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HHS/HRSA RIN: 0906-AA73 Publication ID: Spring 2013 
Title: Add Vascularized Composite Allografts to the Definition of Organs Covered by the Rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN) 
Abstract: This final rule adds vascularized composite allografts (VCA) to the definition of "organs" for purpose of coverage under the National Organ Transplant Act (NOTA) and the OPTN final rule. NOTA authorizes the Secretary to include by regulation additional organs under the definition of organ. Currently, the OPTN final rule defines covered organs as "a human kidney, liver, heart, lung, pancreas, or intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract)." VCA transplantation comprises transplants of a variety of body parts (i.e., hand and face transplants) that are not currently regulated and which share common characteristics. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 121   
Legal Authority: sec 301 of the National Organ Transplant Act (NOTA) of 1984, as amended    sec 371 to 376 of the Public Health Service Act    sec 1138 of the Social Security Act   
Legal Deadline:  None
Action Date FR Cite
NPRM  12/16/2011  76 FR 78216   
NPRM Comment Period End  02/14/2012    
Final Action  07/00/2013 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Dr. James Bowman
Medical Director, Division of Transplantation
Department of Health and Human Services
Health Resources and Services Administration
5600 Fishers Lane, Room 12C-06,
Rockville, MD 20857
Phone:301 443-4861

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