Requires the Secretary of Health and Human Services to provide for a program of research, demonstration projects, and education to ensure that immunizations are routinely offered to adults and adolescents by public and private health care providers. Requires such program to collect data on adverse impacts associated with immunizations.
Directs the Secretary to: (1) develop and disseminate information concerning certain diseases and their vaccines, including bacterial meningitis and hepatitis A and B; and (2) maintain a 6 months supply of prioritized vaccines.
Revises provisions governing the National Vaccine Injury Compensation Program, including provisions regarding: (1) equitable relief; (2) derivative petitions; and (3) an extension of the statute of limitations.
Amends Internal Revenue Code provisions concerning the Vaccine Injury Compensation Trust Fund, including to expand compensated loss for injury or death to include related loss.
Amends the Public Health Service Act to require the Secretary to contract with the Institute of Medicine of the National Academy of Science to conduct an ongoing, comprehensive review of new scientific data on childhood vaccines.
[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>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
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