How S 3105 changes current law

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill adds human cadaveric islets to the definition of organs under the Public Health Service Act and excludes them from being classified as drugs or biological products.

• 42 U.S.C. 274b(d)(2)

  pancreas, → and pancreas, human cadaveric islets,

  This change includes human cadaveric islets as recognized organs in the regulation of transplants.

• Notwithstanding any other provision of law, none of the following terms includes human cadaveric islets: The term "drug", as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)).

  This provision clarifies that human cadaveric islets are not classified as drugs.

• Notwithstanding any other provision of law, none of the following terms includes human cadaveric islets: The term "biological product", as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).

  This provision clarifies that human cadaveric islets are not classified as biological products.

• Notwithstanding any other provision of law, none of the following terms includes human cadaveric islets: 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).

  This provision clarifies that human cadaveric islets are not classified as HCT/Ps.

• 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).

  This mandates the Secretary to update relevant regulations to ensure proper classification and regulation of human cadaveric islets.

• 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).

  This requires the Secretary to report to Congress on the progress of regulatory updates regarding human cadaveric islets.