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.

April 1, 2003

Mr. FRIST introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions

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.

END