[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5282 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 5282

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 HOUSE OF REPRESENTATIVES

                             July 26, 2002

  Mr. Greenwood (for himself and Mr. Towns) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 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; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Improved Vaccine 
Affordability and Availability Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
                     TITLE I--STATE VACCINE GRANTS

Sec. 101. Availability of influenza vaccine.
Sec. 102. Program for increasing immunization rates for adults and 
                            adolescents; collection of additional 
                            immunization data.
Sec. 103. Immunization awareness.
Sec. 104. Supply of vaccines.
             TITLE II--VACCINE INJURY COMPENSATION PROGRAM

Sec. 201. Administrative revision of vaccine injury table.
Sec. 202. Equitable relief.
Sec. 203. Parent petitions for compensation.
Sec. 204. Jurisdiction to dismiss actions improperly brought. 
Sec. 205. Clarification of when injury is caused by factor unrelated to 
                            administration of vaccine.
Sec. 206. Basis for calculating projected lost earnings.
Sec. 207. Allowing compensation for family counseling expenses and 
                            expenses of establishing guardianship.
Sec. 208. Allowing payment of interim costs.
Sec. 209. Procedure for paying attorneys' fees.
Sec. 210. Extension of statute of limitations.
Sec. 211. Advisory commission on childhood vaccines.
Sec. 212. Clarification of standards of responsibility.
Sec. 213. Clarification of definition of manufacturer.
Sec. 214. Clarification of definition of vaccine-related injury or 
                            death.
Sec. 215. Clarification of definition of vaccine.
Sec. 216. Ongoing review of childhood vaccine data.
Sec. 217. Pending actions.
Sec. 218. Report.

                     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.''.
    (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; and
            (2) by inserting after paragraph (1) the following:
    ``(2) 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:
            ``(A) 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.
            ``(B) The Secretary shall cooperate with public and private 
        entities to obtain information for the annual evaluations 
        required in subsection (j)(5)(A).
            ``(C) The Secretary shall (relative to fiscal year 2001) 
        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.
            ``(D) 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.
            ``(E) 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.''.

SEC. 103. IMMUNIZATION AWARENESS.

    (a) Development of Information Concerning Meningitis.--
            (1) In general.--The Secretary of Health and Human 
        Services, 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 of Immunization Practices (an advisory 
        committee established by the Secretary of Health and Human 
        Services, acting through 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) a prison or other detention facility; 
                        and
                    (B) is determined appropriate by the Secretary of 
                Health and Human Services.
    (b) Development of Information Concerning Hepatitis.--
            (1) In general.--The Secretary of Health and Human 
        Services, 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 endemnicity for hepatitis 
                        A as defined by the Centers for Disease Control 
                        and Prevention; and
                    (B) is determined appropriate by the Secretary of 
                Health and Human Services.

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.

             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) in subsection (c), by striking paragraph (1) and 
        inserting the following:
            ``(1) In promulgating such regulations, the Secretary shall 
        provide for notice and for at least 9060 days opportunity for 
        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 State or Federal 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. PARENT PETITIONS FOR COMPENSATION.

    (a) Civil Actions.--Section 2111(a)(2) of the Public Health Service 
Act (42 U.S.C. 300aa-(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) No parent or other third party may bring or maintain 
        a civil action against a vaccine administrator or manufacturer 
        in a State or Federal court for damages or equitable relief 
        relating to a vaccine-related injury or death, including but 
        not limited to 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 
                or third party's claim is premised has, in accordance 
                with section 2112, been awarded compensation in a final 
                judgment of the United States Court of Federal Claims 
                and such judgment is subject to no further appeal or 
                review,
                    ``(ii) such parent or other third party is the 
                parent, legal guardian or spouse of the person who 
                sustained the underlying vaccine-related injury and 
                such parent, legal guardian or spouse timely filed a 
                derivative petition, in accordance with section 2116, 
                and
                    ``(iii)(I) the United States Court of Federal 
                Claims has issued judgment under section 2112 on the 
                derivative petition, and such parent, legal guardian or 
                spouse elects under section 2121(a) to file a civil 
                action, or
                    ``(II) such parent, legal guardian or spouse elects 
                to withdraw such derivative petition under section 
                2121(b) or such petition is considered withdrawn under 
                such section.
        Any civil action brought in accordance with this subparagraph 
        shall be subject to the standards and procedures set forth in 
        section 2122 and 2123, regardless of whether the action arises 
        directly from a vaccine-related injury or death associated with 
        the administration of a vaccine. Where the person who sustained 
        the underlying vaccine-related injury or death upon which such 
        parent, legal guardian, or spouse's civil cause of action is 
        premised elects under section 2121(a) to receive the 
        compensation awarded, such parent or third party 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) Applicability.--Section 2111(a)(9) of the Public Health Service 
Act (42 U.S.C. 300aa-11(a)(9)) is amended by inserting before the 
period the following: ``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 parent, 
        legal guardian or spouse of a person--
                    ``(i) who has sustained a vaccine-related injury or 
                death,
                    ``(ii) who has filed a petition for compensation 
                under the Program (or whose legal representative has 
                filed a petition as authorized in subparagraph (A)), 
                and
                    ``(iii) who has, in accordance with section 2112, 
                been awarded compensation in a final judgment of the 
                United States Court of Federal Claims that is subject 
                to no further appeal or review,
        may, if such parent, legal guardian or spouse meets the 
        requirements of subsection (d) of this section, file a 
        derivative petition under this section.''; and
            (2) in paragraph (2)--
                    (A) by inserting after ``filed'' the following: 
                ``by or on behalf of the person who sustained the 
                vaccine-related injury or death''; and
                    (B) by adding at the end the following: ``No 
                parent, legal guardian, or spouse may file more than 
                one derivative petition with respect to each 
                administration of a vaccine.''.
    (d) Derivative Petitions.--Section 2111 of the Public Health 
Service Act (42 U.S.C. 300aa-11) is amended--
            (1) by redesignating subsections (d) and (e) and 
        subsections (e) and (f), respectively; and
            (2) by inserting after subsection (c) the following 
        subsection:
    ``(d) Derivative Petitions.--If the parent, legal guardian, or 
spouse of the person who sustained the vaccine-related injury or death 
seeks compensation under the Program, such parent, legal guardian or 
spouse shall file a timely derivative petition for compensation under 
the Program in accordance with this section. Such a derivative petition 
shall contain--
            ``(1) an affidavit, and supporting documentation, 
        demonstrating that--
                    ``(A) the child, ward, or spouse of such person 
                was, in accordance with section 2112, previously 
                awarded compensation for the underlying vaccine-related 
                injury or death upon which such parent's, legal 
                guardian's, or spouse's derivative claim is premised in 
                a final judgment of the United States Court of Federal 
                Claims and such judgment is subject to no further 
                appeal or review,
                    ``(B) the derivative petition was filed no later 
                than 60 days after the date on which such judgment 
                became final and subject to no further appeal or 
                review,
                    ``(C) such parent, legal guardian or spouse 
                suffered a loss compensable under section 2115(b) as a 
                result of the vaccine-related injury or death sustained 
                by such person's child, ward, or spouse, and
                    ``(D) such parent, legal guardian or spouse has not 
                previously collected an award or settlement of a civil 
                action for damages for such loss, and
            ``(2) records establishing such parent's, legal guardian's, 
        or spouse's legal relationship to the person who sustained the 
        vaccine-related injury or death.''.
    (e) Determination of Eligibility and 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 inserting before ``, and'' the 
        following: ``or, where applicable, section 2111(d)''; and
            (2) in subparagraph (B), by inserting before the period the 
        following: ``or, as applicable, that the injury or loss 
        described in the derivative petition is due to factors 
        unrelated to the vaccine-related injury or death''.
    (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; and
            (2) by inserting after subsection (a) the following:
    ``(b) Derivative Petitions.--Compensation awarded under the Program 
to a parent, legal guardian, 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, ward, or 
spouse shall include compensation for 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.'';
            (3) in subsection (e), by inserting ``, (3), and (4)'' 
        after ``(2)'' and by inserting ``and subsection (b) of this 
        section,'' following ``section,``;
            (4) in subsection (g)(4)(B), by striking ``subsection (j)'' 
        and inserting ``subsection (k)'';
            (5) in subsection (j)(1), by striking ``(j)'' and inserting 
        ``(k)'';
            (6) in subsection (j)(2), by inserting ``, or to a parent 
        or spouse of a person who sustained a vaccine-related injury or 
        death,'' following ``death''; and
            (7) in subsection (k), 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, which shall have jurisdiction over such 
civil action, and which shall dismiss such action. 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 provided herein, 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. 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. 207. ALLOWING COMPENSATION FOR FAMILY COUNSELING EXPENSES AND 
              EXPENSES OF ESTABLISHING 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 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(c) of the Public Health Service Act (42 U.S.C. 300aa-15(c)) is 
amended--
            (1) in paragraph (2), by striking ``and'' at the end;
            (2) in paragraph (3), by inserting a closed parenthesis 
        before the period in that paragraph, and 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 guardianships (as provided 
        for in paragraph (6) of subsection (a)); and''.

SEC. 208. ALLOWING PAYMENT OF INTERIM COSTS.

    Section 2115(f) of the Public Health Service Act (42 U.S.C. 300aa-
15(f)) is amended by adding at the end the following:
    ``(4) A special master or court may make an interim award of costs 
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; and
            ``(D) the petitioner provides documentation verifying the 
        expenditure of the amount for which compensation is sought.''.

SEC. 209. PROCEDURE FOR PAYING ATTORNEYS' FEES.

    Section 2115(f) of the Public Health Service Act (42 U.S.C. 300aa-
15(f)), as amended by section 205, is further amended 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. 210. 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) Effect of Amendment on Previously Untimely Claims.--Section 
2121 of the Public Health Service Act (42 U.S.C. 300aa-21) is amended 
by adding at the end the following:
    ``(d) Previously Untimely Claims.--Notwithstanding subsection (a), 
(b), or (c) of this section, if a petition is filed under section 
2111(a), and such petition would have been untimely under the statute 
of limitations set forth in section 2116, as in effect prior to the 
effective date of this subsection, the special master shall dismiss the 
petition if the special master determines that the petitioner did not 
sustain a vaccine-related illness, disability, injury or condition as 
listed on the Vaccine Injury Table.''.
    (c) Claims Based on Revisions to Table.--Strike all of section 
2116(b) of the Public Health Service Act (42 U.S.C. 300aa-16(b)) and 
insert 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 must 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 8 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.''.
    (d) 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 after the expiration of 60 days 
after the date on which the United States Court of Federal Claims has 
entered final judgment and the time for all further appeals or review 
has expired on the underlying claim of the person who sustained the 
vaccine-related injury or death upon which the derivative petition in 
premised.''.
    (e) Timely Resolutions of Claims.--
            (1) Special master decision.--Section 2112(d)(3)(A)(ii) of 
        the Public Health Service Act (42 U.S.C. 300aa-12(d)(3)(A)(ii)) 
        is amended by adding at the end the following: ``For purposes 
        of this provision, the petition shall be deemed filed on the 
        date on which 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, including an affidavit and supporting 
        documentation, are served on the Secretary and filed with the 
        clerk of the United States Court of Federal Claims.''.
            (2) Court of federal claims decision.--Section 2121(b)(2) 
        of the Public Health Service Act (42 U.S.C. 300aa-21(b)(2) is 
        amended by adding at the end the following: ``For purposes of 
        this provision, the petition shall be deemed filed on the date 
        on which 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, including an affidavit and supporting 
        documentation, are served on the Secretary and filed with the 
        clerk of the United States Court of Federal Claims.''.

SEC. 211. 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. 212. 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) 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) 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. 213. 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. 214. 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. 215. CLARIFICATION OF DEFINITION OF VACCINE.

    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 but not limited to 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 vaccines's product license application and 
product label.''.

SEC. 216. 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. 2129. 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 paragraph (1), the Institute of Medicine 
shall submit to the Secretary a report on the findings of studies 
conducted, 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 paragraph (1), the Secretary shall enter into a contract with 
another qualified nongovernmental scientific organization for the 
purposes described in paragraphs (1) and (2).
    ``(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. 217. 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. 218. 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 of Health and Human Services regarding 
the status of the Vaccine Trust Fund, and shall make recommendations to 
the Secretary regarding the allocation of disbursements from the Fund.
                                 <all>