0910-AF65 200604 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation FDA and Health Resources and Services Administration (HRSA) are issuing a direct final rule and companion proposed rule to amend the regulations to consider as part of an organ (and regulated by HRSA) those blood vessels recovered with vascularized human organs that are intended for use in organ transplantation; and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products (regulated by FDA). We are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation will be governed by the regulations pertaining to organs. We believe this change will eliminate unnecessary burden resulting from an organ procurement organization’s efforts to comply with both FDA and HRSA requirements with respect to vascular tissue (FDA jurisdiction) and organs (HRSA jurisdiction). Substantive, Nonsignificant Previously Published in The Unified Agenda Proposed Rule Stage No No 21 CFR 1271 42 CFR 121 42 USC 216 42 USC 243 42 USC 263a 42 USC 264 42 USC 271 42 USC 273 to 274d 42 USC 1302 42 USC 1306 No NPRM - Companion to Direct Final Rule 06/00/2006 Direct Final Rule 06/00/2006 No None NA Not Collected 0906 Health Resources and Services Administration HRSA Joint Paula McKeever S. 0910 Food and Drug Administration FDA 301 827-1520 301 443-9718 paula.mckeever@fda.hhs.gov Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45, Rockville MD 20857-0001