3.0.0 3449 2022-12-30T03:48:58Z 2022-12-30T03:48:58Z Senate S 2022-01-10 117 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2022-01-10T21:30:23Z PREVENT Pandemics Act 117 3799 S 2022-03-15 Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Related bill CRS 2022-01-10 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2022-01-10 Introduced in Senate IntroReferral 10000 9 Library of Congress P000595 Sen. Peters, Gary C. [D-MI] Gary Peters D MI N C001035 Sen. Collins, Susan M. [R-ME] Susan Collins R ME M. 2022-01-10 True Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Licensing and registrations Manufacturing Health 00 2022-01-10 Introduced in Senate 2022-08-05T16:03:38Z Registration of Certain Foreign Establishments Act

This bill expands statutory provisions that require foreign manufacturers of drugs or medical devices for the U.S. market to register with the Food and Drug Administration.

Specifically, if an establishment outside of the United States manufactures (or otherwise processes or prepares) a drug or medical device to be imported (or offered for import) into the United States, the establishment must comply with the registration requirements even if the drug or medical device in question undergoes further manufacturing at another non-U.S. establishment prior to importation into the United States.

]]> Registration of Certain Foreign Establishments Act Display Title Registration of Certain Foreign Establishments Act Short Title(s) as Introduced Registration of Certain Foreign Establishments Act Introduced in Senate IS Official Title as Introduced A bill to require foreign establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device to register with the Food and Drug Administration regardless of whether the drug or device undergoes further manufacture, preparation, propagation, compounding, or processing at a separate establishment outside the United States prior to being imported into the United States. Introduced in Senate IS Introduced in Senate 2022-01-10T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117s3449is/xml/BILLS-117s3449is.xml 2022-01-10 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.