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HHS/FDA RIN: 0910-AF65 Publication ID: Fall 2005 
Title: ●Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation 
Abstract: 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). 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1271    42 CFR 121   
Legal Authority: 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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM - Companion to Direct Final Rule  12/00/2005    
Direct Final Rule  12/00/2005    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Related Agencies: Joint: HHS/HRSA; 
Agency Contact:
Paula S. McKeever
Senior Scientific Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45,
Rockville, MD 20857-0001
Phone:301 827-1520
Fax:301 443-9718
Email: paula.mckeever@fda.hhs.gov