Sec. 2504. Increasing EUA decision transparency

195 words·~1 min read·/bill/117/hr/2617/unknown/section-2504

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

Section 564(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3(h) ) is amended— in paragraph (1)— by inserting on the internet website of the Food and Drug Administration and after promptly publish ; 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 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 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 .