Increase Access to COVID Testing Act
Bill: S.3516 | Sponsor: Sen. Sasse, Ben (R-NE)
Policy area: Health

Summary:
Increase Access to COVID Testing Act
This bill directs the Food and Drug Administration (FDA) to provide upon request emergency use authorization for COVID-19 rapid antigen tests approved for use in the European Union.
During the declared COVID-19 public health emergency, the FDA shall grant emergency use authorization to a COVID-19 rapid antigen test upon a proper request by the test's manufacturer if (1) the test is on the European Commission Directorate-General for Health and Food Safety's common list for approved COVID-19 tests, and (2) the request is for the non-laboratory use of the test without a prescription.
The bill waives certain requirements for a request for emergency use authorization under this bill, such as a finding from the FDA that the test may be effective in diagnosing COVID-19.
If a test authorized under this bill is removed from the EU common list, the FDA must determine within 30 days of such removal whether the emergency use authorization for the test should continue.

To require the Secretary of Health and Human Services to provide 
emergency use authorization with respect to certain COVID-19 diagnostic 
             tests approved for use in the European Union.

    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 ``Increase Access to COVID Testing 
Act''.

SEC. 2. EMERGENCY USE APPROVAL OF CERTAIN COVID-19 TESTS.

    (a) In General.--For the duration of the public health emergency 
declared under section 319 of the Public Health Service Act (42 U.S.C. 
247d) with respect to COVID-19, the Secretary of Health and Human 
Services shall authorize the introduction into interstate commerce, 
pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb-3), without regard for any specific criteria under 
subsection (c)(2) of such section, of any antigen diagnostic test to 
detect SARS-CoV-2 that is described in subsection (b), upon request by 
the manufacturer under such section 564.
    (b) Tests Described.--An antigen diagnostic test to detect SARS-
CoV-2 described in this subsection is such a test--
            (1) that is included on the common list of COVID-19 rapid 
        antigen tests of the European Commission Directorate-General 
        for Health and Food Safety; and
            (2) for which the emergency use authorization request is 
        for an at-home, or other non-laboratory site, use, without a 
        prescription.
    (c) Terms of Authorization.--
            (1) In general.--A diagnostic test authorized as described 
        in subsection (a) shall be subject to the same terms and 
        requirements as other products authorized under section 564 of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3).
            (2) Change in status in the eu.--In the case of an antigen 
        diagnostic test authorized as described in subsection (a), if 
        the European Commission Directorate-General for Health and Food 
        Safety removes such test from the common list described in 
        subsection (b)(1), the Secretary of Health and Human Services, 
        not later than 30 days after such removal from the common list, 
        shall conduct a review of the test to determine whether the 
        emergency use authorization under section 564 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3) should 
        continue.
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