0906-AA73 201110 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0906 Health Resources and Services Administration HRSA 0900 Department of Health and Human Services HHS Add Vascularized Composite Allografts to the Definition of Organs Covered by the Rule Governing the Operation of the Organ Procurement and Transplantation Network (OPTN) 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. Other Significant Previously Published in The Unified Agenda Proposed Rule Stage No No 42 CFR 121 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 No NPRM 12/16/2011 76 FR 78216 NPRM Comment Period End 02/14/2012 No No None No No James Bowman Dr. 0906 Health Resources and Services Administration HRSA 301 443-4861 5600 Fishers Lane, Room 12C-06, Rockville MD 20857