[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3394 Introduced in Senate (IS)]

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117th CONGRESS
  1st Session
                                S. 3394

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


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                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

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''.
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