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To regulate human cadaveric islets for transplantation as organs.
Summary
The ISLET Act would amend the Public Health Service Act to regulate human cadaveric islets, the insulin-producing cells of the pancreas, as organs for transplantation purposes. The bill clarifies that human cadaveric islets are not considered drugs, biological products, or human cells and tissues under current federal law, thereby allowing them to be regulated under the organ transplantation framework. The Secretary of Health and Human Services would be required to update federal regulations within one year to implement this regulatory change and report to Congress within six months on progress. The amendment adds human cadaveric islets to the legal definition of organs in the Public Health Service Act.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
- Rep. Norman, Ralph [R-SC-5] (R-SC)
5 cosponsors
- Rep. Bacon, Don [R-NE-2] (R-NE)
- Rep. Garbarino, Andrew R. [R-NY-2] (R-NY)
- Rep. Gill, Brandon [R-TX-26] (R-TX)
- Rep. LaLota, Nick [R-NY-1] (R-NY)
- Rep. Mann, Tracey [R-KS-1] (R-KS)
Actions (2)
- Mar 19, 2026 Referred to the House Committee on Energy and Commerce. · house
- Mar 19, 2026 Introduced in House
Similar bills (6)
Bills with similar text or summary — includes reintroductions across Congresses. Ranked by semantic similarity of the bill text (computed locally); a neutral discovery aid, not a claim the bills are duplicates.
Full text
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., 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). <all>
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