3.0.0 3516 2023-08-07T15:00:31Z 2023-08-07T15:00:31Z Senate S 2022-01-18 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2022-01-19T01:09:11Z 2022-01-18 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2022-01-18 Introduced in Senate IntroReferral 10000 9 Library of Congress S001197 Sen. Sasse, Ben [R-NE] Ben Sasse R NE N Health 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 Health 00 2022-01-18 Introduced in Senate 2023-08-07T14:59:55Z 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.

]]> Increase Access to COVID Testing Act Display Title Increase Access to COVID Testing Act Short Title(s) as Introduced Increase Access to COVID Testing Act Introduced in Senate IS Official Title as Introduced 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. Introduced in Senate IS Introduced in Senate 2022-01-18T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s3516is/xml/BILLS-117s3516is.xml 2022-01-18 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.