ISLET Act

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 8018 Introduced in House (IH)] <DOC> 119th CONGRESS 2d Session H. R. 8018 To regulate human cadaveric islets for transplantation as organs. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES March 19, 2026 Mr. Norman (for himself and Mr. Bacon) introduced the following bill; which was referred to the Committee on Energy and Commerce _______________________________________________________________________ A BILL To regulate human cadaveric islets for transplantation as organs. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, SECTION 1. SHORT TITLE. This Act may be cited as the ``Increase Support for Life-saving Endocrine Transplantation Act'' or the ``ISLET Act''. SEC. 2. REGULATION OF HUMAN CADAVERIC ISLET TRANSPLANTS. (a) In General.--Section 374(d)(2) of the Public Health Service Act (42 U.S.C. 274b(d)(2)) is amended by striking ``pancreas,'' and inserting ``and pancreas, human cadaveric islets,''. (b) Clarification.--Notwithstanding any other provision of law, none of the following terms includes human cadaveric islets: (1) The term ``drug'', as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)). (2) The term ``biological product'', as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)). (3) The term ``human cells, tissues, or cellular or tissue- based products (HCT/Ps)'', as defined in section 1271.3 of title 21, Code of Federal Regulations (or any successor regulations). (c) Regulations.-- (1) In general.--Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ``Secretary'') shall update regulations promulgated under parts F, G, and H of title III of the Public Health Service Act (42 U.S.C. 262 et seq., 264 et seq