Emergency Use Transparency Act

Bill: 117-s-3394
Sponsor: full_name: Sen. Hassan, Margaret Wood [D-NH]
Introduced: 2021-12-14
Policy area: Health
Subjects: Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Emergency medical services and trauma care

Food and Drug Administration (FDA)

Government information and archives

Health technology, devices, supplies
Latest action: action_date: 2021-12-14
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2021-12-14
action_desc: Introduced in Senate
text: <p><strong>Emergency Use Transparency Act</strong></p> <p>This bill expands existing statutory provisions requiring the Food and Drug Administration (FDA) to publish notices of authorizations, terminations, or revocations of emergency use authorizations for medical products. </p> <p>Specifically, the bill requires the FDA to publish such notices on its website. The bill also allows the FDA's disclosures to include a summary of data or information from additional types of submissions. </p>

tv_txt: II 117th CONGRESS 1st Session S. 3394 IN THE SENATE OF THE UNITED STATES 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 A BILL To 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 .