H.R. 8018

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8018 Introduced in House (IH)]

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119th CONGRESS
2d Session
H. R. 8018

To regulate human cadaveric islets for transplantation as organs.

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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

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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., 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).
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