ISLET Act

3.0.0 4304 2025-12-05T09:16:13Z 2025-12-05T09:16:13Z House H HR 2023-06-22 118 https://www.congress.gov/bill/118th-congress/house-bill/4304 <pre>[Congressional Record Volume 169, Number 109 (Thursday, June 22, 2023)][House]From the Congressional Record Online through the Government Publishing Office [<a href="https://www.gpo.gov">www.gpo.gov</a>]By Mr. ROSENDALE:H.R. 4304.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8The single subject of this legislation is:Healthcare[Page H3111]</pre> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2023-06-23T18:17:34Z Referred To 2023-06-22T14:35:25Z ISLET Act 118 2205 S 2023-06-22 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Identical bill CRS 2023-06-23 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2023-06-22 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2023-06-22 Introduced in House IntroReferral Intro-H 9 Library of Congress 2023-06-22 Introduced in House IntroReferral 1000 9 Library of Congress R000103 Rep. Rosendale Sr., Matthew M. [R-MT-2] Matthew Rosendale R MT M. 2 N B001298 Rep. Bacon, Don [R-NE-2] Don Bacon R NE 2 2023-06-22 True G000596 Rep. Greene, Marjorie Taylor [R-GA-14] Marjorie Greene R GA Taylor 14 2023-06-22 True B000740 Rep. Bice, Stephanie I. [R-OK-5] Stephanie Bice R OK I. 5 2023-06-30 False S000522 Rep. Smith, Christopher H. [R-NJ-4] CHRISTOPHER SMITH R NJ H. 4 2023-09-05 False Health Administrative law and regulatory procedures 2024-02-12T21:00:33Z Congressional oversight 2024-02-12T21:00:33Z Department of Health and Human Services 2024-02-12T21:00:33Z Digestive and metabolic diseases 2024-02-12T21:00:33Z Organ and tissue donation and transplantation 2024-02-12T21:00:33Z Health 2023-07-26T16:50:11Z

00 2023-06-22 Introduced in House 2024-05-10T16:41:42Z <html><body bgcolor="#FFFFFF">Increase Support for Life-saving Endocrine Transplantation Act or the ISLET Act This bill removes pancreatic islets that are donated from human cadavers from regulation as a drug or biological product by the Food and Drug Administration (FDA). (Islets are groups of cells, including those that make insulin, in the pancreas, and islet transplantation is an experimental treatment for certain conditions, such as type 1 diabetes.) Current FDA guidance treats pancreatic islets as a biological product, which makes them subject to the biological license application process and related standards for manufacturing practices, safety, identity, purity, and potency. The bill, instead, treats human cadaveric islets as organs, which makes them subject to the regulatory framework that governs the allocation, safety, and efficacy of organ donation and transplantation. That framework, developed by the Health Resources and Services Administration, is carried out by contract through the Organ Procurement and Transplantation Network. (The network is a public-private partnership that links the professionals involved in the U.S. donation and transplantation system.) Specifically, the bill defines human cadaveric islets as organs and excludes them from definitions related to the regulation of drugs and biological products.</body></html>

ISLET Act Display Title 45 ISLET Act 2024-07-24T15:21:23Z Short Title(s) as Introduced 101 ISLET Act 2024-05-24T13:38:22Z Introduced in House IH Short Title(s) as Introduced 101 Increase Support for Life-saving Endocrine Transplantation Act 2024-05-24T13:38:22Z Introduced in House IH Official Title as Introduced 6 To regulate human cadaveric islets for transplantation as organs. 2024-03-18T21:03:08Z Introduced in House IH Introduced in House 2023-06-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118hr4304ih/xml/BILLS-118hr4304ih.xml 2023-06-23 Referred to the Subcommittee on Health. 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.