Department of Health and Human Services March 3, 2008 – Federal Register Recent Federal Regulation Documents

HRSA, Healthcare Systems Bureau, Division of Transplantation (DoT) is in the process of information- gathering to assist in determining whether it should engage in rulemaking with respect to vascularized composite allografts, described more fully below. The purpose of this solicitation is to receive feedback from stakeholders and the public on the following questions: (1) Whether vascularized composite allografts should be included within the definition of organs covered by the regulations governing the operation of the Organ Procurement and Transplantation Network (OPTN) (referred to here as the ``final rule''), and regulated as such, and the likely impact of such an amendment; (2) whether vascularized composite allografts should be added to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended, (NOTA) and the likely impact of such an addition; and (3) if either of these changes are pursued, the optimal way to define vascularized composite allografts for the above-described purposes. This Request for Information is limited to information-gathering and is not a proposal to make any determinations regarding Federal oversight of vascularized composite allografts.