Proposal overview
Status: Implemented
Sponsoring Committee: Vascularized Composite Allograft (VCA) Transplantation
Strategic Goal: Promote the efficient management of the OPTN
Effective date: September 1, 2018
Clarifications of Policies and Bylaws Mini brief (PDF - 946 KB)
Combined policy notice for VCA Membership Requirements (PDF - 637 KB) (2020)
Policy notice 1 (PDF - 75 KB) Target implementation date: December 2021
Policy notice 2 (PDF - 55 KB) Effective date: September 1, 2018
Problem statement
The Organ Procurement and Transplantation Network (OPTN) Final Rule1 requires the OPTN to implement policies related to VCAs and identify all covered body parts in any policies specific to VCAs. Current OPTN/UNOS Bylaws and Policies do not consistently specify these covered body parts. This proposal contains a list of covered body parts to include in OPTN/UNOS Bylaws and Policies in order to meet the requirements of the Final Rule.
The list of covered body parts is not an endorsement of research on a new type of organ transplant by the U.S. Department of Health and Human Services or the OPTN. The intent of these modifications is to make the OPTN/UNOS Bylaws and Policies consistent with the federal regulation, to provide transparency in what body parts are considered VCAs, and to define the scope of oversight by the OPTN.
- CFR §121.4(e)(3), https://www.ecfr.gov/current/title-42/chapter-I/subchapter-K/part-121
Background
This proposal was approved by the board at its June 2016 meeting, and is pending implementation.
Board briefing paper (PDF - 425 KB) (6/2016)
Public comment proposal (PDF - 353 KB)
Comments
The comment period for this proposal is now closed.