Regulatory Counsel

0910-AI11 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Requirements for Determining Donor Eligibility and Donation Suitability of Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use

FDA is proposing to revise certain regulations applicable to establishments that collect blood or blood components, including blood or blood components intended solely for autologous use. The proposed rule would revise and permit limited exceptions to certain donor eligibility and donation suitability requirements. The proposed rule would provide more flexibility to accommodate advancing technology, while continuing to help ensure the safety of the nation’s blood supply and donor health.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No Not Yet Determined 42 U.S.C. 216 42 U.S.C. 262 42 U.S.C. 264 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 352 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 371 No NPRM 04/00/2024 No No None Undetermined No No Karen Fikes Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 karen.fikes@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301, Silver Spring MD 20993