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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1855 Reported in Senate (RS)]

                                                       Calendar No. 263
112th CONGRESS
  1st Session
                                S. 1855

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

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           November 10, 2011

 Mr. Burr (for himself, Mr. Harkin, Mr. Enzi, Mr. Casey, Ms. Mikulski, 
Mr. Alexander, Mr. Lieberman, Ms. Collins, Mrs. Hagan, Mr. Roberts, and 
  Mr. Bennet) introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

                           December 16, 2011

               Reported by Mr. Harkin, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL

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

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

<DELETED>SECTION 1. SHORT TITLE; TABLE OF CONTENTS.</DELETED>

<DELETED>    (a) Short Title.--This Act may be cited as the ``Pandemic 
and All-Hazards Preparedness Act Reauthorization of 2011''.</DELETED>
<DELETED>    (b) Table of Contents.--The table of contents of this Act 
is as follows:</DELETED>

<DELETED>Sec. 1. Short title; table of contents.
<DELETED>TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR 
                       PUBLIC HEALTH EMERGENCIES

<DELETED>Sec. 101. National Health Security Strategy.
<DELETED>Sec. 102. Assistant Secretary for Preparedness and Response.
<DELETED>Sec. 103. Modernization of the National Disaster Medical 
                            System.
<DELETED>Sec. 104. Continuing the role of the Department of Veterans 
                            Affairs.
<DELETED>TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS 
                              AND RESPONSE

<DELETED>Sec. 201. Improving State and local public health security.
<DELETED>Sec. 202. Hospital preparedness and medical surge capacity.
<DELETED>Sec. 203. Enhancing situational awareness and biosurveillance.
      <DELETED>TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW

<DELETED>Sec. 301. Special protocol assessment.
<DELETED>Sec. 302. Authorized use for medical products.
<DELETED>Sec. 303. Definitions.
<DELETED>Sec. 304. Enhancing medical countermeasure activities.
<DELETED>Sec. 305. Regulatory management plans.
<DELETED>Sec. 306. Report.
<DELETED>Sec. 307. Pediatric medical countermeasures.
<DELETED>Sec. 308. Technical and conforming amendments.
    <DELETED>TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED 
                        RESEARCH AND DEVELOPMENT

<DELETED>Sec. 401. BioShield.
<DELETED>Sec. 402. Biomedical Advanced Research and Development 
                            Authority.
<DELETED>Sec. 403. Strategic National Stockpile.
<DELETED>Sec. 404. National Biodefense Science Board.

<DELETED>TITLE I--STRENGTHENING NATIONAL PREPAREDNESS AND RESPONSE FOR 
                  PUBLIC HEALTH EMERGENCIES</DELETED>

<DELETED>SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.</DELETED>

<DELETED>    (a) In General.--Section 2802 of the Public Health Service 
Act (42 U.S.C. 300hh-1) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)(1), by striking ``2009'' and 
        inserting ``2014''; and</DELETED>
        <DELETED>    (2) in subsection (b)--</DELETED>
                <DELETED>    (A) in paragraph (3)--</DELETED>
                        <DELETED>    (i) in the matter preceding 
                        subparagraph (A), by inserting ``and which may 
                        include dental health facilities'' after 
                        ``mental health facilities''; and</DELETED>
                        <DELETED>    (ii) in subparagraph (D), by 
                        inserting ``(which may include such dental 
                        health assets)'' after ``medical 
                        assets'';</DELETED>
                <DELETED>    (B) in paragraph (4)--</DELETED>
                        <DELETED>    (i) in subparagraph (A), by 
                        inserting ``, including the unique needs and 
                        considerations of individuals with 
                        disabilities,'' after ``medical needs of at-
                        risk individuals''; and</DELETED>
                        <DELETED>    (ii) in subparagraph (B), by 
                        inserting ``the'' before ``purpose of this 
                        section''; and</DELETED>
                <DELETED>    (C) by adding at the end the 
                following:</DELETED>
        <DELETED>    ``(7) Countermeasures.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(8) Medical and public health community 
        resiliency.--Strengthening the ability of State and local 
        communities to prepare for, respond to, and ensure resiliency 
        in the event of public health emergencies, whether naturally 
        occurring, unintentional, or deliberate by--</DELETED>
                <DELETED>    ``(A) optimizing alignment and integration 
                of medical and public health preparedness and response 
                planning and capabilities with and into routine daily 
                activities; and</DELETED>
                <DELETED>    ``(B) promoting familiarity with local 
                medical and public health systems.''.</DELETED>
<DELETED>    (b) At-Risk Individuals.--Section 2814 of the Public 
Health Service Act (42 U.S.C. 300hh-16) is amended--</DELETED>
        <DELETED>    (1) by striking paragraph (7);</DELETED>
        <DELETED>    (2) by redesignating paragraphs (1) through (6) 
        and (8) as paragraphs (2) through (7) and (10), 
        respectively;</DELETED>
        <DELETED>    (3) by inserting before paragraph (2) (as so 
        redesignated), the following:</DELETED>
        <DELETED>    ``(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;''; 
        and</DELETED>
        <DELETED>    (4) by inserting after paragraph (7) (as so 
        redesignated), the following:</DELETED>
        <DELETED>    ``(8) 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;</DELETED>
        <DELETED>    ``(9) 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; 
        and''.</DELETED>

<DELETED>SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND 
              RESPONSE.</DELETED>

<DELETED>    Section 2811 of the Public Health Service Act (42 U.S.C. 
300hh-10) is amended--</DELETED>
        <DELETED>    (1) in subsection (b)(4), by adding at the end the 
        following:</DELETED>
                <DELETED>    ``(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.'';</DELETED>
        <DELETED>    (2) by striking subsection (c) and inserting the 
        following:</DELETED>
<DELETED>    ``(c) Functions.--The Assistant Secretary for Preparedness 
and Response shall--</DELETED>
        <DELETED>    ``(1) have authority over and responsibility for--
        </DELETED>
                <DELETED>    ``(A) the National Disaster Medical System 
                (in accordance with section 301 of the Pandemic and 
                All-Hazards Preparedness Act);</DELETED>
                <DELETED>    ``(B) the Hospital Preparedness 
                Cooperative Agreement Program pursuant to section 319C-
                2;</DELETED>
                <DELETED>    ``(C) the Medical Reserve Corps pursuant 
                to section 2813;</DELETED>
                <DELETED>    ``(D) the Emergency System for Advance 
                Registration of Volunteer Health Professionals pursuant 
                to section 319I; and</DELETED>
                <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(2) exercise the responsibilities and 
        authorities of the Secretary with respect to the coordination 
        of--</DELETED>
                <DELETED>    ``(A) the Public Health Emergency 
                Preparedness Cooperative Agreement Program pursuant to 
                section 319C-1;</DELETED>
                <DELETED>    ``(B) the Strategic National Stockpile; 
                and</DELETED>
                <DELETED>    ``(C) the Cities Readiness 
                Initiative;</DELETED>
        <DELETED>    ``(3) align and coordinate medical and public 
        health preparedness and response grants and cooperative 
        agreements 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--</DELETED>
                <DELETED>    ``(A) optimize and streamline medical and 
                public health preparedness capabilities and the ability 
                of local communities to respond to public health 
                emergencies;</DELETED>
                <DELETED>    ``(B) minimize duplication of efforts with 
                regard to medical and public health preparedness and 
                response programs; and</DELETED>
                <DELETED>    ``(C) gather and disseminate best 
                practices among grant and cooperative agreement 
                recipients, as appropriate;</DELETED>
        <DELETED>    ``(4) carry out drills and operational exercises, 
        in coordination with the Department of Homeland Security, the 
        Department of Defense, 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--</DELETED>
                <DELETED>    ``(A) identified threats for which 
                countermeasures are available and for which no 
                countermeasures are available; and</DELETED>
                <DELETED>    ``(B) unknown threats for which no 
                countermeasures are available; and</DELETED>
        <DELETED>    ``(5) assume other duties as determined 
        appropriate by the Secretary.''; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(e) Public Health Emergency Medical Countermeasures 
Enterprise Strategy and Implementation Plan.--</DELETED>
        <DELETED>    ``(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 coordination 
        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'.</DELETED>
        <DELETED>    ``(2) Requirements.--The plan under paragraph (1) 
        shall--</DELETED>
                <DELETED>    ``(A) consider and reflect the full 
                spectrum of medical countermeasure-related activities, 
                including research, advanced research, development, 
                procurement, stockpiling, deployment, and 
                distribution;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(D) be informed by the recommendations 
                of the National Biodefense Science Board pursuant to 
                section 319M;</DELETED>
                <DELETED>    ``(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));</DELETED>
                <DELETED>    ``(F) identify progress made in meeting 
                the goals, benchmarks, and milestones identified under 
                subparagraph (C) in plans submitted subsequent to the 
                initial plan; and</DELETED>
                <DELETED>    ``(G) be made publically 
                available.</DELETED>
        <DELETED>    ``(3) GAO report.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(B) Content.--The report described in 
                subparagraph (A) shall review and assess--</DELETED>
                        <DELETED>    ``(i) the near-term, mid-term, and 
                        long-term medical countermeasure needs and 
                        identified priorities of the Federal Government 
                        pursuant to paragraph (2)(B);</DELETED>
                        <DELETED>    ``(ii) the activities of the 
                        Department of Health and Human Services with 
                        respect to advanced research and development 
                        pursuant to section 319L; and</DELETED>
                        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) include consideration of the entire medical 
        countermeasures enterprise, including--</DELETED>
                <DELETED>    ``(A) basic research, advanced research 
                and development;</DELETED>
                <DELETED>    ``(B) approval, clearance, licensure, and 
                authorized uses of products; and</DELETED>
                <DELETED>    ``(C) procurement, stockpiling, 
                maintenance, and replenishment of all products in the 
                Strategic National Stockpile;</DELETED>
        <DELETED>    ``(2) include measurable outputs and outcomes to 
        allow for the tracking of the progress made toward identified 
        goals;</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(4) be made available to the appropriate 
        committees of Congress upon request.</DELETED>
<DELETED>    ``(g) Interagency Coordination Plan.--Not later than one 
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--</DELETED>
        <DELETED>    ``(1) the research, advanced research, 
        development, procurement, stockpiling, and distribution of 
        countermeasures to meet identified needs; and</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 103. MODERNIZATION OF THE NATIONAL DISASTER MEDICAL 
              SYSTEM.</DELETED>

<DELETED>    Section 2812 of the Public Health Service Act (42 U.S.C. 
300hh-11) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)(3), by adding at the end the 
        following:</DELETED>
                <DELETED>    (A) in subparagraph (A), in clause (i) by 
                inserting ``, including at-risk individuals as 
                applicable'' after ``victims of a public health 
                emergency'';</DELETED>
                <DELETED>    (B) by redesignating subparagraph (C) as 
                subparagraph (E); and</DELETED>
                <DELETED>    (C) by inserting after subparagraph (B), 
                the following:</DELETED>
                <DELETED>    ``(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.''.</DELETED>
                <DELETED>    ``(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</DELETED>
        <DELETED>    (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''.</DELETED>

<DELETED>SEC. 104. CONTINUING THE ROLE OF THE DEPARTMENT OF VETERANS 
              AFFAIRS.</DELETED>

<DELETED>    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''.</DELETED>

<DELETED>TITLE II--OPTIMIZING STATE AND LOCAL ALL-HAZARDS PREPAREDNESS 
                         AND RESPONSE</DELETED>

<DELETED>SEC. 201. IMPROVING STATE AND LOCAL PUBLIC HEALTH 
              SECURITY.</DELETED>

<DELETED>    (a) Cooperative Agreements.--Section 319C-1 of the Public 
Health Service Act (42 U.S.C. 247d-3a) is amended--</DELETED>
        <DELETED>    (1) in subsection (b)(2)--</DELETED>
                <DELETED>    (A) in subparagraph (A)--</DELETED>
                        <DELETED>    (i) by striking clauses (i) and 
                        (ii) and inserting the following:</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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);'';</DELETED>
                        <DELETED>    (ii) in clause (iv), by striking 
                        ``and'' at the end;</DELETED>
                        <DELETED>    (iii) in clause (v), by adding 
                        ``and'' after the semicolon; and</DELETED>
                        <DELETED>    (iv) by adding at the end the 
                        following:</DELETED>
                        <DELETED>    ``(vi) a description of how, as 
                        appropriate, the entity may partner with 
                        relevant public and private stakeholders in 
                        public health emergency preparedness and 
                        response''; and</DELETED>
                <DELETED>    (B) in subparagraph (C), by inserting ``, 
                including addressing the needs of at-risk 
                individuals,'' after ``capabilities of such 
                entity'';</DELETED>
        <DELETED>    (2) in subsection (g)--</DELETED>
                <DELETED>    (A) in paragraph (1), by striking 
                subparagraph (A) and inserting the following:</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    (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).''; and</DELETED>
        <DELETED>    (3) in subsection (i)--</DELETED>
                <DELETED>    (A) in paragraph (1)(A)--</DELETED>
                        <DELETED>    (i) by striking ``$824,000,000 for 
                        fiscal year 2007'' and inserting ``$632,900,000 
                        for fiscal year 2012''; and</DELETED>
                        <DELETED>    (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</DELETED>
                <DELETED>    (B) by adding at the end the 
                following:</DELETED>
        <DELETED>    ``(7) Availability of cooperative agreement 
        funds.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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).''.</DELETED>
<DELETED>    (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''.</DELETED>

<DELETED>SEC. 202. HOSPITAL PREPAREDNESS AND MEDICAL SURGE 
              CAPACITY.</DELETED>

<DELETED>    (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''.</DELETED>
<DELETED>    (b) Encouraging Health Professional Volunteers.--
</DELETED>
        <DELETED>    (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''.</DELETED>
        <DELETED>    (2) Volunteers.--Section 2813 of the Public Health 
        Service Act (42 U.S.C. 300hh-15) is amended--</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (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''.</DELETED>
<DELETED>    (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--</DELETED>
        <DELETED>    (1) by striking subsection (c) and inserting the 
        following:</DELETED>
<DELETED>    ``(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.'';</DELETED>
        <DELETED>    (2) by striking subsection (g) and inserting the 
        following:</DELETED>
<DELETED>    ``(g) Coordination.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    (3) in subsection (j)--</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (B) by adding at the end the 
                following:</DELETED>
        <DELETED>    ``(4) Availability of cooperative agreement 
        funds.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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).''.</DELETED>

<DELETED>SEC. 203. ENHANCING SITUATIONAL AWARENESS AND 
              BIOSURVEILLANCE.</DELETED>

<DELETED>    Section 319D of the Public Health Service Act (42 U.S.C. 
247d-4) is amended--</DELETED>
        <DELETED>    (1) in subsection (b)--</DELETED>
                <DELETED>    (A) in paragraph (1)(B), by inserting 
                ``poison control centers,'' after 
                ``hospitals,'';</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (C) in paragraph (3), by inserting before 
                the period the following: ``and update such standards 
                as necessary'';</DELETED>
        <DELETED>    (2) in subsection (d)--</DELETED>
                <DELETED>    (A) in the subsection heading, by striking 
                ``Public Health Situational Awareness'' and inserting 
                ``Modernizing Public Health Situational Awareness and 
                BioSurveillance'';</DELETED>
                <DELETED>    (B) in paragraph (1)--</DELETED>
                        <DELETED>    (i) by striking ``Pandemic and 
                        All-Hazards Preparedness Act'' and inserting 
                        ``Pandemic and All-Hazards Preparedness Act 
                        Reauthorization of 2011''; and</DELETED>
                        <DELETED>    (ii) by inserting ``, novel 
                        emerging threats,'' after ``disease 
                        outbreaks'';</DELETED>
                <DELETED>    (C) by striking paragraph (2) and 
                inserting the following:</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) develop, implement, and evaluate the 
                network described in paragraph (1), utilizing the 
                elements described in paragraph (3); and</DELETED>
                <DELETED>    ``(B) modernize and enhance 
                biosurveillance activities.'';</DELETED>
                <DELETED>    (D) in paragraph (5), by striking 
                subparagraph (A) and inserting the following:</DELETED>
                <DELETED>    ``(A) utilize applicable interoperability 
                standards as determined by the Secretary, and in 
                coordination with the Office of the National 
                Coordinator for Health Information Technology, through 
                a joint public and private sector process;''; 
                and</DELETED>
                <DELETED>    (E) by adding at the end the 
                following:</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(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; 
                and</DELETED>
                <DELETED>    ``(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.'';</DELETED>
        <DELETED>    (3) in subsection (e)(5), by striking ``4 years 
        after the date of enactment of the Pandemic and All-Hazards 
        Preparedness Act, the Government Accountability Office'' and 
        inserting ``3 years after the date of enactment of the Pandemic 
        and All-Hazards Preparedness Act Reauthorization of 
        2011'';</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (5) by adding at the end the following:</DELETED>
<DELETED>    ``(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 of such health 
threats, early detection of health events, and overall situational 
awareness of disease activity.''.</DELETED>

 <DELETED>TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW</DELETED>

<DELETED>SEC. 301. SPECIAL PROTOCOL ASSESSMENT.</DELETED>

<DELETED>    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--</DELETED>
        <DELETED>    ``(i)(I) of clinical trials intended to form the 
        primary basis of an effectiveness claim; or</DELETED>
        <DELETED>    ``(II) in the case where human efficacy studies 
        are not ethical or practicable, of animal and clinical trials 
        which, in combination, are intended to form the primary basis 
        of an effectiveness claim; or</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>The sponsor or applicant''.</DELETED>

<DELETED>SEC. 302. AUTHORIZED USE FOR MEDICAL PRODUCTS.</DELETED>

<DELETED>    Section 564 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb-3) is amended--</DELETED>
        <DELETED>    (1) in the section heading, by striking ``for use 
        in emergencies'' and inserting ``for use in response to 
        declared emergency or identified material threat'';</DELETED>
        <DELETED>    (2) in subsection (a)--</DELETED>
                <DELETED>    (A) in paragraph (1)--</DELETED>
                        <DELETED>    (i) in the paragraph heading, by 
                        striking ``Emergency'' and inserting 
                        ``Authorized''; and</DELETED>
                        <DELETED>    (ii) by striking ``(referred to in 
                        this section as an `emergency use')'' and 
                        inserting ``or with respect to a material 
                        threat (referred to in this section as an 
                        `authorized use')'';</DELETED>
                <DELETED>    (B) in paragraph (2), by striking ``an 
                emergency use'' and inserting ``the use'';</DELETED>
                <DELETED>    (C) in paragraph (3), by striking ``An 
                emergency use authorized'' and inserting ``An 
                authorized use'';</DELETED>
                <DELETED>    (D) by redesignating paragraph (4) as 
                paragraph (5);</DELETED>
                <DELETED>    (E) by inserting after paragraph (3) the 
                following:</DELETED>
        <DELETED>    ``(4) Extension of expiration date.--</DELETED>
                <DELETED>    ``(A) Authority to extend expiration 
                date.--The Secretary may extend the expiration date of 
                an approved product in accordance with this 
                paragraph.</DELETED>
                <DELETED>    ``(B) Expiration date.--For purposes of 
                this paragraph, the term `expiration date' means the 
                date that appears on the label of an approved product 
                to reflect the results of stability testing and to 
                ensure that the product meets applicable standards of 
                identity, strength, quality, and purity at the time of 
                use.</DELETED>
                <DELETED>    ``(C) Effect of extension.--If the 
                expiration date of an approved product is extended by 
                the Secretary under this paragraph, then, 
                notwithstanding any other provision of this Act, the 
                extended expiration date shall not affect the approval 
                status of the product or the authorization of the 
                product under this section.</DELETED>
                <DELETED>    ``(D) Eligibility.--A product shall be 
                eligible for extension of the expiration date of such 
                product if--</DELETED>
                        <DELETED>    ``(i)(I) the product 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</DELETED>
                        <DELETED>    ``(II) the product is intended for 
                        use to prevent, diagnose, or treat a serious or 
                        life-threatening disease or condition caused by 
                        a product described in subclause (I); 
                        and</DELETED>
                        <DELETED>    ``(ii) the product is intended for 
                        use during the circumstances of an emergency or 
                        a material threat described in subsection 
                        (b)(1).</DELETED>
                <DELETED>    ``(E) Determinations by secretary.--Before 
                extending the expiration date of an approved product 
                under this paragraph, the Secretary shall determine--
                </DELETED>
                        <DELETED>    ``(i) that extension of the 
                        expiration date will help protect public 
                        health;</DELETED>
                        <DELETED>    ``(ii) that any extension of 
                        expiration is supported by scientific 
                        evaluation; and</DELETED>
                        <DELETED>    ``(iii) 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.</DELETED>
                <DELETED>    ``(F) Scope of extension.--With respect to 
                each extension of an expiration date granted under this 
                paragraph, the Secretary shall determine--</DELETED>
                        <DELETED>    ``(i) the batch, lot, or unit to 
                        which such extension shall apply;</DELETED>
                        <DELETED>    ``(ii) the duration of such 
                        extension; and</DELETED>
                        <DELETED>    ``(iii) any conditions to 
                        effectuate such extension that are necessary 
                        and appropriate to protect public health or 
                        safety.''; and</DELETED>
                <DELETED>    (F) in paragraph (5)(B), as so 
                redesignated, by striking ``emergency use'' and 
                inserting ``authorized use'';</DELETED>
        <DELETED>    (3) in subsection (b)--</DELETED>
                <DELETED>    (A) in the subsection heading, by striking 
                ``Emergency'' and inserting ``Emergency or Threat 
                Justifying Authorized Use'';</DELETED>
                <DELETED>    (B) in paragraph (1)--</DELETED>
                        <DELETED>    (i) in the matter preceding 
                        subparagraph (A), by striking ``may declare an 
                        emergency'' and inserting ``may make a 
                        declaration that the circumstances 
                        exist'';</DELETED>
                        <DELETED>    (ii) in subparagraph (B), by 
                        striking ``; or'' and inserting a 
                        semicolon;</DELETED>
                        <DELETED>    (iii) in subparagraph (C), by 
                        striking ``national security'' and all that 
                        follows through the period and inserting 
                        ``national security, or the health and security 
                        of United States citizens living abroad, and 
                        that involves a specified biological, chemical, 
                        radiological, or nuclear agent or agents, or a 
                        specified disease or condition that may be 
                        attributable to such agent or agents; or''; 
                        and</DELETED>
                        <DELETED>    (iv) by adding at the end the 
                        following:</DELETED>
                <DELETED>    ``(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.'';</DELETED>
                <DELETED>    (C) in paragraph (2)(A)--</DELETED>
                        <DELETED>    (i) in clause (i), by striking ``; 
                        or'' and inserting a semicolon;</DELETED>
                        <DELETED>    (ii) by redesignating clause (ii) 
                        as clause (iii); and</DELETED>
                        <DELETED>    (iii) by inserting after clause 
                        (i) the following:</DELETED>
                        <DELETED>    ``(ii) a change in the regulatory 
                        status of the product such that the 
                        circumstances described in subsection (a)(2) 
                        have ceased to exist; or''; and</DELETED>
                <DELETED>    (D) in paragraph (3)(B), by striking 
                ``emergency use'' and inserting ``authorized 
                use'';</DELETED>
        <DELETED>    (4) in subsection (c)--</DELETED>
                <DELETED>    (A) in the matter preceding paragraph 
                (1)--</DELETED>
                        <DELETED>    (i) by striking ``emergency use'' 
                        and inserting ``authorized use'';</DELETED>
                        <DELETED>    (ii) by inserting ``the Assistant 
                        Secretary for Preparedness and Response,'' 
                        after ``consultation with'';</DELETED>
                        <DELETED>    (iii) by striking ``Health and'' 
                        and inserting ``Health, and''; and</DELETED>
                        <DELETED>    (iv) by striking ``circumstances 
                        of the emergency involved'' and inserting 
                        ``applicable circumstances described in 
                        subsection (b)(1)''; and</DELETED>
                <DELETED>    (B) in paragraph (2)--</DELETED>
                        <DELETED>    (i) in the matter preceding 
                        subparagraph (A), by inserting ``and the 
                        material threat posed by the agent or agents 
                        identified in a declaration under subsection 
                        (b)(1)(D), if applicable'' after ``if 
                        available,''; and</DELETED>
                        <DELETED>    (ii) in subparagraph (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,'';</DELETED>
        <DELETED>    (5) in subsection (e)(1)--</DELETED>
                <DELETED>    (A) in subparagraph (A), in the matter 
                preceding clause (i)--</DELETED>
                        <DELETED>    (i) by striking ``emergency use'' 
                        and inserting ``authorized use''; and</DELETED>
                        <DELETED>    (ii) by striking ``circumstances 
                        of the emergency'' and inserting ``applicable 
                        circumstances described in subsection 
                        (b)(1)'';</DELETED>
                <DELETED>    (B) in subparagraph (A)(i)--</DELETED>
                        <DELETED>    (i) in subclause (I), by striking 
                        ``has authorized the emergency use'' and 
                        inserting ``has authorized under this section 
                        the use''; and</DELETED>
                        <DELETED>    (ii) in subclause (II), by 
                        striking ``emergency use'' and inserting 
                        ``authorized use'';</DELETED>
                <DELETED>    (C) in subparagraph (A)(ii)(I), by 
                striking ``authorized the emergency use'' and inserting 
                ``has authorized under this section the 
                use'';</DELETED>
                <DELETED>    (D) in clauses (iii) and (iv) of 
                subparagraph (A), by striking ``emergency use'' each 
                place such term appears and inserting ``authorized 
                use'';</DELETED>
                <DELETED>    (E) in subparagraph (A), by adding at the 
                end the following:</DELETED>
                        <DELETED>    ``(v) Appropriate conditions with 
                        respect to the collection and analysis of 
                        safety and effectiveness information useful to 
                        inform the approval, licensure, or clearance of 
                        the product, especially for a product for which 
                        human efficacy studies are not ethical or 
                        practicable.'';</DELETED>
                <DELETED>    (F) in subparagraph (B)--</DELETED>
                        <DELETED>    (i) by striking ``emergency use'' 
                        each place such term appears and inserting 
                        ``authorized use'';</DELETED>
                        <DELETED>    (ii) by striking clause (iii); 
                        and</DELETED>
                        <DELETED>    (iii) by redesignating clause (iv) 
                        as clause (iii);</DELETED>
        <DELETED>    (6) in subsection (e)--</DELETED>
                <DELETED>    (A) in paragraph (2)--</DELETED>
                        <DELETED>    (i) by striking ``emergency use'' 
                        each place such term appears and inserting 
                        ``authorized use''; and</DELETED>
                        <DELETED>    (ii) in subparagraph (A), by 
                        striking ``circumstances of the emergency'' and 
                        inserting ``applicable circumstances described 
                        in subsection (b)(1)'';</DELETED>
                <DELETED>    (B) in paragraph (3)--</DELETED>
                        <DELETED>    (i) by striking ``emergency use'' 
                        and inserting ``use''; and</DELETED>
                        <DELETED>    (ii) by striking ``circumstances 
                        of the emergency'' and inserting ``applicable 
                        circumstances described in subsection (b)(1)''; 
                        and</DELETED>
                <DELETED>    (C) in paragraph (4), by striking 
                ``emergency use'' and inserting ``use'';</DELETED>
        <DELETED>    (7) in subsection (g)--</DELETED>
                <DELETED>    (A) in the subsection heading, by 
                inserting ``Review and'' before 
                ``Revocation'';</DELETED>
                <DELETED>    (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--</DELETED>
                <DELETED>    ``(A) an unapproved product for which an 
                authorization was issued under this section; 
                or</DELETED>
                <DELETED>    ``(B) an unapproved use of an approved 
                product for which an authorization was issued under 
                this section.''; and</DELETED>
                <DELETED>    (C) by amending paragraph (2) to read as 
                follows:</DELETED>
        <DELETED>    ``(2) Revision and revocation.--The Secretary may 
        revise or revoke an authorization under this section if--
        </DELETED>
                <DELETED>    ``(A) the circumstances described under 
                subsection (b)(1) no longer exist;</DELETED>
                <DELETED>    ``(B) the criteria under subsection (c) 
                for issuance of such authorization are no longer met; 
                or</DELETED>
                <DELETED>    ``(C) other circumstances make such 
                revision or revocation appropriate to protect the 
                public health or safety.''; and</DELETED>
        <DELETED>    (8) in subsection (h)(1), by inserting ``, 
        revision,'' after ``termination''.</DELETED>

<DELETED>SEC. 303. DEFINITIONS.</DELETED>

<DELETED>    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:</DELETED>
<DELETED>    ``(a) Definitions.--In this section--</DELETED>
        <DELETED>    ``(1) the term `countermeasure' means a qualified 
        countermeasure, a security countermeasure, and a qualified 
        pandemic or epidemic product;</DELETED>
        <DELETED>    ``(2) the term `qualified countermeasure' has the 
        meaning given such term in section 319F-1 of the Public Health 
        Service Act;</DELETED>
        <DELETED>    ``(3) the term `qualified pandemic or epidemic 
        product' has the meaning given such term in section 319F-3 of 
        such Act; and</DELETED>
        <DELETED>    ``(4) the term `security countermeasure' has the 
        meaning given such term in section 319F-2 of such 
        Act.</DELETED>
<DELETED>    ``(b) General Duties.--The Secretary, in 
consultation''.</DELETED>

<DELETED>SEC. 304. ENHANCING MEDICAL COUNTERMEASURE 
              ACTIVITIES.</DELETED>

<DELETED>    Section 565 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360bbb-4), as amended by section 303, is further amended--
</DELETED>
        <DELETED>    (1) in the section heading, by striking 
        ``technical assistance'' and inserting ``countermeasure 
        development, review, and technical assistance'';</DELETED>
        <DELETED>    (2) in subsection (b), by striking the subsection 
        heading and all that follows through ``shall establish'' and 
        inserting the following:</DELETED>
<DELETED>    ``(b) General Duties.--The Secretary, in consultation with 
the Assistant Secretary for Preparedness and Response, shall accelerate 
the development, stockpiling, approval, licensure, and clearance of 
qualified countermeasures, security countermeasures, and qualified 
pandemic or epidemic products--</DELETED>
        <DELETED>    ``(1) by ensuring 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;</DELETED>
        <DELETED>    ``(2) by ensuring 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;</DELETED>
        <DELETED>    ``(3) by promoting countermeasure expertise within 
        the Food and Drug Administration by--</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(B) training Food and Drug 
                Administration personnel regarding review of 
                countermeasures for approval, licensure, or clearance; 
                and</DELETED>
                <DELETED>    ``(C) establishing protocols to ensure 
                that countermeasure reviewers have sufficient training 
                or experience with countermeasures;</DELETED>
        <DELETED>    ``(4) by maintaining teams, composed of Food and 
        Drug Administration personnel with expertise on countermeasures 
        (including specific countermeasures, classes or groups of 
        countermeasures, or other countermeasure-related technologies 
        and capabilities), that shall--</DELETED>
                <DELETED>    ``(A) work with countermeasure sponsors 
                and applicants to identify and help resolve scientific 
                issues related to the approval, licensure, or clearance 
                of countermeasures;</DELETED>
                <DELETED>    ``(B) encourage the exchange of scientific 
                ideas by holding public meetings at least twice 
                annually; and</DELETED>
                <DELETED>    ``(C) improve and advance the science 
                relating to the development of new tools, standards, 
                and approaches to assessing and evaluating 
                countermeasures--</DELETED>
                        <DELETED>    ``(i) in order to inform the 
                        process for countermeasure approval, clearance, 
                        and licensure; and</DELETED>
                        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(5) by establishing''; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
<DELETED>    ``(c) Development and Animal Modeling Procedures.--
</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) a meeting to discuss proposed animal 
                model development activities; and</DELETED>
                <DELETED>    ``(B) a meeting prior to initiating 
                pivotal animal studies.</DELETED>
        <DELETED>    ``(2) Juvenile models.--To facilitate the 
        development and selection of animal models that could translate 
        to juvenile studies, any meeting conducted under paragraph (1) 
        shall include discussion of juvenile animal models, as 
        appropriate.</DELETED>
<DELETED>    ``(d) Review and Approval of Countermeasures.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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)(C).''.</DELETED>

<DELETED>SEC. 305. REGULATORY MANAGEMENT PLANS.</DELETED>

<DELETED>    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:</DELETED>
<DELETED>    ``(e) Regulatory Management Plan.--</DELETED>
        <DELETED>    ``(1) In general.--</DELETED>
                <DELETED>    ``(A) Initiation of process.--The 
                Secretary, in consultation with the Assistant Secretary 
                for Preparedness and Response and the product sponsor 
                or applicant, shall initiate a formal process for 
                obtaining scientific feedback and interactions 
                regarding the development and regulatory review of any 
                countermeasure.</DELETED>
                <DELETED>    ``(B) Content.--</DELETED>
                        <DELETED>    ``(i) In general.--The process 
                        initiated under subparagraph (A) shall include 
                        the development of a written regulatory 
                        management plan that shall be made part of the 
                        administrative record. Except as provided in 
                        paragraph (2), such plan shall be completed not 
                        later than 45 days after the date on which an 
                        investigational new drug application or 
                        investigational device exemption is approved 
                        with respect to the countermeasure 
                        involved.</DELETED>
                        <DELETED>    ``(ii) Content of plan.--The 
                        content of a regulatory management plan under 
                        clause (i) shall be consistent with sections 
                        319L and 319F-2 of the Public Health Service 
                        Act. Such plan shall include--</DELETED>
                                <DELETED>    ``(I) guidance from the 
                                Secretary regarding the data required 
                                to support the approval, clearance, or 
                                licensure of the countermeasure 
                                involved;</DELETED>
                                <DELETED>    ``(II) guidance from the 
                                Secretary regarding the data necessary 
                                to inform any authorization under 
                                section 564;</DELETED>
                                <DELETED>    ``(III) guidance from the 
                                Secretary regarding the data necessary 
                                to support the positioning and delivery 
                                of countermeasures, including to the 
                                Strategic National Stockpile;</DELETED>
                                <DELETED>    ``(IV) guidance from the 
                                Secretary regarding the data necessary 
                                to support the submission of protocols 
                                for review under section 
                                505(b)(5)(B);</DELETED>
                                <DELETED>    ``(V) an agreement between 
                                the Secretary and the countermeasure 
                                sponsor or applicant regarding 
                                developmental milestones that will 
                                trigger responses by the Secretary as 
                                described in subclause (VI);</DELETED>
                                <DELETED>    ``(VI) performance targets 
                                and goals for timely and appropriate 
                                responses by the Secretary to the 
                                triggers described under subclause (V), 
                                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;</DELETED>
                                <DELETED>    ``(VII) guidance from the 
                                Secretary regarding any gaps in 
                                scientific knowledge that will need 
                                resolution prior to countermeasure 
                                approval, licensure, or clearance, and 
                                plans for conducting the necessary 
                                scientific research;</DELETED>
                                <DELETED>    ``(VIII) 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</DELETED>
                                <DELETED>    ``(IX) as necessary and 
                                appropriate, and to the extent 
                                practicable, a plan for developing 
                                pediatric dosing and administration 
                                with respect to the 
                                countermeasure.</DELETED>
                        <DELETED>    ``(iii) Modification of plan.--Not 
                        later than 45 days after the Secretary becomes 
                        aware of a new substantial scientific issue 
                        essential to the review of a countermeasure, 
                        the Secretary shall--</DELETED>
                                <DELETED>    ``(I) determine, in 
                                consultation with the countermeasure 
                                sponsor or applicant, if such issue 
                                necessitates a modification to the 
                                regulatory management plan; 
                                and</DELETED>
                                <DELETED>    ``(II) if the Secretary so 
                                determines, make such 
                                modification.</DELETED>
        <DELETED>    ``(2) Countermeasures under review.--</DELETED>
                <DELETED>    ``(A) In general.--Not later than 45 days 
                after the date of enactment of this subsection, the 
                Secretary shall establish a procedure for developing 
                regulatory management plans for countermeasures that 
                are under review by the Food and Drug Administration as 
                of the date of enactment of this subsection. Subject to 
                subparagraph (B), the regulatory management plans for 
                all such countermeasures shall be developed not later 
                than 274 days after the date of enactment of this 
                subsection.</DELETED>
                <DELETED>    ``(B) Exception.--The sponsor or applicant 
                with respect to a countermeasure described subparagraph 
                (A) may elect not to establish a regulatory management 
                plan under this subsection. Such sponsor or applicant 
                shall notify the Secretary of such an election not 
                later than 30 days after the Secretary makes the 
                procedures established under subparagraph (A) publicly 
                available. If notification of such an election is not 
                received by the Secretary by such date, the procedures 
                established under subparagraph (A) shall apply to the 
                countermeasure.''.</DELETED>

<DELETED>SEC. 306. REPORT.</DELETED>

<DELETED>    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:</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) with respect to the development of new 
        tools, standards, and approaches to assess and evaluate 
        countermeasures--</DELETED>
                <DELETED>    ``(A) the identification of the priorities 
                of the Food and Drug Administration and the progress 
                made on such priorities; and</DELETED>
                <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(2) the extent to which the performance targets 
        and goals set forth in subsection (e)(1)(B) and the regulatory 
        management plans established under such subsection have been 
        met, including, for each countermeasure reviewed--</DELETED>
                <DELETED>    ``(A) whether the regulatory management 
                plan was completed within the required timeframe, and 
                the length of time taken to complete such 
                plan;</DELETED>
                <DELETED>    ``(B) whether the Secretary adhered to the 
                timely and appropriate response times set forth in such 
                plan; and</DELETED>
                <DELETED>    ``(C) explanations for any failure to meet 
                such performance targets and goals;</DELETED>
        <DELETED>    ``(3) the number of regulatory teams established 
        pursuant to subsection (b)(4) and the number of products, 
        classes of products, or technologies assigned to each such 
        team;</DELETED>
        <DELETED>    ``(4) an estimate of resources obligated to 
        countermeasure development and regulatory assessment, including 
        Center specific objectives and accomplishments; and</DELETED>
        <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES.</DELETED>

<DELETED>    (a) Pediatric Studies of Drugs.--Section 505A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended--
</DELETED>
        <DELETED>    (1) in subsection (d), by adding at the end the 
        following:</DELETED>
        <DELETED>    ``(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 conduct of pediatric 
        studies under this section.''; and</DELETED>
        <DELETED>    (2) in subsection (n)(1), by adding at the end the 
        following:</DELETED>
                <DELETED>    ``(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), 
                prior to any action with respect to such drug under 
                subparagraph (A) or (B), the Secretary shall refer all 
                pediatric studies in the written request to the 
                Assistant Secretary for Preparedness and Response and 
                the Director of the Biomedical Advanced Research and 
                Development Authority.''.</DELETED>
<DELETED>    (b) Addition to Priority List Considerations.--Section 
409I of the Public Health Service Act (42 U.S.C. 284m) is amended--
</DELETED>
        <DELETED>    (1) by striking subsection (a)(2) and inserting 
        the following:</DELETED>
        <DELETED>    ``(2) Consideration of available information.--In 
        developing and prioritizing the list under paragraph (1), the 
        Secretary--</DELETED>
                <DELETED>    ``(A) shall consider--</DELETED>
                        <DELETED>    ``(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;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(iii) the adequacy of necessary 
                        infrastructure to conduct pediatric 
                        pharmacological research, including research 
                        networks and trained pediatric investigators; 
                        and</DELETED>
                <DELETED>    ``(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</DELETED>
        <DELETED>    (2) in subsection (b), by striking ``subsection 
        (a)'' and inserting ``paragraphs (1) and (2)(A) of subsection 
        (a)''.</DELETED>
<DELETED>    (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--</DELETED>
        <DELETED>    (1) in subparagraph (C), by striking the period 
        and inserting ``; and''; and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
                <DELETED>    ``(D) the development of countermeasures 
                (as defined in section 565(a) of the Federal Food, 
                Drug, and Cosmetic Act) for pediatric 
                populations.''.</DELETED>

<DELETED>SEC. 308. TECHNICAL AND CONFORMING AMENDMENTS.</DELETED>

<DELETED>    (a) Section 319F-2(c)(1)(B)(ii) of the Public Health 
Service Act (42 U.S.C. 247d-6b(c)(1)(B)(ii)) is amended by striking 
``emergency''.</DELETED>
<DELETED>    (b) Section 319F-3(i) of such Act (42 U.S.C. 247d-6d(i)) 
is amended--</DELETED>
        <DELETED>    (1) in paragraph (1)(C), by striking 
        ``emergency''; and</DELETED>
        <DELETED>    (2) in paragraph (7)(B)(iii), by striking 
        ``emergency''.</DELETED>

    <DELETED>TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED 
                   RESEARCH AND DEVELOPMENT</DELETED>

<DELETED>SEC. 401. BIOSHIELD.</DELETED>

<DELETED>    (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:</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) in meeting the security 
                countermeasure needs identified under this section; 
                and</DELETED>
                <DELETED>    ``(B) on the annual Public Health 
                Emergency Medical Countermeasures Enterprise and 
                Strategy Implementation Plan (pursuant to section 
                2811(d)).''.</DELETED>
<DELETED>    (b) Procurement of Countermeasures.--Section 319F-2(c) of 
the Public Health Service Act (42 U.S.C. 247d-6b(c)) is amended--
</DELETED>
        <DELETED>    (1) in paragraph (1)(B)(i)(III)(bb), by striking 
        ``eight years'' and inserting ``10 years'';</DELETED>
        <DELETED>    (2) in paragraph (5)(B)(ii), by striking ``eight 
        years'' and inserting ``10 years'';</DELETED>
        <DELETED>    (3) in paragraph (7)(C)--</DELETED>
                <DELETED>    (A) in clause (i)(I), by inserting 
                ``including advanced research and development,'' after 
                ``as may reasonably be required,'';</DELETED>
                <DELETED>    (B) in clause (ii)--</DELETED>
                        <DELETED>    (i) in subclause (III), by 
                        striking ``eight years'' and inserting ``10 
                        years''; and</DELETED>
                        <DELETED>    (ii) by striking subclause (IX) 
                        and inserting the following:</DELETED>
                                <DELETED>    ``(IX) Contract terms.--
                                The Secretary, in any contract for 
                                procurement under this section--
                                </DELETED>
                                        <DELETED>    ``(aa) may 
                                        specify--</DELETED>

                                                <DELETED>    ``(AA) the 
                                                dosing and 
                                                administration 
                                                requirements for the 
                                                countermeasure to be 
                                                developed and 
                                                procured;</DELETED>

                                                <DELETED>    ``(BB) the 
                                                amount of funding that 
                                                will be dedicated by 
                                                the Secretary for 
                                                advanced research, 
                                                development, and 
                                                procurement of the 
                                                countermeasure; 
                                                and</DELETED>

                                                <DELETED>    ``(CC) the 
                                                specifications the 
                                                countermeasure must 
                                                meet to qualify for 
                                                procurement under a 
                                                contract under this 
                                                section; and</DELETED>

                                        <DELETED>    ``(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</DELETED>
                <DELETED>    (C) by adding at the end the 
                following:</DELETED>
                        <DELETED>    ``(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 an allowable and allocable 
                        direct cost of the contract 
                        involved.'';</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (5) in paragraph (10), by adding at the end the 
        following:</DELETED>
                <DELETED>    ``(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).''.</DELETED>

<DELETED>SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT 
              AUTHORITY.</DELETED>

<DELETED>    (a) Duties.--Section 319L(c)(4) of the Public Health 
Service Act (42 U.S.C. 247d-7e(c)(4)) is amended--</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (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''.</DELETED>
<DELETED>    (b) 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:</DELETED>
                <DELETED>    ``(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.''.</DELETED>
<DELETED>    (c) 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:</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (d) 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''.</DELETED>
<DELETED>    (e) 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''.</DELETED>
<DELETED>    (f) 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:</DELETED>
<DELETED>    ``(f) Independent Evaluation.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) the extent to which flexible 
                manufacturing capacity under this section is dedicated 
                to chemical, biological, radiological, and nuclear 
                threats;</DELETED>
                <DELETED>    ``(B) the activities supported by flexible 
                manufacturing initiatives; and</DELETED>
                <DELETED>    ``(C) the ability of flexible 
                manufacturing activities carried out under this section 
                to--</DELETED>
                        <DELETED>    ``(i) secure and leverage leading 
                        technical expertise with respect to 
                        countermeasure advanced research, development, 
                        and manufacturing processes; and</DELETED>
                        <DELETED>    ``(ii) meet the surge 
                        manufacturing capacity needs presented by novel 
                        and emerging threats, including chemical, 
                        biological, radiological and nuclear 
                        agents.''.</DELETED>
<DELETED>    (g) Definitions.--</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) in the matter preceding clause (i), by 
                striking ``to--'' and inserting ``--'';</DELETED>
                <DELETED>    (B) in clause (i)--</DELETED>
                        <DELETED>    (i) by striking ``diagnose'' and 
                        inserting ``to diagnose''; and</DELETED>
                        <DELETED>    (ii) by striking ``; or'' and 
                        inserting a semicolon;</DELETED>
                <DELETED>    (C) in clause (ii)--</DELETED>
                        <DELETED>    (i) by striking ``diagnose'' and 
                        inserting ``to diagnose''; and</DELETED>
                        <DELETED>    (ii) by striking the period at the 
                        end and inserting ``; or''; and</DELETED>
                <DELETED>    (D) by adding at the end the 
                following:</DELETED>
                        <DELETED>    ``(iii) is a product or technology 
                        intended to enhance the purpose of a drug, 
                        biological product, or device described in 
                        clause (i) or (ii).''.</DELETED>
        <DELETED>    (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--</DELETED>
                <DELETED>    (A) in clause (i)(II), by striking ``; 
                or'' and inserting ``;'';</DELETED>
                <DELETED>    (B) in clause (ii), by striking ``; and'' 
                and inserting ``; or''; and</DELETED>
                <DELETED>    (C) by adding at the end the 
                following:</DELETED>
                <DELETED>    ``(B) a product or technology intended to 
                enhance the purpose of a drug, biological product, or 
                device described in clause (i) or (ii); 
                and''.</DELETED>

<DELETED>SEC. 403. STRATEGIC NATIONAL STOCKPILE.</DELETED>

<DELETED>    Section 319F-2 of the Public Health Service Act (42 U.S.C. 
247d-6b) is amended--</DELETED>
        <DELETED>    (1) in subsection (a)--</DELETED>
                <DELETED>    (A) in paragraph (1)--</DELETED>
                        <DELETED>    (i) by inserting ``consistent with 
                        section 2811'' before ``by the Secretary to be 
                        appropriate''; and</DELETED>
                        <DELETED>    (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</DELETED>
                <DELETED>    (B) in paragraph (2)--</DELETED>
                        <DELETED>    (i) by redesignating subparagraphs 
                        (E) through (H) as subparagraphs (F) through 
                        (I), respectively; and</DELETED>
                        <DELETED>    (ii) by inserting after 
                        subparagraph (D), the following:</DELETED>
                <DELETED>    ``(E) identify and address the potential 
                depletion and ensure appropriate replenishment of 
                medical countermeasures, including those currently in 
                the stockpile;''; and</DELETED>
        <DELETED>    (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''.</DELETED>

<DELETED>SEC. 404. NATIONAL BIODEFENSE SCIENCE BOARD.</DELETED>

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

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 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'';
                    (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.
                    ``(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
                                    (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 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);
                    ``(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 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 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
                            (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.''.
                                                       Calendar No. 263

112th CONGRESS

  1st Session

                                S. 1855

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                           December 16, 2011

                       Reported with an amendment
```