“A bill to regulate human cadaveric islets for transplantation as organs.”
No CRS summary available for this bill.
This section includes human cadaveric islets alongside pancreas in organ procurement organization requirements by amending Section 374(d)(2) of the Public Health Service Act. (Human cadaveric islets are pancreatic cell clusters from deceased donors transplanted to treat type 1 diabetes.) It clarifies that human cadaveric islets are not included in the definitions of (1) drug under the Federal Food, Drug, and Cosmetic Act, (2) biological product under the Public Health Service Act, or (3) human cells, tissues, or cellular or tissue-based products (HCT/Ps) under FDA regulations. (Thus, such islets are excluded from FDA drug, biologic, and tissue establishment and product regulations.) Directs the Secretary of Health and Human Services to update regulations under parts F, G, and H of title III of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, among others, within one year of enactment to implement the amendment; requires a progress report to Congress within six months of enactment.