Section 1 Short title
This Act may be cited as the “Increase Support for Life-saving Endocrine Transplantation Act” or the “ISLET Act”.
Increase Support for Life-saving Endocrine Transplantation Act
A BILL
To regulate human cadaveric islets for transplantation as organs.
Sec. 2 Regulation of human cadaveric islet transplants
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,”.
Clarification— 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)).
The term biological product, as defined in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).
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).
Regulations—
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).
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).