Sec. 2141. Timely review of vaccines by the Advisory Committee on Immunization Practices

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Section 2102(a) of the Public Health Service Act ( 42 U.S.C. 300aa–2(a) ) is amended by adding at the end the following: Upon the licensure of any vaccine or any new indication for a vaccine, the Director of the Program shall direct the Advisory Committee on Immunization Practices, at its next regularly scheduled meeting, to consider the use of the vaccine. If the Advisory Committee does not make recommendations with respect to the use of a vaccine at the Advisory Committee’s first regularly scheduled meeting after the licensure of the vaccine or any new indication for the vaccine, the Advisory Committee, at the request of the sponsor of the vaccine, shall make such recommendations on an expedited basis.

If a vaccine is designated as a breakthrough therapy under section 506 of the Federal Food, Drug, and Cosmetic Act and is licensed under section 351 of this Act, the Advisory Committee shall make recommendations with respect to the use of the vaccine on an expedited basis. In this paragraph, the terms Advisory Committee on Immunization Practices and Advisory Committee mean the advisory committee on immunization practices established by the Secretary pursuant to section 222, acting through the Director of the Centers for Disease Control and Prevention. .

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42 USC 300aa–2(a)

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Sec. 2141

Timely review of vaccines by the Advisory Committee on Immunization Practices

Cite42 USC 300aa–2(a)

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