[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2122 Placed on Calendar Senate (PCS)]

                                                       Calendar No. 214
108th CONGRESS
  1st Session
                                H. R. 2122


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 17, 2003

            Received; read twice and placed on the calendar

_______________________________________________________________________

                                 AN ACT


 
 To enhance research, development, procurement, and use of biomedical 
countermeasures to respond to public health threats affecting national 
                   security, and for other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Project BioShield Act of 2003''.

SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT ---
              AUTHORITIES.

    (a) In General.--Part B of title III of the Public Health Service 
Act (42 U.S.C. 243 et seq.) is amended by inserting after section 319F 
the following section:

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

    ``(a) In General.--
            ``(1) Authority.--In conducting and supporting research and 
        development activities regarding biomedical countermeasures 
        under section 319F(h), the Secretary may conduct and support 
        such activities in accordance with this section if the 
        activities concern qualified countermeasures.
            ``(2) Qualified countermeasure.--For purposes of this 
        section, the term `qualified countermeasure' means a priority 
        countermeasure (as defined in section 319F(h) and as determined 
        by the Secretary in accordance with such section and consistent 
        with sections 302(2) and 304(a) of the Homeland Security Act of 
        2002) against a chemical, biological, radiological, or nuclear 
        agent that may cause a public health emergency affecting 
        national security.
            ``(3) Interagency cooperation.--
                    ``(A) In general.--In carrying out activities under 
                this section, the Secretary is authorized, subject to 
                subparagraph (B), to enter into interagency agreements 
                and other collaborative undertakings with other 
                agencies of the United States Government.
                    ``(B) Limitation.--An agreement or undertaking 
                under this paragraph shall not authorize another agency 
                to exercise the authorities provided by this section.
            ``(4) Availability of facilities to the secretary.--In any 
        grant, contract, or cooperative agreement entered into under 
        the authority provided in this section with respect to a 
        biocontainment laboratory or other related or ancillary 
        specialized research facility that the Secretary determines 
        necessary for the purpose of performing, administering, or 
        supporting qualified countermeasure research and development, 
        the Secretary may provide that the facility that is the object 
        of such grant, contract, or cooperative agreement shall be 
        available as needed to the Secretary to respond to public 
        health emergencies affecting national security.
            ``(5) Transfers of qualified countermeasures.--Each 
        agreement for an award of a grant, contract, or cooperative 
        agreement under section 319F(h) for the development of a 
        qualified countermeasure shall provide that the recipient of 
        the award will comply with all applicable export-related 
        controls with respect to such countermeasure.
    ``(b) Expedited Procurement Authority.--
            ``(1) Increased simplified acquisition threshold for 
        qualified countermeasure procurements.--
                    ``(A) In general.--For any procurement by the 
                Secretary of property or services for use (as 
                determined by the Secretary) in performing, 
                administering, or supporting qualified countermeasure 
                research or development activities under this section 
                that the Secretary determines necessary to respond to 
                pressing research and development needs under this 
                section, the amount specified in section 4(11) of the 
                Office of Federal Procurement Policy Act (41 U.S.C. 
                403(11)), as applicable pursuant to section 302A(a) of 
                the Federal Property and Administrative Services Act of 
                1949 (41 U.S.C. 252a(a)), shall be deemed to be 
                $25,000,000 in the administration, with respect to such 
                procurement, of--
                            ``(i) section 303(g)(1)(A) of the Federal 
                        Property and Administrative Services Act of 
                        1949 (41 U.S.C. 253(g)(1)(A)) and its 
                        implementing regulations; and
                            ``(ii) section 302A(b) of such Act (41 
                        U.S.C. 252a(b)) and its implementing 
                        regulations.
                    ``(B) Application of certain provisions.--
                Notwithstanding subparagraph (A) and the provision of 
                law and regulations referred to in such subparagraph, 
                each of the following provisions shall apply to 
                procurements described in this paragraph to the same 
                extent that such provisions would apply to such 
                procurements in the absence of subparagraph (A):
                            ``(i) Chapter 37 of title 40, United States 
                        Code (relating to contract work hours and 
                        safety standards).
                            ``(ii) Subsections (a) and (b) of section 7 
                        of the Anti-Kickback Act of 1986 (41 U.S.C. 
                        57(a) and (b)).
                            ``(iii) Section 304C of the Federal 
                        Property and Administrative Services Act of 
                        1949 (41 U.S.C. 254d) (relating to the --- 
                        examination of contractor records).
                    ``(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.
            ``(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 applicable government-wide regulations, 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.
            ``(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 any other 
                provision of law, including subsection (f), 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 any other provision of law, the 
                following authorizations by the head of a procuring 
                activity are committed to agency discretion:
                            ``(i) An authorization under section 
                        3553(c)(2) of title 31, United States Code, to 
                        award a contract for a procurement described in 
                        paragraph (1) of this subsection.
                            ``(ii) An authorization under section 
                        3553(d)(3)(C) of such title to perform a 
                        contract for a procurement described in 
                        paragraph (1) of this subsection.
    ``(c) Authority to Expedite Peer Review.--
            ``(1) In general.--The Secretary may, as the Secretary 
        determines necessary to respond to pressing qualified 
        countermeasure research and development needs under this 
        section, employ such expedited peer review procedures 
        (including consultation with appropriate scientific experts) as 
        the Secretary, in consultation with the Director of NIH, deems 
        appropriate to obtain assessment of scientific and technical 
        merit and likely contribution to the field of qualified 
        countermeasure research, in place of the peer review and 
        advisory council review procedures that would be required under 
        sections 301(a)(3), 405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, 
        and 494, as applicable to a grant, contract, or cooperative 
        agreement--
                    ``(A) that is for performing, administering, or 
                supporting qualified countermeasure research and 
                development activities; and
                    ``(B) the amount of which is not greater than 
                $1,500,000.
            ``(2) Subsequent phases of research.--The Secretary's 
        determination of whether to employ expedited peer review with 
        respect to 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.
    ``(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 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 person, officer, employee, 
                or governing board member.
            ``(3) Internal controls to be instituted.--
                    ``(A) In general.--The Secretary shall institute 
                appropriate internal controls for contracts under this 
                subsection, including procedures for the Secretary to 
                make a determination of whether a person, or an 
                officer, employee, or governing board member of a 
                person, is deemed to be an employee of the Department 
                of Health and Human Services pursuant to paragraph (2).
                    ``(B) Determination of employee status to be 
                final.--A determination by the Secretary under 
                subparagraph (A) that a person, or an officer, 
                employee, or governing board member of a person, is or 
                is not deemed to be an employee of the Department of 
                Health and Human Services shall be final and binding on 
                the Secretary and the Attorney General and other 
                parties to any civil action or proceeding.
            ``(4) Number of personal services contracts limited.--The 
        number of experts and consultants whose personal services are 
        obtained under paragraph (1) shall not exceed 30 at any time.
    ``(e) Streamlined Personnel Authority.--
            ``(1) In general.--In addition to any other personnel 
        authorities, the Secretary may, as the Secretary determines 
        necessary to respond to pressing qualified countermeasure 
        research and development needs under this section, without 
        regard to such 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) 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)--
                    (A) by inserting ``or the Director of the National 
                Institute of Allergy and Infectious Diseases'' after 
                ``Director of the Center''; and
                    (B) by inserting ``, or in the case of the 
                Institute, to any qualified public or private entity,'' 
                after ``private entities'';
            (2) in subsection (c)--
                    (A) in paragraph (1), by inserting ``or the 
                Director of the National Institute of Allergy and 
                Infectious Diseases'' after ``Director of the Center''; 
                and
                    (B) in paragraph (2), in the matter preceding 
                subparagraph (A), by striking ``subsection (i)'' and 
                inserting ``subsection (i)(1)'';
            (3) in subsection (d), by inserting ``or the Director of 
        the National Institute of Allergy and Infectious Diseases'' 
        after ``Director of the Center'';
            (4) in subsection (e)--
                    (A) in paragraph (1)--
                            (i) in the matter preceding subparagraph 
                        (A), by inserting ``or the Director of the 
                        National Institute of Allergy and Infectious 
                        Diseases'' after ``Director of the Center'';
                            (ii) in subparagraph (A), by inserting 
                        ``(or, in the case of the Institute, 75 
                        percent)'' after ``50 percent''; and
                            (iii) in subparagraph (B), by inserting 
                        ``(or, in the case of the Institute, 75 
                        percent)'' after ``40 percent'';
                    (B) in paragraph (2), by inserting ``or the 
                Director of the National Institute of Allergy and 
                Infectious Diseases'' after ``Director of the Center''; 
                and
                    (C) in paragraph (4), by inserting ``of the Center 
                or the Director of the National Institute of Allergy 
                and Infectious Diseases'' after ``Director'';
            (5) in subsection (f)--
                    (A) in paragraph (1), by inserting ``in the case of 
                an award by the Director of the Center,'' before ``the 
                applicant''; and
                    (B) in paragraph (2), by inserting ``of the Center 
                or the Director of the National Institute of Allergy 
                and Infectious Diseases'' after ``Director''; and
            (6) in subsection (i)--
                    (A) by striking ``Appropriations.--For the purpose 
                of carrying out this section,'' and inserting the 
                following: ``Appropriations.--
            ``(1) Center.--For the purpose of carrying out this section 
        with respect to the Center,''; and
                    (B) by adding at the end the following:
            ``(2) National institute of allergy and infectious 
        diseases.--For the purpose of carrying out this section with 
        respect to the National Institute of Allergy and Infectious 
        Diseases, there are authorized to be appropriated such sums as 
        may be necessary for each of the fiscal years 2003 and 2004.''.
    (c) Additional Authority.--Section 319F of the Public Health 
Service Act (42 U.S.C. 247d-6) is amended--
            (1) by redesignating subsections (i) and (j) as subsections 
        (j) and (k), respectively; and
            (2) by inserting after subsection (h) the following 
        subsection:
    ``(i) Priority Countermeasures for Strategic National Stockpile.--
            ``(1) In general.--The Secretary, taking into consideration 
        any recommendations of the working group under subsection (a), 
        may initiate and sustain a program that results in the delivery 
        of priority countermeasures for placement in the stockpile 
        under section 319F-2.
            ``(2) Authorization of appropriations.--For the purpose of 
        carrying out paragraph (1), there are authorized to be 
        appropriated such sums as may be necessary for each of the 
        fiscal years 2004 through 2013.''.
    (d) 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 through 2013.''; 
        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 through 2013.''.
    (e) 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''.
    (f) Rule of Construction.--Nothing in this section has any legal 
effect on sections 302(2), 302(4), 304(a), or 304(b) of the Homeland 
Security Act of 2002.

SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

    (a) Additional Authority Regarding Strategic National Stockpile.--
            (1) Transfer of program.--Section 121 of the Public Health 
        Security and Bioterrorism Preparedness and Response Act of 2002 
        (116 Stat. 611; 42 U.S.C. 300hh-12) is transferred from such 
        Act to the Public Health Service Act, is redesignated as 
        section 319F-2, and is inserted after section 319F-1 of the 
        Public Health Service Act (as added by section 2 of this Act).
            (2) Additional authority.--Section 319F-2 of the Public 
        Health Service Act, as added by paragraph (1), is amended to 
        read as follows:

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

    ``(a) Strategic National Stockpile.--
            ``(1) In general.--The Secretary of Homeland Security 
        (referred to in this section as the `Homeland Security 
        Secretary'), in coordination with the Secretary and the 
        Secretary of Veterans Affairs, shall maintain a stockpile or 
        stockpiles of drugs, vaccines and other biological products, 
        medical devices, and other supplies in such numbers, types, and 
        amounts as are determined by the Secretary to be appropriate 
        and practicable, taking into account other available sources, 
        to provide for the emergency health security of the United 
        States, including the emergency health security of children and 
        other vulnerable populations, in the event of a bioterrorist 
        attack or other public health emergency.
            ``(2) Procedures.--The Secretary, in managing the stockpile 
        under paragraph (1), shall--
                    ``(A) consult with the working group under section 
                319F(a);
                    ``(B) ensure that adequate procedures are followed 
                with respect to such stockpile for inventory management 
                and accounting, and for the physical security of the 
                stockpile;
                    ``(C) in consultation with Federal, State, and 
                local officials, take into consideration the timing and 
                location of special events;
                    ``(D) review and revise, as appropriate, the 
                contents of the stockpile on a regular basis to ensure 
                that emerging threats, advanced technologies, and new 
                countermeasures are adequately considered;
                    ``(E) devise plans for the effective and timely 
                supply-chain management of the stockpile, in 
                consultation with appropriate Federal, State and local 
                agencies, and the public and private health care 
                infrastructure; and
                    ``(F) 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 priority countermeasure (as defined in section 
                319F(h) and as determined by the Secretary in 
                accordance with such section and consistent with 
                sections 302(2) and 304(a) of the Homeland Security Act 
                of 2002) that--
                            ``(i)(I) is against a chemical, biological, 
                        radiological, or nuclear agent identified as a 
                        material threat under paragraph (2)(A)(ii);
                            ``(II) is determined 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, for use as a countermeasure to a 
                        chemical, biological, radiological, or nuclear 
                        agent identified as a material threat under 
                        paragraph (2)(A)(ii); or
                            ``(bb) is a priority 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 after 
                        the date of a determination under paragraph 
                        (5); or
                            ``(ii) is authorized under section 564 of 
                        the Federal Food, Drug, and Cosmetic Act for 
                        emergency use.
            ``(2) Determination of material threats.--
                    ``(A) Material threat.--The Homeland Security 
                Secretary, in consultation with 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.
                    ``(B) Public health impact; necessary 
                countermeasures.--The Secretary shall on an ongoing 
                basis--
                            ``(i) assess the potential public health 
                        consequences of use against the United States 
                        population of agents identified under 
                        subparagraph (A)(ii); and
                            ``(ii) determine, on the basis of such 
                        assessment, the agents for which priority 
                        countermeasures are necessary to protect the 
                        public health from a material threat.
                    ``(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). Such notice shall 
                be in unclassified or, if necessary, classified form.
                    ``(D) Assuring access to threat information.--In 
                making the assessment and determination required under 
                subparagraph (A), the Homeland Security Secretary shall 
                use all information to which such Secretary is entitled 
                under section 202 of the Homeland Security Act of 2002, 
                including but not limited to information, regardless of 
                its level of classification, relating to current and 
                emerging threats of chemical, biological, radiological, 
                and nuclear agents.
            ``(3) Assessment of availability and appropriateness of 
        countermeasures.--The Secretary, in consultation with the 
        Homeland Security Secretary, shall assess on an ongoing basis 
        the availability and appropriateness of specific 
        countermeasures to address specific threats identified under 
        paragraph (2).
            ``(4) Call for development of countermeasures; commitment 
        for recommendation for procurement.--
                    ``(A) Proposal to the president.--If, pursuant to 
                an assessment under paragraph (3), the Homeland 
                Security Secretary and the Secretary make a 
                determination that a countermeasure would be 
                appropriate but is either currently unavailable for 
                procurement as a security countermeasure or is 
                approved, licensed, or cleared only for alternative 
                uses, such Secretaries may jointly submit to the 
                President a proposal to--
                            ``(i) issue a call for the development of 
                        such countermeasure; and
                            ``(ii) make a commitment that, upon the 
                        first development of such countermeasure that 
                        meets the conditions for procurement under 
                        paragraph (5), the Secretaries will, based in 
                        part on information obtained pursuant to such 
                        call, make a recommendation under paragraph (6) 
                        that the special reserve fund under paragraph 
                        (10) be made available for the procurement of 
                        such countermeasure.
                    ``(B) Countermeasure specifications.--The Homeland 
                Security Secretary and the Secretary shall, to the 
                extent practicable, include in the proposal under 
                subparagraph (A)--
                            ``(i) estimated quantity of purchase (in 
                        the form of number of doses or number of 
                        effective courses of treatments regardless of 
                        dosage form);
                            ``(ii) necessary measures of minimum safety 
                        and effectiveness;
                            ``(iii) estimated price for each dose or 
                        effective course of treatment regardless of 
                        dosage form; and
                            ``(iv) other information that may be 
                        necessary to encourage and facilitate research, 
                        development, and manufacture of the 
                        countermeasure or to provide specifications for 
                        the countermeasure.
                    ``(C) Presidential approval.--If the President 
                approves a proposal under subparagraph (A), the 
                Homeland Security Secretary and the Secretary shall 
                make known to persons who may respond to a call for the 
                countermeasure involved--
                            ``(i) the call for the countermeasure;
                            ``(ii) specifications for the 
                        countermeasure under subparagraph (B); and
                            ``(iii) the commitment described in 
                        subparagraph (A)(ii).
            ``(5) Secretary's determination of countermeasures 
        appropriate for funding from special reserve fund.--
                    ``(A) In general.--The Secretary, in accordance 
                with the provisions of this paragraph, shall identify 
                specific security countermeasures that the Secretary 
                determines, in consultation with the Homeland Security 
                Secretary, to be appropriate for inclusion in the 
                stockpile under subsection (a) pursuant to procurements 
                made with amounts in the special reserve fund under 
                paragraph (10) (referred to in this subsection 
                individually as a `procurement under this subsection').
                    ``(B) Requirements.--In making a determination 
                under subparagraph (A) with respect to a security 
                countermeasure, the Secretary shall determine and 
                consider the following:
                            ``(i) The quantities of the product that 
                        will be needed to meet the needs of the 
                        stockpile.
                            ``(ii) The feasibility of production and 
                        delivery within five 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 identification of the potential 
                supplier or suppliers of such countermeasure, and 
                whether other potential suppliers of the same or 
                similar countermeasures were considered and rejected 
                for procurement under this section and the reasons 
                therefor.
                    ``(D) Subsequent specific countermeasures.--
                Procurement under this subsection of a security 
                countermeasure for a particular purpose does not 
                preclude the subsequent procurement under this 
                subsection of any other security countermeasure for 
                such purpose if the Secretary has determined under 
                paragraph (5)(A) that such countermeasure is 
                appropriate for inclusion in the stockpile and if, as 
                determined by the Secretary, such countermeasure 
                provides improved safety or effectiveness, or for other 
                reasons enhances preparedness to respond to threats of 
                use of a biological, chemical, radiological, or nuclear 
                agent. Such a determination by the Secretary is 
                committed to agency discretion.
                    ``(E) Rule of construction.--Recommendations and 
                approvals under this paragraph apply solely to 
                determinations that the special reserve fund under 
                paragraph (10) will be made available for a procurement 
                of a security countermeasure, and not to the substance 
                of contracts for such procurement or other matters 
                relating to awards of such contracts.
            ``(7) Procurement.--
                    ``(A) In general.--For purposes of a procurement 
                under this subsection that is approved by the President 
                under paragraph (6), the Homeland Security Secretary 
                and the Secretary shall have responsibilities in 
                accordance with subparagraphs (B) and (C).
                    ``(B) Interagency agreements.--
                            ``(i) For procurement.--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 the Secretary's costs of such 
                        procurement, other than as provided in clause 
                        (ii).
                            ``(ii) For administrative costs.--The 
                        agreement entered into between the Homeland 
                        Security Secretary and the Secretary for 
                        managing the stockpile under subsection (a) 
                        shall provide for reimbursement of the 
                        Secretary's administrative costs relating to 
                        procurements under this subsection.
                    ``(C) Procurement.--
                            ``(i) In general.--The Secretary shall be 
                        responsible for--
                                    ``(I) arranging for procurement of 
                                a security countermeasure, including 
                                negotiating terms (including quantity, 
                                production schedule, and price) of, and 
                                entering into, contracts and 
                                cooperative agreements, and for 
                                carrying out such other activities as 
                                may reasonably be required, in 
                                accordance with the provisions of this 
                                subparagraph; and
                                    ``(II) promulgating such 
                                regulations as the Secretary determines 
                                necessary to implement the provisions 
                                of this subsection.
                            ``(ii) Contract terms.--A contract for 
                        procurements under this subsection shall (or, 
                        as specified below, may) include the following 
                        terms:
                                    ``(I) Payment conditioned on 
                                substantial delivery.--The contract 
                                shall provide that no payment may be 
                                made until delivery has been made of a 
                                substantial portion (as determined by 
                                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 under the contract, except in 
                                special circumstances as determined by 
                                the Secretary on a contract by contract 
                                basis. Nothing in this subclause may be 
                                construed as affecting rights of 
                                vendors under provisions of law or 
                                regulation (including the Federal 
                                Acquisition Regulation) relating to 
                                termination of contracts for the 
                                convenience of the Government.
                                    ``(II) 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.
                                    ``(III) 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.
                                    ``(IV) Non-stockpile transfers of 
                                security countermeasures.--The contract 
                                shall provide that the vendor will 
                                comply with all applicable export-
                                related controls with respect to such 
                                countermeasure.
                            ``(iii) Availability of simplified 
                        acquisition procedures.--
                                    ``(I) In general.--If the Secretary 
                                determines that there is a pressing 
                                need for a procurement of a specific 
                                countermeasure, the amount of the 
                                procurement under this subsection shall 
                                be deemed to be below the threshold 
                                amount specified in section 4(11) of 
                                the Office of Federal Procurement 
                                Policy Act (41 U.S.C. 403(11)), for 
                                purposes of application to such 
                                procurement, pursuant to section 
                                302A(a) of the Federal Property and 
                                Administrative Services Act of 1949 (41 
                                U.S.C. 252a(a)), of--
                                            ``(aa) section 303(g)(1)(A) 
                                        of the Federal Property and 
                                        Administrative Services Act of 
                                        1949 (41 U.S.C. 253(g)(1)(A)) 
                                        and its implementing 
                                        regulations; and
                                            ``(bb) section 302A(b) of 
                                        such Act (41 U.S.C. 252a(b)) 
                                        and its implementing 
                                        regulations.
                                    ``(II) Application of certain 
                                provisions.--Notwithstanding subclause 
                                (I) and the provision of law and 
                                regulations referred to in such clause, 
                                each of the following provisions shall 
                                apply to procurements described in this 
                                clause to the same extent that such 
                                provisions would apply to such 
                                procurements in the absence of 
                                subclause (I):
                                            ``(aa) Chapter 37 of title 
                                        40, United States Code 
                                        (relating to contract work 
                                        hours and safety standards).
                                            ``(bb) Subsections (a) and 
                                        (b) of section 7 of the Anti-
                                        Kickback Act of 1986 (41 U.S.C. 
                                        57(a) and (b)).
                                            ``(cc) Section 304C of the 
                                        Federal Property and 
                                        Administrative Services Act of 
                                        1949 (41 U.S.C. 254d) (relating 
                                        to the --- examination of 
                                        contractor records).
                            ``(iv) Procedures other than full and open 
                        competition.--
                                    ``(I) In general.--In using the 
                                authority provided in section 303(c)(1) 
                                of title III of the Federal Property 
                                and Administrative Services Act of 1949 
                                (41 U.S.C. 253(c)(1)) to use procedures 
                                other than competitive procedures in 
                                the case of a procurement under this 
                                subsection, the phrase `available from 
                                only one responsible source' in such 
                                section 303(c)(1) shall be deemed to 
                                mean `available from only one 
                                responsible source or only from a 
                                limited number of responsible sources'.
                                    ``(II) Relation to other 
                                authorities.--The authority under 
                                subclause (I) is in addition to any 
                                other authority to use procedures other 
                                than competitive procedures.
                                    ``(III) Applicable government-wide 
                                regulations.--The Secretary shall 
                                implement this clause in accordance 
                                with applicable government-wide 
                                regulations, 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.
                            ``(v) Premium provision in multiple award 
                        contracts.--
                                    ``(I) In general.--If, under this 
                                subsection, the Secretary enters into 
                                contracts with more than one vendor to 
                                procure a security countermeasure, such 
                                Secretary may, notwithstanding any 
                                other provision of law, include in each 
                                of such contracts a provision that--
                                            ``(aa) identifies an 
                                        increment of the total quantity 
                                        of security countermeasure 
                                        required, whether by percentage 
                                        or by numbers of units; and
                                            ``(bb) promises to pay one 
                                        or more specified premiums 
                                        based on the priority of such 
                                        vendors' production and 
                                        delivery of the increment 
                                        identified under item (aa), in 
                                        accordance with the terms and 
                                        conditions of the contract.
                                    ``(II) Determination of 
                                government's requirement not 
                                reviewable.--If the Secretary includes 
                                in each of a set of contracts a 
                                provision as described in subclause 
                                (I), such Secretary's determination of 
                                the total quantity of security 
                                countermeasure required, and any 
                                amendment of such determination, is 
                                committed to agency discretion.
                            ``(vi) Extension of closing date for 
                        receipt of proposals not reviewable.--A 
                        decision by the Secretary to extend the closing 
                        date for receipt of proposals for a procurement 
                        under this subsection is committed to agency 
                        discretion.
                            ``(vii) Limiting competition to sources 
                        responding to request for information.--In 
                        conducting a procurement under this subsection, 
                        the Secretary may exclude a source that has not 
                        responded to a request for information under 
                        section 303A(a)(1)(B) of the Federal Property 
                        and Administrative Services Act of 1949 (41 
                        U.S.C. 253a(a)(1)(B)) if such request has given 
                        notice that the Secretary may so exclude such a 
                        source.
            ``(8) Interagency cooperation.--
                    ``(A) In general.--In carrying out activities under 
                this section, the Homeland Security Secretary and the 
                Secretary are authorized, subject to subparagraph (B), 
                to enter into interagency agreements and other 
                collaborative undertakings with other agencies of the 
                United States Government.
                    ``(B) Limitation.--An agreement or undertaking 
                under this paragraph shall not authorize another agency 
                to exercise the authorities provided by this section to 
                the Homeland Security Secretary or to the Secretary.
            ``(9) Restrictions on use of funds.--Amounts in the special 
        reserve fund under paragraph (10) shall not be used to pay--
                    ``(A) costs for the purchase of vaccines under 
                procurement contracts entered into before the date of 
                the enactment of the Project BioShield Act of 2003; or
                    ``(B) administrative costs.
            ``(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 Committee on 
                        Health, Education, Labor, and Pensions, the 
                        Committee on Appropriations, and the Committee 
                        on Government Affairs.
    ``(d) Disclosures.--No Federal agency shall disclose under section 
552 of title 5, United States Code, any information identifying the 
location at which materials in the stockpile under subsection (a) are 
stored.
    ``(e) Definition.--For purposes of subsection (a), the term 
`stockpile' includes--
            ``(1) a physical accumulation (at one or more locations) of 
        the supplies described in subsection (a); or
            ``(2) a contractual agreement between the Secretary and a 
        vendor or vendors under which such vendor or vendors agree to 
        provide to such Secretary supplies described in subsection (a).
    ``(f) Authorization of Appropriations.--
            ``(1) Strategic national stockpile.--For the purpose of 
        carrying out subsection (a), there are authorized to be 
        appropriated $640,000,000 for fiscal year 2002, and such sums 
        as may be necessary for each of fiscal years 2003 through 2006. 
        Such authorization is in addition to amounts in the special 
        reserve fund under subsection (c)(10).
            ``(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) Amendment 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 by adding at the end the following:

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

    ``(a) Authorization of Appropriations.--For the procurement of 
security countermeasures under section 319F-2(c) of the Public Health 
Service Act (referred to in this section as the `security 
countermeasures program'), there is authorized to be appropriated up to 
$5,593,000,000 for the fiscal years 2004 through 2013. Of the amounts 
appropriated under the preceding sentence, not to exceed $3,418,000,000 
may be obligated during the fiscal years 2004 through 2008, of which 
not to exceed $890,000,000 may be obligated during fiscal year 2004.
    ``(b) Special Reserve Fund.--For purposes of the security 
countermeasures program, the term `special reserve fund' means the 
appropriations account established as a result of any appropriations 
made under subsection (a).
    ``(c) Availability.--
            ``(1) Integrity of special reserve fund; limitation of 
        obligational authority to fund purposes; intent of congress 
        against reprogramming.--Subject to paragraph (2), all amounts 
        appropriated under subsection (a) are available for obligation 
        through the end of fiscal year 2013 and only for the specific 
        purposes set forth in the security countermeasures program. It 
        is the intent of the Congress that no portion of such amount 
        that remains unobligated for such purposes shall be applied, 
        through reprogramming or otherwise, to any other purpose.
            ``(2) Initial availability for particular procurements.--
        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 $5,000,000 for fiscal 
        year 2003, and such sums as may be necessary for each of the 
        fiscal years 2004 through 2006, for the hiring of professional 
        personnel within the Directorate for Information Analysis and 
        Infrastructure Protection, who shall be analysts responsible 
        for chemical, biological, radiological, and nuclear threat 
        assessment (including but not limited to analysis of chemical, 
        biological, radiological, and nuclear agents, the means by 
        which such agents could be weaponized or used in a terrorist 
        attack, and the capabilities, plans, and intentions of 
        terrorists and other non-state actors who may have or acquire 
        such agents). All such analysts shall meet the applicable 
        standards and qualifications for the performance of 
        intelligence activities promulgated by the Director of Central 
        Intelligence pursuant to section 104 of the National Security 
        Act of 1947.
            ``(2) Intelligence sharing infrastructure.--For the purpose 
        of carrying out the acquisition and deployment of secure 
        facilities (including information technology and physical 
        infrastructure, whether mobile and temporary, or permanent) 
        sufficient to permit the Secretary to receive, not later than 
        December 31, 2003, 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 2003 through 2006.''.

SEC. 4. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the 
following section:

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

    ``(a) In General.--
            ``(1) Emergency uses.--Notwithstanding sections 505, 
        510(k), and 515 of this Act and section 351 of the Public 
        Health Service Act, and subject to the provisions of this 
        section, the Secretary may authorize the introduction into 
        interstate commerce, during the effective period of a 
        declaration under subsection (b), of a drug, device, or 
        biological product intended for use in an actual or potential 
        emergency (referred to in this section as an `emergency use').
            ``(2) Approval status of product.--An authorization under 
        paragraph (1) may authorize an emergency use of a product 
        that--
                    ``(A) is not approved, licensed, or cleared for 
                commercial distribution under a provision of law 
                referred to in such paragraph (referred to in this 
                section as an `unapproved product'); or
                    ``(B) is approved, licensed, or cleared under such 
                a provision, but which use is not under such provision 
                an approved, licensed, or cleared use of the product 
                (referred to in this section as an `unapproved use of 
                an approved product').
            ``(3) Relation to other uses.--An emergency use authorized 
        under paragraph (1) for a product is in addition to any other 
        use that is authorized for the product under a provision of law 
        referred to in such paragraph.
            ``(4) Definitions.--For purposes of this section:
                    ``(A) The term `biological product' has the meaning 
                given such term in section 351 of the Public Health 
                Service Act.
                    ``(B) The term `emergency use' has the meaning 
                indicated for such term in paragraph (1).
                    ``(C) The term `product' means a drug, device, or 
                biological product.
                    ``(D) The term `unapproved product' has the meaning 
                indicated for such term in paragraph (2)(A).
                    ``(E) The term `unapproved use of an approved 
                product' has the meaning indicated for such term in 
                paragraph (2)(B).
    ``(b) Declaration of Emergency.--
            ``(1) In general.--The Secretary may declare an emergency 
        justifying the authorization under this subsection for a 
        product on the basis of--
                    ``(A) a determination by the Secretary of Homeland 
                Security that there is a national emergency, or a 
                significant potential for a national 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 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, affecting national security and involving 
                a specified biological, chemical, radiological, or 
                nuclear agent or agents, or a specified disease or 
                condition that may be attributable to such agent or 
                agents.
            ``(2) Termination of declaration.--
                    ``(A) In general.--A declaration under this 
                subsection shall terminate upon the earlier of--
                            ``(i) a determination by the Secretary, in 
                        consultation as appropriate with the Secretary 
                        of Homeland Security or the Secretary of 
                        Defense, that the circumstances described in 
                        paragraph (1) have ceased to exist; or
                            ``(ii) the expiration of the one-year 
                        period beginning on the date on which the 
                        declaration is made.
                    ``(B) Renewal.--Notwithstanding subparagraph (A), 
                the Secretary may renew a declaration under this 
                subsection, and this paragraph shall apply to any such 
                renewal.
            ``(3) Advance notice of termination.--In terminating a 
        declaration under this section, the Secretary shall provide 
        advance notice that the declaration 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 shipments of the 
                product, including the return of such shipments to the 
                manufacturer (in the case of a manufacturer that 
                chooses to have the shipments returned); and
                    ``(B) in the case of unapproved uses of approved 
                products, a sufficient period for the disposition of 
                any labeling that was provided with respect to the 
                emergency use involved.
            ``(4) Publication.--The Secretary shall promptly publish in 
        the Federal Register each declaration, determination, 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 detecting, 
                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 or approved under 
                        this Act or the Public Health Service Act, for 
                        detecting, diagnosing, treating, or preventing 
                        such a disease or condition caused by such an 
                        agent; and
                    ``(B) the known and potential benefits of the 
                product, when used to detect, 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 detecting, 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.--
            ``(1) In general.--An authorization of a product under this 
        section shall state--
                    ``(A) each disease or condition that the product 
                may be used to detect, diagnose, prevent, or treat 
                within the scope of the authorization;
                    ``(B) the Secretary's conclusions, made under 
                subsection (c)(2)(B), that the known and potential 
                benefits of the product, when used to detect, diagnose, 
                prevent, or treat such disease or condition, outweigh 
                the known and potential risks of the product; and
                    ``(C) the Secretary's conclusions, made under 
                subsection (c), concerning the safety and potential 
                effectiveness of the product in detecting, diagnosing, 
                preventing, or treating such diseases or conditions, 
                including an assessment of the available scientific 
                evidence.
            ``(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.
    ``(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 feasible given the circumstances of the 
                emergency, shall, for persons who choose to carry out 
                one or more activities 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, to the extent feasible given the 
                        circumstances of the emergency, 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, to the extent feasible given the 
                        circumstances of the emergency, individuals to 
                        whom the product is administered are informed--
                                    ``(I) that the Secretary has 
                                authorized the emergency use of the 
                                product;
                                    ``(II) of the significant known and 
                                potential benefits and risks of such 
                                use, and of the extent to which such 
                                benefits and risks are unknown; and
                                    ``(III) of the option to accept or 
                                refuse administration of the product, 
                                of the consequences, if any, of 
                                refusing administration of the product, 
                                and of the alternatives to the product 
                                that are available and of their 
                                benefits and risks.
                            ``(iii) Appropriate conditions for the 
                        monitoring and reporting of adverse events 
                        associated with the emergency use of the 
                        product.
                            ``(iv) For manufacturers of the product, 
                        appropriate conditions concerning recordkeeping 
                        and reporting, including records access by the 
                        Secretary, with respect to the emergency use of 
                        the product.
                    ``(B) Authority for additional conditions.--With 
                respect to the emergency use of an unapproved product, 
                the Secretary, to the extent feasible given the 
                circumstances of the emergency, may, for persons who 
                choose to carry out one or more activities 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) 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.
                            ``(iv) With respect to the emergency use of 
                        the product, waive or limit, to the extent 
                        appropriate given the circumstances of the 
                        emergency, conditions 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 in section 501.
            ``(2) Unapproved use.--With respect to the emergency use of 
        a product that is an unapproved use of an approved product:
                    ``(A) The Secretary may, for manufacturers of the 
                product who choose to carry out one or more activities 
                for which the authorization is issued, establish any of 
                the conditions described in clauses (i) through (iv) of 
                paragraph (1)(A).
                    ``(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), an authorization under this section regarding the 
                emergency use may, for persons who do not manufacture 
                the product and who choose to act under this clause, 
                authorize such persons to provide information on the 
                product in addition to the labeling provided by the 
                manufacturer, subject to compliance with clause (i). 
                Such additional information shall not be considered 
                labeling for purposes of section 502.
    ``(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 for continued use 
        with respect to patients to whom it was administered during the 
        period described by paragraph (1), to the extent found 
        necessary by such patients' attending physicians.
    ``(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, in the Secretary's 
        unreviewable discretion, the criteria under subsection (c) for 
        issuance of such authorization are no longer met.
    ``(h) Publication.--The Secretary shall promptly publish in the 
Federal Register a notice of each authorization, and each termination 
or revocation of an authorization, and an explanation of the reasons 
therefor, under this section.
    ``(i) Actions Committed to Agency Discretion.--Actions under the 
authority of this section by the Secretary, by the Secretary of 
Defense, or by the Secretary of Homeland Security are committed to 
agency discretion.
    ``(j) Rules of Construction.--Nothing in this section shall be 
construed to impair or otherwise affect--
            ``(1) 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) the authority of the Secretary of Defense with 
        respect to the Department of Defense, including the armed 
        forces, under other provisions of Federal law; or
            ``(3) the authority of the Secretary under section 319F-2 
        to manage the stockpile under such section.
    ``(k) Application to Members of Armed Forces.--
            ``(1) Waiver of requirement relating to option to refuse.--
        In the case of administration of a countermeasure to members of 
        the armed forces, a requirement, under subsection 
        (e)(1)(A)(ii)(III), designed to ensure that individuals are 
        informed of an option to accept or refuse administration of a 
        product, may be waived by the President if the President 
        determines, in writing, that complying with such requirement is 
        not feasible, is contrary to the best interests of the members 
        affected, or is not in the interests of national security.
            ``(2) Provision of information to member of the armed 
        forces.--If the Secretary makes a determination that it is not 
        feasible for the information required by subsection 
        (e)(1)(A)(ii) to be provided to a member of the armed forces 
        prior to the administration of the product, such information 
        shall be provided to such member of the armed forces (or next-
        of-kin in the case of the death of a member) to whom the 
        product was administered as soon as possible, but not later 
        than 30 days, after such administration. Information concerning 
        the administration of the product shall be recorded in the 
        medical record of the member.
            ``(3) Effect on statute pertaining to investigational new 
        drugs.--In the case of an authorization based on a 
        determination by the Secretary of Defense under subsection 
        (b)(1)(B), section 1107 of title 10, United States Code, shall 
        not apply to use of a product that is the subject of such 
        authorization, within the scope of such authorization and while 
        such authorization is effective.
    ``(l) 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 --
            ``(1) shall not be subject to any requirements pursuant to 
        section 505(i) or 520(g); and
            ``(2) shall not be subject to any requirements otherwise 
        applicable to clinical investigations pursuant to other 
        provisions of this Act.
    ``(m) Discretion Regarding Use of Authorization.--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 notify 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 an activity or activities 
under the authorization. This section does not have any legal effect on 
a person who does not carry out any activity for which an authorization 
under this section is issued, or who carries out such an activity 
pursuant to other provisions of this Act or section 351 of the Public 
Health Service Act.
    ``(n) Enforcement.--A person who carries out an activity pursuant 
to an authorization under this section, but who fails to comply with 
applicable conditions under subsection (e), is with respect to that act 
of noncompliance subject to the provisions of law specified in 
subsection (a) and to the enforcement of such provisions under section 
301.''.

SEC. 5. REPORTS REGARDING AUTHORITIES UNDER THIS ACT.

    (a) Secretary of Health and Human Services.--
            (1) Annual reports on particular exercises of authority.--
                    (A) Relevant authorities.--The Secretary of Health 
                and Human Services (referred to in this subsection as 
                the ``Secretary'') shall submit reports in accordance 
                with subparagraph (B) regarding the exercise of 
                authority under the following provisions of law:
                            (i) With respect to section 319F-1 of the 
                        Public Health Service Act (as added by section 
                        2 of this Act):
                                    (I) Subsection (b)(1) (relating to 
                                increased simplified acquisition 
                                threshold).
                                    (II) Subsection (b)(2) (relating to 
                                procedures other than full and open 
                                competition).
                                    (III) Subsection (c) (relating to 
                                expedited peer review procedures).
                            (ii) With respect to section 319F-2 of the 
                        Public Health Service Act (as added by section 
                        3 of this Act):
                                    (I) Subsection (c)(7)(C)(iii) 
                                (relating to simplified acquisition 
                                procedures).
                                    (II) Subsection (c)(7)(C)(iv) 
                                (relating to procedures other than full 
                                and open competition).
                                    (III) Subsection (c)(7)(C)(v) 
                                (relating to premium provision in 
                                multiple-award contracts).
                            (iii) With respect to section 564 of the 
                        Federal Food, Drug, and Cosmetic Act (as added 
                        by section 4 of this Act):
                                    (I) Subsection (a)(1) (relating to 
                                emergency uses of certain drugs and 
                                devices).
                                    (II) Subsection (b)(1) (relating to 
                                a declaration of an emergency).
                                    (III) Subsection (e) (relating to 
                                conditions on authorization).
                    (B) Contents of reports.--The Secretary shall 
                annually submit to the designated congressional 
                committees a report that summarizes--
                            (i) the particular actions that were taken 
                        under the authorities specified in subparagraph 
                        (A), including, as applicable, the 
                        identification of the threat agent, emergency, 
                        or the biomedical countermeasure with respect 
                        to which the authority was used;
                            (ii) the reasons underlying the decision to 
                        use such authorities, including, as applicable, 
                        the options that were considered and rejected 
                        with respect to the use of such authorities;
                            (iii) the identification of each person or 
                        entity that received, or was considered and 
                        rejected for, grants, cooperative agreements, 
                        or contracts pursuant to the use of such 
                        authorities; and
                            (iv) whether, with respect to each 
                        procurement that is approved by the President 
                        under section 319F-2(c)(6) of the Public Health 
                        Service Act (as added by section 3 of this 
                        Act), a contract was entered into within one 
                        year after such approval by the President.
            (2) Annual summaries regarding certain activity.--The 
        Secretary shall annually submit to the designated congressional 
        committees a report that summarizes the activity undertaken 
        pursuant to the following authorities under section 319F-1 of 
        the Public Health Service Act (as added by section 2 of this 
        Act):
                    (A) Subsection (b)(3) (relating to increased 
                micropurchase threshold).
                    (B) Subsection (d) (relating to authority for 
                personal services contracts).
                    (C) Subsection (e) (relating to streamlined 
                personnel authority).
        With respect to subparagraph (B), the report shall include a 
        provision specifying, for the one-year period for which the 
        report is submitted, the number of persons who were paid 
        amounts greater than $100,000 and the number of persons who 
        were paid amounts between $50,000 and $100,000.
    (b) National Academy of Sciences Review.--
            (1) In general.--Not later than four years after the date 
        of the enactment of this Act, the Secretary of Health and Human 
        Services shall request the National Academy of Sciences to 
        enter into an agreement for a review of the biomedical 
        countermeasure research and development authorities established 
        in this Act to determine whether and to what extent activities 
        undertaken pursuant to such authorities have enhanced the 
        development of biomedical countermeasures affecting national 
        security, and to recommend any legislative or administrative 
        changes necessary to improve the ability of the Secretary to 
        carry out these activities in the future. The Secretary shall 
        ensure that the results of the study are submitted to the 
        designated congressional committees not later than five years 
        after such date of enactment.
            (2) Certain contents.--The report under paragraph (1) shall 
        include--
                    (A) a summary of the most recent analysis by the 
                Department of Homeland Security and the intelligence 
                community of the domestic threat from chemical, 
                biological, radiological, and nuclear agents;
                    (B) the Academy's assessment of the current 
                availability of countermeasures to address such 
                threats;
                    (C) the Academy'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
                    (D)(i) the Academy'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.
    (c) General Accounting Office Review.--Four years after the date of 
the enactment of this Act, the Comptroller General of the United States 
shall initiate a study--
            (1)(A) 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
            (B) to recommend any legislative or administrative changes 
        necessary to improve the utilization or effectiveness of such 
        authorities in the future;
            (2)(A) to review the internal controls instituted by such 
        Secretary with respect to such authorities, where required by 
        this Act; and
            (B) to recommend any legislative or administrative changes 
        necessary to improve the effectiveness of such controls; and
            (3)(A) 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
            (B) to recommend any legislative or administrative changes 
        necessary to improve the utilization or effectiveness of such 
        authority and to enhance protection of the public health.
The results of the study shall be submitted to the designated 
congressional committees not later than five years after the date of 
the enactment of this Act.
    (d) Report Regarding Barriers to Procurement of Security 
Countermeasures.--
            (1) 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.
            (2) Additional barriers.--Not later than one year after the 
        date of enactment of this Act, such Secretaries shall jointly 
        report to the designated congressional committees any other 
        potential barriers to the procurement of security 
        countermeasures that have not been addressed by this Act.
    (e) Status of Program for Chemical Terrorism Preparedness.--Not 
later than 270 days after the date of the enactment of this Act, the 
Secretary of Homeland Security shall submit to the designated 
congressional committees a report describing the status of the program 
carried out by the Secretary to enhance the preparedness of the United 
States to respond to terrorist attacks involving chemical agents.
    (f) 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 Committee on Health, Education, 
        Labor, and Pensions, the Committee on Appropriations, and the 
        Committee on Government Affairs.

SEC. 6. OUTREACH.

    The Secretary of Health and Human Services shall develop outreach 
measures to ensure to the extent practicable that diverse institutions, 
including Historically Black Colleges and Universities and those 
serving large proportions of Hispanics, Native Americans, Asian-Pacific 
Americans, or other underrepresented populations, are meaningfully 
aware of available research and development grants, contracts, 
cooperative agreements, and procurements conducted under sections 2 and 
3 of this Act.

SEC. 7. RECOMMENDATION FOR EXPORT CONTROLS ON CERTAIN BIOMEDICAL 
              COUNTERMEASURES.

    Upon the award of any grant, contract, or cooperative agreement 
under section 2 or 3 of this Act for the research, development, or 
procurement of a qualified countermeasure or a security countermeasure 
(as those terms are defined in this Act), the Secretary of Health and 
Human Services shall, in consultation with the heads of other 
appropriate Federal agencies, determine whether the countermeasure 
involved in such grant, contract, or cooperative agreement is subject 
to existing export-related controls and, if not, may make a 
recommendation to the appropriate Federal agency or agencies that such 
countermeasure should be included on the list of controlled items 
subject to such controls.

SEC. 8. ENSURING COORDINATION, COOPERATION AND THE ELIMINATION OF 
              UNNECESSARY DUPLICATION IN PROGRAMS DESIGNED TO PROTECT 
              THE HOMELAND FROM BIOLOGICAL, CHEMICAL, RADIOLOGICAL, AND 
              NUCLEAR AGENTS.

    (a) Ensuring Coordination of Programs.--The Secretary of Health and 
Human Services, the Secretary of Homeland Security, and the Secretary 
of Defense shall ensure that the activities of their respective 
Departments coordinate, complement, and do not unnecessarily duplicate 
programs to identify potential domestic threats from biological, 
chemical, radiological or nuclear agents, detect domestic incidents 
involving such agents, analyze such incidents, and develop necessary 
countermeasures. The aforementioned Secretaries shall further ensure 
that information and technology possessed by the Departments relevant 
to these activities are shared with the other Departments.
    (b) Designation of Agency Coordination Officer.--The Secretary of 
Health and Human Services, the Secretary of Homeland Security, and the 
Secretary of Defense shall each designate an officer or employee of 
their respective Departments who shall coordinate, through regular 
meetings and communications, with the other aforementioned Departments 
such programs and activities carried out by their Departments.

            Passed the House of Representatives July 16, 2003.

            Attest:

                                                 JEFF TRANDAHL,

                                                                 Clerk.




                                                       Calendar No. 214

108th CONGRESS

  1st Session

                               H. R. 2122

_______________________________________________________________________

                                 AN ACT

 To enhance research, development, procurement, and use of biomedical 
countermeasures to respond to public health threats affecting national 
                   security, and for other purposes.

_______________________________________________________________________

                             July 17, 2003

            Received; read twice and placed on the calendar