Page:United States Statutes at Large Volume 100 Part 5.djvu/302

 100 STAT. 3776

Federal Register' publication.

PUBLIC LAW 99-660—NOV. 14, 1986

disseminate vaccine information materials for distribution by health care providers to the legal representatives of any child receiving a vaccine set forth in the Vaccine Injury Table. Such materials shall be published in the Federal Register and may be revised.
 * ?QJ) DEVELOPMENT AND REVISION OF MATERIALS.—Such m a t e r i a l s

shall be developed or revised by rule— "(1) after notice to the public, opportunity for a public hearV ing, and 90 days of comment thereon, and 'tmn "^^^ ^^ consultation with the Advisory Commission on Child"^' hood Vaccines, appropriate health care providers and parent ^. ^, organizations, the Centers for Disease Control, and the Food and Drug Administration. "(c) INFORMATION REQUIREMENTS.—The information in such materials shall be presented in understandable terms and shall include— "(1) the frequency, severity, and potential long-term effects of ,fr the disease to be prevented by the vaccine, "(2) the symptoms or reactions to the vaccine which, if they occur, should be brought to the immediate attention of the health care provider, "(3) precautionary measures legal representatives should take IIo 4 ^ reduce the risk of any major adverse reactions to the vaccine that may occur, "(4) early warning signs or symptoms to which legal rep'||., resentatives should be alert as possible precursors to such major ?. adverse reactions, "(5) a description of the manner in which legal representa.,, ^^f „; „4 tives should monitor such major adverse reactions, including a e.s lic /^3.i * ^ form on which reactions can be recorded to assist l ^ a l f "* '" representatives in reporting information to appropriate authorities, J,,, "(6) a specification of when, how, and to whom legal rep^ resentatives should report any major adverse reaction, ^ "(7) the contraindications to (and bases for delay of) the ^^ ". administration of the vaccine, "(8) an identification of the groups, categories, or characteristics of potential recipients of the vaccine who may be at significantly higher risk of major adverse reaction to the vaccine than ^^^.jp tJ^e general population, "(9) a summary of relevant State and Federal laws concerning the vaccine, including information on— f "(A) the number of vaccinations required for school attendance and the schedule recommended for such vac'J, cinations, and "(B) the availability of the Program, and ,! "(10) such other relevant information as may be determined by the Secretary. "(d) HEALTH CARE PROVIDER DUTIES.—On and after a date deter* mined by the Secretary which is— „,_ ^, "(1) after the Secretary develops the information materials required by subsection (a), and "(2) not later than 6 months after the date such materials are •j'ddt published in the Federal Register, each health care provider who administers a vaccine set forth in the Vaccine Injury Table shall provide to the legal representatives of any child to whom such provider intends to administer such vaccine n.r,, ^. a copy of the information materials developed pursuant to subsec•^i' r- fe tion (a), or other written information which meets the requirements

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