[House Report 112-286]
[From the U.S. Government Publishing Office]


112th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 1st Session                                                    112-286

======================================================================



 
   PANDEMIC AND ALL-HAZARDS PREPAREDNESS REAUTHORIZATION ACT OF 2011

                                _______
                                

 November 16, 2011.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

  Mr. Upton, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 2405]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on on Energy and Commerce, to whom was 
referred the bill (H.R. 2405) to reauthorize certain provisions 
of the Public Health Service Act and the Federal Food, Drug, 
and Cosmetic Act relating to public health preparedness and 
countermeasure development, and for other purposes, having 
considered the same, report favorably thereon with an amendment 
and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................    12
Background and Need for Legislation..............................    13
Hearings.........................................................    14
Committee Consideration..........................................    14
Committee Votes..................................................    15
Committee Oversight Findings.....................................    15
Statement of General Performance Goals and Objectives............    15
New Budget Authority, Entitlement Authority, and Tax Expenditures    15
Earmarks.........................................................    15
Committee Cost Estimate..........................................    15
Congressional Budget Office Estimate.............................    15
Federal Mandates Statement.......................................    20
Advisory Committee Statement.....................................    20
Applicability to Legislative Branch..............................    20
Section-by-Section Analysis of the Legislation...................    20
Changes in Existing Law Made by the Bill.........................    27

    The amendment is as follows:
    Strike all after the enacting clause and insert the 
following:

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 2011''.
  (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Reauthorization of certain provisions relating to public health 
preparedness.
Sec. 3. Temporary redeployment of personnel during a public health 
emergency.
Sec. 4. Coordination by Assistant Secretary for Preparedness and 
Response.
Sec. 5. Eliminating duplicative Project Bioshield reports.
Sec. 6. Authorization for medical products for use in emergencies.
Sec. 7. Additional provisions related to medical products for emergency 
use.
Sec. 8. Products held for emergency use.
Sec. 9. Accelerate countermeasure development by strengthening FDA's 
role in reviewing products for national security priorities.

SEC. 2. REAUTHORIZATION OF CERTAIN PROVISIONS RELATING TO PUBLIC HEALTH 
                    PREPAREDNESS.

  (a) Vaccine Tracking and Distribution.--Subsection (e) of section 
319A of the Public Health Service Act (42 U.S.C. 247d-1) is amended by 
striking ``such sums for each of fiscal years 2007 through 2011'' and 
inserting ``$30,800,000 for each of fiscal years 2012 through 2016''.
  (b) Improving State and Local Public Health Security.--Effective on 
October 1, 2011, section 319C-1 of the Public Health Service Act (42 
U.S.C. 247d-3a) is amended--
          (1) in subsection (b)(2)(A)--
                  (A) in clause (iv), by striking ``and'' at the end;
                  (B) in clause (v), by adding ``and'' at the end; and
                  (C) by adding at the end the following:
                          ``(vi) 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;'';
          (2) in subsection (f)--
                  (A) in paragraph (2), by inserting ``and'' at the 
                end;
                  (B) in paragraph (3), by striking ``; and'' and 
                inserting a period; and
                  (C) by striking paragraph (4);
          (3) by striking subsection (h); and
          (4) in subsection (i)--
                  (A) in paragraph (1)--
                          (i) by amending subparagraph (A) to read as 
                        follows:
                  ``(A) In general.--For the purpose of carrying out 
                this section, there is authorized to be appropriated 
                $632,900,000 for each of fiscal years 2012 through 
                2016.''; and
                          (ii) by striking subparagraph (B); and
                  (B) in subparagraphs (C) and (D) of paragraph (3), by 
                striking ``(1)(A)(i)(I)'' each place it appears and 
                inserting ``(1)(A)''.
  (c) Partnerships for State and Regional Hospital 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 (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 goals of the National 
        Health Security Strategy under section 2802.''; and
          (3) by amending subsection (j)(1) to read as follows:
          ``(1) In general.--For purposes of carrying out this section, 
        there is authorized to be appropriated $378,000,000 for each of 
        fiscal years 2012 through 2016.''.
  (d) CDC Programs for Combating Public Health Threats.--Section 319D 
of the Public Health Service Act (42 U.S.C. 247d-4) is amended--
          (1) by striking subsection (c); and
          (2) in subsection (g), by striking ``such sums as may be 
        necessary in each of fiscal years 2007 through 2011'' and 
        inserting ``$160,121,000 for each of fiscal years 2012 through 
        2016''.
  (e) Dental Emergency Responders: Public Health and Medical 
Response.--
          (1) 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''.
          (2) National health security strategy.--Section 2802(b)(3) of 
        the Public Health Service Act (42 U.S.C. 300hh-1(b)(3)) is 
        amended--
                  (A) in the matter preceding subparagraph (A), by 
                inserting ``and which may include dental health 
                facilities'' after ``mental health facilities''; and
                  (B) in subparagraph (D), by inserting ``(which may 
                include dental health assets)'' after ``medical 
                assets''.
  (f) Procurement of Countermeasures.--
          (1) Contract terms.--Subclause (IX) of section 319F-
        2(c)(7)(C)(ii) of the Public Health Service Act (42 U.S.C. 
        247d-6b(c)(7)(C)(ii)) is amended to read as follows:
                                  ``(IX) Contract terms.--The 
                                Secretary, in any contract for 
                                procurement under this section--
                                          ``(aa) may specify--
                                                  ``(AA) the dosing and 
                                                administration 
                                                requirements for 
                                                countermeasures to be 
                                                developed and procured;
                                                  ``(BB) the amount of 
                                                funding that will be 
                                                dedicated by the 
                                                Secretary for 
                                                development and 
                                                acquisition 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).''.
          (2) Reauthorization of the special reserve fund.--Section 
        319F-2 of the Public Health Service Act (42 U.S.C. 247d-6b) is 
        amended--
                  (A) in subsection (c)--
                          (i) by striking ``special reserve fund under 
                        paragraph (10)'' each place it appears and 
                        inserting ``special reserve fund as defined in 
                        subsection (g)(5)''; and
                          (ii) by striking paragraphs (9) and (10); and
                  (B) 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) Notice of insufficient funds.--Not later than 15 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 Committee on Energy and Commerce of the House of 
        Representatives and the Committee on Health, Education, Labor, 
        and Pensions of the Senate a report detailing the amount of 
        such funds available for procurement and the impact such 
        funding will have--
                  ``(A) in meeting the security countermeasure needs 
                identified under this section; and
                  ``(B) on the annual Countermeasure Implementation 
                Plan under section 2811(d).
          ``(3) Use of special reserve fund for advanced research and 
        development.--The Secretary may utilize not more than 30 
        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.
          ``(4) Restrictions on use of funds.--Amounts in the special 
        reserve fund shall not be used to pay--
                  ``(A) 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); and
                  ``(B) any administrative expenses, including 
                salaries.
          ``(5) Definition.--In this section, 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 paragraph (1) of this 
        paragraph.''.
  (g) 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 ``are authorized to be 
appropriated $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 ``is authorized to be appropriated $5,900,000 for each of 
fiscal years 2012 through 2016''.
  (h) Biomedical Advanced Research and Development Authority.--
          (1) 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.''.
          (2) Biodefense medical countermeasure development fund.--
        Paragraph (2) of section 319L(d) of the Public Health Service 
        Act (42 U.S.C. 247d-7e(d)) is amended to read as follows:
          ``(2) Funding.--To carry out the purposes of this section, 
        there is authorized to be appropriated to the Fund $415,000,000 
        for each of fiscal years 2012 through 2016, the amounts to 
        remain available until expended.''.
          (3) 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 ``the date that is 7 years 
        after the date of enactment of the Pandemic and All-Hazards 
        Preparedness Act'' and inserting ``September 30, 2016''.
  (i) 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), by adding at the end the following:
                  ``(D) Administration.--The Secretary may determine 
                and pay claims for reimbursement for services under 
                subparagraph (A) directly or by contract providing for 
                payment in advance or by way of reimbursement.''; and
          (2) in subsection (g), by striking ``such sums as may be 
        necessary for each of the fiscal years 2007 through 2011'' and 
        inserting ``$56,000,000 for each of fiscal years 2012 through 
        2016''.
  (j) National Health Security Strategy Timeline.--Section 2802(a)(1) 
of the Public Health Service Act (42 U.S.C. 300hh-1(a)(1)) is amended 
by striking ``2009'' and inserting ``2014''.
  (k) Enhancing Surge Capacity.--Section 2802(b) of the Public Health 
Service Act (42 U.S.C. 300hh-1(b)(3)) is amended--
          (1) in paragraph (1)(A), by inserting ``, including drills 
        and exercises to ensure medical surge capacity for events 
        without notice'' after ``exercises''; and
          (2) in paragraph (3)--
                  (A) in the matter preceding subparagraph (A), as 
                amended by subsection (e)(2) of this section--
                          (i) by inserting ``availability, 
                        coordination, accessibility,'' after ``response 
                        capabilities,'';
                          (ii) by striking ``including mental health 
                        facilities'' and inserting ``including mental 
                        health and ambulatory care facilities''; and
                          (iii) by striking ``trauma care and emergency 
                        medical service systems'' and inserting 
                        ``trauma care, critical care, and emergency 
                        medical service systems''; and
                  (B) in subparagraph (B), by striking ``Medical 
                evacuation and fatality management'' and inserting 
                ``Fatality management, and coordinated medical triage 
                and evacuation to the appropriate medical institution 
                based on patient medical need as part of regional 
                systems''.
  (l) Volunteer Medical Reserve Corps.--Section 2813(i) of the Public 
Health Service Act (42 U.S.C. 300hh-15(i)) is amended by striking 
``$22,000,000 for fiscal year 2007, and such sums as may be necessary 
for each of fiscal years 2008 through 2011'' and inserting 
``$11,900,000 for each of fiscal years 2012 through 2016''.
  (m) Extension of Limited Antitrust Exemption.--Section 405(b) of the 
Pandemic and All-Hazard Preparedness Act (42 U.S.C. 247d-6a note) is 
amended by striking ``at the end of the 6-year period that begins on 
the date of enactment of this Act'' and inserting ``on September 30, 
2016''.

SEC. 3. TEMPORARY REDEPLOYMENT OF 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 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 a request that is from a State, locality, 
        territory, tribe, or the Freely Associated States and that 
        includes such information and assurances as the Secretary may 
        require, the Secretary may authorize the requesting entity to 
        temporarily redeploy to immediately address a public health 
        emergency non-Federal personnel funded in whole or in part 
        through--
                  ``(A) any program under this Act; or
                  ``(B) at the discretion of the Secretary, any other 
                program funded in whole or in part by the Department of 
                Health and Human Services.
          ``(2) Activation of emergency redeployment.--
                  ``(A) Public health emergency.--The Secretary may 
                exercise the authority vested by paragraph (1) only 
                during the period of a public health emergency 
                determined pursuant to subsection (a).
                  ``(B) Considerations.--In authorizing a temporary 
                redeployment under paragraph (1), the Secretary shall 
                consider each of the following:
                          ``(i) The degree to which the emergency 
                        cannot be adequately and appropriately 
                        addressed by the public health workforce.
                          ``(ii) The degree to which the emergency 
                        requires or would otherwise benefit from 
                        supplemental staffing from those funded through 
                        nonpreparedness Federal programs.
                          ``(iii) The degree to which such programs 
                        would be adversely affected by the 
                        redeployment.
                          ``(iv) Such other factors as the Secretary 
                        may deem appropriate.
                  ``(C) Termination and extension.--
                          ``(i) Termination.--The authority to 
                        authorize 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), 30 
                                days after the activation of the 
                                Secretary's authority pursuant to 
                                subparagraph (A).
                          ``(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, but only if--
                                  ``(I) the extension is requested by 
                                the entity that requested authority to 
                                authorize a temporary redeployment; and
                                  ``(II) the Secretary gives notice to 
                                the Congress in conjunction with the 
                                extension.''.

SEC. 4. COORDINATION BY 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)(3)--
                  (A) by inserting ``stockpiling, distribution,'' 
                before ``and procurement''; and
                  (B) by inserting ``, security measures (as defined in 
                section 319F-2,'' after ``qualified countermeasures (as 
                defined in section 319F-1)'';
          (2) in subsection (b)(4), by adding at the end the following:
                  ``(D) Identification of inefficiencies.--Identify 
                gaps, duplication, and other inefficiencies in public 
                health preparedness activities and the actions 
                necessary to overcome these obstacles.
                  ``(E) Development of countermeasure implementation 
                plan.--Lead the development of a coordinated 
                Countermeasure Implementation Plan under subsection 
                (d).
                  ``(F) Countermeasures budget analysis.--Oversee the 
                development of a comprehensive, cross-cutting 5-year 
                budget analysis with respect to activities described in 
                paragraph (3)--
                          ``(i) to inform prioritization of resources; 
                        and
                          ``(ii) to ensure that challenges to such 
                        activities are adequately addressed.
                  ``(G) Grant programs for medical and public health 
                preparedness capabilities.--Coordinate, in consultation 
                with the Secretary of Homeland Security, grant programs 
                of the Department of Health and Human Services relating 
                to medical and public health preparedness capabilities 
                and the activities of local communities to respond to 
                public health emergencies, including the--
                          ``(i) coordination of relevant program 
                        requirements, timelines, and measurable goals 
                        of such grant programs; and
                          ``(ii) establishment of a system for 
                        gathering and disseminating best practices 
                        among grant recipients.'';
          (3) by amending subsection (c) to read as follows:
  ``(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 and coordination;
          ``(2) have authority over and responsibility for--
                  ``(A) the National Disaster Medical System (in 
                accordance with section 301 of the Pandemic and All-
                Hazards Preparedness Act);
                  ``(B) the Hospital Preparedness Cooperative Agreement 
                Program pursuant to section 319C-2;
                  ``(C) the Biomedical Advanced Research and 
                Development Authority under section 319L; and
                  ``(D) the Emergency System for Advance Registration 
                of Volunteer Health Professionals pursuant to section 
                319I;
          ``(3) provide policy coordination and oversight of--
                  ``(A) the Strategic National Stockpile under section 
                319F-2;
                  ``(B) the Cities Readiness Initiative; and
                  ``(C) the Medical Reserve Corps pursuant to section 
                2813; and
          ``(4) assume other duties as determined appropriate by the 
        Secretary.''; and
          (4) by adding at the end the following:
  ``(d) Countermeasure Implementation Plan.--Not later than 6 months 
after the date of enactment of this subsection, and annually 
thereafter, the Assistant Secretary for Preparedness and Response shall 
submit through the Secretary to the Committee on Energy and Commerce of 
the House of Representatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a Countermeasure Implementation Plan 
that--
          ``(1) describes the chemical, biological, radiological, and 
        nuclear threats facing 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;
          ``(2) evaluates the progress of all activities with respect 
        to such countermeasures or products, including research, 
        advanced research, development, procurement, stockpiling, 
        deployment, and utilization;
          ``(3) identifies and prioritizes near-, mid-, and long-term 
        needs with respect to such countermeasures or products to 
        address chemical, biological, radiological, and nuclear 
        threats;
          ``(4) identifies, with respect to each category of threat, a 
        summary of all advanced development and procurement awards, 
        including--
                  ``(A) 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);
                  ``(B) projected timelines for development and 
                procurement of such countermeasures or products;
                  ``(C) clearly defined goals, benchmarks, and 
                milestones for each such countermeasure or product, 
                including information on the number of doses required, 
                the intended use of the countermeasure or product, and 
                the required countermeasure or product characteristics; 
                and
                  ``(D) projected needs with regard to the 
                replenishment of the Strategic National Stockpile;
          ``(5) evaluates progress made in meeting the goals, 
        benchmarks, and milestones identified under paragraph (4)(C);
          ``(6) reports on the amount of funds available for 
        procurement in the special reserve fund as defined in section 
        319F-2(g)(5) and the impact this funding will have on meeting 
        the requirements under section 319F-2;
          ``(7) incorporates input from Federal, State, local, and 
        tribal stakeholders; and
          ``(8) addresses the needs of pediatric populations with 
        respect to such countermeasures and products in the Strategic 
        National Stockpile and includes--
                  ``(A) a list of such countermeasures and products 
                necessary to address the needs of pediatric 
                populations;
                  ``(B) a description of measures taken to coordinate 
                with 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;
                  ``(C) 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
                  ``(D) an evaluation of the progress made in 
                addressing gaps identified pursuant to subparagraph 
                (C).
Notwithstanding any other provision of this subsection, the Plan shall 
not include any confidential commercial information, proprietary 
information, or information that could reveal vulnerabilities of the 
Nation in the preparation for or ability to respond to chemical, 
biological, radiological, or nuclear threats.''.
  (b) Consultation in Authorizing Medical Products for Use in 
Emergencies.--Subsection (c) of section 564 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb-3) is amended by striking 
``consultation with the Director of the National Institutes of Health'' 
and inserting ``consultation with the Assistant Secretary for 
Preparedness and Response, the Director of the National Institutes of 
Health,''.
  (c) Biosurveillance Plan.--Not later than one year after the date of 
the enactment of this Act, the Secretary of Health and Human Services 
shall prepare and submit to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a plan to improve information sharing, 
coordination, and communications among disparate biosurveillance 
systems supported by the Department of Health and Human Services.

SEC. 5. ELIMINATING DUPLICATIVE PROJECT BIOSHIELD REPORTS.

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

SEC. 6. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.

  Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360bbb-3) is amended--
          (1) in subsection (a)--
                  (A) in paragraph (1), by striking ``sections 505, 
                510(k), and 515 of this Act'' and inserting ``any 
                provision of this Act'';
                  (B) in paragraph (2)(A), by striking ``under a 
                provision of law referred to in such paragraph'' and 
                inserting ``under a provision of law in section 505, 
                510(k), or 515 of this Act or section 351 of the Public 
                Health Service Act''; and
                  (C) in paragraph (3), by striking ``a provision of 
                law referred to in such paragraph'' and inserting ``a 
                provision of law referred to in paragraph (2)(A)'';
          (2) in subsection (b)--
                  (A) in the subsection heading, by striking 
                ``Declaration of Emergency'' and inserting 
                ``Declaration Supporting Emergency Use Authorization'';
                  (B) in paragraph (1)--
                          (i) in the matter preceding subparagraph (A), 
                        by striking ``an emergency justifying'' and 
                        inserting ``that circumstances exist 
                        justifying'';
                          (ii) in subparagraph (A), by striking 
                        ``specified'';
                          (iii) in subparagraph (B), by striking 
                        ``specified''; and
                          (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, involving a heightened 
                risk to national security or the health and security of 
                United States citizens abroad, and involving a 
                biological, chemical, radiological, or nuclear agent or 
                agents, or a disease or condition that may be 
                attributable to such agent or agents.'';
                  (C) in paragraph (2)--
                          (i) by amending subparagraph (A) to read as 
                        follows:
                  ``(A) In general.--A declaration under this 
                subsection shall terminate upon a determination by the 
                Secretary, in consultation with, as appropriate, the 
                Secretary of Homeland Security or the Secretary of 
                Defense, that the circumstances described in paragraph 
                (1) have ceased to exist.'';
                          (ii) by striking subparagraph (B); and
                          (iii) by redesignating subparagraph (C) as 
                        subparagraph (B); and
                  (D) in paragraph (4), by striking ``advance notice of 
                termination, and renewal'' and inserting ``and advance 
                notice of termination'';
          (3) in subsection (c)(1), by striking ``specified in'' and 
        insert ``covered by'';
          (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)(B), by amending clause (iii) to 
                read as follows:
                          ``(iii) Appropriate conditions with respect 
                        to the collection and analysis of information 
                        concerning the safety and effectiveness of the 
                        product with respect to the actual use of such 
                        product pursuant to an authorization under this 
                        section.'';
                  (B) in paragraph (2)--
                          (i) in subparagraph (A)--
                                  (I) by striking ``manufacturer of the 
                                product'' and inserting ``person''; and
                                  (II) by inserting ``or in paragraph 
                                (1)(B)'' before the period at the end;
                          (ii) in subparagraph (B)(i), by inserting ``, 
                        with the exception of extensions of a product's 
                        expiration date authorized under section 
                        564A(b)'' before the period at the end; 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 
                a product, the Secretary shall not impose conditions 
                that would restrict distribution or administration of 
                the product that is solely for the approved uses.'';
                  (C) by amending paragraph (3) to read as follows:
          ``(3) Good manufacturing practice; prescription; 
        practitioner's authorization.--With respect to the emergency 
        use of a product for which an authorization under this section 
        is issued (whether for an unapproved product or an unapproved 
        use of an approved product), the Secretary may waive or limit, 
        to the extent appropriate given the circumstances of the 
        emergency--
                  ``(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).''; and
                  (D) by adding at the end the following:
          ``(5) Existing authorities.--Nothing in this section 
        restricts any authority vested in the Secretary by any other 
        provision of this Act or the Public Health Service Act for 
        establishing conditions of authorization for a product.''; and
          (6) in subsection (g)--
                  (A) in the heading, by striking ``Revocation of 
                Authorization'' and inserting ``Review, Modification, 
                and Revocation of Authorization'';
                  (B) in paragraph (1), by striking ``periodically 
                review'' and inserting ``review not less than every 
                three years''; and
                  (C) by adding at the end the following:
          ``(3) Modification.--The Secretary may modify an 
        authorization under this section or the conditions of such an 
        authorization, at any time, based on a review of the 
        authorization or new information that is otherwise obtained, 
        including information obtained during an emergency.''.

SEC. 7. ADDITIONAL PROVISIONS RELATED TO MEDICAL PRODUCTS FOR EMERGENCY 
                    USE.

  (a) In General.--The Federal Food, Drug, and Cosmetic Act is amended 
by inserting after section 564 (21 U.S.C. 360bbb-3) the following:

``SEC. 564A. ADDITIONAL PROVISIONS RELATED TO MEDICAL PRODUCTS FOR 
                    EMERGENCY USE.

  ``(a) Definitions.--For purposes of this section:
          ``(1) The term `product' means a drug, device, or biological 
        product.
          ``(2) The term `eligible product' means a product that is--
                  ``(A) approved or cleared under this chapter or 
                licensed under section 351 of the Public Health Service 
                Act; and
                  ``(B) intended to be used to diagnose, prevent, or 
                treat a disease or condition involving a biological, 
                chemical, radiological, or nuclear agent or agents 
                during--
                          ``(i) a domestic emergency or military 
                        emergency involving heightened risk of attack 
                        with such an agent or agents; or
                          ``(ii) a public health emergency affecting 
                        national security or the health and security of 
                        United States citizens abroad.
  ``(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 eligible product is intended to be held for 
                use for a domestic, military, or public health 
                emergency described in subsection (a)(2)(B);
                  ``(B) 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
                  ``(C) 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.
  ``(c) Current Good Manufacturing Practices.--
          ``(1) In general.--The Secretary may, when the circumstances 
        of a domestic, military, or public health emergency described 
        in subsection (a)(2)(B) 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) Mass Dispensing.--The requirements of section 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 an actual emergency 
        described in subsection (a)(2)(B); 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.
  ``(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 (as defined in section 
        564(a)(2)(A)) and shall not be deemed adulterated or misbranded 
        under this Act because of--
                  ``(A) the issuance of emergency use instructions 
                under paragraph (1) with respect to such product; or
                  ``(B) the introduction or delivery for introduction 
                of such product into interstate commerce accompanied by 
                such instructions during an emergency response to an 
                actual emergency described in subsection (a)(2)(B).''.
  (b) 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, an actual or 
potential domestic emergency or military emergency involving heightened 
risk of attack with a biological, chemical, radiological, or nuclear 
agent, or an actual or potential public health emergency affecting 
national security or the health and security of United States citizens 
abroad.''.

SEC. 8. 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 section 7, the 
following:

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

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

SEC. 9. ACCELERATE COUNTERMEASURE DEVELOPMENT BY STRENGTHENING FDA'S 
                    ROLE IN REVIEWING PRODUCTS FOR NATIONAL SECURITY 
                    PRIORITIES.

  (a) In General.--Section 565 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb-4) is amended to read as follows:

``SEC. 565. COUNTERMEASURE DEVELOPMENT AND REVIEW.

  ``(a) Countermeasures and Products.--The countermeasures and products 
referred to in this subsection are--
          ``(1) qualified countermeasures (as defined in section 319F-1 
        of the Public Health Service Act);
          ``(2) security countermeasures (as defined in section 319F-2 
        of such Act); and
          ``(3) qualified pandemic or epidemic products (as defined in 
        section 319F-3 of such Act) that the Secretary determines to be 
        a priority.
  ``(b) In General.--
          ``(1) Involvement of fda personnel in interagency 
        activities.--For the purpose of accelerating the development, 
        stockpiling, approval, clearance, and licensure of 
        countermeasures and products referred to in subsection (a), the 
        Secretary shall expand the involvement of Food and Drug 
        Administration personnel in interagency activities with the 
        Assistant Secretary for Preparedness and Response (including 
        the Biomedical Advanced Research and Development Authority), 
        the Centers for Disease Control and Prevention, the National 
        Institutes of Health, and the Department of Defense.
          ``(2) Technical assistance.--The Secretary shall establish 
        within the Food and Drug Administration a team of experts on 
        manufacturing and regulatory activities (including compliance 
        with current Good Manufacturing Practices) to provide both off-
        site and on-site technical assistance to the manufacturers of 
        countermeasures and products referred to in subsection (a). On-
        site technical assistance shall be provided upon the request of 
        the manufacturer and at the discretion of the Secretary if the 
        Secretary determines that the provision of such assistance 
        would accelerate the development, manufacturing, or approval, 
        clearance, or licensure of countermeasures and products 
        referred to in subsection (a).
  ``(c) Agency Interaction With Security Countermeasure Sponsors.--
          ``(1) In general.--For security countermeasures (as defined 
        in section 319F-2 of the Public Health Service Act) that are 
        procured under such section 319F-2--
                  ``(A) the Secretary shall establish a process for 
                frequent scientific feedback and interactions between 
                the Food and Drug Administration and the security 
                countermeasure sponsor (referred to in this subsection 
                as the `sponsor'), designed to facilitate the approval, 
                clearance, and licensure of the security 
                countermeasures;
                  ``(B) such feedback and interactions shall include 
                meetings and, in accordance with subsection (b)(2), on-
                site technical assistance; and
                  ``(C) at the request of the Secretary, the process 
                under this paragraph shall include participation by the 
                Food and Drug Administration in meetings between the 
                Biomedical Advanced Research and Development Authority 
                and sponsors on the development of such 
                countermeasures.
          ``(2) Regulatory management plan.--
                  ``(A) In general.--The process established under 
                paragraph (1) shall allow for the development of a 
                written regulatory management plan (in this paragraph 
                referred to as the `plan') for a security 
                countermeasure (as defined in paragraph (1)) in 
                accordance with this paragraph.
                  ``(B) Proposal and finalization of plan.--In carrying 
                out the process under paragraph (1), the Secretary 
                shall direct the Food and Drug Administration, upon 
                submission of a written request by the sponsor that 
                includes a proposed plan and relevant data and future 
                planning detail to support such a plan, to work with 
                the sponsor to agree on a final plan within a 
                reasonable time not to exceed 90 days. The basis for 
                this agreement shall be the proposed plan submitted by 
                the sponsor. Notwithstanding the preceding sentence, 
                the Secretary shall retain full discretion to determine 
                the contents of the final plan or to determine that no 
                such plan can be agreed upon. If the Secretary 
                determines that no final plan can be agreed upon, the 
                Secretary shall provide to the sponsor, in writing, the 
                scientific or regulatory rationale why such agreement 
                cannot be reached. If a final plan is agreed upon, it 
                shall be shared with the sponsor in writing.
                  ``(C) Contents.--The plan shall include an agreement 
                on the nature of, and timelines for, feedback and 
                interactions between the sponsor and the Food and Drug 
                Administration, shall provide reasonable flexibility in 
                implementing and adjusting the agreement under this 
                paragraph as warranted during the countermeasure 
                development process, and shall identify--
                          ``(i) the current regulatory status of the 
                        countermeasure, an assessment of known 
                        scientific gaps relevant to approval, 
                        clearance, or licensure of the countermeasure, 
                        and a proposed pathway to approval, clearance, 
                        or licensure of the countermeasure;
                          ``(ii) developmental milestones whose 
                        completion will result in meetings to be 
                        scheduled within a reasonable time between the 
                        applicable review division of the Food and Drug 
                        Administration and the sponsor;
                          ``(iii) sponsor submissions that will result 
                        in written feedback from the review division 
                        within a reasonable time;
                          ``(iv) feedback by the Food and Drug 
                        Administration regarding the data required to 
                        support delivery of the countermeasure to the 
                        Strategic National Stockpile under section 
                        319F-2 of the Public Health Service Act;
                          ``(v) feedback by the Food and Drug 
                        Administration regarding data required to 
                        support submission of a proposed agreement on 
                        the design and size of clinical trials for 
                        review under section 505(b)(5)(B); and
                          ``(vi) other issues that have the potential 
                        to delay approval, clearance, or licensure.
                  ``(D) Changes.--Changes to the plan shall be made by 
                subsequent agreement between the Secretary and the 
                sponsor. If after reasonable attempts to negotiate 
                changes to the plan the Secretary and the sponsor are 
                unable to finalize such changes, the Secretary shall 
                provide to the sponsor, in writing, the scientific or 
                regulatory rationale why such changes are required or 
                cannot be included in the plan.
          ``(3) Applicability to certain qualified pandemic or epidemic 
        products.--The Secretary may, with respect to qualified 
        pandemic or epidemic products (as defined in section 319F-3 of 
        the Public Health Service Act) for which a contract for 
        advanced research and development is entered into under section 
        319L of such Act, choose to apply the provisions of paragraphs 
        (1) and (2) to the same extent and in the same manner as such 
        provisions apply with respect to security countermeasures.
  ``(d) 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 2011, the Secretary shall provide final 
        guidance to industry regarding the development of animal models 
        to support approval, clearance, or licensure of countermeasures 
        and products 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.
  ``(e) Biennial Report.--Not later than January 1, 2013, and every 2 
years thereafter, the Secretary shall submit a report to the Committee 
on Energy and Commerce of the House of Representatives and the 
Committee on Health, Education, Labor, and Pensions of the Senate, 
that, with respect to the preceding 2 fiscal years, includes--
          ``(1) the number of full-time equivalent employees of the 
        Food and Drug Administration who directly support the review of 
        countermeasures and products referred to in subsection (a);
          ``(2) estimates of funds obligated by the Food and Drug 
        Administration for review of such countermeasures and products;
          ``(3) the number of regulatory teams at the Food and Drug 
        Administration specific to such countermeasures and products 
        and, for each such team, the assigned products, classes of 
        products, or technologies;
          ``(4) the length of time between each request by the sponsor 
        of such a countermeasure or product for information and the 
        provision of such information by the Food and Drug 
        Administration;
          ``(5) the number, type, and frequency of official 
        interactions between the Food and Drug Administration and--
                  ``(A) sponsors of a countermeasure or product 
                referred to in subsection (a); or
                  ``(B) another agency engaged in development or 
                management of portfolios for such countermeasures or 
                products, 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;
          ``(6) a description of other measures that, as determined by 
        the Secretary, are appropriate to determine the efficiency of 
        the regulatory teams described in paragraph (3); and
          ``(7) the regulatory science priorities that relate to 
        countermeasures or products referred to in subsection (a) and 
        which the Food and Drug Administration is addressing and the 
        progress made on these priorities.''.
  (b) Special Protocol Assessment.--Subparagraph (B) of section 
505(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)(5)) is amended to read as follows:
  ``(B)(i) The Secretary shall meet with a sponsor of an investigation 
or an applicant for approval for a drug under this subsection or 
section 351 of the Public Health Service Act if the sponsor or 
applicant makes a reasonable written request for a meeting for the 
purpose of reaching agreement on the design and size of--
          ``(I) clinical trials intended to form the primary basis of 
        an effectiveness claim; or
          ``(II) animal efficacy trials and any associated clinical 
        trials that in combination are intended to form the primary 
        basis of an effectiveness claim for a countermeasure or product 
        referred to in section 565(a) when human efficacy studies are 
        not ethical or feasible.
  ``(ii) The sponsor or applicant shall provide information necessary 
for discussion and agreement on the design and size of the clinical 
trials. Minutes of any such meeting shall be prepared by the Secretary 
and made available to the sponsor or applicant upon request.''.

                          Purpose and Summary

    H.R. 2405, the ``Pandemic and All-Hazards Preparedness 
Reauthorization Act of 2011,'' was introduced on June 28, 2011, 
by Representative Mike Rogers (R-MI) and referred to the 
Committee on Energy and Commerce.
    The legislation would facilitate the development of 
chemical, biological, radioactive, and nuclear (CBRN) medical 
countermeasures (MCMs) and bolster the nation's public health 
preparedness infrastructure so the Nation can better respond to 
public health emergencies and disasters, including those caused 
by CBRN attack.

                  Background and Need for Legislation

    In the wake of the September 11th terrorist attacks, 
Congress took important steps to build the Nation's health 
infrastructure and foster the development of CBRN MCMs to 
enable the Nation to better respond to CBRN attacks. As part of 
these steps, Congress enacted two key pieces of legislation, 
the ``Project BioShield Act of 2004'' (Project BioShield) (P.L. 
108-276) and the ``Pandemic and All-Hazards Preparedness Act of 
2006'' (PAHPA) (P.L. 109-417), and they have dramatically 
improved our nation's ability to respond to public health 
emergencies and disasters, including those caused by terrorism. 
As described in this report, the ``Pandemic and All-Hazards 
Preparedness Reauthorization Act of 2011'' would reauthorize 
and improve certain provisions of Project BioShield and PAHPA 
in order to increase certainty and predictability, clarify the 
role of the Assistant Secretary for Preparedness and Response 
(ASPR) as the leader of preparedness and response, and 
strengthen our nation's preparedness infrastructure.
    The 108th Congress passed Project BioShield to encourage 
the private sector to develop MCMs against CBRN agents that 
would not otherwise have a commercial market and bring 
certainty and predictability to the MCM development space. 
Project BioShield included provisions that, among other things, 
authorized funds for the purchase of MCMs through the Special 
Reserve Fund (SRF) and enabled the Secretary of the Department 
of Health and Human Services (HHS) to authorize the emergency 
use of medical products. The SRF was intended to be a secure 
funding source for the procurement of critical MCMs; it is 
critical because it clearly demonstrates the Federal 
government's commitment to MCM procurement. By increasing 
certainty and predictability, which this legislation seeks to 
do through the reauthorization of the Special Reserve Fund and 
the Biodefense Advanced Research and Development Authority 
(BARDA) as well as the establishment of the Regulatory 
Management Plan process, among other provisions, H.R. 2405 
would build on the provisions of Project BioShield to encourage 
investment, research, and development and increase the 
likelihood of securing the MCMs necessary to protect our 
citizens during health emergencies and disasters, including 
those caused by terrorism.
    Shortly after the enactment of Project BioShield, the 109th 
Congress passed PAHPA, which reauthorized a number of expiring 
preparedness and response programs in the Public Health Service 
Act and established several new authorities. For instance, 
PAHPA established BARDA, a new authority within HHS, to foster 
advanced MCM development and facilitate interactions between 
HHS and MCM developers. PAHPA also established a crucial new 
position at HHS, the Assistant Secretary for Preparedness and 
Response, to lead the Federal government's efforts and 
coordination for CBRN preparedness and response. H.R. 2405 
includes provisions to clarify that the ASPR has lead 
responsibility within HHS for emergency preparedness and 
response policy and coordination. Finally, PAHPA included 
provisions to build the nation's public health infrastructure. 
The provisions of H.R. 2405 would reauthorize many of these 
PAHPA provisions to continue the effort to strengthen our 
Nation's preparedness infrastructure.

                                Hearings

    On July 21, 2011, the Subcommittee on Health held a hearing 
entitled ``Legislative Hearing to Address Bioterrorism, 
Controlled Substances and Public Health Issues.'' H.R. 2405, 
the ``Pandemic and All-Hazards Preparedness Reauthorization Act 
of 2011,'' was one of three bills considered at this hearing. 
The Subcommittee received testimony from: Representative 
Charlie Dent (PA-15); Nicole Lurie, M.D., M.S.P.H, Assistant 
Secretary for Preparedness and Response, U.S. Department of 
Health and Human Services; and Howard K. Koh, M.D., M.P.H, 
Assistant Secretary for Health, U.S. Department of Health and 
Human Services.

                        Committee Consideration

    H.R. 2405, the ``Pandemic and All-Hazards Preparedness 
Reauthorization Act of 2011,'' was introduced on June 28, 2011, 
by Representative Mike Rogers (R-MI) and referred to the 
Committee on Energy and Commerce.
    The Subcommittee on Health held a legislative hearing on 
July 21, 2011, entitled, ``Legislative Hearing to Address 
Bioterrorism, Controlled Substances and Public Health Issues,'' 
during which it considered H.R. 2405. On July 26, 2011, the 
Subcommittee met in open markup session to consider H.R. 2405. 
The Subcommittee favorably reported an Amendment in the Nature 
of a Substitute, which included technical changes recommended 
by the Administration and the reauthorization of two programs 
from the original PAHPA law passed in 2006: the Medical Reserve 
Corps and the Emergency System for Advance Registration of 
Health Professional Volunteers. Thereafter, the Subcommittee 
ordered that H.R. 2405 be favorably forwarded to the full 
Committee for consideration.
    On July 28, 2011, the Committee on Energy and Commerce met 
in open markup session to consider H.R. 2405, as approved by 
the Subcommittee on Health. The Committee considered an 
Amendment in the Nature of a Substitute, which included 
provisions to improve the accountability of the Hospital 
Preparedness Cooperative Agreement Program, enhance surge 
capacity as part of the National Health Security Strategy, 
allow the temporary reassignment of federally funded personnel 
at the request of states or localities, and enhance reporting 
on biosurveillance efforts. It also further clarified that the 
ASPR would lead emergency response efforts across the various 
HHS agencies and among federal interagency partners. The 
Committee also considered an amendment to the Amendment in the 
Nature of a Substitute. In addition to a number of technical 
and conforming changes, the amendment to the Amendment in the 
Nature of a Substitute included provisions that would provide 
increased clarity and flexibility to enhance our nation's 
ability to pre-position and deploy medical countermeasures. In 
addition, it included provisions that would enable the federal 
government to extend the shelf-life of current countermeasures 
in the Strategic National Stockpile and to dispense medical 
countermeasures requiring prescriptions on a mass-level during 
emergencies.
    The full Committee approved both the amendment to the 
Amendment in the Nature of a Substitute and the Amendment in 
the Nature of a Substitute by voice vote, and ordered that H.R. 
2405 be favorably reported to the House by voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the recorded 
votes on the motion to report legislation and amendments 
thereto. There were no recorded votes taken in connection with 
ordering H.R. 2405 reported. A motion to order H.R. 2405 be 
reported to the House, as amended, was agreed to by voice vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the oversight findings and 
recommendations of the Committee are reflected in the 
descriptive portions of this report, including the finding that 
the nation must facilitate development of CBRN MCMs and bolster 
our public health preparedness infrastructure so the nation can 
better respond to public health emergencies and disasters, 
including those caused by CBRN attack.

         Statement of General Performance Goals and Objectives

    In accordance with clause 3(c)(4) of rule XIII of the Rules 
of the House of Representatives, the performance goals and 
objectives of the Committee are reflected in the descriptive 
portions of this report, including the goal that the nation 
facilitate the development of CBRN MCMs and bolster our public 
health preparedness infrastructure so the nation can better 
respond to public health emergencies and disasters, including 
those caused by CBRN attack.

           New Budget Authority, Entitlement Authority, and 
                            Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
2405, the ``Pandemic and All-Hazards Preparedness 
Reauthorization Act of 2011,'' would result in no new or 
increased budget authority, entitlement authority, or tax 
expenditures or revenues.

                                Earmarks

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI, 
the Committee finds that H.R. 2405, the ``Pandemic and All-
Hazards Preparedness Reauthorization Act of 2011,'' contains no 
earmarks, limited tax benefits, or limited tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                Washington, DC, September 26, 2011.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 2405, the Pandemic 
and All-Hazards Preparedness Reauthorization Act of 2011.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Andrea Noda.
            Sincerely,
                                              Douglas W. Elmendorf.
    Enclosure.

H.R. 2405--Pandemic and All-Hazards Preparedness Reauthorization Act of 
        2011

    Summary: H.R. 2405 would amend the Public Health Service 
Act to authorize funding for certain activities carried out by 
various agencies and offices within the Department of Health 
and Human Services (HHS) that would support the readiness of 
the public health system to address public health and medical 
emergencies. Those activities are conducted by the Centers for 
Disease Control and Prevention (CDC), the Food and Drug 
Administration (FDA), and several offices within the HHS Office 
of the Secretary.
    CBO estimates that implementing the bill would cost $395 
million in 2012 and $7.9 billion over the 2012-2016 period, 
assuming the appropriation of the authorized amounts. The 
funding authorized by H.R. 2405 is similar to the appropriation 
amounts enacted in recent years for the same activities. Pay-
as-you-go procedures do not apply to this legislation because 
it would not affect direct spending or revenues.
    H.R. 2405 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
    Estimated cost to the Federal Government: The estimated 
budgetary impact of H.R. 2405 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                 By fiscal year, in millions of dollars--
                                                         -------------------------------------------------------
                                                            2012     2013     2014     2015     2016   2012-2016
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Centers for Disease Control and Prevention:
    State and Local Public Health Security:
        Authorization Level.............................      633      633      633      633      633     3,165
        Estimated Outlays...............................      130      440      540      600      615     2,325
    Public Health Threats:
        Authorization Level.............................      160      160      160      160      160       800
        Estimated Outlays...............................       55      120      145      150      155       625
    Vaccine Tracking and Distribution:
        Authorization Level.............................       31       31       31       31       31       155
        Estimated Outlays...............................       15       25       30       30       30       130
Food and Drug Administration:
    Estimated Authorization.............................       15       30       35       40       40       160
    Estimated Outlays...................................       15       25       35       35       40       150
Office of the Assistant Secretary for Health:
    Authorization Level.................................       12       12       12       12       12        60
    Estimated Outlays...................................        5       10       10       10       10        45
Office of the Assistant Secretary for Preparedness and
 Response:
    Procurement of Countermeasures:
        Authorization Level.............................    2,800        0        0        0        0     2,800
        Estimated Outlays...............................        0        0      365      665      330     1,360
    Advance Development of Countermeasures:
        Authorization Level.............................      415      415      415      415      415     2,075
        Estimated Outlays...............................       85      315      380      405      415     1,600
    Hospital Preparedness:
        Authorization Level.............................      378      378      378      378      378     1,890
        Estimated Outlays...............................       75      265      320      360      365     1,385
    National Disaster Medical System:
        Authorization Level.............................       56       56       56       56       56       280
        Estimated Outlays...............................       10       45       50       55       55       215
    Emergency Volunteer Registration:
        Authorization Level.............................        6        6        6        6        6        30
        Estimated Outlays...............................        5        5        5        5        5        25
Total Changes:
    Authorization Level.................................    4,506    1,721    1,726    1,731    1,731    11,415
    Estimated Outlays...................................      395    1,250    1,880    2,315    2,020     7,860
----------------------------------------------------------------------------------------------------------------

    Basis of estimate: For this estimate, CBO assumes that H.R. 
2405 will be enacted near the start of fiscal year 2012 and 
that the authorized amounts will be appropriated for each year.
    The bill contains provisions that would authorize funding 
for activities administered by CDC, FDA, the Office of the 
Assistant Secretary of Health (ASH), and the Office of the 
Assistant Secretary for Preparedness and Response (ASPR) to 
improve the coordination of preparedness activities and to 
increase medical system capacity in the event of a public 
health emergency.

Centers for Disease Control and Prevention

    H.R. 2405 would authorize funding through 2016 for 
activities related to preparing for a public health emergency 
at levels similar to the appropriations for recent years.
    State and Local Public Health Security. H.R. 2405 would 
allow CDC to continue to administer cooperative agreements with 
state and local governments to help prepare for public health 
emergencies. Entities receiving funding through those 
cooperative agreements must submit plans for responding to an 
outbreak of pandemic influenza and contribute matching funds. 
This bill would authorize the appropriation of $633 million 
each fiscal year for 2012 through 2016 for CDC to administer 
those cooperative agreements. Based on historical spending 
patterns of similar programs, CBO estimates that implementing 
that provision would cost $130 million in 2012 and $2.3 billion 
over the 2012-2016 period, assuming appropriation of the 
authorized amounts.
    Public Health Threats. H.R. 2405 would authorize funding 
for the Secretary to continue to expand, enhance, and improve 
the capacity for CDC to respond effectively to bioterrorism and 
other public health emergencies. H.R. 2405 would also authorize 
funding to establish and maintain surveillance programs and 
networks that enhance coordinated efforts in response to 
outbreaks of infectious diseases and public health emergencies. 
The bill would authorize the appropriation of $160 million a 
year for fiscal years 2012 through 2016. Based on historical 
spending patterns for similar programs, CBO estimates that 
implementing that provision would cost $55 million in 2012 and 
$625 million over the 2012-2016 period, assuming appropriation 
of the authorized amounts.
    Vaccine Tracking and Distribution. CDC collaborates with 
officials in state, local, and tribal governments as well as 
private entities, such as vaccine manufacturers, wholesalers, 
and distributors, to track the distribution of vaccines for 
pandemic flu and to promote effective distribution of vaccines 
for the seasonal flu. H.R. 2405 would authorize the Secretary 
to continue those activities and would authorize the 
appropriation $31 million for each fiscal year over the 2012-
2016 period. Assuming appropriation of authorized amounts, CBO 
estimates that implementing that provision would cost $15 
million in 2012 and $130 million over the 2012-2016 period, 
based on historical spending patterns for similar programs.

Food and Drug Administration

    H.R. 2405 would expand the role of FDA personnel in 
supporting the development, stockpiling, approval and licensure 
of medical countermeasures (such as diagnostic tests, drugs, 
vaccines and other treatments for response to chemical, 
biological, radiological and nuclear threats) as well as 
medical responses to pandemics and epidemics. The bill would 
require the formation of a team of experts on manufacturing and 
regulatory activities within the FDA to provide both off-site 
and on-site technical assistance to manufacturers of those 
products. CBO estimates that the FDA would require the 
appropriation of an additional $15 million in 2012 and $160 
million for the 2012-2016 period for such activities. Assuming 
the appropriation of those amounts, CBO estimates those 
provisions would cost $150 million over the 2012-2016 period.

Office of the Assistant Secretary of Health

    The Medical Reserve Corps (MRC) is a community-based 
program that coordinates medical and public health volunteers 
to support public health activities, including emergency 
preparedness and response efforts. The bill would authorize 
funding for the MRC, which is operated by the HHS Office of the 
Surgeon General within the ASH. The MRC received an 
appropriation of just under $12 million for fiscal year 2011. 
The bill would authorize the same amount for each fiscal year 
over the 2012-2016 period. Based on historical spending 
patterns for similar programs, CBO estimates that implementing 
that provision would cost $5 million in 2012 and $45 million 
over the 2012-2016 period, assuming appropriation of authorized 
amounts.

Office of the Assistant Secretary for Preparedness and Response

    H.R. 2405 would authorize funding for the following 
activities administered by ASPR related to medical system 
capacity and countermeasure development and procurement.
    Procurement of Countermeasures. Project Bioshield, a 
special reserve fund established for the procurement of 
biodefense countermeasures, is funded by an appropriation of 
approximately $5.6 billion for fiscal years 2004-2013. H.R. 
2405 would authorize an additional appropriation of $2.8 
billion for fiscal years 2014-2018 to the fund for continuing 
those activities. H.R. 2405 would allow up to 30 percent of the 
$2.8 billion to be used for advance research and development of 
countermeasures. Based on historical spending patterns, CBO 
estimates that implementing the provision would cost $1.4 
billion over the 2012-2016 period, assuming appropriation of 
the authorized amount.
    Advance Development of Countermeasures. The Biomedical 
Advance Research and Development Authority (BARDA) office 
within ASPR supports the advance development of medical 
countermeasures to respond to bioterrorism and other public 
health emergencies. BARDA is funded by the Biodefense Medical 
Countermeasure Development Fund. H.R. 2405 would authorize $415 
million for the fund in each year for fiscal years 2012 through 
2016. Based on historical spending patterns, CBO estimates that 
implementing that provision would cost $85 million in 2012 and 
$1.6 billion over the 2012-2016 period, assuming appropriation 
of the authorized amounts.
    Hospital Preparedness. The bill would authorize a grant 
program that provides funding to entities such as states, 
localities, or health care facilities to enhance hospital 
capacity to handle a surge of patients in the event of a public 
health emergency. The grant program received an appropriation 
of $378 million in fiscal year 2011. The bill would authorize 
the same amount in each fiscal year over the 2012-2016 period. 
Assuming appropriation of authorized amounts, CBO estimates 
that implementing that provision would cost $75 million in 2012 
and $1.4 billion over the 2012-2016 period, based on historical 
spending patterns of similar programs.
    National Disaster Medical System (NDMS). The bill would 
authorize funding for the NDMS, which is a partnership between 
HHS, the Departments of Defense, Homeland Security, and 
Veterans Affairs. It provides for medical assistance to states 
and localities when responding to a large-scale public health 
emergency. In fiscal year 2011, the NDMS received an 
appropriation of $56 million. The bill would authorize the same 
amount in each fiscal year over the 2012-2016 period. Based on 
historical spending patterns of similar programs, CBO estimates 
that implementing that provision would cost $215 million over 
the 2012-2016 period, assuming appropriation of authorized 
amounts.
    Emergency Volunteer Registration. The Emergency System for 
Advance Registration of Volunteer Health Professionals (ESAR-
VHP) is a national database that links state credential 
verification systems in order to streamline the pre-
registration of volunteer health professionals who are willing 
to respond in the event of a public health emergency. The ESAR-
VHP received an appropriation of about $6 million in fiscal 
year 2011. The bill would authorize the same amount in each 
fiscal year over the 2012-2016 period. Assuming appropriation 
of authorized amounts, CBO estimates that implementing that 
provision would cost $25 million over the 2012-2016 period, 
based on historical spending patterns of similar programs.
    Pay-As-You-Go considerations: None.
    Intergovernmental and private-sector impact: H.R. 2405 
contains no intergovernmental or private-sector mandates as 
defined in UMRA. Programs and activities authorized in the bill 
would benefit state, local, and tribal agencies that prepare 
for and respond to public health emergencies.
    Estimate prepared by: Federal costs: Stephanie Cameron, 
Andrea Noda, Ellen Werble; Impact on state, local, and tribal 
governments: Lisa Ramirez-Branum; Impact on the private sector: 
Jimmy Jin.
    Estimate approved by: Holly Harvey, Deputy Assistant 
Director for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1--Short title and table of contents

    This section includes the name of the bill: ``Pandemic and 
All-Hazards Preparedness Reauthorization Act of 2011.''

Section 2--Reauthorization of certain provisions relating to public 
        health preparedness

    This section includes the following provisions:
     Section 2(a)--Vaccine tracking and distribution. 
This provision would reauthorize the vaccine tracking and 
distribution program used during an influenza pandemic. The 
bill would authorize the program at $30.8 million each year for 
five years (FY 2012-2016). This level of funding is equal to 
the program's FY 2011 appropriated level.
     Section 2(b)--Public health preparedness grants. 
This provision would reauthorize the Public Health Emergency 
Preparedness Cooperative Agreement (PHEP) administered by the 
Centers for Disease Control and Prevention (CDC). These grants 
to state and local health departments have greatly improved the 
Nation's ability to respond to many public health hazards. The 
bill would require those applying for the grants to describe 
any activities they will use to analyze clinical specimens, 
including any utilization of poison control centers, which the 
Committee believes are vital components to our nation's 
preparedness infrastructure and therefore should be utilized. 
Poison Control Centers possess the capacity and expertise to 
assist in responding to a public health emergency. The bill 
would authorize the program at $632.9 million each year for 
five years (FY 2012-2016). This level of funding is equal to 
the program's FY 2011 appropriated level.
     Section 2(c)--Health system preparedness grants. 
This provision would reauthorize the Hospital Preparedness 
Program Cooperative Agreement administered by the ASPR. These 
grants to states and hospitals have greatly improved our 
Nation's preparedness for disasters that would result in a 
surge in the need for medical care. The bill includes language 
that would require the awards to take into account the needs of 
pediatric and other at-risk populations. The bill also would 
require the HHS Secretary to implement evidence-based metrics 
to ensure that those receiving awards meet the goals of the 
National Health Security Strategy. The bill would authorize the 
program at $378 million each year for five years (FY 2012-
2016). This level of funding is equal to the program's FY 2011 
appropriated level.
     Section 2(d)--CDC surveillance and capacity. The 
provision would reauthorize the Federal, state, and local 
surveillance and situational awareness capacity program. The 
bill would authorize the program at $160.1 million each year 
for five years (FY 2012-2016). This level of funding is equal 
to the program's FY 2011 appropriated level.
     Section 2(e)--Dental emergency responders. This 
provision would incorporate dentists by name into Federal and 
state disaster response frameworks, allowing dentists to be 
deployed during a natural or man-made disaster. This provision 
is based on H.R. 570, the ``Dental Emergency Responder Act of 
2011'', which was introduced by Rep. Michael Burgess (R-TX) on 
February 9, 2011, and reported favorably by the Committee 
earlier this Congress. Recent disasters have made clear the 
critical need for a prepared, robust national medical response 
framework. Currently, dentists, allied dental personnel, and 
dental facilities are not part of that framework. These 
individuals and offices are both eager and willing to 
participate and otherwise assist in supporting medical and 
public health responses to disasters. The legislation would 
allow but not require these health care professionals to assist 
in public health emergencies.
     Section 2(f)--BioShield Special Reserve Fund. This 
provision would reauthorize the Project BioShield Special 
Reserve Fund, originally created in 2004. The SRF was intended 
to be used solely for procuring medical countermeasures in 
response to chemical, biological, radiological, or nuclear 
threats against the nation. Since 2004, the SRF has 
successfully procured medical countermeasures for the Strategic 
National Stockpile, protecting against threats such as anthrax 
and smallpox.
    The Committee believes stable funding for MCM development 
and procurement is vital to create producer interest in and 
willingness to enter this space. The SRF is intended to be a 
secure funding source for the procurement of critical MCMs; it 
is critical because it clearly demonstrates the Federal 
government's commitment to MCM procurement. As such, the 
Committee believes these funds for development and procurement 
of MCMs should go to these specific activities and not be 
diverted. Because substantial funds have, in fact, been 
diverted to non-MCM activities, causing significant fear that 
there are or will soon be insufficient funds to support MCM 
development and procurement, H.R. 2405 would prohibit SRF funds 
from being used for anything other than MCM development and 
procurement, as defined under sections 319L and 319F-2 of the 
Public Health Service Act.
    This legislation would reauthorize the SRF at $2.8 billion 
over five years (FY 2014-2018). This level of funding is 
consistent with the SRF's original, 10-year appropriation of 
$5.6 billion for FY 2004-2013. In addition to reauthorizing the 
SRF, the provision also would:
           Require the Federal government to clearly 
        define the purpose of a particular contract as it 
        relates to the medical countermeasure being procured.
           Require the HHS Secretary to provide a 
        report to Congress when funds available in the SRF go 
        below $1.5 billion. The report would detail how the 
        level of funding in the SRF would affect our nation's 
        ability to develop medical countermeasures for public 
        health threats.
           Allow the HHS Secretary to use up to 30 
        percent of funds available in the SRF for advanced 
        research and development of medical countermeasures at 
        BARDA. These funds would supplement, not supplant, 
        BARDA's funding through the annual appropriations 
        process.
     Section 2(g)--Emergency System for Advance 
Registration of Health Professions Volunteers (ESAR-VHP). This 
provision would reauthorize the ESAR-VHP program, which 
supports state and territories in establishing standardized 
volunteer registration programs for disasters and public health 
and medical emergencies. The program is funded at $5.9 million 
each year for five years (FY 2012-2016). This level of funding 
is equal to the program's FY 2011 appropriated level.
     Section 2(h)--Biomedical Advanced Research and 
Development Authority. This provision would reauthorize BARDA, 
which was created in 2006 to help bridge the ``valley of 
death'' between medical countermeasure development and 
procurement. BARDA has been successful in getting many early-
stage medical countermeasures through the expensive, time 
consuming development process so that these products can be 
procured for the Strategic National Stockpile. The bill would 
reauthorize BARDA at $415 million each year for five years (FY 
2012-2016). This level of funding is equal to the program's FY 
2011 appropriated level. The bill also would extend the 
requirement that the HHS Secretary withhold from FOIA 
disclosure specific technical data or scientific information 
created during the advanced research and development of a 
medical countermeasure that would reveal vulnerabilities of 
existing medical or public health defenses against CBRN 
threats. Finally, the bill would require the Federal government 
to clearly define the purpose of a particular advanced research 
and development contract as it relates to the medical 
countermeasure under contract.
     Section 2(i)--National Disaster Medical System 
(NDMS). The bill would reauthorize the NDMS, which assists in 
managing the Federal government's medical response to major 
emergencies and disasters. The bill would reauthorize the 
program at $56 million each year for five years (FY 2012-2016). 
This level of funding is equal to the program's FY 2011 
appropriated level. Under this provision, the HHS Secretary 
could pay third party vendors to assist in the Federal response 
to emergencies and disasters.
     Section 2(j)--National Health Security Strategy 
Timeline. This provision would change the submission date of 
the National Health Security Strategy to 2014.
     Section 2(k)--Enhancing Surge Capacity. This 
provision would modify the goals in the National Health 
Security Strategy to ensure that periodic evaluation of 
Federal, State, local, and tribal preparedness will include 
drills and exercises to ensure medical surge capacity, 
particularly for events without notice. The goals for medical 
preparedness capacity would be expanded to include 
availability, coordination, and accessibility of resources. The 
provision also would change the definition of the components of 
medical preparedness under the strategy to include both 
ambulatory care and critical care. Finally, the provision would 
ensure that medical evacuation goals include triage and 
evacuation to the appropriate medical institution based on the 
medical needs of the patient, as part of regional systems.
     Section 2(l)--Volunteer Medical Reserve Corps. 
This provision would reauthorize the Medical Reserve Corps, 
which engages local volunteers to strengthen public health, 
emergency response and community resiliency. The bill would 
reauthorize the program at $11.9 million each year for five 
years (FY 2012-2016). This level of funding is equal to the 
program's FY 2011 appropriated level.
     Section 2(m)--Extension of anti-trust exemptions. 
This provision would extend limited anti-trust exemptions for 
meetings regarding medical countermeasure development that 
include national security information.

Section 3--Temporary redeployment of personnel during a public health 
        emergency

    The section would allow the HHS Secretary to redeploy 
nonFederal personnel (funded through the Public Health Service 
Act or programs funded through HHS) to assist in public health 
emergencies and disasters, but only at the request of the state 
or locality.

Section 4--Improving coordination by the Assistant Secretary for 
        Preparedness and Response

    The ASPR serves as the principal advisor to the HHS 
Secretary on all matters related to bioterrorism and other 
public health emergencies. Additionally, the ASPR plays a vital 
role in coordinating emergency response efforts across the 
various HHS agencies and among HHS; other Federal departments, 
agencies, and offices; and state and local officials. The 
Committee believes that it is clear that the successful 
execution of the ASPR's mission, which, according to the ASPR, 
is to ``lead the nation in preventing, responding to and 
recovering from the adverse health effects of public health 
emergencies and disasters,'' is vital to ensuring that our 
Nation is prepared to effectively respond to a CBRN threat or 
emergency.\1\ While centralizing significant coordination 
authority with the ASPR is necessary, the Federal response to 
recent emergencies has not always clearly demonstrated which 
office or agency leads our nation's efforts on preparedness and 
response.
---------------------------------------------------------------------------
    \1\http://www.hhs.gov/open/contacts/aspr.html.
---------------------------------------------------------------------------
    The section would amend Section 2811 of the Public Health 
Service Act to clarify that the ASPR has lead responsibility 
within HHS for emergency preparedness and response policy and 
coordination. The Committee believes this clarification is 
essential, not only to better coordinate our nation's 
preparedness efforts, but also to ensure that, if there is a 
public health emergency or disaster, the public, and those 
involved in responding to such an emergency or disaster, 
understand the division of responsibilities. To this end, the 
bill includes the following provisions that would require the 
ASPR to:
           Streamline and better coordinate HHS 
        preparedness grants in order to avoid duplication, as 
        well as to disseminate best practices.
           Conduct a comprehensive five-year budget 
        analysis of the entire medical countermeasure 
        enterprise to ensure prioritization of limited 
        resources.
           Identify gaps, duplication, and other 
        inefficiencies in public health preparedness activities 
        and the actions necessary to overcome these obstacles.
           Conduct a Countermeasure Implementation Plan 
        (CIP) in order to improve transparency, accountability, 
        and success of the entire medical countermeasure 
        enterprise. The CIP would require ASPR to identify 
        threats against the nation, create measurable goals to 
        address these threats, report on progress of meeting 
        these goals, identify budget and funding needs, and 
        identify specific timelines for medical countermeasure 
        development. The CIP would be presented to Congress 6 
        months after the date of enactment of H.R. 2405 and 
        annually thereafter.
          In the CIP, the Committee believes that the ASPR 
        would have to address the needs of pediatric 
        populations with respect to countermeasures and 
        products in the Strategic National Stockpile, as there 
        have been a number of concerns raised in this area. 
        Specifically, the ASPR would have to include a list of 
        qualified countermeasures and products necessary to 
        address the needs of pediatric populations and a plan 
        for addressing these needs. Through this process, the 
        ASPR should remedy gaps in the pediatric countermeasure 
        enterprise in addition to ensuring that countermeasures 
        developed and approved in the future have pediatric 
        labeling, dosages, and formulations, where feasible. 
        Finally, with respect to pediatric populations, the 
        ASPR would be required to advise the HHS Secretary on 
        issues pertaining to pediatric qualified 
        countermeasures and products.
           Be consulted when the HHS Secretary 
        authorizes medical products for use during emergencies.
           Submit a plan on improving coordination of 
        the biosurveillance systems of HHS.
    The Committee underscores that it is not its intent to move 
the day-to-day operations of the Cities Readiness Initiative 
(CRI), the Medical Reserve Corps or the SNS. Rather, the 
legislation is designed to ensure that the ASPR has policy 
oversight and coordination authority over these preparedness 
programs.

Section 5--Eliminating duplicative Project Bioshield reports

    This section would repeal a report included under Project 
Bioshield that is duplicative of parts of the new 
Countermeasure Implementation Plan created in Section 4.

Section 6--Authorization for medical products for use in emergencies

    This section would amend FDA's current Emergency Use 
Authority (EUA) authority to enable FDA to authorize the 
distribution, stockpiling, and use of products before an actual 
emergency. Specifically, the provisions would:
           Enable the HHS Secretary to make a threat 
        determination of a significant potential for a public 
        health emergency (as opposed to an actual emergency) 
        justifying issuance of an EUA and thus allowing FDA to 
        take important, life-saving steps before the emergency 
        actually occurs.
           Permit FDA to collect and analyze 
        information about safety and effectiveness beyond the 
        effective period of the EUA, but only for products 
        actually used in an emergency.
           Allow FDA to issue an EUA for products or 
        uses that otherwise may violate provisions of Federal 
        Food, Drug, and Cosmetic Act (i.e. adulteration and 
        misbranding provisions), but are important to 
        protecting Americans.
    The Committee notes that it intends the provisions applying 
to emergency use authority to include countermeasures and 
products for pediatric populations.

Section 7--Additional provisions related to medical products for 
        emergency use

    This section would provide added flexibility for emergency 
dispensing and use of eligible, FDA-approved medical 
countermeasure products. Specifically, the provisions would:
           Enable FDA to extend the expiration date for 
        medical countermeasures intended to be used for 
        emergency responses.
           Allow waivers of current Good Manufacturing 
        Practices (cGMP) without rendering a product 
        adulterated or misbranded.
           Authorize mass dispensing of medical 
        countermeasures during an actual emergency without an 
        individual prescription if permitted under state law or 
        permitted by an order of the HHS Secretary.
           Authorize the HHS Secretary to create and 
        issue emergency use instructions concerning a product's 
        conditions of use.
     Authorize the HHS Secretary to waive a Risk 
Evaluation and Mitigation Strategy if the Secretary determines 
that a waiver is required to mitigate the effects or reduce the 
severity of emergencies.

Section 8--Product held for emergency use

    This section would authorize pre-positioning of medical 
countermeasure by federal, state or local governments in 
anticipation of emergencies, allowing faster response during an 
actual emergency.

Section 9--Accelerating medical countermeasure development by 
        strengthening FDA's role in reviewing products for national 
        security priorities

    Transparency, certainty, and predictability are 
particularly important in the context of MCM research and 
development because the stakes are so high for MCM sponsors and 
the American public. Because in some instances sponsors can 
rely only on the Federal government to purchase their MCM 
products, risk associated with investing the time and resources 
necessary to enter the countermeasure space is significant. By 
increasing transparency, accountability, and predictability in 
this area, which this legislation seeks to do, the Committee 
believes the bill will encourage investment, research, and 
development in the space and increase the likelihood of 
securing the MCMs necessary for public health emergencies and 
disasters, including those caused by terrorism.
    This section includes provisions aimed at providing greater 
transparency, predictability, and certainty for medical 
countermeasure sponsors by increasing FDA's interaction with 
sponsors and requiring FDA to provide additional clarity around 
the requirements of the approval, clearance, and licensure 
processes. Specifically, the section would:
           Increase the involvement of FDA personnel in 
        interagency, countermeasure-related activities.
           Permit FDA to provide on-site and off-site 
        technical assistance to countermeasure manufacturers.
           Require FDA to establish a process for 
        frequent scientific feedback and interaction with those 
        sponsors whose countermeasures have been procured under 
        Project BioShield, in order to facilitate the approval, 
        clearance, and licensure of the countermeasures. As 
        part of this process, the bill would allow for the 
        development of regulatory management plans (RMPs) 
        through which eligible sponsors can create an agreement 
        with the FDA to have scientific exchanges throughout 
        the product development process. The Committee believes 
        the use of RMPs will reduce the uncertainty and risk 
        experienced by countermeasure sponsors. Under the bill, 
        these plans would be developed by the sponsors and 
        include information on the following: current 
        regulatory status of the countermeasure; proposed 
        pathway to approval, clearance or licensure of the 
        countermeasure including the data, clinical trials and 
        any other information required for such approval, 
        clearance or licensure; developmental milestones which 
        will result in meetings between the sponsor and FDA; 
        sponsor submissions which will result in written 
        feedback and any other information; or issues that 
        would facilitate or delay approval. FDA, upon receipt 
        of a proposal with relevant data from a sponsor, would 
        have 90 days to work with the sponsor to agree on a 
        Regulatory Management Plan. FDA retains full discretion 
        to determine the contents of the final plan, or to 
        determine that no final plan can be agreed upon. In the 
        latter case, FDA will provide the sponsor with the 
        scientific or regulatory rationale why such agreement 
        cannot be reached. Under the bill, the HHS would have 
        the authority to apply this process to other qualified 
        pandemic or epidemic products.
           Set forth a timeline for FDA's issuance of a 
        final guidance on development of animal models. FDA 
        would have one year to provide the final guidance, but 
        the deadline could be extended by six months if the HHS 
        Secretary submits a report to Congress on the status of 
        the guidance.
           Expand the use of Special Protocol 
        Assessments to the use of animal trials and any 
        associated clinical trials necessary to support 
        licensure of countermeasures referenced in Section 
        565(a) of the Federal Food, Drug, and Cosmetic Act when 
        human efficacy studies are not ethical or feasible.
           Require FDA to report on countermeasure 
        development and review activities on a biennial basis, 
        starting on January 1, 2013.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

PUBLIC HEALTH SERVICE ACT

           *       *       *       *       *       *       *


TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *


Part B--Federal-State Cooperation

           *       *       *       *       *       *       *


SEC. 319. PUBLIC HEALTH EMERGENCIES.

  (a) * * *

           *       *       *       *       *       *       *

  (e) Temporary Redeployment of 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 a request that is 
        from a State, locality, territory, tribe, or the Freely 
        Associated States and that includes such information 
        and assurances as the Secretary may require, the 
        Secretary may authorize the requesting entity to 
        temporarily redeploy to immediately address a public 
        health emergency non-Federal personnel funded in whole 
        or in part through--
                  (A) any program under this Act; or
                  (B) at the discretion of the Secretary, any 
                other program funded in whole or in part by the 
                Department of Health and Human Services.
          (2) Activation of emergency redeployment.--
                  (A) Public health emergency.--The Secretary 
                may exercise the authority vested by paragraph 
                (1) only during the period of a public health 
                emergency determined pursuant to subsection 
                (a).
                  (B) Considerations.--In authorizing a 
                temporary redeployment under paragraph (1), the 
                Secretary shall consider each of the following:
                          (i) The degree to which the emergency 
                        cannot be adequately and appropriately 
                        addressed by the public health 
                        workforce.
                          (ii) The degree to which the 
                        emergency requires or would otherwise 
                        benefit from supplemental staffing from 
                        those funded through nonpreparedness 
                        Federal programs.
                          (iii) The degree to which such 
                        programs would be adversely affected by 
                        the redeployment.
                          (iv) Such other factors as the 
                        Secretary may deem appropriate.
                  (C) Termination and extension.--
                          (i) Termination.--The authority to 
                        authorize 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), 
                                30 days after the activation of 
                                the Secretary's authority 
                                pursuant to subparagraph (A).
                          (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, but only if--
                                  (I) the extension is 
                                requested by the entity that 
                                requested authority to 
                                authorize a temporary 
                                redeployment; and
                                  (II) the Secretary gives 
                                notice to the Congress in 
                                conjunction with the extension.

SEC. 319A. VACCINE TRACKING AND DISTRIBUTION.

  (a) * * *

           *       *       *       *       *       *       *

  (e) Authorization of Appropriations.--There are authorized to 
be appropriated to carry out this section, [such sums for each 
of fiscal years 2007 through 2011] $30,800,000 for each of 
fiscal years 2012 through 2016.

           *       *       *       *       *       *       *


SEC. 319C-1. IMPROVING STATE AND LOCAL PUBLIC HEALTH SECURITY.

  (a) * * *
  (b) Eligible Entities.--To be eligible to receive an award 
under subsection (a), an entity shall--
          (1) * * *
          (2) prepare and submit to the Secretary an 
        application at such time, and in such manner, and 
        containing such information as the Secretary may 
        require, including--
                  (A) an All-Hazards Public Health Emergency 
                Preparedness and Response Plan which shall 
                include--
                          (i) * * *

           *       *       *       *       *       *       *

                          (iv) a description of the mechanism 
                        the entity will implement to utilize 
                        the Emergency Management Assistance 
                        Compact or other mutual aid agreements 
                        for medical and public health mutual 
                        aid; [and]
                          (v) a description of how the entity 
                        will include the State Unit on Aging in 
                        public health emergency preparedness; 
                        and
                          (vi) 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;

           *       *       *       *       *       *       *

  (f) Consultation With Homeland Security.--In making awards 
under subsection (a), the Secretary shall consult with the 
Secretary of Homeland Security to--
          (1) * * *
          (2) minimize duplicative funding of programs and 
        activities; and
          (3) analyze activities, including exercises and 
        drills, conducted under this section to develop 
        recommendations and guidance on best practices for such 
        activities[; and] .
          [(4) disseminate such recommendations and guidance, 
        including through expanding existing lessons learned 
        information systems to create a single Internet-based 
        point of access for sharing and distributing medical 
        and public health best practices and lessons learned 
        from drills, exercises, disasters, and other 
        emergencies.]

           *       *       *       *       *       *       *

  [(h) Grants for Real-Time Disease Detection Improvement.--
          [(1) In general.--The Secretary may award grants to 
        eligible entities to carry out projects described under 
        paragraph (4).
          [(2) Eligible entity.--For purposes of this section, 
        the term ``eligible entity'' means an entity that is--
                  [(A)(i)a hospital, clinical laboratory, 
                university; or
                  [(ii) a poison control center or professional 
                organization in the field of poison control; 
                and
                  [(B) a participant in the network established 
                under subsection 319D(d).
          [(3) Application.--Each eligible entity desiring a 
        grant under this subsection shall submit to the 
        Secretary an application at such time, in such manner, 
        and containing such information as the Secretary may 
        require.
          [(4) Use of funds.--
                  [(A) In general.--An eligible entity 
                described in paragraph (2)(A)(i) that receives 
                a grant under this subsection shall use the 
                funds awarded pursuant to such grant to carry 
                out a pilot demonstration project to purchase 
                and implement the use of advanced diagnostic 
                medical equipment to analyze real-time clinical 
                specimens for pathogens of public health or 
                bioterrorism significance and report any 
                results from such project to State, local, and 
                tribal public health entities and the network 
                established under section 319D(d).
                  [(B) Other entities.--An eligible entity 
                described in paragraph (2)(A)(ii) that receives 
                a grant under this section shall use the funds 
                awarded pursuant to such grant to--
                          [(i) improve the early detection, 
                        surveillance, and investigative 
                        capabilities of poison control centers 
                        for chemical, biological, radiological, 
                        and nuclear events by training poison 
                        information personnel to improve the 
                        accuracy of surveillance data, 
                        improving the definitions used by the 
                        poison control centers for 
                        surveillance, and enhancing timely and 
                        efficient investigation of data 
                        anomalies;
                          [(ii) improve the capabilities of 
                        poison control centers to provide 
                        information to health care providers 
                        and the public with regard to chemical, 
                        biological, radiological, or nuclear 
                        threats or exposures, in consultation 
                        with the appropriate State, local, and 
                        tribal public health entities; or
                          [(iii) provide surge capacity in the 
                        event of a chemical, biological, 
                        radiological, or nuclear event through 
                        the establishment of alternative poison 
                        control center worksites and the 
                        training of nontraditional personnel.]
  (i) Funding.--
          (1) Authorization of appropriations.--
                  [(A) In general.--For the purpose of carrying 
                out this section, there is authorized to be 
                appropriated $824,000,000 for fiscal year 2007, 
                of which $35,000,000 shall be used to carry out 
                subsection (h), for awards pursuant to 
                paragraph (3) (subject to the authority of the 
                Secretary to make awards pursuant to paragraphs 
                (4) and (5)), and such sums as may be necessary 
                for each of fiscal years 2008 through 2011.
                  [(B) Coordination.--There are authorized to 
                be appropriated, $10,000,000 for fiscal year 
                2007 to carry out subsection (f)(4) of this 
                section and section 2814.]
                  (A) In general.--For the purpose of carrying 
                out this section, there is authorized to be 
                appropriated $632,900,000 for each of fiscal 
                years 2012 through 2016.

           *       *       *       *       *       *       *

          (3) Determination of amount.--
                  (A) * * *

           *       *       *       *       *       *       *

                  (C) Increase on basis of population.--After 
                determining the base amount for a State under 
                subparagraph (B), the Secretary shall increase 
                the base amount by an amount equal to the 
                product of--
                          (i) the amount appropriated under 
                        paragraph [(1)(A)(i)(I)] (1)(A) for the 
                        fiscal year, less an amount equal to 
                        the sum of all base amounts determined 
                        for the States under subparagraph (B), 
                        and less the amount, if any, reserved 
                        by the Secretary under paragraphs (4) 
                        and (5); and

           *       *       *       *       *       *       *

                  (D) Minimum amount.--Subject to the amount 
                appropriated under paragraph [(1)(A)(i)(I)] 
                (1)(A), an award pursuant to subparagraph (A) 
                for a State shall be the greater of the base 
                amount as increased under subparagraph (C), or 
                the minimum amount under this subparagraph. The 
                minimum amount under this subparagraph is--
                          (i) in the case of each of the 
                        several States, the District of 
                        Columbia, and the Commonwealth of 
                        Puerto Rico, an amount equal to the 
                        lesser of--
                                  (I) * * *
                                  (II) if the amount 
                                appropriated under paragraph 
                                [(1)(A)(i)(I)] (1)(A) is less 
                                than $667,000,000, an amount 
                                equal to 0.75 percent of the 
                                amount appropriated under such 
                                paragraph, less the amount, if 
                                any, reserved by the Secretary 
                                under paragraphs (4) and (5); 
                                or

           *       *       *       *       *       *       *


SEC. 319C-2. PARTNERSHIPS FOR STATE AND REGIONAL HOSPITAL PREPAREDNESS 
                    TO IMPROVE SURGE CAPACITY.

  (a) In General.--The Secretary shall award competitive grants 
or cooperative agreements to eligible entities to enable such 
entities to improve surge capacity and enhance community and 
hospital preparedness for public health emergencies, including 
capacity and preparedness to address the needs of pediatric and 
other at-risk populations.

           *       *       *       *       *       *       *

  (i) Performance and Accountability.--[The requirements of]
          (1) In general.--The requirements of section 319C-
        1(g), (j), and (k) shall apply to entities receiving 
        awards under this section (regardless of whether such 
        entities are described under subsection (b)(1)(A) or 
        (b)(2)(A)) in the same manner as such requirements 
        apply to entities under section 319C-1. An entity 
        described in subsection (b)(1)(A) shall make such 
        reports available to the lead health official of the 
        State in which such partnership is located.
          (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 goals of the National Health 
        Security Strategy under section 2802.
  (j) Authorization of Appropriations.--
          [(1) In general.--For the purpose of carrying out 
        this section, there is authorized to be appropriated 
        $474,000,000 for fiscal year 2007, and such sums as may 
        be necessary for each of fiscal years 2008 through 
        2011.]
          (1) In general.--For purposes of carrying out this 
        section, there is authorized to be appropriated 
        $378,000,000 for each of fiscal years 2012 through 
        2016.

           *       *       *       *       *       *       *


SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND PREVENTION.

  (a) * * *

           *       *       *       *       *       *       *

  [(c) Authorization of Appropriations.--
          [(1) Facilities; capacities.--
                  [(A) Facilities.--For the purpose of carrying 
                out subsection (a)(2), there are authorized to 
                be appropriated $300,000,000 for each of the 
                fiscal years 2002 and 2003, and such sums as 
                may be necessary for each of the fiscal years 
                2004 through 2006.
                  [(B) Mission; Improving capacities.--For the 
                purposes of achieving the mission of the 
                Centers for Disease Control and Prevention 
                described in subsection (a)(1), for carrying 
                out subsection (a)(3), for better conducting 
                the capacities described in section 319A, and 
                for supporting public health activities, there 
                are authorized to be appropriated such sums as 
                may be necessary for each of the fiscal years 
                2002 through 2006.
          [(2) National communications and surveillance 
        networks.--For the purpose of carrying out subsection 
        (b), there are authorized to be appropriated such sums 
        as may be necessary for each of the fiscal years 2002 
        through 2006.]

           *       *       *       *       *       *       *

  (g) Authorization of Appropriations.--There are authorized to 
be appropriated to carry out this section, [such sums as may be 
necessary in each of fiscal years 2007 through 2011] 
$160,121,000 for each of fiscal years 2012 through 2016.

           *       *       *       *       *       *       *


SEC. 319F. PUBLIC HEALTH COUNTERMEASURES TO A BIOTERRORIST ATTACK.

  (a) All-Hazards Public Health and Medical Response Curricula 
and Training.--
          (1) * * *

           *       *       *       *       *       *       *

          (5) Dissemination and training.--
                  (A) * * *
                  (B) Certain entities.--The education and 
                training activities described in subparagraph 
                (A) may be carried out by Federal [public 
                health or medical] public health, medical, or 
                dental entities, appropriate educational 
                entities, professional organizations and 
                societies, private accrediting organizations, 
                and other nonprofit institutions or entities 
                meeting criteria established by the Secretary.

           *       *       *       *       *       *       *


SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE AND SECURITY COUNTERMEASURE 
                    PROCUREMENTS.

  (a) * * *

           *       *       *       *       *       *       *

  (c) Additional Authority Regarding Procurement of Certain 
Countermeasures; Availability of Special Reserve Fund.--
          (1) In general.--
                  (A) Use of fund.--A security countermeasure 
                may, in accordance with this subsection, be 
                procured with amounts in the [special reserve 
                fund under paragraph (10)] special reserve fund 
                as defined in subsection (g)(5).

           *       *       *       *       *       *       *

          (4) Call for development of countermeasures; 
        commitment for recommendation for procurement.--
                  (A) Proposal to the president.--If, pursuant 
                to an assessment under paragraph (3), the 
                Homeland Security Secretary and the Secretary 
                make a determination that a countermeasure 
                would be appropriate but is either currently 
                not developed or unavailable for procurement as 
                a security countermeasure or is approved, 
                licensed, or cleared only for alternative uses, 
                such Secretaries may jointly submit to the 
                President a proposal to--
                          (i) * * *
                          (ii) make a commitment that, upon the 
                        first development of such 
                        countermeasure that meets the 
                        conditions for procurement under 
                        paragraph (5), the Secretaries will, 
                        based in part on information obtained 
                        pursuant to such call, make a 
                        recommendation under paragraph (6) that 
                        the [special reserve fund under 
                        paragraph (10)] special reserve fund as 
                        defined in subsection (g)(5) be made 
                        available for the procurement of such 
                        countermeasure.

           *       *       *       *       *       *       *

          (5) Secretary's determination of countermeasures 
        appropriate for funding from special reserve fund.--
                  (A) In general.--The Secretary, in accordance 
                with the provisions of this paragraph, shall 
                identify specific security countermeasures that 
                the Secretary determines, in consultation with 
                the Homeland Security Secretary, to be 
                appropriate for inclusion in the stockpile 
                under subsection (a) pursuant to procurements 
                made with amounts in the [special reserve fund 
                under paragraph (10)] special reserve fund as 
                defined in subsection (g)(5) (referred to in 
                this subsection individually as a ``procurement 
                under this subsection'').

           *       *       *       *       *       *       *

          (6) Recommendation for president's approval.--
                  (A) Recommendation for procurement.--In the 
                case of a security countermeasure that the 
                Secretary has, in accordance with paragraphs 
                (3) and (5), determined to be appropriate for 
                procurement under this subsection, the Homeland 
                Security Secretary and the Secretary shall 
                jointly submit to the President, in 
                coordination with the Director of the Office of 
                Management and Budget, a recommendation that 
                the [special reserve fund under paragraph (10)] 
                special reserve fund as defined in subsection 
                (g)(5) be made available for the procurement of 
                such countermeasure.
                  (B) Presidential approval.--The [special 
                reserve fund under paragraph (10)] special 
                reserve fund as defined in subsection (g)(5) is 
                available for a procurement of a security 
                countermeasure only if the President has 
                approved a recommendation under subparagraph 
                (A) regarding the countermeasure.
                  (C) Notice to designated congressional 
                committees.--The Secretary and the Homeland 
                Security Secretary shall notify the designated 
                congressional committees of each decision of 
                the President to approve a recommendation under 
                subparagraph (A). Such notice shall include an 
                explanation of the decision to make available 
                the [special reserve fund under paragraph (10)] 
                special reserve fund as defined in subsection 
                (g)(5) for procurement of such a 
                countermeasure, including, where available, the 
                number of, nature of, and other information 
                concerning potential suppliers of such 
                countermeasure, and whether other potential 
                suppliers of the same or similar 
                countermeasures were considered and rejected 
                for procurement under this section and the 
                reasons therefor.

           *       *       *       *       *       *       *

                  (E) Rule of construction.--Recommendations 
                and approvals under this paragraph apply solely 
                to determinations that the [special reserve 
                fund under paragraph (10)] special reserve fund 
                as defined in subsection (g)(5) will be made 
                available for a procurement of a security 
                countermeasure, and not to the substance of 
                contracts for such procurement or other matters 
                relating to awards of such contracts.
          (7) Procurement.--
                  (A) * * *
                  (B) Interagency agreement; cost.--The 
                Homeland Security Secretary shall enter into an 
                agreement with the Secretary for procurement of 
                a security countermeasure in accordance with 
                the provisions of this paragraph. The [special 
                reserve fund under paragraph (10)] special 
                reserve fund as defined in subsection (g)(5) 
                shall be available for payments made by the 
                Secretary to a vendor for such procurement.
                  (C) Procurement.--
                          (i) * * *
                          (ii) Contract terms.--A contract for 
                        procurements under this subsection 
                        shall (or, as specified below, may) 
                        include the following terms:
                                  (I) * * *

           *       *       *       *       *       *       *

                                  (IV) Storage by vendor.--The 
                                contract may provide that the 
                                vendor will provide storage for 
                                stocks of a product delivered 
                                to the ownership of the Federal 
                                Government under the contract, 
                                for such period and under such 
                                terms and conditions as the 
                                Secretary may specify, and in 
                                such case amounts from the 
                                [special reserve fund under 
                                paragraph (10)] special reserve 
                                fund as defined in subsection 
                                (g)(5) shall be available for 
                                costs of shipping, handling, 
                                storage, and related costs for 
                                such product.

           *       *       *       *       *       *       *

                                  [(IX) Contract terms.--The 
                                Secretary, in any contract for 
                                procurement under this section, 
                                may specify--
                                          [(aa) the dosing and 
                                        administration 
                                        requirements for 
                                        countermeasures to be 
                                        developed and procured;
                                          [(bb) the amount of 
                                        funding that will be 
                                        dedicated by the 
                                        Secretary for 
                                        development and 
                                        acquisition of the 
                                        countermeasure; and
                                          [(cc) the 
                                        specifications the 
                                        countermeasure must 
                                        meet to qualify for 
                                        procurement under a 
                                        contract under this 
                                        section.]
                                  (IX) Contract terms.--The 
                                Secretary, in any contract for 
                                procurement under this 
                                section--
                                          (aa) may specify--
                                                  (AA) the 
                                                dosing and 
                                                administration 
                                                requirements 
                                                for 
                                                countermeasures 
                                                to be developed 
                                                and procured;
                                                  (BB) the 
                                                amount of 
                                                funding that 
                                                will be 
                                                dedicated by 
                                                the Secretary 
                                                for development 
                                                and acquisition 
                                                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).

           *       *       *       *       *       *       *

          [(9) Restrictions on use of funds.--Amounts in the 
        special reserve fund as defined in subsection (g)(5) 
        shall not be used to pay--
                  [(A) costs for the purchase of vaccines under 
                procurement contracts entered into before the 
                date of the enactment of the Project BioShield 
                Act of 2004; or
                  [(B) costs other than payments made by the 
                Secretary to a vendor for a procurement of a 
                security countermeasure under paragraph (7).
          [(10) Definitions.--
                  [(A) Special reserve fund.--For purposes of 
                this subsection, the term ``special reserve 
                fund'' has the meaning given such term in 
                section 510 of the Homeland Security Act of 
                2002.
                  [(B) Designated congressional committees.--
                For purposes of this section, the term 
                ``designated congressional committees'' means 
                the following committees of the Congress:
                          [(i) In the House of Representatives: 
                        the Committee on Energy and Commerce, 
                        the Committee on Appropriations, the 
                        Committee on Government Reform, and the 
                        Select Committee on Homeland Security 
                        (or any successor to the Select 
                        Committee).
                          [(ii) In the Senate: the appropriate 
                        committees.]

           *       *       *       *       *       *       *

  (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) Notice of insufficient funds.--Not later than 15 
        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 Committee on Energy 
        and Commerce of the House of Representatives and the 
        Committee on Health, Education, Labor, and Pensions of 
        the Senate a report detailing the amount of such funds 
        available for procurement and the impact such funding 
        will have--
                  (A) in meeting the security countermeasure 
                needs identified under this section; and
                  (B) on the annual Countermeasure 
                Implementation Plan under section 2811(d).
          (3) Use of special reserve fund for advanced research 
        and development.--The Secretary may utilize not more 
        than 30 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.
          (4) Restrictions on use of funds.--Amounts in the 
        special reserve fund shall not be used to pay--
                  (A) 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); and
                  (B) any administrative expenses, including 
                salaries.
          (5) Definition.--In this section, 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 paragraph (1) of this paragraph.

           *       *       *       *       *       *       *


SEC. 319I. EMERGENCY SYSTEM FOR ADVANCE REGISTRATION OF HEALTH 
                    PROFESSIONS VOLUNTEERS.

  (a) * * *

           *       *       *       *       *       *       *

  (k) Authorization of Appropriations.--For the purpose of 
carrying out this section, there [are authorized to be 
appropriated $2,000,000 for fiscal year 2002, and such sums as 
may be necessary for each of the fiscal years 2003 through 
2011] is authorized to be appropriated $5,900,000 for each of 
fiscal years 2012 through 2016.

           *       *       *       *       *       *       *


SEC. 319L. BIOMEDICAL ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY.

  (a) * * *

           *       *       *       *       *       *       *

  (c) Biomedical Advanced Research and Development Authority.--
          (1) * * *

           *       *       *       *       *       *       *

          (5) Transaction authorities.--
                  (A) * * *

           *       *       *       *       *       *       *

                  (G) Government purpose.--In awarding 
                contracts, grants, and cooperative agreements 
                under this section, the Secretary shall provide 
                a clear statement of defined Government purpose 
                related to activities included in subsection 
                (a)(6)(B) for a qualified countermeasure or 
                qualified pandemic or epidemic product.

           *       *       *       *       *       *       *

  (d) Fund.--
          (1) * * *
          [(2) Funding.--To carry out the purposes of this 
        section, there are authorized to be appropriated to the 
        Fund--
                  [(A) $1,070,000,000 for fiscal years 2006 
                through 2008, the amounts to remain available 
                until expended; and
                  [(B) such sums as may be necessary for 
                subsequent fiscal years, the amounts to remain 
                available until expended.]
          (2) Funding.--To carry out the purposes of this 
        section, there is authorized to be appropriated to the 
        Fund $415,000,000 for each of fiscal years 2012 through 
        2016, the amounts to remain available until expended.
  (e) Inapplicability of Certain Provisions.--
          (1) Disclosure.--
                  (A) * * *

           *       *       *       *       *       *       *

                  (C) Sunset.--This paragraph shall cease to 
                have force or effect on [the date that is 7 
                years after the date of enactment of the 
                Pandemic and All-Hazards Preparedness Act] 
                September 30, 2016.

           *       *       *       *       *       *       *


   TITLE XXVIII--NATIONAL ALL-HAZARDS PREPAREDNESS FOR PUBLIC HEALTH 
                              EMERGENCIES

 Subtitle A--National All-Hazards Preparedness and Response Planning, 
Coordinating, and Reporting

           *       *       *       *       *       *       *


SEC. 2802. NATIONAL HEALTH SECURITY STRATEGY.

  (a) In General.--
          (1) Preparedness and response regarding public health 
        emergencies.--Beginning in [2009] 2014 and every four 
        years thereafter, the Secretary shall prepare and 
        submit to the relevant committees of Congress a 
        coordinated strategy (to be known as the National 
        Health Security Strategy) and any revisions thereof, 
        and an accompanying implementation plan for public 
        health emergency preparedness and response. Such 
        National Health Security Strategy shall identify the 
        process for achieving the preparedness goals described 
        in subsection (b) and shall be consistent with the 
        National Preparedness Goal, the National Incident 
        Management System, and the National Response Plan 
        developed pursuant to section 502(6) of the Homeland 
        Security Act of 2002, or any successor plan.

           *       *       *       *       *       *       *

  (b) Preparedness Goals.--The National Health Security 
Strategy shall include provisions in furtherance of the 
following:
          (1) Integration.--Integrating public health and 
        public and private medical capabilities with other 
        first responder systems, including through--
                  (A) the periodic evaluation of Federal, 
                State, local, and tribal preparedness and 
                response capabilities through drills and 
                exercises, including drills and exercises to 
                ensure medical surge capacity for events 
                without notice; and

           *       *       *       *       *       *       *

          (3) Medical.--Increasing the preparedness, response 
        capabilities, availability, coordination, 
        accessibility, and surge capacity of hospitals, other 
        health care facilities ([including mental health 
        facilities] including mental health and ambulatory care 
        facilities and which may include dental health 
        facilities), and [trauma care and emergency medical 
        service systems] trauma care, critical care, and 
        emergency medical service systems, with respect to 
        public health emergencies, which shall include 
        developing plans for the following:
                  (A) * * *
                  (B) [Medical evacuation and fatality 
                management] Fatality management, and 
                coordinated medical triage and evacuation to 
                the appropriate medical institution based on 
                patient medical need as part of regional 
                systems.

           *       *       *       *       *       *       *

                  (D) Effective utilization of any available 
                public and private mobile medical assets (which 
                may include dental health assets) and 
                integration of other Federal assets.

           *       *       *       *       *       *       *


      Subtitle B--All-Hazards Emergency Preparedness and Response

SEC. 2811. COORDINATION OF PREPAREDNESS FOR AND RESPONSE TO ALL-HAZARDS 
                    PUBLIC HEALTH EMERGENCIES.

  (a) * * *
  (b) Duties.--Subject to the authority of the Secretary, the 
Assistant Secretary for Preparedness and Response shall carry 
out the following functions:
          (1) * * *

           *       *       *       *       *       *       *

          (3) Countermeasures.--Oversee advanced research, 
        development, stockpiling, distribution, and procurement 
        of qualified countermeasures (as defined in section 
        319F-1), security measures (as defined in section 319F-
        2), and qualified pandemic or epidemic products (as 
        defined in section 319F-3).
          (4) Coordination.--
                  (A) * * *

           *       *       *       *       *       *       *

                  (D) Identification of inefficiencies.--
                Identify gaps, duplication, and other 
                inefficiencies in public health preparedness 
                activities and the actions necessary to 
                overcome these obstacles.
                  (E) Development of countermeasure 
                implementation plan.--Lead the development of a 
                coordinated Countermeasure Implementation Plan 
                under subsection (d).
                  (F) Countermeasures budget analysis.--Oversee 
                the development of a comprehensive, cross-
                cutting 5-year budget analysis with respect to 
                activities described in paragraph (3)--
                          (i) to inform prioritization of 
                        resources; and
                          (ii) to ensure that challenges to 
                        such activities are adequately 
                        addressed.
                  (G) Grant programs for medical and public 
                health preparedness capabilities.--Coordinate, 
                in consultation with the Secretary of Homeland 
                Security, grant programs of the Department of 
                Health and Human Services relating to medical 
                and public health preparedness capabilities and 
                the activities of local communities to respond 
                to public health emergencies, including the--
                          (i) coordination of relevant program 
                        requirements, timelines, and measurable 
                        goals of such grant programs; and
                          (ii) establishment of a system for 
                        gathering and disseminating best 
                        practices among grant recipients.

           *       *       *       *       *       *       *

  [(c) Functions.--The Assistant Secretary for Preparedness and 
Response shall--
          [(1) have authority over and responsibility for--
                  [(A) the National Disaster Medical System (in 
                accordance with section 301 of the Pandemic and 
                All-Hazards Preparedness Act); and
                  [(B) the Hospital Preparedness Cooperative 
                Agreement Program pursuant to section 319C-2;
          [(2) exercise the responsibilities and authorities of 
        the Secretary with respect to the coordination of--
                  [(A) the Medical Reserve Corps pursuant to 
                section 2813;
                  [(B) the Emergency System for Advance 
                Registration of Volunteer Health Professionals 
                pursuant to section 319I;
                  [(C) the Strategic National Stockpile; and
                  [(D) the Cities Readiness Initiative; and
          [(3) assume other duties as determined appropriate by 
        the Secretary.]
  (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 and coordination;
          (2) have authority over and responsibility for--
                  (A) the National Disaster Medical System (in 
                accordance with section 301 of the Pandemic and 
                All-Hazards Preparedness Act);
                  (B) the Hospital Preparedness Cooperative 
                Agreement Program pursuant to section 319C-2;
                  (C) the Biomedical Advanced Research and 
                Development Authority under section 319L; and
                  (D) the Emergency System for Advance 
                Registration of Volunteer Health Professionals 
                pursuant to section 319I;
          (3) provide policy coordination and oversight of--
                  (A) the Strategic National Stockpile under 
                section 319F-2;
                  (B) the Cities Readiness Initiative; and
                  (C) the Medical Reserve Corps pursuant to 
                section 2813; and
          (4) assume other duties as determined appropriate by 
        the Secretary.
  (d) Countermeasure Implementation Plan.--Not later than 6 
months after the date of enactment of this subsection, and 
annually thereafter, the Assistant Secretary for Preparedness 
and Response shall submit through the Secretary to the 
Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate a Countermeasure Implementation Plan 
that--
          (1) describes the chemical, biological, radiological, 
        and nuclear threats facing 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;
          (2) evaluates the progress of all activities with 
        respect to such countermeasures or products, including 
        research, advanced research, development, procurement, 
        stockpiling, deployment, and utilization;
          (3) identifies and prioritizes near-, mid-, and long-
        term needs with respect to such countermeasures or 
        products to address chemical, biological, radiological, 
        and nuclear threats;
          (4) identifies, with respect to each category of 
        threat, a summary of all advanced development and 
        procurement awards, including--
                  (A) 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);
                  (B) projected timelines for development and 
                procurement of such countermeasures or 
                products;
                  (C) clearly defined goals, benchmarks, and 
                milestones for each such countermeasure or 
                product, including information on the number of 
                doses required, the intended use of the 
                countermeasure or product, and the required 
                countermeasure or product characteristics; and
                  (D) projected needs with regard to the 
                replenishment of the Strategic National 
                Stockpile;
          (5) evaluates progress made in meeting the goals, 
        benchmarks, and milestones identified under paragraph 
        (4)(C);
          (6) reports on the amount of funds available for 
        procurement in the special reserve fund as defined in 
        section 319F-2(g)(5) and the impact this funding will 
        have on meeting the requirements under section 319F-2;
          (7) incorporates input from Federal, State, local, 
        and tribal stakeholders; and
          (8) addresses the needs of pediatric populations with 
        respect to such countermeasures and products in the 
        Strategic National Stockpile and includes--
                  (A) a list of such countermeasures and 
                products necessary to address the needs of 
                pediatric populations;
                  (B) a description of measures taken to 
                coordinate with 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;
                  (C) 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
                  (D) an evaluation of the progress made in 
                addressing gaps identified pursuant to 
                subparagraph (C).
Notwithstanding any other provision of this subsection, the 
Plan shall not include any confidential commercial information, 
proprietary information, or information that could reveal 
vulnerabilities of the Nation in the preparation for or ability 
to respond to chemical, biological, radiological, or nuclear 
threats.

SEC. 2812. NATIONAL DISASTER MEDICAL SYSTEM.

  (a) National Disaster Medical System.--
          (1) * * *

           *       *       *       *       *       *       *

          (3) Purpose of system.--
                  (A) * * *

           *       *       *       *       *       *       *

                  (D) Administration.--The Secretary may 
                determine and pay claims for reimbursement for 
                services under subparagraph (A) directly or by 
                contract providing for payment in advance or by 
                way of reimbursement.

           *       *       *       *       *       *       *

  (g) Authorization of Appropriations.--For the purpose of 
providing for the Assistant Secretary for Preparedness and 
Response and the operations of the National Disaster Medical 
System, other than purposes for which amounts in the Public 
Health Emergency Fund under section 319 are available, there 
are authorized to be appropriated [such sums as may be 
necessary for each of the fiscal years 2007 through 2011] 
$56,000,000 for each of fiscal years 2012 through 2016.

SEC. 2813. VOLUNTEER MEDICAL RESERVE CORPS.

  (a) * * *

           *       *       *       *       *       *       *

  (i) Authorization of Appropriations.--There is authorized to 
be appropriated to carry out this section, [$22,000,000 for 
fiscal year 2007, and such sums as may be necessary for each of 
fiscal years 2008 through 2011] $11,900,000 for each of fiscal 
years 2012 through 2016.

           *       *       *       *       *       *       *

                              ----------                              


      SECTION 405 OF THE PANDEMIC AND ALL-HAZARD PREPAREDNESS ACT

SEC. 405. COLLABORATION AND COORDINATION.

  (a) * * *
  (b) Sunset..--The applicability of this section shall expire 
[at the end of the 6-year period that begins on the date of 
enactment of this Act] on September 30, 2016.
                              ----------                              


FEDERAL FOOD, DRUG, AND COSMETIC ACT

           *       *       *       *       *       *       *


                      CHAPTER V--DRUGS AND DEVICES

Subchapter A--Drugs and Devices

           *       *       *       *       *       *       *


                               NEW DRUGS

  Sec. 505. (a) * * *
  (b)(1) * * *

           *       *       *       *       *       *       *

  (5)(A) * * *
  [(B) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under 
this subsection or section 351 of the Public Health Service Act 
if the sponsor or applicant makes a reasonable written request 
for a meeting for the purpose of reaching agreement on the 
design and size of clinical trials intended to form the primary 
basis of an effectiveness claim or, with respect to an 
applicant for approval of a biological product under section 
351(k) of the Public Health Service Act, any necessary clinical 
study or studies. The sponsor or applicant shall provide 
information necessary for discussion and agreement on the 
design and size of the clinical trials. Minutes of any such 
meeting shall be prepared by the Secretary and made available 
to the sponsor or applicant upon request.]
  (B)(i) The Secretary shall meet with a sponsor of an 
investigation or an applicant for approval for a drug under 
this subsection or section 351 of the Public Health Service Act 
if the sponsor or applicant makes a reasonable written request 
for a meeting for the purpose of reaching agreement on the 
design and size of--
          (I) clinical trials intended to form the primary 
        basis of an effectiveness claim; or
          (II) animal efficacy trials and any associated 
        clinical trials that in combination are intended to 
        form the primary basis of an effectiveness claim for a 
        countermeasure or product referred to in section 565(a) 
        when human efficacy studies are not ethical or 
        feasible.
  (ii) The sponsor or applicant shall provide information 
necessary for discussion and agreement on the design and size 
of the clinical trials. Minutes of any such meeting shall be 
prepared by the Secretary and made available to the sponsor or 
applicant upon request.

           *       *       *       *       *       *       *


SEC. 505-1. RISK EVALUATION AND MITIGATION STRATEGIES.

  (a) * * *

           *       *       *       *       *       *       *

  (f) Providing Safe Access for Patients to Drugs With Known 
Serious Risks That Would Otherwise Be Unavailable.--
          (1) * * *

           *       *       *       *       *       *       *

          [(7) Waiver in public health emergencies.--The 
        Secretary may waive any requirement of this subsection 
        during the period described in section 319(a) of the 
        Public Health Service Act with respect to a qualified 
        countermeasure described under section 319F-1(a)(2) of 
        such Act, to which a requirement under this subsection 
        has been applied, if the Secretary has--
                  [(A) declared a public health emergency under 
                such section 319; and
                  [(B) determined that such waiver is required 
                to mitigate the effects of, or reduce the 
                severity of, such public health emergency.]

           *       *       *       *       *       *       *

  (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, an actual or potential domestic emergency or 
military emergency involving heightened risk of attack with a 
biological, chemical, radiological, or nuclear agent, or an 
actual or potential public health emergency affecting national 
security or the health and security of United States citizens 
abroad.

           *       *       *       *       *       *       *


Subchapter E--General Provisions Relating to Drugs and Devices

           *       *       *       *       *       *       *


SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.

  (a) In General.--
          (1) Emergency uses.--Notwithstanding [sections 505, 
        510(k), and 515 of this Act] any provision of this Act 
        and section 351 of the Public Health Service Act, and 
        subject to the provisions of this section, the 
        Secretary may authorize the introduction into 
        interstate commerce, during the effective period of a 
        declaration under subsection (b), of a drug, device, or 
        biological product intended for use in an actual or 
        potential emergency (referred to in this section as an 
        ``emergency use'').
          (2) Approval status of product.--An authorization 
        under paragraph (1) may authorize an emergency use of a 
        product that--
                  (A) is not approved, licensed, or cleared for 
                commercial distribution [under a provision of 
                law referred to in such paragraph] under a 
                provision of law in section 505, 510(k), or 515 
                of this Act or section 351 of the Public Health 
                Service Act (referred to in this section as an 
                ``unapproved product''); or

           *       *       *       *       *       *       *

          (3) Relation to other uses.--An emergency use 
        authorized under paragraph (1) for a product is in 
        addition to any other use that is authorized for the 
        product under [a provision of law referred to in such 
        paragraph] a provision of law referred to in paragraph 
        (2)(A).

           *       *       *       *       *       *       *

  (b) [Declaration of Emergency]  Declaration Supporting 
Emergency Use Authorization.--
          (1) In general.--The Secretary may declare [an 
        emergency justifying] that circumstances exist 
        justifying the authorization under this subsection for 
        a product on the basis of--
                  (A) a determination by the Secretary of 
                Homeland Security that there is a domestic 
                emergency, or a significant potential for a 
                domestic emergency, involving a heightened risk 
                of attack with a [specified] biological, 
                chemical, radiological, or nuclear agent or 
                agents;
                  (B) a determination by the Secretary of 
                Defense that there is a military emergency, or 
                a significant potential for a military 
                emergency, involving a heightened risk to 
                United States military forces of attack with a 
                [specified] biological, chemical, radiological, 
                or nuclear agent or agents; or
                  [(C) a determination by the Secretary of a 
                public health emergency under section 319 of 
                the Public Health Service Act that affects, or 
                has a significant potential to affect, national 
                security, and that involves a specified 
                biological, chemical, radiological, or nuclear 
                agent or agents, or a specified disease or 
                condition that may be attributable to such 
                agent or agents.]
                  (C) a determination by the Secretary that 
                there is a public health emergency, or a 
                significant potential for a public health 
                emergency, involving a heightened risk to 
                national security or the health and security of 
                United States citizens abroad, and involving a 
                biological, chemical, radiological, or nuclear 
                agent or agents, or a disease or condition that 
                may be attributable to such agent or agents.
          (2) Termination of declaration.--
                  [(A) In general.--A declaration under this 
                subsection shall terminate upon the earlier 
                of--
                          [(i) a determination by the 
                        Secretary, in consultation as 
                        appropriate with the Secretary of 
                        Homeland Security or the Secretary of 
                        Defense, that the circumstances 
                        described in paragraph (1) have ceased 
                        to exist; or
                          [(ii) the expiration of the one-year 
                        period beginning on the date on which 
                        the declaration is made.
                  [(B) Renewal.--Notwithstanding subparagraph 
                (A), the Secretary may renew a declaration 
                under this subsection, and this paragraph shall 
                apply to any such renewal.]
                  (A) In general.--A declaration under this 
                subsection shall terminate upon a determination 
                by the Secretary, in consultation with, as 
                appropriate, the Secretary of Homeland Security 
                or the Secretary of Defense, that the 
                circumstances described in paragraph (1) have 
                ceased to exist.
                  [(C)] (B) Disposition of product.--If an 
                authorization under this section with respect 
                to an unapproved product ceases to be effective 
                as a result of a termination under subparagraph 
                (A) of this paragraph, the Secretary shall 
                consult with the manufacturer of such product 
                with respect to the appropriate disposition of 
                the product.

           *       *       *       *       *       *       *

          (4) Publication.--The Secretary shall promptly 
        publish in the Federal Register each declaration, 
        determination, [advance notice of termination, and 
        renewal] and advance notice of termination under this 
        subsection.
  (c) Criteria for Issuance of Authorization.--The Secretary 
may issue an authorization under this section with respect to 
the emergency use of a product only if, after [consultation 
with the Director of the National Institutes of Health] 
consultation with the Assistant Secretary for Preparedness and 
Response, the Director of the National Institutes of Health, 
and the Director of the Centers for Disease Control and 
Prevention (to the extent feasible and appropriate given the 
circumstances of the emergency involved), the Secretary 
concludes--
          (1) that an agent [specified in] covered by a 
        declaration under subsection (b) can cause a serious or 
        life-threatening disease or condition;

           *       *       *       *       *       *       *

  (d) Scope of Authorization.--An authorization of a product 
under this section shall state--
          (1) * * *

           *       *       *       *       *       *       *

          (3) the Secretary's conclusions, made under 
        subsection (c), concerning the safety and potential 
        effectiveness of the product in diagnosing, preventing, 
        or treating such diseases or conditions, including, to 
        the extent practicable given the circumstances of the 
        emergency, an assessment of the available scientific 
        evidence.
  (e) Conditions of Authorization.--
          (1) Unapproved product.--
                  (A) * * *
                  (B) Authority for additional conditions.--
                With respect to the emergency use of an 
                unapproved product, the Secretary may, for a 
                person who carries out any activity for which 
                the authorization is issued, establish such 
                conditions on an authorization under this 
                section as the Secretary finds necessary or 
                appropriate to protect the public health, 
                including the following:
                          (i) * * *

           *       *       *       *       *       *       *

                          [(iii) Appropriate conditions with 
                        respect to the collection and analysis 
                        of information, during the period when 
                        the authorization is in effect, 
                        concerning the safety and effectiveness 
                        of the product with respect to the 
                        emergency use of such product.]
                          (iii) Appropriate conditions with 
                        respect to the collection and analysis 
                        of information concerning the safety 
                        and effectiveness of the product with 
                        respect to the actual use of such 
                        product pursuant to an authorization 
                        under this section.

           *       *       *       *       *       *       *

          (2) Unapproved use.--With respect to the emergency 
        use of a product that is an unapproved use of an 
        approved product:
                  (A) For a [manufacturer of the product] 
                person who carries out any activity for which 
                the authorization is issued, the Secretary 
                shall, to the extent practicable given the 
                circumstances of the emergency, establish 
                conditions described in clauses (i) and (ii) of 
                paragraph (1)(A), and may establish conditions 
                described in clauses (iii) and (iv) of such 
                paragraph or in paragraph (1)(B).
                  (B)(i) If the authorization under this 
                section regarding the emergency use authorizes 
                a change in the labeling of the product, but 
                the manufacturer of the product chooses not to 
                make such change, such authorization may not 
                authorize distributors of the product or any 
                other person to alter or obscure the labeling 
                provided by the manufacturer, with the 
                exception of extensions of a product's 
                expiration date authorized under section 
                564A(b).

           *       *       *       *       *       *       *

                  [(C) The Secretary may establish with respect 
                to the distribution and administration of the 
                product for the unapproved use conditions no 
                more restrictive than those established by the 
                Secretary with respect to the distribution and 
                administration of the product for the approved 
                use.]
                  (C) In establishing conditions under this 
                paragraph with respect to the distribution and 
                administration of a product, the Secretary 
                shall not impose conditions that would restrict 
                distribution or administration of the product 
                that is solely for the approved uses.
          [(3) Good manufacturing practice.--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 circumstances of the 
        emergency, 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.]
          (3) Good manufacturing practice; prescription; 
        practitioner's authorization.--With respect to the 
        emergency use of a product for which an authorization 
        under this section is issued (whether for an unapproved 
        product or an unapproved use of an approved product), 
        the Secretary may waive or limit, to the extent 
        appropriate given the circumstances of the emergency--
                  (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).

           *       *       *       *       *       *       *

          (5) Existing authorities.--Nothing in this section 
        restricts any authority vested in the Secretary by any 
        other provision of this Act or the Public Health 
        Service Act for establishing conditions of 
        authorization for a product.

           *       *       *       *       *       *       *

  (g) [Revocation of Authorization]  Review, Modification, and 
Revocation of Authorization.--
          (1) Review.--The Secretary shall [periodically 
        review] review not less than every three years the 
        circumstances and the appropriateness of an 
        authorization under this section.

           *       *       *       *       *       *       *

          (3) Modification.--The Secretary may modify an 
        authorization under this section or the conditions of 
        such an authorization, at any time, based on a review 
        of the authorization or new information that is 
        otherwise obtained, including information obtained 
        during an emergency.

           *       *       *       *       *       *       *


SEC. 564A. ADDITIONAL PROVISIONS RELATED TO MEDICAL PRODUCTS FOR 
                    EMERGENCY USE.

  (a) Definitions.--For purposes of this section:
          (1) The term ``product'' means a drug, device, or 
        biological product.
          (2) The term ``eligible product'' means a product 
        that is--
                  (A) approved or cleared under this chapter or 
                licensed under section 351 of the Public Health 
                Service Act; and
                  (B) intended to be used to diagnose, prevent, 
                or treat a disease or condition involving a 
                biological, chemical, radiological, or nuclear 
                agent or agents during--
                          (i) a domestic emergency or military 
                        emergency involving heightened risk of 
                        attack with such an agent or agents; or
                          (ii) a public health emergency 
                        affecting national security or the 
                        health and security of United States 
                        citizens abroad.
  (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 eligible product is intended to be 
                held for use for a domestic, military, or 
                public health emergency described in subsection 
                (a)(2)(B);
                  (B) 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
                  (C) 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.
  (c) Current Good Manufacturing Practices.--
          (1) In general.--The Secretary may, when the 
        circumstances of a domestic, military, or public health 
        emergency described in subsection (a)(2)(B) 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) Mass Dispensing.--The requirements of section 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 an actual 
        emergency described in subsection (a)(2)(B); 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.
  (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 (as 
        defined in section 564(a)(2)(A)) and shall not be 
        deemed adulterated or misbranded under this Act because 
        of--
                  (A) the issuance of emergency use 
                instructions under paragraph (1) with respect 
                to such product; or
                  (B) the introduction or delivery for 
                introduction of such product into interstate 
                commerce accompanied by such instructions 
                during an emergency response to an actual 
                emergency described in subsection (a)(2)(B).

SEC. 564B. PRODUCTS HELD FOR EMERGENCY USE.

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

[SEC. 565. TECHNICAL ASSISTANCE.

  [The Secretary, in consultation with the Commissioner of Food 
and Drugs, shall establish within the Food and Drug 
Administration a team of experts on manufacturing and 
regulatory activities (including compliance with current Good 
Manufacturing Practice) to provide both off-site and on-site 
technical assistance to the manufacturers of qualified 
countermeasures (as defined in section 319F-1 of the Public 
Health Service Act), security countermeasures (as defined in 
section 319F-2 of such Act), or vaccines, at the request of 
such a manufacturer and at the discretion of the Secretary, if 
the Secretary determines that a shortage or potential shortage 
may occur in the United States in the supply of such vaccines 
or countermeasures and that the provision of such assistance 
would be beneficial in helping alleviate or avert such 
shortage.]

SEC. 565. COUNTERMEASURE DEVELOPMENT AND REVIEW.

  (a) Countermeasures and Products.--The countermeasures and 
products referred to in this subsection are--
          (1) qualified countermeasures (as defined in section 
        319F-1 of the Public Health Service Act);
          (2) security countermeasures (as defined in section 
        319F-2 of such Act); and
          (3) qualified pandemic or epidemic products (as 
        defined in section 319F-3 of such Act) that the 
        Secretary determines to be a priority.
  (b) In General.--
          (1) Involvement of fda personnel in interagency 
        activities.--For the purpose of accelerating the 
        development, stockpiling, approval, clearance, and 
        licensure of countermeasures and products referred to 
        in subsection (a), the Secretary shall expand the 
        involvement of Food and Drug Administration personnel 
        in interagency activities with the Assistant Secretary 
        for Preparedness and Response (including the Biomedical 
        Advanced Research and Development Authority), the 
        Centers for Disease Control and Prevention, the 
        National Institutes of Health, and the Department of 
        Defense.
          (2) Technical assistance.--The Secretary shall 
        establish within the Food and Drug Administration a 
        team of experts on manufacturing and regulatory 
        activities (including compliance with current Good 
        Manufacturing Practices) to provide both off-site and 
        on-site technical assistance to the manufacturers of 
        countermeasures and products referred to in subsection 
        (a). On-site technical assistance shall be provided 
        upon the request of the manufacturer and at the 
        discretion of the Secretary if the Secretary determines 
        that the provision of such assistance would accelerate 
        the development, manufacturing, or approval, clearance, 
        or licensure of countermeasures and products referred 
        to in subsection (a).
  (c) Agency Interaction With Security Countermeasure 
Sponsors.--
          (1) In general.--For security countermeasures (as 
        defined in section 319F-2 of the Public Health Service 
        Act) that are procured under such section 319F-2--
                  (A) the Secretary shall establish a process 
                for frequent scientific feedback and 
                interactions between the Food and Drug 
                Administration and the security countermeasure 
                sponsor (referred to in this subsection as the 
                ``sponsor''), designed to facilitate the 
                approval, clearance, and licensure of the 
                security countermeasures;
                  (B) such feedback and interactions shall 
                include meetings and, in accordance with 
                subsection (b)(2), on-site technical 
                assistance; and
                  (C) at the request of the Secretary, the 
                process under this paragraph shall include 
                participation by the Food and Drug 
                Administration in meetings between the 
                Biomedical Advanced Research and Development 
                Authority and sponsors on the development of 
                such countermeasures.
          (2) Regulatory management plan.--
                  (A) In general.--The process established 
                under paragraph (1) shall allow for the 
                development of a written regulatory management 
                plan (in this paragraph referred to as the 
                ``plan'') for a security countermeasure (as 
                defined in paragraph (1)) in accordance with 
                this paragraph.
                  (B) Proposal and finalization of plan.--In 
                carrying out the process under paragraph (1), 
                the Secretary shall direct the Food and Drug 
                Administration, upon submission of a written 
                request by the sponsor that includes a proposed 
                plan and relevant data and future planning 
                detail to support such a plan, to work with the 
                sponsor to agree on a final plan within a 
                reasonable time not to exceed 90 days. The 
                basis for this agreement shall be the proposed 
                plan submitted by the sponsor. Notwithstanding 
                the preceding sentence, the Secretary shall 
                retain full discretion to determine the 
                contents of the final plan or to determine that 
                no such plan can be agreed upon. If the 
                Secretary determines that no final plan can be 
                agreed upon, the Secretary shall provide to the 
                sponsor, in writing, the scientific or 
                regulatory rationale why such agreement cannot 
                be reached. If a final plan is agreed upon, it 
                shall be shared with the sponsor in writing.
                  (C) Contents.--The plan shall include an 
                agreement on the nature of, and timelines for, 
                feedback and interactions between the sponsor 
                and the Food and Drug Administration, shall 
                provide reasonable flexibility in implementing 
                and adjusting the agreement under this 
                paragraph as warranted during the 
                countermeasure development process, and shall 
                identify--
                          (i) the current regulatory status of 
                        the countermeasure, an assessment of 
                        known scientific gaps relevant to 
                        approval, clearance, or licensure of 
                        the countermeasure, and a proposed 
                        pathway to approval, clearance, or 
                        licensure of the countermeasure;
                          (ii) developmental milestones whose 
                        completion will result in meetings to 
                        be scheduled within a reasonable time 
                        between the applicable review division 
                        of the Food and Drug Administration and 
                        the sponsor;
                          (iii) sponsor submissions that will 
                        result in written feedback from the 
                        review division within a reasonable 
                        time;
                          (iv) feedback by the Food and Drug 
                        Administration regarding the data 
                        required to support delivery of the 
                        countermeasure to the Strategic 
                        National Stockpile under section 319F-2 
                        of the Public Health Service Act;
                          (v) feedback by the Food and Drug 
                        Administration regarding data required 
                        to support submission of a proposed 
                        agreement on the design and size of 
                        clinical trials for review under 
                        section 505(b)(5)(B); and
                          (vi) other issues that have the 
                        potential to delay approval, clearance, 
                        or licensure.
                  (D) Changes.--Changes to the plan shall be 
                made by subsequent agreement between the 
                Secretary and the sponsor. If after reasonable 
                attempts to negotiate changes to the plan the 
                Secretary and the sponsor are unable to 
                finalize such changes, the Secretary shall 
                provide to the sponsor, in writing, the 
                scientific or regulatory rationale why such 
                changes are required or cannot be included in 
                the plan.
          (3) Applicability to certain qualified pandemic or 
        epidemic products.--The Secretary may, with respect to 
        qualified pandemic or epidemic products (as defined in 
        section 319F-3 of the Public Health Service Act) for 
        which a contract for advanced research and development 
        is entered into under section 319L of such Act, choose 
        to apply the provisions of paragraphs (1) and (2) to 
        the same extent and in the same manner as such 
        provisions apply with respect to security 
        countermeasures.
  (d) 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 2011, the Secretary 
        shall provide final guidance to industry regarding the 
        development of animal models to support approval, 
        clearance, or licensure of countermeasures and products 
        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.
  (e) Biennial Report.--Not later than January 1, 2013, and 
every 2 years thereafter, the Secretary shall submit a report 
to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, 
and Pensions of the Senate, that, with respect to the preceding 
2 fiscal years, includes--
          (1) the number of full-time equivalent employees of 
        the Food and Drug Administration who directly support 
        the review of countermeasures and products referred to 
        in subsection (a);
          (2) estimates of funds obligated by the Food and Drug 
        Administration for review of such countermeasures and 
        products;
          (3) the number of regulatory teams at the Food and 
        Drug Administration specific to such countermeasures 
        and products and, for each such team, the assigned 
        products, classes of products, or technologies;
          (4) the length of time between each request by the 
        sponsor of such a countermeasure or product for 
        information and the provision of such information by 
        the Food and Drug Administration;
          (5) the number, type, and frequency of official 
        interactions between the Food and Drug Administration 
        and--
                  (A) sponsors of a countermeasure or product 
                referred to in subsection (a); or
                  (B) another agency engaged in development or 
                management of portfolios for such 
                countermeasures or products, 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;
          (6) a description of other measures that, as 
        determined by the Secretary, are appropriate to 
        determine the efficiency of the regulatory teams 
        described in paragraph (3); and
          (7) the regulatory science priorities that relate to 
        countermeasures or products referred to in subsection 
        (a) and which the Food and Drug Administration is 
        addressing and the progress made on these priorities.

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                              ----------                              


                     PROJECT BIOSHIELD ACT OF 2004

[SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.

  [(a) Secretary of Health and Human Services.--
          [(1) Annual reports on particular exercises of 
        authority.--
                  [(A) Relevant authorities.--The Secretary of 
                Health and Human Services (referred to in this 
                subsection as the ``Secretary'') shall submit 
                reports in accordance with subparagraph (B) 
                regarding the exercise of authority under the 
                following provisions of law:
                          [(i) With respect to section 319F-1 
                        of the Public Health Service Act (as 
                        added by section 2 of this Act):
                                  [(I) Subsection (b)(1) 
                                (relating to increased 
                                simplified acquisition 
                                threshold).
                                  [(II) Subsection (b)(2) 
                                (relating to procedures other 
                                than full and open 
                                competition).
                                  [(III) Subsection (c) 
                                (relating to expedited peer 
                                review procedures).
                          [(ii) With respect to section 319F-2 
                        of the Public Health Service Act (as 
                        added by section 3 of this Act):
                                  [(I) Subsection 
                                (c)(7)(C)(iii) (relating to 
                                simplified acquisition 
                                procedures).
                                  [(II) Subsection 
                                (c)(7)(C)(iv) (relating to 
                                procedures other than full and 
                                open competition).
                                  [(III) Subsection 
                                (c)(7)(C)(v) (relating to 
                                premium provision in multiple-
                                award contracts).
                          [(iii) With respect to section 564 of 
                        the Federal Food, Drug, and Cosmetic 
                        Act (as added by section 4 of this 
                        Act):
                                  [(I) Subsection (a)(1) 
                                (relating to emergency uses of 
                                certain drugs and devices).
                                  [(II) Subsection (b)(1) 
                                (relating to a declaration of 
                                an emergency).
                                  [(III) Subsection (e) 
                                (relating to conditions on 
                                authorization).
                  [(B) Contents of reports.--The Secretary 
                shall annually submit to the designated 
                congressional committees a report that 
                summarizes--
                          [(i) the particular actions that were 
                        taken under the authorities specified 
                        in subparagraph (A), 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; and
                          [(iv) whether, with respect to each 
                        procurement that is approved by the 
                        President under section 319F-2(c)(6) of 
                        the Public Health Service Act (as added 
                        by section 3 of this Act), a contract 
                        was entered into within one year after 
                        such approval by the President.
          [(2) Annual summaries regarding certain activity.--
        The Secretary shall annually submit to the designated 
        congressional committees a report that summarizes the 
        activity undertaken pursuant to the following 
        authorities under section 319F-1 of the Public Health 
        Service Act (as added by section 2 of this Act):
                  [(A) Subsection (b)(3) (relating to increased 
                micropurchase threshold).
                  [(B) Subsection (d) (relating to authority 
                for personal services contracts).
                  [(C) Subsection (e) (relating to streamlined 
                personnel authority).
        With respect to subparagraph (B), the report shall 
        include a provision specifying, for the one-year period 
        for which the report is submitted, the number of 
        persons who were paid amounts greater than $100,000 and 
        the number of persons who were paid amounts between 
        $50,000 and $100,000.
          [(3) Report on additional barriers to procurement of 
        security countermeasures.--Not later than one year 
        after the date of the enactment of this Act, the 
        Secretary, in consultation with the Secretary of 
        Homeland Security, shall report to the designated 
        congressional committees any potential barriers to the 
        procurement of security countermeasures that have not 
        been addressed by this Act.
  [(b) General Accounting Office Review.--
          [(1) In general.--Four years after the date of the 
        enactment of this Act, the Comptroller General of the 
        United States shall initiate a study--
                  [(A)(i)to review the Secretary of Health and 
                Human Services' utilization of the authorities 
                granted under this Act with respect to 
                simplified acquisition procedures, procedures 
                other than full and open competition, increased 
                micropurchase thresholds, personal services 
                contracts, streamlined personnel authority, and 
                the purchase of security countermeasures under 
                the special reserve fund; and
                  [(ii) to make recommendations to improve the 
                utilization or effectiveness of such 
                authorities in the future;
                  [(B)(i)to review and assess the adequacy of 
                the internal controls instituted by such 
                Secretary with respect to such authorities, 
                where required by this Act; and
                  [(ii) to make recommendations to improve the 
                effectiveness of such controls;
                  [(C)(i)to review such Secretary's utilization 
                of the authority granted under this Act to 
                authorize an emergency use of a biomedical 
                countermeasure, including the means by which 
                the Secretary determines whether and under what 
                conditions any such authorizations should be 
                granted and the benefits and adverse impacts, 
                if any, resulting from the use of such 
                authority; and
                  [(ii) to make recommendations to improve the 
                utilization or effectiveness of such authority 
                and to enhance protection of the public health;
                  [(D) to identify any purchases or 
                procurements that would not have been made or 
                would have been significantly delayed except 
                for the authorities described in subparagraph 
                (A)(i); and
                  [(E)(i)to determine whether and to what 
                extent activities undertaken pursuant to the 
                biomedical countermeasure research and 
                development authorities established in this Act 
                have enhanced the development of biomedical 
                countermeasures affecting national security; 
                and
                  [(ii) to make recommendations to improve the 
                ability of the Secretary to carry out these 
                activities in the future.
          [(2) Additional provisions regarding determination on 
        development of biomedical countermeasures affecting 
        national security.--In the report under paragraph (1), 
        the determination under subparagraph (E) of such 
        paragraph shall include--
                  [(A) the Comptroller General's assessment of 
                the current availability of countermeasures to 
                address threats identified by the Secretary of 
                Homeland Security;
                  [(B) the Comptroller General's assessment of 
                the extent to which programs and activities 
                under this Act will reduce any gap between the 
                threat and the availability of countermeasures 
                to an acceptable level of risk; and
                  [(C)(i)the Comptroller General's assessment 
                of threats to national security that are posed 
                by technology that will enable, during the 10-
                year period beginning on the date of the 
                enactment of this Act, the development of 
                antibiotic resistant, mutated, or bioengineered 
                strains of biological agents; and
                  [(ii) recommendations on short-term and long-
                term governmental strategies for addressing 
                such threats, including recommendations for 
                Federal policies regarding research priorities, 
                the development of countermeasures, and 
                investments in technology.
          [(3) Report.--A report providing the results of the 
        study under paragraph (1) shall be submitted to the 
        designated congressional committees not later than five 
        years after the date of the enactment of this Act.
  [(c) Report Regarding Biocontainment Facilities.--Not later 
than 120 days after the date of the enactment of this Act, the 
Secretary of Homeland Security and the Secretary of Health and 
Human Services shall jointly report to the designated 
congressional committees whether there is a lack of adequate 
large-scale biocontainment facilities necessary for the testing 
of security countermeasures in accordance with Food and Drug 
Administration requirements.
  [(d) Designated Congressional Committees.--For purposes of 
this section, the term ``designated congressional committees'' 
means the following committees of the Congress:
          [(1) In the House of Representatives: the Committee 
        on Energy and Commerce, the Committee on 
        Appropriations, the Committee on Government Reform, and 
        the Select Committee on Homeland Security (or any 
        successor to the Select Committee).
          [(2) In the Senate: the appropriate committees.]

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