117th CONGRESS 1st Session |
To amend the Federal Food, Drug, and Cosmetic Act with respect to emergency use authorization transparency.
December 14, 2021
Ms. Hassan (for herself, Mr. Braun, and Ms. Murkowski) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
To amend the Federal Food, Drug, and Cosmetic Act with respect to emergency use authorization transparency.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
This Act may be cited as the “Emergency Use Transparency Act”.
SEC. 2. Increasing EUA transparency.
Section 564(h)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb–3(h)(1)) is amended—
(1) by inserting “on the internet website of the Food and Drug Administration and” after “promptly publish”; and
(2) 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), 520m(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”.