The ISLET Act would change federal rules so that human cadaveric islets used for transplantation are treated as organs. It amends section 374(d)(2) of the Public Health Service Act to add "human cadaveric islets" alongside the pancreas. The bill also says that human cadaveric islets are not "drugs," not "biological products," and not "HCT/Ps" (human cells, tissues, or cellular or tissue-based products) as those terms are defined in existing law and regulations. The Secretary of Health and Human Services must update related regulations under parts F, G, and H of title III of the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act within 1 year after enactment. The Secretary must report to Congress on progress updating those regulations within 6 months. The measure was introduced in the House and referred to the Committee on Energy and Commerce.
This bill changes how human cadaveric islets are classified under federal law: they would be treated as organs rather than as drugs, biological products, or HCT/Ps. That changes which federal rules apply and which parts of HHS oversee them. The Department of Health and Human Services must revise its regulations within a year and tell Congress about its progress within six months.
No publicly available information on costs. The bill requires HHS to update regulations within 1 year and to report in 6 months, but it does not include any cost estimates or budget details.
No publicly available information.
No publicly available information.