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HHS/HRSA RIN: 0906-AA73 Publication ID: Spring 2009 
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: The Department of Health and Human Services, Health Resources and Services Administration, Healthcare Systems Bureau, Division of Transplantation (DOT) plans to issue a notice of proposed rulemaking to include vascularized composite allografts (VCA) to the definition of ‘organs’ for purpose of coverage under 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, or 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: Proposed 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
Timetable:
Action Date FR Cite
NPRM  12/00/2009    
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. Elizabeth Ortiz-Rios
Medical Officer
Department of Health and Human Services
Health Resources and Services Administration
Room 12C-06, 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 443-4423
Fax:301 584-6095
Email: eortiz-rios@hrsa.gov