119-s3105

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3105 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 3105

 To regulate human cadaveric islets for transplantation as organs.

_______________________________________________________________________

 IN THE SENATE OF THE UNITED STATES

 November 5, 2025

Mr. Lee (for himself and Mr. Budd) 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.

 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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