Page:United States Statutes at Large Volume 100 Part 5.djvu/305

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PUBLIC LAW 99-000—MMMM. DD, 1986

PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3779

ered by that section. The term 'manufacture' means to manufacture, import, process, or distribute a vaccine. "(4) The term 'significant aggravation' means any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by substantial deterioration of health. "(5) The term 'vaccine-related injury or death' means an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant intentionally added to such a vaccine. "(6)(A) The term 'Advisory Commission on Childhood Vaccines' means the Commission established under section 2119. "(B) The term 'Vaccine Injury Table' means the table set out in section 2114.". Ante, p. 3764. (b) CONFORMING AMENDMENTS.—

(1) Sections 217(c), 465(f), and 497 of the Public Health Service 42 USC 218, 286, Act (42 U.S.C. 218(c), 286(f), 289(f)) are each amended by striking 289f. out "2101" and inserting in lieu thereof "2301". (2) Section 305(h) of such Act (42 U.S.C. 242c(h)) is amended by striking out "2113" each place it occurs and inserting in lieu thereof "2313". SEC. 312. RELATED STUDIES. (a) REVIEW OF PERTUSSIS VACCINES AND RELATED ILLNESSES AND

CONDITIONS.—Not later than 3 years after the effective date of this title, the Secretary of Health and Human Services shall complete a review of all relevant medical and scientific information (including information obtained from the studies required under subsection (e)) on the nature, circumstances, and extent of the relationship, if any, between vaccines containing pertussis (including whole cell, extracts, and specific antigens) and the following illnesses and conditions: (1) Hemolytic anemia. (2) Hjrpsarrhythmia. (3) Infantile spasms. (4) Reye's sjoidrome. (5) Peripheral mononeuropathy. (6) Deaths classified as sudden infant death sjmdrome. (7) Aseptic meningitis. (8) Juvenile diabetes. (9) Autism. (10) Learning disabilities. (11) Hyperactivity. (12) Such other illnesses and conditions as the Secretary may choose to review or as the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Health Service Act recommends for inclusion in such review. The review under this subsection shall include notice and opportunity for a public hearing, consideration of written information submitted by the public, and consultation with such Advisory Commission. Ob) FINDINGS WITH RESPECT TO PERTUSSIS.—Not later than 3 years after the effective date of this title, the Secretary shall make, and publish in the Federal Register, the following specific findings:

42 USC 300aa-l note.

Ante, p. 3771.

Federal Register, publication.