3.0.0 2205 2025-12-05T09:16:01Z 2025-12-05T09:16:01Z Senate S S 2023-06-22 118 https://www.congress.gov/bill/118th-congress/senate-bill/2205 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred To 2023-06-22T20:56:50Z 118 4304 HR 2023-06-23 Referred to the Subcommittee on Health. Identical bill CRS 2023-06-22 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2023-06-22 Introduced in Senate IntroReferral 10000 9 Library of Congress L000577 Sen. Lee, Mike [R-UT] Mike Lee R UT N B001305 Sen. Budd, Ted [R-NC] Ted Budd R NC 2023-06-22 True B001243 Sen. Blackburn, Marsha [R-TN] Marsha Blackburn R TN 2023-06-22 True P000603 Sen. Paul, Rand [R-KY] Rand Paul R KY 2023-07-11 False Health Administrative law and regulatory procedures 2024-02-12T21:00:38Z Congressional oversight 2024-02-12T21:00:38Z Department of Health and Human Services 2024-02-12T21:00:38Z Digestive and metabolic diseases 2024-02-12T21:00:38Z Organ and tissue donation and transplantation 2024-02-12T21:00:38Z Health 2023-08-03T22:00:40Z

00 2023-06-22 Introduced in Senate 2024-07-16T22:56:29Z <p><strong>Increase Support for Life-saving Endocrine Transplantation Act or the ISLET Act</strong></p><p>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.)</p><p>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.</p><p>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.)</p><p>Specifically, the bill defines human cadaveric islets as organs and excludes them from definitions related to the regulation of drugs and biological products.</p>

Display Title 45 2024-07-24T15:21:16Z Short Title(s) as Introduced 101 2024-05-24T13:38:06Z Introduced in Senate IS Short Title(s) as Introduced 101 2024-05-24T13:38:06Z Introduced in Senate IS Official Title as Introduced 6 2024-02-14T09:08:24Z Introduced in Senate IS Introduced in Senate 2023-06-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s2205is/xml/BILLS-118s2205is.xml 2023-06-22 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.