Page:United States Statutes at Large Volume 100 Part 5.djvu/303

 PUBLIC LAW 99-660—NOV. 14, 1986

100 STAT. 3777

of this section. Such materials or other information shall be provided prior to the administration of such vaccine. -IW'X"

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MANDATE FOR SAFER CHILDHOOD VACCINES

2127. (a) GENERAL RULE.—In the administration of this 42 USC subtitle and other pertinent laws under the jurisdiction of the 300aa-27. Secretary, the Secretary shall— "(1) promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those vaccines on the market on the effective date of this subtitle and 3« promote the refinement of such vaccines, and 1 g 3 "(2) make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines. "(b) REPORT.—Within 2 years after the effective date of this subtitle, and periodically thereafter, the Secretary shall prepare and transmit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursuant to subsection (a) during the preceding 2-year period. "SEC.

MANUFACTURER RECORDKEEPING AND REPORTING

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2128. (a) GENERAL RULE.—Each vaccine manufacturer of a vaccine set forth in the Vaccine Injury Table or any other vaccine the administration of which is mandated by the law or regulations of any State, shall, with respect to each batch, lot, or other quantity manufactured or licensed after the effective date of this subtitle— "(1) prepare and maintain records documenting the history of the manufacturing, processing, testing, repooling, and reworking of each batch, lot, or other quantity of such vaccine, including the identification of any significant problems encountered in the production, testing, or handling of such batch, lot, or other quantity, "(2) if a safety test on such batch, lot, or other quantity indicates a potential imminent or substantial public health hazard is presented, report to the Secretary within 24 hours of such safety test which the manufacturer (or manufacturer's representative) conducted, including the date of the test, the type of vaccine tested, the identity of the batch, lot, or other quantity tested, whether the batch, lot, or other quantity tested is the product of repooling or reworking of previous batches, lots, or other quantities (and, if so, the identity of the previous batches, lots, or other quantities which were repooled or reworked), the complete test results, and the name and address of the person responsible for conducting the test, "(3) include with each such report a certification signed by a responsible corporate official that such report is true and complete, and "(4) prepare, maintain, and upon request submit to the Secretary product distribution records for each such vaccine by batch, lot, or other quantity number. "SEC.

State and local governments.

42 USC

300aa-28.

,-*a Safety.

0811 S^.

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