“To regulate human cadaveric islets for transplantation as organs.”
No CRS summary available for this bill.
This section amends Section 374(d)(2) of the Public Health Service Act to include human cadaveric islets alongside pancreas in provisions governing organ procurement and transplantation. It clarifies, notwithstanding any other provision of law, that human cadaveric islets are excluded from the definitions of (1) drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act, (2) biological product under section 351(i) of the Public Health Service Act, and (3) human cells, tissues, or cellular or tissue-based products (HCT/Ps) under FDA regulations at 21 CFR 1271.3. (Thus, oversight shifts from FDA drug, biologic, or HCT/P regulation to the organ transplantation framework.) The section further directs the Secretary of Health and Human Services to update relevant regulations within one year of enactment and to report to Congress on progress within six months of enactment.