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[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 307 Enrolled Bill (ENR)]

        H.R.307

                     One Hundred Thirteenth Congress

                                 of the

                        United States of America

                          AT THE FIRST SESSION

          Begun and held at the City of Washington on Thursday,
           the third day of January, two thousand and thirteen

                                 An Act

 
To reauthorize certain programs under the Public Health Service Act and 
 the Federal Food, Drug, and Cosmetic Act with respect to public health 
   security and all-hazards preparedness and response, and for other 
                                purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
    (a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness Reauthorization Act of 2013''.
    (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. Temporary reassignment of State and local personnel during a 
          public health emergency.
Sec. 202. Improving State and local public health security.
Sec. 203. Hospital preparedness and medical surge capacity.
Sec. 204. Enhancing situational awareness and biosurveillance.
Sec. 205. Eliminating duplicative Project Bioshield reports.

           TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW

Sec. 301. Special protocol assessment.
Sec. 302. Authorization for 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 (1)(A), by inserting ``, including drills 
        and exercises to ensure medical surge capacity for events 
        without notice'' after ``exercises''; and
            (B) in paragraph (3)--
                (i) in the matter preceding subparagraph (A)--

                    (I) by striking ``facilities), and trauma care'' 
                and inserting ``and ambulatory care 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 (B), by striking ``Medical 
            evacuation and fatality management'' and inserting 
            ``Fatality management'';
                (iv) by redesignating subparagraphs (C), (D), and (E) 
            as subparagraphs (D), (E), and (F), respectively;
                (v) by inserting after subparagraph (B), the following 
            the new subparagraph:
            ``(C) Coordinated medical triage and evacuation to 
        appropriate medical institutions based on patient medical need, 
        taking into account regionalized systems of care.'';
                (vi) in subparagraph (E), as redesignated by clause 
            (iv), by inserting ``(which may include such dental health 
            assets)'' after ``medical assets''; and
                (vii) by adding at the end the following:
            ``(G) Optimizing a coordinated and flexible approach to the 
        medical surge capacity of hospitals, other health care 
        facilities, critical care, trauma care (which may include 
        trauma centers), and emergency medical systems.'';
            (C) 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
            (D) 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) in paragraph (4), by striking ``2811(b)(3)(B)'' and 
    inserting ``2802(b)(4)(B)'';
        (3) by redesignating paragraphs (1) through (4) as paragraphs 
    (2) through (5), respectively;
        (4) 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;'';
        (5) by amending paragraph (2) (as so redesignated) to read as 
    follows:
        ``(2) oversee the implementation of the preparedness goals 
    described in section 2802(b) with respect to the public health and 
    medical needs of at-risk individuals in the event of a public 
    health emergency, as described in section 2802(b)(4);''; and
        (6) 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.
    (a) In General.--Section 2811 of the Public Health Service Act (42 
U.S.C. 300hh-10) is amended--
        (1) in subsection (b)--
            (A) in paragraph (3), by inserting ``, security 
        countermeasures (as defined in section 319F-2),'' after 
        ``qualified countermeasures (as defined in section 319F-1)'';
            (B) in paragraph (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 504(6) of the Homeland Security Act of 2002, or any 
        successor plan, before, during, and following public health 
        emergencies.
            ``(E) Identification of inefficiencies.--Identify and 
        minimize gaps, duplication, and other inefficiencies in medical 
        and public health preparedness and response activities and the 
        actions necessary to overcome these obstacles.
            ``(F) Coordination of grants and agreements.--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 consultation with the Secretary of Homeland 
        Security, to--
                ``(i) optimize and streamline medical and public health 
            preparedness and response capabilities and the ability of 
            local communities to respond to public health emergencies; 
            and
                ``(ii) gather and disseminate best practices among 
            grant and cooperative agreement recipients, as appropriate.
            ``(G) Drill and operational exercises.--Carry out drills 
        and operational exercises, in consultation 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 and response, including 
        exercises based on--
                ``(i) identified threats for which countermeasures are 
            available and for which no countermeasures are available; 
            and
                ``(ii) unknown threats for which no countermeasures are 
            available.
            ``(H) National security priority.--On a periodic basis 
        consult with, as applicable and appropriate, 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.''; and
            (C) by adding at the end the following:
        ``(7) Countermeasures budget plan.--Develop, and update on an 
    annual basis, a coordinated 5-year budget plan based on the medical 
    countermeasure priorities described in subsection (d). Each such 
    plan shall--
            ``(A) include consideration of the entire medical 
        countermeasures enterprise, including--
                ``(i) basic research and advanced research and 
            development;
                ``(ii) approval, clearance, licensure, and authorized 
            uses of products; and
                ``(iii) procurement, stockpiling, maintenance, and 
            replenishment of all products in the Strategic National 
            Stockpile;
            ``(B) inform prioritization of resources and include 
        measurable outputs and outcomes to allow for the tracking of 
        the progress made toward identified priorities;
            ``(C) 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
            ``(D) be made available to the appropriate committees of 
        Congress upon request.'';
        (2) by striking subsection (c) and inserting the following:
    ``(c) Functions.--The Assistant Secretary for Preparedness and 
Response shall--
        ``(1) have lead responsibility within the Department of Health 
    and Human Services for emergency preparedness and response policy 
    coordination and strategic direction;
        ``(2) have authority over and responsibility for--
            ``(A) the National Disaster Medical System pursuant to 
        section 2812;
            ``(B) the Hospital Preparedness Cooperative Agreement 
        Program pursuant to section 319C-2;
            ``(C) the Biomedical Advanced Research and Development 
        Authority pursuant to section 319L;
            ``(D) the Medical Reserve Corps pursuant to section 2813;
            ``(E) the Emergency System for Advance Registration of 
        Volunteer Health Professionals pursuant to section 319I; and
            ``(F) 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;
        ``(3) 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 pursuant to section 
        319F-2; and
            ``(C) the Cities Readiness Initiative; and
        ``(4) assume other duties as determined appropriate by the 
    Secretary.''; and
        (3) by adding at the end the following:
    ``(d) 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 year thereafter, the 
    Assistant Secretary for Preparedness and Response 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. In developing such a plan, the Assistant Secretary 
    for Preparedness and Response shall consult 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 
    Food and Drugs. 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) describe the chemical, biological, radiological, and 
        nuclear agent or agents that may present a threat to the Nation 
        and the corresponding efforts to develop qualified 
        countermeasures (as defined in section 319F-1), security 
        countermeasures (as defined in section 319F-2), or qualified 
        pandemic or epidemic products (as defined in section 319F-3) 
        for each threat;
            ``(B) evaluate the progress of all activities with respect 
        to such countermeasures or products, including research, 
        advanced research, development, procurement, stockpiling, 
        deployment, distribution, and utilization;
            ``(C) identify and prioritize near-, mid-, and long-term 
        needs with respect to such countermeasures or products to 
        address a chemical, biological, radiological, and nuclear 
        threat or threats;
            ``(D) identify, with respect to each category of threat, a 
        summary of all awards and contracts, including advanced 
        research and development and procurement, that includes--
                ``(i) the time elapsed from the issuance of the initial 
            solicitation or request for a proposal to the adjudication 
            (such as the award, denial of award, or solicitation 
            termination); and
                ``(ii) an identification of projected timelines, 
            anticipated funding allocations, benchmarks, and milestones 
            for each medical countermeasure priority under subparagraph 
            (C), including projected needs with regard to replenishment 
            of the Strategic National Stockpile;
            ``(E) be informed by the recommendations of the National 
        Biodefense Science Board pursuant to section 319M;
            ``(F) evaluate progress made in meeting timelines, 
        allocations, benchmarks, and milestones identified under 
        subparagraph (D)(ii);
            ``(G) report on the amount of funds available for 
        procurement in the special reserve fund as defined in section 
        319F-2(h) and the impact this funding will have on meeting the 
        requirements under section 319F-2;
            ``(H) incorporate input from Federal, State, local, and 
        tribal stakeholders;
            ``(I) 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 (C), 
        including with regard to the projected needs for related 
        stockpiling and replenishment of the Strategic National 
        Stockpile, including by addressing the needs of pediatric 
        populations with respect to such countermeasures and products 
        in the Strategic National Stockpile, including--
                ``(i) a list of such countermeasures and products 
            necessary to address the needs of pediatric populations;
                ``(ii) a description of measures taken to coordinate 
            with the Office of Pediatric Therapeutics of the Food and 
            Drug Administration to maximize the labeling, dosages, and 
            formulations of such countermeasures and products for 
            pediatric populations;
                ``(iii) a description of existing gaps in the Strategic 
            National Stockpile and the development of such 
            countermeasures and products to address the needs of 
            pediatric populations; and
                ``(iv) an evaluation of the progress made in addressing 
            priorities identified pursuant to subparagraph (C);
            ``(J) identify the use of authority and activities 
        undertaken pursuant to sections 319F-1(b)(1), 319F-1(b)(2), 
        319F-1(b)(3), 319F-1(c), 319F-1(d), 319F-1(e), 319F-
        2(c)(7)(C)(iii), 319F-2(c)(7)(C)(iv), and 319F-2(c)(7)(C)(v) of 
        this Act, and subsections (a)(1), (b)(1), and (e) of section 
        564 of the Federal Food, Drug, and Cosmetic Act, by 
        summarizing--
                ``(i) the particular actions that were taken under the 
            authorities specified, including, as applicable, the 
            identification of the threat agent, emergency, or the 
            biomedical countermeasure with respect to which the 
            authority was used;
                ``(ii) the reasons underlying the decision to use such 
            authorities, including, as applicable, the options that 
            were considered and rejected with respect to the use of 
            such authorities;
                ``(iii) the number of, nature of, and other information 
            concerning the persons and entities that received a grant, 
            cooperative agreement, or contract pursuant to the use of 
            such authorities, and the persons and entities that were 
            considered and rejected for such a grant, cooperative 
            agreement, or contract, except that the report need not 
            disclose the identity of any such person or entity;
                ``(iv) whether, with respect to each procurement that 
            is approved by the President under section 319F-2(c)(6), a 
            contract was entered into within one year after such 
            approval by the President; and
                ``(v) with respect to section 319F-1(d), for the one-
            year period for which the report is submitted, the number 
            of persons who were paid amounts totaling $100,000 or 
            greater and the number of persons who were paid amounts 
            totaling at least $50,000 but less than $100,000; and
            ``(K) be made publicly available.
        ``(3) GAO report.--
            ``(A) In general.--Not later than 1 year after the date of 
        the submission to the Congress of the first Public Health 
        Emergency Medical Countermeasures Enterprise Strategy and 
        Implementation Plan, the Comptroller General of the United 
        States 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 paragraph (2)(C);
                ``(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 timelines, 
            allocations, benchmarks, and milestones identified in the 
            Public Health Emergency Medical Countermeasures Enterprise 
            Strategy and Implementation Plan under this subsection.
    ``(e) Protection of National Security.--In carrying out subsections 
(b)(7) and (d), the Secretary shall ensure that information and items 
that could compromise national security, contain confidential 
commercial information, or contain proprietary information are not 
disclosed.''.
    (b) Interagency Coordination Plan.--In the first Public Health 
Emergency Countermeasures Enterprise Strategy and Implementation Plan 
submitted under subsection (d) of section 2811 of the Public Health 
Service Act (42 U.S.C. 300hh-10) (as added by subsection (a)(3)), the 
Secretary of Health and Human Services, in consultation with the 
Secretary of Defense, shall include a description of 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.
    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 
following:
``SEC. 2811A. NATIONAL ADVISORY COMMITTEE ON CHILDREN AND DISASTERS.
    ``(a) Establishment.--The Secretary, in consultation with the 
Secretary of Homeland Security, shall establish an advisory committee 
to be known as the `National Advisory Committee on Children and 
Disasters' (referred to in this section as the `Advisory Committee').
    ``(b) Duties.--The Advisory Committee shall--
        ``(1) provide advice and consultation with respect to the 
    activities carried out pursuant to section 2814, as applicable and 
    appropriate;
        ``(2) evaluate and provide input with respect to the medical 
    and public health needs of children as they relate to preparation 
    for, response to, and recovery from all-hazards emergencies; and
        ``(3) provide advice and consultation with respect to State 
    emergency preparedness and response activities and children, 
    including related drills and exercises pursuant to the preparedness 
    goals under section 2802(b).
    ``(c) Additional Duties.--The Advisory Committee may provide advice 
and recommendations to the Secretary with respect to children and the 
medical and public health grants and cooperative agreements as 
applicable to preparedness and response activities authorized under 
this title and title III.
    ``(d) Membership.--
        ``(1) In general.--The Secretary, in consultation with such 
    other Secretaries as may be appropriate, shall appoint not to 
    exceed 15 members to the Advisory Committee. In appointing such 
    members, the Secretary shall ensure that the total membership of 
    the Advisory Committee is an odd number.
        ``(2) Required members.--The Secretary, in consultation with 
    such other Secretaries as may be appropriate, may appoint to the 
    Advisory Committee under paragraph (1) such individuals as may be 
    appropriate to perform the duties described in subsections (b) and 
    (c), which may include--
            ``(A) the Assistant Secretary for Preparedness and 
        Response;
            ``(B) the Director of the Biomedical Advanced Research and 
        Development Authority;
            ``(C) the Director of the Centers for Disease Control and 
        Prevention;
            ``(D) the Commissioner of Food and Drugs;
            ``(E) the Director of the National Institutes of Health;
            ``(F) the Assistant Secretary of the Administration for 
        Children and Families;
            ``(G) the Administrator of the Federal Emergency Management 
        Agency;
            ``(H) at least two non-Federal health care professionals 
        with expertise in pediatric medical disaster planning, 
        preparedness, response, or recovery;
            ``(I) at least two representatives from State, local, 
        territorial, or tribal agencies with expertise in pediatric 
        disaster planning, preparedness, response, or recovery; and
            ``(J) representatives from such Federal agencies (such as 
        the Department of Education and the Department of Homeland 
        Security) as determined necessary to fulfill the duties of the 
        Advisory Committee, as established under subsections (b) and 
        (c).
    ``(e) Meetings.--The Advisory Committee shall meet not less than 
biannually.
    ``(f) Sunset.--The Advisory Committee shall terminate on September 
30, 2018.''.
    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 ``$52,700,000 for each of fiscal years 2014 through 
    2018''.
    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 ``$155,300,000 
for each of fiscal years 2014 through 2018 to carry out this section''.

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

    SEC. 201. TEMPORARY REASSIGNMENT OF STATE AND LOCAL PERSONNEL 
      DURING A PUBLIC HEALTH EMERGENCY.
    Section 319 of the Public Health Service Act (42 U.S.C. 247d) is 
amended by adding at the end the following:
    ``(e) Temporary Reassignment of State and Local Personnel During a 
Public Health Emergency.--
        ``(1) Emergency reassignment of federally funded personnel.--
    Notwithstanding any other provision of law, and subject to 
    paragraph (2), upon request by the Governor of a State or a tribal 
    organization or such Governor or tribal organization's designee, 
    the Secretary may authorize the requesting State or Indian tribe to 
    temporarily reassign, for purposes of immediately addressing a 
    public health emergency in the State or Indian tribe, State and 
    local public health department or agency personnel funded in whole 
    or in part through programs authorized under this Act, as 
    appropriate.
        ``(2) Activation of emergency reassignment.--
            ``(A) Public health emergency.--The Secretary may authorize 
        a temporary reassignment of personnel under paragraph (1) only 
        during the period of a public health emergency determined 
        pursuant to subsection (a).
            ``(B) Contents of request.--To seek authority for a 
        temporary reassignment of personnel under paragraph (1), the 
        Governor of a State or a tribal organization shall submit to 
        the Secretary a request for such reassignment flexibility and 
        shall include in the request each of the following:
                ``(i) An assurance that the public health emergency in 
            the geographic area of the requesting State or Indian tribe 
            cannot be adequately and appropriately addressed by the 
            public health workforce otherwise available.
                ``(ii) An assurance that the public health emergency 
            would be addressed more efficiently and effectively through 
            the requested temporary reassignment of State and local 
            personnel described in paragraph (1).
                ``(iii) An assurance that the requested temporary 
            reassignment of personnel is consistent with any applicable 
            All-Hazards Public Health Emergency Preparedness and 
            Response Plan under section 319C-1.
                ``(iv) An identification of--

                    ``(I) each Federal program from which personnel 
                would be temporarily reassigned pursuant to the 
                requested authority; and
                    ``(II) the number of personnel who would be so 
                reassigned from each such program.

                ``(v) Such other information and assurances upon which 
            the Secretary and Governor of a State or tribal 
            organization agree.
            ``(C) Consideration.--In reviewing a request for temporary 
        reassignment under paragraph (1), the Secretary shall consider 
        the degree to which the program or programs funded in whole or 
        in part by programs authorized under this Act would be 
        adversely affected by the reassignment.
            ``(D) Termination and extension.--
                ``(i) Termination.--A State or Indian tribe's temporary 
            reassignment of personnel under paragraph (1) shall 
            terminate upon the earlier of the following:

                    ``(I) The Secretary's determination that the public 
                health emergency no longer exists.
                    ``(II) Subject to clause (ii), the expiration of 
                the 30-day period following the date on which the 
                Secretary approved the State or Indian tribe's request 
                for such reassignment flexibility.

                ``(ii) Extension of reassignment flexibility.--The 
            Secretary may extend reassignment flexibility of personnel 
            under paragraph (1) beyond the date otherwise applicable 
            under clause (i)(II) if the public health emergency still 
            exists as of such date, but only if--

                    ``(I) the State or Indian tribe that submitted the 
                initial request for a temporary reassignment of 
                personnel submits a request for an extension of such 
                temporary reassignment; and
                    ``(II) the request for an extension contains the 
                same information and assurances necessary for the 
                approval of an initial request for such temporary 
                reassignment pursuant to subparagraph (B).

        ``(3) Voluntary nature of temporary reassignment of state and 
    local personnel.--
            ``(A) In general.--Unless otherwise provided under the law 
        or regulation of the State or Indian tribe that receives 
        authorization for temporary reassignment of personnel under 
        paragraph (1), personnel eligible for reassignment pursuant to 
        such authorization--
                ``(i) shall have the opportunity to volunteer for 
            temporary reassignment; and
                ``(ii) shall not be required to agree to a temporary 
            reassignment.
            ``(B) Prohibition on conditioning federal awards.--The 
        Secretary may not condition the award of a grant, contract, or 
        cooperative agreement under this Act on the requirement that a 
        State or Indian tribe require that personnel eligible for 
        reassignment pursuant to an authorization under paragraph (1) 
        agree to such reassignment.
        ``(4) Notice to congress.--The Secretary shall give notice to 
    the Congress in conjunction with the approval under this subsection 
    of--
            ``(A) any initial request for temporary reassignment of 
        personnel; and
            ``(B) any request for an extension of such temporary 
        reassignment.
        ``(5) Guidance.--The Secretary shall--
            ``(A) not later than 6 months after the enactment of this 
        subsection, issue proposed guidance on the temporary 
        reassignment of personnel under this subsection; and
            ``(B) after providing notice and a 60-day period for public 
        comment, finalize such guidance.
        ``(6) Report to congress.--Not later than 4 years after the 
    date of enactment of the Pandemic and All-Hazards Preparedness 
    Reauthorization Act of 2013, the Comptroller General of the United 
    States shall conduct an independent evaluation, and submit to the 
    appropriate committees of the Congress a report, on temporary 
    reassignment under this subsection, including--
            ``(A) a description of how, and under what circumstances, 
        such temporary reassignment has been used by States and Indian 
        tribes;
            ``(B) an analysis of how such temporary reassignment has 
        assisted States and Indian tribes in responding to public 
        health emergencies;
            ``(C) an evaluation of how such temporary reassignment has 
        improved operational efficiencies in responding to public 
        health emergencies;
            ``(D) an analysis of the extent to which, if any, Federal 
        programs from which personnel have been temporarily reassigned 
        have been adversely affected by the reassignment; and
            ``(E) recommendations on how medical surge capacity could 
        be improved in responding to public health emergencies and the 
        impact of the reassignment flexibility under this section on 
        such surge capacity.
        ``(7) Definitions.--In this subsection--
            ``(A) the terms `Indian tribe' and `tribal organization' 
        have the meanings given such terms in section 4 of the Indian 
        Self-Determination and Education Assistance Act; and
            ``(B) the term `State' includes, in addition to the 
        entities listed in the definition of such term in section 2, 
        the Freely Associated States.
        ``(8) Sunset.--This subsection shall terminate on September 30, 
    2018.''.
    SEC. 202. 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)(1)(C), by striking ``consortium of 
    entities described in subparagraph (A)'' and inserting ``consortium 
    of States'';
        (2) 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 
            (designated under section 658D of the Child Care and 
            Development Block Grant Act of 1990);
                ``(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, 
            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
                ``(ix) a description of any activities that such entity 
            will use to analyze real-time clinical specimens for 
            pathogens of public health or bioterrorism significance, 
            including any utilization of poison control centers;''; and
            (B) in subparagraph (C), by inserting ``, including 
        addressing the needs of at-risk individuals,'' after 
        ``capabilities of such entity'';
        (3) in subsection (f)--
            (A) in paragraph (2), by adding ``and'' at the end;
            (B) in paragraph (3), by striking ``; and'' and inserting a 
        period; and
            (C) by striking paragraph (4);
        (4) 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).'';
        (5) by striking subsection (h);
        (6) by redesignating subsections (i), (j), and (k) as 
    subsections (h), (i), and (j), respectively;
        (7) in subsection (h), as so redesignated--
            (A) in paragraph (1)--
                (i) in subparagraph (A)--

                    (I) by striking ``$824,000,000 for fiscal year 
                2007, of which $35,000,000 shall be used to carry out 
                subsection (h),'' and inserting ``$641,900,000 for 
                fiscal year 2014''; and
                    (II) by striking ``such sums as may be necessary 
                for each of fiscal years 2008 through 2011'' and 
                inserting ``$641,900,000 for each of fiscal years 2015 
                through 2018'';

                (ii) by striking subparagraph (B);
                (iii) by redesignating subparagraphs (C) and (D) as 
            subparagraphs (B) and (C), respectively; and
                (iv) in subparagraph (C), as so redesignated, by 
            striking ``subparagraph (C)'' and inserting ``subparagraph 
            (B)'';
            (B) in subparagraphs (C) and (D) of paragraph (3), by 
        striking ``(1)(A)(i)(I)'' each place it appears and inserting 
        ``(1)(A)'';
            (C) in paragraph (4)(B), by striking ``subsection (c)'' and 
        inserting ``subsection (b)''; and
            (D) 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
        (8) in subsection (i), as so redesignated--
            (A) in paragraph (1)(E), by striking ``subsection (k)'' and 
        inserting ``subsection (j)'';
            (B) 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 2014 through 2018''.
    (c) Technical and Conforming Amendments.--
        (1) Section 319C-1(b)(1)(B) of the Public Health Service Act 
    (42 U.S.C. 247d-3a(b)(1)(B)) is amended by striking ``subsection 
    (i)(4)'' and inserting ``subsection (h)(4)''.
        (2) Section 319C-2 of the Public Health Service Act (42 U.S.C. 
    247d-3b) is amended--
            (A) in subsection (i), by striking ``(j), and (k)'' and 
        inserting ``(i), and (j)''; and
            (B) in subsection (j)(3), by striking ``319C-1(i)'' and 
        inserting ``319C-1(h)''.
    SEC. 203. 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 ``$5,000,000 for 
    each of fiscal years 2014 through 2018''.
        (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 ``$11,200,000 for each 
        of fiscal years 2014 through 2018''.
    (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 (a), by inserting ``, including, as 
    appropriate, capacity and preparedness to address the needs of 
    children and other at-risk individuals'' before the period at the 
    end;
        (2) in subsection (b)(1)(A)(ii), by striking ``centers, 
    primary'' and inserting ``centers, community health centers, 
    primary'';
        (3) 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.'';
        (4) 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).'';
        (5) in subsection (i)--
            (A) by striking ``The requirements of'' and inserting the 
        following:
        ``(1) In general.--The requirements of''; and
            (B) by adding at the end the following:
        ``(2) Meeting goals of national health security strategy.--The 
    Secretary shall implement objective, evidence-based metrics to 
    ensure that entities receiving awards under this section are 
    meeting, to the extent practicable, the applicable goals of the 
    National Health Security Strategy under section 2802.''; and
        (6) in subsection (j)--
            (A) by amending paragraph (1) to read as follows:
        ``(1) In general.--For purposes of carrying out this section, 
    there is authorized to be appropriated $374,700,000 for each of 
    fiscal years 2014 through 2018.''; 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. 204. ENHANCING SITUATIONAL AWARENESS AND BIOSURVEILLANCE.
    (a) In General.--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 at the 
        end 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 at the 
        end the following: ``and update such standards as necessary'';
        (2) by striking subsection (c);
        (3) by redesignating subsections (d) through (g) as subsections 
    (c) through (f), respectively;
        (4) in subsection (c), as so redesignated--
            (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 
            Reauthorization Act of 2013''; 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 Reauthorization Act of 2013, 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);
            ``(B) modernize and enhance biosurveillance activities; and
            ``(C) improve information sharing, coordination, and 
        communication among disparate biosurveillance systems supported 
        by the Department of Health and Human Services.'';
            (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 and 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 Human 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.'';
        (5) in subsection (d), as so redesignated--
            (A) in paragraph (1), by striking ``subsection (d)'' and 
        inserting ``subsection (c)'';
            (B) in paragraph (4)(B), by striking ``subsection (d)'' and 
        inserting ``subsection (c)''; and
            (C) in paragraph (5)--
                (i) 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 Reauthorization Act 
            of 2013''; and
                (ii) by striking ``subsection (d)'' and inserting 
            ``subsection (c)'';
        (6) in subsection (f), as so redesignated, by striking ``such 
    sums as may be necessary in each of fiscal years 2007 through 
    2011'' and inserting ``$138,300,000 for each of fiscal years 2014 
    through 2018''; and
        (7) by adding at the end the following:
    ``(g) Definition.--For purposes of this section the term 
`biosurveillance' means the process of gathering near real-time 
biological data that relates to human and zoonotic disease activity and 
threats to human or animal 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.''.
    (b) Technical and Conforming Amendment.--Section 319C-1(b)(2)(D) of 
the Public Health Service Act (42 U.S.C. 247d-3a(b)(2)(D)) is amended 
by striking ``section 319D(d)(3)'' and inserting ``section 
319D(c)(3)''.
    SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS.
    Section 5 of the Project Bioshield Act of 2004 (42 U.S.C. 247d-6c) 
is repealed.

           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 
        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 section of 
        this Act or the Public Health Service Act 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 living 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)--
                (i) in subparagraph (A), 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.''; 
        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 or an unapproved use 
    of an approved 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 or use, 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 (1)(B), by amending clause (iii) to read 
        as follows:
                ``(iii) Appropriate conditions with respect to 
            collection and analysis of information concerning the 
            safety and effectiveness of the product with respect to the 
            use of such product during the period when the 
            authorization is in effect and a reasonable time following 
            such period.'';
            (C) 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 distributed or administered for the 
        approved use.''; and
            (D) 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.'';
        (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 Secretary of 
    any application or submission pending before the Food and Drug 
    Administration for a product for which an authorization under this 
    section is issued.''; and
        (9) by adding at the end the following:
    ``(m) Categorization of Laboratory Tests Associated With Devices 
Subject to Authorization.--
        ``(1) In general.--In issuing an authorization under this 
    section with respect to a device, the Secretary may, subject to the 
    provisions of this section, determine that a laboratory examination 
    or procedure associated with such device shall be deemed, for 
    purposes of section 353 of the Public Health Service Act, to be in 
    a particular category of examinations and procedures (including the 
    category described by subsection (d)(3) of such section) if, based 
    on the totality of scientific evidence available to the Secretary--
            ``(A) such categorization would be beneficial to protecting 
        the public health; and
            ``(B) the known and potential benefits of such 
        categorization under the circumstances of the authorization 
        outweigh the known and potential risks of the categorization.
        ``(2) Conditions of determination.--The Secretary may establish 
    appropriate conditions on the performance of the examination or 
    procedure pursuant to such determination.
        ``(3) Effective period.--A determination under this subsection 
    shall be effective for purposes of section 353 of the Public Health 
    Service Act notwithstanding any other provision of that section 
    during the effective period of the relevant declaration under 
    subsection (b).''.
    (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; 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) Expiration Dating.--
        ``(1) In general.--The Secretary may extend the expiration date 
    and authorize the introduction or delivery for introduction into 
    interstate commerce of an eligible product after the expiration 
    date provided by the manufacturer if--
            ``(A) the expiration date extension is intended to support 
        the United States ability to protect--
                ``(i) the public health; or
                ``(ii) military preparedness and effectiveness; and
            ``(B) the expiration date extension is supported by an 
        appropriate scientific evaluation that is conducted or accepted 
        by the Secretary.
        ``(2) Requirements and conditions.--Any extension of an 
    expiration date under paragraph (1) shall, as part of the 
    extension, identify--
            ``(A) each specific lot, batch, or other unit of the 
        product for which extended expiration is authorized;
            ``(B) the duration of the extension; and
            ``(C) any other requirements or conditions as the Secretary 
        may deem appropriate for the protection of the public health, 
        which may include requirements for, or conditions on, product 
        sampling, storage, packaging or repackaging, transport, 
        labeling, notice to product recipients, recordkeeping, periodic 
        testing or retesting, or product disposition.
        ``(3) Effect.--Notwithstanding any other provision of this Act 
    or the Public Health Service Act, an eligible product shall not be 
    considered an unapproved product (as defined in section 
    564(a)(2)(A)) and shall not be deemed adulterated or misbranded 
    under this Act because, with respect to such product, the Secretary 
    has, under paragraph (1), extended the expiration date and 
    authorized the introduction or delivery for introduction into 
    interstate commerce of such product after the expiration date 
    provided by the manufacturer.
        ``(4) 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.
    ``(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 (as defined in section 
    564(a)(2)(A)) 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 Dispensing.--The requirements of sections 503(b) 
and 520(e) shall not apply to an eligible product, and the product 
shall not be considered an unapproved product (as defined in section 
564(a)(2)(A)) and shall not be deemed adulterated or misbranded under 
this Act because it is dispensed without an individual prescription, 
if--
        ``(1) the product is dispensed during the circumstances 
    described in subsection (a)(1)(C); and
        ``(2) such dispensing without an individual prescription 
    occurs--
            ``(A) as permitted under the law of the State in which the 
        product is dispensed; or
            ``(B) in accordance with an order issued by the Secretary, 
        for the purposes and duration of the circumstances described in 
        subsection (a)(1)(C).
    ``(e) 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, or 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, or 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 enumerator 
    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, 319L, and 2811 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; and
            ``(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) Final Guidance on Development of Animal Models.--
        ``(1) In general.--Not later than 1 year after the date of the 
    enactment of the Pandemic and All-Hazards Preparedness 
    Reauthorization Act of 2013, the Secretary shall provide final 
    guidance to industry regarding the development of animal models to 
    support approval, clearance, or licensure of countermeasures 
    referred to in subsection (a) when human efficacy studies are not 
    ethical or feasible.
        ``(2) Authority to extend deadline.--The Secretary may extend 
    the deadline for providing final guidance under paragraph (1) by 
    not more than 6 months upon submission by the Secretary of a report 
    on the status of such guidance to the Committee on Energy and 
    Commerce of the House of Representatives and the Committee on 
    Health, Education, Labor, and Pensions of the Senate.
    ``(d) 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.
    ``(e) 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:
    ``(f) 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 a 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.--
            ``(A) Plans for security countermeasures.--The Secretary 
        shall establish regulatory management plans for all security 
        countermeasures for which a request is submitted under 
        paragraph (3)(A).
            ``(B) Plans for other eligible countermeasures.--The 
        Secretary shall determine whether resources are available to 
        establish regulatory management plans for eligible 
        countermeasures that are not security countermeasures. If 
        resources are available to establish regulatory management 
        plans for eligible countermeasures that are not security 
        countermeasures, and if resources are not available to 
        establish regulatory management plans for all eligible 
        countermeasures for which requests have been submitted, the 
        Director of the Biomedical Advanced Research and Development 
        Authority, in consultation with the Commissioner, shall 
        prioritize which eligible countermeasures may receive 
        regulatory management plans.''.
    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:
    ``(g) Annual Report.--Not later than 180 days after the date of 
enactment of this subsection, and annually thereafter, the Secretary 
shall make publicly available on the Web site of the Food and Drug 
Administration 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, 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 (f), the 
    extent to which the performance targets and goals set forth in 
    subsection (f)(4)(B) and the regulatory management plan have 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--
            ``(A) Center-specific objectives and accomplishments; and
            ``(B) the number of full-time equivalent employees of the 
        Food and Drug Administration who directly support the review of 
        countermeasures;
        ``(5) the number of countermeasure applications and submissions 
    submitted, the number of countermeasures approved, licensed, or 
    cleared, the status of remaining submitted applications and 
    submissions, and the number of each type of authorization issued 
    pursuant to section 564;
        ``(6) the number of written requests for a regulatory 
    management plan submitted under subsection (f)(3)(A), the number of 
    regulatory management plans developed, and the number of such plans 
    developed for security countermeasures; and
        ``(7) the number, type, and frequency of meetings between the 
    Food and Drug Administration and--
            ``(A) sponsors of a countermeasure as defined in subsection 
        (a); or
            ``(B) another agency engaged in development or management 
        of portfolios for such countermeasures, including the Centers 
        for Disease Control and Prevention, the Biomedical Advanced 
        Research and Development Authority, the National Institutes of 
        Health, and the appropriate agencies of the Department of 
        Defense.''.
    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) 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 (2)(C), by striking ``the designated 
    congressional committees (as defined in paragraph (10))'' and 
    inserting ``the appropriate committees of Congress'';
        (3) in paragraph (5)(B)(ii), by striking ``eight years'' and 
    inserting ``10 years'';
        (4) in subparagraph (C) of paragraph (6)--
            (A) in the subparagraph heading, by striking ``designated 
        congressional committees'' and inserting ``appropriate 
        congressional committees''; and
            (B) by striking ``the designated congressional committees'' 
        and inserting ``the appropriate congressional committees''; and
        (5) 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.''.
    (b) Reauthorization of the Special Reserve Fund.--Section 319F-2 of 
the Public Health Service Act (42 U.S.C. 247d-6b) is amended--
        (1) in subsection (c)--
            (A) by striking ``special reserve fund under paragraph 
        (10)'' each place it appears and inserting ``special reserve 
        fund as defined in subsection (h)''; and
            (B) by striking paragraphs (9) and (10); and
        (2) by adding at the end the following:
    ``(g) Special Reserve Fund.--
        ``(1) Authorization of appropriations.--In addition to amounts 
    appropriated to the special reserve fund prior to the date of the 
    enactment of this subsection, there is authorized to be 
    appropriated, for the procurement of security countermeasures under 
    subsection (c) and for carrying out section 319L (relating to the 
    Biomedical Advanced Research and Development Authority), 
    $2,800,000,000 for the period of fiscal years 2014 through 2018. 
    Amounts appropriated pursuant to the preceding sentence are 
    authorized to remain available until September 30, 2019.
        ``(2) Use of special reserve fund for advanced research and 
    development.--The Secretary may utilize not more than 50 percent of 
    the amounts authorized to be appropriated under paragraph (1) to 
    carry out section 319L (related to the Biomedical Advanced Research 
    and Development Authority). Amounts authorized to be appropriated 
    under this subsection to carry out section 319L are in addition to 
    amounts otherwise authorized to be appropriated to carry out such 
    section.
        ``(3) Restrictions on use of funds.--Amounts in the special 
    reserve fund shall not be used to pay costs other than payments 
    made by the Secretary to a vendor for advanced development (under 
    section 319L) or for procurement of a security countermeasure under 
    subsection (c)(7).
        ``(4) 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 annual Public Health Emergency Medical 
        Countermeasures Enterprise and Strategy Implementation Plan 
        (pursuant to section 2811(d)).
    ``(h) Definitions.--In this section:
        ``(1) The term `advanced research and development' has the 
    meaning given such term in section 319L(a).
        ``(2) The term `special reserve fund' means the `Biodefense 
    Countermeasures' appropriations account, any appropriation made 
    available pursuant to section 521(a) of the Homeland Security Act 
    of 2002, and any appropriation made available pursuant to 
    subsection (g)(1).''.
    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) 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.''.
    (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:
        ``(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 2014 through 2018, such amounts to remain 
    available until expended.''.
    (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 ``12 
years''.
    (e) Extension of Limited Antitrust Exemption.--
        (1) In general.--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 ``12-year''.
        (2) Effective date.--This subsection shall take effect as if 
    enacted on December 17, 2012.
    (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:
    ``(f) Independent Evaluation.--
        ``(1) In general.--Not later than 180 days after the date of 
    enactment of this subsection, the Comptroller General of the United 
    States 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 Comptroller General of the United 
    States 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.''.
    (g) 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.
    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 of the 
            second sentence 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)(D), by inserting before the semicolon 
        at the end the following: ``and that the potential depletion of 
        countermeasures currently in the stockpile is identified and 
        appropriately addressed, including through necessary 
        replenishment''; 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. Such authorization is in addition to 
    amounts in the special reserve fund referred to in subsection 
    (c)(10)(A).'' and inserting ``$533,800,000 for each of fiscal years 
    2014 through 2018. Such authorization is in addition to amounts in 
    the special reserve fund referred to in subsection (h).''.
    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 clause (i), by striking ``and'' at the end;
                (ii) in clause (ii), by striking the period and 
            inserting a semicolon; and
                (iii) 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).''; and
        (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.''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.
```