[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6672 Engrossed in House (EH)]

112th CONGRESS
  2d Session
                                H. R. 6672

_______________________________________________________________________

                                 AN ACT


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

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Pandemic and All-
Hazards Preparedness Reauthorization Act of 2012''.
    (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 redeployment of federally funded personnel during a 
                            public health emergency.
Sec. 202. Improving State and local public health security.
Sec. 203. Hospital preparedness and medical surge capacity.
Sec. 204. Enhancing situational awareness and biosurveillance.
Sec. 205. Eliminating duplicative Project Bioshield reports.
           TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW

Sec. 301. Special protocol assessment.
Sec. 302. Authorization for medical products for use in emergencies.
Sec. 303. Definitions.
Sec. 304. Enhancing medical countermeasure activities.
Sec. 305. Regulatory management plans.
Sec. 306. Report.
Sec. 307. Pediatric medical countermeasures.
  TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND 
                              DEVELOPMENT

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

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

SEC. 101. NATIONAL HEALTH SECURITY STRATEGY.

    (a) In General.--Section 2802 of the Public Health Service Act (42 
U.S.C. 300hh-1) is amended--
            (1) in subsection (a)(1), by striking ``2009'' and 
        inserting ``2014''; and
            (2) in subsection (b)--
                    (A) in paragraph (1)(A), by inserting ``, including 
                drills and exercises to ensure medical surge capacity 
                for events without notice'' after ``exercises''; and
                    (B) in paragraph (3)--
                            (i) in the matter preceding subparagraph 
                        (A)--
                                    (I) by striking ``facilities), and 
                                trauma care'' and inserting ``and 
                                ambulatory care facilities and which 
                                may include dental health facilities), 
                                and trauma care, critical care,''; and
                                    (II) by inserting ``(including 
                                related availability, accessibility, 
                                and coordination)'' after ``public 
                                health emergencies'';
                            (ii) in subparagraph (A), by inserting 
                        ``and trauma'' after ``medical'';
                            (iii) in subparagraph (B), by striking 
                        ``Medical evacuation and fatality management'' 
                        and inserting ``Fatality management'';
                            (iv) by redesignating subparagraphs (C), 
                        (D), and (E) as subparagraphs (D), (E), and 
                        (F), respectively;
                            (v) by inserting after subparagraph (B), 
                        the following the new subparagraph:
                    ``(C) Coordinated medical triage and evacuation to 
                appropriate medical institutions based on patient 
                medical need, taking into account regionalized systems 
                of care.'';
                            (vi) in subparagraph (E), as redesignated 
                        by clause (iv), by inserting ``(which may 
                        include such dental health assets)'' after 
                        ``medical assets''; and
                            (vii) by adding at the end the following:
                    ``(G) Optimizing a coordinated and flexible 
                approach to the medical surge capacity of hospitals, 
                other health care facilities, critical care, and trauma 
                care (which may include trauma centers) and emergency 
                medical systems.'';
                    (C) in paragraph (4)--
                            (i) in subparagraph (A), by inserting ``, 
                        including the unique needs and considerations 
                        of individuals with disabilities,'' after 
                        ``medical needs of at-risk individuals''; and
                            (ii) in subparagraph (B), by inserting 
                        ``the'' before ``purpose of this section''; and
                    (D) by adding at the end the following:
            ``(7) Countermeasures.--
                    ``(A) Promoting strategic initiatives to advance 
                countermeasures to diagnose, mitigate, prevent, or 
                treat harm from any biological agent or toxin, 
                chemical, radiological, or nuclear agent or agents, 
                whether naturally occurring, unintentional, or 
                deliberate.
                    ``(B) For purposes of this paragraph, the term 
                `countermeasures' has the same meaning as the terms 
                `qualified countermeasures' under section 319F-1, 
                `qualified pandemic and epidemic products' under 
                section 319F-3, and `security countermeasures' under 
                section 319F-2.
            ``(8) Medical and public health community resiliency.--
        Strengthening the ability of States, local communities, and 
        tribal communities to prepare for, respond to, and be resilient 
        in the event of public health emergencies, whether naturally 
        occurring, unintentional, or deliberate by--
                    ``(A) optimizing alignment and integration of 
                medical and public health preparedness and response 
                planning and capabilities with and into routine daily 
                activities; and
                    ``(B) promoting familiarity with local medical and 
                public health systems.''.
    (b) At-Risk Individuals.--Section 2814 of the Public Health Service 
Act (42 U.S.C. 300hh-16) is amended--
            (1) by striking paragraphs (5), (7), and (8);
            (2) in paragraph (4), by striking ``2811(b)(3)(B)'' and 
        inserting ``2802(b)(4)(B)'';
            (3) by redesignating paragraphs (1) through (4) as 
        paragraphs (2) through (5), respectively;
            (4) by inserting before paragraph (2) (as so redesignated), 
        the following:
            ``(1) monitor emerging issues and concerns as they relate 
        to medical and public health preparedness and response for at-
        risk individuals in the event of a public health emergency 
        declared by the Secretary under section 319;'';
            (5) by amending paragraph (2) (as so redesignated) to read 
        as follows:
            ``(2) oversee the implementation of the preparedness goals 
        described in section 2802(b) with respect to the public health 
        and medical needs of at-risk individuals in the event of a 
        public health emergency, as described in section 2802(b)(4);'';
            (6) by inserting after paragraph (6), the following:
            ``(7) disseminate and, as appropriate, update novel and 
        best practices of outreach to and care of at-risk individuals 
        before, during, and following public health emergencies in as 
        timely a manner as is practicable, including from the time a 
        public health threat is identified; and
            ``(8) ensure that public health and medical information 
        distributed by the Department of Health and Human Services 
        during a public health emergency is delivered in a manner that 
        takes into account the range of communication needs of the 
        intended recipients, including at-risk individuals.''.

SEC. 102. ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE.

    (a) In General.--Section 2811 of the Public Health Service Act (42 
U.S.C. 300hh-10) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (3), by inserting ``, security 
                countermeasures (as defined in section 319F-2),'' after 
                ``qualified countermeasures (as defined in section 
                319F-1)'';
                    (B) in paragraph (4), by adding at the end the 
                following:
                    ``(D) Policy coordination and strategic 
                direction.--Provide integrated policy coordination and 
                strategic direction with respect to all matters related 
                to Federal public health and medical preparedness and 
                execution and deployment of the Federal response for 
                public health emergencies and incidents covered by the 
                National Response Plan developed pursuant to section 
                504(6) of the Homeland Security Act of 2002, or any 
                successor plan, before, during, and following public 
                health emergencies.
                    ``(E) Identification of inefficiencies.--Identify 
                and minimize gaps, duplication, and other 
                inefficiencies in medical and public health 
                preparedness and response activities and the actions 
                necessary to overcome these obstacles.
                    ``(F) Coordination of grants and agreements.--Align 
                and coordinate medical and public health grants and 
                cooperative agreements as applicable to preparedness 
                and response activities authorized under this Act, to 
                the extent possible, including program requirements, 
                timelines, and measurable goals, and in consultation 
                with the Secretary of Homeland Security, to--
                            ``(i) optimize and streamline medical and 
                        public health preparedness and response 
                        capabilities and the ability of local 
                        communities to respond to public health 
                        emergencies; and
                            ``(ii) gather and disseminate best 
                        practices among grant and cooperative agreement 
                        recipients, as appropriate.
                    ``(G) Drill and operational exercises.--Carry out 
                drills and operational exercises, in consultation with 
                the Department of Homeland Security, the Department of 
                Defense, the Department of Veterans Affairs, and other 
                applicable Federal departments and agencies, as 
                necessary and appropriate, to identify, inform, and 
                address gaps in and policies related to all-hazards 
                medical and public health preparedness and response, 
                including exercises based on--
                            ``(i) identified threats for which 
                        countermeasures are available and for which no 
                        countermeasures are available; and
                            ``(ii) unknown threats for which no 
                        countermeasures are available.
                    ``(H) National security priority.--On a periodic 
                basis consult with, as applicable and appropriate, the 
                Assistant to the President for National Security 
                Affairs, to provide an update on, and discuss, medical 
                and public health preparedness and response activities 
                pursuant to this Act and the Federal Food, Drug, and 
                Cosmetic Act, including progress on the development, 
                approval, clearance, and licensure of medical 
                countermeasures.''; and
                    (C) by adding at the end the following:
            ``(7) Countermeasures budget plan.--Develop, and update on 
        an annual basis, a coordinated 5-year budget plan based on the 
        medical countermeasure priorities described in subsection (d). 
        Each such plan shall--
                    ``(A) include consideration of the entire medical 
                countermeasures enterprise, including--
                            ``(i) basic research and advanced research 
                        and development;
                            ``(ii) approval, clearance, licensure, and 
                        authorized uses of products; and
                            ``(iii) procurement, stockpiling, 
                        maintenance, and replenishment of all products 
                        in the Strategic National Stockpile;
                    ``(B) inform prioritization of resources and 
                include measurable outputs and outcomes to allow for 
                the tracking of the progress made toward identified 
                priorities;
                    ``(C) identify medical countermeasure life-cycle 
                costs to inform planning, budgeting, and anticipated 
                needs within the continuum of the medical 
                countermeasure enterprise consistent with section 319F-
                2; and
                    ``(D) be made available to the appropriate 
                committees of Congress upon request.'';
            (2) by striking subsection (c) and inserting the following:
    ``(c) Functions.--The Assistant Secretary for Preparedness and 
Response shall--
            ``(1) have lead responsibility within the Department of 
        Health and Human Services for emergency preparedness and 
        response policy coordination and strategic direction;
            ``(2) have authority over and responsibility for--
                    ``(A) the National Disaster Medical System pursuant 
                to section 2812;
                    ``(B) the Hospital Preparedness Cooperative 
                Agreement Program pursuant to section 319C-2;
                    ``(C) the Biomedical Advanced Research and 
                Development Authority pursuant to section 319L;
                    ``(D) the Medical Reserve Corps pursuant to section 
                2813;
                    ``(E) the Emergency System for Advance Registration 
                of Volunteer Health Professionals pursuant to section 
                319I; and
                    ``(F) administering grants and related authorities 
                related to trauma care under parts A through C of title 
                XII, such authority to be transferred by the Secretary 
                from the Administrator of the Health Resources and 
                Services Administration to such Assistant Secretary;
            ``(3) exercise the responsibilities and authorities of the 
        Secretary with respect to the coordination of--
                    ``(A) the Public Health Emergency Preparedness 
                Cooperative Agreement Program pursuant to section 319C-
                1;
                    ``(B) the Strategic National Stockpile pursuant to 
                section 319F-2; and
                    ``(C) the Cities Readiness Initiative; and
            ``(4) assume other duties as determined appropriate by the 
        Secretary.''; and
            (3) by adding at the end the following:
    ``(d) Public Health Emergency Medical Countermeasures Enterprise 
Strategy and Implementation Plan.--
            ``(1) In general.--Not later than 180 days after the date 
        of enactment of this subsection, and every year thereafter, the 
        Assistant Secretary for Preparedness and Response shall develop 
        and submit to the appropriate committees of Congress a 
        coordinated strategy and accompanying implementation plan for 
        medical countermeasures to address chemical, biological, 
        radiological, and nuclear threats. In developing such a plan, 
        the Assistant Secretary for Preparedness and Response shall 
        consult with the Director of the Biomedical Advanced Research 
        and Development Authority, the Director of the National 
        Institutes of Health, the Director of the Centers for Disease 
        Control and Prevention, and the Commissioner of Food and Drugs. 
        Such strategy and plan shall be known as the `Public Health 
        Emergency Medical Countermeasures Enterprise Strategy and 
        Implementation Plan'.
            ``(2) Requirements.--The plan under paragraph (1) shall--
                    ``(A) describe the chemical, biological, 
                radiological, and nuclear agent or agents that may 
                present a threat to the Nation and the corresponding 
                efforts to develop qualified countermeasures (as 
                defined in section 319F-1), security countermeasures 
                (as defined in section 319F-2), or qualified pandemic 
                or epidemic products (as defined in section 319F-3) for 
                each threat;
                    ``(B) evaluate the progress of all activities with 
                respect to such countermeasures or products, including 
                research, advanced research, development, procurement, 
                stockpiling, deployment, distribution, and utilization;
                    ``(C) identify and prioritize near-, mid-, and 
                long-term needs with respect to such countermeasures or 
                products to address a chemical, biological, 
                radiological, and nuclear threat or threats;
                    ``(D) identify, with respect to each category of 
                threat, a summary of all awards and contracts, 
                including advanced research and development and 
                procurement, that includes--
                            ``(i) the time elapsed from the issuance of 
                        the initial solicitation or request for a 
                        proposal to the adjudication (such as the 
                        award, denial of award, or solicitation 
                        termination); and
                            ``(ii) an identification of projected 
                        timelines, anticipated funding allocations, 
                        benchmarks, and milestones for each medical 
                        countermeasure priority under subparagraph (C), 
                        including projected needs with regard to 
                        replenishment of the Strategic National 
                        Stockpile;
                    ``(E) be informed by the recommendations of the 
                National Biodefense Science Board pursuant to section 
                319M;
                    ``(F) evaluate progress made in meeting timelines, 
                allocations, benchmarks, and milestones identified 
                under subparagraph (D)(ii);
                    ``(G) report on the amount of funds available for 
                procurement in the special reserve fund as defined in 
                section 319F-2(h) and the impact this funding will have 
                on meeting the requirements under section 319F-2;
                    ``(H) incorporate input from Federal, State, local, 
                and tribal stakeholders;
                    ``(I) identify the progress made in meeting the 
                medical countermeasure priorities for at-risk 
                individuals (as defined in 2802(b)(4)(B)), as 
                applicable under subparagraph (C), including with 
                regard to the projected needs for related stockpiling 
                and replenishment of the Strategic National Stockpile, 
                including by addressing the needs of pediatric 
                populations with respect to such countermeasures and 
                products in the Strategic National Stockpile, 
                including--
                            ``(i) a list of such countermeasures and 
                        products necessary to address the needs of 
                        pediatric populations;
                            ``(ii) a description of measures taken to 
                        coordinate with the Office of Pediatric 
                        Therapeutics of the Food and Drug 
                        Administration to maximize the labeling, 
                        dosages, and formulations of such 
                        countermeasures and products for pediatric 
                        populations;
                            ``(iii) a description of existing gaps in 
                        the Strategic National Stockpile and the 
                        development of such countermeasures and 
                        products to address the needs of pediatric 
                        populations; and
                            ``(iv) an evaluation of the progress made 
                        in addressing priorities identified pursuant to 
                        subparagraph (C);
                    ``(J) identify the use of authority and activities 
                undertaken pursuant to sections 319F-1(b)(1), 319F-
                1(b)(2), 319F-1(b)(3), 319F-1(c), 319F-1(d), 319F-1(e), 
                319F-2(c)(7)(C)(iii), 319F-2 (c)(7)(C)(iv), and 319F-
                2(c)(7)(C)(v) of this Act, and subsections (a)(1), 
                (b)(1), and (e) of section 564 of the Federal Food, 
                Drug, and Cosmetic Act, by summarizing--
                            ``(i) the particular actions that were 
                        taken under the authorities specified, 
                        including, as applicable, the identification of 
                        the threat agent, emergency, or the biomedical 
                        countermeasure with respect to which the 
                        authority was used;
                            ``(ii) the reasons underlying the decision 
                        to use such authorities, including, as 
                        applicable, the options that were considered 
                        and rejected with respect to the use of such 
                        authorities;
                            ``(iii) the number of, nature of, and other 
                        information concerning the persons and entities 
                        that received a grant, cooperative agreement, 
                        or contract pursuant to the use of such 
                        authorities, and the persons and entities that 
                        were considered and rejected for such a grant, 
                        cooperative agreement, or contract, except that 
                        the report need not disclose the identity of 
                        any such person or entity;
                            ``(iv) whether, with respect to each 
                        procurement that is approved by the President 
                        under section 319F-2(c)(6), a contract was 
                        entered into within one year after such 
                        approval by the President; and
                            ``(v) with respect to section 319F-1(d), 
                        for the one-year period for which the report is 
                        submitted, the number of persons who were paid 
                        amounts totaling $100,000 or greater and the 
                        number of persons who were paid amounts 
                        totaling at least $50,000 but less than 
                        $100,000; and
                    ``(K) be made publicly available.
            ``(3) GAO report.--
                    ``(A) In general.--Not later than 1 year after the 
                date of the submission to the Congress of the first 
                Public Health Emergency Medical Countermeasures 
                Enterprise Strategy and Implementation Plan, the 
                Comptroller General of the United States shall conduct 
                an independent evaluation, and submit to the 
                appropriate committees of Congress a report, concerning 
                such Strategy and Implementation Plan.
                    ``(B) Content.--The report described in 
                subparagraph (A) shall review and assess--
                            ``(i) the near-term, mid-term, and long-
                        term medical countermeasure needs and 
                        identified priorities of the Federal Government 
                        pursuant to paragraph (2)(C);
                            ``(ii) the activities of the Department of 
                        Health and Human Services with respect to 
                        advanced research and development pursuant to 
                        section 319L; and
                            ``(iii) the progress made toward meeting 
                        the timelines, allocations, benchmarks, and 
                        milestones identified in the Public Health 
                        Emergency Medical Countermeasures Enterprise 
                        Strategy and Implementation Plan under this 
                        subsection.
    ``(e) Protection of National Security.--In carrying out subsections 
(b)(7) and (d), the Secretary shall ensure that information and items 
that could compromise national security, contain confidential 
commercial information, or contain proprietary information are not 
disclosed.''.
    (b) Interagency Coordination Plan.--In the first Public Health 
Emergency Countermeasures Enterprise Strategy and Implementation Plan 
submitted under subsection (d) of section 2811 of the Public Health 
Service Act (42 U.S.C. 300hh-10) (as added by subsection (a)(3)), the 
Secretary of Health and Human Services, in consultation with the 
Secretary of Defense, shall include a description of the manner in 
which the Department of Health and Human Services is coordinating with 
the Department of Defense regarding countermeasure activities to 
address chemical, biological, radiological, and nuclear threats. Such 
report shall include information with respect to--
            (1) the research, advanced research, development, 
        procurement, stockpiling, and distribution of countermeasures 
        to meet identified needs; and
            (2) the coordination of efforts between the Department of 
        Health and Human Services and the Department of Defense to 
        address countermeasure needs for various segments of the 
        population.

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

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

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

    ``(a) Establishment.--The Secretary, in consultation with the 
Secretary of Homeland Security, shall establish an advisory committee 
to be known as the `National Advisory Committee on Children and 
Disasters' (referred to in this section as the `Advisory Committee').
    ``(b) Duties.--The Advisory Committee shall--
            ``(1) provide advice and consultation with respect to the 
        activities carried out pursuant to section 2814, as applicable 
        and appropriate;
            ``(2) evaluate and provide input with respect to the 
        medical and public health needs of children as they relate to 
        preparation for, response to, and recovery from all-hazards 
        emergencies; and
            ``(3) provide advice and consultation with respect to State 
        emergency preparedness and response activities and children, 
        including related drills and exercises pursuant to the 
        preparedness goals under section 2802(b).
    ``(c) Additional Duties.--The Advisory Committee may provide advice 
and recommendations to the Secretary with respect to children and the 
medical and public health grants and cooperative agreements as 
applicable to preparedness and response activities authorized under 
this title and title III.
    ``(d) Membership.--
            ``(1) In general.--The Secretary, in consultation with such 
        other Secretaries as may be appropriate, shall appoint not to 
        exceed 15 members to the Advisory Committee. In appointing such 
        members, the Secretary shall ensure that the total membership 
        of the Advisory Committee is an odd number.
            ``(2) Required members.--The Secretary, in consultation 
        with such other Secretaries as may be appropriate, may appoint 
        to the Advisory Committee under paragraph (1) such individuals 
        as may be appropriate to perform the duties described in 
        subsections (b) and (c), which may include--
                    ``(A) the Assistant Secretary for Preparedness and 
                Response;
                    ``(B) the Director of the Biomedical Advanced 
                Research and Development Authority;
                    ``(C) the Director of the Centers for Disease 
                Control and Prevention;
                    ``(D) the Commissioner of Food and Drugs;
                    ``(E) the Director of the National Institutes of 
                Health;
                    ``(F) the Assistant Secretary of the Administration 
                for Children and Families;
                    ``(G) the Administrator of the Federal Emergency 
                Management Agency;
                    ``(H) at least two non-Federal health care 
                professionals with expertise in pediatric medical 
                disaster planning, preparedness, response, or recovery;
                    ``(I) at least two representatives from State, 
                local, territorial, or tribal agencies with expertise 
                in pediatric disaster planning, preparedness, response, 
                or recovery; and
                    ``(J) representatives from such Federal agencies 
                (such as the Department of Education and the Department 
                of Homeland Security) as determined necessary to 
                fulfill the duties of the Advisory Committee, as 
                established under subsections (b) and (c).
    ``(e) Meetings.--The Advisory Committee shall meet not less than 
biannually.
    ``(f) Sunset.--The Advisory Committee shall terminate on the date 
that is 5 years after the date of enactment of the Pandemic and All-
Hazards Preparedness Reauthorization Act of 2012.''.

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 2013 through 
        2017''.

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 2013 through 2017 to carry out this section''.

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

SEC. 201. TEMPORARY REDEPLOYMENT OF FEDERALLY FUNDED 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 Redeployment of Federally Funded Personnel During a 
Public Health Emergency.--
            ``(1) Emergency redeployment of federally funded 
        personnel.--Notwithstanding any other provision of law, and 
        subject to paragraph (2), upon request by the Governor of a 
        State or the chief of a tribe or such Governor or chief's 
        designee, the Secretary may authorize the requesting State or 
        tribe to temporarily redeploy, for purposes of immediately 
        addressing a public health emergency in the State or tribe, 
        non-Federal personnel funded in whole or in part through, as 
        appropriate, programs under this Act.
            ``(2) Activation of emergency redeployment.--
                    ``(A) Public health emergency.--The Secretary may 
                authorize a temporary redeployment 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 redeployment of personnel under paragraph 
                (1), the Governor of a State or the chief of a tribe 
                shall submit to the Secretary a request for such 
                authority 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 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 
                        redeployment of personnel.
                            ``(iii) An assurance that the requested 
                        temporary redeployment of personnel is 
                        consistent with the 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 
                                redeployed pursuant to the requested 
                                authority; and
                                    ``(II) the number of personnel who 
                                would be so redeployed from each such 
                                program.
                            ``(v) Such other information and assurances 
                        as the Secretary may require.
                    ``(C) Consideration.--In reviewing a request for 
                temporary redeployment under paragraph (1) of personnel 
                funded through a Federal program, the Secretary shall 
                consider the degree to which the program would be 
                adversely affected by the redeployment.
                    ``(D) Termination and extension.--
                            ``(i) Termination.--A State or tribe's 
                        authority for a temporary redeployment of 
                        personnel under paragraph (1) shall terminate 
                        upon the earlier of the following:
                                    ``(I) The Secretary's determination 
                                that the public health emergency no 
                                longer exists.
                                    ``(II) Subject to clause (ii), the 
                                expiration of the 30-day period 
                                following the date on which the 
                                Secretary approved the State or tribe's 
                                request for such authority.
                            ``(ii) Extension authority.--The Secretary 
                        may extend the authority to authorize a 
                        temporary redeployment 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 tribe that 
                                submitted the initial request for 
                                authority for a temporary redeployment 
                                of personnel submits a request for an 
                                extension of such authority; and
                                    ``(II) the request for an extension 
                                contains the same type of information 
                                and assurances necessary for the 
                                approval of an initial request for such 
                                authority.
            ``(3) Notice to personnel of possibility of redeployment.--
        The Secretary shall ensure that, if a State or tribe receives 
        Federal funds for personnel who are subject to the Secretary's 
        redeployment authority under this subsection, the State or 
        tribe gives notice to such personnel of the possibility of 
        redeployment--
                    ``(A) at the time of hiring; or
                    ``(B) in the case of personnel hired before the 
                date of the enactment of this subsection, as soon as 
                practicable.
            ``(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 authority for a 
                temporary redeployment of personnel; and
                    ``(B) any request for an extension of such 
                authority.
            ``(5) Guidance.--The Secretary shall--
                    ``(A) not later than 6 months after the enactment 
                of this subsection, issue proposed guidance on the 
                temporary redeployment 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 2012, the Comptroller General of the 
        United States shall conduct an independent evaluation, and 
        submit to the appropriate committees of the Congress a report, 
        on the Secretary's authority under this subsection, including--
                    ``(A) a description of how, and under what 
                circumstances, such authority has been used by States 
                and tribes;
                    ``(B) an analysis of how such authority has 
                assisted States and tribes in responding to public 
                health emergencies;
                    ``(C) an evaluation of how such authority 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 redeployed pursuant to such authority have 
                been adversely affected by the redeployment; and
                    ``(E) recommendations on how such authority could 
                be improved to further assist in responding to public 
                health emergencies.
            ``(7) Definition.--In this subsection, 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.--The authority under this subsection shall 
        terminate on the date that is 5 years after the date of 
        enactment of the Pandemic and All-Hazards Preparedness 
        Reauthorization Act of 2012.''.

SEC. 202. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.

    (a) Cooperative Agreements.--Section 319C-1 of the Public Health 
Service Act (42 U.S.C. 247d-3a) is amended--
            (1) in subsection (b)(1)(C), by striking ``consortium of 
        entities described in subparagraph (A)'' and inserting 
        ``consortium of States'';
            (2) in subsection (b)(2)--
                    (A) in subparagraph (A)--
                            (i) by striking clauses (i) and (ii) and 
                        inserting the following:
                            ``(i) a description of the activities such 
                        entity will carry out under the agreement to 
                        meet the goals identified under section 2802, 
                        including with respect to chemical, biological, 
                        radiological, or nuclear threats, whether 
                        naturally occurring, unintentional, or 
                        deliberate;
                            ``(ii) a description of the activities such 
                        entity will carry out with respect to pandemic 
                        influenza, as a component of the activities 
                        carried out under clause (i), and consistent 
                        with the requirements of paragraphs (2) and (5) 
                        of subsection (g);'';
                            (ii) in clause (iv), by striking ``and'' at 
                        the end; and
                            (iii) by adding at the end the following:
                            ``(vi) a description of how, as 
                        appropriate, the entity may partner with 
                        relevant public and private stakeholders in 
                        public health emergency preparedness and 
                        response;
                            ``(vii) a description of how the entity, as 
                        applicable and appropriate, will coordinate 
                        with State emergency preparedness and response 
                        plans in public health emergency preparedness, 
                        including State educational agencies (as 
                        defined in section 9101(41) of the Elementary 
                        and Secondary Education Act of 1965) and State 
                        child care lead agencies (designated under 
                        section 658D of the Child Care and Development 
                        Block Grant Act of 1990);
                            ``(viii) in the case of entities that 
                        operate on the United States-Mexico border or 
                        the United States-Canada border, a description 
                        of the activities such entity will carry out 
                        under the agreement that are specific to the 
                        border area including disease detection, 
                        identification, investigation, and preparedness 
                        and response activities related to emerging 
                        diseases and infectious disease outbreaks 
                        whether naturally occurring or due to 
                        bioterrorism, consistent with the requirements 
                        of this section; and
                            ``(ix) a description of any activities that 
                        such entity will use to analyze real-time 
                        clinical specimens for pathogens of public 
                        health or bioterrorism significance, including 
                        any utilization of poison control centers;''; 
                        and
                    (B) in subparagraph (C), by inserting ``, including 
                addressing the needs of at-risk individuals,'' after 
                ``capabilities of such entity'';
            (3) in subsection (f)--
                    (A) in paragraph (2), by adding ``and'' at the end;
                    (B) in paragraph (3), by striking ``; and'' and 
                inserting a period; and
                    (C) by striking paragraph (4);
            (4) in subsection (g)--
                    (A) in paragraph (1), by striking subparagraph (A) 
                and inserting the following:
                    ``(A) include outcome goals representing 
                operational achievements of the National Preparedness 
                Goals developed under section 2802(b) with respect to 
                all-hazards, including chemical, biological, 
                radiological, or nuclear threats; and''; and
                    (B) in paragraph (2)(A), by adding at the end the 
                following: ``The Secretary shall periodically update, 
                as necessary and appropriate, such pandemic influenza 
                plan criteria and shall require the integration of such 
                criteria into the benchmarks and standards described in 
                paragraph (1).'';
            (5) by striking subsection (h);
            (6) in subsection (i)--
                    (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 2013''; 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 
                                2014 through 2017'';
                            (ii) by striking subparagraph (B);
                            (iii) by redesignating subparagraphs (C) 
                        and (D) as subparagraphs (B) and (C), 
                        respectively; and
                            (iv) in subparagraph (C), as so 
                        redesignated, by striking ``subparagraph (C)'' 
                        and inserting ``subparagraph (B)'';
                    (B) in subparagraphs (C) and (D) of paragraph (3), 
                by striking ``(1)(A)(i)(I)'' each place it appears and 
                inserting ``(1)(A)'';
                    (C) in paragraph (4)(B), by striking ``subsection 
                (c)'' and inserting ``subsection (b)''; and
                    (D) by adding at the end the following:
            ``(7) Availability of cooperative agreement funds.--
                    ``(A) In general.--Amounts provided to an eligible 
                entity under a cooperative agreement under subsection 
                (a) for a fiscal year and remaining unobligated at the 
                end of such year shall remain available to such entity 
                for the next fiscal year for the purposes for which 
                such funds were provided.
                    ``(B) Funds contingent on achieving benchmarks.--
                The continued availability of funds under subparagraph 
                (A) with respect to an entity shall be contingent upon 
                such entity achieving the benchmarks and submitting the 
                pandemic influenza plan as described in subsection 
                (g).''; and
            (7) in subsection (j), by striking paragraph (3).
    (b) Vaccine Tracking and Distribution.--Section 319A(e) of the 
Public Health Service Act (42 U.S.C. 247d-1(e)) is amended by striking 
``such sums for each of fiscal years 2007 through 2011'' and inserting 
``$30,800,000 for each of fiscal years 2013 through 2017''.

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 2013 through 
        2017''.
            (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 2013 
                through 2017''.
    (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 capacity 
        and preparedness to address the needs of pediatric and other 
        at-risk populations'' before the period at the end;
            (2) in subsection (b)(1)(A)(ii), by striking ``centers, 
        primary'' and inserting ``centers, community health centers, 
        primary'';
            (3) by striking subsection (c) and inserting the following:
    ``(c) Use of Funds.--An award under subsection (a) shall be 
expended for activities to achieve the preparedness goals described 
under paragraphs (1), (3), (4), (5), and (6) of section 2802(b) with 
respect to all-hazards, including chemical, biological, radiological, 
or nuclear threats.'';
            (4) by striking subsection (g) and inserting the following:
    ``(g) Coordination.--
            ``(1) Local response capabilities.--An eligible entity 
        shall, to the extent practicable, ensure that activities 
        carried out under an award under subsection (a) are coordinated 
        with activities of relevant local Metropolitan Medical Response 
        Systems, local Medical Reserve Corps, the local Cities 
        Readiness Initiative, and local emergency plans.
            ``(2) National collaboration.--Partnerships consisting of 
        one or more eligible entities under this section may, to the 
        extent practicable, collaborate with other partnerships 
        consisting of one or more eligible entities under this section 
        for purposes of national coordination and collaboration with 
        respect to activities to achieve the preparedness goals 
        described under paragraphs (1), (3), (4), (5), and (6) of 
        section 2802(b).'';
            (5) in subsection (i)--
                    (A) by striking ``The requirements of'' and 
                inserting the following:
            ``(1) In general.--The requirements of''; and
                    (B) by adding at the end the following:
            ``(2) Meeting goals of national health security strategy.--
        The Secretary shall implement objective, evidence-based metrics 
        to ensure that entities receiving awards under this section are 
        meeting, to the extent practicable, the applicable goals of the 
        National Health Security Strategy under section 2802.''; and
            (6) in subsection (j)--
                    (A) by amending paragraph (1) to read as follows:
            ``(1) In general.--For purposes of carrying out this 
        section, there is authorized to be appropriated $374,700,000 
        for each of fiscal years 2013 through 2017.''; and
                    (B) by adding at the end the following:
            ``(4) Availability of cooperative agreement funds.--
                    ``(A) In general.--Amounts provided to an eligible 
                entity under a cooperative agreement under subsection 
                (a) for a fiscal year and remaining unobligated at the 
                end of such year shall remain available to such entity 
                for the next fiscal year for the purposes for which 
                such funds were provided.
                    ``(B) Funds contingent on achieving benchmarks.--
                The continued availability of funds under subparagraph 
                (A) with respect to an entity shall be contingent upon 
                such entity achieving the benchmarks and submitting the 
                pandemic influenza plan as required under subsection 
                (i).''.

SEC. 204. ENHANCING SITUATIONAL AWARENESS AND BIOSURVEILLANCE.

    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); and
            (3) in subsection (d)--
                    (A) in the subsection heading, by striking ``Public 
                Health Situational Awareness'' and inserting 
                ``Modernizing Public Health Situational Awareness and 
                BioSurveillance'';
                    (B) in paragraph (1)--
                            (i) by striking ``Pandemic and All-Hazards 
                        Preparedness Act'' and inserting ``Pandemic and 
                        All-Hazards Preparedness Reauthorization Act of 
                        2012''; and
                            (ii) by inserting ``, novel emerging 
                        threats,'' after ``disease outbreaks'';
                    (C) by striking paragraph (2) and inserting the 
                following:
            ``(2) Strategy and implementation plan.--Not later than 180 
        days after the date of enactment of the Pandemic and All-
        Hazards Preparedness Reauthorization Act of 2012, the Secretary 
        shall submit to the appropriate committees of Congress a 
        coordinated strategy and an accompanying implementation plan 
        that identifies and demonstrates the measurable steps the 
        Secretary will carry out to--
                    ``(A) develop, implement, and evaluate the network 
                described in paragraph (1), utilizing the elements 
                described in paragraph (3);
                    ``(B) modernize and enhance biosurveillance 
                activities; and
                    ``(C) improve information sharing, coordination, 
                and communication among disparate biosurveillance 
                systems supported by the Department of Health and Human 
                Services.'';
                    (D) in paragraph (3)(D), by inserting ``community 
                health centers, health centers'' after ``poison 
                control,'';
                    (E) in paragraph (5), by striking subparagraph (A) 
                and inserting the following:
                    ``(A) utilize applicable interoperability standards 
                as determined by the Secretary, and in consultation 
                with the Office of the National Coordinator for Health 
                Information Technology, through a joint public and 
                private sector process;''; and
                    (F) by adding at the end the following:
            ``(6) Consultation with the national biodefense science 
        board.--In carrying out this section and consistent with 
        section 319M, the National Biodefense Science Board shall 
        provide expert advice and guidance, including recommendations, 
        regarding the measurable steps the Secretary should take to 
        modernize and enhance biosurveillance activities pursuant to 
        the efforts of the Department of Health and Human Services to 
        ensure comprehensive, real-time, all-hazards biosurveillance 
        capabilities. In complying with the preceding sentence, the 
        National Biodefense Science Board shall--
                    ``(A) identify the steps necessary to achieve a 
                national biosurveillance system for human health, with 
                international connectivity, where appropriate, that is 
                predicated on State, regional, and community level 
                capabilities and creates a networked system to allow 
                for two-way information flow between and among Federal, 
                State, and local government public health authorities 
                and clinical health care providers;
                    ``(B) identify any duplicative surveillance 
                programs under the authority of the Secretary, or 
                changes that are necessary to existing programs, in 
                order to enhance and modernize such activities, 
                minimize duplication, strengthen and streamline such 
                activities under the authority of the Secretary, and 
                achieve real-time and appropriate data that relate to 
                disease activity, both human and zoonotic; and
                    ``(C) coordinate with applicable existing advisory 
                committees of the Director of the Centers for Disease 
                Control and Prevention, including such advisory 
                committees consisting of representatives from State, 
                local, and tribal public health authorities and 
                appropriate public and private sector health care 
                entities and academic institutions, in order to provide 
                guidance on public health surveillance activities.'';
            (4) in subsection (e)(5), by striking ``4 years after the 
        date of enactment of the Pandemic and All-Hazards Preparedness 
        Act'' and inserting ``3 years after the date of enactment of 
        the Pandemic and All-Hazards Preparedness Reauthorization Act 
        of 2012'';
            (5) in subsection (g), 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 2013 through 
        2017''; and
            (6) by adding at the end the following:
    ``(h) Definition.--For purposes of this section the term 
`biosurveillance' means the process of gathering near real-time 
biological data that relates to 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.''.

SEC. 205. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS.

    Section 5 of the Project Bioshield Act of 2004 (42 U.S.C. 247d-6c) 
is repealed.

           TITLE III--ENHANCING MEDICAL COUNTERMEASURE REVIEW

SEC. 301. SPECIAL PROTOCOL ASSESSMENT.

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

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

    (a) In General.--Section 564 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb-3) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1), by striking ``sections 505, 
                510(k), and 515 of this Act'' and inserting ``any 
                provision of this Act'';
                    (B) in paragraph (2)(A), by striking ``under a 
                provision of law referred to in such paragraph'' and 
                inserting ``under section 505, 510(k), or 515 of this 
                Act or section 351 of the Public Health Service Act''; 
                and
                    (C) in paragraph (3), by striking ``a provision of 
                law referred to in such paragraph'' and inserting ``a 
                section of this Act or the Public Health Service Act 
                referred to in paragraph (2)(A)'';
            (2) in subsection (b)--
                    (A) in the subsection heading, by striking 
                ``Emergency'' and inserting ``Emergency or Threat 
                Justifying Emergency Authorized Use'';
                    (B) in paragraph (1)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``may declare an emergency'' 
                        and inserting ``may make a declaration that the 
                        circumstances exist'';
                            (ii) in subparagraph (A), by striking 
                        ``specified'';
                            (iii) in subparagraph (B)--
                                    (I) by striking ``specified''; and
                                    (II) by striking ``; or'' and 
                                inserting a semicolon;
                            (iv) by amending subparagraph (C) to read 
                        as follows:
                    ``(C) a determination by the Secretary that there 
                is a public health emergency, or a significant 
                potential for a public health emergency, that affects, 
                or has a significant potential to affect, national 
                security or the health and security of United States 
                citizens living abroad, and that involves a biological, 
                chemical, radiological, or nuclear agent or agents, or 
                a disease or condition that may be attributable to such 
                agent or agents; or''; and
                            (v) by adding at the end the following:
                    ``(D) the identification of a material threat 
                pursuant to section 319F-2 of the Public Health Service 
                Act sufficient to affect national security or the 
                health and security of United States citizens living 
                abroad.'';
                    (C) in paragraph (2)--
                            (i) in subparagraph (A), by amending clause 
                        (ii) to read as follows:
                            ``(ii) a change in the approval status of 
                        the product such that the circumstances 
                        described in subsection (a)(2) have ceased to 
                        exist.'';
                            (ii) by striking subparagraph (B); and
                            (iii) by redesignating subparagraph (C) as 
                        subparagraph (B);
                    (D) in paragraph (4), by striking ``advance notice 
                of termination, and renewal under this subsection.'' 
                and inserting ``, and advance notice of termination 
                under this subsection.''; and
                    (E) by adding at the end the following:
            ``(5) Explanation by secretary.--If an authorization under 
        this section with respect to an unapproved product or an 
        unapproved use of an approved product has been in effect for 
        more than 1 year, the Secretary shall provide in writing to the 
        sponsor of such product an explanation of the scientific, 
        regulatory, or other obstacles to approval, licensure, or 
        clearance of such product or use, including specific actions to 
        be taken by the Secretary and the sponsor to overcome such 
        obstacles.'';
            (3) in subsection (c)--
                    (A) in the matter preceding paragraph (1)--
                            (i) by inserting ``the Assistant Secretary 
                        for Preparedness and Response,'' after 
                        ``consultation with'';
                            (ii) by striking ``Health and'' and 
                        inserting ``Health, and''; and
                            (iii) by striking ``circumstances of the 
                        emergency involved'' and inserting ``applicable 
                        circumstances described in subsection (b)(1)'';
                    (B) in paragraph (1), by striking ``specified'' and 
                inserting ``referred to''; and
                    (C) in paragraph (2)(B), by inserting ``, taking 
                into consideration the material threat posed by the 
                agent or agents identified in a declaration under 
                subsection (b)(1)(D), if applicable'' after ``risks of 
                the product'';
            (4) in subsection (d)(3), by inserting ``, to the extent 
        practicable given the circumstances of the emergency,'' after 
        ``including'';
            (5) in subsection (e)--
                    (A) in paragraph (1)(A), by striking 
                ``circumstances of the emergency'' and inserting 
                ``applicable circumstances described in subsection 
                (b)(1)'';
                    (B) in paragraph (1)(B), by amending clause (iii) 
                to read as follows:
                            ``(iii) Appropriate conditions with respect 
                        to collection and analysis of information 
                        concerning the safety and effectiveness of the 
                        product with respect to the use of such product 
                        during the period when the authorization is in 
                        effect and a reasonable time following such 
                        period.'';
                    (C) in paragraph (2)--
                            (i) in subparagraph (A)--
                                    (I) by striking ``manufacturer of 
                                the product'' and inserting ``person'';
                                    (II) by striking ``circumstances of 
                                the emergency'' and inserting 
                                ``applicable circumstances described in 
                                subsection (b)(1)''; and
                                    (III) by inserting at the end 
                                before the period ``or in paragraph 
                                (1)(B)'';
                            (ii) in subparagraph (B)(i), by inserting 
                        before the period at the end ``, except as 
                        provided in section 564A with respect to 
                        authorized changes to the product expiration 
                        date''; and
                            (iii) by amending subparagraph (C) to read 
                        as follows:
                    ``(C) In establishing conditions under this 
                paragraph with respect to the distribution and 
                administration of the product for the unapproved use, 
                the Secretary shall not impose conditions that would 
                restrict distribution or administration of the product 
                when distributed or administered for the approved 
                use.''; and
                    (D) by amending paragraph (3) to read as follows:
            ``(3) Good manufacturing practice; prescription.--With 
        respect to the emergency use of a product for which an 
        authorization under this section is issued (whether an 
        unapproved product or an unapproved use of an approved 
        product), the Secretary may waive or limit, to the extent 
        appropriate given the applicable circumstances described in 
        subsection (b)(1)--
                    ``(A) requirements regarding current good 
                manufacturing practice otherwise applicable to the 
                manufacture, processing, packing, or holding of 
                products subject to regulation under this Act, 
                including such requirements established under section 
                501 or 520(f)(1), and including relevant conditions 
                prescribed with respect to the product by an order 
                under section 520(f)(2);
                    ``(B) requirements established under section 
                503(b); and
                    ``(C) requirements established under section 
                520(e).'';
            (6) in subsection (g)--
                    (A) in the subsection heading, by inserting 
                ``Review and'' before ``Revocation'';
                    (B) in paragraph (1), by inserting after the period 
                at the end the following: ``As part of such review, the 
                Secretary shall regularly review the progress made with 
                respect to the approval, licensure, or clearance of--
                    ``(A) an unapproved product for which an 
                authorization was issued under this section; or
                    ``(B) an unapproved use of an approved product for 
                which an authorization was issued under this 
                section.''; and
                    (C) by amending paragraph (2) to read as follows:
            ``(2) Revision and revocation.--The Secretary may revise or 
        revoke an authorization under this section if--
                    ``(A) the circumstances described under subsection 
                (b)(1) no longer exist;
                    ``(B) the criteria under subsection (c) for 
                issuance of such authorization are no longer met; or
                    ``(C) other circumstances make such revision or 
                revocation appropriate to protect the public health or 
                safety.'';
            (7) in subsection (h)(1), by adding after the period at the 
        end the following: ``The Secretary shall make any revisions to 
        an authorization under this section available on the Internet 
        Web site of the Food and Drug Administration.'';
            (8) by adding at the end of subsection (j) the following:
            ``(4) Nothing in this section shall be construed as 
        authorizing a delay in the review or other consideration by the 
        Secretary of any application or submission pending before the 
        Food and Drug Administration for a product for which an 
        authorization under this section is issued.''; and
            (9) by adding at the end the following:
    ``(m) Categorization of Laboratory Tests Associated With Devices 
Subject to Authorization.--
            ``(1) In general.--In issuing an authorization under this 
        section with respect to a device, the Secretary may, subject to 
        the provisions of this section, determine that a laboratory 
        examination or procedure associated with such device shall be 
        deemed, for purposes of section 353 of the Public Health 
        Service Act, to be in a particular category of examinations and 
        procedures (including the category described by subsection 
        (d)(3) of such section) if, based on the totality of scientific 
        evidence available to the Secretary--
                    ``(A) such categorization would be beneficial to 
                protecting the public health; and
                    ``(B) the known and potential benefits of such 
                categorization under the circumstances of the 
                authorization outweigh the known and potential risks of 
                the categorization.
            ``(2) Conditions of determination.--The Secretary may 
        establish appropriate conditions on the performance of the 
        examination or procedure pursuant to such determination.
            ``(3) Effective period.--A determination under this 
        subsection shall be effective for purposes of section 353 of 
        the Public Health Service Act notwithstanding any other 
        provision of that section during the effective period of the 
        relevant declaration under subsection (b).''.
    (b) Emergency Use of Medical Products.--Subchapter E of chapter V 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) 
is amended by inserting after section 564 the following:

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

    ``(a) Definitions.--In this section:
            ``(1) Eligible product.--The term `eligible product' means 
        a product that--
                    ``(A) is approved or cleared under this chapter or 
                licensed under section 351 of the Public Health Service 
                Act;
                    ``(B)(i) is intended for use to prevent, diagnose, 
                or treat a disease or condition involving a biological, 
                chemical, radiological, or nuclear agent or agents; or
                    ``(ii) is intended for use to prevent, diagnose, or 
                treat a serious or life-threatening disease or 
                condition caused by a product described in clause (i); 
                and
                    ``(C) is intended for use during the circumstances 
                under which--
                            ``(i) a determination described in 
                        subparagraph (A), (B), or (C) of section 
                        564(b)(1) has been made by the Secretary of 
                        Homeland Security, the Secretary of Defense, or 
                        the Secretary, respectively; or
                            ``(ii) the identification of a material 
                        threat described in subparagraph (D) of section 
                        564(b)(1) has been made pursuant to section 
                        319F-2 of the Public Health Service Act.
            ``(2) Product.--The term `product' means a drug, device, or 
        biological product.
    ``(b) Expiration Dating.--
            ``(1) In general.--The Secretary may extend the expiration 
        date and authorize the introduction or delivery for 
        introduction into interstate commerce of an eligible product 
        after the expiration date provided by the manufacturer if--
                    ``(A) the expiration date extension is intended to 
                support the United States ability to protect--
                            ``(i) the public health; or
                            ``(ii) military preparedness and 
                        effectiveness; and
                    ``(B) the expiration date extension is supported by 
                an appropriate scientific evaluation that is conducted 
                or accepted by the Secretary.
            ``(2) Requirements and conditions.--Any extension of an 
        expiration date under paragraph (1) shall, as part of the 
        extension, identify--
                    ``(A) each specific lot, batch, or other unit of 
                the product for which extended expiration is 
                authorized;
                    ``(B) the duration of the extension; and
                    ``(C) any other requirements or conditions as the 
                Secretary may deem appropriate for the protection of 
                the public health, which may include requirements for, 
                or conditions on, product sampling, storage, packaging 
                or repackaging, transport, labeling, notice to product 
                recipients, recordkeeping, periodic testing or 
                retesting, or product disposition.
            ``(3) Effect.--Notwithstanding any other provision of this 
        Act or the Public Health Service Act, an eligible product shall 
        not be considered an unapproved product (as defined in section 
        564(a)(2)(A)) and shall not be deemed adulterated or misbranded 
        under this Act because, with respect to such product, the 
        Secretary has, under paragraph (1), extended the expiration 
        date and authorized the introduction or delivery for 
        introduction into interstate commerce of such product after the 
        expiration date provided by the manufacturer.
            ``(4) Expiration date.--For purposes of this subsection, 
        the term `expiration date' means the date established through 
        appropriate stability testing required by the regulations 
        issued by the Secretary to ensure that the product meets 
        applicable standards of identity, strength, quality, and purity 
        at the time of use.
    ``(c) Current Good Manufacturing Practice.--
            ``(1) In general.--The Secretary may, when the 
        circumstances of a domestic, military, or public health 
        emergency or material threat described in subsection (a)(1)(C) 
        so warrant, authorize, with respect to an eligible product, 
        deviations from current good manufacturing practice 
        requirements otherwise applicable to the manufacture, 
        processing, packing, or holding of products subject to 
        regulation under this Act, including requirements under section 
        501 or 520(f)(1) or applicable conditions prescribed with 
        respect to the eligible product by an order under section 
        520(f)(2).
            ``(2) Effect.--Notwithstanding any other provision of this 
        Act or the Public Health Service Act, an eligible product shall 
        not be considered an unapproved product (as defined in section 
        564(a)(2)(A)) and shall not be deemed adulterated or misbranded 
        under this Act because, with respect to such product, the 
        Secretary has authorized deviations from current good 
        manufacturing practices under paragraph (1).
    ``(d) Emergency Dispensing.--The requirements of sections 503(b) 
and 520(e) shall not apply to an eligible product, and the product 
shall not be considered an unapproved product (as defined in section 
564(a)(2)(A)) and shall not be deemed adulterated or misbranded under 
this Act because it is dispensed without an individual prescription, 
if--
            ``(1) the product is dispensed during the circumstances 
        described in subsection (a)(1)(C); and
            ``(2) such dispensing without an individual prescription 
        occurs--
                    ``(A) as permitted under the law of the State in 
                which the product is dispensed; or
                    ``(B) in accordance with an order issued by the 
                Secretary, for the purposes and duration of the 
                circumstances described in subsection (a)(1)(C).
    ``(e) Emergency Use Instructions.--
            ``(1) In general.--The Secretary, acting through an 
        appropriate official within the Department of Health and Human 
        Services, may create and issue emergency use instructions to 
        inform health care providers or individuals to whom an eligible 
        product is to be administered concerning such product's 
        approved, licensed, or cleared conditions of use.
            ``(2) Effect.--Notwithstanding any other provisions of this 
        Act or the Public Health Service Act, a product shall not be 
        considered an unapproved product and shall not be deemed 
        adulterated or misbranded under this Act because of the 
        issuance of emergency use instructions under paragraph (1) with 
        respect to such product or the introduction or delivery for 
        introduction of such product into interstate commerce 
        accompanied by such instructions--
                    ``(A) during an emergency response to an actual 
                emergency that is the basis for a determination 
                described in subsection (a)(1)(C)(i); or
                    ``(B) by a government entity (including a Federal, 
                State, local, or tribal government entity), or a person 
                acting on behalf of such a government entity, in 
                preparation for an emergency response.''.
    (c) Risk Evaluation and Mitigation Strategies.--Section 505-1 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1), is 
amended--
            (1) in subsection (f), by striking paragraph (7); and
            (2) by adding at the end the following:
    ``(k) Waiver in Public Health Emergencies.--The Secretary may waive 
any requirement of this section with respect to a qualified 
countermeasure (as defined in section 319F-1(a)(2) of the Public Health 
Service Act) to which a requirement under this section has been 
applied, if the Secretary determines that such waiver is required to 
mitigate the effects of, or reduce the severity of, the circumstances 
under which--
            ``(1) a determination described in subparagraph (A), (B), 
        or (C) of section 564(b)(1) has been made by the Secretary of 
        Homeland Security, the Secretary of Defense, or the Secretary, 
        respectively; or
            ``(2) the identification of a material threat described in 
        subparagraph (D) of section 564(b)(1) has been made pursuant to 
        section 319F-2 of the Public Health Service Act.''.
    (d) Products Held for Emergency Use.--The Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) is amended by inserting after 
section 564A, as added by subsection (b), the following:

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

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

SEC. 303. DEFINITIONS.

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

SEC. 304. ENHANCING MEDICAL COUNTERMEASURE ACTIVITIES.

    Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-4), as amended by section 303, is further amended--
            (1) in the section heading, by striking ``technical 
        assistance'' and inserting ``countermeasure development, 
        review, and technical assistance'';
            (2) in subsection (b), by striking the subsection 
        enumerator and all that follows through ``shall establish'' and 
        inserting the following:
    ``(b) General Duties.--In order to accelerate the development, 
stockpiling, approval, licensure, and clearance of qualified 
countermeasures, security countermeasures, and qualified pandemic or 
epidemic products, the Secretary, in consultation with the Assistant 
Secretary for Preparedness and Response, shall--
            ``(1) ensure the appropriate involvement of Food and Drug 
        Administration personnel in interagency activities related to 
        countermeasure advanced research and development, consistent 
        with sections 319F, 319F-1, 319F-2, 319F-3, 319L, and 2811 of 
        the Public Health Service Act;
            ``(2) ensure the appropriate involvement and consultation 
        of Food and Drug Administration personnel in any flexible 
        manufacturing activities carried out under section 319L of the 
        Public Health Service Act, including with respect to meeting 
        regulatory requirements set forth in this Act;
            ``(3) promote countermeasure expertise within the Food and 
        Drug Administration by--
                    ``(A) ensuring that Food and Drug Administration 
                personnel involved in reviewing countermeasures for 
                approval, licensure, or clearance are informed by the 
                Assistant Secretary for Preparedness and Response on 
                the material threat assessment conducted under section 
                319F-2 of the Public Health Service Act for the agent 
                or agents for which the countermeasure under review is 
                intended;
                    ``(B) training Food and Drug Administration 
                personnel regarding review of countermeasures for 
                approval, licensure, or clearance;
                    ``(C) holding public meetings at least twice 
                annually to encourage the exchange of scientific ideas; 
                and
                    ``(D) establishing protocols to ensure that 
                countermeasure reviewers have sufficient training or 
                experience with countermeasures;
            ``(4) maintain teams, composed of Food and Drug 
        Administration personnel with expertise on countermeasures, 
        including specific countermeasures, populations with special 
        clinical needs (including children and pregnant women that may 
        use countermeasures, as applicable and appropriate), classes or 
        groups of countermeasures, or other countermeasure-related 
        technologies and capabilities, that shall--
                    ``(A) consult with countermeasure experts, 
                including countermeasure sponsors and applicants, to 
                identify and help resolve scientific issues related to 
                the approval, licensure, or clearance of 
                countermeasures, through workshops or public meetings; 
                and
                    ``(B) improve and advance the science relating to 
                the development of new tools, standards, and approaches 
                to assessing and evaluating countermeasures--
                            ``(i) in order to inform the process for 
                        countermeasure approval, clearance, and 
                        licensure; and
                            ``(ii) with respect to the development of 
                        countermeasures for populations with special 
                        clinical needs, including children and pregnant 
                        women, in order to meet the needs of such 
                        populations, as necessary and appropriate; and
            ``(5) establish''; and
            (3) by adding at the end the following:
    ``(c) Final Guidance on Development of Animal Models.--
            ``(1) In general.--Not later than 1 year after the date of 
        the enactment of the Pandemic and All-Hazards Preparedness 
        Reauthorization Act of 2012, the Secretary shall provide final 
        guidance to industry regarding the development of animal models 
        to support approval, clearance, or licensure of countermeasures 
        referred to in subsection (a) when human efficacy studies are 
        not ethical or feasible.
            ``(2) Authority to extend deadline.--The Secretary may 
        extend the deadline for providing final guidance under 
        paragraph (1) by not more than 6 months upon submission by the 
        Secretary of a report on the status of such guidance to the 
        Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions of the Senate.
    ``(d) Development and Animal Modeling Procedures.--
            ``(1) Availability of animal model meetings.--To facilitate 
        the timely development of animal models and support the 
        development, stockpiling, licensure, approval, and clearance of 
        countermeasures, the Secretary shall, not later than 180 days 
        after the enactment of this subsection, establish a procedure 
        by which a sponsor or applicant that is developing a 
        countermeasure for which human efficacy studies are not ethical 
        or practicable, and that has an approved investigational new 
        drug application or investigational device exemption, may 
        request and receive--
                    ``(A) a meeting to discuss proposed animal model 
                development activities; and
                    ``(B) a meeting prior to initiating pivotal animal 
                studies.
            ``(2) Pediatric models.--To facilitate the development and 
        selection of animal models that could translate to pediatric 
        studies, any meeting conducted under paragraph (1) shall 
        include discussion of animal models for pediatric populations, 
        as appropriate.
    ``(e) Review and Approval of Countermeasures.--
            ``(1) Material threat.--When evaluating an application or 
        submission for approval, licensure, or clearance of a 
        countermeasure, the Secretary shall take into account the 
        material threat posed by the chemical, biological, 
        radiological, or nuclear agent or agents identified under 
        section 319F-2 of the Public Health Service Act for which the 
        countermeasure under review is intended.
            ``(2) Review expertise.--When practicable and appropriate, 
        teams of Food and Drug Administration personnel reviewing 
        applications or submissions described under paragraph (1) shall 
        include a reviewer with sufficient training or experience with 
        countermeasures pursuant to the protocols established under 
        subsection (b)(3)(D).''.

SEC. 305. REGULATORY MANAGEMENT PLANS.

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

SEC. 306. REPORT.

    Section 565 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-4), as amended by section 305, is further amended by adding at 
the end the following:
    ``(g) Annual Report.--Not later than 180 days after the date of 
enactment of this subsection, and annually thereafter, the Secretary 
shall make publicly available on the Web site of the Food and Drug 
Administration a report that details the countermeasure development and 
review activities of the Food and Drug Administration, including--
            ``(1) with respect to the development of new tools, 
        standards, and approaches to assess and evaluate 
        countermeasures--
                    ``(A) the identification of the priorities of the 
                Food and Drug Administration and the progress made on 
                such priorities; and
                    ``(B) the identification of scientific gaps that 
                impede the development, approval, licensure, or 
                clearance of countermeasures for populations with 
                special clinical needs, including children and pregnant 
                women, and the progress made on resolving these 
                challenges;
            ``(2) with respect to countermeasures for which a 
        regulatory management plan has been agreed upon under 
        subsection (f), the extent to which the performance targets and 
        goals set forth in subsection (f)(4)(B) and the regulatory 
        management plan have been met, including, for each such 
        countermeasure--
                    ``(A) whether the regulatory management plan was 
                completed within the required timeframe, and the length 
                of time taken to complete such plan;
                    ``(B) whether the Secretary adhered to the timely 
                and appropriate response times set forth in such plan; 
                and
                    ``(C) explanations for any failure to meet such 
                performance targets and goals;
            ``(3) the number of regulatory teams established pursuant 
        to subsection (b)(4), the number of products, classes of 
        products, or technologies assigned to each such team, and the 
        number of, type of, and any progress made as a result of 
        consultations carried out under subsection (b)(4)(A);
            ``(4) an estimate of resources obligated to countermeasure 
        development and regulatory assessment, including--
                    ``(A) Center-specific objectives and 
                accomplishments; and
                    ``(B) the number of full-time equivalent employees 
                of the Food and Drug Administration who directly 
                support the review of countermeasures;
            ``(5) the number of countermeasure applications and 
        submissions submitted, the number of countermeasures approved, 
        licensed, or cleared, the status of remaining submitted 
        applications and submissions, and the number of each type of 
        authorization issued pursuant to section 564;
            ``(6) the number of written requests for a regulatory 
        management plan submitted under subsection (f)(3)(A), the 
        number of regulatory management plans developed, and the number 
        of such plans developed for security countermeasures; and
            ``(7) the number, type, and frequency of meetings between 
        the Food and Drug Administration and--
                    ``(A) sponsors of a countermeasure as defined in 
                subsection (a); or
                    ``(B) another agency engaged in development or 
                management of portfolios for such countermeasures, 
                including the Centers for Disease Control and 
                Prevention, the Biomedical Advanced Research and 
                Development Authority, the National Institutes of 
                Health, and the appropriate agencies of the Department 
                of Defense.''.

SEC. 307. PEDIATRIC MEDICAL COUNTERMEASURES.

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

  TITLE IV--ACCELERATING MEDICAL COUNTERMEASURE ADVANCED RESEARCH AND 
                              DEVELOPMENT

SEC. 401. BIOSHIELD.

    (a) Procurement of Countermeasures.--Section 319F-2(c) of the 
Public Health Service Act (42 U.S.C. 247d-6b(c)) is amended--
            (1) in paragraph (1)(B)(i)(III)(bb), by striking ``eight 
        years'' and inserting ``10 years'';
            (2) in paragraph (2)(C), by striking ``the designated 
        congressional committees (as defined in paragraph (10))'' and 
        inserting ``the appropriate committees of Congress'';
            (3) in paragraph (5)(B)(ii), by striking ``eight years'' 
        and inserting ``10 years'';
            (4) in subparagraph (C) of paragraph (6)--
                    (A) in the subparagraph heading, by striking 
                ``designated congressional committees'' and inserting 
                ``appropriate congressional committees''; and
                    (B) by striking ``the designated congressional 
                committees'' and inserting ``the appropriate 
                congressional committees''; and
            (5) in paragraph (7)(C)--
                    (A) in clause (i)(I), by inserting ``including 
                advanced research and development,'' after ``as may 
                reasonably be required,'';
                    (B) in clause (ii)--
                            (i) in subclause (III), by striking ``eight 
                        years'' and inserting ``10 years''; and
                            (ii) by striking subclause (IX) and 
                        inserting the following:
                                    ``(IX) Contract terms.--The 
                                Secretary, in any contract for 
                                procurement under this section--
                                            ``(aa) may specify--

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

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

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

                                            ``(bb) shall provide a 
                                        clear statement of defined 
                                        Government purpose limited to 
                                        uses related to a security 
                                        countermeasure, as defined in 
                                        paragraph (1)(B).''; and
                    (C) by adding at the end the following:
                            ``(viii) Flexibility.--In carrying out this 
                        section, the Secretary may, consistent with the 
                        applicable provisions of this section, enter 
                        into contracts and other agreements that are in 
                        the best interest of the Government in meeting 
                        identified security countermeasure needs, 
                        including with respect to reimbursement of the 
                        cost of advanced research and development as a 
                        reasonable, allowable, and allocable direct 
                        cost of the contract involved.''.
    (b) Reauthorization of the Special Reserve Fund.--Section 319F-2 of 
the Public Health Service Act (42 U.S.C. 247d-6b) is amended--
            (1) in subsection (c)--
                    (A) by striking ``special reserve fund under 
                paragraph (10)'' each place it appears and inserting 
                ``special reserve fund as defined in subsection (h)''; 
                and
                    (B) by striking paragraphs (9) and (10); and
            (2) by adding at the end the following:
    ``(g) Special Reserve Fund.--
            ``(1) Authorization of appropriations.--In addition to 
        amounts appropriated to the special reserve fund prior to the 
        date of the enactment of this subsection, there is authorized 
        to be appropriated, for the procurement of security 
        countermeasures under subsection (c) and for carrying out 
        section 319L (relating to the Biomedical Advanced Research and 
        Development Authority), $2,800,000,000 for the period of fiscal 
        years 2014 through 2018. Amounts appropriated pursuant to the 
        preceding sentence are authorized to remain available until 
        September 30, 2019.
            ``(2) Use of special reserve fund for advanced research and 
        development.--The Secretary may utilize not more than 50 
        percent of the amounts authorized to be appropriated under 
        paragraph (1) to carry out section 319L (related to the 
        Biomedical Advanced Research and Development Authority). 
        Amounts authorized to be appropriated under this subsection to 
        carry out section 319L are in addition to amounts otherwise 
        authorized to be appropriated to carry out such section.
            ``(3) Restrictions on use of funds.--Amounts in the special 
        reserve fund shall not be used to pay costs other than payments 
        made by the Secretary to a vendor for advanced development 
        (under section 319L) or for procurement of a security 
        countermeasure under subsection (c)(7).
            ``(4) Report.--Not later than 30 days after any date on 
        which the Secretary determines that the amount of funds in the 
        special reserve fund available for procurement is less than 
        $1,500,000,000, the Secretary shall submit to the appropriate 
        committees of Congress a report detailing the amount of such 
        funds available for procurement and the impact such reduction 
        in funding will have--
                    ``(A) in meeting the security countermeasure needs 
                identified under this section; and
                    ``(B) on the annual Public Health Emergency Medical 
                Countermeasures Enterprise and Strategy Implementation 
                Plan (pursuant to section 2811(d)).
    ``(h) Definitions.--In this section:
            ``(1) The term `advanced research and development' has the 
        meaning given such term in section 319L(a).
            ``(2) The term `special reserve fund' means the `Biodefense 
        Countermeasures' appropriations account, any appropriation made 
        available pursuant to section 521(a) of the Homeland Security 
        Act of 2002, and any appropriation made available pursuant to 
        subsection (g)(1).''.

SEC. 402. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.

    (a) Duties.--Section 319L(c)(4) of the Public Health Service Act 
(42 U.S.C. 247d-7e(c)(4)) is amended--
            (1) in subparagraph (B)(iii), by inserting ``(which may 
        include advanced research and development for purposes of 
        fulfilling requirements under the Federal Food, Drug, and 
        Cosmetic Act or section 351 of this Act)'' after 
        ``development''; and
            (2) in subparagraph (D)(iii), by striking ``and vaccine 
        manufacturing technologies'' and inserting ``vaccine-
        manufacturing technologies, dose-sparing technologies, 
        efficacy-increasing technologies, and platform technologies''.
    (b) Transaction Authorities.--Section 319L(c)(5) of the Public 
Health Service Act (42 U.S.C. 247d-7e(c)(5)) is amended by adding at 
the end the following:
                    ``(G) Government purpose.--In awarding contracts, 
                grants, and cooperative agreements under this section, 
                the Secretary shall provide a clear statement of 
                defined Government purpose related to activities 
                included in subsection (a)(6)(B) for a qualified 
                countermeasure or qualified pandemic or epidemic 
                product.''.
    (c) Fund.--Paragraph (2) of section 319L(d) of the Public Health 
Service Act (42 U.S.C. 247d-7e(d)(2)) is amended to read as follows:
            ``(2) Funding.--To carry out the purposes of this section, 
        there is authorized to be appropriated to the Fund $415,000,000 
        for each of fiscal years 2013 through 2017, 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 ``11 
years''.
    (e) Extension of Limited Antitrust Exemption.--Section 405(b) of 
the Pandemic and All-Hazards Preparedness Act (42 U.S.C. 247d-6a note) 
is amended by striking ``6-year'' and inserting ``11-year''.
    (f) Independent Evaluation.--Section 319L of the Public Health 
Service Act (42 U.S.C. 247d-7e) is amended by adding at the end the 
following:
    ``(f) Independent Evaluation.--
            ``(1) In general.--Not later than 180 days after the date 
        of enactment of this subsection, the Comptroller General of the 
        United States shall conduct an independent evaluation of the 
        activities carried out to facilitate flexible manufacturing 
        capacity pursuant to this section.
            ``(2) Report.--Not later than 1 year after the date of 
        enactment of this subsection, the Comptroller General of the 
        United States shall submit to the appropriate committees of 
        Congress a report concerning the results of the evaluation 
        conducted under paragraph (1). Such report shall review and 
        assess--
                    ``(A) the extent to which flexible manufacturing 
                capacity under this section is dedicated to chemical, 
                biological, radiological, and nuclear threats;
                    ``(B) the activities supported by flexible 
                manufacturing initiatives; and
                    ``(C) the ability of flexible manufacturing 
                activities carried out under this section to--
                            ``(i) secure and leverage leading technical 
                        expertise with respect to countermeasure 
                        advanced research, development, and 
                        manufacturing processes; and
                            ``(ii) meet the surge manufacturing 
                        capacity needs presented by novel and emerging 
                        threats, including chemical, biological, 
                        radiological, and nuclear agents.''.
    (g) Definitions.--
            (1) Qualified countermeasure.--Section 319F-1(a)(2)(A) of 
        the Public Health Service Act (42 U.S.C. 247d-6a(a)(2)(A)) is 
        amended--
                    (A) in the matter preceding clause (i), by striking 
                ``to--'' and inserting ``--'';
                    (B) in clause (i)--
                            (i) by striking ``diagnose'' and inserting 
                        ``to diagnose''; and
                            (ii) by striking ``; or'' and inserting a 
                        semicolon;
                    (C) in clause (ii)--
                            (i) by striking ``diagnose'' and inserting 
                        ``to diagnose''; and
                            (ii) by striking the period at the end and 
                        inserting ``; or''; and
                    (D) by adding at the end the following:
                            ``(iii) is a product or technology intended 
                        to enhance the use or effect of a drug, 
                        biological product, or device described in 
                        clause (i) or (ii).''.
            (2) Qualified pandemic or epidemic product.--Section 319F-
        3(i)(7)(A) of the Public Health Service Act (42 U.S.C. 247d-
        6d(i)(7)(A)) is amended--
                    (A) in clause (i)(II), by striking ``; or'' and 
                inserting ``;'';
                    (B) in clause (ii), by striking ``; and'' and 
                inserting ``; or''; and
                    (C) by adding at the end the following:
                            ``(iii) a product or technology intended to 
                        enhance the use or effect of a drug, biological 
                        product, or device described in clause (i) or 
                        (ii); and''.
            (3) Technical amendments.--Section 319F-3(i) of the Public 
        Health Service Act (42 U.S.C. 247d-6d(i)) is amended--
                    (A) in paragraph (1)(C), by inserting ``, 564A, or 
                564B'' after ``564''; and
                    (B) in paragraph (7)(B)(iii), by inserting ``, 
                564A, or 564B'' after ``564''.

SEC. 403. STRATEGIC NATIONAL STOCKPILE.

    Section 319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) 
is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) by inserting ``consistent with section 
                        2811'' before ``by the Secretary to be 
                        appropriate''; and
                            (ii) by inserting before the period at the 
                        end of the second sentence the following: ``and 
                        shall submit such review annually to the 
                        appropriate congressional committees of 
                        jurisdiction to the extent that disclosure of 
                        such information does not compromise national 
                        security''; and
                    (B) in paragraph (2)(D), by inserting before the 
                semicolon at the end the following: ``and that the 
                potential depletion of countermeasures currently in the 
                stockpile is identified and appropriately addressed, 
                including through necessary replenishment''; and
            (2) in subsection (f)(1), by striking ``$640,000,000 for 
        fiscal year 2002, and such sums as may be necessary for each of 
        fiscal years 2003 through 2006. Such authorization is in 
        addition to amounts in the special reserve fund referred to in 
        subsection (c)(10)(A).'' and inserting ``$533,800,000 for each 
        of fiscal years 2013 through 2017. 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.''.

            Passed the House of Representatives December 19, 2012.

            Attest:

                                                                 Clerk.
112th CONGRESS

  2d Session

                               H. R. 6672

_______________________________________________________________________

                                 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.