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.
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—
by inserting on the internet website of the Food and Drug Administration and
after promptly publish
; and
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
.