''.
       (c) Advice and Recommendations of the Pediatric Advisory 
     Committee Regarding Countermeasures for Pediatric 
     Populations.--Subsection (b)(2) of section 14 of the Best 
     Pharmaceuticals for Children Act (42 U.S.C. 284m note) is 
     amended--
       (1) in subparagraph (C), by striking the period and 
     inserting ``; and''; and
       (2) by adding at the end the following:
       ``(D) the development of countermeasures (as defined in 
     section 565(a) of the Federal Food, Drug, and Cosmetic Act) 
     for pediatric populations.''.

  TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND 
                              DEVELOPMENT

     SEC. 401. BIOSHIELD.

       (a) Reauthorization of the Special Reserve Fund.--Section 
     319F-2(c) of the Public Health Service Act (42 U.S.C. 247d-
     6b(c)) is amended by adding at the end the following:
       ``(11) Reauthorization of the special reserve fund.--In 
     addition to amounts otherwise appropriated, there are 
     authorized to be appropriated for the special reserve fund, 
     $2,800,000,000 for the fiscal years 2014 through 2018.
       ``(12) Report.--Not later than 30 days after any date on 
     which the Secretary determines that the amount of funds in 
     the special reserve fund available for procurement is less 
     than $1,500,000,000, the Secretary shall submit to the 
     appropriate committees of Congress a report detailing the 
     amount of such funds available for procurement and the impact 
     such reduction in funding will have--
       ``(A) in meeting the security countermeasure needs 
     identified under this section; and
       ``(B) on the biennial Public Health Emergency Medical 
     Countermeasures Enterprise and Strategy Implementation Plan 
     (pursuant to section 2811(d)).''.
       (b) Procurement of Countermeasures.--Section 319F-2(c) of 
     the Public Health Service Act (42 U.S.C. 247d-6b(c)) is 
     amended--
       (1) in paragraph (1)(B)(i)(III)(bb), by striking ``eight 
     years'' and inserting ``10 years'';
       (2) in paragraph (5)(B)(ii), by striking ``eight years'' 
     and inserting ``10 years'';
       (3) in paragraph (7)(C)--
       (A) in clause (i)(I), by inserting ``including advanced 
     research and development,'' after ``as may reasonably be 
     required,'';
       (B) in clause (ii)--
       (i) in subclause (III), by striking ``eight years'' and 
     inserting ``10 years''; and
       (ii) by striking subclause (IX) and inserting the 
     following:

       ``(IX) Contract terms.--The Secretary, in any contract for 
     procurement under this section--

       ``(aa) may specify--
       ``(AA) the dosing and administration requirements for the 
     countermeasure to be developed and procured;
       ``(BB) the amount of funding that will be dedicated by the 
     Secretary for advanced research, development, and procurement 
     of the countermeasure; and
       ``(CC) the specifications the countermeasure must meet to 
     qualify for procurement under a contract under this section; 
     and
       ``(bb) shall provide a clear statement of defined 
     Government purpose limited to uses related to a security 
     countermeasure, as defined in paragraph (1)(B).''; and
       (C) by adding at the end the following:
       ``(viii) Flexibility.--In carrying out this section, the 
     Secretary may, consistent with the applicable provisions of 
     this section, enter into contracts and other agreements that 
     are in the best interest of the Government in meeting 
     identified security countermeasure needs, including

[[Page 3134]]

     with respect to reimbursement of the cost of advanced 
     research and development as a reasonable, allowable, and 
     allocable direct cost of the contract involved.'';
       (4) in paragraph (9)(B), by inserting before the period the 
     following: ``, except that this subparagraph shall not be 
     construed to prohibit the use of such amounts as otherwise 
     authorized in this title''; and
       (5) in paragraph (10), by adding at the end the following:
       ``(C) Advanced research and development.--For purposes of 
     this paragraph, the term `advanced research and development' 
     shall have the meaning given such term in section 319L(a).''.

     SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT 
                   AUTHORITY.

       (a) Duties.--Section 319L(c)(4) of the Public Health 
     Service Act (42 U.S.C. 247d-7e(c)(4)) is amended--
       (1) in subparagraph (B)(iii), by inserting ``(which may 
     include advanced research and development for purposes of 
     fulfilling requirements under the Federal Food, Drug, and 
     Cosmetic Act or section 351 of this Act)'' after 
     ``development''; and
       (2) in subparagraph (D)(iii), by striking ``and vaccine 
     manufacturing technologies'' and inserting ``vaccine 
     manufacturing technologies, dose sparing technologies, 
     efficacy increasing technologies, and platform 
     technologies''.
       (b) Strategic Public-private Partnership.--Section 
     319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d-
     7e(c)(4)) is amended by adding at the end the following:
       ``(E) Strategic investor.--
       ``(i) In general.--To support the purposes described in 
     paragraph (2), the Secretary, acting through the Director of 
     BARDA, may enter into an agreement (including through the use 
     of grants, contracts, cooperative agreements, or other 
     transactions as described in paragraph (5)) with an 
     independent, non-profit entity to--

       ``(I) foster and accelerate the development and innovation 
     of medical countermeasures and technologies that may assist 
     advanced research and development of qualified 
     countermeasures and qualified pandemic or epidemic products, 
     including strategic investment through the use of venture 
     capital practices and methods;
       ``(II) promote the development of new and promising 
     technologies that address urgent medical countermeasure 
     needs, as identified by the Secretary;
       ``(III) address unmet public health needs that are directly 
     related to medical countermeasure requirements, such as novel 
     antimicrobials for multidrug resistant organisms and multiuse 
     platform technologies for diagnostics, prophylaxis, vaccines, 
     and therapeutics; and
       ``(IV) provide expert consultation and advice to foster 
     viable medical countermeasure innovators, including helping 
     qualified countermeasure innovators navigate unique industry 
     challenges with respect to developing chemical, biological, 
     radiological, and nuclear countermeasure products.

       ``(ii) Eligibility.--

       ``(I) In general.--To be eligible to enter into an 
     agreement under clause (i) an entity shall--

       ``(aa) be an independent, non-profit entity not otherwise 
     affiliated with the Department of Health and Human Services;
       ``(bb) have a demonstrated record of being able to create 
     linkages between innovators and investors and leverage such 
     partnerships and resources for the purpose of addressing 
     identified strategic needs of the Federal Government;
       ``(cc) have experience in promoting novel technology 
     innovation;
       ``(dd) be problem driven and solution focused based on the 
     needs, requirements, and problems identified by the Secretary 
     under clause (iv);
       ``(ee) demonstrate the ability, or the potential ability, 
     to promote the development of medical countermeasure 
     products; and
       ``(ff) demonstrate expertise, or the capacity to develop or 
     acquire expertise, related to technical and regulatory 
     considerations with respect to medical countermeasures.

       ``(II) Partnering experience.--In selecting an entity with 
     which to enter into an agreement under clause (i), the 
     Secretary shall place a high value on the demonstrated 
     experience of the entity in partnering with the Federal 
     Government to meet identified strategic needs.

       ``(iii) Not agency.--An entity that enters into an 
     agreement under clause (i) shall not be deemed to be a 
     Federal agency for any purpose, including for any purpose 
     under title 5, United States Code.
       ``(iv) Direction.--Pursuant to an agreement entered into 
     under this subparagraph, the Secretary, acting through the 
     Director of BARDA, shall provide direction to the entity that 
     enters into an agreement under clause (i). As part of this 
     agreement the Director of BARDA shall--

       ``(I) communicate the medical countermeasure needs, 
     requirements, and problems to be addressed by the entity 
     under the agreement;
       ``(II) develop a description of work to be performed by the 
     entity under the agreement;
       ``(III) provide technical feedback and appropriate 
     oversight over work carried out by the entity under the 
     agreement, including subsequent development and partnerships 
     consistent with the needs and requirements set forth in this 
     subparagraph;
       ``(IV) ensure fair consideration of products developed 
     under the agreement in order to maintain competition to the 
     maximum practical extent, as applicable and appropriate under 
     applicable provisions of this section; and
       ``(V) ensure, as a condition of the agreement--

       ``(aa) a comprehensive set of policies that demonstrate a 
     commitment to transparency and accountability;
       ``(bb) protection against conflicts of interest through a 
     comprehensive set of policies that address potential 
     conflicts of interest, ethics, disclosure, and reporting 
     requirements;
       ``(cc) that the entity provides monthly accounting on the 
     use of funds provided under such agreement; and
       ``(dd) that the entity provides on a quarterly basis, 
     reports regarding the progress made toward meeting the 
     identified needs set forth in the agreement.
       ``(v) Supplement not supplant.--Activities carried out 
     under this subparagraph shall supplement, and not supplant, 
     other activities carried out under this section.
       ``(vi) No establishment of entity.--To prevent unnecessary 
     duplication and target resources effectively, nothing in this 
     subparagraph shall be construed to authorize the Secretary to 
     establish within the Department of Health and Human Services 
     a strategic investor entity.
       ``(vii) Transparency and oversight.--Upon request, the 
     Secretary shall provide to Congress the information provided 
     to the Secretary under clause (iv)(V)(dd).
       ``(viii) Independent evaluation.--Not later than 4 years 
     after the date of enactment of this subparagraph, the 
     Government Accountability Office shall conduct an independent 
     evaluation, and submit to the Secretary and the appropriate 
     committees of Congress a report, concerning the activities 
     conducted under this subparagraph. Such report shall include 
     recommendations with respect to any agreement or activities 
     carried out pursuant to this subparagraph.
       ``(ix) Sunset.--This subparagraph shall have no force or 
     effect after September 30, 2016.''.
       (c) Transaction Authorities.--Section 319L(c)(5) of the 
     Public Health Service Act (42 U.S.C. 247d-7e(c)(5)) is 
     amended by adding at the end the following:
       ``(G) Government purpose.--In awarding contracts, grants, 
     and cooperative agreements under this section, the Secretary 
     shall provide a clear statement of defined Government purpose 
     related to activities included in subsection (a)(6)(B) for a 
     qualified countermeasure or qualified pandemic or epidemic 
     product.''.
       (d) Fund.--Paragraph (2) of section 319L(d) of the Public 
     Health Service Act (42 U.S.C. 247d-7e(d)(2)) is amended to 
     read as follows:
       ``(2) Funding.--To carry out the purposes of this section, 
     there is authorized to be appropriated to the Fund 
     $415,000,000 for each of fiscal years 2012 through 2016, such 
     amounts to remain available until expended.''.
       (e) Continued Inapplicability of Certain Provisions.--
     Section 319L(e)(1)(C) of the Public Health Service Act (42 
     U.S.C. 247d-7e(e)(1)(C)) is amended by striking ``7 years'' 
     and inserting ``10 years''.
       (f) Extension of Limited Antitrust Exemption.--Section 
     405(b) of the Pandemic and All-Hazards Preparedness Act (42 
     U.S.C. 247d-6a note) is amended by striking ``6-year'' and 
     inserting ``10-year''.
       (g) Independent Evaluation.--Section 319L of the Public 
     Health Service Act (42 U.S.C. 247d-7e) is amended by adding 
     at the end the following:
       ``(f) Independent Evaluation.--
       ``(1) In general.--Not later than 180 days after the date 
     of enactment of this subsection, the Government 
     Accountability Office shall conduct an independent evaluation 
     of the activities carried out to facilitate flexible 
     manufacturing capacity pursuant to this section.
       ``(2) Report.--Not later than 1 year after the date of 
     enactment of this subsection, the Government Accountability 
     Office shall submit to the appropriate committees of Congress 
     a report concerning the results of the evaluation conducted 
     under paragraph (1). Such report shall review and assess--
       ``(A) the extent to which flexible manufacturing capacity 
     under this section is dedicated to chemical, biological, 
     radiological, and nuclear threats;
       ``(B) the activities supported by flexible manufacturing 
     initiatives; and
       ``(C) the ability of flexible manufacturing activities 
     carried out under this section to--
       ``(i) secure and leverage leading technical expertise with 
     respect to countermeasure advanced research, development, and 
     manufacturing processes; and
       ``(ii) meet the surge manufacturing capacity needs 
     presented by novel and emerging threats, including chemical, 
     biological, radiological and nuclear agents.''.
       (h) Definitions.--
       (1) Qualified countermeasure.--Section 319F-1(a)(2)(A) of 
     the Public Health Service Act (42 U.S.C. 247d-6a(a)(2)(A)) is 
     amended--
       (A) in the matter preceding clause (i), by striking ``to--
     '' and inserting ``--'';
       (B) in clause (i)--
       (i) by striking ``diagnose'' and inserting ``to diagnose''; 
     and
       (ii) by striking ``; or'' and inserting a semicolon;
       (C) in clause (ii)--
       (i) by striking ``diagnose'' and inserting ``to diagnose''; 
     and
       (ii) by striking the period at the end and inserting ``; 
     or''; and
       (D) by adding at the end the following:
       ``(iii) is a product or technology intended to enhance the 
     use or effect of a drug, biological product, or device 
     described in clause (i) or (ii).''.
       (2) Qualified pandemic or epidemic product.--Section 319F-
     3(i)(7)(A) of the Public

[[Page 3135]]

     Health Service Act (42 U.S.C. 247d6d(i)(7)(A)) is amended--
       (A) in clause (i)(II), by striking ``; or'' and inserting 
     ``;'';
       (B) in clause (ii), by striking ``; and'' and inserting ``; 
     or''; and
       (C) by adding at the end the following:
       ``(iii) a product or technology intended to enhance the use 
     or effect of a drug, biological product, or device described 
     in clause (i) or (ii); and''.
       (3) Technical amendments.--Section 319F-3(i) of the Public 
     Health Service Act (42 U.S.C. 247d-6d(i)) is amended--
       (A) in paragraph (1)(C), by inserting ``, 564A, or 564B'' 
     after ``564''; and
       (B) in paragraph (7)(B)(iii), by inserting ``, 564A, or 
     564B'' after ``564''.

     SEC. 403. STRATEGIC NATIONAL STOCKPILE.

       (a) In General.--Section 319F-2 of the Public Health 
     Service Act (42 U.S.C. 247d-6b) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1)--
       (i) by inserting ``consistent with section 2811'' before 
     ``by the Secretary to be appropriate''; and
       (ii) by inserting before the period at the end the 
     following: ``and shall submit such review annually to the 
     appropriate Congressional committees of jurisdiction to the 
     extent that disclosure of such information does not 
     compromise national security''; and
       (B) in paragraph (2)--
       (i) by redesignating subparagraphs (E) through (H) as 
     subparagraphs (F) through (I), respectively; and
       (ii) by inserting after subparagraph (D), the following:
       ``(E) identify and address the potential depletion and 
     ensure appropriate replenishment of medical countermeasures, 
     including those currently in the stockpile;''; and
       (2) in subsection (f)(1), by striking ``$640,000,000 for 
     fiscal year 2002, and such sums as may be necessary for each 
     of fiscal years 2003 through 2006'' and inserting 
     ``$522,486,000 for each of fiscal years 2012 through 2016''.
       (b) Report on Potassium Iodide.--Not later than 270 days 
     after the date of enactment of this Act, the Secretary of 
     Health and Human Services shall submit to the appropriate 
     Committees of Congress a report regarding the stockpiling of 
     potassium iodide. Such report shall include--
       (1) an assessment of the availability of potassium iodide 
     at Federal, State, and local levels; and
       (2) a description of the extent to which such activities 
     and policies provide public health protection in the event of 
     a nuclear incident, whether unintentional or deliberate, 
     including an act of terrorism.

     SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD.

       Section 319M(a) of the Public Health Service Act (42 U.S.C. 
     247d-f(a)) is amended--
       (1) in paragraph (2)--
       (A) in subparagraph (D)--
       (i) in the matter preceding clause (i), by striking 
     ``five'' and inserting ``six'';
       (ii) in clause (i), by striking ``and'' at the end;
       (iii) in clause (ii), by striking the period and inserting 
     a semicolon; and
       (iv) by adding at the end the following:
       ``(iii) one such member shall be an individual with 
     pediatric subject matter expertise; and
       ``(iv) one such member shall be a State, tribal, 
     territorial, or local public health official.''; and
       (B) by adding at the end the following flush sentence:
     ``Nothing in this paragraph shall preclude a member of the 
     Board from satisfying two or more of the requirements 
     described in subparagraph (D).'';
       (2) in paragraph (5)--
       (A) in subparagraph (B), by striking ``and'' at the end;
       (B) in subparagraph (C), by striking the period and 
     inserting ``; and''; and
       (C) by adding at the end the following:
       ``(D) provide any recommendation, finding, or report 
     provided to the Secretary under this paragraph to the 
     appropriate committees of Congress.''; and
       (3) in paragraph (8), by adding at the end the following: 
     ``Such chairperson shall serve as the deciding vote in the 
     event that a deciding vote is necessary with respect to 
     voting by members of the Board.''.

  Mr. REID. Mr. President, I ask unanimous consent that the Harkin 
amendment, which is at desk, be agreed to, the committee-reported 
substitute, as amended, be agreed to, the bill, as amended, be read the 
third time and passed, with no intervening action or debate, and that 
any statements relating to the measure be printed in the Record.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  The amendment (No. 1823) was agreed to, as follows:

            (Purpose: To make certain technical corrections)

       On page 80, line 18, insert ``medical and public health'' 
     before ``needs of children''.
       On page 80, lines 19 and 20, strike ``, including public 
     health emergencies''.
       On page 82, between lines 5 and 6, insert the following:
       ``(G) the Administrator of the Federal Emergency Management 
     Agency;''.
       On page 82, line 6, strike ``(G) at least two'' and insert 
     ``(H) at least two non-Federal''.
       On page 82, line 9, strike ``(H)'' and insert ``(I)''.
       On page 82, line 13, strike ``(I)'' and insert ``(J)''.

  The committee amendment in the nature of a substitute, as amended, 
was agreed to.
  The bill (S. 1855), as amended, was ordered to be engrossed for a 
third reading, was read the third time, and passed, as follows:

                                S. 1855

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Pandemic 
     and All-Hazards Preparedness Act Reauthorization of 2011''.
       (b) Table of Contents.--The table of contents of 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.

 TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR PUBLIC 
                           HEALTH EMERGENCIES

     SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

       (a) In General.--Section 2802 of the Public Health Service 
     Act (42 U.S.C. 300hh-1) is amended--
       (1) in subsection (a)(1), by striking ``2009'' and 
     inserting ``2014''; and
       (2) in subsection (b)--
       (A) in paragraph (3)--
       (i) in the matter preceding subparagraph (A)--

       (I) by striking ``facilities), and trauma care'' and 
     inserting ``facilities and which may include dental health 
     facilities), and trauma care, critical care,''; and
       (II) by inserting ``(including related availability, 
     accessibility, and coordination)'' after ``public health 
     emergencies'';

       (ii) in subparagraph (A), by inserting ``and trauma'' after 
     ``medical'';
       (iii) in subparagraph (D), by inserting ``(which may 
     include such dental health assets)'' after ``medical 
     assets'';
       (iv) by adding at the end the following:
       ``(F) Optimizing a coordinated and flexible approach to the 
     medical surge capacity of hospitals, other healthcare 
     facilities, and trauma care (which may include trauma 
     centers) and emergency medical systems.'';
       (B) in paragraph (4)--
       (i) in subparagraph (A), by inserting ``, including the 
     unique needs and considerations of individuals with 
     disabilities,'' after ``medical needs of at-risk 
     individuals''; and
       (ii) in subparagraph (B), by inserting ``the'' before 
     ``purpose of this section''; and
       (C) by adding at the end the following:
       ``(7) Countermeasures.--
       ``(A) Promoting strategic initiatives to advance 
     countermeasures to diagnose, mitigate, prevent, or treat harm 
     from any biological agent or toxin, chemical, radiological, 
     or nuclear agent or agents, whether naturally occurring, 
     unintentional, or deliberate.
       ``(B) For purposes of this paragraph the term 
     `countermeasures' has the same meaning as the terms 
     `qualified countermeasures' under section 319F-1, `qualified 
     pandemic and epidemic products' under section 319F-3, and 
     `security countermeasures' under section 319F-2.
       ``(8) Medical and public health community resiliency.--
     Strengthening the ability of States, local communities, and 
     tribal communities to prepare for, respond to, and

[[Page 3136]]

     be resilient in the event of public health emergencies, 
     whether naturally occurring, unintentional, or deliberate 
     by--
       ``(A) optimizing alignment and integration of medical and 
     public health preparedness and response planning and 
     capabilities with and into routine daily activities; and
       ``(B) promoting familiarity with local medical and public 
     health systems.''.
       (b) At-Risk Individuals.--Section 2814 of the Public Health 
     Service Act (42 U.S.C. 300hh-16) is amended--
       (1) by striking paragraphs (5), (7), and (8);
       (2) by redesignating paragraphs (1) through (4) as 
     paragraphs (2) through (5), respectively;
       (3) by inserting before paragraph (2) (as so redesignated), 
     the following:
       ``(1) monitor emerging issues and concerns as they relate 
     to medical and public health preparedness and response for 
     at-risk individuals in the event of a public health emergency 
     declared by the Secretary under section 319;'';
       (4) in paragraph (2) (as so redesignated), by striking 
     ``National Preparedness goal'' and inserting ``preparedness 
     goals, as described in section 2802(b),''; and
       (5) by inserting after paragraph (6), the following:
       ``(7) disseminate and, as appropriate, update novel and 
     best practices of outreach to and care of at-risk individuals 
     before, during, and following public health emergencies in as 
     timely a manner as is practicable, including from the time a 
     public health threat is identified; and
       ``(8) ensure that public health and medical information 
     distributed by the Department of Health and Human Services 
     during a public health emergency is delivered in a manner 
     that takes into account the range of communication needs of 
     the intended recipients, including at-risk individuals.''.

     SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

       Section 2811 of the Public Health Service Act (42 U.S.C. 
     300hh-10) is amended--
       (1) in subsection (b)(4), by adding at the end the 
     following:
       ``(D) Policy coordination and strategic direction.--Provide 
     integrated policy coordination and strategic direction with 
     respect to all matters related to Federal public health and 
     medical preparedness and execution and deployment of the 
     Federal response for public health emergencies and incidents 
     covered by the National Response Plan developed pursuant to 
     section 502(6) of the Homeland Security Act of 2002, or any 
     successor plan, before, during, and following public health 
     emergencies.'';
       (2) by striking subsection (c) and inserting the following:
       ``(c) Functions.--The Assistant Secretary for Preparedness 
     and Response shall--
       ``(1) have authority over and responsibility for--
       ``(A) the National Disaster Medical System (in accordance 
     with section 301 of the Pandemic and All-Hazards Preparedness 
     Act);
       ``(B) the Hospital Preparedness Cooperative Agreement 
     Program pursuant to section 319C-2;
       ``(C) the Medical Reserve Corps pursuant to section 2813;
       ``(D) the Emergency System for Advance Registration of 
     Volunteer Health Professionals pursuant to section 319I; and
       ``(E) administering grants and related authorities related 
     to trauma care under parts A through C of title XII, such 
     authority to be transferred by the Secretary from the 
     Administrator of the Health Resources and Services 
     Administration to such Assistant Secretary;
       ``(2) exercise the responsibilities and authorities of the 
     Secretary with respect to the coordination of--
       ``(A) the Public Health Emergency Preparedness Cooperative 
     Agreement Program pursuant to section 319C-1;
       ``(B) the Strategic National Stockpile; and
       ``(C) the Cities Readiness Initiative;
       ``(3) align and coordinate medical and public health grants 
     and cooperative agreements as applicable to preparedness and 
     response activities authorized under this Act, to the extent 
     possible, including program requirements, timelines, and 
     measurable goals, and in coordination with the Secretary of 
     Homeland Security, to--
       ``(A) optimize and streamline medical and public health 
     preparedness capabilities and the ability of local 
     communities to respond to public health emergencies;
       ``(B) minimize duplication of efforts with regard to 
     medical and public health preparedness and response programs; 
     and
       ``(C) gather and disseminate best practices among grant and 
     cooperative agreement recipients, as appropriate;
       ``(4) carry out drills and operational exercises, in 
     coordination with the Department of Homeland Security, the 
     Department of Defense, the Department of Veterans Affairs, 
     and other applicable Federal departments and agencies, as 
     necessary and appropriate, to identify, inform, and address 
     gaps in and policies related to all-hazards medical and 
     public health preparedness, including exercises based on--
       ``(A) identified threats for which countermeasures are 
     available and for which no countermeasures are available; and
       ``(B) unknown threats for which no countermeasures are 
     available; and
       ``(5) assume other duties as determined appropriate by the 
     Secretary.''; and
       (3) by adding at the end the following:
       ``(d) National Security Priority.--The Secretary, acting 
     through the Assistant Secretary for Preparedness and 
     Response, shall on a periodic basis conduct meetings, as 
     applicable and appropriate, with the Assistant to the 
     President for National Security Affairs to provide an update 
     on, and discuss, medical and public health preparedness and 
     response activities pursuant to this Act and the Federal 
     Food, Drug, and Cosmetic Act, including progress on the 
     development, approval, clearance, and licensure of medical 
     countermeasures.
       ``(e) Public Health Emergency Medical Countermeasures 
     Enterprise Strategy and Implementation Plan.--
       ``(1) In general.--Not later than 180 days after the date 
     of enactment of this subsection, and every other year 
     thereafter, the Secretary, acting through the Assistant 
     Secretary for Preparedness and Response and in consultation 
     with the Director of the Biomedical Advanced Research and 
     Development Authority, the Director of the National 
     Institutes of Health, the Director of the Centers for Disease 
     Control and Prevention, and the Commissioner of the Food and 
     Drug Administration, shall develop and submit to the 
     appropriate committees of Congress a coordinated strategy and 
     accompanying implementation plan for medical countermeasures 
     to address chemical, biological, radiological, and nuclear 
     threats. Such strategy and plan shall be known as the `Public 
     Health Emergency Medical Countermeasures Enterprise Strategy 
     and Implementation Plan'.
       ``(2) Requirements.--The plan under paragraph (1) shall--
       ``(A) consider and reflect the full spectrum of medical 
     countermeasure-related activities, including research, 
     advanced research, development, procurement, stockpiling, 
     deployment, and distribution;
       ``(B) identify and prioritize near-term, mid-term, and 
     long-term priority qualified and security countermeasure (as 
     defined in sections 319F-1 and 319F-2) needs and goals of the 
     Federal Government according to chemical, biological, 
     radiological, and nuclear threat or threats;
       ``(C) identify projected timelines, anticipated funding 
     allocations, benchmarks, and milestones for each medical 
     countermeasure priority under subparagraph (B), including 
     projected needs with regard to replenishment of the Strategic 
     National Stockpile;
       ``(D) be informed by the recommendations of the National 
     Biodefense Science Board pursuant to section 319M;
       ``(E) report on advanced research and development awards 
     and the date of the issuance of contract awards, including 
     awards made through the special reserve fund (as defined in 
     section 319F-2(c)(10));
       ``(F) identify progress made in meeting the goals, 
     benchmarks, and milestones identified under subparagraph (C) 
     in plans submitted subsequent to the initial plan;
       ``(G) identify the progress made in meeting the medical 
     countermeasure priorities for at-risk individuals, (as 
     defined in 2802(b)(4)(B)), as applicable under subparagraph 
     (B), including with regard to the projected needs for related 
     stockpiling and replenishment of the Strategic National 
     Stockpile; and
       ``(H) be made publicly available.
       ``(3) GAO report.--
       ``(A) In general.--Not later than 1 year after the date on 
     which a Public Health Emergency Medical Countermeasures 
     Enterprise Strategy and Implementation Plan under this 
     subsection is issued by the Secretary, the Government 
     Accountability Office shall conduct an independent evaluation 
     and submit to the appropriate committees of Congress a report 
     concerning such strategy and implementation plan.
       ``(B) Content.--The report described in subparagraph (A) 
     shall review and assess--
       ``(i) the near-term, mid-term, and long-term medical 
     countermeasure needs and identified priorities of the Federal 
     Government pursuant to subparagraphs (A) and (B) of paragraph 
     (2);
       ``(ii) the activities of the Department of Health and Human 
     Services with respect to advanced research and development 
     pursuant to section 319L; and
       ``(iii) the progress made toward meeting the goals, 
     benchmarks, and milestones identified in the Public Health 
     Emergency Medical Countermeasures Enterprise Strategy and 
     Implementation Plan under this subsection.
       ``(f) Internal Multiyear Planning Process.--The Secretary 
     shall develop, and update on an annual basis, a coordinated 
     5-year budget plan based on the medical countermeasure 
     priorities and goals described in subsection (e). Each such 
     plan shall--
       ``(1) include consideration of the entire medical 
     countermeasures enterprise, including--
       ``(A) basic research, advanced research and development;
       ``(B) approval, clearance, licensure, and authorized uses 
     of products; and
       ``(C) procurement, stockpiling, maintenance, and 
     replenishment of all products in the Strategic National 
     Stockpile;

[[Page 3137]]

       ``(2) include measurable outputs and outcomes to allow for 
     the tracking of the progress made toward identified goals;
       ``(3) identify medical countermeasure life-cycle costs to 
     inform planning, budgeting, and anticipated needs within the 
     continuum of the medical countermeasure enterprise consistent 
     with section 319F-2; and
       ``(4) be made available to the appropriate committees of 
     Congress upon request.
       ``(g) Interagency Coordination Plan.--Not later than 1 year 
     after the date of enactment of this subsection, the 
     Secretary, in coordination with the Secretary of Defense, 
     shall submit to the appropriate committees of Congress a 
     report concerning the manner in which the Department of 
     Health and Human Services is coordinating with the Department 
     of Defense regarding countermeasure activities to address 
     chemical, biological, radiological, and nuclear threats. Such 
     report shall include information with respect to--
       ``(1) the research, advanced research, development, 
     procurement, stockpiling, and distribution of countermeasures 
     to meet identified needs; and
       ``(2) the coordination of efforts between the Department of 
     Health and Human Services and the Department of Defense to 
     address countermeasure needs for various segments of the 
     population.
       ``(h) Protection of National Security.--In carrying out 
     subsections (e), (f), and (g), the Secretary shall ensure 
     that information and items that could compromise national 
     security are not disclosed.''.

     SEC. 103. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND 
                   DISASTERS.

       Subtitle B of title XXVIII of the Public Health Service Act 
     (42 U.S.C. 300hh et seq.) is amended by inserting after 
     section 2811 the end the following:

     ``SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND 
                   DISASTERS.

       ``(a) Establishment.--The Secretary, in consultation with 
     the Secretary of Homeland Security, shall establish an 
     advisory committee to be known as the `National Advisory 
     Committee on Children and Disasters' (referred to in this 
     section as the `Advisory Committee').
       ``(b) Duties.--The Advisory Committee shall--
       ``(1) provide advice and consultation with respect to the 
     activities carried out pursuant to section 2814, as 
     applicable and appropriate;
       ``(2) evaluate and provide input with respect to the 
     medical and public health needs of children as they relate to 
     preparation for, response to, and recovery from all-hazards; 
     and
       ``(3) provide advice and consultation to States and 
     territories with respect to State emergency preparedness and 
     response activities and children, including related drills 
     and exercises pursuant to the preparedness goals under 
     section 2802(b).
       ``(c) Additional Duties.--The Advisory Committee may 
     provide advice and recommendations to the Secretary with 
     respect to children and the medical and public health grants 
     and cooperative agreements as applicable to preparedness and 
     response activities authorized under this title and title 
     III.
       ``(d) Membership.--
       ``(1) In general.--The Secretary, in consultation with such 
     other Secretaries as may be appropriate, shall appoint not to 
     exceed 15 members to the Advisory Committee. In appointing 
     such members, the Secretary shall ensure that the total 
     membership of the Advisory Committee is an odd number.
       ``(2) Required members.--The Secretary, in consultation 
     with such other Secretaries as may be appropriate, may 
     appoint to the Advisory Committee under paragraph (1) such 
     individuals as may be appropriate to perform the duties 
     described in subsections (b) and (c), which may include--
       ``(A) the Assistant Secretary for Preparedness and 
     Response;
       ``(B) the Director of the Biomedical Advanced Research and 
     Development Authority;
       ``(C) the Director of the Centers for Disease Control and 
     Prevention;
       ``(D) the Commissioner of Food and Drugs;
       ``(E) the Director of the National Institutes of Health;
       ``(F) the Assistant Secretary of the Administration for 
     Children and Families;
       ``(G) the Administrator of the Federal Emergency Management 
     Agency;
       ``(H) at least two non-Federal health care professionals 
     with expertise in pediatric medical disaster planning, 
     preparedness, response, or recovery;
       ``(I) at least two representatives from State, local, 
     territories, or tribal agencies with expertise in pediatric 
     disaster planning, preparedness, response, or recovery; and
       ``(J) representatives from such Federal agencies (such as 
     the Department of Education and the Department of Homeland 
     Security) as determined necessary to fulfill the duties of 
     the Advisory Committee, as established under subsections (b) 
     and (c).
       ``(e) Meetings.--The Advisory Committee shall meet not less 
     than biannually.
       ``(f) Sunset.--The Advisory Committee shall terminate on 
     the date that is 5 years after the date of enactment of the 
     Pandemic and All-Hazards Preparedness Act Reauthorization of 
     2011.''.

     SEC. 104. MODERNIZATION OF THE NATIONAL DISASTER MEDICAL 
                   SYSTEM.

       Section 2812 of the Public Health Service Act (42 U.S.C. 
     300hh-11) is amended--
       (1) in subsection (a)(3)--
       (A) in subparagraph (A), in clause (i) by inserting ``, 
     including at-risk individuals as applicable'' after ``victims 
     of a public health emergency'';
       (B) by redesignating subparagraph (C) as subparagraph (E); 
     and
       (C) by inserting after subparagraph (B), the following:
       ``(C) Considerations for at-risk populations.--The 
     Secretary shall take steps to ensure that an appropriate 
     specialized and focused range of public health and medical 
     capabilities are represented in the National Disaster Medical 
     System, which take into account the needs of at-risk 
     individuals, in the event of a public health emergency.''.
       ``(D) Administration.--The Secretary may determine and pay 
     claims for reimbursement for services under subparagraph (A) 
     directly or through contracts that provide for payment in 
     advance or by way of reimbursement.''; and
       (2) in subsection (g), by striking ``such sums as may be 
     necessary for each of the fiscal years 2007 through 2011'' 
     and inserting ``$56,000,000 for each of fiscal years 2012 
     through 2016''.

     SEC. 105. CONTINUING THE ROLE OF THE DEPARTMENT OF VETERANS 
                   AFFAIRS.

       Section 8117(g) of title 38, United States Code, is amended 
     by striking ``such sums as may be necessary to carry out this 
     section for each of fiscal years 2007 through 2011'' and 
     inserting ``$156,500,000 for each of fiscal years 2012 
     through 2016 to carry out this section''.

   TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS AND 
                                RESPONSE

     SEC. 201. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.

       (a) Cooperative Agreements.--Section 319C-1 of the Public 
     Health Service Act (42 U.S.C. 247d-3a) is amended--
       (1) in subsection (b)(2)--
       (A) in subparagraph (A)--
       (i) by striking clauses (i) and (ii) and inserting the 
     following:
       ``(i) a description of the activities such entity will 
     carry out under the agreement to meet the goals identified 
     under section 2802, including with respect to chemical, 
     biological, radiological, or nuclear threats, whether 
     naturally occurring, unintentional, or deliberate;
       ``(ii) a description of the activities such entity will 
     carry out with respect to pandemic influenza, as a component 
     of the activities carried out under clause (i), and 
     consistent with the requirements of paragraphs (2) and (5) of 
     subsection (g);'';
       (ii) in clause (iv), by striking ``and'' at the end; and
       (iii) by adding at the end the following:
       ``(vi) a description of how, as appropriate, the entity may 
     partner with relevant public and private stakeholders in 
     public health emergency preparedness and response;
       ``(vii) a description of how the entity, as applicable and 
     appropriate, will coordinate with State emergency 
     preparedness and response plans in public health emergency 
     preparedness, including State educational agencies (as 
     defined in section 9101(41) of the Elementary and Secondary 
     Education Act of 1965) and State child care lead agencies (as 
     defined in section 658D of the Child Care and Development 
     Block Grant Act); and
       ``(viii) in the case of entities that operate on the United 
     States-Mexico border or the United States-Canada border, a 
     description of the activities such entity will carry out 
     under the agreement that are specific to the border area 
     including disease detection, identification, and 
     investigation, and preparedness and response activities 
     related to emerging diseases and infectious disease outbreaks 
     whether naturally-occurring or due to bioterrorism, 
     consistent with the requirements of this section;''; and
       (B) in subparagraph (C), by inserting ``, including 
     addressing the needs of at-risk individuals,'' after 
     ``capabilities of such entity'';
       (2) in subsection (g)--
       (A) in paragraph (1), by striking subparagraph (A) and 
     inserting the following:
       ``(A) include outcome goals representing operational 
     achievements of the National Preparedness Goals developed 
     under section 2802(b) with respect to all-hazards, including 
     chemical, biological, radiological, or nuclear threats; 
     and''; and
       (B) in paragraph (2)(A), by adding at the end the 
     following: ``The Secretary shall periodically update, as 
     necessary and appropriate, such pandemic influenza plan 
     criteria and shall require the integration of such criteria 
     into the benchmarks and standards described in paragraph 
     (1).'';
       (3) in subsection (i)--
       (A) in paragraph (1)(A)--
       (i) by striking ``$824,000,000 for fiscal year 2007'' and 
     inserting ``$632,900,000 for fiscal year 2012''; and
       (ii) by striking ``such sums as may be necessary for each 
     of fiscal years 2008 through 2011'' and inserting 
     ``$632,900,000 for each of fiscal years 2013 through 2016''; 
     and
       (B) by adding at the end the following:
       ``(7) Availability of cooperative agreement funds.--

[[Page 3138]]

       ``(A) In general.--Amounts provided to an eligible entity 
     under a cooperative agreement under subsection (a) for a 
     fiscal year and remaining unobligated at the end of such year 
     shall remain available to such entity for the next fiscal 
     year for the purposes for which such funds were provided.
       ``(B) Funds contingent on achieving benchmarks.--The 
     continued availability of funds under subparagraph (A) with 
     respect to an entity shall be contingent upon such entity 
     achieving the benchmarks and submitting the pandemic 
     influenza plan as described in subsection (g).''; and
       (4) in subsection (j), by striking paragraph (3).
       (b) Vaccine Tracking and Distribution.--Section 319A(e) of 
     the Public Health Service Act (42 U.S.C. 247d-1(e)) is 
     amended by striking ``such sums for each of fiscal years 2007 
     through 2011'' and inserting ``$30,800,000 for each of fiscal 
     years 2012 through 2016''.
       (c) GAO Report.--Section 319C-1 of the Public Health 
     Service Act (42 U.S.C. 247d-3a) is amended by adding at the 
     end the following:
       ``(l) GAO Report.--
       ``(1) In general.--Not later than 1 year after the date of 
     enactment of the Pandemic and All-Hazards Preparedness Act 
     Reauthorization of 2011, the Government Accountability Office 
     shall conduct an independent evaluation, and submit to the 
     appropriate committees of Congress a report, concerning 
     Federal programs at the Department of Health and Human 
     Services that support medical and public health preparedness 
     and response programs at the State and local levels.
       ``(2) Content.--The report described in paragraph (1) shall 
     review and assess--
       ``(A) the extent to which grant and cooperative agreement 
     requirements and goals have been met by recipients;
       ``(B) the extent to which such grants and cooperative 
     agreements have supported medical and public health 
     preparedness and response goals pursuant to section 2802(b), 
     as appropriate and applicable;
       ``(C) whether recipients or the Department of Health and 
     Human Services have identified any factors that may impede a 
     recipient's ability to achieve programmatic goals and 
     requirements; and
       ``(D) instances in which funds may not have been used 
     appropriately, in accordance with grant and cooperative 
     agreement requirements, and actions taken to address 
     inappropriate expenditures.''.

     SEC. 202. HOSPITAL PREPAREDNESS AND MEDICAL SURGE CAPACITY.

       (a) All-Hazards Public Health and Medical Response 
     Curricula and Training.--Section 319F(a)(5)(B) of the Public 
     Health Service Act (42 U.S.C. 247d-6(a)(5)(B)) is amended by 
     striking ``public health or medical'' and inserting ``public 
     health, medical, or dental''.
       (b) Encouraging Health Professional Volunteers.--
       (1) Emergency system for advance registration of volunteer 
     health professionals.--Section 319I(k) of the Public Health 
     Service Act (42 U.S.C. 247d-7b(k)) is amended by striking 
     ``$2,000,000 for fiscal year 2002, and such sums as may be 
     necessary for each of the fiscal years 2003 through 2011'' 
     and inserting ``$5,900,000 for each of fiscal years 2012 
     through 2016''.
       (2) Volunteers.--Section 2813 of the Public Health Service 
     Act (42 U.S.C. 300hh-15) is amended--
       (A) in subsection (d)(2), by adding at the end the 
     following: ``Such training exercises shall, as appropriate 
     and applicable, incorporate the needs of at-risk individuals 
     in the event of a public health emergency.''; and
       (B) in subsection (i), by striking ``$22,000,000 for fiscal 
     year 2007, and such sums as may be necessary for each of 
     fiscal years 2008 through 2011'' and inserting ``$11,900,000 
     for each of fiscal years 2012 through 2016''.
       (c) Partnerships for State and Regional Preparedness To 
     Improve Surge Capacity.--Section 319C-2 of the Public Health 
     Service Act (42 U.S.C. 247d-3b) is amended--
       (1) in subsection (b)(1)(A)(ii), by striking ``centers, 
     primary'' and inserting ``centers, community health centers, 
     primary'';
       (2) by striking subsection (c) and inserting the following:
       ``(c) Use of Funds.--An award under subsection (a) shall be 
     expended for activities to achieve the preparedness goals 
     described under paragraphs (1), (3), (4), (5), and (6) of 
     section 2802(b) with respect to all-hazards, including 
     chemical, biological, radiological, or nuclear threats.'';
       (3) by striking subsection (g) and inserting the following:
       ``(g) Coordination.--
       ``(1) Local response capabilities.--An eligible entity 
     shall, to the extent practicable, ensure that activities 
     carried out under an award under subsection (a) are 
     coordinated with activities of relevant local Metropolitan 
     Medical Response Systems, local Medical Reserve Corps, the 
     local Cities Readiness Initiative, and local emergency plans.
       ``(2) National collaboration.--Partnerships consisting of 
     one or more eligible entities under this section may, to the 
     extent practicable, collaborate with other partnerships 
     consisting of one or more eligible entities under this 
     section for purposes of national coordination and 
     collaboration with respect to activities to achieve the 
     preparedness goals described under paragraphs (1), (3), (4), 
     (5), and (6) of section 2802(b).''; and
       (4) in subsection (j)--
       (A) in paragraph (1), by striking ``$474,000,000 for fiscal 
     year 2007, and such sums as may be necessary for each of 
     fiscal years 2008 through 2011'' and inserting ``$378,000,000 
     for each of fiscal years 2012 through 2016''; and
       (B) by adding at the end the following:
       ``(4) Availability of cooperative agreement funds.--
       ``(A) In general.--Amounts provided to an eligible entity 
     under a cooperative agreement under subsection (a) for a 
     fiscal year and remaining unobligated at the end of such year 
     shall remain available to such entity for the next fiscal 
     year for the purposes for which such funds were provided.
       ``(B) Funds contingent on achieving benchmarks.--The 
     continued availability of funds under subparagraph (A) with 
     respect to an entity shall be contingent upon such entity 
     achieving the benchmarks and submitting the pandemic 
     influenza plan as required under subsection (i).''.

     SEC. 203. ENHANCING SITUATIONAL AWARENESS AND 
                   BIOSURVEILLANCE.

       Section 319D of the Public Health Service Act (42 U.S.C. 
     247d-4) is amended--
       (1) in subsection (b)--
       (A) in paragraph (1)(B), by inserting ``poison control 
     centers,'' after ``hospitals,'';
       (B) in paragraph (2), by inserting before the period the 
     following: ``, allowing for coordination to maximize all-
     hazards medical and public health preparedness and response 
     and to minimize duplication of effort''; and
       (C) in paragraph (3), by inserting before the period the 
     following: ``and update such standards as necessary'';
       (2) in subsection (d)--
       (A) in the subsection heading, by striking ``Public Health 
     Situational Awareness'' and inserting ``Modernizing Public 
     Health Situational Awareness and BioSurveillance'';
       (B) in paragraph (1)--
       (i) by striking ``Pandemic and All-Hazards Preparedness 
     Act'' and inserting ``Pandemic and All-Hazards Preparedness 
     Act Reauthorization of 2011''; and
       (ii) by inserting ``, novel emerging threats,'' after 
     ``disease outbreaks'';
       (C) by striking paragraph (2) and inserting the following:
       ``(2) Strategy and implementation plan.--Not later than 180 
     days after the date of enactment of the Pandemic and All-
     Hazards Preparedness Act Reauthorization of 2011, the 
     Secretary shall submit to the appropriate committees of 
     Congress, a coordinated strategy and an accompanying 
     implementation plan that identifies and demonstrates the 
     measurable steps the Secretary will carry out to--
       ``(A) develop, implement, and evaluate the network 
     described in paragraph (1), utilizing the elements described 
     in paragraph (3); and
       ``(B) modernize and enhance biosurveillance activities.'';
       (D) in paragraph (3)(D), by inserting ``community health 
     centers, health centers'' after ``poison control,'';
       (E) in paragraph (5), by striking subparagraph (A) and 
     inserting the following:
       ``(A) utilize applicable interoperability standards as 
     determined by the Secretary, and in consultation with the 
     Office of the National Coordinator for Health Information 
     Technology, through a joint public and private sector 
     process;''; and
       (F) by adding at the end the following:
       ``(6) Consultation with the national biodefense science 
     board.--In carrying out this section consistent with section 
     319M, the National Biodefense Science Board shall provide 
     expert advice and guidance, including recommendations, 
     regarding the measurable steps the Secretary should take to 
     modernize and enhance biosurveillance activities pursuant to 
     the efforts of the Department of Health and Humans Services 
     to ensure comprehensive, real-time all-hazards 
     biosurveillance capabilities. In complying with the preceding 
     sentence, the National Biodefense Science Board shall--
       ``(A) identify the steps necessary to achieve a national 
     biosurveillance system for human health, with international 
     connectivity, where appropriate, that is predicated on State, 
     regional, and community level capabilities and creates a 
     networked system to allow for two-way information flow 
     between and among Federal, State, and local government public 
     health authorities and clinical health care providers;
       ``(B) identify any duplicative surveillance programs under 
     the authority of the Secretary, or changes that are necessary 
     to existing programs, in order to enhance and modernize such 
     activities, minimize duplication, strengthen and streamline 
     such activities under the authority of the Secretary, and 
     achieve real-time and appropriate data that relate to disease 
     activity, both human and zoonotic; and
       ``(C) coordinate with applicable existing advisory 
     committees of the Director of the Centers for Disease Control 
     and Prevention, including such advisory committees consisting 
     of representatives from State, local, and tribal public 
     health authorities and appropriate public and private sector 
     health

[[Page 3139]]

     care entities and academic institutions, in order to provide 
     guidance on public health surveillance activities.'';
       (3) in subsection (e)(5), by striking ``4 years after the 
     date of enactment of the Pandemic and All-Hazards 
     Preparedness Act'' and inserting ``3 years after the date of 
     enactment of the Pandemic and All-Hazards Preparedness Act 
     Reauthorization of 2011'';
       (4) in subsection (g), by striking ``such sums as may be 
     necessary in each of fiscal years 2007 through 2011'' and 
     inserting ``$160,121,000 for each of fiscal years 2012 
     through 2016''; and
       (5) by adding at the end the following:
       ``(h) Definition.--For purposes of this section the term 
     `biosurveillance' means the process of gathering near real-
     time, biological data that relates to disease activity and 
     threats to human or zoonotic health, in order to achieve 
     early warning and identification of such health threats, 
     early detection and prompt ongoing tracking of health events, 
     and overall situational awareness of disease activity.''.

           TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW

     SEC. 301. SPECIAL PROTOCOL ASSESSMENT.

       Section 505(b)(5)(B) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by striking 
     ``size of clinical trials intended'' and all that follows 
     through ``. The sponsor or applicant'' and inserting the 
     following: ``size--
       ``(i)(I) of clinical trials intended to form the primary 
     basis of an effectiveness claim; or
       ``(II) in the case where human efficacy studies are not 
     ethical or feasible, of animal and any associated clinical 
     trials which, in combination, are intended to form the 
     primary basis of an effectiveness claim; or
       ``(ii) with respect to an application for approval of a 
     biological product under section 351(k) of the Public Health 
     Service Act, of any necessary clinical study or studies.

     The sponsor or applicant''.

     SEC. 302. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN 
                   EMERGENCIES.

       (a) In General.--Section 564 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1), by striking ``sections 505, 510(k), 
     and 515 of this Act'' and inserting ``any provision of this 
     Act'';
       (B) in paragraph (2)(A), by striking ``under a provision of 
     law referred to in such paragraph'' and inserting ``under a 
     provision of law in section 505, 510(k), or 515 of this Act 
     or section 351 of the Public Health Service Act''; and
       (C) in paragraph (3), by striking ``a provision of law 
     referred to in such paragraph'' and inserting ``a provision 
     of law referred to in paragraph (2)(A)'';
       (2) in subsection (b)--
       (A) in the subsection heading, by striking ``Emergency'' 
     and inserting ``Emergency or Threat Justifying Emergency 
     Authorized Use'';
       (B) in paragraph (1)--
       (i) in the matter preceding subparagraph (A), by striking 
     ``may declare an emergency'' and inserting ``may make a 
     declaration that the circumstances exist'';
       (ii) in subparagraph (A), by striking ``specified'';
       (iii) in subparagraph (B)--

       (I) by striking ``specified''; and
       (II) by striking ``; or'' and inserting a semicolon;

       (iv) by amending subparagraph (C) to read as follows:
       ``(C) a determination by the Secretary that there is a 
     public health emergency, or a significant potential for a 
     public health emergency, that affects, or has a significant 
     potential to affect, national security or the health and 
     security of United States citizens abroad, and that involves 
     a biological, chemical, radiological, or nuclear agent or 
     agents, or a disease or condition that may be attributable to 
     such agent or agents; or''; and
       (v) by adding at the end the following:
       ``(D) the identification of a material threat pursuant to 
     section 319F-2 of the Public Health Service Act sufficient to 
     affect national security or the health and security of United 
     States citizens living abroad.'';
       (C) in paragraph (2)(A)--
       (i) by amending clause (ii) to read as follows:
       ``(ii) a change in the approval status of the product such 
     that the circumstances described in subsection (a)(2) have 
     ceased to exist.'';
       (ii) by striking subparagraph (B); and
       (iii) by redesignating subparagraph (C) as subparagraph 
     (B);
       (D) in paragraph (4), by striking ``advance notice of 
     termination, and renewal under this subsection.'' and 
     inserting ``, and advance notice of termination under this 
     subsection. The Secretary shall make any renewal under this 
     subsection available on the Internet Web site of the Food and 
     Drug Administration.''; and
       (E) by adding at the end the following:
       ``(5) Explanation by secretary.--If an authorization under 
     this section with respect to an unapproved product has been 
     in effect for more than 1 year, the Secretary shall provide 
     in writing to the sponsor of such product, an explanation of 
     the scientific, regulatory, or other obstacles to approval, 
     licensure, or clearance of such product, including specific 
     actions to be taken by the Secretary and the sponsor to 
     overcome such obstacles.'';
       (3) in subsection (c)--
       (A) in the matter preceding paragraph (1)--
       (i) by inserting ``the Assistant Secretary for Preparedness 
     and Response,'' after ``consultation with'';
       (ii) by striking ``Health and'' and inserting ``Health, 
     and''; and
       (iii) by striking ``circumstances of the emergency 
     involved'' and inserting ``applicable circumstances described 
     in subsection (b)(1)'';
       (B) in paragraph (1), by striking ``specified'' and 
     inserting ``referred to''; and
       (C) in paragraph (2)(B), by inserting ``, taking into 
     consideration the material threat posed by the agent or 
     agents identified in a declaration under subsection 
     (b)(1)(D), if applicable'' after ``risks of the product'';
       (4) in subsection (d)(3), by inserting ``, to the extent 
     practicable given the circumstances of the emergency,'' after 
     ``including'';
       (5) in subsection (e)--
       (A) in paragraph (1)(A), by striking ``circumstances of the 
     emergency'' and inserting ``applicable circumstances 
     described in subsection (b)(1)'';
       (B) in paragraph (2)--
       (i) in subparagraph (A)--

       (I) by striking ``manufacturer of the product'' and 
     inserting ``person'';
       (II) by striking ``circumstances of the emergency'' and 
     inserting ``applicable circumstances described in subsection 
     (b)(1)''; and
       (III) by inserting at the end before the period ``or in 
     paragraph (1)(B)'';

       (ii) in subparagraph (B)(i), by inserting before the period 
     at the end ``, except as provided in section 564A with 
     respect to authorized changes to the product expiration 
     date''; and
       (iii) by amending subparagraph (C) to read as follows:
       ``(C) In establishing conditions under this paragraph with 
     respect to the distribution and administration of the product 
     for the unapproved use, the Secretary shall not impose 
     conditions that would restrict distribution or administration 
     of the product when done solely for the approved use.''; and
       (C) by amending paragraph (3) to read as follows:
       ``(3) Good manufacturing practice; prescription.--With 
     respect to the emergency use of a product for which an 
     authorization under this section is issued (whether an 
     unapproved product or an unapproved use of an approved 
     product), the Secretary may waive or limit, to the extent 
     appropriate given the applicable circumstances described in 
     subsection (b)(1)--
       ``(A) requirements regarding current good manufacturing 
     practice otherwise applicable to the manufacture, processing, 
     packing, or holding of products subject to regulation under 
     this Act, including such requirements established under 
     section 501 or 520(f)(1), and including relevant conditions 
     prescribed with respect to the product by an order under 
     section 520(f)(2);
       ``(B) requirements established under section 503(b); and
       ``(C) requirements established under section 520(e).'';
       (6) in subsection (g)--
       (A) in the subsection heading, by inserting ``Review and'' 
     before ``Revocation'';
       (B) in paragraph (1), by inserting after the period at the 
     end the following: ``As part of such review, the Secretary 
     shall regularly review the progress made with respect to the 
     approval, licensure, or clearance of--
       ``(A) an unapproved product for which an authorization was 
     issued under this section; or
       ``(B) an unapproved use of an approved product for which an 
     authorization was issued under this section.''; and
       (C) by amending paragraph (2) to read as follows:
       ``(2) Revision and revocation.--The Secretary may revise or 
     revoke an authorization under this section if--
       ``(A) the circumstances described under subsection (b)(1) 
     no longer exist;
       ``(B) the criteria under subsection (c) for issuance of 
     such authorization are no longer met; or
       ``(C) other circumstances make such revision or revocation 
     appropriate to protect the public health or safety.'';
       (7) in subsection (h)(1), by adding after the period at the 
     end the following: ``The Secretary shall make any revisions 
     to an authorization under this section available on the 
     Internet Web site of the Food and Drug Administration.''; and
       (8) by adding at the end of subsection (j) the following:
       ``(4) Nothing in this section shall be construed as 
     authorizing a delay in the review or other consideration by 
     the Food and Drug Administration of any application pending 
     before the Administration for a countermeasure or product 
     referred to in subsection (a).''.
       (b) Emergency Use of Medical Products.--Subchapter E of 
     chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb et seq.) is amended by inserting after section 
     564 the following:

[[Page 3140]]



     ``SEC. 564A. EMERGENCY USE OF MEDICAL PRODUCTS.

       ``(a) Definitions.--In this section:
       ``(1) Eligible product.--The term `eligible product' means 
     a product that--
       ``(A) is approved or cleared under this chapter or licensed 
     under section 351 of the Public Health Service Act;
       ``(B)(i) is intended for use to prevent, diagnose, or treat 
     a disease or condition involving a biological, chemical, 
     radiological, or nuclear agent or agents, including a product 
     intended to be used to prevent or treat pandemic influenza; 
     or
       ``(ii) is intended for use to prevent, diagnose, or treat a 
     serious or life-threatening disease or condition caused by a 
     product described in clause (i); and
       ``(C) is intended for use during the circumstances under 
     which--
       ``(i) a determination described in subparagraph (A), (B), 
     or (C) of section 564(b)(1) has been made by the Secretary of 
     Homeland Security, the Secretary of Defense, or the 
     Secretary, respectively; or
       ``(ii) the identification of a material threat described in 
     subparagraph (D) of section 564(b)(1) has been made pursuant 
     to section 319F-2 of the Public Health Service Act.
       ``(2) Product.--The term `product' means a drug, device, or 
     biological product.
       ``(b) Extension of Expiration Date.--
       ``(1) Authority to extend expiration date.--The Secretary 
     may extend the expiration date of an eligible product in 
     accordance with this subsection.
       ``(2) Expiration date.--For purposes of this subsection, 
     the term `expiration date' means the date established through 
     appropriate stability testing required by the regulations 
     issued by the Secretary to ensure that the product meets 
     applicable standards of identity, strength, quality, and 
     purity at the time of use.
       ``(3) Effect of extension.--Notwithstanding any other 
     provision of this Act or the Public Health Service Act, if 
     the expiration date of an eligible product is extended in 
     accordance with this section, the introduction or delivery 
     for introduction into interstate commerce of such product 
     after the expiration date provided by the manufacturer and 
     within the duration of such extension shall not be deemed to 
     render the product--
       ``(A) an unapproved product; or
       ``(B) adulterated or misbranded under this Act.
       ``(4) Determinations by secretary.--Before extending the 
     expiration date of an eligible product under this subsection, 
     the Secretary shall determine--
       ``(A) that extension of the expiration date will help 
     protect public health;
       ``(B) that any extension of expiration is supported by 
     scientific evaluation that is conducted or accepted by the 
     Secretary;
       ``(C) what changes to the product labeling, if any, are 
     required or permitted, including whether and how any 
     additional labeling communicating the extension of the 
     expiration date may alter or obscure the labeling provided by 
     the manufacturer; and
       ``(D) that any other conditions that the Secretary deems 
     appropriate have been met.
       ``(5) Scope of extension.--With respect to each extension 
     of an expiration date granted under this subsection, the 
     Secretary shall determine--
       ``(A) the batch, lot, or unit to which such extension shall 
     apply;
       ``(B) the duration of such extension; and
       ``(C) any conditions to effectuate such extension that are 
     necessary and appropriate to protect public health or safety.
       ``(c) Current Good Manufacturing Practice.--
       ``(1) In general.--The Secretary may, when the 
     circumstances of a domestic, military, or public health 
     emergency or material threat described in subsection 
     (a)(1)(C) so warrant, authorize, with respect to an eligible 
     product, deviations from current good manufacturing practice 
     requirements otherwise applicable to the manufacture, 
     processing, packing, or holding of products subject to 
     regulation under this Act, including requirements under 
     section 501 or 520(f)(1) or applicable conditions prescribed 
     with respect to the eligible product by an order under 
     section 520(f)(2).
       ``(2) Effect.--Notwithstanding any other provision of this 
     Act or the Public Health Service Act, an eligible product 
     shall not be considered an unapproved product and shall not 
     be deemed adulterated or misbranded under this Act because, 
     with respect to such product, the Secretary has authorized 
     deviations from current good manufacturing practices under 
     paragraph (1).
       ``(d) Emergency Use Instructions.--
       ``(1) In general.--The Secretary, acting through an 
     appropriate official within the Department of Health and 
     Human Services, may create and issue emergency use 
     instructions to inform health care providers or individuals 
     to whom an eligible product is to be administered concerning 
     such product's approved, licensed, or cleared conditions of 
     use.
       ``(2) Effect.--Notwithstanding any other provisions of this 
     Act or the Public Health Service Act, a product shall not be 
     considered an unapproved product and shall not be deemed 
     adulterated or misbranded under this Act because of the 
     issuance of emergency use instructions under paragraph (1) 
     with respect to such product or the introduction or delivery 
     for introduction of such product into interstate commerce 
     accompanied by such instructions--
       ``(A) during an emergency response to an actual emergency 
     that is the basis for a determination described in subsection 
     (a)(1)(C)(i); or
       ``(B) by a government entity (including a Federal, State, 
     local, and tribal government entity), or a person acting on 
     behalf of such a government entity, in preparation for an 
     emergency response.''.
       (c) Risk Evaluation and Mitigation Strategies.--Section 
     505-1 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355-1), is amended--
       (1) in subsection (f), by striking paragraph (7); and
       (2) by adding at the end the following:
       ``(k) Waiver in Public Health Emergencies.--The Secretary 
     may waive any requirement of this section with respect to a 
     qualified countermeasure (as defined in section 319F-1(a)(2) 
     of the Public Health Service Act) to which a requirement 
     under this section has been applied, if the Secretary 
     determines that such waiver is required to mitigate the 
     effects of, or reduce the severity of, the circumstances 
     under which--
       ``(1) a determination described in subparagraph (A), (B), 
     or (C) of section 564(b)(1) has been made by the Secretary of 
     Homeland Security, the Secretary of Defense, or the 
     Secretary, respectively; or
       ``(2) the identification of a material threat described in 
     subparagraph (D) of section 564(b)(1) has been made pursuant 
     to section 319F-2 of the Public Health Service Act.''.
       (d) Products Held for Emergency Use.--The Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is amended by 
     inserting after section 564A, as added by subsection (b), the 
     following:

     ``SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.

       ``It is not a violation of any section of this Act or of 
     the Public Health Service Act for a government entity 
     (including a Federal, State, local, and tribal government 
     entity), or a person acting on behalf of such a government 
     entity, to introduce into interstate commerce a product (as 
     defined in section 564(a)(4)) intended for emergency use, if 
     that product--
       ``(1) is intended to be held and not used; and
       ``(2) is held and not used, unless and until that product--
       ``(A) is approved, cleared, or licensed under section 505, 
     510(k), or 515 of this Act or section 351 of the Public 
     Health Service Act;
       ``(B) is authorized for investigational use under section 
     505 or 520 of this Act or section 351 of the Public Health 
     Service Act; or
       ``(C) is authorized for use under section 564.''.

     SEC. 303. DEFINITIONS.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4) is amended by striking ``The Secretary, in 
     consultation'' and inserting the following:
       ``(a) Definitions.--In this section--
       ``(1) the term `countermeasure' means a qualified 
     countermeasure, a security countermeasure, and a qualified 
     pandemic or epidemic product;
       ``(2) the term `qualified countermeasure' has the meaning 
     given such term in section 319F-1 of the Public Health 
     Service Act;
       ``(3) the term `security countermeasure' has the meaning 
     given such term in section 319F-2 of such Act; and
       ``(4) the term `qualified pandemic or epidemic product' 
     means a product that meets the definition given such term in 
     section 319F-3 of the Public Health Service Act and--
       ``(A) that has been identified by the Department of Health 
     and Human Services or the Department of Defense as receiving 
     funding directly related to addressing chemical, biological, 
     radiological or nuclear threats, including pandemic 
     influenza; or
       ``(B) is included under this paragraph pursuant to a 
     determination by the Secretary.
       ``(b) General Duties.--The Secretary, in consultation''.

     SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVITIES.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4), as amended by section 303, is further 
     amended--
       (1) in the section heading, by striking ``TECHNICAL 
     ASSISTANCE'' and inserting ``COUNTERMEASURE DEVELOPMENT, 
     REVIEW, AND TECHNICAL ASSISTANCE'';
       (2) in subsection (b), by striking the subsection heading 
     and all that follows through ``shall establish'' and 
     inserting the following:
       ``(b) General Duties.--In order to accelerate the 
     development, stockpiling, approval, licensure, and clearance 
     of qualified countermeasures, security countermeasures, and 
     qualified pandemic or epidemic products, the Secretary, in 
     consultation with the Assistant Secretary for Preparedness 
     and Response, shall--
       ``(1) ensure the appropriate involvement of Food and Drug 
     Administration personnel in interagency activities related to 
     countermeasure advanced research and development, consistent 
     with sections 319F, 319F-1, 319F-2, 319F-3, and 319L of the 
     Public Health Service Act;
       ``(2) ensure the appropriate involvement and consultation 
     of Food and Drug Administration personnel in any flexible 
     manufacturing activities carried out under section

[[Page 3141]]

     319L of the Public Health Service Act, including with respect 
     to meeting regulatory requirements set forth in this Act;
       ``(3) promote countermeasure expertise within the Food and 
     Drug Administration by--
       ``(A) ensuring that Food and Drug Administration personnel 
     involved in reviewing countermeasures for approval, 
     licensure, or clearance are informed by the Assistant 
     Secretary for Preparedness and Response on the material 
     threat assessment conducted under section 319F-2 of the 
     Public Health Service Act for the agent or agents for which 
     the countermeasure under review is intended;
       ``(B) training Food and Drug Administration personnel 
     regarding review of countermeasures for approval, licensure, 
     or clearance;
       ``(C) holding public meetings at least twice annually to 
     encourage the exchange of scientific ideas; and
       ``(D) establishing protocols to ensure that countermeasure 
     reviewers have sufficient training or experience with 
     countermeasures;
       ``(4) maintain teams, composed of Food and Drug 
     Administration personnel with expertise on countermeasures, 
     including specific countermeasures, populations with special 
     clinical needs (including children and pregnant women that 
     may use countermeasures, as applicable and appropriate), 
     classes or groups of countermeasures, or other 
     countermeasure-related technologies and capabilities, that 
     shall--
       ``(A) consult with countermeasure experts, including 
     countermeasure sponsors and applicants, to identify and help 
     resolve scientific issues related to the approval, licensure, 
     or clearance of countermeasures, through workshops or public 
     meetings;
       ``(B) improve and advance the science relating to the 
     development of new tools, standards, and approaches to 
     assessing and evaluating countermeasures--
       ``(i) in order to inform the process for countermeasure 
     approval, clearance, and licensure; and
       ``(ii) with respect to the development of countermeasures 
     for populations with special clinical needs, including 
     children and pregnant women, in order to meet the needs of 
     such populations, as necessary and appropriate; and
       ``(5) establish''; and
       (3) by adding at the end the following:
       ``(c) Development and Animal Modeling Procedures.--
       ``(1) Availability of animal model meetings.--To facilitate 
     the timely development of animal models and support the 
     development, stockpiling, licensure, approval, and clearance 
     of countermeasures, the Secretary shall, not later than 180 
     days after the enactment of this subsection, establish a 
     procedure by which a sponsor or applicant that is developing 
     a countermeasure for which human efficacy studies are not 
     ethical or practicable, and that has an approved 
     investigational new drug application or investigational 
     device exemption, may request and receive--
       ``(A) a meeting to discuss proposed animal model 
     development activities; and
       ``(B) a meeting prior to initiating pivotal animal studies.
       ``(2) Pediatric models.--To facilitate the development and 
     selection of animal models that could translate to pediatric 
     studies, any meeting conducted under paragraph (1) shall 
     include discussion of animal models for pediatric 
     populations, as appropriate.
       ``(d) Review and Approval of Countermeasures.--
       ``(1) Material threat.--When evaluating an application or 
     submission for approval, licensure, or clearance of a 
     countermeasure, the Secretary shall take into account the 
     material threat posed by the chemical, biological, 
     radiological, or nuclear agent or agents identified under 
     section 319F-2 of the Public Health Service Act for which the 
     countermeasure under review is intended.
       ``(2) Review expertise.--When practicable and appropriate, 
     teams of Food and Drug Administration personnel reviewing 
     applications or submissions described under paragraph (1) 
     shall include a reviewer with sufficient training or 
     experience with countermeasures pursuant to the protocols 
     established under subsection (b)(3)(D).''.

     SEC. 305. REGULATORY MANAGEMENT PLANS.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4), as amended by section 304, is further 
     amended by adding at the end the following:
       ``(e) Regulatory Management Plan.--
       ``(1) Definition.--In this subsection, the term `eligible 
     countermeasure' means--
       ``(A) a security countermeasure with respect to which the 
     Secretary has entered into a procurement contract under 
     section 319F-2(c) of the Public Health Service Act; or
       ``(B) a countermeasure with respect to which the Biomedical 
     Advanced Research and Development Authority has provided 
     funding under section 319L of the Public Health Service Act 
     for advanced research and development.
       ``(2) Regulatory management plan process.--The Secretary, 
     in consultation with the Assistant Secretary for Preparedness 
     and Response and the Director of the Biomedical Advanced 
     Research and Development Authority, shall establish a formal 
     process for obtaining scientific feedback and interactions 
     regarding the development and regulatory review of eligible 
     countermeasures by facilitating the development of written 
     regulatory management plans in accordance with this 
     subsection.
       ``(3) Submission of request and proposed plan by sponsor or 
     applicant.--
       ``(A) In general.--A sponsor or applicant of an eligible 
     countermeasure may initiate the process described under 
     paragraph (2) upon submission of written request to the 
     Secretary. Such request shall include a proposed regulatory 
     management plan.
       ``(B) Timing of submission.--A sponsor or applicant may 
     submit a written request under subparagraph (A) after the 
     eligible countermeasure has an investigational new drug or 
     investigational device exemption in effect.
       ``(C) Response by secretary.--The Secretary shall direct 
     the Food and Drug Administration, upon submission of a 
     written request by a sponsor or applicant under subparagraph 
     (A), to work with the sponsor or applicant to agree on a 
     regulatory management plan within a reasonable time not to 
     exceed 90 days. If the Secretary determines that no plan can 
     be agreed upon, the Secretary shall provide to the sponsor or 
     applicant, in writing, the scientific or regulatory rationale 
     why such agreement cannot be reached.
       ``(4) Plan.--The content of a regulatory management plan 
     agreed to by the Secretary and a sponsor or applicant shall 
     include--
       ``(A) an agreement between the Secretary and the sponsor or 
     applicant regarding developmental milestones that will 
     trigger responses by the Secretary as described in 
     subparagraph (B);
       ``(B) performance targets and goals for timely and 
     appropriate responses by the Secretary to the triggers 
     described under subparagraph (A), including meetings between 
     the Secretary and the sponsor or applicant, written feedback, 
     decisions by the Secretary, and other activities carried out 
     as part of the development and review process; and
       ``(C) an agreement on how the plan shall be modified, if 
     needed.
       ``(5) Milestones and performance targets.--The 
     developmental milestones described in paragraph (4)(A) and 
     the performance targets and goals described in paragraph 
     (4)(B) shall include--
       ``(A) feedback from the Secretary regarding the data 
     required to support the approval, clearance, or licensure of 
     the eligible countermeasure involved;
       ``(B) feedback from the Secretary regarding the data 
     necessary to inform any authorization under section 564;
       ``(C) feedback from the Secretary regarding the data 
     necessary to support the positioning and delivery of the 
     eligible countermeasure, including to the Strategic National 
     Stockpile;
       ``(D) feedback from the Secretary regarding the data 
     necessary to support the submission of protocols for review 
     under section 505(b)(5)(B);
       ``(E) feedback from the Secretary regarding any gaps in 
     scientific knowledge that will need resolution prior to 
     approval, licensure, or clearance of the eligible 
     countermeasure, and plans for conducting the necessary 
     scientific research;
       ``(F) identification of the population for which the 
     countermeasure sponsor or applicant seeks approval, 
     licensure, or clearance, and the population for which desired 
     labeling would not be appropriate, if known; and
       ``(G) as necessary and appropriate, and to the extent 
     practicable, a plan for demonstrating safety and 
     effectiveness in pediatric populations, and for developing 
     pediatric dosing, formulation, and administration with 
     respect to the eligible countermeasure, provided that such 
     plan would not delay authorization under section 564, 
     approval, licensure, or clearance for adults.
       ``(6) Prioritization.--If the Commissioner of Food and 
     Drugs determines that resources are not available to 
     establish regulatory management plans under this section for 
     all eligible countermeasures for which a request is submitted 
     under paragraph (3)(A), the Director of the Biomedical 
     Advanced Research and Development Authority, in consultation 
     with the Commissioner of Food and Drugs, shall prioritize 
     which eligible countermeasures may receive regulatory 
     managements plans, and in doing so shall give priority to 
     eligible countermeasures that are security 
     countermeasures.''.

     SEC. 306. REPORT.

       Section 565 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360bbb-4), as amended by section 305, is further 
     amended by adding at the end the following:
       ``(f) Annual Report.--Not later than 180 days after the 
     date of enactment of this subsection, and annually 
     thereafter, the Secretary shall submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a report that details the countermeasure 
     development and review activities of the Food and Drug 
     Administration, including--
       ``(1) with respect to the development of new tools, 
     standards, and approaches to assess and evaluate 
     countermeasures--
       ``(A) the identification of the priorities of the Food and 
     Drug Administration and the progress made on such priorities; 
     and

[[Page 3142]]

       ``(B) the identification of scientific gaps that impede the 
     development or approval, licensure, or clearance of 
     countermeasures for populations with special clinical needs, 
     including children and pregnant women, and the progress made 
     on resolving these challenges;
       ``(2) with respect to countermeasures for which a 
     regulatory management plan has been agreed upon under 
     subsection (e), the extent to which the performance targets 
     and goals set forth in subsection (e)(4)(B) and the 
     regulatory management plan has been met, including, for each 
     such countermeasure--
       ``(A) whether the regulatory management plan was completed 
     within the required timeframe, and the length of time taken 
     to complete such plan;
       ``(B) whether the Secretary adhered to the timely and 
     appropriate response times set forth in such plan; and
       ``(C) explanations for any failure to meet such performance 
     targets and goals;
       ``(3) the number of regulatory teams established pursuant 
     to subsection (b)(4), the number of products, classes of 
     products, or technologies assigned to each such team, and the 
     number of, type of, and any progress made as a result of 
     consultations carried out under subsection (b)(4)(A);
       ``(4) an estimate of resources obligated to countermeasure 
     development and regulatory assessment, including Center 
     specific objectives and accomplishments;
       ``(5) the number of countermeasure applications submitted, 
     the number of countermeasures approved, licensed, or cleared, 
     the status of remaining submitted applications, and the 
     number of each type of authorization issued pursuant to 
     section 564; and
       ``(6) the number of written requests for a regulatory 
     management plan submitted under subsection (e)(3)(A), the 
     number of regulatory management plans developed, and the 
     number of such plans developed for security 
     countermeasures.''.

     SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES.

       (a) Pediatric Studies of Drugs.--Section 505A of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is 
     amended--
       (1) in subsection (d), by adding at the end the following:
       ``(5) Consultation.--With respect to a drug that is a 
     qualified countermeasure (as defined in section 319F-1 of the 
     Public Health Service Act), a security countermeasure (as 
     defined in section 319F-2 of the Public Health Service Act), 
     or a qualified pandemic or epidemic product (as defined in 
     section 319F-3 of the Public Health Service Act), the 
     Secretary shall solicit input from the Assistant Secretary 
     for Preparedness and Response regarding the need for and, 
     from the Director of the Biomedical Advanced Research and 
     Development Authority regarding the conduct of, pediatric 
     studies under this section.''; and
       (2) in subsection (n)(1), by adding at the end the 
     following:
       ``(C) For a drug that is a qualified countermeasure (as 
     defined in section 319F-1 of the Public Health Service Act), 
     a security countermeasure (as defined in section 319F-2 of 
     the Public Health Service Act), or a qualified pandemic or 
     epidemic product (as defined in section 319F-3 of such Act), 
     in addition to any action with respect to such drug under 
     subparagraph (A) or (B), the Secretary shall notify the 
     Assistant Secretary for Preparedness and Response and the 
     Director of the Biomedical Advanced Research and Development 
     Authority of all pediatric studies in the written request 
     issued by the Commissioner of Food and Drugs.''.
       (b) Addition to Priority List Considerations.--Section 409I 
     of the Public Health Service Act (42 U.S.C. 284m) is 
     amended--
       (1) by striking subsection (a)(2) and inserting the 
     following:
       ``(2) Consideration of available information.--In 
     developing and prioritizing the list under paragraph (1), the 
     Secretary--
       ``(A) shall consider--
       ``(i) therapeutic gaps in pediatrics that may include 
     developmental pharmacology, pharmacogenetic determinants of 
     drug response, metabolism of drugs and biologics in children, 
     and pediatric clinical trials;
       ``(ii) particular pediatric diseases, disorders or 
     conditions where more complete knowledge and testing of 
     therapeutics, including drugs and biologics, may be 
     beneficial in pediatric populations; and
       ``(iii) the adequacy of necessary infrastructure to conduct 
     pediatric pharmacological research, including research 
     networks and trained pediatric investigators; and
       ``(B) may consider the availability of qualified 
     countermeasures (as defined in section 319F-1), security 
     countermeasures (as defined in section 319F-2), and qualified 
     pandemic or epidemic products (as defined in section 319F-3) 
     to address the needs of pediatric populations, in 
     consultation with the Assistant Secretary for Preparedness 
     and Response, consistent with the purposes of this 
     section.''; and
       (2) in subsection (b), by striking ``subsection (a)'' and 
     inserting ``paragraphs (1) and (2)(A) of subsection (a)''.
       (c) Advice and Recommendations of the Pediatric Advisory 
     Committee Regarding Countermeasures for Pediatric 
     Populations.--Subsection (b)(2) of section 14 of the Best 
     Pharmaceuticals for Children Act (42 U.S.C. 284m note) is 
     amended--
       (1) in subparagraph (C), by striking the period and 
     inserting ``; and''; and
       (2) by adding at the end the following:
       ``(D) the development of countermeasures (as defined in 
     section 565(a) of the Federal Food, Drug, and Cosmetic Act) 
     for pediatric populations.''.

  TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND 
                              DEVELOPMENT

     SEC. 401. BIOSHIELD.

       (a) Reauthorization of the Special Reserve Fund.--Section 
     319F-2(c) of the Public Health Service Act (42 U.S.C. 247d-
     6b(c)) is amended by adding at the end the following:
       ``(11) Reauthorization of the special reserve fund.--In 
     addition to amounts otherwise appropriated, there are 
     authorized to be appropriated for the special reserve fund, 
     $2,800,000,000 for the fiscal years 2014 through 2018.
       ``(12) Report.--Not later than 30 days after any date on 
     which the Secretary determines that the amount of funds in 
     the special reserve fund available for procurement is less 
     than $1,500,000,000, the Secretary shall submit to the 
     appropriate committees of Congress a report detailing the 
     amount of such funds available for procurement and the impact 
     such reduction in funding will have--
       ``(A) in meeting the security countermeasure needs 
     identified under this section; and
       ``(B) on the biennial Public Health Emergency Medical 
     Countermeasures Enterprise and Strategy Implementation Plan 
     (pursuant to section 2811(d)).''.
       (b) Procurement of Countermeasures.--Section 319F-2(c) of 
     the Public Health Service Act (42 U.S.C. 247d-6b(c)) is 
     amended--
       (1) in paragraph (1)(B)(i)(III)(bb), by striking ``eight 
     years'' and inserting ``10 years'';
       (2) in paragraph (5)(B)(ii), by striking ``eight years'' 
     and inserting ``10 years'';
       (3) in paragraph (7)(C)--
       (A) in clause (i)(I), by inserting ``including advanced 
     research and development,'' after ``as may reasonably be 
     required,'';
       (B) in clause (ii)--
       (i) in subclause (III), by striking ``eight years'' and 
     inserting ``10 years''; and
       (ii) by striking subclause (IX) and inserting the 
     following:

       ``(IX) Contract terms.--The Secretary, in any contract for 
     procurement under this section--

       ``(aa) may specify--
       ``(AA) the dosing and administration requirements for the 
     countermeasure to be developed and procured;
       ``(BB) the amount of funding that will be dedicated by the 
     Secretary for advanced research, development, and procurement 
     of the countermeasure; and
       ``(CC) the specifications the countermeasure must meet to 
     qualify for procurement under a contract under this section; 
     and
       ``(bb) shall provide a clear statement of defined 
     Government purpose limited to uses related to a security 
     countermeasure, as defined in paragraph (1)(B).''; and
       (C) by adding at the end the following:
       ``(viii) Flexibility.--In carrying out this section, the 
     Secretary may, consistent with the applicable provisions of 
     this section, enter into contracts and other agreements that 
     are in the best interest of the Government in meeting 
     identified security countermeasure needs, including with 
     respect to reimbursement of the cost of advanced research and 
     development as a reasonable, allowable, and allocable direct 
     cost of the contract involved.'';
       (4) in paragraph (9)(B), by inserting before the period the 
     following: ``, except that this subparagraph shall not be 
     construed to prohibit the use of such amounts as otherwise 
     authorized in this title''; and
       (5) in paragraph (10), by adding at the end the following:
       ``(C) Advanced research and development.--For purposes of 
     this paragraph, the term `advanced research and development' 
     shall have the meaning given such term in section 319L(a).''.

     SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT 
                   AUTHORITY.

       (a) Duties.--Section 319L(c)(4) of the Public Health 
     Service Act (42 U.S.C. 247d-7e(c)(4)) is amended--
       (1) in subparagraph (B)(iii), by inserting ``(which may 
     include advanced research and development for purposes of 
     fulfilling requirements under the Federal Food, Drug, and 
     Cosmetic Act or section 351 of this Act)'' after 
     ``development''; and
       (2) in subparagraph (D)(iii), by striking ``and vaccine 
     manufacturing technologies'' and inserting ``vaccine 
     manufacturing technologies, dose sparing technologies, 
     efficacy increasing technologies, and platform 
     technologies''.
       (b) Strategic Public-private Partnership.--Section 
     319L(c)(4) of the Public Health Service Act (42 U.S.C. 247d-
     7e(c)(4)) is amended by adding at the end the following:
       ``(E) Strategic investor.--
       ``(i) In general.--To support the purposes described in 
     paragraph (2), the Secretary, acting through the Director of 
     BARDA, may enter into an agreement (including through the use 
     of grants, contracts, cooperative agreements, or other 
     transactions as described in paragraph (5)) with an 
     independent, non-profit entity to--

[[Page 3143]]

       ``(I) foster and accelerate the development and innovation 
     of medical countermeasures and technologies that may assist 
     advanced research and development of qualified 
     countermeasures and qualified pandemic or epidemic products, 
     including strategic investment through the use of venture 
     capital practices and methods;
       ``(II) promote the development of new and promising 
     technologies that address urgent medical countermeasure 
     needs, as identified by the Secretary;
       ``(III) address unmet public health needs that are directly 
     related to medical countermeasure requirements, such as novel 
     antimicrobials for multidrug resistant organisms and multiuse 
     platform technologies for diagnostics, prophylaxis, vaccines, 
     and therapeutics; and
       ``(IV) provide expert consultation and advice to foster 
     viable medical countermeasure innovators, including helping 
     qualified countermeasure innovators navigate unique industry 
     challenges with respect to developing chemical, biological, 
     radiological, and nuclear countermeasure products.

       ``(ii) Eligibility.--

       ``(I) In general.--To be eligible to enter into an 
     agreement under clause (i) an entity shall--

       ``(aa) be an independent, non-profit entity not otherwise 
     affiliated with the Department of Health and Human Services;
       ``(bb) have a demonstrated record of being able to create 
     linkages between innovators and investors and leverage such 
     partnerships and resources for the purpose of addressing 
     identified strategic needs of the Federal Government;
       ``(cc) have experience in promoting novel technology 
     innovation;
       ``(dd) be problem driven and solution focused based on the 
     needs, requirements, and problems identified by the Secretary 
     under clause (iv);
       ``(ee) demonstrate the ability, or the potential ability, 
     to promote the development of medical countermeasure 
     products; and
       ``(ff) demonstrate expertise, or the capacity to develop or 
     acquire expertise, related to technical and regulatory 
     considerations with respect to medical countermeasures.

       ``(II) Partnering experience.--In selecting an entity with 
     which to enter into an agreement under clause (i), the 
     Secretary shall place a high value on the demonstrated 
     experience of the entity in partnering with the Federal 
     Government to meet identified strategic needs.

       ``(iii) Not agency.--An entity that enters into an 
     agreement under clause (i) shall not be deemed to be a 
     Federal agency for any purpose, including for any purpose 
     under title 5, United States Code.
       ``(iv) Direction.--Pursuant to an agreement entered into 
     under this subparagraph, the Secretary, acting through the 
     Director of BARDA, shall provide direction to the entity that 
     enters into an agreement under clause (i). As part of this 
     agreement the Director of BARDA shall--

       ``(I) communicate the medical countermeasure needs, 
     requirements, and problems to be addressed by the entity 
     under the agreement;
       ``(II) develop a description of work to be performed by the 
     entity under the agreement;
       ``(III) provide technical feedback and appropriate 
     oversight over work carried out by the entity under the 
     agreement, including subsequent development and partnerships 
     consistent with the needs and requirements set forth in this 
     subparagraph;
       ``(IV) ensure fair consideration of products developed 
     under the agreement in order to maintain competition to the 
     maximum practical extent, as applicable and appropriate under 
     applicable provisions of this section; and
       ``(V) ensure, as a condition of the agreement--

       ``(aa) a comprehensive set of policies that demonstrate a 
     commitment to transparency and accountability;
       ``(bb) protection against conflicts of interest through a 
     comprehensive set of policies that address potential 
     conflicts of interest, ethics, disclosure, and reporting 
     requirements;
       ``(cc) that the entity provides monthly accounting on the 
     use of funds provided under such agreement; and
       ``(dd) that the entity provides on a quarterly basis, 
     reports regarding the progress made toward meeting the 
     identified needs set forth in the agreement.
       ``(v) Supplement not supplant.--Activities carried out 
     under this subparagraph shall supplement, and not supplant, 
     other activities carried out under this section.
       ``(vi) No establishment of entity.--To prevent unnecessary 
     duplication and target resources effectively, nothing in this 
     subparagraph shall be construed to authorize the Secretary to 
     establish within the Department of Health and Human Services 
     a strategic investor entity.
       ``(vii) Transparency and oversight.--Upon request, the 
     Secretary shall provide to Congress the information provided 
     to the Secretary under clause (iv)(V)(dd).
       ``(viii) Independent evaluation.--Not later than 4 years 
     after the date of enactment of this subparagraph, the 
     Government Accountability Office shall conduct an independent 
     evaluation, and submit to the Secretary and the appropriate 
     committees of Congress a report, concerning the activities 
     conducted under this subparagraph. Such report shall include 
     recommendations with respect to any agreement or activities 
     carried out pursuant to this subparagraph.
       ``(ix) Sunset.--This subparagraph shall have no force or 
     effect after September 30, 2016.''.
       (c) Transaction Authorities.--Section 319L(c)(5) of the 
     Public Health Service Act (42 U.S.C. 247d-7e(c)(5)) is 
     amended by adding at the end the following:
       ``(G) Government purpose.--In awarding contracts, grants, 
     and cooperative agreements under this section, the Secretary 
     shall provide a clear statement of defined Government purpose 
     related to activities included in subsection (a)(6)(B) for a 
     qualified countermeasure or qualified pandemic or epidemic 
     product.''.
       (d) Fund.--Paragraph (2) of section 319L(d) of the Public 
     Health Service Act (42 U.S.C. 247d-7e(d)(2)) is amended to 
     read as follows:
       ``(2) Funding.--To carry out the purposes of this section, 
     there is authorized to be appropriated to the Fund 
     $415,000,000 for each of fiscal years 2012 through 2016, such 
     amounts to remain available until expended.''.
       (e) Continued Inapplicability of Certain Provisions.--
     Section 319L(e)(1)(C) of the Public Health Service Act (42 
     U.S.C. 247d-7e(e)(1)(C)) is amended by striking ``7 years'' 
     and inserting ``10 years''.
       (f) Extension of Limited Antitrust Exemption.--Section 
     405(b) of the Pandemic and All-Hazards Preparedness Act (42 
     U.S.C. 247d-6a note) is amended by striking ``6-year'' and 
     inserting ``10-year''.
       (g) Independent Evaluation.--Section 319L of the Public 
     Health Service Act (42 U.S.C. 247d-7e) is amended by adding 
     at the end the following:
       ``(f) Independent Evaluation.--
       ``(1) In general.--Not later than 180 days after the date 
     of enactment of this subsection, the Government 
     Accountability Office shall conduct an independent evaluation 
     of the activities carried out to facilitate flexible 
     manufacturing capacity pursuant to this section.
       ``(2) Report.--Not later than 1 year after the date of 
     enactment of this subsection, the Government Accountability 
     Office shall submit to the appropriate committees of Congress 
     a report concerning the results of the evaluation conducted 
     under paragraph (1). Such report shall review and assess--
       ``(A) the extent to which flexible manufacturing capacity 
     under this section is dedicated to chemical, biological, 
     radiological, and nuclear threats;
       ``(B) the activities supported by flexible manufacturing 
     initiatives; and
       ``(C) the ability of flexible manufacturing activities 
     carried out under this section to--
       ``(i) secure and leverage leading technical expertise with 
     respect to countermeasure advanced research, development, and 
     manufacturing processes; and
       ``(ii) meet the surge manufacturing capacity needs 
     presented by novel and emerging threats, including chemical, 
     biological, radiological and nuclear agents.''.
       (h) Definitions.--
       (1) Qualified countermeasure.--Section 319F-1(a)(2)(A) of 
     the Public Health Service Act (42 U.S.C. 247d-6a(a)(2)(A)) is 
     amended--
       (A) in the matter preceding clause (i), by striking ``to--
     '' and inserting ``--'';
       (B) in clause (i)--
       (i) by striking ``diagnose'' and inserting ``to diagnose''; 
     and
       (ii) by striking ``; or'' and inserting a semicolon;
       (C) in clause (ii)--
       (i) by striking ``diagnose'' and inserting ``to diagnose''; 
     and
       (ii) by striking the period at the end and inserting ``; 
     or''; and
       (D) by adding at the end the following:
       ``(iii) is a product or technology intended to enhance the 
     use or effect of a drug, biological product, or device 
     described in clause (i) or (ii).''.
       (2) Qualified pandemic or epidemic product.--Section 319F-
     3(i)(7)(A) of the Public Health Service Act (42 U.S.C. 247d-
     6d(i)(7)(A)) is amended--
       (A) in clause (i)(II), by striking ``; or'' and inserting 
     ``;'';
       (B) in clause (ii), by striking ``; and'' and inserting ``; 
     or''; and
       (C) by adding at the end the following:
       ``(iii) a product or technology intended to enhance the use 
     or effect of a drug, biological product, or device described 
     in clause (i) or (ii); and''.
       (3) Technical amendments.--Section 319F-3(i) of the Public 
     Health Service Act (42 U.S.C. 247d-6d(i)) is amended--
       (A) in paragraph (1)(C), by inserting ``, 564A, or 564B'' 
     after ``564''; and
       (B) in paragraph (7)(B)(iii), by inserting ``, 564A, or 
     564B'' after ``564''.

     SEC. 403. STRATEGIC NATIONAL STOCKPILE.

       (a) In General.--Section 319F-2 of the Public Health 
     Service Act (42 U.S.C. 247d-6b) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1)--
       (i) by inserting ``consistent with section 2811'' before 
     ``by the Secretary to be appropriate''; and

[[Page 3144]]

       (ii) by inserting before the period at the end the 
     following: ``and shall submit such review annually to the 
     appropriate Congressional committees of jurisdiction to the 
     extent that disclosure of such information does not 
     compromise national security''; and
       (B) in paragraph (2)--
       (i) by redesignating subparagraphs (E) through (H) as 
     subparagraphs (F) through (I), respectively; and
       (ii) by inserting after subparagraph (D), the following:
       ``(E) identify and address the potential depletion and 
     ensure appropriate replenishment of medical countermeasures, 
     including those currently in the stockpile;''; and
       (2) in subsection (f)(1), by striking ``$640,000,000 for 
     fiscal year 2002, and such sums as may be necessary for each 
     of fiscal years 2003 through 2006'' and inserting 
     ``$522,486,000 for each of fiscal years 2012 through 2016''.
       (b) Report on Potassium Iodide.--Not later than 270 days 
     after the date of enactment of this Act, the Secretary of 
     Health and Human Services shall submit to the appropriate 
     Committees of Congress a report regarding the stockpiling of 
     potassium iodide. Such report shall include--
       (1) an assessment of the availability of potassium iodide 
     at Federal, State, and local levels; and
       (2) a description of the extent to which such activities 
     and policies provide public health protection in the event of 
     a nuclear incident, whether unintentional or deliberate, 
     including an act of terrorism.

     SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD.

       Section 319M(a) of the Public Health Service Act (42 U.S.C. 
     247d-f(a)) is amended--
       (1) in paragraph (2)--
       (A) in subparagraph (D)--
       (i) in the matter preceding clause (i), by striking 
     ``five'' and inserting ``six'';
       (ii) in clause (i), by striking ``and'' at the end;
       (iii) in clause (ii), by striking the period and inserting 
     a semicolon; and
       (iv) by adding at the end the following:
       ``(iii) one such member shall be an individual with 
     pediatric subject matter expertise; and
       ``(iv) one such member shall be a State, tribal, 
     territorial, or local public health official.''; and
       (B) by adding at the end the following flush sentence:

     ``Nothing in this paragraph shall preclude a member of the 
     Board from satisfying two or more of the requirements 
     described in subparagraph (D).'';
       (2) in paragraph (5)--
       (A) in subparagraph (B), by striking ``and'' at the end;
       (B) in subparagraph (C), by striking the period and 
     inserting ``; and''; and
       (C) by adding at the end the following:
       ``(D) provide any recommendation, finding, or report 
     provided to the Secretary under this paragraph to the 
     appropriate committees of Congress.''; and
       (3) in paragraph (8), by adding at the end the following: 
     ``Such chairperson shall serve as the deciding vote in the 
     event that a deciding vote is necessary with respect to 
     voting by members of the Board.''.

                          ____________________