S. 3394Senate117th Congress (2021-2023)In Committee

Emergency Use Transparency Act

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Updated February 8, 2026 at 8:35 AM UTC

The Emergency Use Transparency Act amends the Federal Food, Drug, and Cosmetic Act to make information about the FDA’s emergency use authorizations (EUAs) more publicly available. It requires the FDA to post summaries of EUA applications on its website. The law also expands the range of FDA and Public Health Service Act submissions that must be disclosed, even if the information could reveal the existence of the application.

Key Provisions

The FDA must promptly publish summaries of EUA applications on its internet website.
The disclosure requirement is broadened to include applications, requests, or submissions under many FDA and Public Health Service Act sections (e.g., 505, 512, 515, 520, 571, 572, etc.), and the FDA must publish them even if the summary may reveal the existence or data of the submission.

Legislative Activity

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1 earlier action

SenateIntro Referral Latest Action

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

December 14, 2021

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SenateIntro Referral

Introduced in Senate

December 14, 2021

SenateIntro Referral

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Health, Education, Labor, and Pensions Committee

December 14, 2021

Bill Text

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Introduced in SenateIssued December 14, 2021

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.

Short title

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

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.