42 U.S.C. § 300aa: Establishment

The Secretary shall establish in the Department of Health and Human Services a National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The Program shall be administered by a Director selected by the Secretary. Except as provided in subsection (b), if any provision [of] part A or B of subtitle 2 of title XXI of the Public Health Service Act [ 42 U.S.C. 300aa–10 et seq., 300aa–21 et seq.], as added by section 311(a), or the application of such a provision to any person or circumstance is held invalid by reason of a violation of the Constitution, both such parts shall be considered invalid. If any amendment made by section 6601 of the Omnibus Budget Reconciliation Act of 1989 [ Pub. L. 101–239 , amending sections 300aa–10 to 300aa–17, 300aa–21, 300aa–23, 300aa–26, and 300aa–27 of this title] to title XXI of the Public Health Service Act [ 42 U.S.C. 300aa–1 et seq.] or the application of such a provision to any person or circumstance is held invalid by reason of the Constitution, subsection (a) shall not apply and such title XXI of the Public Health Service Act without such amendment shall continue in effect.” arrange for a broad study of the risks (other than the risks considered under section 102 [ 21 U.S.C. 382 ]) to children associated with each vaccine set forth in the Vaccine Injury Table under section 2114 of such Act [ 42 U.S.C. 300aa–14 ], and the circumstances under which any such vaccine should not be administered, the circumstances under which administration of any such vaccine should be delayed beyond its usual time of administration, and 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. 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. 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. 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 [ 42 U.S.C. 300aa–19 ]. 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. the risk to potential recipients of the vaccines with respect to which the guidelines are established, the medical and other characteristics of such potential recipients, and the risks to the public of not having such vaccines administered. physicians and other health care providers, professional health associations, State and local governments and agencies, and other relevant entities.” an assessment of the impact of the amendments made by this title [enacting this subchapter, amending sections 218, 242c, 262, 286, and 289f of this title, redesignating former sections 300aa to 300aa–15 of this title as sections 300cc to 300cc–15 of this title, and enacting provisions set out as notes under this section and sections 201 and 300aa–1 of this title] on the supply of vaccines listed in the Vaccine Injury Table under section 2114 of the Public Health Service Act [ 42 U.S.C. 300aa–14 ], and an assessment of the ability of the administrators of vaccines (including public clinics and private administrators) to provide such vaccines to children.”