3.0.0 6155 2022-02-08T23:17:33Z 2022-02-08T23:17:33Z House HR 2020-03-09 116 [Congressional Record Volume 166, Number 45 (Monday, March 9, 2020)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. GROTHMAN:H.R. 6155.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8[Page H1556]]]> hsif00 Energy and Commerce Committee House Standing Referred to 2020-03-09T16:05:25Z 116 19 HR 2019-12-19 Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Related bill CRS 116 1895 S 2019-07-08 Placed on Senate Legislative Calendar under General Orders. Calendar No. 133. Related bill CRS 116 2103 S 2019-07-11 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S4809) Related bill CRS 2020-03-09 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2020-03-09 Introduced in House IntroReferral Intro-H 9 Library of Congress 2020-03-09 Introduced in House IntroReferral 1000 9 Library of Congress G000576 Rep. Grothman, Glenn [R-WI-6] Glenn Grothman R WI 6 N Health Drug safety, medical device, and laboratory regulation Licensing and registrations Prescription drugs Health

00 2020-03-09 Introduced in House 2021-09-15T20:04:34Z This bill requires the Food and Drug Administration (FDA) to continue to review applications for certain biological products under an earlier review process, notwithstanding recent FDA guidance. Specifically, the bill applies to applications that were filed under the earlier process on or before March 23, 2019, and were still pending on March 23, 2020. (A 2009 law established a new procedure for approving biological products but allowed certain products in an already approved product class to receive approval under the earlier procedure until March 23, 2020; subsequently, in December 2018, the FDA issued guidance stating that an application filed under the earlier procedure that is not approved by March, 23, 2020, will not be approved.)

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Display Title Official Title as Introduced Introduced in House IH Introduced in House 2020-03-09T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr6155ih/xml/BILLS-116hr6155ih.xml 2020-03-09 Referred to the House Committee on Energy and Commerce. 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.