[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4304 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 4304

   To regulate human cadaveric islets for transplantation as organs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 22, 2023

   Mr. Rosendale (for himself, Mr. Bacon, and Ms. Greene of Georgia) 
 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).
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