Increase Access to COVID Testing Act

Bill: 117-s-3516
Sponsor: full_name: Sen. Sasse, Ben [R-NE]
Introduced: 2022-01-18
Policy area: Health
Subjects: Cardiovascular and respiratory health

Drug safety, medical device, and laboratory regulation

Emergency medical services and trauma care

Europe

European Union

Infectious and parasitic diseases

Medical tests and diagnostic methods
Latest action: action_date: 2022-01-18
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Summaries:
action_date: 2022-01-18
action_desc: Introduced in Senate
text: <p><strong>Increase Access to COVID Testing Act</strong></p> <p>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.</p> <p>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. </p> <p>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. </p> <p>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. </p>

tv_txt: II 117th CONGRESS 2d Session S. 3516 IN THE SENATE OF THE UNITED STATES January 18, 2022 Mr. Sasse introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL 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.

1. Short title This Act may be cited as the Increase Access to COVID Testing Act . 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.