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







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, and Mr. Graham of South Carolina) introduced 
the following bill; which was read twice and referred to the Committee 
               on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

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

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

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

Sec. 301. Short title.
                    Subtitle A--State Vaccine Grants

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

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

          TITLE I--PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL

SEC. 101. SHORT TITLE.

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

SEC. 102. AMENDMENT TO THE PUBLIC HEALTH SERVICE ACT.

    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:

``SEC. 224A. PROTECTION FOR SMALLPOX EMERGENCY PERSONNEL.

    ``(a) Definitions.--In this section:
            ``(1) Covered countermeasure.--The term `covered 
        countermeasure' means a covered countermeasure as specified in 
        article III of the Declaration.
            ``(2) Covered individual.--The term `covered individual' 
        means an individual--
                    ``(A) who is--
                            ``(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
                            ``(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
                    ``(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--
                            ``(i) the expiration of the 120-day period 
                        that begins on the effective date of the 
                        initial interim final regulations to implement 
                        this section;
                            ``(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
                            ``(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.
            ``(3) Covered injury.--The term `covered injury' includes--
                    ``(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
                    ``(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.
            ``(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.
            ``(5) Eligible individual.--The term `eligible individual' 
        means an individual who is (as determined in accordance with 
        section 3)--
                    ``(A) a covered individual who sustains a covered 
                injury as the direct result of administration of a 
                covered countermeasure; or
                    ``(B) any individual who contracts vaccinia during 
                the effective period of the Declaration or within 30 
                days after the end of such period--
                            ``(i) to whom vaccinia vaccine was not 
                        administered;
                            ``(ii) who has resided with, or has been in 
                        close contact with, a covered individual; and
                            ``(iii) who sustains a covered injury as 
                        the direct result of contracting vaccinia.
            ``(6) Secretary.--Except as provided otherwise, the term 
        `Secretary' means the Secretary of Health and Human Services.
    ``(b) Determination of Eligibility.--
            ``(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--
                    ``(A) whether the individual is an eligible 
                individual;
                    ``(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
                    ``(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).
            ``(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.
            ``(3) Determination of causation.--
                    ``(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.
                    ``(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.
            ``(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--
                    ``(A) the date a covered countermeasure was 
                administered to the individual; or
                    ``(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.
            ``(5) Review of determination.--
                    ``(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.
                    ``(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.
    ``(c) Countermeasure Injury Table.--
            ``(1) Smallpox countermeasure injury table.--The Secretary 
        shall establish by interim final regulation a table 
        identifying--
                    ``(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
                    ``(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.
            ``(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.
    ``(d) Medical Benefits.--
            ``(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.
            ``(2) Limitations.--
                    ``(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.
                    ``(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.).
    ``(e) Compensation for Lost Employment Income.--
            ``(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).
            ``(2) Amount of compensation.--
                    ``(A) In general.--Compensation under this 
                subsection shall be at the rate of 66\2/3\ 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.
                    ``(B) Treatment of self-employment income.--For 
                purposes of this subsection--
                            ``(i) the term `employment income' includes 
                        income from self-employment; and
                            ``(ii) for purposes of computation of pay 
                        and determination of wage-earning capacity 
                        under subparagraph (A), self-employment income 
                        shall be treated as wages.
            ``(3) Limitations.--
                    ``(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.
                    ``(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.
                    ``(C) Limit on total benefits.--Total benefits paid 
                to an individual under this subsection shall not exceed 
                $50,000.
                    ``(D) Waiting period.--An eligible individual is 
                not entitled to compensation under this subsection for 
                the first 5 work days of disability.
    ``(f) Payment for Death and Permanent, Total Disability.--
            ``(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.
            ``(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.
            ``(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.
            ``(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).
            ``(5) Limitations.--
                    ``(A) Disability benefits.--No benefit is payable 
                under paragraph (1) with respect to the disability of 
                an eligible individual if--
                            ``(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
                            ``(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.).
                    ``(B) Death benefits.--No benefit is payable under 
                paragraph (2) with respect to the death of an eligible 
                individual if--
                            ``(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
                            ``(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.).
    ``(g) Administration.--
            ``(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.
            ``(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.
    ``(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.
    ``(i) Relationship to Other Laws.--
            ``(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.
            ``(2) Relationship to the federal tort claims act.--
                    ``(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.
                    ``(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).
            ``(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.''.

                      TITLE II--PROJECT BIOSHIELD

SEC. 201. SHORT TITLE.

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

SEC. 202. BIOMEDICAL COUNTERMEASURE RESEARCH AND DEVELOPMENT 
              AUTHORITIES.

    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. 409I. 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 and the Director of the National 
                Institute of Allergy and Infectious Diseases.
                    ``(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.
                    ``(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.
            ``(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) Facilities Authority.--
            ``(1) Agency facilities.--In addition to any similar 
        authority provided under any other provision of law, in 
        carrying out this section, the Secretary may--
                    ``(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
                    ``(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.
            ``(2) Facilities of grantee or cooperative agreement 
        partner.--
                    ``(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.
                    ``(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.
                    ``(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.
                    ``(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--
                            ``(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
                            ``(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.
                    ``(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.
    ``(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.
            ``(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.''.

 SEC. 203. BIOMEDICAL COUNTERMEASURES PROCUREMENT.

    Section 121 of the Public Health Security and Bioterrorism 
Preparedness and Response Act of 2002 (42 U.S.C. 300hh-12) is amended--
            (1) by redesignating subsections (c) through (e) as 
        subsections (d) through (f), respectively; and
            (2) by inserting after subsection (b) the following:
    ``(c) Biomedical Countermeasures Procurement.--
            ``(1) Determination of material threats.--
                    ``(A) Risk of use.--The Secretary, in consultation 
                with the heads of other agencies as appropriate, shall 
                on an ongoing basis--
                            ``(i) assess current and emerging threats 
                        of use of chemical, biological, radiological, 
                        and nuclear agents; and
                            ``(ii) determine which of such agents 
                        present a material risk of use against the 
                        United States population.
                    ``(B) Public health impact.--The Secretary of 
                Health and Human Services, in consultation with the 
                Secretary, shall on an ongoing basis--
                            ``(i) assess the potential public health 
                        consequences of use against the United States 
                        population of agents identified under 
                        subparagraph (A)(ii); and
                            ``(ii) determine, on the basis of such 
                        assessment, the agents for which 
                        countermeasures are necessary to protect the 
                        public health.
            ``(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).
            ``(3) Secretary's determination of countermeasures 
        appropriate for procurement under this subsection.--
                    ``(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).
                    ``(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:
                            ``(i) Determination of qualified 
                        countermeasure.--Such Secretary must determine 
                        that the product is a qualified countermeasure 
                        (as defined in paragraph (7)).
                            ``(ii) Determination of quantities needed 
                        and feasibility of production and 
                        distribution.--Such 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.
                            ``(iii) Determination of no significant 
                        commercial market.--Such Secretary shall--
                                    ``(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
                                    ``(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.
            ``(4) Recommendation for president's approval.--
                    ``(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.
                    ``(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.
                    ``(C) Notice to congress.--The Secretary shall 
                notify Congress of each decision of the President to 
                approve a recommendation under subparagraph (A).
            ``(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):
                    ``(A) Interagency agreements.--
                            ``(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).
                            ``(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).
                    ``(B) Procurement.--
                            ``(i) In general.--The Secretary of Health 
                        and Human Services shall be responsible for--
                                    ``(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
                                    ``(II) promulgating regulations to 
                                implement clauses (v), (vi), and (vii), 
                                and any other provisions of this 
                                subsection.
                            ``(ii) Contract terms.--A contract for 
                        procurements under this subsection shall (or, 
                        as otherwise specified in this clause, may) 
                        include the following terms:
                                    ``(I) Payment conditioned on 
                                substantial delivery.--The contract 
                                shall provide that no payment may be 
                                made until delivery has been made of a 
                                substantial portion (as determined by 
                                the Secretary of Health and Human 
                                Services) of the total number of units 
                                contracted for.
                                    ``(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).
                                    ``(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.
                                    ``(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.
                                    ``(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.
                            ``(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--
                                    ``(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.
                            ``(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.
                            ``(v) Premium provision in multiple award 
                        contracts.--
                                    ``(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--
                                            ``(aa) identifies an 
                                        increment of the total quantity 
                                        of countermeasure required, 
                                        whether by percentage or by 
                                        numbers of units; and
                                            ``(bb) promises to pay one 
                                        or more specified premiums 
                                        based on the priority of such 
                                        persons' production and 
                                        delivery of the increment 
                                        identified under item (aa), in 
                                        accordance with the terms and 
                                        conditions of the contract.
                                    ``(II) Determination of 
                                government's requirement not 
                                reviewable.--If the Secretary 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.
                            ``(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.
                            ``(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.
            ``(6) Interagency cooperation.--
                    ``(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.
                    ``(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.
            ``(7) Definitions.--In this subsection:
                    ``(A) Qualified countermeasure.--The term 
                `qualified countermeasure' means a biomedical 
                countermeasure--
                            ``(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
                            ``(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).
                    ``(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--
                            ``(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
                            ``(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).
            ``(8) Appropriations.--
                    ``(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)).
                    ``(B) Restrictions.--Amounts appropriated under 
                this paragraph shall not be available to pay--
                            ``(i) costs for the purchase of vaccines 
                        under procurement contracts entered into before 
                        January 1, 2003;
                            ``(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
                            ``(iii) administrative costs.''.

 SEC. 204. 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 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.
    ``(b) Declaration of Emergency.--
            ``(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--
                    ``(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;
                    ``(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
                    ``(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.
            ``(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) Publication.--The Secretary shall promptly publish in 
        the Federal Register each declaration, determination, and 
        renewal under this subsection.
    ``(c) Criteria for Issuance of Authorization.--The Secretary may 
issue an authorization under this section with respect to 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 that the product may be 
        used to detect, diagnose, prevent, or treat 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.--
            ``(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:
                    ``(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--
                            ``(i) that the Secretary has authorized the 
                        product solely for emergency use;
                            ``(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
                            ``(iii) of the alternatives to the product 
                        that are available, and of their benefits and 
                        risks.
                    ``(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--
                            ``(i) that the Secretary has authorized the 
                        product solely for emergency use;
                            ``(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
                            ``(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.
                    ``(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.
                    ``(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.
                    ``(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.
                    ``(F) The Secretary may impose requirements 
                concerning recordkeeping and reporting, including 
                records access by the Secretary and publication of 
                data.
                    ``(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.
                    ``(H) The Secretary may impose requirements for the 
                monitoring and reporting of adverse events associated 
                with use of the product.
            ``(2) Waiver.--The Secretary may waive any condition 
        imposed under this subsection.
    ``(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 a notice of each authorization, and each termination 
or revocation of an authorization, under this section.
    ``(i) Recordkeeping.--
            ``(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--
                    ``(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 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.
                    ``(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)(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.
            ``(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)(1).''.

SEC. 205. DEVELOPING NEW COUNTERMEASURES AND PROTECTING EXISTING 
              COUNTERMEASURES AGAINST BIOTERRORISM.

    Section 319F of the Public Health Service Act (42 U.S.C. 247d-6) is 
amended by adding at the end the following:
    ``(k) Limited Antitrust Exemption.--
            ``(1) Countermeasures development meetings.--
                    ``(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').
                    ``(B) Meeting and consultation conditions.--A 
                meeting or consultation conducted under subparagraph 
                (A) shall--
                            ``(i) be chaired or, in the case of a 
                        consultation, facilitated by the Secretary or 
                        the designee of the Secretary;
                            ``(ii) be open to parties involved in the 
                        development, manufacture, distribution, 
                        purchase, or sale of priority countermeasures, 
                        as determined by the Secretary;
                            ``(iii) be open to the Attorney General and 
                        the Chairperson;
                            ``(iv) be limited to discussions involving 
                        the development, manufacture, distribution, or 
                        sale of priority countermeasures, consistent 
                        with the purposes of this title; and
                            ``(v) be conducted in such manner as to 
                        ensure that national security, confidential, 
                        and proprietary information is not disclosed 
                        outside the meeting or consultation.
                    ``(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.
                    ``(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.
            ``(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--
                    ``(A) an explanation of the intended purpose of the 
                agreement or conduct;
                    ``(B) a specific statement of the substance of the 
                agreement or conduct;
                    ``(C) a description of the methods that will be 
                utilized to achieve the objectives of the agreement or 
                conduct;
                    ``(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
                    ``(E) any other relevant information reasonably 
                requested by the Attorney General, in consultation with 
                the Chairperson and the Secretary.
            ``(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.
            ``(4) Limited antitrust exemption.--
                    ``(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).
                    ``(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.
                    ``(C) Application of laws.--
                            ``(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.
                            ``(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).
                    ``(D) Determination.--In making a determination 
                under this subparagraph, the Attorney General, in 
                consultation with the Chairperson and the Secretary 
                shall consider--
                            ``(i) whether the agreement or conduct 
                        involved would facilitate the availability of 
                        priority countermeasures;
                            ``(ii) whether the exemption from the 
                        antitrust laws would promote the public 
                        interest;
                            ``(iii) the competitive impact to areas not 
                        directly related to the purposes of the 
                        agreement or conduct; and
                            ``(iv) any other factors determined 
                        relevant by the Attorney General and the 
                        Chairperson.
            ``(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).
            ``(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.
            ``(7) Guidelines.--The Attorney General and the Chairperson 
        may develop and issue guidelines to implement this subsection.
            ``(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.
            ``(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.
    ``(l) Definitions.--In this section:
            ``(1) Antitrust laws.--The term `antitrust laws'--
                    ``(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
                    ``(B) includes any State law similar to the laws 
                referred to in subparagraph (A).
            ``(2) Covered activities.--
                    ``(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--
                            ``(i) theoretical analysis, 
                        experimentation, or the systematic study of 
                        phenomena or observable facts related to the 
                        development of priority countermeasures;
                            ``(ii) the development or testing of basic 
                        engineering techniques related to the 
                        development of priority countermeasures;
                            ``(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;
                            ``(iv) the production, distribution, or 
                        marketing of a product, process, or service 
                        related to the development of priority 
                        countermeasures;
                            ``(v) the testing in connection with the 
                        production of a product, process, or service 
                        related to the development of priority 
                        countermeasures;
                            ``(vi) the collection, exchange, and 
                        analysis of research or production information 
                        related to the development of priority 
                        countermeasures; or
                            ``(vii) any combination of the purposes 
                        described in clauses (i) through (vi);
                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.
                    ``(B) Exception.--The term `covered activities' 
                shall not include the following activities involving 2 
                or more persons:
                            ``(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.
                            ``(ii) Entering into any agreement or 
                        engaging in any other conduct--
                                    ``(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
                                    ``(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.
                            ``(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).
                            ``(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.
                            ``(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.
            ``(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.
            ``(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)).
            ``(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).''.

       TITLE III--IMPROVED VACCINE AFFORDABILITY AND AVAILABILITY

SEC. 301. SHORT TITLE.

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

                    Subtitle A--State Vaccine Grants

SEC. 311. AVAILABILITY OF INFLUENZA VACCINE.

    Section 317(j) of the Public Health Service Act (42 U.S.C. 247b(j)) 
is amended by adding at the end the following:
    ``(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.
    ``(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.
    ``(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:
            ``(i) Increasing influenza immunization rates in 
        populations considered by the Secretary to be at high risk for 
        influenza-related complications and in their contacts.
            ``(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.
            ``(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.
            ``(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.
    ``(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.''.

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

    (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:
    ``(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.
    ``(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).
    ``(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.
    ``(5) The Secretary shall annually submit to Congress a report 
that--
            ``(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
            ``(B) describes any issues identified by the Secretary that 
        may affect such rates.
    ``(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.''.
    (b) Research, Demonstrations, and Education.--Section 317(k) of the 
Public Health Service Act (42 U.S.C. 247b(k)) is amended--
            (1) by redesignating paragraphs (2) through (4) as 
        paragraphs (3) through (5), respectively;
            (2) by inserting after paragraph (1) the following:
    ``(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:
            ``(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.
            ``(ii) The Secretary shall cooperate with public and 
        private entities to obtain information for the annual 
        evaluations required in subsection (j)(5)(A).
            ``(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.
            ``(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.
            ``(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.
    ``(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.''.

SEC. 313. IMMUNIZATION AWARENESS.

    (a) Development of Information Concerning Meningitis.--
            (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).
            (2) Entities.--An entity is described in this paragraph if 
        the entity--
                    (A) is--
                            (i) a college or university; or
                            (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
                    (B) is determined appropriate by the Secretary.
    (b) Development of Information Concerning Hepatitis.--
            (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.
            (2) Entities.--An entity is described in this paragraph if 
        the entity--
                    (A) is--
                            (i) a health care clinic that serves 
                        individuals diagnosed as being infected with 
                        HIV or as having other sexually transmitted 
                        diseases;
                            (ii) an organization or business that 
                        counsels individuals about international travel 
                        or who arranges for such travel;
                            (iii) a police, fire, or emergency medical 
                        services organization that responds to natural 
                        or man-made disasters or emergencies;
                            (iv) a prison or other detention facility;
                            (v) a college or university; or
                            (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
                    (B) is determined appropriate by the Secretary.

SEC. 314. SUPPLY OF VACCINES.

    (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.
    (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.
    (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.

SEC. 315. COMMUNICATION.

    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.

SEC. 316. FAST TRACK.

    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.

SEC. 317. STUDY.

    (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.
    (b) Requirements.--The study under subsection (a) shall include a 
review of the regulatory requirements, guidelines, practices, and 
policies--
            (1) for the development and licensing of vaccines and the 
        licensing of vaccine manufacturing facilities;
            (2) for inspections and other activities for maintaining 
        compliance and enforcement of the requirements applicable to 
        such vaccines and facilities; and
            (3) that may have contributed to temporary or long-term 
        shortages of vaccines.
    (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--
            (1) the results of the study under subsection (a); and
            (2) recommendations for modifications to the regulatory 
        requirements, guidelines, practices, and policies described in 
        subsection (b).

            Subtitle B--Vaccine Injury Compensation Program

SEC. 321. ADMINISTRATIVE REVISION OF VACCINE INJURY TABLE.

    Section 2114 of the Public Health Service Act (42 U.S.C. 300aa-14) 
is amended--
            (1) by striking subsection (c)(1) and inserting the 
        following:
            ``(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
            (2) in subsection (d), by striking ``90 days'' and 
        inserting ``60 days''.

SEC. 322. EQUITABLE RELIEF.

    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--''.

SEC. 323. DERIVATIVE PETITIONS FOR COMPENSATION.

    (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--
            (1) in subparagraph (B), by inserting ``or (B)'' after 
        ``subparagraph (A)'';
            (2) by redesignating subparagraph (B) as subparagraph (C); 
        and
            (3) by inserting after subparagraph (A) the following:
            ``(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--
                    ``(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;
                    ``(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
                    ``(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
                    ``(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.
            ``(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).''.
    (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.''.
    (c) Petitioners.--Section 2111(b) of the Public Health Service Act 
(42 U.S.C. 300aa-11(b)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A), by striking ``(B)'' and 
                inserting ``(C)'';
                    (B) by redesignating subparagraph (B) as 
                subparagraph (C); and
                    (C) by inserting after subparagraph (A) the 
                following:
            ``(B) Except as provided in subparagraph (C), any legal 
        representative or spouse of a person--
                    ``(i) who has sustained a vaccine-related injury or 
                death; and
                    ``(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));
        may, if such legal representative or spouse meets the 
        requirements of subsection (d), file a derivative petition 
        under this section.''; and
            (2) in paragraph (2)--
                    (A) by inserting ``by or on behalf of the person 
                who sustained the vaccine-related injury or death'' 
                after ``filed''; and
                    (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.''.
    (d) Derivative Petition Contents.--Section 2111 of the Public 
Health Service Act (42 U.S.C. 300aa-11) is amended--
            (1) by redesignating subsections (d) and (e) as subsections 
        (e) and (f), respectively; and
            (2) by inserting after subsection (c) the following:
    ``(d) Derivative Petitions.--
            ``(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.
            ``(2) Such a derivative petition shall contain--
                    ``(A) except for records that are unavailable as 
                described in subsection (c)(3), an affidavit, and 
                supporting documentation, demonstrating that--
                            ``(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;
                            ``(ii) the derivative petition was timely 
                        filed;
                            ``(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
                            ``(iv) such legal representative or spouse 
                        has not previously collected an award or 
                        settlement of a civil action for damages for 
                        such loss; and
                    ``(B) records establishing such legal 
                representative's or spouse's relationship to the person 
                who sustained the vaccine-related injury or death.''.
    (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--
            (1) in subparagraph (A), by striking ``and'' and inserting 
        ``or, as applicable, section 2111(d),'';
            (2) in subparagraph (B), by striking the period and 
        inserting ``, and''; and
            (3) by inserting before the flush matter at the end, the 
        following:
                    ``(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.''.
    (f) Compensation.--Section 2115 of the Public Health Service Act 
(42 U.S.C. 300aa-15) is amended--
            (1) by redesignating subsections (b) through (j) as 
        subsections (c) through (k), respectively;
            (2) by inserting after subsection (a) the following:
    ``(b) Derivative Petitions.--
            ``(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.
            ``(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.'';
            (3) in subsection (e)(2), as so redesignated by paragraph 
        (1)--
                    (A) by striking ``(2) and (3)'' and inserting 
                ``(2), (3), (4), (5), and (6)''; and
                    (B) by inserting ``and subsection (b),'' after 
                ``(a),'';
            (4) in subsection (g), as so redesignated by paragraph (1), 
        in paragraph (4)(B), by striking ``subsection (j)'' and 
        inserting ``subsection (k)'';
            (5) in subsection (j), as so redesignated by paragraph 
        (1)--
                    (A) in paragraph (1), by striking ``subsection 
                (j)'' and inserting ``subsection (k)''; and
                    (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
            (6) in subsection (k), as so redesignated by paragraph (1), 
        by striking ``subsection (f)(4)(B)'' and inserting ``subsection 
        (g)(4)(B)''.

SEC. 324. JURISDICTION TO DISMISS ACTIONS IMPROPERLY BROUGHT.

    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.''.

SEC. 325. CLARIFICATION OF WHEN INJURY IS CAUSED BY FACTOR UNRELATED TO 
              ADMINISTRATION OF VACCINE.

    Section 2113(a)(2)(B) of the Public Health Service Act (42 U.S.C. 
300aa-13(a)(2)(B)) is amended--
            (1) by inserting ``structural lesions, genetic disorders,'' 
        after ``and related anoxia),'';
            (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
            (3) by striking ``but'' and inserting ``and''.

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

    (a) In General.--Section 2115(a) of the Public Health Service Act 
(42 U.S.C. 300aa-15(a)) is amended--
            (1) in paragraph (2), by striking ``$250,000'' and 
        inserting ``$350,000''; and
            (2) in paragraph (4), by striking ``$250,000'' and 
        inserting ``$350,000''.
    (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.

SEC. 327. BASIS FOR CALCULATING PROJECTED LOST EARNINGS.

    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.''.

SEC. 328. ALLOWING COMPENSATION FOR FAMILY COUNSELING EXPENSES AND 
              EXPENSES OF ESTABLISHING AND MAINTAINING GUARDIANSHIP.

    (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:
            ``(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.''.
    (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:
            ``(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.''.
    (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)--
            (1) in paragraph (2), by striking ``and'' at the end;
            (2) in paragraph (3), by striking ``(e)'' and inserting 
        ``(f)'';
            (3) by redesignating paragraph (3) as paragraph (5); and
            (4) by inserting after paragraph (2), the following:
            ``(3) family counseling expenses (as provided for in 
        paragraph (5) of subsection (a));
            ``(4) expenses of establishing and maintaining 
        guardianships (as provided for in paragraph (6) of subsection 
        (a)); and''.

SEC. 329. ALLOWING PAYMENT OF INTERIM COSTS.

    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:
            ``(4) A special master or court may make an interim award 
        of costs subject to final adjustment if--
                    ``(A) the case involves a vaccine administered on 
                or after October 1, 1988;
                    ``(B) the special master or court has determined 
                that the petitioner is entitled to compensation under 
                the Program;
                    ``(C) the award is limited to other costs (within 
                the meaning of paragraph (1)(B)) incurred in the 
                proceeding;
                    ``(D) not more than 1 prior award has been made 
                with respect to such petition; and
                    ``(E) the petitioner provides documentation 
                verifying the expenditure of the amount for which 
                compensation is sought.''.

SEC. 330. PROCEDURE FOR PAYING ATTORNEYS' FEES.

    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:
            ``(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--
                    ``(A) the petitioner expressly consents; or
                    ``(B) the special master or court determines, after 
                affording to the Secretary and to all interested 
                persons the opportunity to submit relevant information, 
                that--
                            ``(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
                            ``(ii) there are otherwise exceptional 
                        circumstances and good cause for paying such 
                        fees or costs solely to the petitioner's 
                        attorney.''.

SEC. 331. EXTENSION OF STATUTE OF LIMITATIONS.

    (a) General Rule.--Section 2116(a) of the Public Health Service Act 
(42 U.S.C. 300aa-16(a)) is amended--
            (1) in paragraph (2), by striking ``36 months'' and 
        inserting ``6 years''; and
            (2) in paragraph (3), by striking ``48 months'' and 
        inserting ``6 years''.
    (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:
    ``(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--
            ``(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
            ``(2) either--
                    ``(A) the petition satisfies the conditions 
                described in subsection (a); or
                    ``(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.''.
    (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:
    ``(d) Derivative Petitions.--No derivative petition may be filed 
for compensation under the Program later than the earlier of--
            ``(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
            ``(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.''.
    (d) Timely Resolutions of Claims.--
            (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.''.
            (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.''.
            (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.''.

SEC. 332. ADVISORY COMMISSION ON CHILDHOOD VACCINES.

    (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.''.
    (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''.

SEC. 333. CLARIFICATION OF STANDARDS OF RESPONSIBILITY.

    (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
    (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''.
    (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''.
    (d) Construction.--Section 2122(d) of the Public Health Service Act 
(42 U.S.C. 300aa-22(d)) is amended--
            (1) by inserting ``or equitable relief'' after ``for 
        damages''; and
            (2) by inserting ``or relief'' after ``which damages''.
    (e) Past or Present Physical Injury.--Section 2122 of the Public 
Health Service Act (42 U.S.C. 300aa-22) is amended--
            (1) by redesignating subsections (d) and (e) as subsections 
        (e) and (f), respectively; and
            (2) by inserting after subsection (c) the following:
    ``(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.''.

SEC. 334. CLARIFICATION OF DEFINITION OF MANUFACTURER.

    Section 2133(3) of the Public Health Service Act (42 U.S.C. 300aa-
33(3)) is amended--
            (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
            (2) in the second sentence, by inserting ``including any 
        component or ingredient of any such vaccine'' before the 
        period.

SEC. 335. CLARIFICATION OF DEFINITION OF VACCINE-RELATED INJURY OR 
              DEATH.

    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.''.

SEC. 336. CLARIFICATION OF DEFINITION OF VACCINE AND DEFINITION OF 
              PHYSICAL INJURY.

    Section 2133 of the Public Health Service Act (42 U.S.C. 300aa-33) 
is amended by adding at the end the following:
    ``(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.
    ``(8) The term `physical injury' means a manifest physical illness, 
condition, or death, including a neurological disease or disorder.''.

SEC. 337. AMENDMENTS TO VACCINE INJURY COMPENSATION TRUST FUND.

    (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''.
    (b) Increase in Limit on Administrative Expenses.--Subparagraph (B) 
of section 9510(c)(1) of the Internal Revenue Code of 1986 is amended--
            (1) by striking ``(but not in excess of the base amount of 
        $9,500,000 for any fiscal year)''; and
            (2) by striking the period and inserting ``, provided that 
        such administrative costs shall not exceed the greater of--
                            ``(i) the base amount of $9,500,000 for any 
                        fiscal year,
                            ``(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,
                            ``(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,
                            ``(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
                            ``(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.''.
    (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''.

SEC. 338. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.

    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:

``SEC. 2129A. ONGOING REVIEW OF CHILDHOOD VACCINE DATA.

    ``(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).
    ``(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.
    ``(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).
    ``(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.''.

SEC. 339. PENDING ACTIONS.

    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.

SEC. 340. REPORT.

    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.
                                 <all>