[Congressional Bills 108th Congress]
[From the U.S. Government Printing Office]
[S. 15 Enrolled Bill (ENR)]

        S.15

                       One Hundred Eighth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Tuesday,
           the twentieth day of January, two thousand and four


                                 An Act


 
   To amend the Public Health Service Act to provide protections and 
 countermeasures against chemical, radiological, or nuclear agents that 
 may be used in a terrorist attack against the United States by giving 
       the National Institutes of Health contracting flexibility, 
 infrastructure improvements, and expediting the scientific peer review 
  process, and streamlining the Food and Drug Administration approval 
                       process of countermeasures.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Project BioShield Act of 2004''.
SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT--
AUTHORITIES.
    (a) In General.--Part B of title III of the Public Health Service 
Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319F 
the following section:

``SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES REGARDING 
              QUALIFIED COUNTERMEASURE RESEARCH AND DEVELOPMENT 
              ACTIVITIES.

    ``(a) In General.--
        ``(1) Authority.--In conducting and supporting research and 
    development activities regarding countermeasures under section 
    319F(h), the Secretary may conduct and support such activities in 
    accordance with this section and, in consultation with the Director 
    of the National Institutes of Health, as part of the program under 
    section 446, if the activities concern qualified countermeasures.
        ``(2) Qualified countermeasure.--For purposes of this section, 
    the term `qualified countermeasure' means a drug (as that term is 
    defined by section 201(g)(1) of the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that 
    term is defined by section 351(i) of this Act (42 U.S.C. 262(i))), 
    or device (as that term is defined by section 201(h) of the Federal 
    Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) that the Secretary 
    determines to be a priority (consistent with sections 302(2) and 
    304(a) of the Homeland Security Act of 2002) to--
            ``(A) treat, identify, or prevent harm from any biological, 
        chemical, radiological, or nuclear agent that may cause a 
        public health emergency affecting national security; or
            ``(B) treat, identify, or prevent harm from a condition 
        that may result in adverse health consequences or death and may 
        be caused by administering a drug, biological product, or 
        device that is used as described in subparagraph (A).
        ``(3) Interagency cooperation.--
            ``(A) In general.--In carrying out activities under this 
        section, the Secretary is authorized, subject to subparagraph 
        (B), to enter into interagency agreements and other 
        collaborative undertakings with other agencies of the United 
        States Government.
            ``(B) Limitation.--An agreement or undertaking under this 
        paragraph shall not authorize another agency to exercise the 
        authorities provided by this section.
        ``(4) Availability of facilities to the secretary.--In any 
    grant, contract, or cooperative agreement entered into under the 
    authority provided in this section with respect to a biocontainment 
    laboratory or other related or ancillary specialized research 
    facility that the Secretary determines necessary for the purpose of 
    performing, administering, or supporting qualified countermeasure 
    research and development, the Secretary may provide that the 
    facility that is the object of such grant, contract, or cooperative 
    agreement shall be available as needed to the Secretary to respond 
    to public health emergencies affecting national security.
        ``(5) Transfers of qualified countermeasures.--Each agreement 
    for an award of a grant, contract, or cooperative agreement under 
    section 319F(h) for the development of a qualified countermeasure 
    shall provide that the recipient of the award will comply with all 
    applicable export-related controls with respect to such 
    countermeasure.
    ``(b) Expedited Procurement Authority.--
        ``(1) Increased simplified acquisition threshold for qualified 
    countermeasure procurements.--
            ``(A) In general.--For any procurement by the Secretary of 
        property or services for use (as determined by the Secretary) 
        in performing, administering, or supporting qualified 
        countermeasure research or development activities under this 
        section that the Secretary determines necessary to respond to 
        pressing research and development needs under this section, the 
        amount specified in section 4(11) of the Office of Federal 
        Procurement Policy Act (41 U.S.C. 403(11)), as applicable 
        pursuant to section 302A(a) of the Federal Property and 
        Administrative Services Act of 1949 (41 U.S.C. 252a(a)), shall 
        be deemed to be $25,000,000 in the administration, with respect 
        to such procurement, of--
                ``(i) section 303(g)(1)(A) of the Federal Property and 
            Administrative Services Act of 1949 (41 U.S.C. 
            253(g)(1)(A)) and its implementing regulations; and
                ``(ii) section 302A(b) of such Act (41 U.S.C. 252a(b)) 
            and its implementing regulations.
            ``(B) Application of certain provisions.--Notwithstanding 
        subparagraph (A) and the provision of law and regulations 
        referred to in such subparagraph, each of the following 
        provisions shall apply to procurements described in this 
        paragraph to the same extent that such provisions would apply 
        to such procurements in the absence of subparagraph (A):
                ``(i) Chapter 37 of title 40, United States Code 
            (relating to contract work hours and safety standards).
                ``(ii) Subsections (a) and (b) of section 7 of the 
            Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and (b)).
                ``(iii) Section 304C of the Federal Property and 
            Administrative Services Act of 1949 (41 U.S.C. 254d) 
            (relating to the examination of contractor records).
                ``(iv) Section 3131 of title 40, United States Code 
            (relating to bonds of contractors of public buildings or 
            works).
                ``(v) Subsection (a) of section 304 of the Federal 
            Property and Administrative Services Act of 1949 (41 U.S.C. 
            254(a)) (relating to contingent fees to middlemen).
                ``(vi) Section 6002 of the Solid Waste Disposal Act (42 
            U.S.C. 6962).
                ``(vii) Section 1354 of title 31, United States Code 
            (relating to the limitation on the use of appropriated 
            funds for contracts with entities not meeting veterans 
            employment reporting requirements).
            ``(C) Internal controls to be instituted.--The Secretary 
        shall institute appropriate internal controls for procurements 
        that are under this paragraph, including requirements with 
        regard to documenting the justification for use of the 
        authority in this paragraph with respect to the procurement 
        involved.
            ``(D) Authority to limit competition.--In conducting a 
        procurement under this paragraph, the Secretary may not use the 
        authority provided for under subparagraph (A) to conduct a 
        procurement on a basis other than full and open competition 
        unless the Secretary determines that the mission of the 
        BioShield Program under the Project BioShield Act of 2004 would 
        be seriously impaired without such a limitation.
        ``(2) Procedures other than full and open competition.--
            ``(A) In general.--In using the authority provided in 
        section 303(c)(1) of title III of the Federal Property and 
        Administrative Services Act of 1949 (41 U.S.C. 253(c)(1)) to 
        use procedures other than competitive procedures in the case of 
        a procurement described in paragraph (1) of this subsection, 
        the phrase `available from only one responsible source' in such 
        section 303(c)(1) shall be deemed to mean `available from only 
        one responsible source or only from a limited number of 
        responsible sources'.
            ``(B) Relation to other authorities.--The authority under 
        subparagraph (A) is in addition to any other authority to use 
        procedures other than competitive procedures.
            ``(C) Applicable government-wide regulations.--The 
        Secretary shall implement this paragraph in accordance with 
        government-wide regulations implementing such section 303(c)(1) 
        (including requirements that offers be solicited from as many 
        potential sources as is practicable under the circumstances, 
        that required notices be published, and that submitted offers 
        be considered), as such regulations apply to procurements for 
        which an agency has authority to use procedures other than 
        competitive procedures when the property or services needed by 
        the agency are available from only one responsible source or 
        only from a limited number of responsible sources and no other 
        type of property or services will satisfy the needs of the 
        agency.
        ``(3) Increased micropurchase threshold.--
            ``(A) In general.--For a procurement described by paragraph 
        (1), the amount specified in subsections (c), (d), and (f) of 
        section 32 of the Office of Federal Procurement Policy Act (41 
        U.S.C. 428) shall be deemed to be $15,000 in the administration 
        of that section with respect to such procurement.
            ``(B) Internal controls to be instituted.--The Secretary 
        shall institute appropriate internal controls for purchases 
        that are under this paragraph and that are greater than $2,500.
            ``(C) Exception to preference for purchase card 
        mechanism.--No provision of law establishing a preference for 
        using a Government purchase card method for purchases shall 
        apply to purchases that are under this paragraph and that are 
        greater than $2,500.
        ``(4) Review.--
            ``(A) Review allowed.--Notwithstanding subsection (f), 
        section 1491 of title 28, United States Code, and section 3556 
        of title 31 of such Code, review of a contracting agency 
        decision relating to a procurement described in paragraph (1) 
        may be had only by filing a protest--
                ``(i) with a contracting agency; or
                ``(ii) with the Comptroller General under subchapter V 
            of chapter 35 of title 31, United States Code.
            ``(B) Override of stay of contract award or performance 
        committed to agency discretion.--Notwithstanding section 1491 
        of title 28, United States Code, and section 3553 of title 31 
        of such Code, the following authorizations by the head of a 
        procuring activity are committed to agency discretion:
                ``(i) An authorization under section 3553(c)(2) of 
            title 31, United States Code, to award a contract for a 
            procurement described in paragraph (1) of this subsection.
                ``(ii) An authorization under section 3553(d)(3)(C) of 
            such title to perform a contract for a procurement 
            described in paragraph (1) of this subsection.
    ``(c) Authority to Expedite Peer Review.--
        ``(1) In general.--The Secretary may, as the Secretary 
    determines necessary to respond to pressing qualified 
    countermeasure research and development needs under this section, 
    employ such expedited peer review procedures (including 
    consultation with appropriate scientific experts) as the Secretary, 
    in consultation with the Director of NIH, deems appropriate to 
    obtain assessment of scientific and technical merit and likely 
    contribution to the field of qualified countermeasure research, in 
    place of the peer review and advisory council review procedures 
    that would be required under sections 301(a)(3), 405(b)(1)(B), 
    405(b)(2), 406(a)(3)(A), 492, and 494, as applicable to a grant, 
    contract, or cooperative agreement--
            ``(A) that is for performing, administering, or supporting 
        qualified countermeasure research and development activities; 
        and
            ``(B) the amount of which is not greater than $1,500,000.
        ``(2) Subsequent phases of research.--The Secretary's 
    determination of whether to employ expedited peer review with 
    respect to any subsequent phases of a research grant, contract, or 
    cooperative agreement under this section shall be determined 
    without regard to the peer review procedures used for any prior 
    peer review of that same grant, contract, or cooperative agreement. 
    Nothing in the preceding sentence may be construed to impose any 
    requirement with respect to peer review not otherwise required 
    under any other law or regulation.
    ``(d) Authority for Personal Services Contracts.--
        ``(1) In general.--For the purpose of performing, 
    administering, or supporting qualified countermeasure research and 
    development activities, the Secretary may, as the Secretary 
    determines necessary to respond to pressing qualified 
    countermeasure research and development needs under this section, 
    obtain by contract (in accordance with section 3109 of title 5, 
    United States Code, but without regard to the limitations in such 
    section on the period of service and on pay) the personal services 
    of experts or consultants who have scientific or other professional 
    qualifications, except that in no case shall the compensation 
    provided to any such expert or consultant exceed the daily 
    equivalent of the annual rate of compensation for the President.
        ``(2) Federal tort claims act coverage.--
            ``(A) In general.--A person carrying out a contract under 
        paragraph (1), and an officer, employee, or governing board 
        member of such person, shall, subject to a determination by the 
        Secretary, be deemed to be an employee of the Department of 
        Health and Human Services for purposes of claims under sections 
        1346(b) and 2672 of title 28, United States Code, for money 
        damages for personal injury, including death, resulting from 
        performance of functions under such contract.
            ``(B) Exclusivity of remedy.--The remedy provided by 
        subparagraph (A) shall be exclusive of any other civil action 
        or proceeding by reason of the same subject matter against the 
        entity involved (person, officer, employee, or governing board 
        member) for any act or omission within the scope of the Federal 
        Tort Claims Act.
            ``(C) Recourse in case of gross misconduct or contract 
        violation.--
                ``(i) In general.--Should payment be made by the United 
            States to any claimant bringing a claim under this 
            paragraph, either by way of administrative determination, 
            settlement, or court judgment, the United States shall 
            have, notwithstanding any provision of State law, the right 
            to recover against any entity identified in subparagraph 
            (B) for that portion of the damages so awarded or paid, as 
            well as interest and any costs of litigation, resulting 
            from the failure of any such entity to carry out any 
            obligation or responsibility assumed by such entity under a 
            contract with the United States or from any grossly 
            negligent or reckless conduct or intentional or willful 
            misconduct on the part of such entity.
                ``(ii) Venue.--The United States may maintain an action 
            under this subparagraph against such entity in the district 
            court of the United States in which such entity resides or 
            has its principal place of business.
        ``(3) Internal controls to be instituted.--
            ``(A) In general.--The Secretary shall institute 
        appropriate internal controls for contracts under this 
        subsection, including procedures for the Secretary to make a 
        determination of whether a person, or an officer, employee, or 
        governing board member of a person, is deemed to be an employee 
        of the Department of Health and Human Services pursuant to 
        paragraph (2).
            ``(B) Determination of employee status to be final.--A 
        determination by the Secretary under subparagraph (A) that a 
        person, or an officer, employee, or governing board member of a 
        person, is or is not deemed to be an employee of the Department 
        of Health and Human Services shall be final and binding on the 
        Secretary and the Attorney General and other parties to any 
        civil action or proceeding.
        ``(4) Number of personal services contracts limited.--The 
    number of experts and consultants whose personal services are 
    obtained under paragraph (1) shall not exceed 30 at any time.
    ``(e) Streamlined Personnel Authority.--
        ``(1) In general.--In addition to any other personnel 
    authorities, the Secretary may, as the Secretary determines 
    necessary to respond to pressing qualified countermeasure research 
    and development needs under this section, without regard to those 
    provisions of title 5, United States Code, governing appointments 
    in the competitive service, and without regard to the provisions of 
    chapter 51 and subchapter III of chapter 53 of such title relating 
    to classification and General Schedule pay rates, appoint 
    professional and technical employees, not to exceed 30 such 
    employees at any time, to positions in the National Institutes of 
    Health to perform, administer, or support qualified countermeasure 
    research and development activities in carrying out this section.
        ``(2) Limitations.--The authority provided for under paragraph 
    (1) shall be exercised in a manner that--
            ``(A) recruits and appoints individuals based solely on 
        their abilities, knowledge, and skills;
            ``(B) does not discriminate for or against any applicant 
        for employment on any basis described in section 2302(b)(1) of 
        title 5, United States Code;
            ``(C) does not allow an official to appoint an individual 
        who is a relative (as defined in section 3110(a)(3) of such 
        title) of such official;
            ``(D) does not discriminate for or against an individual 
        because of the exercise of any activity described in paragraph 
        (9) or (10) of section 2302(b) of such title; and
            ``(E) accords a preference, among equally qualified 
        persons, to persons who are preference eligibles (as defined in 
        section 2108(3) of such title).
        ``(3) Internal controls to be instituted.--The Secretary shall 
    institute appropriate internal controls for appointments under this 
    subsection.
    ``(f) Actions Committed to Agency Discretion.--Actions by the 
Secretary under the authority of this section are committed to agency 
discretion.''.
    (b) Technical Amendment.--Section 481A of the Public Health Service 
Act (42 U.S.C. 287a-2) is amended--
        (1) in subsection (a)(1), by inserting ``or the Director of the 
    National Institute of Allergy and Infectious Diseases'' after 
    ``Director of the Center'';
        (2) in subsection (c)--
            (A) in paragraph (1), by inserting ``or the Director of the 
        National Institute of Allergy and Infectious Diseases'' after 
        ``Director of the Center''; and
            (B) in paragraph (2), in the matter preceding subparagraph 
        (A), by striking ``subsection (i)'' and inserting ``subsection 
        (i)(1)'';
        (3) in subsection (d), by inserting ``or the Director of the 
    National Institute of Allergy and Infectious Diseases'' after 
    ``Director of the Center'';
        (4) in subsection (e)--
            (A) in paragraph (1)--
                (i) in the matter preceding subparagraph (A), by 
            inserting ``or the Director of the National Institute of 
            Allergy and Infectious Diseases'' after ``Director of the 
            Center'';
                (ii) in subparagraph (A), by inserting ``(or, in the 
            case of the Institute, 75 percent)'' after ``50 percent''; 
            and
                (iii) in subparagraph (B), by inserting ``(or, in the 
            case of the Institute, 75 percent)'' after ``40 percent'';
            (B) in paragraph (2), by inserting ``or the Director of the 
        National Institute of Allergy and Infectious Diseases'' after 
        ``Director of the Center''; and
            (C) in paragraph (4), by inserting ``of the Center or the 
        Director of the National Institute of Allergy and Infectious 
        Diseases'' after ``Director'';
        (5) in subsection (f)--
            (A) in paragraph (1), by inserting ``in the case of an 
        award by the Director of the Center,'' before ``the 
        applicant''; and
            (B) in paragraph (2), by inserting ``of the Center or the 
        Director of the National Institute of Allergy and Infectious 
        Diseases'' after ``Director''; and
        (6) in subsection (i)--
            (A) by striking ``Appropriations.--For the purpose of 
        carrying out this section,'' and inserting the following: 
        ``Appropriations.--
        ``(1) Center.--For the purpose of carrying out this section 
    with respect to the Center,''; and
            (B) by adding at the end the following:
        ``(2) National institute of allergy and infectious diseases.--
    For the purpose of carrying out this section with respect to the 
    National Institute of Allergy and Infectious Diseases, there are 
    authorized to be appropriated such sums as may be necessary for 
    each of the fiscal years 2004 and 2005.''.
    (c) Additional Authorizations of Appropriations.--Section 2106 of 
the Public Health Service Act (42 U.S.C. 300aa-6) is amended--
        (1) in subsection (a), by striking ``authorized to be 
    appropriated'' and all that follows and inserting the following: 
    ``authorized to be appropriated such sums as may be necessary for 
    each of the fiscal years 2004 and 2005.''; and
        (2) in subsection (b), by striking ``authorized to be 
    appropriated'' and all that follows and inserting the following: 
    ``authorized to be appropriated such sums as may be necessary for 
    each of the fiscal years 2004 and 2005.''.
    (d) Technical Amendments.--Section 319F of the Public Health 
Service Act (42 U.S.C. 247d-6) is amended--
        (1) in subsection (a), by inserting ``the Secretary of Homeland 
    Security,'' after ``Management Agency,''; and
        (2) in subsection (h)(4)(B), by striking ``to diagnose 
    conditions'' and inserting ``to treat, identify, or prevent 
    conditions''.
    (e) Rule of Construction.--Nothing in this section has any legal 
effect on sections 302(2), 302(4), 304(a), or 304(b) of the Homeland 
Security Act of 2002.
SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.
    (a) Additional Authority Regarding Strategic National Stockpile.--
        (1) Transfer of program.--Section 121 of the Public Health 
    Security and Bioterrorism Preparedness and Response Act of 2002 
    (116 Stat. 611; 42 U.S.C. 300hh-12) is transferred from such Act to 
    the Public Health Service Act, is redesignated as section 319F-2, 
    and is inserted after section 319F-1 of the Public Health Service 
    Act (as added by section 2 of this Act).
        (2) Additional authority.--Section 319F-2 of the Public Health 
    Service Act, as added by paragraph (1), is amended to read as 
    follows:

``SEC. 319F-2. STRATEGIC NATIONAL STOCKPILE.

    ``(a) Strategic National Stockpile.--
        ``(1) In general.--The Secretary, in coordination with the 
    Secretary of Homeland Security (referred to in this section as the 
    `Homeland Security Secretary'), shall maintain a stockpile or 
    stockpiles of drugs, vaccines and other biological products, 
    medical devices, and other supplies in such numbers, types, and 
    amounts as are determined by the Secretary to be appropriate and 
    practicable, taking into account other available sources, to 
    provide for the emergency health security of the United States, 
    including the emergency health security of children and other 
    vulnerable populations, in the event of a bioterrorist attack or 
    other public health emergency.
        ``(2) Procedures.--The Secretary, in managing the stockpile 
    under paragraph (1), shall--
            ``(A) consult with the working group under section 319F(a);
            ``(B) ensure that adequate procedures are followed with 
        respect to such stockpile for inventory management and 
        accounting, and for the physical security of the stockpile;
            ``(C) in consultation with Federal, State, and local 
        officials, take into consideration the timing and location of 
        special events;
            ``(D) review and revise, as appropriate, the contents of 
        the stockpile on a regular basis to ensure that emerging 
        threats, advanced technologies, and new countermeasures are 
        adequately considered;
            ``(E) devise plans for the effective and timely supply-
        chain management of the stockpile, in consultation with 
        appropriate Federal, State and local agencies, and the public 
        and private health care infrastructure;
            ``(F) deploy the stockpile as required by the Secretary of 
        Homeland Security to respond to an actual or potential 
        emergency;
            ``(G) deploy the stockpile at the discretion of the 
        Secretary to respond to an actual or potential public health 
        emergency or other situation in which deployment is necessary 
        to protect the public health or safety; and
            ``(H) ensure the adequate physical security of the 
        stockpile.
    ``(b) Smallpox Vaccine Development.--
        ``(1) In general.--The Secretary shall award contracts, enter 
    into cooperative agreements, or carry out such other activities as 
    may reasonably be required in order to ensure that the stockpile 
    under subsection (a) includes an amount of vaccine against smallpox 
    as determined by such Secretary to be sufficient to meet the health 
    security needs of the United States.
        ``(2) Rule of construction.--Nothing in this section shall be 
    construed to limit the private distribution, purchase, or sale of 
    vaccines from sources other than the stockpile described in 
    subsection (a).
    ``(c) Additional Authority Regarding Procurement of Certain 
Biomedical 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).
            ``(B) Security countermeasure.--For purposes of this 
        subsection, the term `security countermeasure' means a drug (as 
        that term is defined by section 201(g)(1) of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological 
        product (as that term is defined by section 351(i) of this Act 
        (42 U.S.C. 262(i))), or device (as that term is defined by 
        section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321(h))) that--
                ``(i)(I) the Secretary determines to be a priority 
            (consistent with sections 302(2) and 304(a) of the Homeland 
            Security Act of 2002) to treat, identify, or prevent harm 
            from any biological, chemical, radiological, or nuclear 
            agent identified as a material threat under paragraph 
            (2)(A)(ii), or to treat, identify, or prevent harm from a 
            condition that may result in adverse health consequences or 
            death and may be caused by administering a drug, biological 
            product, or device against such an agent;
                ``(II) the Secretary determines under paragraph 
            (2)(B)(ii) to be a necessary countermeasure; and
                ``(III)(aa) is approved or cleared under chapter V of 
            the Federal Food, Drug, and Cosmetic Act or licensed under 
            section 351 of this Act; or
                ``(bb) is a countermeasure for which the Secretary 
            determines that sufficient and satisfactory clinical 
            experience or research data (including data, if available, 
            from pre-clinical and clinical trials) support a reasonable 
            conclusion that the countermeasure will qualify for 
            approval or licensing within eight years after the date of 
            a determination under paragraph (5); or
                ``(ii) is authorized for emergency use under section 
            564 of the Federal Food, Drug, and Cosmetic Act.
        ``(2) Determination of material threats.--
            ``(A) Material threat.--The Homeland Security Secretary, in 
        consultation with the Secretary and the heads of other agencies 
        as appropriate, shall on an ongoing basis--
                ``(i) assess current and emerging threats of chemical, 
            biological, radiological, and nuclear agents; and
                ``(ii) determine which of such agents present a 
            material threat against the United States population 
            sufficient to affect national security.
            ``(B) Public health impact; necessary countermeasures.--The 
        Secretary shall on an ongoing basis--
                ``(i) assess the potential public health consequences 
            for the United States population of exposure to agents 
            identified under subparagraph (A)(ii); and
                ``(ii) determine, on the basis of such assessment, the 
            agents identified under subparagraph (A)(ii) for which 
            countermeasures are necessary to protect the public health.
            ``(C) Notice to congress.--The Secretary and the Homeland 
        Security Secretary shall promptly notify the designated 
        congressional committees (as defined in paragraph (10)) that a 
        determination has been made pursuant to subparagraph (A) or 
        (B).
            ``(D) Assuring access to threat information.--In making the 
        assessment and determination required under subparagraph (A), 
        the Homeland Security Secretary shall use all relevant 
        information to which such Secretary is entitled under section 
        202 of the Homeland Security Act of 2002, including but not 
        limited to information, regardless of its level of 
        classification, relating to current and emerging threats of 
        chemical, biological, radiological, and nuclear agents.
        ``(3) Assessment of availability and appropriateness of 
    countermeasures.--The Secretary, in consultation with the Homeland 
    Security Secretary, shall assess on an ongoing basis the 
    availability and appropriateness of specific countermeasures to 
    address specific threats identified under paragraph (2).
        ``(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 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) issue a call for the development of such 
            countermeasure; and
                ``(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) be made available for the procurement of such 
            countermeasure.
            ``(B) Countermeasure specifications.--The Homeland Security 
        Secretary and the Secretary shall, to the extent practicable, 
        include in the proposal under subparagraph (A)--
                ``(i) estimated quantity of purchase (in the form of 
            number of doses or number of effective courses of 
            treatments regardless of dosage form);
                ``(ii) necessary measures of minimum safety and 
            effectiveness;
                ``(iii) estimated price for each dose or effective 
            course of treatment regardless of dosage form; and
                ``(iv) other information that may be necessary to 
            encourage and facilitate research, development, and 
            manufacture of the countermeasure or to provide 
            specifications for the countermeasure.
            ``(C) Presidential approval.--If the President approves a 
        proposal under subparagraph (A), the Homeland Security 
        Secretary and the Secretary shall make known to persons who may 
        respond to a call for the countermeasure involved--
                ``(i) the call for the countermeasure;
                ``(ii) specifications for the countermeasure under 
            subparagraph (B); and
                ``(iii) the commitment described in subparagraph 
            (A)(ii).
        ``(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) (referred to in this subsection 
        individually as a `procurement under this subsection').
            ``(B) Requirements.--In making a determination under 
        subparagraph (A) with respect to a security countermeasure, the 
        Secretary shall determine and consider the following:
                ``(i) The quantities of the product that will be needed 
            to meet the needs of the stockpile.
                ``(ii) The feasibility of production and delivery 
            within eight years of sufficient quantities of the product.
                ``(iii) Whether there is a lack of a significant 
            commercial market for the product at the time of 
            procurement, other than as a security countermeasure.
        ``(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) be made available for the 
        procurement of such countermeasure.
            ``(B) Presidential approval.--The special reserve fund 
        under paragraph (10) 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) 
        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.
            ``(D) Subsequent specific countermeasures.--Procurement 
        under this subsection of a security countermeasure for a 
        particular purpose does not preclude the subsequent procurement 
        under this subsection of any other security countermeasure for 
        such purpose if the Secretary has determined under paragraph 
        (5)(A) that such countermeasure is appropriate for inclusion in 
        the stockpile and if, as determined by the Secretary, such 
        countermeasure provides improved safety or effectiveness, or 
        for other reasons enhances preparedness to respond to threats 
        of use of a biological, chemical, radiological, or nuclear 
        agent. Such a determination by the Secretary is committed to 
        agency discretion.
            ``(E) Rule of construction.--Recommendations and approvals 
        under this paragraph apply solely to determinations that the 
        special reserve fund under paragraph (10) 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) In general.--For purposes of a procurement under this 
        subsection that is approved by the President under paragraph 
        (6), the Homeland Security Secretary and the Secretary shall 
        have responsibilities in accordance with subparagraphs (B) and 
        (C).
            ``(B) Interagency agreement; costs.--
                ``(i) Interagency agreement.--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) shall be available for payments 
            made by the Secretary to a vendor for such procurement.
                ``(ii) Other costs.--The actual costs to the Secretary 
            under this section, other than the costs described in 
            clause (i), shall be paid from the appropriation provided 
            for under subsection (f)(1).
            ``(C) Procurement.--
                ``(i) In general.--The Secretary shall be responsible 
            for--

                    ``(I) arranging for procurement of a security 
                countermeasure, including negotiating terms (including 
                quantity, production schedule, and price) of, and 
                entering into, contracts and cooperative agreements, 
                and for carrying out such other activities as may 
                reasonably be required, in accordance with the 
                provisions of this subparagraph; and
                    ``(II) promulgating such regulations as the 
                Secretary determines necessary to implement the 
                provisions of this subsection.

                ``(ii) Contract terms.--A contract for procurements 
            under this subsection shall (or, as specified below, may) 
            include the following terms:

                    ``(I) Payment conditioned on delivery.--The 
                contract shall provide that no payment may be made 
                until delivery has been made of a portion, acceptable 
                to the Secretary, of the total number of units 
                contracted for, except that, notwithstanding any other 
                provision of law, the contract may provide that, if the 
                Secretary determines (in the Secretary's discretion) 
                that an advance payment is necessary to ensure success 
                of a project, the Secretary may pay an amount, not to 
                exceed 10 percent of the contract amount, in advance of 
                delivery. The contract shall provide that such advance 
                payment is required to be repaid if there is a failure 
                to perform by the vendor under the contract. Nothing in 
                this subclause may be construed as affecting rights of 
                vendors under provisions of law or regulation 
                (including the Federal Acquisition Regulation) relating 
                to termination of contracts for the convenience of the 
                Government.
                    ``(II) Discounted payment.--The contract may 
                provide for a discounted price per unit of a product 
                that is not licensed, cleared, or approved as described 
                in paragraph (1)(B)(i)(III)(aa) at the time of 
                delivery, and may provide for payment of an additional 
                amount per unit if the product becomes so licensed, 
                cleared, or approved before the expiration date of the 
                contract (including an additional amount per unit of 
                product delivered before the effective date of such 
                licensing, clearance, or approval).
                    ``(III) Contract duration.--The contract shall be 
                for a period not to exceed five years, except that, in 
                first awarding the contract, the Secretary may provide 
                for a longer duration, not exceeding eight years, if 
                the Secretary determines that complexities or other 
                difficulties in performance under the contract justify 
                such a period. The contract shall be renewable for 
                additional periods, none of which shall exceed five 
                years.
                    ``(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) shall be available 
                for costs of shipping, handling, storage, and related 
                costs for such product.
                    ``(V) Product approval.--The contract shall provide 
                that the vendor seek approval, clearance, or licensing 
                of the product from the Secretary; for a timetable for 
                the development of data and other information to 
                support such approval, clearance, or licensing; and 
                that the Secretary may waive part or all of this 
                contract term on request of the vendor or on the 
                initiative of the Secretary.
                    ``(VI) Non-stockpile transfers of security 
                countermeasures.--The contract shall provide that the 
                vendor will comply with all applicable export-related 
                controls with respect to such countermeasure.

                ``(iii) Availability of simplified acquisition 
            procedures.--

                    ``(I) In general.--If the Secretary determines that 
                there is a pressing need for a procurement of a 
                specific countermeasure, the amount of the procurement 
                under this subsection shall be deemed to be below the 
                threshold amount specified in section 4(11) of the 
                Office of Federal Procurement Policy Act (41 U.S.C. 
                403(11)), for purposes of application to such 
                procurement, pursuant to section 302A(a) of the Federal 
                Property and Administrative Services Act of 1949 (41 
                U.S.C. 252a(a)), of--

                        ``(aa) section 303(g)(1)(A) of the Federal 
                    Property and Administrative Services Act of 1949 
                    (41 U.S.C. 253(g)(1)(A)) and its implementing 
                    regulations; and
                        ``(bb) section 302A(b) of such Act (41 U.S.C. 
                    252a(b)) and its implementing regulations.

                    ``(II) Application of certain provisions.--
                Notwithstanding subclause (I) and the provision of law 
                and regulations referred to in such clause, each of the 
                following provisions shall apply to procurements 
                described in this clause to the same extent that such 
                provisions would apply to such procurements in the 
                absence of subclause (I):

                        ``(aa) Chapter 37 of title 40, United States 
                    Code (relating to contract work hours and safety 
                    standards).
                        ``(bb) Subsections (a) and (b) of section 7 of 
                    the Anti-Kickback Act of 1986 (41 U.S.C. 57(a) and 
                    (b)).
                        ``(cc) Section 304C of the Federal Property and 
                    Administrative Services Act of 1949 (41 U.S.C. 
                    254d) (relating to the examination of contractor 
                    records).
                        ``(dd) Section 3131 of title 40, United States 
                    Code (relating to bonds of contractors of public 
                    buildings or works).
                        ``(ee) Subsection (a) of section 304 of the 
                    Federal Property and Administrative Services Act of 
                    1949 (41 U.S.C. 254(a)) (relating to contingent 
                    fees to middlemen).
                        ``(ff) Section 6002 of the Solid Waste Disposal 
                    Act (42 U.S.C. 6962).
                        ``(gg) Section 1354 of title 31, United States 
                    Code (relating to the limitation on the use of 
                    appropriated funds for contracts with entities not 
                    meeting veterans employment reporting 
                    requirements).

                    ``(III) Internal controls to be established.--The 
                Secretary shall establish appropriate internal controls 
                for procurements made under this clause, including 
                requirements with respect to documentation of the 
                justification for the use of the authority provided 
                under this paragraph with respect to the procurement 
                involved.
                    ``(IV) Authority to limit competition.--In 
                conducting a procurement under this subparagraph, the 
                Secretary may not use the authority provided for under 
                subclause (I) to conduct a procurement on a basis other 
                than full and open competition unless the Secretary 
                determines that the mission of the BioShield Program 
                under the Project BioShield Act of 2004 would be 
                seriously impaired without such a limitation.

                ``(iv) Procedures other than full and open 
            competition.--

                    ``(I) In general.--In using the authority provided 
                in section 303(c)(1) of title III of the Federal 
                Property and Administrative Services Act of 1949 (41 
                U.S.C. 253(c)(1)) to use procedures other than 
                competitive procedures in the case of a procurement 
                under this subsection, the phrase `available from only 
                one responsible source' in such section 303(c)(1) shall 
                be deemed to mean `available from only one responsible 
                source or only from a limited number of responsible 
                sources'.
                    ``(II) Relation to other authorities.--The 
                authority under subclause (I) is in addition to any 
                other authority to use procedures other than 
                competitive procedures.
                    ``(III) Applicable government-wide regulations.--
                The Secretary shall implement this clause in accordance 
                with government-wide regulations implementing such 
                section 303(c)(1) (including requirements that offers 
                be solicited from as many potential sources as is 
                practicable under the circumstances, that required 
                notices be published, and that submitted offers be 
                considered), as such regulations apply to procurements 
                for which an agency has authority to use procedures 
                other than competitive procedures when the property or 
                services needed by the agency are available from only 
                one responsible source or only from a limited number of 
                responsible sources and no other type of property or 
                services will satisfy the needs of the agency.

                ``(v) Premium provision in multiple award contracts.--

                    ``(I) In general.--If, under this subsection, the 
                Secretary enters into contracts with more than one 
                vendor to procure a security countermeasure, such 
                Secretary may, notwithstanding any other provision of 
                law, include in each of such contracts a provision 
                that--

                        ``(aa) identifies an increment of the total 
                    quantity of security countermeasure required, 
                    whether by percentage or by numbers of units; and
                        ``(bb) promises to pay one or more specified 
                    premiums based on the priority of such vendors' 
                    production and delivery of the increment identified 
                    under item (aa), in accordance with the terms and 
                    conditions of the contract.

                    ``(II) Determination of government's requirement 
                not reviewable.--If the Secretary includes in each of a 
                set of contracts a provision as described in subclause 
                (I), such Secretary's determination of the total 
                quantity of security countermeasure required, and any 
                amendment of such determination, is committed to agency 
                discretion.

                ``(vi) Extension of closing date for receipt of 
            proposals not reviewable.--A decision by the Secretary to 
            extend the closing date for receipt of proposals for a 
            procurement under this subsection is committed to agency 
            discretion.
                ``(vii) Limiting competition to sources responding to 
            request for information.--In conducting a procurement under 
            this subsection, the Secretary may exclude a source that 
            has not responded to a request for information under 
            section 303A(a)(1)(B) of the Federal Property and 
            Administrative Services Act of 1949 (41 U.S.C. 
            253a(a)(1)(B)) if such request has given notice that the 
            Secretary may so exclude such a source.
        ``(8) Interagency cooperation.--
            ``(A) In general.--In carrying out activities under this 
        section, the Homeland Security Secretary and the Secretary are 
        authorized, subject to subparagraph (B), to enter into 
        interagency agreements and other collaborative undertakings 
        with other agencies of the United States Government.
            ``(B) Limitation.--An agreement or undertaking under this 
        paragraph shall not authorize another agency to exercise the 
        authorities provided by this section to the Homeland Security 
        Secretary or to the Secretary.
        ``(9) Restrictions on use of funds.--Amounts in the special 
    reserve fund under paragraph (10) 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.
    ``(d) Disclosures.--No Federal agency shall disclose under section 
552 of title 5, United States Code, any information identifying the 
location at which materials in the stockpile under subsection (a) are 
stored.
    ``(e) Definition.--For purposes of subsection (a), the term 
`stockpile' includes--
        ``(1) a physical accumulation (at one or more locations) of the 
    supplies described in subsection (a); or
        ``(2) a contractual agreement between the Secretary and a 
    vendor or vendors under which such vendor or vendors agree to 
    provide to such Secretary supplies described in subsection (a).
    ``(f) Authorization of Appropriations.--
        ``(1) Strategic national stockpile.--For the purpose of 
    carrying out subsection (a), there are authorized to be 
    appropriated $640,000,000 for fiscal year 2002, and such sums as 
    may be necessary for each of fiscal years 2003 through 2006. Such 
    authorization is in addition to amounts in the special reserve fund 
    referred to in subsection (c)(10)(A).
        ``(2) Smallpox vaccine development.--For the purpose of 
    carrying out subsection (b), there are authorized to be 
    appropriated $509,000,000 for fiscal year 2002, and such sums as 
    may be necessary for each of fiscal years 2003 through 2006.''.
    (b) Amendments to Homeland Security Act of 2002.--Title V of the 
Homeland Security Act of 2002 (116 Stat. 2212; 6 U.S.C. 311 et seq.) is 
amended--
        (1) in section 502(3) (6 U.S.C. 312(3))--
            (A) in subparagraph (B), by striking ``the Strategic 
        National Stockpile,''; and
            (B) in subparagraph (D), by inserting ``, including 
        requiring deployment of the Strategic National Stockpile,'' 
        after ``resources''; and
        (2) by adding at the end the following:

``SEC. 510. PROCUREMENT OF SECURITY COUNTERMEASURES FOR STRATEGIC 
              NATIONAL STOCKPILE.

    ``(a) Authorization of Appropriations.--For the procurement of 
security countermeasures under section 319F-2(c) of the Public Health 
Service Act (referred to in this section as the `security 
countermeasures program'), there is authorized to be appropriated up to 
$5,593,000,000 for the fiscal years 2004 through 2013. Of the amounts 
appropriated under the preceding sentence, not to exceed $3,418,000,000 
may be obligated during the fiscal years 2004 through 2008, of which 
not to exceed $890,000,000 may be obligated during fiscal year 2004.
    ``(b) Special Reserve Fund.--For purposes of the security 
countermeasures program, the term `special reserve fund' means the 
`Biodefense Countermeasures' appropriations account or any other 
appropriation made under subsection (a).
    ``(c) Availability.--Amounts appropriated under subsection (a) 
become available for a procurement under the security countermeasures 
program only upon the approval by the President of such availability 
for the procurement in accordance with paragraph (6)(B) of such 
program.
    ``(d) Related Authorizations of Appropriations.--
        ``(1) Threat assessment capabilities.--For the purpose of 
    carrying out the responsibilities of the Secretary for terror 
    threat assessment under the security countermeasures program, there 
    are authorized to be appropriated such sums as may be necessary for 
    each of the fiscal years 2004 through 2006, for the hiring of 
    professional personnel within the Directorate for Information 
    Analysis and Infrastructure Protection, who shall be analysts 
    responsible for chemical, biological, radiological, and nuclear 
    threat assessment (including but not limited to analysis of 
    chemical, biological, radiological, and nuclear agents, the means 
    by which such agents could be weaponized or used in a terrorist 
    attack, and the capabilities, plans, and intentions of terrorists 
    and other non-state actors who may have or acquire such agents). 
    All such analysts shall meet the applicable standards and 
    qualifications for the performance of intelligence activities 
    promulgated by the Director of Central Intelligence pursuant to 
    section 104 of the National Security Act of 1947.
        ``(2) Intelligence sharing infrastructure.--For the purpose of 
    carrying out the acquisition and deployment of secure facilities 
    (including information technology and physical infrastructure, 
    whether mobile and temporary, or permanent) sufficient to permit 
    the Secretary to receive, not later than 180 days after the date of 
    enactment of the Project BioShield Act of 2004, all classified 
    information and products to which the Under Secretary for 
    Information Analysis and Infrastructure Protection is entitled 
    under subtitle A of title II, there are authorized to be 
    appropriated such sums as may be necessary for each of the fiscal 
    years 2004 through 2006.''.
    (c) Stockpile Functions Transferred.--
        (1) In general.--Except as provided in paragraph (2), there 
    shall be transferred to the Secretary of Health and Human Services 
    the functions, personnel, assets, unexpended balances, and 
    liabilities of the Strategic National Stockpile, including the 
    functions of the Secretary of Homeland Security relating thereto.
        (2) Exceptions.--
            (A) Functions.--The transfer of functions pursuant to 
        paragraph (1) shall not include such functions as are 
        explicitly assigned to the Secretary of Homeland Security by 
        this Act (including the amendments made by this Act).
            (B) Assets and unexpended balances.--The transfer of assets 
        and unexpended balances pursuant to paragraph (1) shall not 
        include the funds appropriated under the heading ``biodefense 
        countermeasures'' in the Department of Homeland Security 
        Appropriations Act, 2004 (Public Law 108-90).
        (3) Conforming amendment.--Section 503 of the Homeland Security 
    Act of 2002 (6 U.S.C. 313) is amended by striking paragraph (6).
SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.
    (a) In General.--Section 564 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb-3) is amended to read as follows:

``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 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 (referred to in this section as an `unapproved 
        product'); or
            ``(B) is approved, licensed, or cleared under such a 
        provision, but which use is not under such provision an 
        approved, licensed, or cleared use of the product (referred to 
        in this section as an `unapproved use of an approved product').
        ``(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.
        ``(4) Definitions.--For purposes of this section:
            ``(A) The term `biological product' has the meaning given 
        such term in section 351 of the Public Health Service Act.
            ``(B) The term `emergency use' has the meaning indicated 
        for such term in paragraph (1).
            ``(C) The term `product' means a drug, device, or 
        biological product.
            ``(D) The term `unapproved product' has the meaning 
        indicated for such term in paragraph (2)(A).
            ``(E) The term `unapproved use of an approved product' has 
        the meaning indicated for such term in paragraph (2)(B).
    ``(b) Declaration of Emergency.--
        ``(1) In general.--The Secretary may declare an emergency 
    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.
        ``(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.
            ``(C) 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.
        ``(3) Advance notice of termination.--The Secretary shall 
    provide advance notice that a declaration under this subsection 
    will be terminated. The period of advance notice shall be a period 
    reasonably determined to provide--
            ``(A) in the case of an unapproved product, a sufficient 
        period for disposition of the product, including the return of 
        such product (except such quantities of product as are 
        necessary to provide for continued use consistent with 
        subsection (f)(2)) to the manufacturer (in the case of a 
        manufacturer that chooses to have such product returned); and
            ``(B) in the case of an unapproved use of an approved 
        product, a sufficient period for the disposition of any 
        labeling, or any information under subsection (e)(2)(B)(ii), as 
        the case may be, that was provided with respect to the 
        emergency use involved.
        ``(4) Publication.--The Secretary shall promptly publish in the 
    Federal Register each declaration, determination, advance notice of 
    termination, and renewal 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 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 a declaration under subsection 
    (b) can cause a serious or life-threatening disease or condition;
        ``(2) that, based on the totality of scientific evidence 
    available to the Secretary, including data from adequate and well-
    controlled clinical trials, if available, it is reasonable to 
    believe that--
            ``(A) the product may be effective in diagnosing, treating, 
        or preventing--
                ``(i) such disease or condition; or
                ``(ii) a serious or life-threatening disease or 
            condition caused by a product authorized under this 
            section, approved or cleared under this Act, or licensed 
            under section 351 of the Public Health Service Act, for 
            diagnosing, treating, or preventing such a disease or 
            condition caused by such an agent; and
            ``(B) the known and potential benefits of the product, when 
        used to diagnose, prevent, or treat such disease or condition, 
        outweigh the known and potential risks of the product;
        ``(3) that there is no adequate, approved, and available 
    alternative to the product for diagnosing, preventing, or treating 
    such disease or condition; and
        ``(4) that such other criteria as the Secretary may by 
    regulation prescribe are satisfied.
    ``(d) Scope of Authorization.--An authorization of a product under 
this section shall state--
        ``(1) each disease or condition that the product may be used to 
    diagnose, prevent, or treat within the scope of the authorization;
        ``(2) the Secretary's conclusions, made under subsection 
    (c)(2)(B), that the known and potential benefits of the product, 
    when used to diagnose, prevent, or treat such disease or condition, 
    outweigh the known and potential risks of the product; and
        ``(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 an assessment of the available scientific evidence.
    ``(e) Conditions of Authorization.--
        ``(1) Unapproved product.--
            ``(A) Required conditions.--With respect to the emergency 
        use of an unapproved product, the Secretary, to the extent 
        practicable given the circumstances of the emergency, shall, 
        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) Appropriate conditions designed to ensure that 
            health care professionals administering the product are 
            informed--

                    ``(I) that the Secretary has authorized the 
                emergency use of the product;
                    ``(II) of the significant known and potential 
                benefits and risks of the emergency use of the product, 
                and of the extent to which such benefits and risks are 
                unknown; and
                    ``(III) of the alternatives to the product that are 
                available, and of their benefits and risks.

                ``(ii) Appropriate conditions designed to ensure that 
            individuals to whom the product is administered are 
            informed--

                    ``(I) that the Secretary has authorized the 
                emergency use of the product;
                    ``(II) of the significant known and potential 
                benefits and risks of such use, and of the extent to 
                which such benefits and risks are unknown; and
                    ``(III) of the option to accept or refuse 
                administration of the product, of the consequences, if 
                any, of refusing administration of the product, and of 
                the alternatives to the product that are available and 
                of their benefits and risks.

                ``(iii) Appropriate conditions for the monitoring and 
            reporting of adverse events associated with the emergency 
            use of the product.
                ``(iv) For manufacturers of the product, appropriate 
            conditions concerning recordkeeping and reporting, 
            including records access by the Secretary, with respect to 
            the emergency use of the product.
            ``(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) Appropriate conditions on which entities may 
            distribute the product with respect to the emergency use of 
            the product (including limitation to distribution by 
            government entities), and on how distribution is to be 
            performed.
                ``(ii) Appropriate conditions on who may administer the 
            product with respect to the emergency use of the product, 
            and on the categories of individuals to whom, and the 
            circumstances under which, the product may be administered 
            with respect to such use.
                ``(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.
                ``(iv) For persons other than manufacturers of the 
            product, appropriate conditions concerning recordkeeping 
            and reporting, including records access by the Secretary, 
            with respect to the emergency use of the product.
        ``(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 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.
            ``(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.
            ``(ii) In the circumstances described in clause (i), for a 
        person who does not manufacture the product and who chooses to 
        act under this clause, an authorization under this section 
        regarding the emergency use shall, to the extent practicable 
        given the circumstances of the emergency, authorize such person 
        to provide appropriate information with respect to such product 
        in addition to the labeling provided by the manufacturer, 
        subject to compliance with clause (i). While the authorization 
        under this section is effective, such additional information 
        shall not be considered labeling for purposes of section 502.
            ``(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.
        ``(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.
        ``(4) Advertising.--The Secretary may establish conditions on 
    advertisements and other promotional descriptive printed matter 
    that relate 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), including, as 
    appropriate--
            ``(A) with respect to drugs and biological products, 
        requirements applicable to prescription drugs pursuant to 
        section 502(n); or
            ``(B) with respect to devices, requirements applicable to 
        restricted devices pursuant to section 502(r).
    ``(f) Duration of Authorization.--
        ``(1) In general.--Except as provided in paragraph (2), an 
    authorization under this section shall be effective until the 
    earlier of the termination of the declaration under subsection (b) 
    or a revocation under subsection (g).
        ``(2) Continued use after end of effective period.--
    Notwithstanding the termination of the declaration under subsection 
    (b) or a revocation under subsection (g), an authorization shall 
    continue to be effective to provide for continued use of an 
    unapproved product with respect to a patient to whom it was 
    administered during the period described by paragraph (1), to the 
    extent found necessary by such patient's attending physician.
    ``(g) Revocation of Authorization.--
        ``(1) Review.--The Secretary shall periodically review the 
    circumstances and the appropriateness of an authorization under 
    this section.
        ``(2) Revocation.--The Secretary may revoke an authorization 
    under this section if the criteria under subsection (c) for 
    issuance of such authorization are no longer met or other 
    circumstances make such revocation appropriate to protect the 
    public health or safety.
    ``(h) Publication; Confidential Information.--
        ``(1) Publication.--The Secretary shall promptly publish in the 
    Federal Register a notice of each authorization, and each 
    termination or revocation of an authorization under this section, 
    and an explanation of the reasons therefor (which may include a 
    summary of data or information that has been submitted to the 
    Secretary in an application under section 505(i) or section 520(g), 
    even if such summary may indirectly reveal the existence of such 
    application).
        ``(2) Confidential information.--Nothing in this section alters 
    or amends section 1905 of title 18, United States Code, or section 
    552(b)(4) of title 5 of such Code.
    ``(i) Actions Committed to Agency Discretion.--Actions under the 
authority of this section by the Secretary, by the Secretary of 
Defense, or by the Secretary of Homeland Security are committed to 
agency discretion.
    ``(j) Rules of Construction.--The following applies with respect to 
this section:
        ``(1) Nothing in this section impairs the authority of the 
    President as Commander in Chief of the Armed Forces of the United 
    States under article II, section 2 of the United States 
    Constitution.
        ``(2) Nothing in this section impairs the authority of the 
    Secretary of Defense with respect to the Department of Defense, 
    including the armed forces, under other provisions of Federal law.
        ``(3) Nothing in this section (including any exercise of 
    authority by a manufacturer under subsection (e)(2)) impairs the 
    authority of the United States to use or manage quantities of a 
    product that are owned or controlled by the United States 
    (including quantities in the stockpile maintained under section 
    319F-2 of the Public Health Service Act).
    ``(k) Relation to Other Provisions.--If a product is the subject of 
an authorization under this section, the use of such product within the 
scope of the authorization shall not be considered to constitute a 
clinical investigation for purposes of section 505(i), section 520(g), 
or any other provision of this Act or section 351 of the Public Health 
Service Act.
    ``(l) Option to Carry Out Authorized Activities.--Nothing in this 
section provides the Secretary any authority to require any person to 
carry out any activity that becomes lawful pursuant to an authorization 
under this section, and no person is required to inform the Secretary 
that the person will not be carrying out such activity, except that a 
manufacturer of a sole-source unapproved product authorized for 
emergency use shall report to the Secretary within a reasonable period 
of time after the issuance by the Secretary of such authorization if 
such manufacturer does not intend to carry out any activity under the 
authorization. This section only has legal effect on a person who 
carries out an activity for which an authorization under this section 
is issued. This section does not modify or affect activities carried 
out pursuant to other provisions of this Act or section 351 of the 
Public Health Service Act. Nothing in this subsection may be construed 
as restricting the Secretary from imposing conditions on persons who 
carry out any activity pursuant to an authorization under this 
section.''.
    (b) Repeal of Termination Provision.--Subsection (d) of section 
1603 of the National Defense Authorization Act for Fiscal Year 2004 (10 
U.S.C. 1107a note) is repealed.
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.
SEC. 6. OUTREACH.
    The Secretary of Health and Human Services shall develop outreach 
measures to ensure to the extent practicable that diverse institutions, 
including Historically Black Colleges and Universities and those 
serving large proportions of Black or African Americans, American 
Indians, Appalachian Americans, Alaska Natives, Asians, Native 
Hawaiians, other Pacific Islanders, Hispanics or Latinos, or other 
underrepresented populations, are meaningfully aware of available 
research and development grants, contracts, cooperative agreements, and 
procurements conducted under sections 2 and 3 of this Act.
SEC. 7. RECOMMENDATION FOR EXPORT CONTROLS ON CERTAIN BIOMEDICAL 
COUNTERMEASURES.
    Upon the award of any grant, contract, or cooperative agreement 
under section 2 or 3 of this Act for the research, development, or 
procurement of a qualified countermeasure or a security countermeasure 
(as those terms are defined in this Act), the Secretary of Health and 
Human Services shall, in consultation with the heads of other 
appropriate Federal agencies, determine whether the countermeasure 
involved in such grant, contract, or cooperative agreement is subject 
to existing export-related controls and, if not, may make a 
recommendation to the appropriate Federal agency or agencies that such 
countermeasure should be included on the list of controlled items 
subject to such controls.
SEC. 8. ENSURING COORDINATION, COOPERATION AND THE ELIMINATION OF 
UNNECESSARY DUPLICATION IN PROGRAMS DESIGNED TO PROTECT THE HOMELAND 
FROM BIOLOGICAL, CHEMICAL, RADIOLOGICAL, AND NUCLEAR AGENTS.
    (a) Ensuring Coordination of Programs.--The Secretary of Health and 
Human Services, the Secretary of Homeland Security, and the Secretary 
of Defense shall ensure that the activities of their respective 
Departments coordinate, complement, and do not unnecessarily duplicate 
programs to identify potential domestic threats from biological, 
chemical, radiological or nuclear agents, detect domestic incidents 
involving such agents, analyze such incidents, and develop necessary 
countermeasures. The aforementioned Secretaries shall further ensure 
that information and technology possessed by the Departments relevant 
to these activities are shared with the other Departments.
    (b) Designation of Agency Coordination Officer.--The Secretary of 
Health and Human Services, the Secretary of Homeland Security, and the 
Secretary of Defense shall each designate an officer or employee of 
their respective Departments who shall coordinate, through regular 
meetings and communications, with the other aforementioned Departments 
such programs and activities carried out by their Departments.
SEC. 9. AUTHORITY OF THE SECRETARY OF HEALTH AND HUMAN SERVICES DURING 
NATIONAL EMERGENCIES.
    Section 1135(b) of the Social Security Act (42 U.S.C. 1320b-5(b)) 
is amended--
        (1) by striking paragraph (3) and inserting the following:
        ``(3) actions under section 1867 (relating to examination and 
    treatment for emergency medical conditions and women in labor) 
    for--
            ``(A) a transfer of an individual who has not been 
        stabilized in violation of subsection (c) of such section if 
        the transfer is necessitated by the circumstances of the 
        declared emergency in the emergency area during the emergency 
        period; or
            ``(B) the direction or relocation of an individual to 
        receive medical screening in an alternate location pursuant to 
        an appropriate State emergency preparedness plan;'';
        (2) in paragraph (5), by striking ``and'' at the end;
        (3) in paragraph (6), by striking the period and inserting ``; 
    and'';
        (4) by inserting after paragraph (6), the following:
        ``(7) sanctions and penalties that arise from noncompliance 
    with the following requirements (as promulgated under the authority 
    of section 264(c) of the Health Insurance Portability and 
    Accountability Act of 1996 (42 U.S.C. 1320d-2 note)--
            ``(A) section 164.510 of title 45, Code of Federal 
        Regulations, relating to--
                ``(i) requirements to obtain a patient's agreement to 
            speak with family members or friends; and
                ``(ii) the requirement to honor a request to opt out of 
            the facility directory;
            ``(B) section 164.520 of such title, relating to the 
        requirement to distribute a notice; or
            ``(C) section 164.522 of such title, relating to--
                ``(i) the patient's right to request privacy 
            restrictions; and
                ``(ii) the patient's right to request confidential 
            communications.''; and
        (5) by adding at the end the following: ``A waiver or 
    modification provided for under paragraph (3) or (7) shall only be 
    in effect if such actions are taken in a manner that does not 
    discriminate among individuals on the basis of their source of 
    payment or of their ability to pay, and shall be limited to a 72-
    hour period beginning upon implementation of a hospital disaster 
    protocol. A waiver or modification under such paragraph (7) shall 
    be withdrawn after such period and the provider shall comply with 
    the requirements under such paragraph for any patient still under 
    the care of the provider.''.

                               Speaker of the House of Representatives.

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