3.0.0 4427 2023-01-11T13:45:20Z 2023-01-11T13:45:20Z Senate S 2020-08-04 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2020-08-04T20:44:09Z 2020-08-04 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2020-08-04 Introduced in Senate IntroReferral 10000 9 Library of Congress H001076 Sen. Hassan, Margaret Wood [D-NH] Maggie Hassan D NH N B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2020-08-04 True M001153 Sen. Murkowski, Lisa [R-AK] Lisa Murkowski R AK 2020-08-04 True Health Advisory bodies Drug safety, medical device, and laboratory regulation Emergency medical services and trauma care Immunology and vaccination Licensing and registrations Health 00 2020-08-04 Introduced in Senate 2021-01-28T16:25:54Z Safe Authorization for Vaccines during Emergencies Act or the SAVE Act

This bill imposes requirements related to the emergency authorization of a vaccine during a declared public health emergency.

If a sponsor of a product seeks Food and Drug Administration (FDA) authorization to use the product as a vaccine to address the threat causing the declared public health emergency, both the FDA and the product sponsor must meet with, and present product-related data and information to, the Vaccines and Related Biological Products Advisory Committee. The Department of Health and Human Services may make an exception to this requirement if convening a meeting would not be in the public interest.

To receive an emergency authorization, the product sponsor must agree to seek FDA market approval for the vaccine within a certain time period.

After an emergency authorization, the Advisory Committee on Immunization Practices shall report recommendations regarding the vaccine to Congress and the Centers for Disease Control and Prevention.

]]> SAVE Act Display Title SAVE Act Short Title(s) as Introduced SAVE Act Introduced in Senate IS Short Title(s) as Introduced Safe Authorization for Vaccines during Emergencies Act Introduced in Senate IS Official Title as Introduced A bill to provide for transparency in emergency use authorization of vaccine products, and for other purposes. Introduced in Senate IS Introduced in Senate 2020-08-04T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s4427is/xml/BILLS-116s4427is.xml 2020-08-04 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.