118 S2205 IS: Increase Support for Life-saving Endocrine Transplantation Act U.S. Senate 2023-06-22 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.

II118th CONGRESS1st SessionS. 2205IN THE SENATE OF THE UNITED STATESJune 22, 2023Mr. 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 PensionsA BILLTo 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).