117 S3394 IS: Emergency Use Transparency Act U.S. Senate 2021-12-14 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

II117th CONGRESS1st SessionS. 3394IN THE SENATE OF THE UNITED STATESDecember 14, 2021Ms. 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 PensionsA BILLTo amend the Federal Food, Drug, and Cosmetic Act with respect to emergency use authorization transparency.

1.

Short title

This Act may be cited as the Emergency Use Transparency Act.

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.