3.0.0 187 2023-03-08T20:12:14Z 2023-03-08T20:12:14Z Senate S 2021-02-03 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2021-02-03T15:02:12Z Pandemic Emergency Manufacturing Act of 2021 117 728 HR 2021-02-03 Referred to the Subcommittee on Health. Related bill CRS 2021-02-03 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2021-02-03 Introduced in Senate IntroReferral 10000 9 Library of Congress W000817 Sen. Warren, Elizabeth [D-MA] Elizabeth Warren D MA A. N Health Blood and blood diseases Cardiovascular and respiratory health Congressional oversight Corporate finance and management Department of Health and Human Services Drug safety, medical device, and laboratory regulation Emergency medical services and trauma care Executive agency funding and structure Federal officials Genetics Government ethics and transparency, public corruption Government information and archives Government studies and investigations Health personnel Health technology, devices, supplies Immunology and vaccination Indian social and development programs Infectious and parasitic diseases Inflation and prices Licensing and registrations Manufacturing Marketing and advertising Medical tests and diagnostic methods Minority health Prescription drugs Public contracts and procurement Public participation and lobbying State and local government operations Strategic materials and reserves Worker safety and health Health 00 2021-02-03 Introduced in Senate 2021-03-24T19:00:38Z Pandemic Emergency Manufacturing Act of 2021

This bill establishes within the Department of Health and Human Services (HHS) an Emergency Office of Manufacturing for Public Health to manufacture and distribute medical products to address COVID-19 (i.e., coronavirus disease 2019) or medical products that are on shortage or vulnerable to shortage.

The office must (1) obtain the rights to manufacture the applicable medicines, ingredients, diagnostic tests, medical devices, personal protective equipment, and supplies; (2) manufacture or contract to manufacture such items; and (3) construct, or enter into construction contracts for, facilities to manufacture certain medicines, such as vaccines.

HHS may issue involuntary licenses allowing the office to make, use, sell, import, or export an invention related to an applicable drug, biological product, or device and to use clinical trial data and confidential information. Such a license must provide the rights holder with reasonable compensation.

The office must (1) provide such COVID-19 products at no cost to federal, state, local, and other health programs and certain domestic health care providers and suppliers; (2) offer COVID-19 products at cost to other commercial and international entities; and (3) offer other medical products to entities at a fair price, based on cost and other considerations.

The office shall prioritize the manufacture of certain COVID-19 products and meet manufacturing timelines specified in the bill.

]]> Pandemic Emergency Manufacturing Act of 2021 Display Title Pandemic Emergency Manufacturing Act of 2021 Official Title as Introduced A bill to amend the Public Health Service Act to establish an Emergency Office of Manufacturing for Public Health, and for other purposes. Introduced in Senate IS Short Title(s) as Introduced Pandemic Emergency Manufacturing Act of 2021 Introduced in Senate IS Introduced in Senate 2021-02-03T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s187is/xml/BILLS-117s187is.xml 2021-02-03 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.