[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 754 Introduced in Senate (IS)]







108th CONGRESS
  1st Session
                                 S. 754

To amend the Public Health Service Act to improve immunization rates by 
 increasing the distribution of vaccines and improving and clarifying 
    the vaccine injury compensation program, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 1, 2003

   Mr. Frist 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 improve immunization rates by 
 increasing the distribution of vaccines and improving and clarifying 
    the vaccine injury compensation program, and for other purposes.

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

SECTION 1. SHORT TITLE.

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

                     TITLE I--STATE VACCINE GRANTS

SEC. 101. 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. 102. 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 101, 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. 103. IMMUNIZATION AWARENESS.

    (a) Development of Information Concerning Meningitis.--
            (1) In general.--The Secretary of Health and Human Services 
        (in this Act 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. 104. 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. 105. 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. 106. 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. 107. 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).

             TITLE II--VACCINE INJURY COMPENSATION PROGRAM

SEC. 201. 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. 202. 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. 203. 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. 204. 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. 205. 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. 206. 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. 207. 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. 208. 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 203(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. 209. 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 203(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. 210. 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 203(f) and 
amended by section 209, 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. 211. 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. 212. 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. 213. 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. 214. 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. 215. 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. 216. 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. 217. 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. 218. 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. 219. PENDING ACTIONS.

    The amendments made by this Act 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. 220. 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>