II 118th CONGRESS 1st Session S. 2205 IN THE SENATE OF THE UNITED STATES June 22, 2023 Mr. Lee (for himself, Mr. Budd , and Mrs. Blackburn ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To regulate human cadaveric islets for transplantation as organs.

1. Short title This Act may be cited as the Increase Support for Life-saving Endocrine Transplantation Act or the ISLET Act . 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., 273 et seq.) and the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ), and such other regulations as the Secretary determines appropriate, to carry out the amendment made by subsection (a). (2) Report Not later than 6 months after the date of enactment of this Act, the Secretary shall report to Congress on the progress made in updating regulations as required under paragraph (1).