3.0.0 1604 2023-01-11T13:50:14Z 2023-01-11T13:50:14Z Senate S 2021-05-13 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2021-05-13T15:43:50Z 2021-05-13 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2021-05-13 Introduced in Senate IntroReferral 10000 9 Library of Congress C001095 Sen. Cotton, Tom [R-AR] Tom Cotton R AR N Health Asia Buy American requirements China Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Emergency medical services and trauma care Executive agency funding and structure Government studies and investigations Health technology, devices, supplies Immunology and vaccination Infectious and parasitic diseases Licensing and registrations Manufacturing Medical research Medical tests and diagnostic methods Public contracts and procurement Strategic materials and reserves Health 00 2021-05-13 Introduced in Senate 2022-02-10T16:58:07Z Operation Warp Speed Act of 2021

This bill modifies procedures for Emergency Use Authorization (EUA) and provides additional authority to the Department of Health and Human Services (HHS) for vaccine production in response to a public health emergency. It also makes changes to the administration of the Strategic National Stockpile. (An EUA temporarily authorizes use of an otherwise unapproved medical product or device in certain emergency situations.)

Among other modifications, the bill places additional requirements on EUA approvals. Specifically, HHS may only approve an EUA if, after consulting four specified agencies, at least three of them vote to grant approval. Currently, HHS's authority to approve an EUA, which it has delegated to the Food and Drug Administration, is not limited by the votes of consulting agencies.

Additionally, the bill authorizes the use of HHS funds to produce a vaccine before it is licensed or authorized in response to a public health emergency. The bill also establishes the Office of Operation Warp Speed within the HHS Office of the Assistant Secretary for Preparedness and Response to expedite the production of vaccines and medical countermeasures to respond to public health emergencies.

With respect to the Strategic National Stockpile, HHS must assess, as part of its annual threat-based review, the levels of and supply chains for materials in the stockpile. HHS must also give priority to domestic manufacturers when procuring materials for the stockpile. If materials cannot be sourced domestically, HHS must give priority to manufacturers that are not located in China.

]]> Operation Warp Speed Act of 2021 Display Title Operation Warp Speed Act of 2021 Official Title as Introduced A bill to codify the successes of rapid development of safe vaccines through Operation Warp Speed, for the next administration to use as a guide in the event of another pandemic. Introduced in Senate IS Short Title(s) as Introduced Operation Warp Speed Act of 2021 Introduced in Senate IS Introduced in Senate 2021-05-13T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s1604is/xml/BILLS-117s1604is.xml 2021-05-13 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.