[House Report 108-147]
[From the U.S. Government Publishing Office]



                                                                       
108th Congress                                            Rept. 108-147
                        HOUSE OF REPRESENTATIVES
 1st Session                                                     Part 3

======================================================================



 
                     PROJECT BIOSHIELD ACT OF 2003

                                _______
                                

                  July 8, 2003.--Ordered to be printed

                                _______
                                

Mr. Cox, from the Select Committee on Homeland Security, submitted the 
                               following

                              R E P O R T

                             together with

                            ADDITIONAL VIEWS

                        [To accompany H.R. 2122]

    The Select Committee on Homeland Security, to whom was 
referred the bill (H.R. 2122) to enhance research, development, 
procurement, and use of biomedical countermeasures to respond 
to public health threats affecting national security, and for 
other purposes, having considered the same, report favorably 
thereon with an amendment and recommend that the bill as 
amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................    17
Background and Need for Legislation..............................    17
Hearings.........................................................    18
Committee Consideration..........................................    19
Committee Votes..................................................    19
Committee Oversight Findings.....................................    27
Statement of General Performance Goals and Objectives............    27
New Budget Authority, Entitlement Authority, and Tax Expenditures    27
Congressional Budget Office Estimate.............................    27
Federal Mandates Statement.......................................    27
Advisory Committee Statement.....................................    27
Constitutional Authority Statement...............................    28
Applicability to Legislative Branch..............................    28
Section-by-Section Analysis of the Legislation...................    28
Changes in Existing Law Made by the Bill, as Reported............    35

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

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 
                    BIOMEDICAL 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)) that affects 
        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 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 qualified 
        countermeasure 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.
  ``(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 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) Use of noncompetitive procedures.--In addition to any 
        other authority to use procedures other than competitive 
        procedures, the Secretary may use such other procedures when--
                  ``(A) the procurement is as described by paragraph 
                (1); 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 
                satisfy the Secretary's needs.
          ``(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.
  ``(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 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 or cooperative agreement.
  ``(d) Authority for Personal Services Contracts.--
          ``(1) In general.--For the purpose of performing, 
        administering, and 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), by inserting ``or the Director of 
        the National Institute of Allergy and Infectious Diseases'' 
        after ``Director of the Center'';
          (2) in subsection (c)--
                  (A) in paragraph (1), by inserting ``or the Director 
                of the National Institute of Allergy and Infectious 
                Diseases'' after ``Director of the Center''; and
                  (B) in paragraph (2), in the matter preceding 
                subparagraph (A), by striking ``subsection (i)'' and 
                inserting ``subsection (i)(1)'';
          (3) in subsection (d), by inserting ``or the Director of the 
        National Institute of Allergy and Infectious Diseases'' after 
        ``Director of the Center'';
          (4) in subsection (e)--
                  (A) in paragraph (1)--
                          (i) in the matter preceding subparagraph (A), 
                        by inserting ``or the Director of the National 
                        Institute of Allergy and Infectious Diseases'' 
                        after ``Director of the Center'';
                          (ii) in subparagraph (A), by inserting ``(or, 
                        in the case of the Institute, 75 percent)'' 
                        after ``50 percent''; and
                          (iii) in subparagraph (B), by inserting 
                        ``(or, in the case of the Institute, 75 
                        percent)'' after ``40 percent'';
                  (B) in paragraph (2), by inserting ``or the Director 
                of the National Institute of Allergy and Infectious 
                Diseases'' after ``Director of the Center''; and
                  (C) in paragraph (4), by inserting ``of the Center or 
                the Director of the National Institute of Allergy and 
                Infectious Diseases'' after ``Director'';
          (5) in subsection (f)--
                  (A) in paragraph (1), by inserting ``in the case of 
                an award by the Director of the Center,'' before ``the 
                applicant''; and
                  (B) in paragraph (2), by inserting ``of the Center or 
                the Director of the National Institute of Allergy and 
                Infectious Diseases'' after ``Director''; and
          (6) in subsection (i)--
                  (A) by striking ``Appropriations.--For the purpose of 
                carrying out this section,'' and inserting the 
                following: ``Appropriations.--
          ``(1) Center.--For the purpose of carrying out this section 
        with respect to the Center,''; and
                  (B) by adding at the end the following:
          ``(2) National institute of allergy and infectious 
        diseases.--For the purpose of carrying out this section with 
        respect to the National Institute of Allergy and Infectious 
        Diseases, there are authorized to be appropriated such sums as 
        may be necessary for fiscal year 2003.''.

SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

  (a) In General.--Part B of title III of the Public Health Service 
Act, as amended by section 2 of this Act, is amended by inserting after 
section 319F-1 the following section:

``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))--
                          ``(i) against a chemical, biological, 
                        radiological, or nuclear agent identified as a 
                        material threat under paragraph (2)(A)(ii);
                          ``(ii) that is determined under paragraph 
                        (2)(B)(ii) to be a necessary countermeasure;
                          ``(iii) that is designed, developed, 
                        modified, or procured for the specific purpose 
                        of preventing, detecting, identifying, 
                        deterring, or mitigating actual or potential 
                        acts of chemical, biological, radiological, or 
                        nuclear catastrophe;
                          ``(iv)(I) that 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
                          ``(II) 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); and
                          ``(v) that relates to an actual or potential 
                        act of terrorism or catastrophic event or to 
                        actual or potential warfare.
          ``(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)) of any determination made pursuant to 
                subparagraph (A) or (B). Such notice shall be in 
                unclassified and, 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 or available 
                under unsuitable conditions, 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) a 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 (2), (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 congress.--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 regulations to 
                                implement clauses (v), (vi), and (vii), 
                                and any other 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.
                                  ``(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 sales of 
                                security countermeasures.--The contract 
                                may provide that the vendor will not at 
                                any time (including after performance 
                                under the contract is otherwise 
                                completed) sell or otherwise provide 
                                such countermeasure to any domestic or 
                                foreign person, or transfer to any such 
                                person any quantity of such security 
                                countermeasure, or any intellectual 
                                property relating thereto that would 
                                enable the development or production of 
                                the countermeasure, without 
                                certification by the Secretary, in 
                                consultation with the Homeland Security 
                                Secretary, the Secretary of Defense, 
                                and the Secretary of State, that such 
                                sale or transfer, or category of sales 
                                or transfers, would not adversely 
                                affect the national security; and that, 
                                for each violation of this provision of 
                                the contract, the United States is 
                                entitled to recover from the person as 
                                liquidated damages an amount equal to 
                                three times the sum of the payments 
                                made to the vendor under the contract.
                          ``(iii) Availability of simplified 
                        acquisition procedures.--
                                  ``(I) In general.--The amount of any 
                                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) 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 subsection 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 the Secretary's needs.
                          ``(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 Homeland Security 
        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 2004, and such sums as may be necessary for each of the 
        fiscal years 2005 and 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.
  ``(e) Emergency Development of Security Countermeasures.--If the 
Secretary of Homeland Security and the Secretary of Health and Human 
Services jointly determine that procurement of a security 
countermeasure that has been approved for procurement using the special 
reserve fund under subsection (a)--
          ``(1) is not proceeding at a sufficiently rapid pace under 
        319F-2 of the Public Health Service Act to protect the national 
        security; or
          ``(2) could be produced significantly less expensively by the 
        government directly than through procurements under such 
        section;
then amounts in the special reserve fund may be used by the Secretary 
of Health and Human Services to produce security countermeasures for 
placement in the stockpile under subsection (a) of section 319F-2 of 
such Act if the joint determination is submitted to the President and 
the President approves such use of the special reserve fund. Amounts 
made available for such use in accordance with the preceding sentence 
are available for obligation as of the date on which the presidential 
approval is made, subject to applicable law regarding the apportionment 
of appropriations. This subsection applies notwithstanding other 
provisions of this section, and notwithstanding section 319F-2 of the 
Public Health Service Act. This subsection may not be construed as 
affecting the amounts specified in subsection (a) as authorizations of 
appropriations or the obligation limits contained therein.''.
  (c) Conforming Amendment.--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 repealed. With respect to the program 
established under former section 121 of such Act, the repeal of such 
section under the preceding sentence applies as a modification of the 
program in accordance with the amendment made by subsection (a) of this 
section, and not as the termination of the program and the 
establishment of a different program.

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 or device 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 `emergency use' has the meaning 
                indicated for such term in paragraph (1).
                  ``(B) The term `product' means a drug or device.
                  ``(C) The term `unapproved product' has the meaning 
                indicated for such term in paragraph (2)(A).
                  ``(D) 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.--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 
                                use of noncompetitive procedures).
                                  (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 use of noncompetitive 
                                procedures).
                                  (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 (as defined in subsection (e)) 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 not 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, and 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, use of 
        noncompetitive procedures, 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 Additional Barriers to Procurement of Security 
Countermeasures.--Not later than 180 days after the date of the 
enactment of this Act, the Secretary of Homeland Security and the 
Secretary of Health and Human Services shall report to the designated 
congressional committees any 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 180 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 and procurements 
conducted under sections 2 and 3 of this Act.

SEC. 7. 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 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 such domestic incidents, 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.

                          Purpose and Summary

    The purpose of the Project BioShield Act of 2003 is to 
provide the Secretary of Health and Human Services with greater 
authority and flexibility to facilitate the research and 
development of biomedical countermeasures; to authorize the 
appropriation of funding for the procurement of security 
countermeasures through the creation of a special reserve fund; 
and to authorize the emergency use of unapproved drugs, 
devices, and biologics and the emergency unapproved use of 
approved drugs, devices, and biologics.

                  Background and Need for Legislation

    During times of national, military, or public health 
emergency, the American people may be placed at risk of 
exposure to biological, chemical, radiological, or nuclear 
agents, and the diseases caused by such agents. Unfortunately, 
there are not approved or available countermeasures to treat 
many diseases or conditions that may be caused by such agents. 
Currently, companies have little incentive to research, 
develop, or produce vaccines or other drugs simply for a 
possible one-time purchase by the Federal government for the 
Strategic National Stockpile. Most current private sector 
research and development dollars go for drugs or devices that 
will have continuous commercial application. In addition, some 
of the current generation of drugs or devices may have special 
uses as countermeasures to biological agents like Ebola, but 
there is little incentive to perform the research or 
development or production activities that might tailor the drug 
or drug approvals for such a purpose.
    Even if a product has been developed to treat such diseases 
or conditions, if the product has not yet been approved by the 
Food and Drug Administration (FDA), access to the therapy is 
greatly limited. Nothing in the Food and Drug Act allows the 
Secretary to suspend the approval requirements to ensure access 
to unapproved drugs and devices on a large-scale basis in times 
of emergency.
    Under present law, if a product is not approved by the FDA, 
then it is unlawful to provide that product to an individual, 
unless the product has been authorized for distribution under 
an investigational new drug (IND) application (for a drug and 
biologic) or an investigational device exemption (IDE). When a 
drug or device is available under such procedures, a number of 
conditions apply that make the use of an IND or IDE infeasible 
in times of national emergency, where drugs and devices may 
need to be deployed at rapid rates. Even if a drug, biologic, 
or device is highly promising in treating a disease or 
condition associated with biological, chemical, radiological, 
or nuclear agents, and even if it is the only therapy 
available, current FDA law does not allow for rapid deployment 
of the product.
    The Project Bioshield Act is designed to help resolve these 
problems and make our nation more secure. Like the Public 
Health Security and Bioterrorism Preparedness and Response Act, 
the Project Bioshield Act is designed to help the 
administration and the nation in public health emergency 
preparedness, but relies on the ingenuity and hard work of 
Americans in the private and public sector to achieve these 
goals.

                                Hearings

    The Subcommittee on Emergency Preparedness and Response 
held a joint hearing with the Subcommittee on Health of the 
Committee on Energy and Commerce on ``Furthering Public Health 
Security: Project Bioshield'' on March 27, 2003. The 
Subcommittee received testimony from: The Honorable Tommy 
Thompson, Secretary, U.S. Department of Health and Human 
Services; Mr. Leighton Read M.D., General Partner, Alloy 
Ventures, on behalf of Biotechnology Industry Organization; Mr. 
Michael Friedman M.D., Chief Medical Officer for Biomedical 
Preparedness, PhRMA; Mr. James Baker Jr., Ruth Dow Doan 
Professor, Center for Biological Nanotechnology; and, Mr. Gary 
Noble M.D., Vice President of Medical and Public Affairs, 
Johnson & Johnson, on behalf of AdvaMed.
    The Full Committee held a hearing on ``Bioshield: 
Countering the Bioterrorist Threat'' on May 15, 2003. The 
Committee received testimony from: Dr. Anthony Fauci, Director, 
National Institute of Allergy and Infectious Diseases; Dr. L. 
Garry Adams, Associate Dean for Research, Biodefense & 
Infectious Diseases, College of Veterinary Medicine, Texas A&M 
University; Dr. Clarence James Peters, Director for Biodefense, 
Center for Biodefense and Emerging Infectious Diseases, 
University of Texas Medical Branch; Dr. Ronald Crystal, 
Professor and Chairman, Department of Genetic Medicine, Weill 
Medical College of Cornell University; William A. Haseltine, 
Ph.D., Chairman and Chief Executive Officer, Human Genome 
Sciences, Inc.; Alan Pemberton, Pharmaceutical Research and 
Manufacturers of America; Robert J. Sutcliffe, Director, 
President and Chief Executive Officer, Digital Gene 
Technologies, Inc.; and, Frank M. Rapoport, Partner, McKenna 
Long & Aldridge LLP.
    The Subcommittee on Emergency Preparedness and Response and 
The Subcommittee on Intelligence and Counterterrorism held a 
joint hearing on ``Does the Homeland Security Act of 2002 give 
the Department the Tools it Needs to Determine Which Bio-
Warfare Threats are Most Serious?'' on June 5, 2003. The 
Committee received testimony from: Paul J. Redmond, Assistant 
Secretary, Information Analysis, Department of Homeland 
Security; and, Eric Tolbert, Director of the Response Division, 
Emergency Preparedness and Response Directorate, Department of 
Homeland Security.
    The Full Committee held a hearing on ``Bioshield: Lessons 
from Current Efforts to Develop Bio-Warfare Countermeasures'' 
on June 6, 2003. The Committee received testimony from: Dr. 
John Ring La Montagne, Deputy Director, National Institute of 
Allergy and Infectious Diseases, National Institutes of Health, 
Department of Health and Human Services; and, Dr. Ali Khan, 
Chief Science Officer, Parasitic Diseases, National Center for 
Infectious Diseases, Center for Disease Control and Prevention, 
Department of Health and Human Services.

                        Committee Consideration

    On Thursday, June 27, 2003, the Full Committee met in open 
markup session and ordered H.R. 2122 reported to the House, as 
amended, by a record vote of 29 yeas and 0 nays.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto.
    H.R. 2122, to enhance research, development, procurement, 
and use of biomedical countermeasures to respond to public 
health threats affecting national security, and for other 
purposes; was ordered favorably reported to the House, amended, 
by a recorded vote of 29 yeas and 0 nays (Roll Call Vote No. 4) 
as follows:


    The following amendments were offered:
    An Amendment in the Nature of a Substitute offered by Mr. 
Cox (#1), was AGREED TO by voice vote, as amended.
    An amendment offered by Mr. Hunter to the Amendment in the 
Nature of a Substitute offered by Mr. Cox (#1A), Page 17, 
beginning on line 23, strike ``Homeland Security Secretary'' 
and insert ``Homeland Security Secretary, Secretary of Defense 
and Secretary of State.'' was AGREED TO by a recorded vote of 
25 yeas and 0 nays (Roll Call Vote No. 1) as follows:


    An amendment offered by Mr. Hunter to the Amendment in the 
Nature of a Substitute offered by Mr. Cox (#1B), Page 52, line 
24, insert a new section entitled ``Ensuring coordination, 
cooperation and the elimination of unnecessary duplication in 
programs designed to protect the homeland from biological, 
chemical, radiological, and nuclear agents'' was AGREED TO by 
voice vote.
    An amendment offered by Mr. DeFazio to the Amendment in the 
Nature of a Substitute offered by Mr. Cox (#1C), to insert a 
new subsection entitled ``Status of Program for Chemical 
Terrorism Preparedness'' was AGREED TO by voice vote.
    An amendment offered by Ms. Slaughter to the Amendment in 
the Nature of a Substitute offered by Mr. Cox (#1D), to insert 
a new section entitled ``Expatriate Corporations'' was NOT 
AGREED TO by a recorded vote of 17 yeas and 18 nays (Roll Call 
Vote No. 2) as follows:


    An amendment offered by Mr. Markey to the Amendment in the 
Nature of a Substitute offered by Mr. Cox (#1E), Page 37, line 
9, add the following: ``If an authorization under the preceding 
sentence for a product is revoked under subsection (g), or if 
the declaration of an emergency under subsection (b) ceases to 
be in effect, the product may not be introduced into interstate 
commerce except in accordance with section 505, 510(k), or 515, 
or section 351 of the Public Health Service Act, as 
applicable.'' was WITHDRAWN.
    An amendment offered by Ms. Jackson-Lee to the Amendment in 
the Nature of a Substitute offered by Mr. Cox (#1F), to insert 
a new section at the end of the bill entitled ``Sec. 6. 
Inclusion of Certain Populations in Research, Development, and 
Procurement Projects.'' was WITHDRAWN.
    An amendment offered by Mr. Tauzin to the Amendment in the 
Nature of a Substitute offered by Mr. Cox (#1G), Page 28, 
strike line 16 and all that follows through page 29, line 19 
was NOT AGREED TO by a recorded vote of 19 yeas and 19 nays 
(Roll Call Vote No. 3). As follows:


    An amendment offered by Mr. Andrews to the Amendment in the 
Nature of a Substitute offered by Mr. Cox (#1H), on page 16, 
line 4 of the Cox-Turner Substitute amendment: add the 
following: ``notwithstanding the preceding provisions of this 
subclause, nothing in this section shall alter the rights of 
the parties afforded by the Federal Acquisition Regulation or 
other applicable laws or regulations regarding a termination 
for the convenience of the government.'' was WITHDRAWN.
    An amendment offered by Ms. Jackson-Lee to the Amendment in 
the Nature of a Substitute offered by Mr. Cox (#1I), to insert 
at the end of the substitute the following section: ``Sec. 6. 
Outreach.'' was AGREED TO by voice vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has held oversight 
hearings and made findings that are reflected in this report.

         Statement of General Performance Goals and Objectives

    The purpose of the Project BioShield Act of 2003 is to 
provide the Secretary of Health and Human Services and the 
Secretary of Homeland Security greater authority and 
flexibility to facilitate the research, development, and 
procurement of biomedical countermeasures.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
2122, the Project Bioshield Act of 2003, would result in no new 
or increased budget authority, entitlement authority, or tax 
expenditures or revenues.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, a cost estimate provided by the 
Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974 was not made available to the 
Committee in time for the filing of this report. The Chairman 
of the Committee shall cause such estimate to be printed in the 
Congressional Record upon its receipt by the Committee.

                       Federal Mandates Statement

    An estimate of Federal mandates prepared by the Director of 
the Congressional Budget Office pursuant to section 423 of the 
Unfunded Mandates Reform Act was not made available to the 
Committee in time for the filing of this report. The Chairman 
of the Committee shall cause such estimate to be printed in the 
Congressional Record upon its receipt by the Committee.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for this legislation is provided in 
Article I, section 8, clause 1, which grants Congress the power 
to provide for the common Defense of the United States.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 establishes the short title of the Act as the 
``Project BioShield Act of 2003.''

Section 2. Biomedical countermeasure research and development 
        authorities

    Section 2(a) of the Project BioShield Act of 2003 amends 
the Public Health Service Act to add a new section 319F-1. The 
section grants the Secretary of the Department of Health and 
Human Services (HHS) additional flexibility and authority in 
conducting research and development with respect to biomedical 
countermeasures against biological, chemical, nuclear and 
radiological agents that may affect national security.
    New subsection 319F-1(a) provides general authority. 
Proposed subparagraph 319F-1(a)(4) makes the facilities of 
entities that enter into a grant or cooperative agreement with 
the Secretary of HHS under this section available as needed to 
such Secretary of HHS to respond to public health emergencies 
affecting national security.
    New subsection 319F-1(b) provides expedited authority for 
governmental procurements used to perform, administer, or 
support pressing research and development activities under this 
section, by (1) increasing the simplified acquisition threshold 
from $100,000 to $25 million; (2) authorizing the use of 
procedures providing for less than full and open competition 
when there are only a limited number of responsible sources and 
no other type of services will satisfy the Secretary of HHS 
needs; and (3) increasing the micropurchase threshold for such 
procurements to $15,000.
    New subsection 319F-1(c) authorizes the Secretary of HHS to 
use expedited peer-review procedures in lieu of otherwise 
applicable peer-review procedures in the case of grants and 
contracts for biomedical countermeasure research and 
development activity, if such grants and contracts do not 
exceed $1,500,000 and are necessary to respond to pressing 
research needs.
    New subsection 319F-1(d) provides additional flexibility to 
the Secretary of HHS with respect to the hiring of experts and 
consultants when necessary to respond to pressing qualified 
countermeasure research and development needs. Under paragraph 
319F-1(d)(2), such experts and consultants are deemed to be 
employees of HHS for purposes of the Federal Torts Claims Act, 
which provides the exclusive remedy against such personnel for 
claims relating to the performance of covered duties.
    New subsection 319F-1(e) provides streamlined personnel 
authority for the Secretary of HHS to appoint up to 30 people 
to positions in the National Institutes of Health without 
regard to ordinary classification criteria, when necessary to 
respond to pressing qualified countermeasure research and 
development needs.
    New subsection 319F-1(f) provides that actions by the 
Secretary of HHS under the section are committed to agency 
discretion.
    Section 2(b) of the Project BioShield Act of 2003 amends 
section 481A of the Public Health Service Act to add the 
Director of the National Institute of Allergy and Infectious 
Diseases to that section, and thus provide to that Director 
certain authorities concerning modernization and construction 
of research facilities. Section 2(b) further authorizes such 
sums as may be necessary for such purposes.

Section 3. Biomedical countermeasures procurement

    Section 3(a) of the Project BioShield Act of 2003 adds a 
new section 319F-2 to the Public Health Service Act. Several 
provisions of new section 319F-2 simply transfer existing 
provisions of law from the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002, as amended 
by the Homeland Security Act of 2002. Proposed Subsection 319F-
2(a) contains language from existing law establishing the 
Strategic National Stockpile. New section 319F-2(b) contains 
language from existing law concerning authorizing procurement 
of smallpox vaccine for the National Strategic Stockpile.
    New section 319F-2(c) requires the Secretary of the 
Department of Homeland Security (DHS) to assess threats that 
may be posed by chemical, biological, radiological, and nuclear 
agents, and requires the HHS Secretary to assess the public 
health consequences of such agents and the availability and 
appropriateness of countermeasures for the threats identified. 
After these steps, the Secretaries jointly may determine and 
recommend to the President that funding for procurement of such 
a countermeasure for the nation's stockpile is appropriate from 
the special reserve fund established by this Act.
    Under section 319F-2(c)(4), the Secretaries of HHS and DHS 
may recommend to the President a proposal to issue a call for 
the development of countermeasures. Such a call includes a 
commitment from the Secretaries to make a recommendation for 
funding procurement of such a countermeasure from the special 
reserve fund, if government specifications for the product are 
achieved. The Secretaries also may secure a Presidential 
approval for funding prior to, or without, conducting a call.
    New section 319F-2(c)(4)(B) provides that the Secretaries 
should include in any call for proposals for countermeasure 
production information that may be necessary to encourage or 
facilitate research and development into such countermeasures. 
The Committee recognizes that an important factor companies 
will consider in determining whether to invest scarce research 
and development dollars into security countermeasures is 
whether and to what extent they may face liability relating to 
the development or production of such countermeasures. The 
Committee thus encourages the Secretaries to indicate in any 
call for proposals the potential availability of 
indemnification or liability protections under other laws. The 
Secretary of Homeland Security is further encouraged to 
designate such countermeasures as ``qualified anti-terrorism 
technologies'' as defined in section 862 of the Homeland 
Security Act.
    Under section 319F-2(c)(7), if the President approves a 
recommendation for funding from the special reserve fund, DHS 
would then enter into an agreement with HHS under which HHS may 
procure the countermeasure for the stockpile using the DHS 
special reserve fund. Contracts under this paragraph are 
subject to certain conditions, including the condition that 
payment shall only be made upon ``substantial delivery,'' 
unless the Secretary of HHS determines an advance of up to 10 
percent of the contract amount is necessary to ensure success 
of the project. This provision does not alter the rights of 
contracting parties under the Federal Acquisition Regulation or 
other applicable laws or regulations regarding a termination 
for the convenience of the government. The Secretary of HHS is 
authorized to include contract provisions limiting or 
forbidding non-stockpile sales of a security countermeasure. 
The Secretary is strongly encouraged to include such provisions 
when it is necessary or desirable in order to protect United 
States national security interests with respect to the transfer 
of highly specialized countermeasures or enabling intellectual 
property, and particularly to guard against the transfer of 
such countermeasures or intellectual property to specific 
foreign entities when the Secretary, in consultation with the 
Secretaries of the Departments of Homeland Security, State, and 
Defense, believes that the transfer would have undesirable 
national security implications or pose an unacceptable risk to 
the national security.
    Section 319F-2(d) contains prohibitions on disclosure of 
information transferred from existing law. Section 319F-2(e) 
contains definitions transferred from existing law.
    Section 319F-2(f) contains authorization of appropriations 
for the Strategic National Stockpile and smallpox vaccine 
development transferred from existing law with one addition. 
The new paragraph makes clear that such existing authorizations 
are in addition to amounts authorized under the special reserve 
fund. Nothing in the Act would restrict or alter the 
Secretaries' existing authority to purchase items for the 
stockpile using existing discretionary appropriations for such 
purpose.
    Section 3(b) of the Project BioShield Act of 2003 adds a 
new section 510 to the Homeland Security Act of 2002. This new 
section authorizes appropriations for the special reserve fund 
referenced in the new section 319F-2(c) of the Public Health 
Service Act. The bill authorizes $890 million in FY 04 for such 
procurements, and aggregate amounts of $3.4 billion and $5.6 
billion over the next five and ten fiscal years respectively. 
All amounts appropriated under this authorization would be 
available for obligation through the end of FY 2013.
    The new section 510 of the Homeland Security Act also 
authorizes $5 million in FY 04 for the hiring of professional 
biological, chemical, radiological, and nuclear threat analysts 
at DHS, and such sums as are necessary to construct secure 
facilities for the receipt of classifiedinformation necessary 
to allow the Secretary of DHS to carry out his threat assessment 
responsibilities under this Act. The Committee expects that the 
Secretary of DHS will receive the full cooperation of other agencies in 
the federal government in getting up-to-date intelligence and other 
information, as required by the Homeland Security Act.
    Subsection 510(e) allows the Secretaries of DHS and HHS to 
use the special reserve fund to produce security 
countermeasures directly, if they jointly determine, and the 
President approves, that procurement is not proceeding rapidly 
enough.
    The Act defines the scope of the new authorities set forth 
in this section as applying to countermeasures against agents 
that the Secretary of DHS believes present ``a material threat 
against the United States population'' and about which the HHS 
and DHS Secretaries make certain additional findings. The 
Committee expects that both Secretaries will consider the 
threat of use of such agents by terrorists against the U.S. 
population to be a significant factor in making their 
respective scope determinations under these provisions. 
However, the Committee also recognizes and encourages the 
Secretaries to consider the emerging threats to public health 
and national security that may be caused by the spread of 
antibiotic resistant organisms or dangerous viruses that may 
spread rapidly and lack effective countermeasures today. These 
threats may affect national security whether by terrorists or 
through natural conditions. The Secretaries should consider 
such factors in determining whether to use these new 
authorities to promote research, development, and production of 
security countermeasures, such as broad-spectrum antibiotics, 
that could be useful against a range of potential threat 
agents.

Section 4. Authorization for medical products for use in emergencies

    Section 4 adds a new section 564 to the Federal Food, Drug, 
and Cosmetic Act. New section 564(a) allows the Secretary of 
Health and Human Services to authorize for introduction into 
interstate commerce unapproved drugs, devices, and biological 
products or unapproved uses of approved drugs, approved/cleared 
devices, and biological products intended for use in an actual 
or potential emergency during the effective period of a 
declaration.
    New section 564(b) allows the Secretary of HHS to declare 
an emergency justifying an emergency use authorization based 
upon a determination by the Secretary of Homeland Security that 
there is a national emergency or the significant potential of 
one, or by a determination of the Secretary of Defense that 
there is a military emergency, or a significant potential of 
one. Such emergencies must involve a heightened risk of attack 
with biological, chemical, radiological, or nuclear agents. 
Similarly, an emergency use authorization can be based upon a 
determination of the Secretary of HHS that there is a public 
health emergency affecting national security and involving 
biological, chemical, radiological, or nuclear agents. In 
making a determination about whether a public health emergency 
under section 319 of the Public Health Service Act affects 
national security, the Secretary may consider all information 
he deems pertinent and appropriate, and nothing in this Act 
requires that the Secretary consult with other executive branch 
officials prior to making such a determination.
    Under this section, any declaration of emergency will last 
for one year, unless the Secretary of HHS terminates it at an 
earlier time. The Secretary of HHS may renew a declaration. The 
Secretary of HHS must publish all declarations, determinations, 
and renewals in the Federal Register, and the Secretary must 
provide reasonable advanced notice that declarations are to be 
terminated under this section. The Committee intends that, 
after a declaration is terminated, final disposition of 
labeling or intrastate disposition of a product may occur. 
Further, the Committee believes that the Commissioner of the 
Food and Drug Administration (Commissioner) may exercise 
enforcement discretion not to object to interstate shipment of 
an unapproved product for return to a manufacturer. A 
determination of what is a ``reasonable'' period for advanced 
notice of termination should consider all factors, so in some 
cases notice immediately preceding termination may be 
reasonable, while in other circumstances it may not.
    Section 564(c) details the criteria for issuance of an 
emergency use authorization. Under this new section, the 
Secretary of HHS, acting through the Commissioner, may issue an 
authorization upon concluding (1) that a biological, chemical, 
radiological, or nuclear agent or agents can cause a serious or 
life-threatening disease or condition; (2) that the drug, 
device or biological product may be effective in detecting, 
diagnosing, treating, or preventing such disease or condition 
(or a serious disease or condition caused by taking a product 
already approved, licensed or cleared by FDA for treating or 
preventing such disease or condition), and the benefits of the 
product outweigh risks; (3) that there is no adequate, 
approved, and available alternative to the product; and, (4) 
other criteria the Secretary may by regulation specify. The 
Commissioner should consult with the Directors of the National 
Institutes of Health and the Centers for Disease Control and 
Prevention prior to issuing an authorization, but such 
consultation is limited by considerations of feasibility and 
appropriateness given the circumstances of the emergency.
    Section 564(d) concerns the scope of an emergency use 
authorization. Under this section, the authorization shall 
state the disease or condition that the product may be used to 
detect, diagnose, prevent, or treat, as well as the 
Commissioner's conclusions about known benefits and risks of 
the product and conclusions concerning safety and potential 
effectiveness. The Committee intends that before issuing an 
authorization under this section, the Commissioner will, where 
feasible given the nature and the extent of the emergency, 
notify the holder of any relevant application under this 
chapter or under section 351 of the Public Health Service Act. 
The purpose of such notification is to allow for discussion of 
the conditions of this authorization as required by subsection 
(e), as well as discussion of whether such product should be 
delivered pursuant to section 319F-2(c) of the Public Health 
Service Act.
    Section 564(e) pertains to products that have never been 
approved, licensed, or cleared by FDA. Under this subsection, 
conditions shall, to the extent feasible given the 
circumstances of the emergency, be applied to persons who 
choose to carry out an activity for which the authorization is 
issued. Such mandatory conditions include information to 
providers about the emergency use of the product as well as 
significant known potential risks and benefits, as well as 
appropriate conditions designed to ensure that to the maximum 
extent feasible given the circumstances of the emergency, 
individuals to whom the product is administered are informed of 
the emergency use of the product, risks and benefits of the 
product, and of the option to accept or refuse the product. 
Further, the Commissioner is given the authority to impose 
other conditions on those who carry out activities for which 
the authorization is issued. Such conditions imposed by the 
Commissioner should be designed to provide maximum flexibility 
to ensure that those who wish to take the product can indeed 
take the product, if made available by the manufacturer.
    Section 564(e) also applies to unapproved uses of approved 
products and the Commissioner may, for manufacturers who choose 
to carry out one or more activities pursuant to an emergency 
use authorization, apply certain conditions. This subsection 
makes clear that manufacturers do not have to avail themselves 
of the emergency use authorization for unapproved uses of 
approved products, and it makes clear that no individual may 
alter or obscure the labeling ofalready approved products. It 
does authorize, however, persons other than the manufacturer to provide 
information about the product concerning the emergency use of the 
product.
    Under section 564(e), the Commissioner may establish 
conditions regarding product labeling and information 
conveyance concerning unapproved products. Further, the 
Committee intends that the Commissioner may establish 
conditions regarding product labeling and information 
conveyance on manufacturers that carry out one or more 
activities pursuant to an emergency use authorization with 
respect to the emergency use of that product that is an 
unapproved use of an approved product.
    Subsection (f) makes clear that an emergency use 
authorization is effective until the declaration is terminated 
or revoked, but allows patients to continue using such products 
in certain instances. Nothing in this subsection is intended to 
require manufacturers or others to provide such products to 
patients.
    Subsection (g) makes clear that the Commissioner shall 
periodically review the appropriateness of an authorization, 
and it provides the Commissioner needed flexibility to revoke 
an authorization if the criteria justifying the authorization 
are no longer met.
    Subsection (h) ensures that the Commissioner shall promptly 
publish in the Federal Register notices of all authorizations, 
terminations, and revocations. Subsection (i) makes clear that 
all determinations under this new section are committed to 
agency discretion. Subsection (j) is a rule of construction 
noting that this new section does not impair or otherwise 
affect certain existing authorities.
    New section 564(k) pertains to members of the Armed Forces 
and, among other things, it specifies that the President may 
waive requirements designed to ensure that such members are 
informed of the option to accept or refuse administration of an 
emergency use product, upon certain findings (which are 
identical to the findings found in section 1107 of Title 10). 
Further, the subsection requires that if certain information is 
not provided to members of the Armed Forces prior to an 
emergency use product being administered to them, then 
information concerning the administration of the product shall 
be placed in the medical record of the member.
    Subsection (l) makes clear that if a product is authorized 
for emergency use under this new section, the investigational 
sections of the Act shall not apply to the products.
    Subsection (m) ensures that no authority in new section 564 
can require a manufacturer of a drug, device, or biological 
product to perform any activity that becomes lawful pursuant to 
the new section. That is, the Commissioner in no way is given 
the authority to, among other things, require a manufacturer to 
introduce into interstate commerce or deliver for introduction 
into interstate commerce any unapproved product or an approved 
product for an unapproved use under this section. Further, even 
if the Commissioner authorizes the emergency use of an already-
approved, licensed or cleared product, a manufacturer can 
refuse to avail themselves of such emergency use authorization 
and continue introducing into interstate commerce its approved 
or cleared product under the Federal Food, Drug and Cosmetic 
Act, or licensed product pursuant to the Public Health Service 
Act. The only obligation in subsection (m) is that if the 
Commissioner authorizes the emergency use of a sole-source 
unapproved product, then the manufacturer of such product must 
inform the Commissioner of its intention not to carry out any 
activity under the authorization within a reasonable period of 
time. Nothing in this section shall be construed as authorizing 
the Commissioner to establish conditions on the distribution, 
administration, or labeling of any other product in any other 
circumstance.
    Subsection (n) ensures that the present enforcement regime 
of the Federal Food, Drug, and Cosmetic Act will apply to 
individuals who carry out an activity or activities pursuant to 
an authorization, but fail to comply with applicable 
conditions. If any person carries out an activity pursuant to 
section 564, but violates a condition imposed by the 
Commissioner, then that person will be subject to Chapter III 
of the Act, where the ``prohibited acts'' are found. If a 
person is found to be in violation of a prohibited act found in 
section 301, then the Committee intends for that person to be 
subject to the enforcement provisions found in sections 302, 
303, and 304. A violation of any condition applied to an 
emergency use product in no way alters or affects the emergency 
use status of the underlying product.

Section 5. Reports

    Section 5(a) requires the Secretary of HHS to submit annual 
reports to Congress concerning the exercise of many of the new 
authorities under the Act. Section 5(b) requires a report from 
the National Academy of Sciences concerning whether and to what 
extent the research authorities granted under the Act have 
enhanced the development of biomedical countermeasures 
affecting national security. Section 5(c) requires the General 
Accounting Office to issue a report concerning the Secretary of 
HHS utilization of these new authorities. Section 5(d) requires 
the Secretaries of HHS and DHS to report any additional 
barriers to procurement of security countermeasures which have 
not been addressed by Bioshield. The Secretaries should include 
in this report information as to whether there is a shortage of 
adequate biocontainment facilities or other resources for 
carrying out necessary research and development and testing. 
Section 5(e) requires the Secretary of DHS to report on the 
status of chemical preparedness.

Section 6. Ensuring coordination, cooperation and the elimination of 
        unnecessary duplication in programs designed to protect the 
        homeland from biological, chemical, radiological, and nuclear 
        agents

    Section 6 requires the Secretaries of the HHS, DHS, and DOD 
to coordinate their efforts to identify and develop 
countermeasures to biological, chemical, radiological, and 
nuclear threats. These Departments are instructed to designate 
agency coordination officers for this purpose.

Section 7. Outreach

    Section 7 instructs the Secretary of HHS to ensure that, to 
the extent practicable, Historically Black Colleges and 
Universities and other minority research institutions are made 
aware of research and development grants and procurements under 
Bioshield.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italics, existing law in which no change 
is proposed is shown in roman):

PUBLIC HEALTH SERVICE ACT

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TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *



Part B--Federal-State Cooperation

           *       *       *       *       *       *       *



SEC. 319F-1. AUTHORITY FOR USE OF CERTAIN PROCEDURES REGARDING 
                    BIOMEDICAL 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)) 
        that affects 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 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 qualified 
        countermeasure 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.
  (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 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) Use of noncompetitive procedures.--In addition to 
        any other authority to use procedures other than 
        competitive procedures, the Secretary may use such 
        other procedures when--
                  (A) the procurement is as described by 
                paragraph (1); 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 satisfy the 
                Secretary's needs.
          (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.
  (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 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 or cooperative agreement.
  (d) Authority for Personal Services Contracts.--
          (1) In general.--For the purpose of performing, 
        administering, and 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.

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))--
                          (i) against a chemical, biological, 
                        radiological, or nuclear agent 
                        identified as a material threat under 
                        paragraph (2)(A)(ii);
                          (ii) that is determined under 
                        paragraph (2)(B)(ii) to be a necessary 
                        countermeasure;
                          (iii) that is designed, developed, 
                        modified, or procured for the specific 
                        purpose of preventing, detecting, 
                        identifying, deterring, or mitigating 
                        actual or potential acts of chemical, 
                        biological, radiological, or nuclear 
                        catastrophe;
                          (iv)(I) that 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
                          (II) 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); and
                          (v) that relates to an actual or 
                        potential act of terrorism or 
                        catastrophic event or to actual or 
                        potential warfare.
          (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)) of any 
                determination made pursuant to subparagraph (A) 
                or (B). Such notice shall be in unclassified 
                and, 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 or available under 
                unsuitable conditions, 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) a 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 
                (2), (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 congress.--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 regulations 
                                to implement clauses (v), (vi), 
                                and (vii), and any other 
                                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.
                                  (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 sales of 
                                security countermeasures.--The 
                                contract may provide that the 
                                vendor will not at any time 
                                (including after performance 
                                under the contract is otherwise 
                                completed) sell or otherwise 
                                provide such countermeasure to 
                                any domestic or foreign person, 
                                or transfer to any such person 
                                any quantity of such security 
                                countermeasure, or any 
                                intellectual property relating 
                                thereto that would enable the 
                                development or production of 
                                the countermeasure, without 
                                certification by the Secretary, 
                                in consultation with the 
                                Homeland Security Secretary, 
                                the Secretary of Defense, and 
                                the Secretary of State, that 
                                such sale or transfer, or 
                                category of sales or transfers, 
                                would not adversely affect the 
                                national security; and that, 
                                for each violation of this 
                                provision of the contract, the 
                                United States is entitled to 
                                recover from the person as 
                                liquidated damages an amount 
                                equal to three times the sum of 
                                the payments made to the vendor 
                                under the contract.
                          (iii) Availability of simplified 
                        acquisition procedures.--
                                  (I) In general.--The amount 
                                of any 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) 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 subsection 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 the Secretary's needs.
                          (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 Homeland 
        Security 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.

           *       *       *       *       *       *       *


TITLE IV--NATIONAL RESEARCH INSTITUTES

           *       *       *       *       *       *       *


Part E--Other Agencies of NIH

           *       *       *       *       *       *       *


SEC. 481A. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.

  (a) Modernization and Construction of Facilities.--
          (1) In general.--The Director of NIH, acting through 
        the Director of the Center or the Director of the 
        National Institute of Allergy and Infectious Diseases, 
        may make grants or contracts to public and nonprofit 
        private entities to expand, remodel, renovate, or alter 
        existing research facilities or construct new research 
        facilities, subject to the provisions of this section.

           *       *       *       *       *       *       *

  (c) Requirements for Grants.--
          (1) In general.--The Director of the Center or the 
        Director of the National Institute of Allergy and 
        Infectious Diseases may make a grant under subsection 
        (a) only if the applicant for the grant meets the 
        following conditions:
                  (A) * * *

           *       *       *       *       *       *       *

          (2) Institutions of emerging excellence.--From the 
        amount appropriated under [subsection (i)] subsection 
        (i)(1) for a fiscal year up to $50,000,000, the 
        Director of the Center shall make available 25 percent 
        of such amount, and from the amount appropriated under 
        such subsection for a fiscal year that is over 
        $50,000,000, the Director of the Center shall make 
        available up to 25 percent of such amount, for grants 
        under subsection (a) to applicants that in addition to 
        meeting the requirements established in paragraph (1), 
        have demonstrated emerging excellence in biomedical or 
        behavioral research, as follows:
                  (A) * * *

           *       *       *       *       *       *       *

  (d) Requirement of Application.--The Director of the Center 
or the Director of the National Institute of Allergy and 
Infectious Diseases may make a grant under subsection (a) only 
if an application for the grant is submitted to the Director 
and the application is in such form, is made in such manner, 
and contains such agreements, assurances, and information as 
the Director determines to be necessary to carry out this 
section.
  (e) Amount of Grant; Payments.--
          (1) Amount.--The amount of any grant awarded under 
        subsection (a) shall be determined by the Director of 
        the Center or the Director of the National Institute of 
        Allergy and Infectious Diseases, except that such 
        amount shall not exceed--
                  (A) 50 percent (or, in the case of the 
                Institute, 75 percent) of the necessary cost of 
                the construction of a proposed facility as 
                determined by the Director; or
                  (B) in the case of a multipurpose facility, 
                40 percent (or, in the case of the Institute, 
                75 percent) of that part of the necessary cost 
                of construction that the Director determines to 
                be proportionate to the contemplated use of the 
                facility.
          (2) Reservation of amounts.--On the approval of any 
        application for a grant under subsection (a), the 
        Director of the Center or the Director of the National 
        Institute of Allergy and Infectious Diseases shall 
        reserve, from any appropriation available for such 
        grants, the amount of such grant, and shall pay such 
        amount, in advance or by way of reimbursement, and in 
        such installments consistent with the construction 
        progress, as the Director may determine appropriate. 
        The reservation of any amount by the Director under 
        this paragraph may be amended by the Director, either 
        on the approval of an amendment of the application or 
        on the revision of the estimated cost of construction 
        of the facility.

           *       *       *       *       *       *       *

          (4) Waiver of limitations.--The limitations imposed 
        under paragraph (1) may be waived at the discretion of 
        the Director of the Center or the Director of the 
        National Institute of Allergy and Infectious Diseases 
        for applicants meeting the conditions described in 
        subsection (c).
  (f ) Recapture of Payments.--If, not later than 20 years 
after the completion of construction for which a grant has been 
awarded under subsection (a)--
          (1) in the case of an award by the Director of the 
        Center, the applicant or other owner of the facility 
        shall cease to be a public or non profit private 
        entity; or
          (2) the facility shall cease to be used for the 
        research purposes for which it was constructed (unless 
        the Director of the Center or the Director of the 
        National Institute of Allergy and Infectious Diseases 
        determines, in accordance with regulations, that there 
        is good cause for releasing the applicant or other 
        owner from obligation to do so),
the United States shall be entitled to recover from the 
applicant or other owner of the facility the amount bearing the 
same ratio to the current value (as determined by an agreement 
between the parties or by action brought in the United States 
District Court for the district in which such facility is 
situated) of the facility as the amount of the Federal 
participation bore to the cost of the construction of such 
facility.

           *       *       *       *       *       *       *

  (i) Authorization of [Appropriations.--For the purpose of 
carrying out this section,] Appropriations.--
          (1) Center.--For the purpose of carrying out this 
        section with respect to the Center, there are 
        authorized to be appropriated $250,000,000 for fiscal 
        year 2001, and such sums as may be necessary for each 
        of the fiscal years 2002 and 2003.
          (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 fiscal 
        year 2003.
                              ----------                              


            SECTION 510 OF THE HOMELAND SECURITY ACT OF 2002

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 2004, and such 
        sums as may be necessary for each of the fiscal years 
        2005 and 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.
  (e) Emergency Development of Security Countermeasures.--If 
the Secretary of Homeland Security and the Secretary of Health 
and Human Services jointly determine that procurement of a 
security countermeasure that has been approved for procurement 
using the special reserve fund under subsection (a)--
          (1) is not proceeding at a sufficiently rapid pace 
        under 319F-2 of the Public Health Service Act to 
        protect the national security; or
          (2) could be produced significantly less expensively 
        by the government directly than through procurements 
        under such section;
then amounts in the special reserve fund may be used by the 
Secretary of Health and Human Services to produce security 
countermeasures for placement in the stockpile under subsection 
(a) of section 319F-2 of such Act if the joint determination is 
submitted to the President and the President approves such use 
of the special reserve fund. Amounts made available for such 
use in accordance with the preceding sentence are available for 
obligation as of the date on which the presidential approval is 
made, subject to applicable law regarding the apportionment of 
appropriations. This subsection applies notwithstanding other 
provisions of this section, and notwithstanding section 319F-2 
of the Public Health Service Act. This subsection may not be 
construed as affecting the amounts specified in subsection (a) 
as authorizations of appropriations or the obligation limits 
contained therein.
                              ----------                              


SECTION 121 OF THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS 
                        AND RESPONSE ACT OF 2002

[SEC. 121. STRATEGIC NATIONAL STOCKPILE.

  [(a) Strategic National Stockpile.--
          [(1) In general.--The Secretary of Health and Human 
        Services (referred to in this section as the 
        ``Secretary''), in coordination with 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) of the Public Health Service 
                Act;
                  [(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 the 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) Disclosures.--No Federal agency shall disclose under 
section 552, United States Code, any information identifying 
the location at which materials in the stockpile under 
subsection (a) are stored.
  [(d) 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 the Secretary supplies 
        described in subsection (a).
  [(e) 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.
          [(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.]
                              ----------                              


        SECTION 564 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

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 or device 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 ``emergency use'' has the 
                meaning indicated for such term in paragraph 
                (1).
                  (B) The term ``product'' means a drug or 
                device.
                  (C) The term ``unapproved product'' has the 
                meaning indicated for such term in paragraph 
                (2)(A).
                  (D) 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.--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.





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