Not later than 1 year after December 29, 2022, the Secretary shall establish an intra-agency coordinating council (referred to in this subsection as the "Council") within the Food and Drug Administration to ensure the consistent and appropriate use of accelerated approval across the Food and Drug Administration, pursuant to section 356(c) of this title.
The members of the Council shall consist of the following senior officials, or a designee of such official, from the Food and Drug Administration and relevant Centers:
The Council shall convene not fewer than 3 times per calendar year to discuss issues related to accelerated approval, including any relevant cross-disciplinary approaches related to product review with respect to accelerated approval.
The Council shall directly engage with product review teams to support the consistent and appropriate use of accelerated approval across the Food and Drug Administration. Such engagement may include-
Not later than 1 year after December 29, 2022, and annually thereafter, the Council shall publish on the public website of the Food and Drug Administration a report on the activities of the Council.
21 U.S.C. §§ 356-2
EDITORIAL NOTES
CODIFICATIONSection was enacted as part of the Food and Drug Omnibus Reform Act of 2022, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
STATUTORY NOTES AND RELATED SUBSIDIARIES
CONSTRUCTIONNothing in section 3210(e) of Pub. L. 117-328 which enacted this section, to be construed to affect ongoing withdrawal proceedings for products approved pursuant to section 356(c) of this title for which a notice of proposed withdrawal has been published in the Federal Register prior to Dec. 29, 2022, see section 3210(f) of Pub. L. 117-328 set out as a Construction of 2022 Amendment note under section 356 of this title.
DEFINITION OF "SECRETARY"Secretary as used in this section means the Secretary of Health and Human Services, see section 3002 of div. FF of Pub. L. 117-328 set out as a note under section 350a-1 of this title.