[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 15 Reported in Senate (RS)]






                                                        Calendar No. 53
108th CONGRESS
  1st Session
                                 S. 15

 To amend the Public Health Service Act to provide for the payment of 
 compensation for certain individuals with injuries resulting from the 
administration of smallpox countermeasures, to provide protections and 
countermeasures against chemical, radiological, or nuclear agents that 
  may be used in a terrorist attack against the United States, and to 
 improve immunization rates by increasing the distribution of vaccines 
 and improving and clarifying the vaccine injury compensation program.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 11, 2003

Mr. Gregg (for himself, Mr. Frist, Mr. Alexander, Mr. Warner, Mr. Enzi, 
Mr. Sessions, Mr. Roberts, Mr. Graham of South Carolina, Mr. Bond,  Mr. 
Inhofe, and Mr. Stevens) introduced the following bill; which was read 
 twice and referred to the Committee on Health, Education, Labor, and 
                                Pensions

                             March 25, 2003

                Reported by Mr. Gregg, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Service Act to provide for the payment of 
 compensation for certain individuals with injuries resulting from the 
administration of smallpox countermeasures, to provide protections and 
countermeasures against chemical, radiological, or nuclear agents that 
  may be used in a terrorist attack against the United States, and to 
 improve immunization rates by increasing the distribution of vaccines 
 and improving and clarifying the vaccine injury compensation program.

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

<DELETED>SECTION 1. SHORT TITLE; TABLE OF CONTENTS.</DELETED>

<DELETED>    (a) Short Title.--This Act may be cited as the 
``Biodefense Improvement and Treatment for America Act''.</DELETED>
<DELETED>    (b) Table of Contents.--The table of contents of this Act 
is as follows:</DELETED>

<DELETED>Sec. 1. Short title; table of contents.
     <DELETED>TITLE I--PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL

<DELETED>Sec. 101. Short title.
<DELETED>Sec. 102. Amendment to the Public Health Service Act.
                  <DELETED>TITLE II--PROJECT BIOSHIELD

<DELETED>Sec. 201. Short title.
<DELETED>Sec. 202. Biomedical countermeasure research and development 
                            authorities.
<DELETED>Sec. 203. Biomedical countermeasures procurement.
<DELETED>Sec. 204. Authorization for medical products for use in 
                            emergencies.
<DELETED>Sec. 205. Developing new countermeasures and protecting 
                            existing countermeasures against 
                            bioterrorism.
  <DELETED>TITLE III--IMPROVED VACCINE AFFORDABILITY AND AVAILABILITY

<DELETED>Sec. 301. Short title.
               <DELETED>Subtitle A--State Vaccine Grants

<DELETED>Sec. 311. Availability of influenza vaccine.
<DELETED>Sec. 312. Program for increasing immunization rates for adults 
                            and adolescents; collection of additional 
                            immunization data.
<DELETED>Sec. 313. Immunization awareness.
<DELETED>Sec. 314. Supply of vaccines.
<DELETED>Sec. 315. Communication.
<DELETED>Sec. 316. Fast track. 
<DELETED>Sec. 317. Study.
        <DELETED>Subtitle B--Vaccine Injury Compensation Program

<DELETED>Sec. 321. Administrative revision of vaccine injury table.
<DELETED>Sec. 322. Equitable relief.
<DELETED>Sec. 323. Derivative petitions for compensation.
<DELETED>Sec. 324. Jurisdiction to dismiss actions improperly brought.
<DELETED>Sec. 325. Clarification of when injury is caused by factor 
                            unrelated to administration of vaccine.
<DELETED>Sec. 326. Increase in award in the case of a vaccine-related 
                            death and for pain and suffering.
<DELETED>Sec. 327. Basis for calculating projected lost earnings.
<DELETED>Sec. 328. Allowing compensation for family counseling expenses 
                            and expenses of establishing and 
                            maintaining guardianship.
<DELETED>Sec. 329. Allowing payment of interim costs.
<DELETED>Sec. 330. Procedure for paying attorneys' fees.
<DELETED>Sec. 331. Extension of statute of limitations.
<DELETED>Sec. 332. Advisory Commission on Childhood Vaccines.
<DELETED>Sec. 333. Clarification of standards of responsibility.
<DELETED>Sec. 334. Clarification of definition of manufacturer.
<DELETED>Sec. 335. Clarification of definition of vaccine-related 
                            injury or death.
<DELETED>Sec. 336. Clarification of definition of vaccine and 
                            definition of physical injury.
<DELETED>Sec. 337. Amendments to Vaccine Injury Compensation Trust 
                            Fund.
<DELETED>Sec. 338. Ongoing review of childhood vaccine data.
<DELETED>Sec. 339. Pending actions.
<DELETED>Sec. 340. Report.

<DELETED>TITLE I--PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL</DELETED>

<DELETED>SEC. 101. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Smallpox Emergency 
Personnel Protection Act of 2003''.</DELETED>

<DELETED>SEC. 102. AMENDMENT TO THE PUBLIC HEALTH SERVICE 
              ACT.</DELETED>

<DELETED>    Part A of title II of the Public Health Service Act (42 
U.S.C. 202 et seq.) is amended by inserting after section 224 the 
following:</DELETED>

<DELETED>``SEC. 224A. PROTECTION FOR SMALLPOX EMERGENCY 
              PERSONNEL.</DELETED>

<DELETED>    ``(a) Definitions.--In this section:</DELETED>
        <DELETED>    ``(1) Covered countermeasure.--The term `covered 
        countermeasure' means a covered countermeasure as specified in 
        article III of the Declaration.</DELETED>
        <DELETED>    ``(2) Covered individual.--The term `covered 
        individual' means an individual--</DELETED>
                <DELETED>    ``(A) who is--</DELETED>
                        <DELETED>    ``(i) a health care worker, a law 
                        enforcement officer, a firefighter, a security-
                        related worker, an emergency medical worker, or 
                        a public safety worker who is identified in a 
                        State, local, or Department of Health and Human 
                        Services plan that is approved by the 
                        Secretary; or</DELETED>
                        <DELETED>    ``(ii) an individual with respect 
                        to whom the Secretary determines and declares 
                        that it is advisable to administer the vaccine 
                        (not including any individual to whom the 
                        Secretary determines only that such vaccine 
                        should be made available); and</DELETED>
                <DELETED>    ``(B) to whom a vaccine is administered 
                during the period in which the Declaration is effective 
                (including the portion of such period before the date 
                of enactment of this section) and ending on the later 
                of--</DELETED>
                        <DELETED>    ``(i) the expiration of the 120-
                        day period that begins on the effective date of 
                        the initial interim final regulations to 
                        implement this section;</DELETED>
                        <DELETED>    ``(ii) the expiration of the 120-
                        day period that begins on the date on which an 
                        individual becomes an individual within a 
                        category specified in subparagraph (A); 
                        or</DELETED>
                        <DELETED>    ``(iii) the date on which the 
                        Secretary publicly announces that an active 
                        case of smallpox has been identified either 
                        within or outside the United States.</DELETED>
        <DELETED>    ``(3) Covered injury.--The term `covered injury' 
        includes--</DELETED>
                <DELETED>    ``(A) an injury, disability, illness, 
                condition, or death determined, pursuant to the 
                procedures established under subsection (b), to have 
                been sustained as the direct result of administration 
                to an individual of a covered countermeasure during the 
                effective period of the Declaration (other than a minor 
                injury such as minor scarring or minor local reaction); 
                and</DELETED>
                <DELETED>    ``(B) an injury, disability, illness, 
                condition, or death determined, pursuant to the 
                procedures established under subsection (b), to have 
                been sustained as the direct result of accidental 
                vaccinia inoculation through contact with an individual 
                who is (or who was accidentally inoculated by) an 
                individual in a category specified in Article IV of the 
                Declaration to whom vaccinia vaccine has been 
                administered during the effective period of the 
                Declaration.</DELETED>
        <DELETED>    ``(4) Declaration.--The term `Declaration' means 
        the Declaration Regarding Administration of Smallpox 
        Countermeasures issued by the Secretary of Health and Human 
        Services on January 24, 2003, and published in the Federal 
        Register on January 28, 2003, including any subsequent 
        amendment.</DELETED>
        <DELETED>    ``(5) Eligible individual.--The term `eligible 
        individual' means an individual who is (as determined in 
        accordance with section 3)--</DELETED>
                <DELETED>    ``(A) a covered individual who sustains a 
                covered injury as the direct result of administration 
                of a covered countermeasure; or</DELETED>
                <DELETED>    ``(B) any individual who contracts 
                vaccinia during the effective period of the Declaration 
                or within 30 days after the end of such period--
                </DELETED>
                        <DELETED>    ``(i) to whom vaccinia vaccine was 
                        not administered;</DELETED>
                        <DELETED>    ``(ii) who has resided with, or 
                        has been in close contact with, a covered 
                        individual; and</DELETED>
                        <DELETED>    ``(iii) who sustains a covered 
                        injury as the direct result of contracting 
                        vaccinia.</DELETED>
        <DELETED>    ``(6) Secretary.--Except as provided otherwise, 
        the term `Secretary' means the Secretary of Health and Human 
        Services.</DELETED>
<DELETED>    ``(b) Determination of Eligibility.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary, in consultation 
        with the Attorney General and the Secretary of Labor, shall 
        establish administrative procedures for determining, as 
        applicable with respect to an individual--</DELETED>
                <DELETED>    ``(A) whether the individual is an 
                eligible individual;</DELETED>
                <DELETED>    ``(B) whether the individual has sustained 
                a covered injury or injuries for which medical benefits 
                and employment income-loss compensation may be 
                available under subsections (d) and (e), and the amount 
                of such benefits or compensation; and</DELETED>
                <DELETED>    ``(C) whether the covered injury or 
                injuries of the individual constitute a compensable 
                disability, or caused the individual's death, for 
                purposes of benefits under subsection (f).</DELETED>
        <DELETED>    ``(2) Covered individuals.--The Secretary may 
        accept a certification, by a Federal, State, or local 
        government entity or private health care entity participating 
        in the administration of covered countermeasures under the 
        Declaration, that an individual is an individual in a category 
        specified in article IV of the Declaration to whom such a 
        countermeasure has been administered by the applicable deadline 
        specified in subsection (a)(2)(B), as establishing that the 
        individual is a covered individual.</DELETED>
        <DELETED>    ``(3) Determination of causation.--</DELETED>
                <DELETED>    ``(A) Injuries specified in injury 
                table.--In any case where an injury or other adverse 
                effect specified in the injury table established under 
                subsection (c) as a known effect of a covered 
                countermeasure manifests in an individual within the 
                time period specified in such table, such injury or 
                other effect shall be rebuttably presumed to have 
                resulted from administration of such covered 
                countermeasure.</DELETED>
                <DELETED>    ``(B) Other determinations.--In making 
                determinations other than those described in 
                subparagraph (A) as to the causation or severity of an 
                injury, the Secretary shall take into consideration all 
                relevant medical and scientific evidence presented for 
                consideration, and may obtain and consider the views of 
                qualified medical experts.</DELETED>
        <DELETED>    ``(4) Deadline for filing claim.--The Secretary 
        shall not consider any claim for a benefit under this 
        subsection with respect to an individual that is filed later 
        than 1 year after--</DELETED>
                <DELETED>    ``(A) the date a covered countermeasure 
                was administered to the individual; or</DELETED>
                <DELETED>    ``(B) in the case of a claim based on 
                contact vaccination (as described in subsection 
                (a)(5)(B)), the date of the first symptom or 
                manifestation of onset of an adverse effect of such 
                vaccination.</DELETED>
        <DELETED>    ``(5) Review of determination.--</DELETED>
                <DELETED>    ``(A) Secretary's review authority.--The 
                Secretary may review a determination under this 
                subsection at any time on the Secretary's own motion or 
                on application, and may affirm, vacate, or modify such 
                determination.</DELETED>
                <DELETED>    ``(B) Secretary's action not judicially 
                reviewable.--The determinations of the Secretary under 
                this subsection shall not be subject to review by 
                another official of the United States or by a court by 
                mandamus or otherwise.</DELETED>
<DELETED>    ``(c) Countermeasure Injury Table.--</DELETED>
        <DELETED>    ``(1) Smallpox countermeasure injury table.--The 
        Secretary shall establish by interim final regulation a table 
        identifying--</DELETED>
                <DELETED>    ``(A) adverse effects (including injuries, 
                disabilities, illnesses, conditions, and deaths) that 
                shall be presumed to result from the administration of 
                (or exposure to) a covered countermeasure; 
                and</DELETED>
                <DELETED>    ``(B) the time periods in which the first 
                symptom, or manifestation of onset of each such adverse 
                effect, must manifest in order for such presumption to 
                apply.</DELETED>
        <DELETED>    ``(2) Amendments.--The Secretary may amend by 
        regulation the table established under paragraph (1). Such 
        amendments shall apply retroactively to claims filed or pending 
        at the time of the promulgation of final amending regulations 
        and to claims filed after such promulgation.</DELETED>
<DELETED>    ``(d) Medical Benefits.--</DELETED>
        <DELETED>    ``(1) In general.--Subject to paragraph (2), an 
        eligible individual shall be entitled to payment by the 
        Secretary for medical items and services as reasonable and 
        necessary to treat a covered injury. The Secretary may consider 
        the provisions of chapter 81 of title 5, United States Code, 
        (and the implementing regulations with respect to such chapter) 
        in determining the amount of such payment and the circumstances 
        under which such payments are reasonable and 
        necessary.</DELETED>
        <DELETED>    ``(2) Limitations.--</DELETED>
                <DELETED>    ``(A) Benefits secondary to other 
                coverage.--The obligation of the Secretary to pay for 
                any services or benefits under paragraph (1) shall be 
                secondary to the obligation of the United States or any 
                third party (including any State or local governmental 
                entity, private insurance carrier, or employer) under 
                any other provision of law or contractual agreement, to 
                pay for or provide such services or benefits.</DELETED>
                <DELETED>    ``(B) No benefits for medicare-eligible 
                individual.--No benefits shall be available to an 
                individual under this subsection with respect to any 
                period in which the individual is eligible for benefits 
                under title XVIII of the Social Security section (42 
                U.S.C. 1395 et seq.).</DELETED>
<DELETED>    ``(e) Compensation for Lost Employment Income.--</DELETED>
        <DELETED>    ``(1) In general.--Subject to paragraphs (2) and 
        (3), an eligible individual shall be entitled to payment of 
        compensation by the Secretary for loss of employment income 
        incurred as a result of a covered injury, at the rate specified 
        in paragraph (2).</DELETED>
        <DELETED>    ``(2) Amount of compensation.--</DELETED>
                <DELETED>    ``(A) In general.--Compensation under this 
                subsection shall be at the rate of 
                66</DELETED>\<DELETED>2/3</DELETED>\ <DELETED>percent 
                of monthly pay. The Secretary may consider the 
                provisions of sections 8114 and 8115 of title 5, United 
                States Code (and any implementing regulations) in 
                determining the amount of such payment and the 
                circumstances under which such payments are reasonable 
                and necessary.</DELETED>
                <DELETED>    ``(B) Treatment of self-employment 
                income.--For purposes of this subsection--</DELETED>
                        <DELETED>    ``(i) the term `employment income' 
                        includes income from self-employment; 
                        and</DELETED>
                        <DELETED>    ``(ii) for purposes of computation 
                        of pay and determination of wage-earning 
                        capacity under subparagraph (A), self-
                        employment income shall be treated as 
                        wages.</DELETED>
        <DELETED>    ``(3) Limitations.--</DELETED>
                <DELETED>    ``(A) Benefits secondary to other 
                coverage.--The obligation of the Secretary to pay 
                compensation under paragraph (1) shall be secondary to 
                the obligation of the United States or any third party 
                (including any State or local governmental entity, 
                private insurance carrier, or employer), under any 
                other law or contractual agreement, to pay compensation 
                for loss of employment income.</DELETED>
                <DELETED>    ``(B) No benefits for death or permanent 
                and total disability.--No payment shall be made under 
                this subsection in compensation for loss of employment 
                income due to the death or permanent and total 
                disability of an eligible individual.</DELETED>
                <DELETED>    ``(C) Limit on total benefits.--Total 
                benefits paid to an individual under this subsection 
                shall not exceed $50,000.</DELETED>
                <DELETED>    ``(D) Waiting period.--An eligible 
                individual is not entitled to compensation under this 
                subsection for the first 5 work days of 
                disability.</DELETED>
<DELETED>    ``(f) Payment for Death and Permanent, Total Disability.--
</DELETED>
        <DELETED>    ``(1) Benefit for permanent and total 
        disability.--Subject to the succeeding provisions of this 
        subsection, an eligible individual who is determined, in 
        accordance with the procedures established under subsection 
        (b), to have a covered injury or injuries meeting the 
        definition of disability in section 216(i) of the Social 
        Security Act (42 U.S.C. 416(i)) shall be entitled to have 
        payment made by the Secretary of an amount determined under 
        paragraph (3), in the same manner as disability benefits are 
        paid pursuant to the Public Safety Officers' Benefits Program 
        under subpart 1 of part L of title I of the Omnibus Crime 
        Control and Safe Streets Act of 1968 (42 U.S.C. 3796 et seq.) 
        with respect to an eligible public safety officer.</DELETED>
        <DELETED>    ``(2) Death benefit.--Subject to the succeeding 
        provisions of this subsection, in the case of an eligible 
        individual whose death is determined, in accordance with the 
        procedures established under subsection (b), to have directly 
        resulted from a covered injury or injuries a death benefit in 
        the amount determined under paragraph (3) shall be payable by 
        the Secretary to the survivor or survivors in the same manner 
        as death benefits are paid pursuant to the Public Safety 
        Officers' Benefits Program under subpart 1 of part L of title I 
        of the Omnibus Crime Control and Safe Streets Act of 1968 (42 
        U.S.C. 3796 et seq.) with respect to an eligible deceased 
        public safety officer.</DELETED>
        <DELETED>    ``(3) Benefit amount.--The amount of the 
        disability or death benefit under paragraph (1) or (2) in a 
        fiscal year shall, subject to paragraph (5)(B), equal the 
        amount of the comparable benefit calculated under the Public 
        Safety Officers' Benefits Program under subpart 1 of part L of 
        title I of the Omnibus Crime Control and Safe Streets Act of 
        1968 (42 U.S.C. 3796 et seq.) in such fiscal year, without 
        regard to any reduction attributable to a limitation on 
        appropriations.</DELETED>
        <DELETED>    ``(4) Benefit in addition to medical benefits.--A 
        benefit under this subsection shall be in addition to any 
        amounts to which an eligible individual may be entitled as 
        medical benefits under subsection (d).</DELETED>
        <DELETED>    ``(5) Limitations.--</DELETED>
                <DELETED>    ``(A) Disability benefits.--No benefit is 
                payable under paragraph (1) with respect to the 
                disability of an eligible individual if--</DELETED>
                        <DELETED>    ``(i) a disability benefit is paid 
                        or payable with respect to such individual 
                        under Public Safety Officers' Benefits Program 
                        under subpart 1 of part L of title I of the 
                        Omnibus Crime Control and Safe Streets Act of 
                        1968 (42 U.S.C. 3796 et seq.); or</DELETED>
                        <DELETED>    ``(ii) a death benefit is paid or 
                        payable with respect to such individual under 
                        paragraph (2) or the Public Safety Officers' 
                        Benefits Program under subpart 1 of part L of 
                        title I of the Omnibus Crime Control and Safe 
                        Streets Act of 1968 (42 U.S.C. 3796 et 
                        seq.).</DELETED>
                <DELETED>    ``(B) Death benefits.--No benefit is 
                payable under paragraph (2) with respect to the death 
                of an eligible individual if--</DELETED>
                        <DELETED>    ``(i) a disability benefit is paid 
                        with respect to such individual under paragraph 
                        (1) or the Public Safety Officers' Benefits 
                        Program under subpart 1 of part L of title I of 
                        the Omnibus Crime Control and Safe Streets Act 
                        of 1968 (42 U.S.C. 3796 et seq.); or</DELETED>
                        <DELETED>    ``(ii) a death benefit is paid or 
                        payable with respect to such individual under 
                        the Public Safety Officers' Benefits Program 
                        under subpart 1 of part L of title I of the 
                        Omnibus Crime Control and Safe Streets Act of 
                        1968 (42 U.S.C. 3796 et seq.).</DELETED>
<DELETED>    ``(g) Administration.--</DELETED>
        <DELETED>    ``(1) Administration by agreement with other 
        agency or agencies.--The Secretary may administer any or all of 
        the provisions of this section through Memorandum of Agreement 
        with the Attorney General or the Secretary of Labor.</DELETED>
        <DELETED>    ``(2) Regulations.--The head of the agency 
        administering this section or any provisions thereof (including 
        any agency head administering such section or provisions 
        through a Memorandum of Agreement under paragraph (1)) may 
        promulgate such implementing regulations as may be determined 
        necessary and appropriate. Initial implementing regulations may 
        be interim final regulations.</DELETED>
<DELETED>    ``(h) Authorization of Appropriations.--There are 
authorized to be appropriated such sums as may be necessary for fiscal 
year 2003 and each succeeding fiscal year to carry out this section, to 
remain available until expended, including administrative costs and 
costs of provision and payment of benefits.</DELETED>
<DELETED>    ``(i) Relationship to Other Laws.--</DELETED>
        <DELETED>    ``(1) No preemption of individual rights.--Except 
        as otherwise provided in this section, nothing in this section 
        shall be construed to override or limit any rights an 
        individual may have to seek compensation, benefits, or redress 
        under any other provision of Federal or State law.</DELETED>
        <DELETED>    ``(2) Relationship to the federal tort claims 
        act.--</DELETED>
                <DELETED>    ``(A) Exhaustion requirement.--An 
                individual may not seek any remedy that may be 
                available under section 224(p) (providing a cause of 
                action under the Federal Tort Claims Act for injuries 
                resulting from administration of smallpox 
                countermeasures under such section 224(p)) unless such 
                individual has first filed a claim for payment or 
                compensation under this section and has received a 
                final determination with respect to such 
                claim.</DELETED>
                <DELETED>    ``(B) Offset of compensation against 
                federal tort claims act recovery.--The value of any 
                compensation or benefits paid to an individual, or the 
                survivor or survivors of such an individual, or the 
                estate of the individual pursuant to a claim under this 
                section shall be offset against any amount to which 
                such individual or the individual's survivor, 
                survivors, or estate are entitled under section 
                224(p).</DELETED>
        <DELETED>    ``(3) Preemption of state laws providing exclusive 
        remedy for work-related injuries.--No provision of a State 
        workers' compensation law or other State law shall be construed 
        to bar claims or benefits under this section, to the extent 
        that it purports to make such State law the exclusive remedy 
        for a work-related injury or otherwise to make benefits under 
        this section unavailable to an otherwise eligible 
        individual.''.</DELETED>

             <DELETED>TITLE II--PROJECT BIOSHIELD</DELETED>

<DELETED>SEC. 201. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Project BioShield Act of 
2003''.</DELETED>

<DELETED>SEC. 202. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT 
              AUTHORITIES.</DELETED>

<DELETED>    Part B of title IV of the Public Health Service Act (42 
U.S.C. 284 et seq.) is amended by adding at the end the 
following:</DELETED>

<DELETED>``SEC. 409I. BIOMEDICAL COUNTERMEASURE RESEARCH AND 
              DEVELOPMENT.</DELETED>

<DELETED>    ``(a) In General.--</DELETED>
        <DELETED>    ``(1) Authority.--In carrying out research 
        responsibilities under this Act, the Secretary may conduct and 
        support research and development with respect to biomedical 
        countermeasures.</DELETED>
        <DELETED>    ``(2) Implementation.--</DELETED>
                <DELETED>    ``(A) In general.--Except as provided in 
                subparagraph (C), authorities assigned by this section 
                to the Secretary shall be carried out through the 
                Director of NIH and the Director of the National 
                Institute of Allergy and Infectious Diseases.</DELETED>
                <DELETED>    ``(B) Lead institute.--The National 
                Institute of Allergy and Infectious Diseases shall be 
                the lead institute for biomedical countermeasure 
                research and development under this section.</DELETED>
                <DELETED>    ``(C) Chemical, radiological, and nuclear 
                agents.--To the extent that an authority described in 
                subparagraph (A) is exercised with respect to a 
                chemical, radiological, or nuclear agent, the Secretary 
                may authorize the Director of NIH to carry out the 
                authority through any national research 
                institute.</DELETED>
        <DELETED>    ``(3) Interagency cooperation.--</DELETED>
                <DELETED>    ``(A) In general.--In carrying out 
                activities under this section, the Secretary is 
                authorized, subject to subparagraph (B), to enter into 
                interagency agreements and other collaborative 
                undertakings with other agencies of the Federal 
                Government and to use other agencies of the Department 
                of Health and Human Services.</DELETED>
                <DELETED>    ``(B) Limitation.--An agreement or 
                undertaking under this paragraph may not authorize 
                another agency to exercise the authorities provided to 
                the Secretary by this section.</DELETED>
<DELETED>    ``(b) Expedited Procurement Authority.--</DELETED>
        <DELETED>    ``(1) Increased simplified acquisition threshold 
        for biomedical countermeasure procurements.--</DELETED>
                <DELETED>    ``(A) In general.--For any procurement by 
                the Secretary, of property or services for use (as 
                determined by the Secretary) in performing, 
                administering, or supporting biomedical countermeasure 
                research or development, the amount specified in 
                section 4(11) of the Office of Federal Procurement 
                Policy Act (41 U.S.C. 403(11)), as applicable pursuant 
                to section 302A(a) of the Federal Property and 
                Administrative Services Act of 1949 (41 U.S.C. 
                252a(a)), shall be deemed to be $25,000,000 in the 
                administration, with respect to such procurement, of--
                </DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(ii) section 302A(b) of such Act 
                        (41 U.S.C. 252a(b)) and its implementing 
                        regulations.</DELETED>
                <DELETED>    ``(B) Internal controls to be 
                instituted.--The Secretary shall institute appropriate 
                internal controls for procurements made under this 
                paragraph, including requirements with respect to 
                documenting the justification for use of the authority 
                provided in this paragraph.</DELETED>
        <DELETED>    ``(2) Use of noncompetitive procedures.--In 
        addition to any other authority to use procedures other than 
        competitive procedures for procurements, the Secretary may use 
        such other noncompetitive procedures when--</DELETED>
                <DELETED>    ``(A) the procurement is as described by 
                paragraph (1)(A); and</DELETED>
                <DELETED>    ``(B) the property or services needed by 
                the Secretary are available from only one responsible 
                source or only from a limited number of responsible 
                sources, and no other type of property or services will 
                meet the needs of the Secretary.</DELETED>
        <DELETED>    ``(3) Increased micropurchase threshold.--
        </DELETED>
                <DELETED>    ``(A) In general.--For a procurement 
                described by paragraph (1)(A), the amount specified in 
                subsections (c), (d), and (f) of section 32 of the 
                Office of Federal Procurement Policy Act (41 U.S.C. 
                428) shall be deemed to be $15,000 in the 
                administration of that section with respect to such 
                procurement.</DELETED>
                <DELETED>    ``(B) Internal controls to be 
                instituted.--The Secretary shall institute appropriate 
                internal controls for procurements that are made under 
                this paragraph and that are greater than 
                $2,500.</DELETED>
                <DELETED>    ``(C) Exception to preference for purchase 
                card mechanism.--No provision of law establishing a 
                preference for using a Federal Government purchase card 
                method for purchases shall apply to procurements made 
                under this paragraph and that are greater than 
                $2,500.</DELETED>
<DELETED>    ``(c) Authority To Expedite Peer Review.--The Secretary 
may, as the Secretary determines necessary to respond to pressing 
research and development needs under this section, employ such 
expedited peer review procedures (including consultation with 
appropriate scientific experts) as the Secretary, in consultation with 
the Director of NIH, determines to be appropriate to obtain an 
assessment of scientific and technical merit and likely contribution to 
the field of biomedical countermeasure research, in place of the peer 
review and advisory council review procedures that would otherwise be 
required under sections 301(a)(3), 405(b)(1)(B), 405(b)(2), 
406(a)(3)(A), 492, and 494, as applicable to a grant, contract, or 
cooperative agreement--</DELETED>
        <DELETED>    ``(1) that is for performing, administering, or 
        supporting biomedical countermeasure research and development; 
        and</DELETED>
        <DELETED>    ``(2) the amount of which is not greater than 
        $1,500,000.</DELETED>
<DELETED>    ``(d) Facilities Authority.--</DELETED>
        <DELETED>    ``(1) Agency facilities.--In addition to any 
        similar authority provided under any other provision of law, in 
        carrying out this section, the Secretary may--</DELETED>
                <DELETED>    ``(A) acquire, lease, construct, improve, 
                renovate, remodel, repair, operate, and maintain 
                laboratories, other research facilities and equipment, 
                and other real or personal property as the Secretary 
                determines necessary for the purpose of performing, 
                administering, and supporting biomedical countermeasure 
                research and development; and</DELETED>
                <DELETED>    ``(B) acquire, without regard to section 
                8141 of title 40, United States Code, by lease or 
                otherwise, through the Administrator of General 
                Services, buildings or parts of buildings in the 
                District of Columbia.</DELETED>
        <DELETED>    ``(2) Facilities of grantee or cooperative 
        agreement partner.--</DELETED>
                <DELETED>    ``(A) In general.--The Secretary may 
                exercise the authorities described in section 481A with 
                respect to biocontainment laboratories and other 
                related or ancillary specialized research facilities as 
                the Secretary determines necessary for the purpose of 
                performing, administering, and supporting biomedical 
                countermeasure research and development.</DELETED>
                <DELETED>    ``(B) Availability of facility to 
                secretary.--A grant or cooperative agreement under 
                subparagraph (A) 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.</DELETED>
                <DELETED>    ``(C) Twenty year use requirement.--A 
                grant or cooperative agreement under this paragraph 
                shall include an agreement by the grantee or 
                cooperative agreement partner that, for not less than 
                20 years after the completion of the acquisition, 
                construction, or other work described in subparagraph 
                (A), the facility will be used for the purposes of the 
                research and development for which it is to be 
                acquired, constructed, or otherwise improved.</DELETED>
                <DELETED>    ``(D) Amount of grant; cost-sharing; 
                payments.--The provisions of section 481A(e) shall 
                apply to a grant or cooperative agreement under this 
                paragraph, except that--</DELETED>
                        <DELETED>    ``(i) authorities exercised under 
                        that section by the Director of the National 
                        Center for Research Resources shall, for 
                        purposes of this paragraph, be exercised by the 
                        Secretary; and</DELETED>
                        <DELETED>    ``(ii) for purposes of this 
                        paragraph, each of the percentages in 
                        subparagraphs (A) and (B) of section 481A(e)(1) 
                        shall be deemed to be 75 percent.</DELETED>
                <DELETED>    ``(E) Recapture of payments.--If, not 
                later than 20 years after the completion of 
                construction for which a grant or cooperative agreement 
                has been awarded under this paragraph, the facility 
                shall cease to be used for the research and development 
                purposes for which it was constructed (unless the 
                Secretary 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, acquisition, or other improvement of 
                such facility.</DELETED>
<DELETED>    ``(e) Authority for Personal Services Contracts.--
</DELETED>
        <DELETED>    ``(1) In general.--For the purpose of performing, 
        administering, and supporting biomedical countermeasure 
        research and development, the Secretary may, as the Secretary 
        determines necessary to respond to pressing research and 
        development needs under this section, obtain by contract (in 
        accordance with section 3109 of title 5, United States Code, 
        but without regard to the limitations in such section on the 
        period of service and on pay) the personal services of experts 
        or consultants who have scientific or other professional 
        qualifications.</DELETED>
        <DELETED>    ``(2) Federal tort claims act coverage.--
        </DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Internal controls to be instituted.--
        </DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(f) Streamlined Personnel Authority.--</DELETED>
        <DELETED>    ``(1) In general.--In addition to any other 
        personnel authorities, the Secretary may, as the Secretary 
        determines necessary to respond to pressing research and 
        development needs under this section, without regard to such 
        provisions of title 5, United States Code, governing 
        appointments in the competitive service, and without regard to 
        the provisions of chapter 51 and subchapter III of chapter 53 
        of such title relating to classification and General Schedule 
        pay rates, appoint professional and technical employees, not to 
        exceed 30 such employees at any time, to positions in the 
        National Institutes of Health to perform, administer, or 
        support biomedical countermeasure research and development in 
        carrying out this section.</DELETED>
        <DELETED>    ``(2) Internal controls to be instituted.--The 
        Secretary shall institute appropriate internal controls for 
        appointments under this subsection.</DELETED>
<DELETED>    ``(g) Definition.--As used in this section, the term 
`biomedical countermeasure' means a drug (as that term is defined by 
section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(g)(1))), biological product (as that term is defined by 
section 351(i) of this Act (42 U.S.C. 262(i))), or device (as that term 
is defined by section 201(h) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321(h))) that is used--</DELETED>
        <DELETED>    ``(1) to treat, identify, or prevent harm from any 
        biological, chemical, radiological, or nuclear agent that may 
        cause a public health emergency affecting national security; 
        or</DELETED>
        <DELETED>    ``(2) to treat, identify, or prevent harm from a 
        condition that may result in adverse health consequences or 
        death and may be caused by administering a drug, biological 
        product, or device that is used as described in paragraph 
        (1).</DELETED>
<DELETED>    ``(h) Actions Committed to Agency Discretion.--Actions by 
the Secretary under the authority of this section are committed to 
agency discretion.''.</DELETED>

<DELETED> SEC. 203. BIOMEDICAL COUNTERMEASURES PROCUREMENT.</DELETED>

<DELETED>    Section 121 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (42 U.S.C. 300hh-12) is amended--
</DELETED>
        <DELETED>    (1) by redesignating subsections (c) through (e) 
        as subsections (d) through (f), respectively; and</DELETED>
        <DELETED>    (2) by inserting after subsection (b) the 
        following:</DELETED>
<DELETED>    ``(c) Biomedical Countermeasures Procurement.--</DELETED>
        <DELETED>    ``(1) Determination of material threats.--
        </DELETED>
                <DELETED>    ``(A) Risk of use.--The Secretary, in 
                consultation with the heads of other agencies as 
                appropriate, shall on an ongoing basis--</DELETED>
                        <DELETED>    ``(i) assess current and emerging 
                        threats of use of chemical, biological, 
                        radiological, and nuclear agents; and</DELETED>
                        <DELETED>    ``(ii) determine which of such 
                        agents present a material risk of use against 
                        the United States population.</DELETED>
                <DELETED>    ``(B) Public health impact.--The Secretary 
                of Health and Human Services, in consultation with the 
                Secretary, shall on an ongoing basis--</DELETED>
                        <DELETED>    ``(i) assess the potential public 
                        health consequences of use against the United 
                        States population of agents identified under 
                        subparagraph (A)(ii); and</DELETED>
                        <DELETED>    ``(ii) determine, on the basis of 
                        such assessment, the agents for which 
                        countermeasures are necessary to protect the 
                        public health.</DELETED>
        <DELETED>    ``(2) Assessment of availability and 
        appropriateness of countermeasures.--The Secretary of Health 
        and Human Services, in consultation with the Secretary, shall 
        assess on an ongoing basis the availability and appropriateness 
        of specific countermeasures to address specific threats 
        identified under paragraph (1).</DELETED>
        <DELETED>    ``(3) Secretary's determination of countermeasures 
        appropriate for procurement under this subsection.--</DELETED>
                <DELETED>    ``(A) In general.--The Secretary of Health 
                and Human Services, in accordance with this paragraph, 
                shall identify specific countermeasures to threats 
                identified under paragraph (1) that such Secretary 
                determines, in consultation with the Secretary of 
                Homeland Security, to be appropriate for procurement 
                with appropriations under this subsection for inclusion 
                in the stockpile under subsection (a).</DELETED>
                <DELETED>    ``(B) Requirements.--In order for the 
                Secretary of Health and Human Services to make the 
                determination under subparagraph (A) with respect to a 
countermeasure, the following requirements must be met:</DELETED>
                        <DELETED>    ``(i) Determination of qualified 
                        countermeasure.--Such Secretary must determine 
                        that the product is a qualified countermeasure 
                        (as defined in paragraph (7)).</DELETED>
                        <DELETED>    ``(ii) Determination of quantities 
                        needed and feasibility of production and 
                        distribution.--Such Secretary must determine--
                        </DELETED>
                                <DELETED>    ``(I) the quantities of 
                                the product that will be needed to meet 
                                the needs of the stockpile; 
                                and</DELETED>
                                <DELETED>    ``(II) that production and 
                                delivery within 5 years of sufficient 
                                quantities of the product, as so 
                                determined, is reasonably expected to 
                                be feasible.</DELETED>
                        <DELETED>    ``(iii) Determination of no 
                        significant commercial market.--Such Secretary 
                        shall--</DELETED>
                                <DELETED>    ``(I) determine that, at 
                                the time of the initial determination 
                                under this paragraph, there is not a 
                                significant commercial market for the 
                                product other than as a homeland 
                                security threat countermeasure; 
                                and</DELETED>
                                <DELETED>    ``(II) annually 
                                redetermine and report to the 
                                President, while a determination under 
                                subparagraph (A) remains in effect with 
                                respect to the product, whether a 
                                significant commercial market exists 
                                for the product other than as a 
                                homeland security threat 
                                countermeasure.</DELETED>
        <DELETED>    ``(4) Recommendation for president's approval.--
        </DELETED>
                <DELETED>    ``(A) Recommendation for procurement.--In 
                the case of a countermeasure that the Secretary and the 
                Secretary of Health and Human Services have determined 
                is appropriate for procurement under this subsection 
                for inclusion in the stockpile, in accordance with the 
                preceding provisions of this subsection, the Secretary 
                and the Secretary of Health and Human Services shall 
                jointly submit to the President, in coordination with 
                the Director of the Office of Management and Budget, a 
                recommendation for procurement under this 
                subsection.</DELETED>
                <DELETED>    ``(B) Presidential approval.--A 
                countermeasure may be procured under this subsection 
                only if the President has approved a recommendation 
                under subparagraph (A) with respect to such 
                countermeasure.</DELETED>
                <DELETED>    ``(C) Notice to congress.--The Secretary 
                shall notify Congress of each decision of the President 
                to approve a recommendation under subparagraph 
                (A).</DELETED>
        <DELETED>    ``(5) Procurement.--The Secretary of Health and 
        Human Services and the Secretary shall be responsible for the 
        following, for purposes of procurement of qualified 
        countermeasures for the stockpile under subsection (a), as 
        approved by the President under paragraph (4):</DELETED>
                <DELETED>    ``(A) Interagency agreements.--</DELETED>
                        <DELETED>    ``(i) For procurement.--The 
                        Secretary shall enter into an agreement with 
                        the Secretary of Health and Human Services for 
                        the procurement of the countermeasure in 
                        accordance with the provisions of this 
                        paragraph. Amounts appropriated under paragraph 
                        (8) shall be available for the Secretary of 
                        Health and Human Service's costs of such 
                        procurement, other than as provided in clause 
                        (ii).</DELETED>
                        <DELETED>    ``(ii) For administrative costs.--
                        The agreement entered into between the 
                        Secretary and the Secretary of Health and Human 
                        Services for managing the stockpile under 
                        subsection (a) shall provide for reimbursement 
                        of the Secretary of Health and Human Service's 
                        administrative costs relating to procurements 
                        under this subsection from appropriations to 
                        carry out such subsection (a).</DELETED>
                <DELETED>    ``(B) Procurement.--</DELETED>
                        <DELETED>    ``(i) In general.--The Secretary 
                        of Health and Human Services shall be 
                        responsible for--</DELETED>
                                <DELETED>    ``(I) arranging for 
                                procurement of the countermeasure, 
                                including negotiating terms (including 
                                quantity, production schedule, and 
                                price) of, and entering into, contracts 
                                and cooperative agreements, and for 
                                carrying out such other activities as 
                                may reasonably be required, in 
                                accordance with the provisions of this 
                                subparagraph; and</DELETED>
                                <DELETED>    ``(II) promulgating 
                                regulations to implement clauses (v), 
                                (vi), and (vii), and any other 
                                provisions of this 
                                subsection.</DELETED>
                        <DELETED>    ``(ii) Contract terms.--A contract 
                        for procurements under this subsection shall 
                        (or, as otherwise specified in this clause, 
                        may) include the following terms:</DELETED>
                                <DELETED>    ``(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 Health and Human 
                                Services) of the total number of units 
                                contracted for.</DELETED>
                                <DELETED>    ``(II) Discounted payment 
                                for unlicensed product.--The contract 
                                may provide for a discounted price per 
                                unit of a product that is not licensed 
                                or approved as described in paragraph 
                                (7)(A) at the time of delivery, and may 
                                provide for payment of an additional 
amount per unit if the product becomes so licensed or approved before 
the expiration date of the contract (including an additional amount per 
unit of product delivered before the effective date of such licensing 
or approval).</DELETED>
                                <DELETED>    ``(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 Government under the 
                                contract, for such period and under 
                                such terms and conditions as the 
                                Secretary of Health and Human Services 
                                may specify, and in such case amounts 
                                appropriated under paragraph (8) shall 
                                be available for costs of shipping, 
                                handling, storage, and related costs 
                                for such product.</DELETED>
                                <DELETED>    ``(IV) Contract 
                                duration.--The contract shall be for a 
                                period not to exceed 5 years, renewable 
                                for additional periods none of which 
                                shall exceed 5 years.</DELETED>
                                <DELETED>    ``(V) Termination for 
                                nondelivery.--In addition to any other 
                                rights of the Secretary of Health and 
                                Human Services to terminate the 
                                contract, the contract may provide that 
                                such Secretary may terminate the 
                                contract for failure to deliver a 
                                reasonable number (as determined by 
                                such Secretary) of units of the product 
                                by 3 years after the date the contract 
                                is entered into, and may further 
                                provide that in such case the vendor 
                                shall not be entitled to any payment 
                                under the contract.</DELETED>
                        <DELETED>    ``(iii) Availability of simplified 
                        acquisition procedures.--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--</DELETED>
                                <DELETED>    ``(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</DELETED>
                                <DELETED>    ``(II) section 302A(b) of 
                                such Act (41 U.S.C. 252a(b)) and its 
                                implementing regulations.</DELETED>
                        <DELETED>    ``(iv) Use of noncompetitive 
                        procedures.--In addition to any other authority 
                        to use procedures other than competitive 
                        procedures, the Secretary of Health and Human 
                        Services 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 such Secretary's 
                        needs.</DELETED>
                        <DELETED>    ``(v) Premium provision in 
                        multiple award contracts.--</DELETED>
                                <DELETED>    ``(I) In general.--If, 
                                under this subsection, the Secretary of 
                                Health and Human Services enters into 
                                contracts with more than one person to 
                                procure a countermeasure, such 
                                Secretary may, notwithstanding any 
                                other provision of law, include in each 
                                of such contracts a provision that--
                                </DELETED>
                                        <DELETED>    ``(aa) identifies 
                                        an increment of the total 
                                        quantity of countermeasure 
                                        required, whether by percentage 
                                        or by numbers of units; 
                                        and</DELETED>
                                        <DELETED>    ``(bb) promises to 
                                        pay one or more specified 
                                        premiums based on the priority 
                                        of such persons' production and 
                                        delivery of the increment 
                                        identified under item (aa), in 
                                        accordance with the terms and 
                                        conditions of the 
                                        contract.</DELETED>
                                <DELETED>    ``(II) Determination of 
                                government's requirement not 
                                reviewable.--If the Secretary of Health 
                                and Human Services includes in each of 
                                a set of contracts a provision as 
                                described in clause (I), such 
                                Secretary's determination of the total 
                                quantity of countermeasure required, 
                                and any amendment of such 
                                determination, is committed to agency 
                                discretion.</DELETED>
                        <DELETED>    ``(vi) Extension of closing date 
                        for receipt of proposals not reviewable.--A 
                        decision by the Secretary of Health and Human 
                        Services to extend the closing date for receipt 
                        of proposals for a procurement under this 
                        subsection is committed to agency 
                        discretion.</DELETED>
                        <DELETED>    ``(vii) Limiting competition to 
                        sources responding to request for 
                        information.--In conducting a procurement under 
                        this subsection, the Secretary of Health and 
                        Human Services may exclude a source that has 
                        not responded to a request for information 
                        under section 303A(a)(1)(B) of the Federal 
                        Property and Administrative Services Act of 
                        1949 (41 U.S.C. 253a(a)(1)(B)) if such request 
                        has given notice that such Secretary may so 
                        exclude such a source.</DELETED>
        <DELETED>    ``(6) Interagency cooperation.--</DELETED>
                <DELETED>    ``(A) In general.--In carrying out 
                activities under this section, the Secretary and the 
                Secretary of Health and Human Services are authorized, 
subject to subparagraph (B), to enter into interagency agreements and 
other collaborative undertakings with other agencies of the United 
States Government.</DELETED>
                <DELETED>    ``(B) Limitation.--An agreement or 
                undertaking under this paragraph shall not authorize 
                another agency to exercise the authorities provided by 
                this section to the Secretary or to the Secretary of 
                Health and Human Services.</DELETED>
        <DELETED>    ``(7) Definitions.--In this subsection:</DELETED>
                <DELETED>    ``(A) Qualified countermeasure.--The term 
                `qualified countermeasure' means a biomedical 
                countermeasure--</DELETED>
                        <DELETED>    ``(i) that is approved under 
                        section 505(a) of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 355) or licensed under 
                        section 351 of the Public Health Service Act 
                        (42 U.S.C. 262) for use as such a 
                        countermeasure to a chemical, biological, 
                        radiological, or nuclear agent identified as a 
                        material threat under paragraph (1); 
                        or</DELETED>
                        <DELETED>    ``(ii) for which the Secretary of 
                        Health and Human Services determines that 
                        sufficient and satisfactory clinical experience 
                        or research data (including data, if available, 
                        from preclinical and clinical trials) support a 
                        reasonable conclusion that the product will 
                        qualify for approval or licensing as such a 
                        countermeasure within 5 years after the date of 
                        a determination under paragraph (3).</DELETED>
                <DELETED>    ``(B) Biomedical countermeasure.--The term 
                `biomedical countermeasure' means a drug (as that term 
                is defined by section 201(g)(1) of the Federal Food, 
                Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))) or 
                biological product (as that term is defined by section 
                351(i) of the Public Health Service Act (42 U.S.C. 
                262(i))) that is used--</DELETED>
                        <DELETED>    ``(i) to treat, identify, or 
                        prevent harm from any biological, chemical, 
                        radiological, or nuclear agent that may cause a 
                        public health emergency affecting national 
                        security; or</DELETED>
                        <DELETED>    ``(ii) to treat, identify, or 
                        prevent harm from a condition that may result 
                        in adverse health consequences or death and may 
                        be caused by administering a drug or biological 
                        product that is used as described in clause 
                        (i).</DELETED>
        <DELETED>    ``(8) Appropriations.--</DELETED>
                <DELETED>    ``(A) In general.-- There are 
                appropriated, out of any moneys in the Treasury not 
                otherwise appropriated, for fiscal year 2003 and for 
                each fiscal year thereafter, such sums as may be 
                necessary for the costs incurred by the Secretary in 
                the procurement of countermeasures under this 
                subsection as approved by the President under paragraph 
                (4) (other than costs specified in subparagraph 
                (B)).</DELETED>
                <DELETED>    ``(B) Restrictions.--Amounts appropriated 
                under this paragraph shall not be available to pay--
                </DELETED>
                        <DELETED>    ``(i) costs for the purchase of 
                        vaccines under procurement contracts entered 
                        into before January 1, 2003;</DELETED>
                        <DELETED>    ``(ii) costs under new contracts, 
                        or costs of new obligations under contracts 
                        previously entered into, for procurement of a 
                        countermeasure after the date of a 
                        determination under paragraph (3)(B)(iii) that 
                        there is a significant commercial market for 
                        the countermeasure other than as a homeland 
                        security threat countermeasure; or</DELETED>
                        <DELETED>    ``(iii) administrative 
                        costs.''.</DELETED>

<DELETED> SEC. 204. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN 
              EMERGENCIES.</DELETED>

<DELETED>    (a) In General.--Subchapter E of Chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb, et seq.) is amended by 
adding at the end the following:</DELETED>

<DELETED>``SEC. 564. AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN 
              EMERGENCIES.</DELETED>

<DELETED>    ``(a) In General.--Notwithstanding sections 505 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 solely 
for use in an actual or potential emergency.</DELETED>
<DELETED>    ``(b) Declaration of Emergency.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary may declare an 
        emergency justifying the authorization of a drug or device 
        under this subsection on the basis of a determination--
        </DELETED>
                <DELETED>    ``(A) by the Secretary of Homeland 
                Security, that there is a national emergency (or a 
                significant potential of a national emergency) 
                involving a heightened risk of attack with a specified 
                biological, chemical, radiological, or nuclear agent or 
                agents;</DELETED>
                <DELETED>    ``(B) by the Secretary of Defense, that 
                there is a military emergency (or a significant 
                potential of a military emergency) involving a 
                heightened risk to United States military forces of 
                attack with a biological, chemical, radiological, or 
                nuclear agent or agents; or</DELETED>
                <DELETED>    ``(C) by the Secretary of a public health 
                emergency under section 319 of the Public Health 
                Service Act, involving a specified disease or condition 
                or a specified biological, chemical, radiological, or 
                nuclear agent or agents.</DELETED>
        <DELETED>    ``(2) Termination of declaration.--</DELETED>
                <DELETED>    ``(A) In general.--A declaration under 
                this subsection shall terminate upon the earlier of--
                </DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(ii) the expiration of the 1-
                        year period beginning on the date on which the 
                        declaration is made.</DELETED>
                <DELETED>    ``(B) Renewal.--Notwithstanding 
                subparagraph (A), the Secretary may renew a declaration 
                under this subsection, and this paragraph shall apply 
                to any such renewal.</DELETED>
        <DELETED>    ``(3) Publication.--The Secretary shall promptly 
        publish in the Federal Register each declaration, 
        determination, and renewal under this subsection.</DELETED>
<DELETED>    ``(c) Criteria for Issuance of Authorization.--The 
Secretary may issue an authorization under this section with respect to 
a product if the Secretary concludes--</DELETED>
        <DELETED>    ``(1) that an agent specified in a declaration 
        under subsection (b) can cause a serious or life-threatening 
        disease or condition;</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) the product may be effective in 
                detecting, diagnosing, treating, or preventing--
                </DELETED>
                        <DELETED>    ``(i) such disease or condition; 
                        or</DELETED>
                        <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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;</DELETED>
        <DELETED>    ``(3) that there is no adequate, approved, and 
        available alternative to the product for detecting, diagnosing, 
        preventing, or treating such disease or condition; 
        and</DELETED>
        <DELETED>    ``(4) that such other criteria as the Secretary 
        may by regulation prescribe are satisfied.</DELETED>
<DELETED>    ``(d) Scope of Authorization.--An authorization of a 
product under this section shall state--</DELETED>
        <DELETED>    ``(1) each disease or condition that the product 
        may be used to detect, diagnose, prevent, or treat within the 
        scope of the authorization; and</DELETED>
        <DELETED>    ``(2) the Secretary's conclusions, under 
        subsection (c), concerning the safety and potential 
        effectiveness of the product in detecting, diagnosing, 
        preventing, or treating such diseases or conditions, including 
        an assessment of the available scientific evidence.</DELETED>
<DELETED>    ``(e) Conditions of Authorization.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary is authorized, by 
        order or regulation, to impose such conditions on an 
        authorization under this section as the Secretary determines 
        are necessary or appropriate to protect the public health, 
        including the following:</DELETED>
                <DELETED>    ``(A) The Secretary shall impose 
                requirements (including requirements concerning product 
                labeling and the provision of information) designed to 
                ensure that, to the maximum extent feasible given the 
                circumstances of the emergency, health care 
                professionals administering the product are informed--
                </DELETED>
                        <DELETED>    ``(i) that the Secretary has 
                        authorized the product solely for emergency 
                        use;</DELETED>
                        <DELETED>    ``(ii) of the significant known 
                        and potential benefits and risks of use of the 
                        product, and of the extent to which such 
                        benefits and risks are unknown; and</DELETED>
                        <DELETED>    ``(iii) of the alternatives to the 
                        product that are available, and of their 
                        benefits and risks.</DELETED>
                <DELETED>    ``(B) The Secretary shall impose 
                requirements (including requirements concerning product 
                labeling and the provision of information) designed to 
                ensure that, to the maximum extent feasible given the 
                circumstances of the emergency, individuals to whom the 
                product is administered are informed--</DELETED>
                        <DELETED>    ``(i) that the Secretary has 
                        authorized the product solely for emergency 
                        use;</DELETED>
                        <DELETED>    ``(ii) of the significant known 
                        and potential benefits and risks of use of the 
                        product, and of the extent to which such 
                        benefits and risks are unknown; and</DELETED>
                        <DELETED>    ``(iii) of any option to accept or 
                        refuse administration of the product, and of 
                        the alternatives to the product that are 
                        available and of their benefits and 
                        risks.</DELETED>
                <DELETED>    ``(C) The Secretary may impose limitations 
                on which entities may distribute the product (including 
                limitation to distribution by government entities), and 
                on how distribution is to be performed.</DELETED>
                <DELETED>    ``(D) The Secretary may impose limitations 
                on who may administer the product, and on the 
                categories of individuals to whom, and the 
                circumstances under which, the product may be 
                administered.</DELETED>
                <DELETED>    ``(E) The Secretary may condition the 
                authorization on the performance of studies, clinical 
                trials, or other research needed to support marketing 
                approval of the product.</DELETED>
                <DELETED>    ``(F) The Secretary may impose 
                requirements concerning recordkeeping and reporting, 
                including records access by the Secretary and 
                publication of data.</DELETED>
                <DELETED>    ``(G) The Secretary may impose (or waive) 
                requirements, with respect to the product, of current 
                good manufacturing practice otherwise applicable to the 
                manufacture, processing, packing, or holding of 
                products subject to regulation under this 
                Act.</DELETED>
                <DELETED>    ``(H) The Secretary may impose 
                requirements for the monitoring and reporting of 
                adverse events associated with use of the 
                product.</DELETED>
        <DELETED>    ``(2) Waiver.--The Secretary may waive any 
        condition imposed under this subsection.</DELETED>
<DELETED>    ``(f) Duration of Authorization.--</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(g) Revocation of Authorization.--</DELETED>
        <DELETED>    ``(1) Review.--The Secretary shall periodically 
        review the circumstances and the appropriateness of an 
        authorization under this section.</DELETED>
        <DELETED>    ``(2) Revocation.--The Secretary may revoke an 
        authorization under this section if, in the Secretary's 
        unreviewable discretion--</DELETED>
                <DELETED>    ``(A) the conditions for such an 
                authorization are no longer met; or</DELETED>
                <DELETED>    ``(B) other circumstances make such 
                revocation appropriate.</DELETED>
<DELETED>    ``(h) Publication.--The Secretary shall promptly publish 
in the Federal Register a notice of each authorization, and each 
termination or revocation of an authorization, under this 
section.</DELETED>
<DELETED>    ``(i) Recordkeeping.--</DELETED>
        <DELETED>    ``(1) In general.--The Secretary may by order or 
        regulation require persons, including a person who holds an 
        authorization under this section, or who manufactures, 
        distributes, prescribes, or administers a product that is the 
        subject of such an authorization, to establish and maintain--
        </DELETED>
                <DELETED>    ``(A) data that is obtained from such 
                activity and that pertains to the effectiveness or 
                safety of such product;</DELETED>
                <DELETED>    ``(B) such records as are necessary to 
                determine, or facilitate a determination, whether there 
                may be any violation of this section or of a regulation 
                promulgated under this section; and</DELETED>
                <DELETED>    ``(C) such additional records as the 
                Secretary may determine necessary.</DELETED>
        <DELETED>    ``(2) Access to records by secretary.--</DELETED>
                <DELETED>    ``(A) Safety and effectiveness 
                information.--The Secretary may by order or regulation 
                require a person who holds an authorization under this 
                section, or who manufactures, distributes, prescribes, 
                or administers a product that is the subject of such an 
                authorization to provide to the Secretary all data that 
                is obtained from such activity and that pertains to the 
                safety or effectiveness of such product.</DELETED>
                <DELETED>    ``(B) Other information.--Every person 
                required under this section to establish or maintain 
                records, and every person in charge or custody of such 
                records, shall, upon request by the Secretary, permit 
                the Secretary at all reasonable times to have access 
                to, to copy, and to verify such records.</DELETED>
<DELETED>    ``(j) Civil Monetary Penalties.--</DELETED>
        <DELETED>    ``(1) In general.--A person who violates a 
        requirement of this section or of a regulation or order 
        promulgated pursuant to this section shall be subject to a 
        civil money penalty of not more than $100,000 in the case of an 
        individual, and not more than $250,000 in the case of any other 
        person, for each violation, not to exceed $1,000,000 for all 
        such violations adjudicated in a single proceeding.</DELETED>
        <DELETED>    ``(2) Assessment of civil penalties.--Paragraphs 
        (3), (4), and (5) of section 303(g) shall apply to a civil 
        penalty under this subsection, and references in such 
        paragraphs to `paragraph (1) or (2)' shall, for purposes of 
        this subsection, be deemed to refer to paragraph (1) of this 
        subsection.</DELETED>
<DELETED>    ``(k) Actions Committed to Agency Discretion.--Actions 
under the authority of this section by the Secretary, by the Secretary 
of Defense, or by the Secretary of Homeland Security are committed to 
agency discretion.</DELETED>
<DELETED>    ``(l) Regulations.--The Secretary may promulgate 
regulations to implement this section.</DELETED>
<DELETED>    ``(m) Construction.--Nothing in this section shall be 
construed to impair or otherwise affect--</DELETED>
        <DELETED>    ``(1) the authority of the President as Commander 
        in Chief of the Armed Forces of the United States under article 
        II, section 2 of the United States Constitution; or</DELETED>
        <DELETED>    ``(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.</DELETED>
<DELETED>    ``(n) Application to Members of Armed Forces.--</DELETED>
        <DELETED>    ``(1) Waiver of requirement relating to option to 
        refuse.--In the case of the administration of a countermeasure 
        to members of the armed forces, a requirement, under subsection 
        (e)(2)(C), designed to ensure that individuals are informed of 
        an option to accept or refuse administration of a product, may 
        be waived by the President if the President determines, in 
        writing, that complying with such requirement is not feasible, 
        is contrary to the best interests of the members affected, or 
        is not in the interests of national security.</DELETED>
        <DELETED>    ``(2) Effect on statute pertaining to 
        investigational new drugs.--In the case of an authorization 
        based on a determination by the Secretary of Defense under 
        subsection (b)(1)(B), section 1107 of title 10, United States 
        Code, shall not apply to use of a product that is the subject 
        of such authorization, within the scope of such authorization 
        and while such authorization is effective.</DELETED>
<DELETED>    ``(o) Relation to Other Provisions.--If a product is the 
subject of an authorization under this section, the use of such product 
within the scope of the authorization--</DELETED>
        <DELETED>    ``(1) shall not be subject to any requirements 
        pursuant to section 505(i) or 520(g); and</DELETED>
        <DELETED>    ``(2) shall not be subject to any requirements 
        otherwise applicable to clinical investigations pursuant to 
        other provisions of this Act.''.</DELETED>
<DELETED>    (b) Prohibited Acts.--Section 301 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331) is amended--</DELETED>
        <DELETED>    (1) in subsection (e)--</DELETED>
                <DELETED>    (A) by striking ``504, 703'' and inserting 
                ``504, 564, 703''; and</DELETED>
                <DELETED>    (B) by striking ``or 519'' and inserting 
                ``519, or 564''; and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
<DELETED>    ``(hh)(1) Promotion or use of a product that is the 
subject of an authorization under section 564 other than as stated in 
the authorization, or other than during the period described by section 
564(g), unless such promotion or use is permitted under another 
provision of this Act.</DELETED>
<DELETED>    ``(2) Failure to comply with an information requirement 
under section 564(e)(1).''.</DELETED>

<DELETED>SEC. 205. DEVELOPING NEW COUNTERMEASURES AND PROTECTING 
              EXISTING COUNTERMEASURES AGAINST BIOTERRORISM.</DELETED>

<DELETED>    Section 319F of the Public Health Service Act (42 U.S.C. 
247d-6) is amended by adding at the end the following:</DELETED>
<DELETED>    ``(k) Limited Antitrust Exemption.--</DELETED>
        <DELETED>    ``(1) Countermeasures development meetings.--
        </DELETED>
                <DELETED>    ``(A) Countermeasures development meetings 
                and consultations.--The Secretary may conduct meetings 
                and consultations with parties involved in the 
                development of countermeasures for the purpose of the 
                development, manufacture, distribution, or sale of 
                priority countermeasures consistent with the purposes 
                of this title. The Secretary shall give notice of such 
                meetings and consultations to the Attorney General and 
                the Chairperson of the Federal Trade Commission 
                (referred to in this subsection as the 
                `Chairperson').</DELETED>
                <DELETED>    ``(B) Meeting and consultation 
                conditions.--A meeting or consultation conducted under 
                subparagraph (A) shall--</DELETED>
                        <DELETED>    ``(i) be chaired or, in the case 
                        of a consultation, facilitated by the Secretary 
                        or the designee of the Secretary;</DELETED>
                        <DELETED>    ``(ii) be open to parties involved 
                        in the development, manufacture, distribution, 
                        purchase, or sale of priority countermeasures, 
                        as determined by the Secretary;</DELETED>
                        <DELETED>    ``(iii) be open to the Attorney 
                        General and the Chairperson;</DELETED>
                        <DELETED>    ``(iv) be limited to discussions 
                        involving the development, manufacture, 
                        distribution, or sale of priority 
                        countermeasures, consistent with the purposes 
                        of this title; and</DELETED>
                        <DELETED>    ``(v) be conducted in such manner 
                        as to ensure that national security, 
                        confidential, and proprietary information is 
                        not disclosed outside the meeting or 
                        consultation.</DELETED>
                <DELETED>    ``(C) Minutes.--The Secretary shall 
                maintain minutes of meetings and consultations under 
                this subsection, which shall not be disclosed under 
                section 552 of title 5, United States Code.</DELETED>
                <DELETED>    ``(D) Exemption.--The antitrust laws shall 
                not apply to meetings and consultations under this 
                paragraph, except that any agreement that results from 
                a meeting or consultation and that has been denied an 
                exemption pursuant to this subsection shall be subject 
                to the antitrust laws.</DELETED>
        <DELETED>    ``(2) Written agreements or conduct.--The 
        Secretary or any party to an agreement or other conduct 
        regarding covered activities entered into or undertaken 
        pursuant to meetings or consultations conducted under paragraph 
        (1), and that is consistent with this paragraph, shall file 
        such written agreement or a description of the conduct involved 
        with the Attorney General and the Chairperson for a 
        determination of whether such agreement or conduct should be 
        exempt from the antitrust laws. In addition to the proposed 
        agreement or description of conduct itself, any such filing 
        shall include--</DELETED>
                <DELETED>    ``(A) an explanation of the intended 
                purpose of the agreement or conduct;</DELETED>
                <DELETED>    ``(B) a specific statement of the 
                substance of the agreement or conduct;</DELETED>
                <DELETED>    ``(C) a description of the methods that 
                will be utilized to achieve the objectives of the 
                agreement or conduct;</DELETED>
                <DELETED>    ``(D) an explanation of the necessity of a 
                cooperative effort among the particular participating 
                parties to achieve the objectives of the agreement or 
                conduct; and</DELETED>
                <DELETED>    ``(E) any other relevant information 
                reasonably requested by the Attorney General, in 
                consultation with the Chairperson and the 
                Secretary.</DELETED>
        <DELETED>    ``(3) Determination.--The Attorney General, in 
        consultation with the Chairperson, shall determine whether an 
        agreement or description of conduct submitted under paragraph 
        (2) should be exempt from the antitrust laws.</DELETED>
        <DELETED>    ``(4) Limited antitrust exemption.--</DELETED>
                <DELETED>    ``(A) In general.--The Attorney General, 
                in consultation with the Chairperson, may, within 30 
                days of the receipt of a notification pursuant to 
                paragraph (2), revoke in whole or in part, the scope of 
                any exemption granted by the Attorney General under a 
                determination under paragraph (3).</DELETED>
                <DELETED>    ``(B) Extension.--The Attorney General may 
                extend the 35-day period referred to in subparagraph 
                (A) for an additional period of not to exceed 20 days. 
                Such additional period may be further extended only by 
                the United States district court, upon an application 
                by the Attorney General after notice to the Secretary 
                and the parties involved.</DELETED>
                <DELETED>    ``(C) Application of laws.--</DELETED>
                        <DELETED>    ``(i) in general.--The antitrust 
                        laws shall not apply to an agreement or conduct 
                        (described in a description of conduct) that is 
                        submitted for review pursuant to paragraph (2) 
                        until such time as the Attorney General 
determines, pursuant to subparagraph (D), that such agreement or 
conduct should not, in whole or in part, be exempt from the antitrust 
laws.</DELETED>
                        <DELETED>    ``(ii) Limited liability.--No 
                        party to an agreement or conduct referred to in 
                        clause (i) shall be liable under the antitrust 
                        laws for any actions reasonably necessary to 
                        carry out the agreement or for conduct taken 
                        after the agreement or description has been 
                        submitted pursuant to paragraph (2) and prior 
                        to any revocation of the exemption by the 
                        Attorney General pursuant to subparagraph 
                        (D).</DELETED>
                <DELETED>    ``(D) Determination.--In making a 
                determination under this subparagraph, the Attorney 
                General, in consultation with the Chairperson and the 
                Secretary shall consider--</DELETED>
                        <DELETED>    ``(i) whether the agreement or 
                        conduct involved would facilitate the 
                        availability of priority 
                        countermeasures;</DELETED>
                        <DELETED>    ``(ii) whether the exemption from 
                        the antitrust laws would promote the public 
                        interest;</DELETED>
                        <DELETED>    ``(iii) the competitive impact to 
                        areas not directly related to the purposes of 
                        the agreement or conduct; and</DELETED>
                        <DELETED>    ``(iv) any other factors 
                        determined relevant by the Attorney General and 
                        the Chairperson.</DELETED>
        <DELETED>    ``(5) Limitation on and renewal of exemptions.--An 
        exemption provided under paragraphs (3) or (4) shall be limited 
        to covered activities, and shall expire on the date that is 3 
        years after the date on which the exemption becomes effective 
        (and at 3 year intervals thereafter, if renewed) unless the 
        Attorney General in consultation with the Chairperson 
        determines that the exemption should be renewed (with 
        modifications, as appropriate) considering the factors 
        described in paragraph (4).</DELETED>
        <DELETED>    ``(6) Limitation on parties.--Any exemption from 
        the antitrust laws provided under this subsection shall not 
        apply to the use of any information acquired in conducting 
        exempted activities for any purposes other than those expressly 
        specified in the antitrust exemption provided for by this 
        subsection.</DELETED>
        <DELETED>    ``(7) Guidelines.--The Attorney General and the 
        Chairperson may develop and issue guidelines to implement this 
        subsection.</DELETED>
        <DELETED>    ``(8) Report.--Not later than 1 year after the 
        date of enactment of this subsection, and annually thereafter, 
        the Attorney General and the Chairperson shall report to the 
        Committee on Health, Education, Labor, and Pensions and the 
        Committee on the Judiciary of the Senate and the Committee on 
        Energy and Commerce and the Committee on the Judiciary of the 
        House of Representatives on the use and continuing need for the 
        exemption from the antitrust laws provided by this 
        subsection.</DELETED>
        <DELETED>    ``(9) Sunset.--The authority of any party to apply 
        for or to obtain a limited antitrust exemption under this 
        subsection shall expire at the end of the 6-year period that 
        begins on the date of enactment of this subsection.</DELETED>
<DELETED>    ``(l) Definitions.--In this section:</DELETED>
        <DELETED>    ``(1) Antitrust laws.--The term `antitrust laws'--
        </DELETED>
                <DELETED>    ``(A) has the meaning given such term in 
                subsection (a) of the first section of the Clayton Act 
                (15 U.S.C. 12(a)), except that such term includes the 
                Act of June 19, 1936 (15 U.S.C. 13 et seq.) commonly 
                known as the Robinson-Patman Act), and section 5 of the 
                Federal Trade Commission Act (15 U.S.C. 45) to the 
                extent such section 5 applies to unfair methods of 
                competition; and</DELETED>
                <DELETED>    ``(B) includes any State law similar to 
                the laws referred to in subparagraph (A).</DELETED>
        <DELETED>    ``(2) Covered activities.--</DELETED>
                <DELETED>    ``(A) In general.--Except as provided in 
                subparagraph (B), the term `covered activities' means 
                any group of activities or conduct, including 
                attempting to make, making, or performing a contract or 
                agreement or engaging in other conduct, for the purpose 
                of--</DELETED>
                        <DELETED>    ``(i) theoretical analysis, 
                        experimentation, or the systematic study of 
                        phenomena or observable facts related to the 
                        development of priority 
                        countermeasures;</DELETED>
                        <DELETED>    ``(ii) the development or testing 
                        of basic engineering techniques related to the 
                        development of priority 
                        countermeasures;</DELETED>
                        <DELETED>    ``(iii) the extension of 
                        investigative findings or theory of a 
                        scientific or technical nature into practical 
                        application for experimental and demonstration 
                        purposes, including the experimental production 
                        and testing of models, prototypes, equipment, 
                        materials, and processes related to the 
                        development of priority 
                        countermeasures;</DELETED>
                        <DELETED>    ``(iv) the production, 
                        distribution, or marketing of a product, 
                        process, or service related to the development 
                        of priority countermeasures;</DELETED>
                        <DELETED>    ``(v) the testing in connection 
                        with the production of a product, process, or 
                        service related to the development of priority 
                        countermeasures;</DELETED>
                        <DELETED>    ``(vi) the collection, exchange, 
                        and analysis of research or production 
                        information related to the development of 
                        priority countermeasures; or</DELETED>
                        <DELETED>    ``(vii) any combination of the 
                        purposes described in clauses (i) through 
                        (vi);</DELETED>
                <DELETED>and such term may include the establishment 
                and operation of facilities for the conduct of covered 
                activities described in clauses (i) through (vi), the 
                conduct of such covered activities on a protracted and 
                proprietary basis, and the processing of applications 
                for patents and the granting of licenses for the 
                results of such covered activities.</DELETED>
                <DELETED>    ``(B) Exception.--The term `covered 
                activities' shall not include the following activities 
                involving 2 or more persons:</DELETED>
                        <DELETED>    ``(i) Exchanging information among 
                        competitors relating to costs, sales, 
                        profitability, prices, marketing, or 
                        distribution of any product, process, or 
                        service if such information is not reasonably 
                        necessary to carry out the purposes of covered 
                        activities.</DELETED>
                        <DELETED>    ``(ii) Entering into any agreement 
                        or engaging in any other conduct--</DELETED>
                                <DELETED>    ``(I) to restrict or 
                                require the sale, licensing, or sharing 
                                of inventions, developments, products, 
                                processes, or services not developed 
                                through, produced by, or distributed or 
                                sold through such covered activities; 
                                or</DELETED>
                                <DELETED>    ``(II) to restrict or 
                                require participation by any person who 
                                is a party to such covered activities 
                                in other research and development 
                                activities, that is not reasonably 
                                necessary to prevent the 
                                misappropriation of proprietary 
                                information contributed by any person 
                                who is a party to such covered 
                                activities or of the results of such 
                                covered activities.</DELETED>
                        <DELETED>    ``(iii) Entering into any 
                        agreement or engaging in any other conduct 
                        allocating a market with a competitor that is 
                        not expressly exempted from the antitrust laws 
                        by a determination under subsection 
                        (k)(4).</DELETED>
                        <DELETED>    ``(iv) Exchanging information 
                        among competitors relating to production (other 
                        than production by such covered activities) of 
                        a product, process, or service if such 
                        information is not reasonably necessary to 
                        carry out the purpose of such covered 
                        activities.</DELETED>
                        <DELETED>    ``(v) Except as otherwise provided 
                        in this subsection or subsection (k), entering 
                        into any agreement or engaging in any other 
                        conduct to restrict or require participation by 
                        any person who is a party to such activities, 
                        in any unilateral or joint activity that is not 
                        reasonably necessary to carry out the purpose 
                        of such covered activities.</DELETED>
        <DELETED>    ``(3) Development.--The term `development' 
        includes the identification of suitable compounds or biological 
        materials, the conduct of preclinical and clinical studies, the 
        preparation of an application for marketing approval, and any 
        other actions related to preparation of a 
        countermeasure.</DELETED>
        <DELETED>    ``(4) Person.--The term `person' has the meaning 
        given such term in subsection (a) of the first section of the 
        Clayton Act (15 U.S.C. 12(a)).</DELETED>
        <DELETED>    ``(5) Priority countermeasure.--The term `priority 
        countermeasure' means a countermeasure, including a drug, 
        medical device, biological product, or diagnostic test to 
        treat, identify, or prevent infection by a biological agent or 
        toxin on the list developed under section 351A(a)(1) and 
        prioritized under subsection (a)(1).''.</DELETED>

        <DELETED>TITLE III--IMPROVED VACCINE AFFORDABILITY AND 
                         AVAILABILITY</DELETED>

<DELETED>SEC. 301. SHORT TITLE.</DELETED>

<DELETED>    This title may be cited as the ``Improved Vaccine 
Affordability and Availability Act''.</DELETED>

          <DELETED>Subtitle A--State Vaccine Grants</DELETED>

<DELETED>SEC. 311. AVAILABILITY OF INFLUENZA VACCINE.</DELETED>

<DELETED>    Section 317(j) of the Public Health Service Act (42 U.S.C. 
247b(j)) is amended by adding at the end the following:</DELETED>
<DELETED>    ``(3)(A) For the purpose of carrying out activities 
relating to influenza vaccine under the immunization program under this 
subsection, there are authorized to be appropriated such sums as may be 
necessary for each of fiscal years 2003 and 2004. Such authorization 
shall be in addition to amounts available under paragraphs (1) and (2) 
for such purpose.</DELETED>
<DELETED>    ``(B) The authorization of appropriations established in 
subparagraph (A) shall not be effective for a fiscal year unless the 
total amount appropriated under paragraphs (1) and (2) for the fiscal 
year is not less than such total for fiscal year 2000.</DELETED>
<DELETED>    ``(C) The purposes for which amounts appropriated under 
subparagraph (A) are available to the Secretary include providing for 
improved State and local infrastructure for influenza immunizations 
under this subsection in accordance with the following:</DELETED>
        <DELETED>    ``(i) Increasing influenza immunization rates in 
        populations considered by the Secretary to be at high risk for 
        influenza-related complications and in their 
        contacts.</DELETED>
        <DELETED>    ``(ii) Recommending that health care providers 
        actively target influenza vaccine that is available in 
        September, October, and November to individuals who are at 
        increased risk for influenza-related complications and to their 
        contacts.</DELETED>
        <DELETED>    ``(iii) Providing for the continued availability 
        of influenza immunizations through December of such year, and 
        for additional periods to the extent that influenza vaccine 
        remains available.</DELETED>
        <DELETED>    ``(iv) Encouraging States, as appropriate, to 
        develop contingency plans (including plans for public and 
        professional educational activities) for maximizing influenza 
        immunizations for high-risk populations in the event of a delay 
        or shortage of influenza vaccine.</DELETED>
<DELETED>    ``(D) The Secretary shall submit to the Committee on 
Energy and Commerce of the House of Representatives, and the Committee 
on Health, Education, Labor, and Pensions of the Senate, periodic 
reports describing the activities of the Secretary under this 
subsection regarding influenza vaccine. The first such report shall be 
submitted not later than June 6, 2003, the second report shall 
be submitted not later than June 6, 2004, and subsequent reports shall 
be submitted biennially thereafter.''.</DELETED>

<DELETED>SEC. 312. PROGRAM FOR INCREASING IMMUNIZATION RATES FOR ADULTS 
              AND ADOLESCENTS; COLLECTION OF ADDITIONAL IMMUNIZATION 
              DATA.</DELETED>

<DELETED>    (a) Activities of Centers for Disease Control and 
Prevention.--Section 317(j) of the Public Health Service Act (42 U.S.C. 
247b(j)), as amended by section 311, is further amended by adding at 
the end the following:</DELETED>
<DELETED>    ``(4)(A) For the purpose of carrying out activities to 
increase immunization rates for adults and adolescents through the 
immunization program under this subsection, and for the purpose of 
carrying out subsection (k)(2), there are authorized to be appropriated 
$50,000,000 for fiscal year 2003, and such sums as may be necessary for 
each of the fiscal years 2004 through 2006. Such authorization is in 
addition to amounts available under paragraphs (1), (2), and (3) for 
such purposes.</DELETED>
<DELETED>    ``(B) In expending amounts appropriated under subparagraph 
(A), the Secretary shall give priority to adults and adolescents who 
are medically underserved and are at risk for vaccine-preventable 
diseases, including as appropriate populations identified through 
projects under subsection (k)(2)(E).</DELETED>
<DELETED>    ``(C) The purposes for which amounts appropriated under 
subparagraph (A) are available include (with respect to immunizations 
for adults and adolescents) the payment of the costs of storing 
vaccines, outreach activities to inform individuals of the availability 
of the immunizations, and other program expenses necessary for the 
establishment or operation of immunization programs carried out or 
supported by States or other public entities pursuant to this 
subsection.</DELETED>
<DELETED>    ``(5) The Secretary shall annually submit to Congress a 
report that--</DELETED>
        <DELETED>    ``(A) evaluates the extent to which the 
        immunization system in the United States has been effective in 
        providing for adequate immunization rates for adults and 
        adolescents, taking into account the applicable year 2010 
        health objectives established by the Secretary regarding the 
        health status of the people of the United States; and</DELETED>
        <DELETED>    ``(B) describes any issues identified by the 
        Secretary that may affect such rates.</DELETED>
<DELETED>    ``(6) In carrying out this subsection and paragraphs (1) 
and (2) of subsection (k), the Secretary shall consider recommendations 
regarding immunizations that are made in reports issued by the 
Institute of Medicine of the National Academy of Sciences.''.</DELETED>
<DELETED>    (b) Research, Demonstrations, and Education.--Section 
317(k) of the Public Health Service Act (42 U.S.C. 247b(k)) is 
amended--</DELETED>
        <DELETED>    (1) by redesignating paragraphs (2) through (4) as 
        paragraphs (3) through (5), respectively;</DELETED>
        <DELETED>    (2) by inserting after paragraph (1) the 
        following:</DELETED>
<DELETED>    ``(2)(A) The Secretary, directly and through grants under 
paragraph (1), shall provide for a program of research, demonstration 
projects, and education in accordance with the following:</DELETED>
        <DELETED>    ``(i) The Secretary shall coordinate with public 
        and private entities (including nonprofit private entities), 
        and develop and disseminate guidelines, toward the goal of 
        ensuring that immunizations are routinely offered to adults and 
        adolescents by public and private health care 
        providers.</DELETED>
        <DELETED>    ``(ii) The Secretary shall cooperate with public 
        and private entities to obtain information for the annual 
        evaluations required in subsection (j)(5)(A).</DELETED>
        <DELETED>    ``(iii) The Secretary shall (relative to fiscal 
        year 2003) increase the extent to which the Secretary collects 
        data on the incidence, prevalence, and circumstances of 
        diseases and adverse events that are experienced by adults and 
        adolescents and may be associated with immunizations, including 
        collecting data in cooperation with commercial 
        laboratories.</DELETED>
        <DELETED>    ``(iv) The Secretary shall ensure that the 
        entities with which the Secretary cooperates for purposes of 
        subparagraphs (A) through (C) include managed care 
        organizations, community-based organizations that provide 
        health services, and other health care providers.</DELETED>
        <DELETED>    ``(v) The Secretary shall provide for projects to 
        identify racial and ethnic minority groups and other health 
        disparity populations for which immunization rates for adults 
        and adolescents are below such rates for the general 
        population, and to determine the factors underlying such 
        disparities.</DELETED>
<DELETED>    ``(B) Authorization of appropriations.--There are 
authorized to be appropriated to carry out this subsection, such sums 
as may be necessary for each of fiscal years 2003 through 
2007.''.</DELETED>

<DELETED>SEC. 313. IMMUNIZATION AWARENESS.</DELETED>

<DELETED>    (a) Development of Information Concerning Meningitis.--
</DELETED>
        <DELETED>    (1) In general.--The Secretary of Health and Human 
        Services (in this title referred to as the ``Secretary''), in 
        consultation with the Director of the Centers for Disease 
        Control and Prevention, shall develop and make available to 
        entities described in paragraph (2) information concerning 
        bacterial meningitis and the availability and effectiveness of 
        vaccinations for populations targeted by the Advisory Committee 
        on Immunization Practices (an advisory committee established by 
        the Secretary, acting through the Director of the Centers for 
        Disease Control and Prevention).</DELETED>
        <DELETED>    (2) Entities.--An entity is described in this 
        paragraph if the entity--</DELETED>
                <DELETED>    (A) is--</DELETED>
                        <DELETED>    (i) a college or university; 
                        or</DELETED>
                        <DELETED>    (ii) any other facility with a 
                        setting similar to a dormitory that houses age-
                        appropriate populations for whom the Advisory 
                        Committee on Immunization Practices recommends 
                        such a vaccination; and</DELETED>
                <DELETED>    (B) is determined appropriate by the 
                Secretary.</DELETED>
<DELETED>    (b) Development of Information Concerning Hepatitis.--
</DELETED>
        <DELETED>    (1) In general.--The Secretary, in consultation 
        with the Director of the Centers for Disease Control and 
Prevention, shall develop and make available to entities described in 
paragraph (2) information concerning hepatitis A and B and the 
availability and effectiveness of vaccinations with respect to such 
diseases.</DELETED>
        <DELETED>    (2) Entities.--An entity is described in this 
        paragraph if the entity--</DELETED>
                <DELETED>    (A) is--</DELETED>
                        <DELETED>    (i) a health care clinic that 
                        serves individuals diagnosed as being infected 
                        with HIV or as having other sexually 
                        transmitted diseases;</DELETED>
                        <DELETED>    (ii) an organization or business 
                        that counsels individuals about international 
                        travel or who arranges for such 
                        travel;</DELETED>
                        <DELETED>    (iii) a police, fire, or emergency 
                        medical services organization that responds to 
                        natural or man-made disasters or 
                        emergencies;</DELETED>
                        <DELETED>    (iv) a prison or other detention 
                        facility;</DELETED>
                        <DELETED>    (v) a college or university; 
                        or</DELETED>
                        <DELETED>    (vi) a public health authority or 
                        children's health service provider in areas of 
                        intermediate or high endemicity for hepatitis A 
                        as defined by the Centers for Disease Control 
                        and Prevention; and</DELETED>
                <DELETED>    (B) is determined appropriate by the 
                Secretary.</DELETED>

<DELETED>SEC. 314. SUPPLY OF VACCINES.</DELETED>

<DELETED>    (a) In General.--The Secretary of Health and Human 
Services, acting through the Director of the Centers for Disease 
Control and Prevention, shall prioritize, acquire, and maintain a 
supply of such prioritized vaccines sufficient to provide vaccinations 
throughout a 6-month period.</DELETED>
<DELETED>    (b) Proceeds.--Any proceeds received by the Secretary of 
Health and Human Services from the sale of vaccines contained in the 
supply described in subsection (a), shall be available to the Secretary 
for the purpose of purchasing additional vaccines for the supply. Such 
proceeds shall remain available until expended.</DELETED>
<DELETED>    (c) Authorization of Appropriations.--There are authorized 
to be appropriated for the purpose of carrying out subsection (a) such 
sums as may be necessary for each of fiscal years 2003 through 
2008.</DELETED>

<DELETED>SEC. 315. COMMUNICATION.</DELETED>

<DELETED>    The Commissioner of Food and Drugs shall ensure that 
vaccine manufacturers receive all forms of compliance guidelines for 
vaccines and that such guidelines are kept up to date.</DELETED>

<DELETED>SEC. 316. FAST TRACK.</DELETED>

<DELETED>    The Commissioner of Food and Drugs shall issue regulations 
to revise the policies of the Food and Drug Administration regarding 
fast-tracking and priority review approval of vaccine products 
currently under development, to allow for the use of new forms of 
existing vaccines in cases where a determination is made that applying 
such approvals is in the public health interest to address the unmet 
need of strengthening the overall vaccine supply.</DELETED>

<DELETED>SEC. 317. STUDY.</DELETED>

<DELETED>    (a) In General.--The Secretary shall contract with the 
Institute of Medicine of the National Academy of Sciences or another 
independent and competent authority, to conduct a study of the 
statutes, regulations, guidelines, and compliance, inspection, and 
enforcement practices and policies of the Department of Health and 
Human Services and of the Food and Drug Administration that are 
applicable to vaccines intended for human use that are in periodic 
short supply in the United States.</DELETED>
<DELETED>    (b) Requirements.--The study under subsection (a) shall 
include a review of the regulatory requirements, guidelines, practices, 
and policies--</DELETED>
        <DELETED>    (1) for the development and licensing of vaccines 
        and the licensing of vaccine manufacturing 
        facilities;</DELETED>
        <DELETED>    (2) for inspections and other activities for 
        maintaining compliance and enforcement of the requirements 
        applicable to such vaccines and facilities; and</DELETED>
        <DELETED>    (3) that may have contributed to temporary or 
        long-term shortages of vaccines.</DELETED>
<DELETED>    (c) Report.--Not later than 6 months after the date of 
enactment of this Act, the Secretary shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives a report that 
contains--</DELETED>
        <DELETED>    (1) the results of the study under subsection (a); 
        and</DELETED>
        <DELETED>    (2) recommendations for modifications to the 
        regulatory requirements, guidelines, practices, and policies 
        described in subsection (b).</DELETED>

   <DELETED>Subtitle B--Vaccine Injury Compensation Program</DELETED>

<DELETED>SEC. 321. ADMINISTRATIVE REVISION OF VACCINE INJURY 
              TABLE.</DELETED>

<DELETED>    Section 2114 of the Public Health Service Act (42 U.S.C. 
300aa-14) is amended--</DELETED>
        <DELETED>    (1) by striking subsection (c)(1) and inserting 
        the following:</DELETED>
        <DELETED>    ``(1) The Secretary may promulgate regulations to 
        modify in accordance with paragraph (3) the Vaccine Injury 
        Table. In promulgating such regulations, the Secretary shall 
        provide for notice and for at least 60 days of public 
        comment.''; and</DELETED>
        <DELETED>    (2) in subsection (d), by striking ``90 days'' and 
        inserting ``60 days''.</DELETED>

<DELETED>SEC. 322. EQUITABLE RELIEF.</DELETED>

<DELETED>    Section 2111(a)(2)(A) of the Public Health Service Act (42 
U.S.C. 300aa-11(a)(2)(A)) is amended by striking ``No person'' and all 
that follows through ``and--'' and inserting the following: ``No person 
may bring or maintain a civil action against a vaccine administrator or 
manufacturer in a Federal or State court for damages arising from, or 
equitable relief relating to, a vaccine-related injury or death 
associated with the administration of a vaccine after October 1, 1988 
and no such court may award damages or equitable relief for any such 
vaccine-related injury or death, unless the person proves past or 
present physical injury and a timely petition has been filed in 
accordance with section 2116 for compensation under the Program for 
such injury or death and--''.</DELETED>

<DELETED>SEC. 323. DERIVATIVE PETITIONS FOR COMPENSATION.</DELETED>

<DELETED>    (a) Limitations on Derivative Petitions.--Section 
2111(a)(2) of the Public Health Service Act (42 U.S.C. 300aa-11(a)(2)) 
is amended--</DELETED>
        <DELETED>    (1) in subparagraph (B), by inserting ``or (B)'' 
        after ``subparagraph (A)'';</DELETED>
        <DELETED>    (2) by redesignating subparagraph (B) as 
        subparagraph (C); and</DELETED>
        <DELETED>    (3) by inserting after subparagraph (A) the 
        following:</DELETED>
        <DELETED>    ``(B)(i) No parent or other third party may bring 
        or maintain a civil action against a vaccine administrator or 
        manufacturer in a Federal or State court for damages or 
        equitable relief relating to a vaccine-related injury or death, 
        including without limitation damages for loss of consortium, 
        society, companionship, or services, loss of earnings, medical 
        or other expenses, and emotional distress, and no court may 
        award damages or equitable relief in such an action, unless--
        </DELETED>
                <DELETED>    ``(I) the person who sustained the 
                underlying vaccine-related injury or death upon which 
                such parent's or other third party's claim is premised 
                has timely filed a petition for compensation in 
                accordance with section 2111;</DELETED>
                <DELETED>    ``(II) such parent or other third party is 
                the legal representative or spouse of the person who 
                sustained the underlying vaccine-related injury or 
                death, and such legal representative or spouse has 
                filed a timely derivative petition, in accordance with 
                section 2116; and</DELETED>
                <DELETED>    ``(III)(aa) the United States Court of 
                Federal Claims has issued judgment under section 2112 
                on the derivative petition, and such legal 
                representative or spouse elects under section 2121(a) 
                to file a civil action; or</DELETED>
                <DELETED>    ``(bb) such legal representative or spouse 
                elects to withdraw such derivative petition under 
                section 2121(b) or such petition is considered 
                withdrawn under such section.</DELETED>
        <DELETED>    ``(ii) Any civil action brought in accordance with 
        this subparagraph shall be subject to the standards and 
        procedures set forth in sections 2122 and 2123, regardless of 
        whether the action arises directly from a vaccine-related 
        injury or death associated with the administration of a 
        vaccine. In a case in which the person who sustained the 
        underlying vaccine-related injury or death upon which such 
        legal representative's or spouse's civil action is premised 
        elects under section 2121(a) to receive the compensation 
        awarded, such legal representative or spouse may not bring a 
        civil action for damages or equitable relief, and no court may 
        award damages or equitable relief, for any injury or loss of 
        the type set forth in section 2115(a) or that might in any way 
        overlap with or otherwise duplicate compensation of the type 
        available under section 2115(a).''.</DELETED>
<DELETED>    (b) Eligible Persons.--Section 2111(a)(9) of the Public 
Health Service Act (42 U.S.C. 300aa-11(a)(9)) is amended by striking 
the period and inserting ``and to a parent or other third party to the 
extent such parent or other third party seeks damages or equitable 
relief relating to a vaccine-related injury or death sustained by a 
person who is qualified to file a petition for compensation under the 
Program.''.</DELETED>
<DELETED>    (c) Petitioners.--Section 2111(b) of the Public Health 
Service Act (42 U.S.C. 300aa-11(b)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1)--</DELETED>
                <DELETED>    (A) in subparagraph (A), by striking 
                ``(B)'' and inserting ``(C)'';</DELETED>
                <DELETED>    (B) by redesignating subparagraph (B) as 
                subparagraph (C); and</DELETED>
                <DELETED>    (C) by inserting after subparagraph (A) 
                the following:</DELETED>
        <DELETED>    ``(B) Except as provided in subparagraph (C), any 
        legal representative or spouse of a person--</DELETED>
                <DELETED>    ``(i) who has sustained a vaccine-related 
                injury or death; and</DELETED>
                <DELETED>    ``(ii) who has filed a petition for 
                compensation under the Program (or whose legal 
                representative has filed such a petition as authorized 
                in subparagraph (A));</DELETED>
        <DELETED>may, if such legal representative or spouse meets the 
        requirements of subsection (d), file a derivative petition 
        under this section.''; and</DELETED>
        <DELETED>    (2) in paragraph (2)--</DELETED>
                <DELETED>    (A) by inserting ``by or on behalf of the 
                person who sustained the vaccine-related injury or 
                death'' after ``filed''; and</DELETED>
                <DELETED>    (B) by adding at the end the following: 
                ``A legal representative or spouse may file only 1 
                derivative petition with respect to each underlying 
                petition.''.</DELETED>
<DELETED>    (d) Derivative Petition Contents.--Section 2111 of the 
Public Health Service Act (42 U.S.C. 300aa-11) is amended--</DELETED>
        <DELETED>    (1) by redesignating subsections (d) and (e) as 
        subsections (e) and (f), respectively; and</DELETED>
        <DELETED>    (2) by inserting after subsection (c) the 
        following:</DELETED>
<DELETED>    ``(d) Derivative Petitions.--</DELETED>
        <DELETED>    ``(1) If the legal representative or spouse of the 
        person who sustained the vaccine-related injury or death seeks 
        compensation under the Program, such legal representative or 
        spouse shall file a timely derivative petition for compensation 
        under the Program in accordance with this section.</DELETED>
        <DELETED>    ``(2) Such a derivative petition shall contain--
        </DELETED>
                <DELETED>    ``(A) except for records that are 
                unavailable as described in subsection (c)(3), an 
                affidavit, and supporting documentation, demonstrating 
                that--</DELETED>
                        <DELETED>    ``(i) the child or spouse of such 
                        person has, in accordance with section 2111, 
                        timely filed a petition for compensation for 
                        the underlying vaccine-related injury or death 
                        upon which such legal representative's or 
                        spouse's derivative petition is 
                        premised;</DELETED>
                        <DELETED>    ``(ii) the derivative petition was 
                        timely filed;</DELETED>
                        <DELETED>    ``(iii) such legal representative 
                        or spouse suffered a loss compensable under 
                        section 2115(b) as a result of the vaccine-
                        related injury or death sustained by such 
                        person; and</DELETED>
                        <DELETED>    ``(iv) such legal representative 
                        or spouse has not previously collected an award 
                        or settlement of a civil action for damages for 
                        such loss; and</DELETED>
                <DELETED>    ``(B) records establishing such legal 
                representative's or spouse's relationship to the person 
                who sustained the vaccine-related injury or 
                death.''.</DELETED>
<DELETED>    (e) Determination of Eligibility for Compensation.--
Section 2113(a)(1) of the Public Health Service Act (42 U.S.C. 300aa-
13(a)(1)) is amended--</DELETED>
        <DELETED>    (1) in subparagraph (A), by striking ``and'' and 
        inserting ``or, as applicable, section 2111(d),'';</DELETED>
        <DELETED>    (2) in subparagraph (B), by striking the period 
        and inserting ``, and''; and</DELETED>
        <DELETED>    (3) by inserting before the flush matter at the 
        end, the following:</DELETED>
                <DELETED>    ``(C) in the case of a derivative 
                petition, that the person who sustained the underlying 
                vaccine-related injury or death upon which the 
                derivative petition is premised has timely filed a 
                petition for compensation in accordance with section 
                2111 and that, with respect to such underlying 
                petition, the special master or court has made the 
                findings specified in subparagraphs (A) and (B) of this 
                paragraph.''.</DELETED>
<DELETED>    (f) Compensation.--Section 2115 of the Public Health 
Service Act (42 U.S.C. 300aa-15) is amended--</DELETED>
        <DELETED>    (1) by redesignating subsections (b) through (j) 
        as subsections (c) through (k), respectively;</DELETED>
        <DELETED>    (2) by inserting after subsection (a) the 
        following:</DELETED>
<DELETED>    ``(b) Derivative Petitions.--</DELETED>
        <DELETED>    ``(1) In general.--Compensation awarded under the 
        Program to a legal representative or spouse who files a 
        derivative petition under section 2111 for a loss sustained as 
        a result of a vaccine-related injury or death sustained by such 
        petitioner's child or spouse shall only include compensation 
        for any loss of consortium, society, companionship, or 
        services, in an amount not to exceed the lesser of $250,000 or 
        the total amount of compensation awarded to the person who 
        sustained the underlying vaccine-related injury or 
        death.</DELETED>
        <DELETED>    ``(2) Multiple individuals.--Where more than 1 
        person files a derivative petition under section 2111 for 
        losses sustained as a result of the same underlying vaccine-
        related injury or death, the aggregate compensation to such 
        persons shall not exceed the lesser of $250,000, or the total 
        amount of compensation awarded to the person who sustained the 
        underlying vaccine-related injury or death. The special master 
        or court shall apportion compensation among the derivative 
        petitioners in proportion to their respective 
        losses.'';</DELETED>
        <DELETED>    (3) in subsection (e)(2), as so redesignated by 
        paragraph (1)--</DELETED>
                <DELETED>    (A) by striking ``(2) and (3)'' and 
                inserting ``(2), (3), (4), (5), and (6)''; 
                and</DELETED>
                <DELETED>    (B) by inserting ``and subsection (b),'' 
                after ``(a),'';</DELETED>
        <DELETED>    (4) in subsection (g), as so redesignated by 
        paragraph (1), in paragraph (4)(B), by striking ``subsection 
        (j)'' and inserting ``subsection (k)'';</DELETED>
        <DELETED>    (5) in subsection (j), as so redesignated by 
        paragraph (1)--</DELETED>
                <DELETED>    (A) in paragraph (1), by striking 
                ``subsection (j)'' and inserting ``subsection (k)''; 
                and</DELETED>
                <DELETED>    (B) in paragraph (2), by inserting ``, or 
                to a legal representative or spouse of a person who 
                sustained a vaccine-related injury or death,'' after 
                ``death''; and</DELETED>
        <DELETED>    (6) in subsection (k), as so redesignated by 
        paragraph (1), by striking ``subsection (f)(4)(B)'' and 
        inserting ``subsection (g)(4)(B)''.</DELETED>

<DELETED>SEC. 324. JURISDICTION TO DISMISS ACTIONS IMPROPERLY 
              BROUGHT.</DELETED>

<DELETED>    Section 2111(a)(3) of the Public Health Service Act (42 
U.S.C. 300aa-11(a)(3)) is amended by adding at the end the following: 
``If any civil action which is barred under subparagraph (A) or (B) of 
paragraph (2) is filed or maintained in a State court, or any vaccine 
administrator or manufacturer is made a party to any civil action 
brought in State court (other than a civil action which may be brought 
under paragraph (2)) for damages or equitable relief for a vaccine-
related injury or death associated with the administration of a vaccine 
after October 1, 1988, the civil action may be removed at any time 
before final judgment by the defendant or defendants to the United 
States Court of Federal Claims. Once removed, the United States Court 
of Federal Claims shall have jurisdiction solely for the purpose of 
adjudicating whether the civil action should be dismissed pursuant to 
this section. If the United States Court of Federal Claims determines 
that the civil action should not be dismissed, the court shall remand 
the action to the State Court. The notice required by section 1446 of 
title 28, United States Code, shall be filed with the United States 
Court of Federal Claims, and that court shall, except as otherwise 
provided in this section, proceed in accordance with sections 1446 
through 1451 of title 28, United States Code.''.</DELETED>

<DELETED>SEC. 325. CLARIFICATION OF WHEN INJURY IS CAUSED BY FACTOR 
              UNRELATED TO ADMINISTRATION OF VACCINE.</DELETED>

<DELETED>    Section 2113(a)(2)(B) of the Public Health Service Act (42 
U.S.C. 300aa-13(a)(2)(B)) is amended--</DELETED>
        <DELETED>    (1) by inserting ``structural lesions, genetic 
        disorders,'' after ``and related anoxia),'';</DELETED>
        <DELETED>    (2) by inserting ``(without regard to whether the 
        cause of the infection, toxin, trauma, structural lesion, 
        genetic disorder, or metabolic disturbance is known)'' after 
        ``metabolic disturbances''; and</DELETED>
        <DELETED>    (3) by striking ``but'' and inserting 
        ``and''.</DELETED>

<DELETED>SEC. 326. INCREASE IN AWARD IN THE CASE OF A VACCINE-RELATED 
              DEATH AND FOR PAIN AND SUFFERING.</DELETED>

<DELETED>    (a) In General.--Section 2115(a) of the Public Health 
Service Act (42 U.S.C. 300aa-15(a)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (2), by striking ``$250,000'' and 
        inserting ``$350,000''; and</DELETED>
        <DELETED>    (2) in paragraph (4), by striking ``$250,000'' and 
        inserting ``$350,000''.</DELETED>
<DELETED>    (b) Death Awards.--Section 2115(a)(2) of the Public Health 
Service Act (42 U.S.C. 300aa-15(a)(2)) is amended by inserting ``(if 
the deceased incurred unreimbursable expenses due to the vaccine-
related injury prior to death in excess of $50,000, the award shall 
also include reimbursement for those unreimbursable expenses that 
exceed $50,000)'' before the period.</DELETED>

<DELETED>SEC. 327. BASIS FOR CALCULATING PROJECTED LOST 
              EARNINGS.</DELETED>

<DELETED>    Section 2115(a)(3)(B) of the Public Health Service Act (42 
U.S.C. 300aa-15(a)(3)(B)) is amended by striking ``loss of earnings'' 
and all that follows and inserting the following: ``loss of earnings 
determined on the basis of the annual estimate of the average (mean) 
gross weekly earnings of wage and salary workers age 18 and over 
(excluding the incorporated self-employed) in the private non-farm 
sector (which includes all industries other than agricultural 
production crops and livestock), as calculated annually by the Bureau 
of Labor Statistics from the quarter sample data of the Current 
Population Survey, or as calculated by such similar method as the 
Secretary may prescribe by regulation, less appropriate taxes and the 
average cost of a health insurance policy, as determined by the 
Secretary.''.</DELETED>

<DELETED>SEC. 328. ALLOWING COMPENSATION FOR FAMILY COUNSELING EXPENSES 
              AND EXPENSES OF ESTABLISHING AND MAINTAINING 
              GUARDIANSHIP.</DELETED>

<DELETED>    (a) Family Counseling Expenses in Post-1988 Cases.--
Section 2115(a) of the Public Health Service Act (42 U.S.C. 300aa-
15(a)) is amended by adding at the end the following:</DELETED>
        <DELETED>    ``(5) Actual unreimbursable expenses that have 
        been or will be incurred for family counseling as is determined 
        to be reasonably necessary and that result from the vaccine-
        related injury from which the petitioner seeks 
        compensation.''.</DELETED>
<DELETED>    (b) Expenses of Establishing and Maintaining Guardianships 
in Post-1988 Cases.--Section 2115(a) of the Public Health Service Act 
(42 U.S.C. 300aa-15(a)), as amended by subsection (a), is further 
amended by adding at the end the following:</DELETED>
        <DELETED>    ``(6) Actual unreimbursable expenses that have 
        been, or will be reasonably incurred to establish and maintain 
        a guardianship or conservatorship for an individual who has 
        suffered a vaccine-related injury, including attorney fees and 
        other costs incurred in a proceeding to establish and maintain 
        such guardianship or conservatorship.''.</DELETED>
<DELETED>    (c) Conforming Amendment for Cases From 1988 and 
Earlier.--Section 2115 of the Public Health Service Act (42 U.S.C. 
300aa-15) is amended in subsection (c), as so redesignated by section 
323(f)--</DELETED>
        <DELETED>    (1) in paragraph (2), by striking ``and'' at the 
        end;</DELETED>
        <DELETED>    (2) in paragraph (3), by striking ``(e)'' and 
        inserting ``(f)'';</DELETED>
        <DELETED>    (3) by redesignating paragraph (3) as paragraph 
        (5); and</DELETED>
        <DELETED>    (4) by inserting after paragraph (2), the 
        following:</DELETED>
        <DELETED>    ``(3) family counseling expenses (as provided for 
        in paragraph (5) of subsection (a));</DELETED>
        <DELETED>    ``(4) expenses of establishing and maintaining 
        guardianships (as provided for in paragraph (6) of subsection 
        (a)); and''.</DELETED>

<DELETED>SEC. 329. ALLOWING PAYMENT OF INTERIM COSTS.</DELETED>

<DELETED>    Section 2115 of the Public Health Service Act (42 U.S.C. 
300aa-15) is amended in subsection (f), as so redesignated by section 
323(f), by adding at the end the following:</DELETED>
        <DELETED>    ``(4) A special master or court may make an 
        interim award of costs subject to final adjustment if--
        </DELETED>
                <DELETED>    ``(A) the case involves a vaccine 
                administered on or after October 1, 1988;</DELETED>
                <DELETED>    ``(B) the special master or court has 
                determined that the petitioner is entitled to 
                compensation under the Program;</DELETED>
                <DELETED>    ``(C) the award is limited to other costs 
                (within the meaning of paragraph (1)(B)) incurred in 
                the proceeding;</DELETED>
                <DELETED>    ``(D) not more than 1 prior award has been 
                made with respect to such petition; and</DELETED>
                <DELETED>    ``(E) the petitioner provides 
                documentation verifying the expenditure of the amount 
                for which compensation is sought.''.</DELETED>

<DELETED>SEC. 330. PROCEDURE FOR PAYING ATTORNEYS' FEES.</DELETED>

<DELETED>    Section 2115 of the Public Health Service Act (42 U.S.C. 
300aa-15), is amended in subsection (f), as so redesignated by section 
323(f) and amended by section 329, by adding at the end the 
following:</DELETED>
        <DELETED>    ``(5) When a special master or court awards 
        attorney fees or costs under paragraph (1) or (4), it may order 
        that such fees or costs be payable solely to the petitioner's 
        attorney if--</DELETED>
                <DELETED>    ``(A) the petitioner expressly consents; 
                or</DELETED>
                <DELETED>    ``(B) the special master or court 
                determines, after affording to the Secretary and to all 
                interested persons the opportunity to submit relevant 
                information, that--</DELETED>
                        <DELETED>    ``(i) the petitioner cannot be 
                        located or refuses to respond to a request by 
                        the special master or court for information, 
                        and there is no practical alternative means to 
                        ensure that the attorney will be reimbursed for 
                        such fees or costs expeditiously; or</DELETED>
                        <DELETED>    ``(ii) there are otherwise 
                        exceptional circumstances and good cause for 
                        paying such fees or costs solely to the 
                        petitioner's attorney.''.</DELETED>

<DELETED>SEC. 331. EXTENSION OF STATUTE OF LIMITATIONS.</DELETED>

<DELETED>    (a) General Rule.--Section 2116(a) of the Public Health 
Service Act (42 U.S.C. 300aa-16(a)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (2), by striking ``36 months'' 
        and inserting ``6 years''; and</DELETED>
        <DELETED>    (2) in paragraph (3), by striking ``48 months'' 
        and inserting ``6 years''.</DELETED>
<DELETED>    (b) Claims Based on Revisions to Table.--Section 2116 of 
the Public Health Service Act (42 U.S.C. 300aa-16) is amended by 
striking subsection (b) and inserting the following:</DELETED>
<DELETED>    ``(b) Effect of Revised Table.--If at any time the Vaccine 
Injury Table is revised and the effect of such revision is to make an 
individual eligible for compensation under the program, where, before 
such revision, such individual was not eligible for compensation under 
the program, or to significantly increase the likelihood that an 
individual will be able to obtain compensation under the program, such 
person may, and shall before filing a civil action for equitable relief 
or monetary damages, notwithstanding section 2111(b)(2), file a 
petition for such compensation if--</DELETED>
        <DELETED>    ``(1) the vaccine-related death or injury with 
        respect to which the petition is filed occurred not more than 
        10 years before the effective date of the revision of the 
        table; and</DELETED>
        <DELETED>    ``(2) either--</DELETED>
                <DELETED>    ``(A) the petition satisfies the 
                conditions described in subsection (a); or</DELETED>
                <DELETED>    ``(B) the date of the occurrence of the 
                first symptom or manifestation of onset of the injury 
                occurred more than 4 years before the petition is 
                filed, and the petition is filed not more than 2 years 
                after the effective date of the revision of the 
                table.''.</DELETED>
<DELETED>    (c) Derivative Petitions.--Section 2116 of the Public 
Health Service Act (42 U.S.C. 300aa-16) is amended by adding at the end 
the following:</DELETED>
<DELETED>    ``(d) Derivative Petitions.--No derivative petition may be 
filed for compensation under the Program later than the earlier of--
</DELETED>
        <DELETED>    ``(1) the last day on which the petition for 
        compensation for the underlying claim of the person who 
        sustained the vaccine-related injury or death upon which the 
        derivative petition is premised may be timely filed; 
        or</DELETED>
        <DELETED>    ``(2) 60 days after the date on which the special 
        master has issued a decision pursuant to section 2112(d)(3) on 
        the underlying claim of the person who sustained the vaccine-
        related injury or death upon which the derivative petition is 
        premised.''.</DELETED>
<DELETED>    (d) Timely Resolutions of Claims.--</DELETED>
        <DELETED>    (1) Special master decision.--Section 
        2112(d)(3)(A) of the Public Health Service Act (42 U.S.C. 
        300aa-12(d)(3)(A)) is amended by adding at the end the 
        following: ``For purposes of this subparagraph, the petition 
        shall be deemed to be filed on the date on which the special 
        master issues a certificate of completeness, indicating that 
        all petition contents and supporting documents required under 
        section 2111(c) and, when applicable, section 2111(d) and the 
        Vaccine Rules of the United States Court of Federal Claims, 
        such as an affidavit and supporting documentation, have been 
        served on the Secretary and filed with the clerk of the United 
        States Court of Federal Claims.''.</DELETED>
        <DELETED>    (2) Derivative petitions.--Section 2112(d)(3)(C) 
        of the Public Health Service Act (42 U.S.C. 300aa-12(d)(3)(C)) 
        is amended by adding at the end the following: ``With respect 
        to any derivative petition filed under section 2111, the period 
        of time during which the petition for compensation for the 
        underlying vaccine-related injury or death upon which such 
        derivative petition is premised is pending shall be treated as 
        a suspension for purposes of this subparagraph.''.</DELETED>
        <DELETED>    (3) Court of federal claims decision.--Section 
        2121(b) of the Public Health Service Act (42 U.S.C. 300aa-
        21(b)) is amended by adding at the end the following: ``For 
        purposes of this subsection, the petition shall be deemed to be 
        filed on the date on which the special master issues a 
        certificate of completeness, indicating that all petition 
        contents and supporting documents required under section 
        2111(c) and, when applicable, section 2111(d) and the Vaccine 
        Rules of the United States Court of Federal Claims, such as an 
        affidavit and supporting documentation, have been served on the 
        Secretary and filed with the clerk of the United States Court 
        of Federal Claims.''.</DELETED>

<DELETED>SEC. 332. ADVISORY COMMISSION ON CHILDHOOD VACCINES.</DELETED>

<DELETED>    (a) Selection of Persons Injured by Vaccines as Public 
Members.--Section 2119(a)(1)(B) of the Public Health Service Act (42 
U.S.C. 300aa-19(a)(1)(B)) is amended by striking ``of whom'' and all 
that follows and inserting the following: ``of whom 1 shall be the 
legal representative of a child who has suffered a vaccine-related 
injury or death, and at least 1 other shall be either the legal 
representative of a child who has suffered a vaccine-related injury or 
death or an individual who has personally suffered a vaccine-related 
injury.''.</DELETED>
<DELETED>    (b) Mandatory Meeting Schedule Eliminated.--Section 
2119(c) of the Public Health Service Act (42 U.S.C. 300aa-19(c)) is 
amended by striking ``not less often than four times per year 
and''.</DELETED>

<DELETED>SEC. 333. CLARIFICATION OF STANDARDS OF 
              RESPONSIBILITY.</DELETED>

<DELETED>    (a) General Rule.--Section 2122(a) of the Public Health 
Service Act (42 U.S.C. 300aa-22(a)) is amended by striking ``and (e) 
State law shall apply to a civil action brought for damages'' and 
inserting ``(d), and (f) State law shall apply to a civil action 
brought for damages or equitable relief''; and</DELETED>
<DELETED>    (b) Unavoidable Adverse Side Effects.--Section 2122(b)(1) 
of the Public Health Service Act (42 U.S.C. 300aa-22(b)(1)) is amended 
by inserting ``or equitable relief'' after ``for damages''.</DELETED>
<DELETED>    (c) Direct Warnings.--Section 2122(c) of the Public Health 
Service Act (42 U.S.C. 300aa-22(c)) is amended by inserting ``or 
equitable relief'' after ``for damages''.</DELETED>
<DELETED>    (d) Construction.--Section 2122(d) of the Public Health 
Service Act (42 U.S.C. 300aa-22(d)) is amended--</DELETED>
        <DELETED>    (1) by inserting ``or equitable relief'' after 
        ``for damages''; and</DELETED>
        <DELETED>    (2) by inserting ``or relief'' after ``which 
        damages''.</DELETED>
<DELETED>    (e) Past or Present Physical Injury.--Section 2122 of the 
Public Health Service Act (42 U.S.C. 300aa-22) is amended--</DELETED>
        <DELETED>    (1) by redesignating subsections (d) and (e) as 
        subsections (e) and (f), respectively; and</DELETED>
        <DELETED>    (2) by inserting after subsection (c) the 
        following:</DELETED>
<DELETED>    ``(d) Past or Present Physical Injury.--No vaccine 
manufacturer or vaccine administrator shall be liable in a civil action 
brought after October 1, 1988, for equitable or monetary relief absent 
proof of past or present physical injury from the administration of a 
vaccine, nor shall any vaccine manufacturer or vaccine administrator be 
liable in any such civil action for claims of medical monitoring, or 
increased risk of harm.''.</DELETED>

<DELETED>SEC. 334. CLARIFICATION OF DEFINITION OF 
              MANUFACTURER.</DELETED>

<DELETED>    Section 2133(3) of the Public Health Service Act (42 
U.S.C. 300aa-33(3)) is amended--</DELETED>
        <DELETED>    (1) in the first sentence, by striking ``under its 
        label any vaccine set forth in the Vaccine Injury Table'' and 
        inserting ``any vaccine set forth in the Vaccine Injury table, 
        including any component or ingredient of any such vaccine''; 
        and</DELETED>
        <DELETED>    (2) in the second sentence, by inserting 
        ``including any component or ingredient of any such vaccine'' 
        before the period.</DELETED>

<DELETED>SEC. 335. CLARIFICATION OF DEFINITION OF VACCINE-RELATED 
              INJURY OR DEATH.</DELETED>

<DELETED>    Section 2133(5) of the Public Health Service Act (42 
U.S.C. 300aa-33(5)) is amended by adding at the end the following: 
``For purposes of the preceding sentence, an adulterant or contaminant 
shall not include any component or ingredient listed in a vaccine's 
product license application or product label.''.</DELETED>

<DELETED>SEC. 336. CLARIFICATION OF DEFINITION OF VACCINE AND 
              DEFINITION OF PHYSICAL INJURY.</DELETED>

<DELETED>    Section 2133 of the Public Health Service Act (42 U.S.C. 
300aa-33) is amended by adding at the end the following:</DELETED>
<DELETED>    ``(7) The term `vaccine' means any preparation or 
suspension, including a preparation or suspension containing an 
attenuated or inactive microorganism or subunit thereof or toxin, 
developed or administered to produce or enhance the body's immune 
response to a disease or diseases and includes all components and 
ingredients listed in the vaccine's product license application and 
product label.</DELETED>
<DELETED>    ``(8) The term `physical injury' means a manifest physical 
illness, condition, or death, including a neurological disease or 
disorder.''.</DELETED>

<DELETED>SEC. 337. AMENDMENTS TO VACCINE INJURY COMPENSATION TRUST 
              FUND.</DELETED>

<DELETED>    (a) Expansion of Compensated Loss.--Section 9510(c)(1)(A) 
of the Internal Revenue Code of 1986 is amended by inserting ``, or 
related loss,'' after ``death''.</DELETED>
<DELETED>    (b) Increase in Limit on Administrative Expenses.--
Subparagraph (B) of section 9510(c)(1) of the Internal Revenue Code of 
1986 is amended--</DELETED>
        <DELETED>    (1) by striking ``(but not in excess of the base 
        amount of $9,500,000 for any fiscal year)''; and</DELETED>
        <DELETED>    (2) by striking the period and inserting ``, 
        provided that such administrative costs shall not exceed the 
        greater of--</DELETED>
                        <DELETED>    ``(i) the base amount of 
                        $9,500,000 for any fiscal year,</DELETED>
                        <DELETED>    ``(ii) 125 percent of the base 
                        amount for any fiscal year in which the total 
                        number of claims pending under such subtitle 
                        exceeds 150 percent of the average number of 
                        claims pending in the preceding 5 
                        years,</DELETED>
                        <DELETED>    ``(iii) 175 percent of the base 
                        amount for any fiscal year in which the total 
                        number of claims pending under such subtitle 
                        exceeds 200 percent of the average number of 
                        claims pending in the preceding 5 
                        years,</DELETED>
                        <DELETED>    ``(iv) 225 percent of the base 
                        amount for any fiscal year in which the total 
                        number of claims pending under such subtitle 
                        exceeds 250 percent of the average number of 
                        claims pending in the preceding 5 years, 
                        or</DELETED>
                        <DELETED>    ``(v) 275 percent of the base 
                        amount for any fiscal year in which the total 
                        number of claims pending under such subtitle 
                        exceeds 300 percent of the average number of 
                        claims pending in the preceding 5 
                        years.''.</DELETED>
<DELETED>    (c) Conforming Amendment.--Section 9510(c)(1)(A) of the 
Internal Revenue Code of 1986 is amended by striking ``October 18, 
2000'' and inserting ``the date of enactment of the Improved Vaccine 
Affordability and Availability Act''.</DELETED>

<DELETED>SEC. 338. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.</DELETED>

<DELETED>    Part C of title XXI of the Public Health Service Act (42 
U.S.C. 300a-25 et seq.) is amended by adding at the end the 
following:</DELETED>

<DELETED>``SEC. 2129A. ONGOING REVIEW OF CHILDHOOD VACCINE 
              DATA.</DELETED>

<DELETED>    ``(a) In General.--Not later than 6 months after the date 
of enactment of this section, the Secretary shall enter into a contract 
with the Institute of Medicine of the National Academy of Science under 
which the Institute shall conduct an ongoing, comprehensive review of 
new scientific data on childhood vaccines (according to priorities 
agreed upon from time to time by the Secretary and the Institute of 
Medicine).</DELETED>
<DELETED>    ``(b) Reports.--Not later than 3 years after the date on 
which the contract is entered into under subsection (a), the Institute 
of Medicine shall submit to the Secretary a report on the findings of 
the studies conducted under such contract, including findings as to any 
adverse events associated with childhood vaccines, including 
conclusions concerning causation of adverse events by such vaccines, 
and other appropriate recommendations, based on such findings and 
conclusions.</DELETED>
<DELETED>    ``(c) Failure to Enter Into Contract.--If the Secretary 
and the Institute of Medicine are unable to enter into the contract 
described in subsection (a), the Secretary shall enter into a contract 
with another qualified nongovernmental scientific organization for the 
purposes described in subsections (a) and (b).</DELETED>
<DELETED>    ``(d) Authorization of Appropriations.--To carry out this 
section, there are authorized to be appropriated such sums as may be 
necessary for each of fiscal years 2003, 2004, 2005 and 
2006.''.</DELETED>

<DELETED>SEC. 339. PENDING ACTIONS.</DELETED>

<DELETED>    The amendments made by this title shall apply to all 
actions or proceedings pending on or after the date of enactment of 
this Act, unless a court of competent jurisdiction has entered judgment 
(regardless of whether the time for appeal has expired) in such action 
or proceeding disposing of the entire action or proceeding.</DELETED>

<DELETED>SEC. 340. REPORT.</DELETED>

<DELETED>    Not later than 1 year after the date of enactment of this 
Act, and annually thereafter, the Advisory Commission on Childhood 
Vaccines shall report to the Secretary regarding the status of the 
Vaccine Injury Compensation Trust Fund, and shall make recommendations 
to the Secretary regarding the allocation of funds from the Vaccine 
Injury Compensation Trust Fund.</DELETED>

SECTION 1. SHORT TITLE.

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

SEC. 2. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT AUTHORITIES.

    (a) In General.--Part B of title IV of the Public Health Service 
Act (42 U.S.C. 284 et seq.) is amended by adding at the end the 
following:

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

    ``(a) In General.--
            ``(1) Authority.--In carrying out research responsibilities 
        under this Act, the Secretary may conduct and support research 
        and development with respect to biomedical countermeasures.
            ``(2) Implementation.--
                    ``(A) In general.--Except as provided in 
                subparagraph (C), authorities assigned by this section 
                to the Secretary shall be carried out through the 
                Director of NIH.
                    ``(B) Lead institute.--The National Institute of 
                Allergy and Infectious Diseases shall be the lead 
                institute for performing, administering, or supporting 
                biomedical countermeasure research and development. The 
                Director of NIH may delegate to the Director of the 
                Institute authorities as are necessary to carry out 
                this function.
                    ``(C) Chemical, radiological, and nuclear agents.--
                To the extent that an authority described in 
                subparagraph (A) is exercised with respect to a 
                chemical, radiological, or nuclear agent, the Secretary 
                may authorize the Director of NIH to carry out the 
                authority through any national research institute.
                    ``(D) Availability of facilities to the 
                secretary.--In any grant or cooperative agreement 
                entered into under the authority provided in this 
                section with respect to a biocontainment laboratory or 
                other related or ancillary specialized research 
                facility that the Secretary determines necessary for 
                the purpose of preforming, administering, and 
                supporting biomedical countermeasures research and 
                development, the Secretary may provide that the 
                facility that is the object of such grant or 
                cooperative agreement shall be available as needed to 
                the Secretary to respond to public health emergencies 
                affecting national security.
            ``(3) Interagency cooperation.--
                    ``(A) In general.--In carrying out activities under 
                this section, the Secretary is authorized, subject to 
                subparagraph (B), to enter into interagency agreements 
                and other collaborative undertakings with other 
                agencies of the Federal Government and to use other 
                agencies of the Department of Health and Human 
                Services.
                    ``(B) Limitation.--An agreement or undertaking 
                under this paragraph may not authorize another agency 
                to exercise the authorities provided to the Secretary 
                by this section.
    ``(b) Expedited Procurement Authority.--
            ``(1) Increased simplified acquisition threshold for 
        biomedical countermeasure procurements.--
                    ``(A) In general.--For any procurement by the 
                Secretary, of property or services for use (as 
                determined by the Secretary) in performing, 
                administering, or supporting biomedical countermeasure 
                research or development, the amount specified in 
                section 4(11) of the Office of Federal Procurement 
                Policy Act (41 U.S.C. 403(11)), as applicable pursuant 
                to section 302A(a) of the Federal Property and 
                Administrative Services Act of 1949 (41 U.S.C. 
                252a(a)), shall be deemed to be $25,000,000 in the 
                administration, with respect to such procurement, of--
                            ``(i) section 303(g)(1)(A) of the Federal 
                        Property and Administrative Services Act of 
                        1949 (41 U.S.C. 253(g)(1)(A)) and its 
                        implementing regulations; and
                            ``(ii) section 302A(b) of such Act (41 
                        U.S.C. 252a(b)) and its implementing 
                        regulations.
                    ``(B) Internal controls to be instituted.--The 
                Secretary shall institute appropriate internal controls 
                for procurements made under this paragraph, including 
                requirements with respect to documenting the 
                justification for use of the authority provided in this 
                paragraph.
            ``(2) Use of noncompetitive procedures.--In addition to any 
        other authority to use procedures other than competitive 
        procedures for procurements, the Secretary may use such other 
        noncompetitive procedures when--
                    ``(A) the procurement is as described by paragraph 
                (1)(A); and
                    ``(B) the property or services needed by the 
                Secretary are available from only one responsible 
                source or only from a limited number of responsible 
                sources, and no other type of property or services will 
                meet the needs of the Secretary.
            ``(3) Increased micropurchase threshold.--
                    ``(A) In general.--For a procurement described by 
                paragraph (1)(A), the amount specified in subsections 
                (c), (d), and (f) of section 32 of the Office of 
                Federal Procurement Policy Act (41 U.S.C. 428) shall be 
                deemed to be $15,000 in the administration of that 
                section with respect to such procurement.
                    ``(B) Internal controls to be instituted.--The 
                Secretary shall institute appropriate internal controls 
                for procurements that are made under this paragraph and 
                that are greater than $2,500.
                    ``(C) Exception to preference for purchase card 
                mechanism.--No provision of law establishing a 
                preference for using a Federal Government purchase card 
                method for purchases shall apply to procurements made 
                under this paragraph and that are greater than $2,500.
    ``(c) Authority To Expedite Peer Review.--The Secretary may, as the 
Secretary determines necessary to respond to pressing research and 
development needs under this section, employ such expedited peer review 
procedures (including consultation with appropriate scientific experts) 
as the Secretary, in consultation with the Director of NIH, determines 
to be appropriate to obtain an assessment of scientific and technical 
merit and likely contribution to the field of biomedical countermeasure 
research, in place of the peer review and advisory council review 
procedures that would otherwise be required under sections 301(a)(3), 
405(b)(1)(B), 405(b)(2), 406(a)(3)(A), 492, and 494, as applicable to a 
grant, contract, or cooperative agreement--
            ``(1) that is for performing, administering, or supporting 
        biomedical countermeasure research and development; and
            ``(2) the amount of which is not greater than $1,500,000.
    ``(d) Agency Facilities.--In addition to any similar authority 
provided under any other provision of law, in carrying out this 
section, the Secretary may--
            ``(1) acquire, lease, construct, improve, renovate, 
        remodel, repair, operate, and maintain laboratories, other 
        research facilities and equipment, and other real or personal 
        property as the Secretary determines necessary for the purpose 
        of performing, administering, and supporting biomedical 
        countermeasure research and development; and
            ``(2) acquire, without regard to section 8141 of title 40, 
        United States Code, by lease or otherwise, through the 
        Administrator of General Services, buildings or parts of 
        buildings in the District of Columbia.
    ``(e) Authority for Personal Services Contracts.--
            ``(1) In general.--For the purpose of performing, 
        administering, and supporting biomedical countermeasure 
        research and development, the Secretary may, as the Secretary 
        determines necessary to respond to pressing research and 
        development needs under this section, obtain by contract (in 
        accordance with section 3109 of title 5, United States Code, 
        but without regard to the limitations in such section on the 
        period of service and on pay) the personal services of experts 
        or consultants who have scientific or other professional 
        qualifications.
            ``(2) Federal tort claims act coverage.--
                    ``(A) In general.--A person carrying out a contract 
                under paragraph (1), and an officer, employee, or 
                governing board member of such person, shall be deemed 
                to be an employee of the Department of Health and Human 
                Services for purposes of claims under sections 1346(b) 
                and 2672 of title 28, United States Code, for money 
                damages for personal injury, including death, resulting 
                from performance of functions under such contract.
                    ``(B) Exclusivity of remedy.--The remedy provided 
                by subparagraph (A) shall be exclusive of any other 
                civil action or proceeding by reason of the same 
                subject matter against the person, officer, employee, 
                or governing board member for any act or omission 
                within the scope of the Federal Tort Claims Act.
                    ``(C) Recourse in case of gross misconduct or 
                contract violation.--
                            ``(i) In general.--Should payment be made 
                        by the United States to any claimant bringing a 
                        claim under this paragraph, either by way of 
                        administrative determination, settlement, or 
                        court judgment, the United States shall have, 
                        notwithstanding any provision of State law, the 
                        right to recover for that portion of the 
                        damages so awarded or paid, as well as interest 
                        and any costs of litigation, resulting from the 
                        failure of any person, officer, employee, or 
                        governing board member to carry out any 
                        obligation or responsibility assumed by such 
                        person, officer, employee, or governing board 
                        member under a contract with the United States 
                        or from any grossly negligent, reckless, or 
                        illegal conduct or willful misconduct on the 
                        part of such person, officer, employee, or 
                        governing board member.
                            ``(ii) Venue.--The United States may 
                        maintain an action under this subparagraph 
                        against such person, officer, employee, or 
                        governing board member in the district court of 
                        the United States in which such person, 
                        officer, employee, or governing board member 
                        resides or has its principal place of business.
            ``(3) Internal controls to be instituted.--
                    ``(A) In general.--The Secretary shall institute 
                appropriate internal controls for contracts under this 
                subsection, including procedures for the Secretary to 
                make a determination of whether a person, or an 
                officer, employee, or governing board member of a 
                person, is deemed to be an employee of the Department 
                of Health and Human Services pursuant to paragraph (2).
                    ``(B) Determination of employee status to be 
                final.--A determination by the Secretary under 
                subparagraph (A) that a person, or an officer, 
                employee, or governing board member of a person, is or 
                is not deemed to be an employee of the Department of 
                Health and Human Services shall be final and binding on 
                the Secretary and the Attorney General and other 
                parties to any civil action or proceeding.
            ``(4) Number of personal services contracts limited.--The 
        number of experts and consultants whose personal services are 
        obtained under paragraph (1) shall not exceed 30 at any time.
    ``(f) Streamlined Personnel Authority.--
            ``(1) In general.--In addition to any other personnel 
        authorities, the Secretary may, as the Secretary determines 
        necessary to respond to pressing research and development needs 
        under this section, without regard to such provisions of title 
        5, United States Code, governing appointments in the 
        competitive service, and without regard to the provisions of 
        chapter 51 and subchapter III of chapter 53 of such title 
        relating to classification and General Schedule pay rates, 
        appoint professional and technical employees, not to exceed 30 
        such employees at any time, to positions in the National 
        Institutes of Health to perform, administer, or support 
        biomedical countermeasure research and development in carrying 
        out this section.
            ``(2) Internal controls to be instituted.--The Secretary 
        shall institute appropriate internal controls for appointments 
        under this subsection.
    ``(g) Definition.--As used in this section, the term `biomedical 
countermeasure' means a drug (as that term is defined by section 
201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(g)(1))), biological product (as that term is defined by section 
351(i) of this Act (42 U.S.C. 262(i))), or device (as that term is 
defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 321(h))) that is used--
            ``(1) to treat, identify, or prevent harm from any 
        biological, chemical, radiological, or nuclear agent that may 
        cause a public health emergency affecting national security; or
            ``(2) to treat, identify, or prevent harm from a condition 
        that may result in adverse health consequences or death and may 
        be caused by administering a drug, biological product, or 
        device that is used as described in paragraph (1).
    ``(h) Actions Committed to Agency Discretion.--Actions by the 
Secretary under the authority of this section are committed to agency 
discretion.''.
    (b) Technical Amendment.--Section 481A of the Public Health Service 
Act (42 U.S.C. 287a-2) is amended--
            (1) in subsection (a)(1), by inserting ``or the Director of 
        the National Institute of Allergy and Infectious Diseases'' 
        after ``Director of the Center'';
            (2) in subsection (c)--
                    (A) in paragraph (1), by inserting ``or the 
                Director of the National Institute of Allergy and 
                Infectious Diseases'' after ``Director of the Center''; 
                and
                    (B) in paragraph (2), in the matter preceding 
                subparagraph (A), by striking ``subsection (i)'' and 
                inserting ``subsection (i)(1)'';
            (3) in subsection (d), by inserting ``or the Director of 
        the National Institute of Allergy and Infectious Diseases'' 
        after ``Director of the Center'';
            (4) in subsection (e)--
                    (A) in paragraph (1)--
                            (i) in the matter preceding subparagraph 
                        (A), by inserting ``or the Director of the 
                        National Institute of Allergy and Infectious 
                        Diseases'' after ``Director of the Center'';
                            (ii) in subparagraph (A), by inserting 
                        ``(or, in the case of the Institute, 75 
                        percent)'' after ``50 percent''; and
                            (iii) in subparagraph (B), by inserting 
                        ``(or, in the case of the Institute, 75 
                        percent)'' after ``40 percent'';
                    (B) in paragraph (2), by inserting ``or the 
                Director of the National Institute of Allergy and 
                Infectious Diseases'' after ``Director of the Center''; 
                and
                    (C) in paragraph (4), by inserting ``of the Center 
                or the Director of the National Institute of Allergy 
                and Infectious Diseases'' after ``Director''; and
            (5) in subsection (f)--
                    (A) in paragraph (1), by inserting ``in the case of 
                an award by the Director of the Center,'' before ``the 
                applicant''; and
                    (B) in paragraph (2), by inserting ``of the Center 
                or the Director of the National Institute of Allergy 
                and Infectious Diseases'' after ``Director''.

 SEC. 3. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

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

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

    ``(a) Determination of Material Threats.--
            ``(1) Risk of use.--The Secretary of Homeland Security, in 
        consultation with the heads of other agencies as appropriate, 
        shall on an ongoing basis--
                    ``(A) assess current and emerging threats of use of 
                chemical, biological, radiological, and nuclear agents; 
                and
                    ``(B) determine which of such agents present a 
                material risk of use against the United States 
                population.
            ``(2) Public health impact.--The Secretary, in consultation 
        with the Secretary of Homeland Security, shall on an ongoing 
        basis--
                    ``(A) assess the potential public health 
                consequences of use against the United States 
                population of agents identified under paragraph (1)(B); 
                and
                    ``(B) determine, on the basis of such assessment, 
                the agents for which countermeasures are necessary to 
                protect the public health.
    ``(b) Assessment of Availability and Appropriateness of 
Countermeasures.--The Secretary, in consultation with the Secretary of 
Homeland Security, shall assess on an ongoing basis the availability 
and appropriateness of specific countermeasures to address specific 
threats identified under subsection (a).
    ``(c) Call for Necessary Countermeasures; Commitment for 
Recommendation for Procurement.--
            ``(1) Proposal to the president.--Based on a determination 
        of necessary countermeasures under subsection (a), and the 
        assessment of availability and appropriateness of 
        countermeasures under subsection (b), the Secretary of Homeland 
        Security and the Secretary may jointly submit to the President 
        a proposal to--
                    ``(A) call for a necessary countermeasure that is 
                not available; and
                    ``(B) commit to make a recommendation for 
                procurement under subsection (e) of the first such 
                specific countermeasure that meets the conditions for 
                procurement under subsection (d).
            ``(2) Countermeasure specifications.--The Secretary of 
        Homeland Security and the Secretary shall, to the extent 
        practicable, include in the recommendation under paragraph 
        (1)--
                    ``(A) estimated quantity of purchase (in the form 
                of number of doses or number of effective courses of 
                treatments regardless of dosage form);
                    ``(B) necessary measures of minimum safety and 
                effectiveness;
                    ``(C) estimated price for each dose or effective 
                course of treatment regardless of dosage form; and
                    ``(D) other information that may be necessary to 
                encourage and facilitate research, development, and 
                manufacture of the countermeasure or to provide 
                specifications for the countermeasure.
            ``(3) Presidential approval.--If the President has approved 
        a request under paragraph (1), the Secretary of Homeland 
        Security and the Secretary shall make known to persons who may 
        respond to a call for the countermeasure--
                    ``(A) the call for the countermeasure;
                    ``(B) specifications for the countermeasure under 
                paragraph (2); and
                    ``(C) a commitment for a recommendation for 
                procurement under subsection (e) of the first such 
                specific countermeasure that meets the conditions for 
                procurement under subsection (d) and the specifications 
                under paragraph (2).
            ``(4) Subsequent specific countermeasures.--Procurement 
        under subsection (f) of the first such specific countermeasure, 
        or any other such countermeasure, that meets the conditions for 
        procurement under subsection (d) and the specifications under 
        paragraph (2) shall not preclude the additional procurement 
        under subsection (f) of a subsequent such countermeasure that 
        meets the conditions of procurement under subsection (d) if 
        such a countermeasure provides improved safety or effectiveness 
        or for other reasons enhances preparedness to respond to 
        threats of use of a biological, chemical, radiological, or 
        nuclear agent.
    ``(d) Secretary's Determination of Countermeasures Appropriate for 
Procurement under this Section.--
            ``(1) In general.--The Secretary, in accordance with this 
        section, shall identify specific countermeasures to threats 
        identified under subsection (a) that the Secretary determines, 
        in consultation with the Secretary of Homeland Security, to be 
        appropriate for procurement with appropriations under this 
        subsection for inclusion in the stockpile under section 121(a) 
        of the Public Health and Bioterrorism Preparedness and Response 
        Act of 2002 (42 U.S.C. 300hh-12(a)).
            ``(2) Requirements.--In order for the Secretary to make the 
        determination under paragraph (1) with respect to a 
        countermeasure, the following requirements must be met:
                    ``(A) Determination of qualified countermeasure.--
                The Secretary must determine that the product is a 
                qualified countermeasure (as defined in subsection 
                (h)).
                    ``(B) Determination of quantities needed and 
                feasibility of production and distribution.--The 
                Secretary must determine--
                            ``(i) the quantities of the product that 
                        will be needed to meet the needs of the 
                        stockpile; and
                            ``(ii) that production and delivery within 
                        5 years of sufficient quantities of the 
                        product, as so determined, is reasonably 
                        expected to be feasible.
                    ``(C) Determination of no significant commercial 
                market.--The Secretary shall--
                            ``(i) determine that, at the time of the 
                        initial determination under this subsection, 
                        there is not a significant commercial market 
                        for the product other than as a biomedical 
                        countermeasure; and
                            ``(ii) annually redetermine and report to 
                        the President, while a determination under 
                        paragraph (1) remains in effect with respect to 
                        the product, whether a significant commercial 
                        market exists for the product other than as a 
                        biomedical countermeasure.
    ``(e) Recommendation for President's Approval.--
            ``(1) Recommendation for procurement.--In the case of a 
        countermeasure that the Secretary of Homeland Security and the 
        Secretary have determined is appropriate for procurement under 
        this section for inclusion in the stockpile, in accordance with 
        the preceding provisions of this section, the Secretary of 
        Homeland Security and the Secretary shall jointly submit to the 
        President, in coordination with the Director of the Office of 
        Management and Budget, a recommendation for procurement under 
        this section.
            ``(2) Presidential approval.--A countermeasure may be 
        procured under this section only if the President has approved 
        a recommendation under paragraph (1) with respect to such 
        countermeasure.
            ``(3) Notice to congress.--The Secretary of Homeland 
        Security shall notify Congress of each decision of the 
        President to approve a recommendation under paragraph (1).
    ``(f) Procurement.--The Secretary and the Secretary of Homeland 
Security shall be responsible for the following, for purposes of 
procurement of qualified countermeasures for the stockpile under 
section 121(a) of the Public Health and Bioterrorism Preparedness and 
Response Act of 2002 (42 U.S.C. 300hh-12(a)), as approved by the 
President under subsection (e):
            ``(1) In general.--The Secretary shall be responsible for--
                    ``(A) arranging for procurement of the 
                countermeasure, including negotiating terms (including 
                quantity, production schedule, and price) of, and 
                entering into, contracts and cooperative agreements, 
                and for carrying out such other activities as may 
                reasonably be required, in accordance with the 
                provisions of this paragraph; and
                    ``(B) promulgating regulations to implement 
                subparagraphs (E), (F), and (G), and any other 
                provisions of this section.
            ``(2) Contract terms.--A contract for procurement under 
        this section shall (or, as otherwise specified in this 
        paragraph, may) include the following terms:
                    ``(A) Payment conditioned on substantial 
                delivery.--The contract shall provide that no payment 
                may be made until delivery has been made of a 
                substantial portion (as determined by the Secretary) of 
                the total number of units contracted for.
                    ``(B) Discounted payment for unlicensed product.--
                The contract may provide for a discounted price per 
                unit of a product that is not licensed or approved as 
                described in subsection (h)(1) at the time of delivery, 
                and may provide for payment of an additional amount per 
                unit if the product becomes so licensed or approved 
                before the expiration date of the contract (including 
                an additional amount per unit of product delivered 
                before the effective date of such licensing or 
                approval).
                    ``(C) Storage by vendor.--The contract may provide 
                that the vendor will provide storage for stocks of a 
                product delivered to the ownership of the Government 
                under the contract, for such period and under such 
                terms and conditions as the Secretary may specify, and 
                in such case amounts appropriated under subsection (i) 
                shall be available for costs of shipping, handling, 
                storage, and related costs for such product.
                    ``(D) Contract duration.--The contract shall be for 
                a period not to exceed 5 years, renewable for 
                additional periods none of which shall exceed 5 years.
                    ``(E) Termination for nondelivery.--In addition to 
                any other rights of the Secretary to terminate the 
                contract, the contract may provide that such Secretary 
                may terminate the contract for failure to deliver a 
                reasonable number (as determined by the Secretary) of 
                units of the product by 3 years after the date the 
                contract is entered into, and may further provide that 
                in such case the vendor shall not be entitled to any 
                payment under the contract.
                    ``(F) Product approval.--The contract shall provide 
                that the vendor seek approval, clearance, or licensing 
                of the product from the Secretary for a timetable for 
                the development of data and other information to 
                support such approval, clearance, or licensing, and 
                that the Secretary may waive part of all of this 
                contract term on request of the vendor or on the 
                initiative of the Secretary.
            ``(3) Availability of simplified acquisition procedures.--
        The amount of any procurement under this section shall be 
        deemed to be below the threshold amount specified in section 
        4(11) of the Office of Federal Procurement Policy Act (41 
        U.S.C. 403(11)), for purposes of application to such 
        procurement, pursuant to section 302A(a) of the Federal 
        Property and Administrative Services Act of 1949 (41 U.S.C. 
        252a(a)), of--
                    ``(A) 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
                    ``(B) section 302A(b) of such Act (41 U.S.C. 
                252a(b)) and its implementing regulations.
            ``(4) Use of noncompetitive procedures.--In addition to any 
        other authority to use procedures other than competitive 
        procedures, the Secretary may use such other procedures for a 
        procurement under this section if the product is available from 
        only one responsible source or only from a limited number of 
        responsible sources, and no other type of product will satisfy 
        such Secretary's needs.
            ``(5) Premium provision in multiple award contracts.--
                    ``(A) In general.--If, under this section, the 
                Secretary enters into contracts with more than one 
                person to procure a countermeasure, such Secretary may, 
                notwithstanding any other provision of law, include in 
                each of such contracts a provision that--
                            ``(i) identifies an increment of the total 
                        quantity of countermeasure required, whether by 
                        percentage or by numbers of units; and
                            ``(ii) promises to pay one or more 
                        specified premiums based on the priority of 
                        such persons' production and delivery of the 
                        increment identified under clause (i), in 
                        accordance with the terms and conditions of the 
                        contract.
                    ``(B) Determination of government's requirement not 
                reviewable.--If the Secretary includes in each of a set 
                of contracts a provision as described in subparagraph 
                (A), such Secretary's determination of the total 
                quantity of countermeasure required, and any amendment 
                of such determination, is committed to agency 
                discretion.
            ``(6) Extension of closing date for receipt of proposals 
        not reviewable.--A decision by the Secretary to extend the 
        closing date for receipt of proposals for a procurement under 
        this subsection is committed to agency discretion.
            ``(7) Limiting competition to sources responding to request 
        for information.--In conducting a procurement under this 
        section, the Secretary may exclude a source that has not 
        responded to a request for information under section 
        303A(a)(1)(B) of the Federal Property and Administrative 
        Services Act of 1949 (41 U.S.C. 253a(a)(1)(B)) if such request 
        has given notice that such Secretary may so exclude such a 
        source.
    ``(g) Interagency Cooperation.--
            ``(1) In general.--In carrying out activities under this 
        section, the Secretary of Homeland Security and the Secretary 
        are authorized, subject to paragraph (2), to enter into 
        interagency agreements and other collaborative undertakings 
        with other agencies of the United States Government.
            ``(2) Limitation.--An agreement or undertaking under this 
        subsection shall not authorize another agency to exercise the 
        authorities provided by this section to the Secretary of 
        Homeland Security or to the Secretary.
    ``(h) Definitions.--In this section:
            ``(1) Qualified countermeasure.--The term `qualified 
        countermeasure' means a biomedical countermeasure--
                    ``(A) that is approved under section 505(a) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
                licensed under section 351 of this Act (42 U.S.C. 262) 
                or that is approved under section 515 or cleared under 
                section 510(k) of the Federal Food, Drug, and Cosmetic 
                Act (21 U.S.C. 360e and 360) for use as such a 
                countermeasure to a chemical, biological, radiological, 
                or nuclear agent identified as a material threat under 
                subsection (a); or
                    ``(B) for which the Secretary determines that 
                sufficient and satisfactory clinical experience or 
                research data (including data, if available, from 
                preclinical and clinical trials) support a reasonable 
                conclusion that the product will qualify for approval 
                or licensing as such a countermeasure within 5 years 
                after the date of a determination under subsection (d).
            ``(2) Biomedical countermeasure.--The term `biomedical 
        countermeasure' means a drug (as that term is defined by 
        section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 321(g)(1))), device (as that term is defined by 
        section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321(h))), or biological product (as that term is defined 
        by section 351(i) of this Act (42 U.S.C. 262(i))) that is 
        used--
                    ``(A) to treat, identify, or prevent harm from any 
                biological, chemical, radiological, or nuclear agent 
                that may cause a public health emergency affecting 
                national security; or
                    ``(B) to treat, identify, or prevent harm from a 
                condition that may result in adverse health 
                consequences or death and may be caused by 
                administering a drug or biological product that is used 
                as described in subparagraph (A).
    ``(i) Appropriations.--
            ``(1) In general.-- There are appropriated, out of any 
        moneys in the Treasury not otherwise appropriated, for fiscal 
        year 2003 and for each fiscal year thereafter, such sums as may 
        be necessary for the costs incurred by the Secretary in the 
        procurement of countermeasures under this subsection as 
        approved by the President under subsection (e) (other than 
        costs specified in paragraph (2)).
            ``(2) Restrictions.--Amounts appropriated under this 
        subsection shall not be available to pay--
                    ``(A) costs for the purchase of vaccines under 
                procurement contracts entered into before January 1, 
                2003;
                    ``(B) costs under new contracts, or costs of new 
                obligations under contracts previously entered into, 
                for procurement of a countermeasure after the date of a 
                determination under subsection (d)(2)(C) that there is 
                a significant commercial market for the countermeasure 
                other than as a biomedical countermeasure; or
                    ``(C) administrative costs.''.

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

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

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

    ``(a) In General.--Notwithstanding sections 505, 510(k), and 515 of 
this Act and section 351 of the Public Health Service Act, and subject 
to the provisions of this section, the Secretary may authorize the 
introduction into interstate commerce, during the effective period of a 
declaration under subsection (b), of a drug, biological product, or 
device intended solely for use in an actual or potential emergency.
    ``(b) Declaration of Emergency.--
            ``(1) In general.--The Secretary may declare an emergency 
        justifying the authorization of a drug, biological product, or 
        device under this subsection on the basis of a determination--
                    ``(A) by the Secretary of Homeland Security, that 
                there is a domestic emergency (or a significant 
                potential of a domestic emergency) involving a 
                heightened risk of attack with a specified biological, 
                chemical, radiological, or nuclear agent;
                    ``(B) by the Secretary of Defense, that there is a 
                military emergency (or a significant potential of a 
                military emergency) involving a heightened risk to 
                United States military forces of attack with a 
                biological, chemical, radiological, or nuclear agent; 
                or
                    ``(C) by the Secretary of a public health emergency 
                under section 319 of the Public Health Service Act, 
                affecting national security and involving a specified 
                biological, chemical, radiological, or nuclear agent or 
                a specified disease or condition that may be 
                attributable to such agent.
            ``(2) Termination of declaration.--
                    ``(A) In general.--A declaration under this 
                subsection shall terminate upon the earlier of--
                            ``(i) a determination by the Secretary, in 
                        consultation as appropriate with the Secretary 
                        of Homeland Security or the Secretary of 
                        Defense, that the circumstances described in 
                        paragraph (1) have ceased to exist; or
                            ``(ii) the expiration of the 1-year period 
                        beginning on the date on which the declaration 
                        is made.
                    ``(B) Renewal.--Notwithstanding subparagraph (A), 
                the Secretary may renew a declaration under this 
                subsection, and this paragraph shall apply to any such 
                renewal.
            ``(3) Notification.--The Secretary shall promptly publish 
        in the Federal Register, and shall notify the appropriate 
        committees of Congress concerning, each declaration, 
        determination, and renewal under this subsection.
    ``(c) Criteria for Issuance of Authorization.--The Secretary may 
issue an authorization under this section with respect to a product if 
the Secretary concludes--
            ``(1) that an agent specified in a declaration under 
        subsection (b) can cause a serious or life-threatening disease 
        or condition;
            ``(2) that, based on the totality of scientific evidence 
        available to the Secretary, including data from adequate and 
        well-controlled clinical trials, if available, it is reasonable 
        to believe that--
                    ``(A) the product may be effective in detecting, 
                diagnosing, treating, or preventing--
                            ``(i) such disease or condition; or
                            ``(ii) a serious or life-threatening 
                        disease or condition caused by a product 
                        authorized under this section or approved under 
                        this Act or the Public Health Service Act, for 
                        detecting, diagnosing, treating, or preventing 
                        such a disease or condition caused by such an 
                        agent; and
                    ``(B) the known and potential benefits of the 
                product, when used to detect, diagnose, prevent, or 
                treat such disease or condition, outweigh the known and 
                potential risks of the product;
            ``(3) that there is no adequate, approved, and available 
        alternative to the product for detecting, diagnosing, 
        preventing, or treating such disease or condition; and
            ``(4) that such other criteria as the Secretary may by 
        regulation prescribe are satisfied.
    ``(d) Scope of Authorization.--An authorization of a product under 
this section shall state--
            ``(1) each disease or condition and the intended use of the 
        product within the scope of the authorization; and
            ``(2) the Secretary's conclusions, under subsection (c), 
        concerning the safety and potential effectiveness of the 
        product in detecting, diagnosing, preventing, or treating such 
        diseases or conditions, including an assessment of the 
        available scientific evidence.
    ``(e) Conditions of Authorization.--The Secretary is authorized to 
impose such conditions on an authorization under this section as the 
Secretary determines are necessary or appropriate to protect the public 
health, including the following:
            ``(1) The Secretary shall impose requirements (including 
        requirements concerning product labeling and the provision of 
        information) designed to ensure that, to the maximum extent 
        feasible given the circumstances of the emergency, health care 
        professionals administering the product are informed--
                    ``(A) that the Secretary has authorized the product 
                solely for emergency use;
                    ``(B) of the significant known and potential 
                benefits and risks of use of the product, and of the 
                extent to which such benefits and risks are unknown; 
                and
                    ``(C) of the alternatives to the product that are 
                available, and of their benefits and risks.
            ``(2) The Secretary shall impose requirements (including 
        requirements concerning product labeling and the provision of 
        information) designed to ensure that, to the maximum extent 
        feasible given the circumstances of the emergency, individuals 
        to whom the product is administered are informed--
                    ``(A) that the Secretary has authorized the product 
                solely for emergency use;
                    ``(B) of the significant known and potential 
                benefits and risks of use of the product, and of the 
                extent to which such benefits and risks are unknown; 
                and
                    ``(C) of any option to accept or refuse 
                administration of the product, and of the alternatives 
                to the product that are available and of their benefits 
                and risks.
            ``(3) The Secretary may impose limitations on which 
        entities may distribute the product (including limitation to 
        distribution by government entities), and on how distribution 
        is to be performed.
            ``(4) The Secretary may impose limitations on who may 
        administer the product, and on the categories of individuals to 
        whom, and the circumstances under which, the product may be 
        administered.
            ``(5) The Secretary may condition the authorization on the 
        performance of studies, clinical trials, or other research 
        needed to support marketing approval of the product.
            ``(6) The Secretary shall impose, to the extent feasible 
        and appropriate given the circumstances of the emergency, 
        requirements concerning recordkeeping and reporting, including 
        records access by the Secretary and publication of data.
            ``(7) The Secretary may waive, to the extent appropriate 
        given the circumstances of the emergency, requirements, with 
        respect to the product, of current good manufacturing practice 
        otherwise applicable to the manufacture, processing, packing, 
        or holding of products subject to regulation under this Act.
            ``(8) The Secretary shall, to the extent feasible and 
        appropriate given the circumstances of the emergency, impose 
        requirements for the monitoring and reporting of adverse events 
        associated with use of the product.
    ``(f) Duration of Authorization.--
            ``(1) In general.--Except as provided in paragraph (2), an 
        authorization under this section shall be effective until the 
        earlier of the termination of the declaration under subsection 
        (b) or a revocation under subsection (g).
            ``(2) Continued use after end of effective period.--An 
        authorization shall continue to be effective for continued use 
        with respect to patients to whom it was administered during the 
        period described by paragraph (1), to the extent found 
        necessary by such patients' attending physicians.
    ``(g) Revocation of Authorization.--
            ``(1) Review.--The Secretary shall periodically review the 
        circumstances and the appropriateness of an authorization under 
        this section.
            ``(2) Revocation.--The Secretary may revoke an 
        authorization under this section if, in the Secretary's 
        unreviewable discretion--
                    ``(A) the conditions for such an authorization are 
                no longer met; or
                    ``(B) other circumstances make such revocation 
                appropriate.
    ``(h) Publication.--The Secretary shall promptly publish in the 
Federal Register, and provide to the appropriate committees of 
Congress, a notice of each authorization, and each termination or 
revocation of an authorization, under this section.
    ``(i) Recordkeeping.--
            ``(1) In general.--The Secretary may require persons, 
        including a person who holds an authorization under this 
        section, or who manufactures, distributes, prescribes, or 
        administers a product that is the subject of such an 
        authorization, to establish and maintain--
                    ``(A) data that is obtained from such activity and 
                that pertains to the effectiveness or safety of such 
                product;
                    ``(B) such records as are necessary to determine, 
                or facilitate a determination, whether there may be any 
                violation of this section or of a regulation 
                promulgated under this section; and
                    ``(C) such additional records as the Secretary may 
                determine necessary.
            ``(2) Access to records by secretary.--
                    ``(A) Safety and effectiveness information.--The 
                Secretary may require a person who holds an 
                authorization under this section, or who manufactures, 
                distributes, prescribes, or administers a product that 
                is the subject of such an authorization to provide to 
                the Secretary all data that is obtained from such 
                activity and that pertains to the safety or 
                effectiveness of such product.
                    ``(B) Other information.--Every person required 
                under this section to establish or maintain records, 
                and every person in charge or custody of such records, 
                shall, upon request by the Secretary, permit the 
                Secretary at all reasonable times to have access to, to 
                copy, and to verify such records.
    ``(j) Civil Monetary Penalties.--
            ``(1) In general.--A person who violates a requirement of 
        this section or of a regulation or order promulgated pursuant 
        to this section shall be subject to a civil money penalty of 
        not more than $100,000 in the case of an individual, and not 
        more than $250,000 in the case of any other person, for each 
        violation, not to exceed $1,000,000 for all such violations 
        adjudicated in a single proceeding.
            ``(2) Assessment of civil penalties.--Paragraphs (3), (4), 
        and (5) of section 303(g) shall apply to a civil penalty under 
        this subsection, and references in such paragraphs to 
        `paragraph (1) or (2)' shall, for purposes of this subsection, 
        be deemed to refer to paragraph (1) of this subsection.
    ``(k) Actions Committed to Agency Discretion.--Actions under the 
authority of this section by the Secretary, by the Secretary of 
Defense, or by the Secretary of Homeland Security are committed to 
agency discretion.
    ``(l) Regulations.--The Secretary may promulgate regulations to 
implement this section.
    ``(m) Construction.--Nothing in this section shall be construed to 
impair or otherwise affect--
            ``(1) the authority of the President as Commander in Chief 
        of the Armed Forces of the United States under article II, 
        section 2 of the United States Constitution; or
            ``(2) the authority of the Secretary of Defense with 
        respect to the Department of Defense, including the armed 
        forces, under other provisions of Federal law.
    ``(n) Application to Members of Armed Forces.--
            ``(1) Waiver of requirement relating to option to refuse.--
        In the case of the administration of a countermeasure to 
        members of the armed forces, a requirement, under subsection 
        (e)(2), 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) Effect on statute pertaining to investigational new 
        drugs.--In the case of an authorization based on a 
        determination by the Secretary of Defense under subsection 
        (b)(1)(B), section 1107 of title 10, United States Code, shall 
        not apply to use of a product that is the subject of such 
        authorization, within the scope of such authorization and while 
        such authorization is effective.
    ``(o) Relation to Other Provisions.--If a product is the subject of 
an authorization under this section, the use of such product within the 
scope of the authorization--
            ``(1) shall not be subject to any requirements pursuant to 
        section 505(i) or 520(g); and
            ``(2) shall not be subject to any requirements otherwise 
        applicable to clinical investigations pursuant to other 
        provisions of this Act.''.
    (b) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended--
            (1) in subsection (e)--
                    (A) by striking ``504, 703'' and inserting ``504, 
                564, 703''; and
                    (B) by striking ``or 519'' and inserting ``519, or 
                564''; and
            (2) by adding at the end the following:
    ``(hh)(1) Promotion or use of a product that is the subject of an 
authorization under section 564 other than as stated in the 
authorization, or other than during the period described by section 
564(g), unless such promotion or use is permitted under another 
provision of this Act.
    ``(2) Failure to comply with an information requirement under 
section 564(e).''.

SEC. 5. AMENDMENTS TO PROVISIONS OF THE HOMELAND SECURITY ACT.

    (a) Declaration Recommending Making Countermeasure Available to 
Individuals.--Section 224(p)(2)(A)(i) of the Public Health Service Act 
(42 U.S.C. 233(p)(2)(A)(i)) is amended--
            (1) by striking ``advisable the administration'' and 
        inserting the following: ``advisable--
                                    ``(I) the administration'';
            (2) by striking the period and inserting ``; or''; and
            (3) by adding at the end the following:
                                    ``(II) making a covered 
                                countermeasure available to a category 
                                or categories of individuals who may 
                                wish to receive it.''.
    (b) Amendment to Accidental Vaccinia Inoculation Provision.--
Section 224(p)(2)(C)(ii)(II) of the Public Health Service Act (42 
U.S.C. 233(p)(2)(C)(ii)(II)) is amended by striking ``resides or has 
resided with'' and inserting ``has resided with, or has had close 
contact with,''.
    (c) Deeming Acts and Omissions to be Within Scope of Employment.--
Section 224(p)(2) of the Public Health Service Act (42 U.S.C. 
233(p)(2)) is amended by adding at the end the following:
                    ``(D) Acts and omissions deemed to be within scope 
                of employment.--
                            ``(i) In general.--In the case of a claim 
                        arising out of alleged transmission of vaccinia 
                        from an individual described in clause (ii), 
                        acts or omissions by such individual shall be 
                        deemed to have been taken within the scope of 
                        such individual's office or employment for 
                        purposes of--
                                    ``(I) subsection (a); and
                                    ``(II) section 1346(b) and chapter 
                                171 of title 28, United States Code.
                            ``(ii) Individuals to whom deeming 
                        applies.--An individual is described by this 
                        clause if--
                                    ``(I) vaccinia vaccine was 
                                administered to such individual as 
                                provided by paragraph (2)(B); and
                                    ``(II) such individual was within a 
                                category of individuals covered by a 
                                declaration under paragraph 
                                (2)(A)(i)(I).''.
    (d) Requirement to Cooperate with United States.--Section 224(p)(5) 
of the Public Health Service Act (42 U.S.C. 233(p)(5)) is amended in 
paragraph heading by striking ``Defendant'' and inserting ``Covered 
person''.
    (e) Amendment to Definition of Covered Countermeasure.--Subclause 
(II) of section 224(p)(7)(A)(i) of the Public Health Service Act (42 
U.S.C. 233(p)(7)(A)(i)(II)) is amended to read as follows:
                                    ``(II) used to control or treat the 
                                adverse effects of vaccinia inoculation 
                                or of administration of another covered 
                                countermeasure; and''.
    (f) Amendment to Definition of Covered Person.--Section 
224(p)(7)(B) of the Public Health Service Act (42 U.S.C. 233(p)(7)(B)) 
is amended--
            (1) in the matter preceding clause (i), by striking 
        ``includes any person'' and inserting ``means a person'';
            (2) in clause (ii)--
                    (A) by striking ``auspices such'' and inserting the 
                following: ``auspices--
                                    ``(I) such''; and
                    (B) by adding at the end the following:
                                    ``(II) a determination was made as 
                                to whether, or under what 
                                circumstances, an individual should 
                                receive a covered countermeasure;
                                    ``(III) the immediate site of 
                                administration of a covered 
                                countermeasure was monitored, managed, 
                                or cared for; or
                                    ``(IV) an evaluation was made of 
                                whether the administration of a covered 
                                countermeasure was effective;'';
            (3) in clause (iii) by striking ``or'';
            (4) by striking clause (iv) and inserting the following:
                            ``(iv) a State, a political subdivision of 
                        a State, or an agency or official of a State or 
                        of such a political subdivision, if such State, 
                        subdivision, agency, or official has 
                        established requirements, provided policy 
                        guidance, or supplied technical or scientific 
                        advice or assistance with respect to 
                        administration of such countermeasures;
                            ``(v) in the case of a claim arising out of 
                        alleged transmission of vaccinia from an 
                        individual--
                                    ``(I) the individual who allegedly 
                                transmitted the vaccinia, if vaccinia 
                                vaccine was administered to such 
                                individual as provided by paragraph 
                                (2)(B) and such individual was within a 
                                category of individuals covered by a 
                                declaration under paragraph 
                                (2)(A)(i)(I); or
                                    ``(II) an entity that employs an 
                                individual described by clause (I) or 
                                where such individual has privileges to 
                                provide health care;
                            ``(vi) an official, agent, or employee of a 
                        person described in clause (i), (ii), (iii), or 
                        (iv);
                            ``(vii) a contractor of, or a volunteer 
                        working for, a person described in clause (i), 
                        (ii), or (iv), if the contractor or volunteer 
                        performs a function for which a person 
                        described in clause (i), (ii), or (iv) is a 
                        covered person; or
                            ``(viii) an individual who has privileges 
                        to provide health care under the auspices of an 
                        entity described in clause (ii) or (v)(II).''.
    (g) Amendment to Definition of Qualified Person.--Section 
224(p)(7)(C) of the Public Health Service Act (42 U.S.C. 233(p)(7)(C)) 
is amended--
            (1) by striking ``who is authorized to'' and inserting the 
        following: ``who--
                            ``(i) is authorized to'';
            (2) by striking the period and inserting ``; or''; and
            (3) by adding at the end the following:
                            ``(ii) is otherwise authorized by the 
                        Secretary to administer such countermeasure.''.
    (h) Definition of ``Arising Out of Administration of a Covered 
Countermeasure''.--Section 224(p)(7) of the Public Health Service Act 
(42 U.S.C. 233(p)(7)) is amended by adding at the end the following:
                    ``(D) Arising out of administration of a covered 
                countermeasure.--
                            ``(i) In general.--The term `arising out of 
                        administration of a covered countermeasure', 
                        when used with respect to a claim or liability, 
                        includes, except as provided in clause (ii), a 
                        claim or liability arising out of--
                                    ``(I) determining whether, or under 
                                what conditions, an individual should 
                                receive a covered countermeasure;
                                    ``(II) obtaining informed consent 
                                of an individual to the administration 
                                of a covered countermeasure;
                                    ``(III) monitoring, management, or 
                                care of an immediate site of 
                                administration of a covered 
                                countermeasure, or evaluation of 
                                whether the administration of the 
                                countermeasure has been effective; or
                                    ``(IV) transmission of vaccinia 
                                virus by an individual to whom vaccinia 
                                vaccine was administered as provided by 
                                paragraph (2)(B).
                            ``(ii) Exception.--Such term shall not 
                        include a claim or liability arising out of 
                        care for or treatment of complications arising 
                        out of the administration of the 
                        countermeasure.''.
    (i) Technical Correction.--Section 224(p)(2)(A)(ii) of the Public 
Health Service Act (42 U.S.C. 233(p)(2)(A)(ii)) is amended by striking 
``paragraph (8)(A)'' and inserting ``paragraph (7)(A)''.
    (j) Effective Date.--This amendments made by this section shall 
take effect as if enacted on November 25, 2002.

SEC. 6. GAO REPORT.

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




                                                        Calendar No. 53

108th CONGRESS

  1st Session

                                 S. 15

_______________________________________________________________________

                                 A BILL

 To amend the Public Health Service Act to provide for the payment of 
 compensation for certain individuals with injuries resulting from the 
administration of smallpox countermeasures, to provide protections and 
countermeasures against chemical, radiological, or nuclear agents that 
  may be used in a terrorist attack against the United States, and to 
 improve immunization rates by increasing the distribution of vaccines 
 and improving and clarifying the vaccine injury compensation program.

_______________________________________________________________________

                             March 25, 2003

                       Reported with an amendment