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HHS/FDA RIN: 0910-AF65 Publication ID: Fall 2006 
Title: Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation 
Abstract: FDA and Health Resources and Services Administration (HRSA) issued 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 took 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 organizationís efforts to comply with both FDA and HRSA requirements with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). We received significant adverse comments in response to the direct final rule. Therefore, the direct final rule is being withdrawn. FDA and HRSA intend to finalize the proposed rule after considering comments. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final 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  05/12/2006  71 FR 27649 
Direct Final Rule  05/12/2006  71 FR 27606 
Comment Period End  07/26/2006   
Direct Final Rule-Withdrawal  09/14/2006  71 FR 54198 
Final Action  09/00/2007   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
Related Agencies: Joint: HHS/HRSA; 
Agency Contact:
Denise Sanchez
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike,
Rockville, MD 20852-1448
Phone:301 827-6210
Fax:301 827-9434

 
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