Pub.L. 108-277 To amend title 18, United States Code, to exempt qualified current and former law enforcement officers from State laws prohibiting the carrying of concealed handguns. <> ...

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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 

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