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HHS/HRSA

RIN: 0906-AA73

Publication ID: Spring 2011

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 notice of proposed rulemaking will add 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, 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  09/00/2011

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