US Codex
Bill
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Emergency Use Transparency Act

S. 3394 · 117th Congress · Dec 14, 2021 · Lineage

A BILL

To amend the Federal Food, Drug, and Cosmetic Act with respect to emergency use authorization transparency.

Section 1 Short title

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”.