Page:United States Statutes at Large Volume 100 Part 5.djvu/308

 100 STAT. 3782

Ante, p. 3771. Federal Register, publication.

Physicians. Hospitals. Nurses. State and local governments.

42 USC 300aa-l note.

Ante, p. 3764.

PUBLIC LAW 99-660—NOV. 14, 1986

(ii) the circumstances under which administration of any such vaccine should be delayed beyond its usual ^' time of administration, and -'(iii) the groups, categories, or characteristics of potential recipients of such vaccine who may be at significantly higher risk of major adverse reactions to such vaccine than the general population of potential recipients. (2)(A) The Secretary shall request the Institute of Medicine of the National Academy of Sciences to conduct the study required by paragraph (1) under an arrangement by which the actual expenses incurred by such Academy in conducting such study will be paid by the Secretary. (B) If the Institute of Medicine is unwilling to conduct such study under such an arrangement, the Secretary shall enter into a similar arrangement with other appropriate nonprofit private groups or associations under which such groups or associations will conduct such study. (C) The Institute of Medicine or other group or association conducting the study required by paragraph (1) shall conduct such studies in consultation with the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Health Service Act. (b) REVISION OF GUIDELINES.—The Secretary shall periodically, but at least every 3 years after establishing guidelines under subsection (a), review and revise such guidelines after notice and opportunity for public hearing and consideration of all relevant medical and scientific information, unless the Secretary finds that on the basis of all relevant information no revision of such guidelines is warranted and publishes such finding in the Federal Register. (c) FACTORS AFFECTING GUIDELINES.—Guidelines under subsection (a) shall take into account— (1) the risk to potential recipients of the vaccines with respect to which the guidelines are established, (2) the medical and other characteristics of such potential recipients, and (3) the risks to the public of not having such vaccines administered. (d) DISSEMINATION.—The Secretary shall widely disseminate the guidelines established under subsection (a) to— (1) physicians and other health care providers, ••-• - * (2) professional health associations, (3) State and local governments and agencies, and (4) other relevant entities. SEC. 314. REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY INFORMATION.

Not later than 1 year after the effective date of this title and after consultation with the Advisory Commission on Childhood Vaccines established under section 2119 of the Public Health Service Act and with other appropriate entities, the Secretary of Health and Human Services shall review the warnings, use instructions, and precautionary information presently issued by manufacturers of vaccines set forth in the Vaccine Injury Table set out in section 2114 of the Public Health Service Act and shall by rule determine whether such warnings, instructions, and information adequately warn health care providers of the nature and extent of dangers posed by such

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