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[113th Congress Public Law 5]
[From the U.S. Government Publishing Office]

[[Page 127 STAT. 161]]

Public Law 113-5
113th Congress

                                 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. <<NOTE: Mar. 13, 2013 -  [H.R. 307]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2013. 42 USC 201 
note.>> 
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.

[[Page 127 STAT. 162]]

  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,

[[Page 127 STAT. 163]]

                or nuclear agent or agents, whether naturally occurring, 
                unintentional, or deliberate.
                    ``(B) <<NOTE: Definition.>>  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)'';

[[Page 127 STAT. 164]]

                    (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) <<NOTE: Consultation.>>  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) <<NOTE: Consultation.>>  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--

[[Page 127 STAT. 165]]

                          ``(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) <<NOTE: Deadline.>>  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

[[Page 127 STAT. 166]]

        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) <<NOTE: Evaluation.>>  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) <<NOTE: Evaluation.>>  evaluate progress made 
                in meeting timelines, allocations, benchmarks, and 
                milestones identified under subparagraph (D)(ii);
                    ``(G) <<NOTE: Reports.>>  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

[[Page 127 STAT. 167]]

                Stockpile, including by addressing the needs of 
                pediatric populations with respect to such 
                countermeasures and products in the Strategic National 
                Stockpile, including--
                          ``(i) <<NOTE: Lists.>>  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) <<NOTE: Evaluation.>>  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) <<NOTE: Public information.>>  be made 
                publicly available.
            ``(3) GAO report.--
                    ``(A) <<NOTE: Evaluation.>>  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

[[Page 127 STAT. 168]]

                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) <<NOTE: 42 USC 300hh-10 note.>>  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. <<NOTE: 42 USC 300hh-10a.>>  NATIONAL ADVISORY 
                            COMMITTEE ON CHILDREN AND DISASTERS.

    ``(a) <<NOTE: Consultation.>>  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--

[[Page 127 STAT. 169]]

            ``(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) <<NOTE: Consultation.>>  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.''.

[[Page 127 STAT. 170]]

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.

[[Page 127 STAT. 171]]

            ``(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) <<NOTE: Determination.>>  The 
                                Secretary's determination that the 
                                public health emergency no longer 
                                exists.
                                    ``(II) <<NOTE: Time period.>>  
                                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

[[Page 127 STAT. 172]]

                                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

[[Page 127 STAT. 173]]

                    ``(E) <<NOTE: Recommenda- tions.>>  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

[[Page 127 STAT. 174]]

                      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 <<NOTE: Criteria.>>  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:

[[Page 127 STAT. 175]]

            ``(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''.

[[Page 127 STAT. 176]]

    (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) <<NOTE: Appropriation authorization.>>  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

[[Page 127 STAT. 177]]

                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) <<NOTE: Deadline.>>  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) <<NOTE: Determination. Consultation.>>  
                utilize applicable interoperability standards as 
                determined by the Secretary, and in consultation with 
                the

[[Page 127 STAT. 178]]

                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 <<NOTE: Guidance. Recommenda- tions.>>  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) <<NOTE: Coordination.>>  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

[[Page 127 STAT. 179]]

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 <<NOTE: Repeal.>>  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)--

[[Page 127 STAT. 180]]

                          (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) <<NOTE: Determination.>>  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

[[Page 127 STAT. 181]]

                    (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) <<NOTE: Waiver. Limitations.>>  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).'';

[[Page 127 STAT. 182]]

            (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: <<NOTE: Review.>>  ``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: <<NOTE: Web posting.>>  ``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) <<NOTE: Determination.>>  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).''.

[[Page 127 STAT. 183]]

    (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. <<NOTE: 21 USC 360bbb-3a.>>  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

[[Page 127 STAT. 184]]

        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) <<NOTE: Definition.>>  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

[[Page 127 STAT. 185]]

        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) <<NOTE: Determination.>>  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. <<NOTE: 21 USC 360bbb-3b.>>  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--

[[Page 127 STAT. 186]]

            ``(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) <<NOTE: Consultations.>>  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;

[[Page 127 STAT. 187]]

                    ``(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) <<NOTE: Deadline.>>  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) <<NOTE: Reports.>>  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) <<NOTE: Deadline.>>  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

[[Page 127 STAT. 188]]

                    ``(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) <<NOTE: Consultation.>>  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.

[[Page 127 STAT. 189]]

                    ``(C) <<NOTE: Time period.>>  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. <<NOTE: Determination.>>  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

[[Page 127 STAT. 190]]

                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) <<NOTE: Determination.>>  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 <<NOTE: Consultation. Prioritization.>>  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) <<NOTE: Public information. Web posting.>>  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

[[Page 127 STAT. 191]]

        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) <<NOTE: Notification.>>  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

[[Page 127 STAT. 192]]

                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) <<NOTE: Consultation.>>  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) <<NOTE: 42 USC 284m-1.>>  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'';

[[Page 127 STAT. 193]]

            (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.--

[[Page 127 STAT. 194]]

            ``(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) <<NOTE: Determination. Procurement.>>  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

[[Page 127 STAT. 195]]

        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) <<NOTE: 42 USC 247d-6a note.>>  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) <<NOTE: Deadline.>>  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). <<NOTE: Review. Assessment.>>  
        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.--

[[Page 127 STAT. 196]]

            (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: <<NOTE: Review. Deadline.>>  ``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

[[Page 127 STAT. 197]]

        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.''.

    Approved March 13, 2013.

LEGISLATIVE HISTORY--H.R. 307:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 159 (2013):
            Jan. 22, considered and passed House.
            Feb. 27, considered and passed Senate, amended.
            Mar. 4, House concurred in Senate amendment.

                                  <all>
```