Pub. L. 117-328, div. FF, tit. II, subtit. E, ch. 1, sec. 2504

INCREASING EUA DECISION TRANSPARENCY.

EnactedYear: 2022Length: 198 wordsOfficial source
SEC. 2504. INCREASING EUA DECISION TRANSPARENCY. Section 564(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(h)) is amended—(1) in paragraph (1)—(A) by inserting “on the internet website of the Food and Drug Administration and” after “promptly publish”; (B) by striking “application under section 505(i), 512(j), or 520(g), even if such summary may indirectly reveal the existence of such application” and inserting “application, request, or submission under this section or section 505(b), 505(i), 505(j), 512(b), 512(j), 512(n), 515, 510(k), 513(f)(2), 520(g), 520(m), 571, or 572 of this Act, or section 351(a) or 351(k) of the Public Health Service Act, even if such summary may reveal the existence of such an application, request, or submission, or data contained in such application, request, or submission”; and (C) by inserting before the period at the end of the second sentence the following: “, which may include a summary of the data and information supporting such revisions”; and (2) in paragraph (2), by adding at the end the following: “Information made publicly available by the Secretary in accordance with paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18, United States Code”.
Pub. L. 117-328, div. FF, tit. II, subtit. E, ch. 1, sec. 2504: INCREASING EUA DECISION TRANSPARENCY. | Justis AI