[108th Congress Public Law 276]
[From the U.S. Government Printing Office]


[DOCID: f:publ276.108]

[[Page 118 STAT. 835]]

Public Law 108-276
108th Congress

                                 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. <<NOTE: July 21, 2004 -  [S. 15]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Project 
BioShield Act of 2004. 42 USC 201 note.>> 

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. <<NOTE: 42 USC 247d-6a.>> 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

[[Page 118 STAT. 836]]

                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):

[[Page 118 STAT. 837]]

                          ``(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

[[Page 118 STAT. 838]]

                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),

[[Page 118 STAT. 839]]

        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

[[Page 118 STAT. 840]]

                      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) <<NOTE: Procedures.>> 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

[[Page 118 STAT. 841]]

                    ``(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

[[Page 118 STAT. 842]]

        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) <<NOTE: 42 USC 247d-6a note.>> 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 <<NOTE: 42 USC 247d-
                    6b.>> 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;

[[Page 118 STAT. 843]]

                    ``(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;

[[Page 118 STAT. 844]]

                          ``(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.--

[[Page 118 STAT. 845]]

                    ``(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').

[[Page 118 STAT. 846]]

                    ``(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) <<NOTE: Applicability.>> Rule of 
                construction.--Recommendations and approvals under this 
                paragraph apply solely to determinations that the 
                special reserve fund under paragraph (10)

[[Page 118 STAT. 847]]

                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) <<NOTE: Regulations.>> promulgatin
                                g 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.

[[Page 118 STAT. 848]]

                                    ``(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--

[[Page 118 STAT. 849]]

                                            ``(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.--

[[Page 118 STAT. 850]]

                                    ``(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.

[[Page 118 STAT. 851]]

                          ``(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

[[Page 118 STAT. 852]]

            ``(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. <<NOTE: 6 USC 320.>> 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

[[Page 118 STAT. 853]]

        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) <<NOTE: Deadline. Classified 
        information.>> 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) <<NOTE: Government organization. 42 USC 247d-6b 
note.>> 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').

[[Page 118 STAT. 854]]

            ``(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

[[Page 118 STAT. 855]]

                      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) <<NOTE: Applicability.>> 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) <<NOTE: Federal 
        Register, publication.>> 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

[[Page 118 STAT. 856]]

                    ``(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

[[Page 118 STAT. 857]]

                                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

[[Page 118 STAT. 858]]

                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.--

[[Page 118 STAT. 859]]

            ``(1) <<NOTE: Federal 
        Register, publication.>> 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) <<NOTE: Applicability.>> 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.

[[Page 118 STAT. 860]]

SEC. 5. REPORTS <<NOTE: 42 USC 247d-6c.>> 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

[[Page 118 STAT. 861]]

                      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) <<NOTE: Deadline.>> 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

[[Page 118 STAT. 862]]

                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. <<NOTE: 42 USC 247d-6a note.>> 

    The Secretary of Health and Human Services shall develop outreach 
measures to ensure to the extent practicable that diverse

[[Page 118 STAT. 863]]

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 <<NOTE: 42 USC 247d-6a note.>> 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 <<NOTE: 42 USC 247d-6a note.>> 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

[[Page 118 STAT. 864]]

                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.''.

    Approved July 21, 2004.

LEGISLATIVE HISTORY--S. 15:
---------------------------------------------------------------------------

CONGRESSIONAL RECORD, Vol. 150 (2004):
            May 19, considered and passed Senate.
            July 14, considered and passed House.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 40 (2004):
            July 21, Presidential remarks.

                                  <all>