[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1504 Placed on Calendar Senate (PCS)]






                                                       Calendar No. 265
108th CONGRESS
  1st Session
                                S. 1504

   To amend the Public Health Service Act to provide protections and 
countermeasures against chemical, radiological, or nuclear agents that 
may be used in a terrorist attack against the United States of America.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                July 30 (legislative day, July 21), 2003

Mr. Gregg (for himself and Mr. Kennedy) introduced the following bill; 
                     which was read the first time

                           September 2, 2003

            Read the second time and placed on the calendar

_______________________________________________________________________

                                 A BILL


 
   To amend the Public Health Service Act to provide protections and 
countermeasures against chemical, radiological, or nuclear agents that 
may be used in a terrorist attack against the United States of America.

    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 IV of the Public Health Service 
Act (42 U.S.C. 284 et seq.) is amended by adding at the end the 
following:

``SEC. 409J. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT.

    ``(a) In General.--
            ``(1) Authority.--In carrying out research responsibilities 
        under this Act, the Secretary may conduct and support research 
        and development with respect to biomedical countermeasures.
            ``(2) Implementation.--
                    ``(A) In general.--Except as provided in 
                subparagraph (C), authorities assigned by this section 
                to the Secretary shall be carried out through the 
                Director of NIH.
                    ``(B) Lead institute.--The National Institute of 
                Allergy and Infectious Diseases shall be the lead 
                institute for performing, administering, or supporting 
                biomedical countermeasure research and development. The 
                Director of NIH may delegate to the Director of the 
                Institute authorities as are necessary to carry out 
                this function.
                    ``(C) Chemical, radiological, and nuclear agents.--
                To the extent that an authority described in 
                subparagraph (A) is exercised with respect to a 
                chemical, radiological, or nuclear agent, the Secretary 
                may authorize the Director of NIH to carry out the 
                authority through any national research institute.
                    ``(D) Availability of facilities to the 
                secretary.--In any grant 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, and 
                supporting biomedical countermeasures research and 
                development, the Secretary may provide that the 
                facility that is the object of such grant or 
                cooperative agreement shall be available as needed to 
                the Secretary to respond to public health emergencies 
                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 Federal Government and to use other 
                agencies of the Department of Health and Human 
                Services.
                    ``(B) Limitation.--An agreement or undertaking 
                under this paragraph may not authorize another agency 
                to exercise the authorities provided to the Secretary 
                by this section.
    ``(b) Expedited Procurement Authority.--
            ``(1) Increased simplified acquisition threshold for 
        biomedical 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 biomedical countermeasure 
                research or development, 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 provisions of 
                law and regulations referred to in such subparagraph, 
                each of the following provisions and implementing 
                regulations shall apply to procurements described in 
                this paragraph to the same extent that such provisions 
                and regulations would apply to such procurements in 
                absence of subparagraph (A):
                            ``(i) Chapter 37 of title 40, United States 
                        Code (relating to contract work hours and 
                        safety standards).
                            ``(ii) Subsections (a) and (b) of section 7 
                        of the Anti-Kickback Act of 1986 (41 U.S.C. 
                        57(a) and (b)).
                            ``(iii) Section 304C of the Federal 
                        Property and Administrative Services Act of 
1949 (41 U.S.C. 254d) (relating to the examination of contractor 
records).
                            ``(iv) Section 3131 of title 40, United 
                        States Code (relating to bonds of contractors 
                        of public buildings or works).
                            ``(v) Section 303G of the Federal Property 
                        and Administrative Services Act of 1949 (41 
                        U.S.C. 253g) (relating to limiting 
                        subcontractor sales).
                            ``(vi) Subsection (a) of section 304 of the 
                        Federal Property and Administrative Services 
                        Act of 1949 (41 U.S.C. 254(a)) (relating to 
                        contingent fees to middlemen), other than the 
                        last sentence of such subsection.
                            ``(vii) Section 6002 of the Solid Waste 
                        Disposal Act (42 U.S.C. 6962).
                            ``(viii) Section 1354 of title 31, United 
                        States Code (relating to the limitation on the 
                        use of appropriated funds for contracts with 
                        entities not meeting veterans' employment 
                        reporting requirements).
                    ``(C) Internal controls to be instituted.--The 
                Secretary shall institute appropriate internal controls 
                for procurements made under this paragraph, including 
                requirements with respect to documenting the 
                justification for use of the authority provided in this 
                paragraph.
            ``(2) Use of noncompetitive procedures.--In addition to any 
        other authority to use procedures other than competitive 
        procedures for procurements, the Secretary may use such other 
        noncompetitive procedures when--
                    ``(A) the procurement is as described by paragraph 
                (1)(A); and
                    ``(B) the property or services needed by the 
                Secretary are available from only one responsible 
                source or only from a limited number of responsible 
                sources, and no other type of property or services will 
                meet the needs of the Secretary.
            ``(3) Increased micropurchase threshold.--
                    ``(A) In general.--For a procurement described by 
                paragraph (1)(A), 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 procurements that are made 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 Federal Government purchase card 
                method for purchases shall apply to procurements made 
                under this paragraph and that are greater than $2,500.
    ``(c) Authority To Expedite Peer Review.--The Secretary may, as the 
Secretary determines necessary to respond to pressing 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, determines 
to be appropriate to obtain an assessment of scientific and technical 
merit and likely contribution to the field of biomedical countermeasure 
research, in place of the peer review and advisory council review 
procedures that would otherwise 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--
            ``(1) that is for performing, administering, or supporting 
        biomedical countermeasure research and development; and
            ``(2) the amount of which is not greater than $1,500,000.
    ``(d) Agency Facilities.--In addition to any similar authority 
provided under any other provision of law, in carrying out this 
section, the Secretary may--
            ``(1) acquire, lease, construct, improve, renovate, 
        remodel, repair, operate, and maintain laboratories, other 
        research facilities and equipment, and other real or personal 
        property as the Secretary determines necessary for the purpose 
        of performing, administering, and supporting biomedical 
        countermeasure research and development; and
            ``(2) acquire, without regard to section 8141 of title 40, 
        United States Code, by lease or otherwise, through the 
        Administrator of General Services, buildings or parts of 
        buildings in the District of Columbia.
    ``(e) Authority for Personal Services Contracts.--
            ``(1) In general.--For the purpose of performing, 
        administering, and supporting biomedical countermeasure 
        research and development, the Secretary may, as the Secretary 
        determines necessary to respond to pressing 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.
            ``(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 for any act or omission within the scope of the Federal 
Tort Claims Act.
                    ``(C) Recourse in case of gross misconduct or 
                contract violation.--
                            ``(i) In general.--Should payment be made 
                        by the United States to any claimant bringing a 
                        claim under this paragraph, either by way of 
                        administrative determination, settlement, or 
                        court judgment, the United States shall have, 
                        notwithstanding any provision of State law, the 
                        right to recover for that portion of the 
                        damages so awarded or paid, as well as interest 
                        and any costs of litigation, resulting from the 
                        failure of any person, officer, employee, or 
                        governing board member to carry out any 
                        obligation or responsibility assumed by such 
                        person, officer, employee, or governing board 
                        member under a contract with the United States 
                        or from any grossly negligent, reckless, or 
                        illegal conduct or willful misconduct on the 
                        part of such person, officer, employee, or 
                        governing board member.
                            ``(ii) Venue.--The United States may 
                        maintain an action under this subparagraph 
                        against such person, officer, employee, or 
                        governing board member in the district court of 
                        the United States in which such person, 
                        officer, employee, or governing board member 
                        resides or has its principal place of business.
            ``(3) Internal controls to be instituted.--
                    ``(A) In general.--The Secretary shall institute 
                appropriate internal controls for contracts under this 
                subsection, including procedures for the Secretary to 
                make a determination of whether a person, or an 
                officer, employee, or governing board member of a 
                person, is deemed to be an employee of the Department 
                of Health and Human Services pursuant to paragraph (2).
                    ``(B) Determination of employee status to be 
                final.--A determination by the Secretary under 
                subparagraph (A) that a person, or an officer, 
                employee, or governing board member of a person, is or 
                is not deemed to be an employee of the Department of 
                Health and Human Services shall be final and binding on 
                the Secretary and the Attorney General and other 
                parties to any civil action or proceeding.
            ``(4) Number of personal services contracts limited.--The 
        number of experts and consultants whose personal services are 
        obtained under paragraph (1) shall not exceed 30 at any time.
    ``(f) 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 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 
        biomedical countermeasure research and development in carrying 
        out this section.
            ``(2) Consistency with certain provisions of title 5.--The 
        authority provided for under paragraph (1) shall be exercised 
        in a manner that is consistent with--
                    ``(A) chapter 23 of title 5, United States Code 
                (relating to merit system principles and prohibited 
                personnel practices); and
                    ``(B) the provisions of title 5, United States 
                Code, relating to preference eligibles.
            ``(3) Internal controls to be instituted.--The Secretary 
        shall institute appropriate internal controls for appointments 
        under this subsection.
    ``(g) Definition.--As used in this section, the term `biomedical 
countermeasure' means a drug (as that term is defined by section 
201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(g)(1))), biological product (as that term is defined by section 
351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is 
defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(h))) that is used--
            ``(1) to treat, identify, or prevent harm from any 
        biological, chemical, radiological, or nuclear agent that may 
        cause a public health emergency affecting national security; or
            ``(2) to treat, identify, or prevent harm from a condition 
        that may result in adverse health consequences or death and may 
        be caused by administering a drug, biological product, or 
        device that is used as described in paragraph (1).
    ``(h) Actions Committed to Agency Discretion.--Actions by the 
Secretary under the authority of this section are committed to agency 
discretion.''.
    (b) Technical Amendment.--Section 481A of the Public Health Service 
Act (42 U.S.C. 287a-2) is amended--
            (1) in subsection (a)(1), by inserting ``or the Director of 
        the National Institute of Allergy and Infectious Diseases'' 
        after ``Director of the Center'';
            (2) in subsection (c)--
                    (A) in paragraph (1), by inserting ``or the 
                Director of the National Institute of Allergy and 
                Infectious Diseases'' after ``Director of the Center''; 
                and
                    (B) in paragraph (2), in the matter preceding 
                subparagraph (A), by striking ``subsection (i)'' and 
                inserting ``subsection (i)(1)'';
            (3) in subsection (d), by inserting ``or the Director of 
        the National Institute of Allergy and Infectious Diseases'' 
        after ``Director of the Center'';
            (4) in subsection (e)--
                    (A) in paragraph (1)--
                            (i) in the matter preceding subparagraph 
                        (A), by inserting ``or the Director of the 
                        National Institute of Allergy and Infectious 
                        Diseases'' after ``Director of the Center'';
                            (ii) in subparagraph (A), by inserting 
                        ``(or, in the case of the Institute, 75 
                        percent)'' after ``50 percent''; and
                            (iii) in subparagraph (B), by inserting 
                        ``(or, in the case of the Institute, 75 
                        percent)'' after ``40 percent'';
                    (B) in paragraph (2), by inserting ``or the 
                Director of the National Institute of Allergy and 
                Infectious Diseases'' after ``Director of the Center''; 
                and
                    (C) in paragraph (4), by inserting ``of the Center 
                or the Director of the National Institute of Allergy 
                and Infectious Diseases'' after ``Director''; and
            (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''.

 SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

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

``SEC. 319A-1. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

    ``(a) Determination of Material Threats.--
            ``(1) Risk of use.--The Secretary of Homeland Security, in 
        consultation with the heads of other agencies as appropriate, 
        shall on an ongoing basis--
                    ``(A) assess current and emerging threats of use of 
                chemical, biological, radiological, and nuclear agents; 
                and
                    ``(B) determine which of such agents present a 
                material risk of use against the United States 
                population.
            ``(2) Public health impact.--The Secretary, in consultation 
        with the Secretary of Homeland Security, shall on an ongoing 
        basis--
                    ``(A) assess the potential public health 
                consequences of use against the United States 
                population of agents identified under paragraph (1)(B); 
                and
                    ``(B) determine, on the basis of such assessment, 
                the agents for which countermeasures are necessary to 
                protect the public health.
    ``(b) Assessment of Availability and Appropriateness of 
Countermeasures.--The Secretary, in consultation with the Secretary of 
Homeland Security, shall assess on an ongoing basis the availability 
and appropriateness of specific countermeasures to address specific 
threats identified under subsection (a).
    ``(c) Call for Necessary Countermeasures; Commitment for 
Recommendation for Procurement.--
            ``(1) Proposal to the president.--Based on a determination 
        of necessary countermeasures under subsection (a), and the 
        assessment of availability and appropriateness of 
        countermeasures under subsection (b), the Secretary of Homeland 
        Security and the Secretary may jointly submit to the President 
        a proposal to--
                    ``(A) call for a necessary countermeasure that is 
                not available; and
                    ``(B) commit to make a recommendation for 
                procurement under subsection (e) of the first such 
                specific countermeasure that meets the conditions for 
                procurement under subsection (d).
            ``(2) Countermeasure specifications.--The Secretary of 
        Homeland Security and the Secretary shall, to the extent 
        practicable, include in the recommendation under paragraph 
        (1)--
                    ``(A) estimated quantity of purchase (in the form 
                of number of doses or number of effective courses of 
                treatments regardless of dosage form);
                    ``(B) necessary measures of minimum safety and 
                effectiveness;
                    ``(C) estimated price for each dose or effective 
                course of treatment regardless of dosage form; and
                    ``(D) other information that may be necessary to 
                encourage and facilitate research, development, and 
                manufacture of the countermeasure or to provide 
                specifications for the countermeasure.
            ``(3) Presidential approval.--If the President has approved 
        a request under paragraph (1), the Secretary of Homeland 
        Security and the Secretary shall make known to persons who may 
        respond to a call for the countermeasure--
                    ``(A) the call for the countermeasure;
                    ``(B) specifications for the countermeasure under 
                paragraph (2); and
                    ``(C) a commitment for a recommendation for 
                procurement under subsection (e) of the first such 
                specific countermeasure that meets the conditions for 
                procurement under subsection (d) and the specifications 
                under paragraph (2).
            ``(4) Subsequent specific countermeasures.--Procurement 
        under subsection (f) of the first such specific countermeasure, 
        or any other such countermeasure, that meets the conditions for 
        procurement under subsection (d) and the specifications under 
        paragraph (2) shall not preclude the additional procurement 
        under subsection (f) of a subsequent such countermeasure that 
        meets the conditions of procurement under subsection (d) if 
        such a 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.
    ``(d) Secretary's Determination of Countermeasures Appropriate for 
Procurement Under this Section.--
            ``(1) In general.--The Secretary, in accordance with this 
        section, shall identify specific countermeasures to threats 
        identified under subsection (a) that the Secretary determines, 
        in consultation with the Secretary of Homeland Security, to be 
        appropriate for procurement with appropriations under this 
        section for inclusion in the stockpile under section 121(a) of 
        the Public Health and Bioterrorism Preparedness and Response 
        Act of 2002 (42 U.S.C. 300hh-12(a)).
            ``(2) Requirements.--In order for the Secretary to make the 
        determination under paragraph (1) with respect to a 
        countermeasure, the following requirements must be met:
                    ``(A) Determination of qualified countermeasure.--
                The Secretary must determine that the product is a 
                qualified countermeasure (as defined in subsection 
                (h)).
                    ``(B) Determination of quantities needed and 
                feasibility of production and distribution.--The 
                Secretary must determine--
                            ``(i) the quantities of the product that 
                        will be needed to meet the needs of the 
                        stockpile; and
                            ``(ii) that production and delivery within 
                        5 years of sufficient quantities of the 
                        product, as so determined, is reasonably 
                        expected to be feasible.
                    ``(C) Determination of no significant commercial 
                market.--The Secretary shall--
                            ``(i) determine that, at the time of the 
                        initial determination under this subsection, 
                        there is not a significant commercial market 
                        for the product other than as a biomedical 
                        countermeasure; and
                            ``(ii) annually redetermine and report to 
                        the President, while a determination under 
                        paragraph (1) remains in effect with respect to 
                        the product, whether a significant commercial 
                        market exists for the product other than as a 
                        biomedical countermeasure.
    ``(e) Recommendation for President's Approval.--
            ``(1) Recommendation for procurement.--In the case of a 
        countermeasure that the Secretary of Homeland Security and the 
        Secretary have determined is appropriate for procurement under 
        this section for inclusion in the stockpile, in accordance with 
        the preceding provisions of this section, the Secretary of 
        Homeland Security and the Secretary shall jointly submit to the 
        President, in coordination with the Director of the Office of 
        Management and Budget, a recommendation for procurement under 
        this section.
            ``(2) Presidential approval.--A countermeasure may be 
        procured under this section only if the President has approved 
        a recommendation under paragraph (1) with respect to such 
        countermeasure.
            ``(3) Notice to congress.--The Secretary of Homeland 
        Security shall notify Congress of each decision of the 
        President to approve a recommendation under paragraph (1).
    ``(f) Procurement.--The Secretary and the Secretary of Homeland 
Security shall be responsible for the following, for purposes of 
procurement of qualified countermeasures for the stockpile under 
section 121(a) of the Public Health and Bioterrorism Preparedness and 
Response Act of 2002 (42 U.S.C. 300hh-12(a)), as approved by the 
President under subsection (e):
            ``(1) In general.--The Secretary shall be responsible for--
                    ``(A) arranging for procurement of the 
                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 paragraph; and
                    ``(B) promulgating regulations to implement 
                paragraphs (5), (6), and (7), and any other provisions 
                of this section.
            ``(2) Contract terms.--A contract for procurement under 
        this section shall (or, as otherwise specified in this 
        paragraph, may) include the following terms:
                    ``(A) 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.
                    ``(B) Discounted payment for unlicensed product.--
                The contract may provide for a discounted price per 
                unit of a product that is not licensed or approved as 
                described in subsection (h)(1) at the time of delivery, 
                and may provide for payment of an additional amount per 
                unit if the product becomes so licensed or approved 
                before the expiration date of the contract (including 
                an additional amount per unit of product delivered 
                before the effective date of such licensing or 
                approval).
                    ``(C) Storage by vendor.--The contract may provide 
                that the vendor will provide storage for stocks of a 
                product delivered to the ownership of the Government 
                under the contract, for such period and under such 
                terms and conditions as the Secretary may specify, and 
                in such case amounts appropriated under subsection (i) 
                shall be available for costs of shipping, handling, 
                storage, and related costs for such product.
                    ``(D) Contract duration.--The contract shall be for 
                a period not to exceed 5 years, renewable for 
                additional periods none of which shall exceed 5 years.
                    ``(E) Termination for nondelivery.--In addition to 
                any other rights of the Secretary to terminate the 
contract, the contract may provide that the Secretary may terminate the 
contract for failure to deliver a reasonable number (as determined by 
the Secretary) of units of the product by 3 years after the date the 
contract is entered into, and may further provide that in such case the 
vendor shall not be entitled to any payment under the contract.
                    ``(F) Product approval.--The contract shall provide 
                that the vendor seek approval, clearance, or licensing 
                of the product from the Secretary; for a timetable for 
                the development of data and other information to 
                support such approval, clearance, or licensing; and 
                that the Secretary may waive part or all of this 
                contract term on request of the vendor or on the 
                initiative of the Secretary.
            ``(3) Availability of simplified acquisition procedures.--
                    ``(A) In general.--The amount of any procurement 
                under this section 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--
                            ``(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 provisions of 
                law and regulations referred to in such subparagraph, 
                each of the following provisions and implementing 
                regulations shall apply to procurements described in 
                this paragraph to the same extent that such provisions 
                and regulations would apply to such procurements in 
                absence of subparagraph (A):
                            ``(i) Chapter 37 of title 40, United States 
                        Code (relating to contract work hours and 
                        safety standards).
                            ``(ii) Subsections (a) and (b) of section 7 
                        of the Anti-Kickback Act of 1986 (41 U.S.C. 
                        57(a) and (b)).
                            ``(iii) Section 304C of the Federal 
                        Property and Administrative Services Act of 
                        1949 (41 U.S.C. 254d) (relating to the 
                        examination of contractor records).
                            ``(iv) Section 3131 of title 40, United 
                        States Code (relating to bonds of contractors 
                        of public buildings or works).
                            ``(v) Section 303G of the Federal Property 
                        and Administrative Services Act of 1949 (41 
                        U.S.C. 253g) (relating to limiting 
                        subcontractor sales).
                            ``(vi) Subsection (a) of section 304 of the 
                        Federal Property and Administrative Services 
                        Act of 1949 (41 U.S.C. 254(a)) (relating to 
                        contingent fees to middlemen), other than the 
                        last sentence of such subsection.
                            ``(vii) Section 6002 of the Solid Waste 
                        Disposal Act (42 U.S.C. 6962).
                            ``(viii) Section 1354 of title 31, United 
                        States Code (relating to the limitation on the 
                        use of appropriated funds for contracts with 
                        entities not meeting veterans' employment 
                        reporting requirements).
            ``(4) Use of noncompetitive procedures.--In addition to any 
        other authority to use procedures other than competitive 
        procedures, the Secretary may use such other procedures for a 
        procurement under this section if the product is available from 
        only one responsible source or only from a limited number of 
        responsible sources, and no other type of product will satisfy 
        such Secretary's needs.
            ``(5) Premium provision in multiple award contracts.--
                    ``(A) In general.--If, under this section, the 
                Secretary enters into contracts with more than one 
                person to procure a countermeasure, such Secretary may, 
                notwithstanding any other provision of law, include in 
                each of such contracts a provision that--
                            ``(i) identifies an increment of the total 
                        quantity of countermeasure required, whether by 
                        percentage or by numbers of units; and
                            ``(ii) promises to pay one or more 
                        specified premiums based on the priority of 
                        such persons' production and delivery of the 
                        increment identified under clause (i), in 
                        accordance with the terms and conditions of the 
                        contract.
                    ``(B) Determination of government's requirement not 
                reviewable.--If the Secretary includes in each of a set 
                of contracts a provision as described in subparagraph 
                (A), such Secretary's determination of the total 
                quantity of countermeasure required, and any amendment 
                of such determination, is committed to agency 
                discretion.
            ``(6) 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.
            ``(7) Limiting competition to sources responding to request 
        for information.--In conducting a procurement under this 
        section, 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 such Secretary may so exclude such a 
        source.
    ``(g) Interagency Cooperation.--
            ``(1) In general.--In carrying out activities under this 
        section, the Secretary of Homeland Security and the Secretary 
        are authorized, subject to paragraph (2), to enter into 
        interagency agreements and other collaborative undertakings 
        with other agencies of the United States Government.
            ``(2) Limitation.--An agreement or undertaking under this 
        subsection shall not authorize another agency to exercise the 
        authorities provided by this section to the Secretary of 
        Homeland Security or to the Secretary.
    ``(h) Definitions.--In this section:
            ``(1) Qualified countermeasure.--The term `qualified 
        countermeasure' means a biomedical countermeasure--
                    ``(A) that is approved under section 505(a) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
                licensed under section 351 of this Act (42 U.S.C. 262) 
                or that is approved under section 515 or cleared under 
                section 510(k) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 360e and 360) for use as such a 
                countermeasure to a chemical, biological, radiological, 
                or nuclear agent identified as a material threat under 
                subsection (a); or
                    ``(B) for which the Secretary determines that 
                sufficient and satisfactory clinical experience or 
                research data (including data, if available, from 
                preclinical and clinical trials) support a reasonable 
                conclusion that the product will qualify for approval 
                or licensing as such a countermeasure within 5 years 
                after the date of a determination under subsection (d).
            ``(2) Biomedical countermeasure.--The term `biomedical 
        countermeasure' means a drug (as that term is defined by 
        section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 321(g)(1))), device (as that term is defined by 
        section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321(h))), or biological product (as that term is defined 
        by section 351(i) of this Act (42 U.S.C. 262(i))) that is 
        used--
                    ``(A) to treat, identify, or prevent harm from any 
                biological, chemical, radiological, or nuclear agent 
                that may cause a public health emergency affecting 
                national security; or
                    ``(B) to treat, identify, or prevent harm from a 
                condition that may result in adverse health 
                consequences or death and may be caused by 
                administering a drug or biological product that is used 
                as described in subparagraph (A).
    ``(i) Appropriations.--
            ``(1) In general.-- There are authorized to be appropriated 
        not to exceed $5,593,000,000 for the period of fiscal years 
        2004 through 2013 for the costs incurred by the Secretary in 
        the procurement of countermeasures under this subsection as 
        approved by the President under subsection (e) (other than 
        costs specified in paragraph (2)). Of the amounts appropriated 
        under the preceding sentence, not to exceed $3,418,000,000 may 
        be obligated during the period of fiscal years 2004 through 
        2008, of which not to exceed $890,000,000 may be obligated 
        during fiscal year 2004.
            ``(2) Restrictions.--Amounts appropriated under this 
        subsection shall not be available to pay--
                    ``(A) costs for the purchase of vaccines under 
                procurement contracts entered into before January 1, 
                2003;
                    ``(B) costs under new contracts, or costs of new 
                obligations under contracts previously entered into, 
                for procurement of a countermeasure after the date of a 
                determination under subsection (d)(2)(C) that there is 
                a significant commercial market for the countermeasure 
                other than as a biomedical countermeasure; or
                    ``(C) administrative costs.''.

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

    (a) In General.--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:

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

    ``(a) In General.--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, biological product, or 
device intended solely for use in an actual or potential emergency.
    ``(b) Declaration of Emergency.--
            ``(1) In general.--The Secretary may declare an emergency 
        justifying the authorization of a drug, biological product, or 
        device under this subsection on the basis of a determination--
                    ``(A) by the Secretary of Homeland Security, that 
                there is a domestic emergency (or a significant 
                potential of a domestic emergency) involving a 
                heightened risk of attack with a specified biological, 
                chemical, radiological, or nuclear agent;
                    ``(B) by the Secretary of Defense, that there is a 
                military emergency (or a significant potential of a 
                military emergency) involving a heightened risk to 
                United States military forces of attack with a 
                biological, chemical, radiological, or nuclear agent; 
                or
                    ``(C) 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 
                a specified disease or condition that may be 
                attributable to such agent.
            ``(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 1-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) Notification.--The Secretary shall promptly publish 
        in the Federal Register, and shall notify the appropriate 
        committees of Congress concerning, 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 a product if 
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.--An authorization of a product under 
this section shall state--
            ``(1) each disease or condition and the intended use of the 
        product within the scope of the authorization; and
            ``(2) the Secretary's conclusions, 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.
    ``(e) Conditions of Authorization.--The Secretary is authorized to 
impose such conditions on an authorization under this section as the 
Secretary determines are necessary or appropriate to protect the public 
health, including the following:
            ``(1) The Secretary shall impose, to the maximum extent 
        feasible given the circumstances of the emergency, requirements 
        (including requirements concerning product labeling and the 
        provision of information) designed to ensure that health care 
        professionals administering the product are informed--
                    ``(A) that the Secretary has authorized the product 
                solely for emergency use;
                    ``(B) of the significant known and potential 
                benefits and risks of use of the product, and of the 
                extent to which such benefits and risks are unknown; 
                and
                    ``(C) of the alternatives to the product that are 
                available, and of their benefits and risks.
            ``(2) The Secretary shall impose, to the maximum extent 
        feasible given the circumstances of the emergency, requirements 
        (including requirements concerning product labeling and the 
        provision of information) designed to ensure that individuals 
        to whom the product is administered are informed--
                    ``(A) that the Secretary has authorized the product 
                solely for emergency use;
                    ``(B) of the significant known and potential 
                benefits and risks of use of the product, and of the 
                extent to which such benefits and risks are unknown; 
                and
                    ``(C) of any option to accept or refuse 
                administration of the product, and of the alternatives 
                to the product that are available and of their benefits 
                and risks.
            ``(3) The Secretary may impose limitations on which 
        entities may distribute the product (including limitation to 
        distribution by government entities), and on how distribution 
        is to be performed.
            ``(4) The Secretary may impose limitations on who may 
        administer the product, and on the categories of individuals to 
        whom, and the circumstances under which, the product may be 
        administered.
            ``(5) The Secretary may condition the authorization on the 
        performance of studies, clinical trials, or other research 
        needed to support marketing approval of the product.
            ``(6) The Secretary shall impose, to the extent feasible 
        and appropriate given the circumstances of the emergency, 
        requirements concerning recordkeeping and reporting, including 
        records access by the Secretary and publication of data.
            ``(7) The Secretary may waive, to the extent appropriate 
        given the circumstances of the emergency, requirements, with 
        respect to the product, of current good manufacturing practice 
        otherwise applicable to the manufacture, processing, packing, 
        or holding of products subject to regulation under this Act.
            ``(8) The Secretary shall impose, to the extent feasible 
        and appropriate given the circumstances of the emergency, 
        requirements for the monitoring and reporting of adverse events 
        associated with use of the product.
    ``(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.--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--
                    ``(A) the conditions for such an authorization are 
                no longer met; or
                    ``(B) other circumstances make such revocation 
                appropriate.
    ``(h) Publication.--The Secretary shall promptly publish in the 
Federal Register, and provide to the appropriate committees of 
Congress, a notice of each authorization, and each termination or 
revocation of an authorization, under this section.
    ``(i) Recordkeeping.--
            ``(1) In general.--The Secretary may require persons, 
        including a person who holds an authorization under this 
        section, or who manufactures, distributes, prescribes, or 
        administers a product that is the subject of such an 
        authorization, to establish and maintain--
                    ``(A) data that is obtained from such activity and 
                that pertains to the effectiveness or safety of such 
                product;
                    ``(B) such records as are necessary to determine, 
                or facilitate a determination, whether there may be any 
                violation of this section or of a regulation 
                promulgated under this section; and
                    ``(C) such additional records as the Secretary may 
                determine necessary.
            ``(2) Access to records by secretary.--
                    ``(A) Safety and effectiveness information.--The 
                Secretary may require a person who holds an 
                authorization under this section, or who manufactures, 
                distributes, prescribes, or administers a product that 
                is the subject of such an authorization to provide to 
                the Secretary all data that is obtained from such 
                activity and that pertains to the safety or 
                effectiveness of such product.
                    ``(B) Other information.--Every person required 
                under this section to establish or maintain records, 
                and every person in charge or custody of such records, 
                shall, upon request by the Secretary, permit the 
                Secretary at all reasonable times to have access to, to 
                copy, and to verify such records.
    ``(j) Civil Monetary Penalties.--
            ``(1) In general.--A person who violates a requirement of 
        this section or of a regulation or order promulgated pursuant 
        to this section shall be subject to a civil money penalty of 
        not more than $100,000 in the case of an individual, and not 
        more than $250,000 in the case of any other person, for each 
        violation, not to exceed $1,000,000 for all such violations 
        adjudicated in a single proceeding.
            ``(2) Assessment of civil penalties.--Paragraphs (3), (4), 
        and (5) of section 303(g) shall apply to a civil penalty under 
        this subsection, and references in such paragraphs to 
        `paragraph (1) or (2)' shall, for purposes of this subsection, 
        be deemed to refer to paragraph (1) of this subsection.
    ``(k) 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.
    ``(l) Regulations.--The Secretary may promulgate regulations to 
implement this section.
    ``(m) 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; or
            ``(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.
    ``(n) Application to Members of Armed Forces.--
            ``(1) Waiver of requirement relating to option to refuse.--
                    ``(A) In general.--In the case of the 
                administration of a product to members of the armed 
forces, a requirement under subsection (e)(2)(C) 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.
                    ``(B) Provision of information to member.--If the 
                Secretary makes a determination that it is not feasible 
                for the information required by subparagraphs (A) and 
                (B) of subsection (e)(2) to be provided prior to the 
                administration of the product, such information shall 
                be provided to members 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 administration. Information 
                concerning the administration of the product shall be 
                recorded in the medical record of the member.
            ``(2) 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.
    ``(o) 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.''.
    (b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended--
            (1) in subsection (e)--
                    (A) by striking ``504, 703'' and inserting ``504, 
                564, 703''; and
                    (B) by striking ``or 519'' and inserting ``519, or 
                564''; and
            (2) by adding at the end the following:
    ``(hh)(1) Promotion or use of a product that is the subject of an 
authorization under section 564 other than as stated in the 
authorization, or other than during the period described by section 
564(g), unless such promotion or use is permitted under another 
provision of this Act.
    ``(2) Failure to comply with an information requirement under 
section 564(e).''.

SEC. 5. AUTHORITY OF THE SECRETARY OF HEALTH AND HUMAN SERVICES DURING 
              NATIONAL EMERGENCIES.

    Section 1135(b) of the Social Security Act (42 U.S.C. 1320b-5(b)) 
is amended--
            (1) by striking paragraph (3) and inserting the following:
            ``(3) sanctions under section 1867 (relating to examination 
        and treatment for emergency medical conditions and women in 
        labor) for--
                    ``(A) a transfer of an individual who has not been 
                stabilized in violation of subsection (c) of such 
                section if the transfer is necessitated by the 
                circumstances of the emergency; or
                    ``(B) the direction or relocation of an individual 
                to receive medical screening in an alternate location 
                pursuant to an appropriate State emergency preparedness 
                plan;'';
            (2) in paragraph (5), by striking ``and'' at the end;
            (3) in paragraph (6), by striking the period and inserting 
        ``; and'';
            (4) by inserting after paragraph (6), the following:
            ``(7) sanctions and penalties that arise from noncompliance 
        with the following requirements (as promulgated under the 
        authority of section 264(c) of the Health Insurance Portability 
        and Accountability Act of 1996 (42 U.S.C. 1320d-2 note)--
                    ``(A) section 164.510 of title 45, Code of Federal 
                Regulations, relating to--
                            ``(i) requirements to obtain a patient's 
                        agreement to speak with family members or 
                        friends; and
                            ``(ii) the requirement to honor a request 
                        to opt out of the facility directory;
                    ``(B) section 164.520 of such title, relating to 
                the requirement to distribute a notice; or
                    ``(C) section 164.522 of such title, relating to--
                            ``(i) the patient's right to request 
                        privacy restrictions; and
                            ``(ii) the patient's right to request 
                        confidential communications.''; and
            (5) by adding at the end the following: ``A waiver or 
        modification provided for under paragraph (7) shall be limited 
        to a 72-hour period beginning upon implementation of a hospital 
        disaster protocol. A waiver or modification under such 
        paragraph (7) shall be withdrawn after such period and the 
        provider shall comply with the requirements under such 
        paragraph for any patient still under the care of the 
        provider.''.

SEC. 6. GAO REPORT.

    Not later than 4 years after the date of enactment of this Act, the 
Comptroller General of the United States shall submit to the 
appropriate committees of Congress a report that--
            (1) describes the activities conducted under the 
        authorities provided for in section 409J(b)(1) of the Public 
        Health Service Act (as added by section 2) and section 319A-
        1(f)(3) and (4) of such Act (as added by section 3);
            (2) identifies any procurements that would have been 
        prohibited except for the authorities provided in the sections 
        described in paragraph (1); and
            (3) assesses the adequacy of the internal controls 
        established by the Secretary of Health and Human Services 
        regarding procurements made under the authorities provided for 
        in the sections described in paragraph (1).

SEC. 7. FUNDING FOR PROJECT BIOSHIELD.

    In the Senate, for purposes of points of order under a concurrent 
resolution on the budget and the Congressional Budget Act of 1974, 
provisions contained in any bill, resolution, amendment, motion, or 
conference report that change the availability of any amounts 
appropriated pursuant to this Act (or an amendment made by this Act) 
shall not be scored with respect to the level of budget authority or 
outlays contained in such bill, resolution, amendment, motion, or 
conference report.




                                                       Calendar No. 265

108th CONGRESS

  1st Session

                                S. 1504

_______________________________________________________________________

                                 A BILL

   To amend the Public Health Service Act to provide protections and 
countermeasures against chemical, radiological, or nuclear agents that 
may be used in a terrorist attack against the United States of America.

_______________________________________________________________________

                           September 2, 2003

            Read the second time and placed on the calendar