The U.S. Congress established the Organ Procurement and Transplantation Network (OPTN) when it enacted the National Organ Transplant Act (NOTA) of 1984. The act called for a unified transplant network to be operated by a private, non-profit organization under federal contract.

Following further study and recommendations from a task force commissioned through NOTA, the U.S. Department of Health and Human Services (HHS) solicited proposals in 1986 for the operation of the OPTN.

The United Network for Organ Sharing (UNOS) was awarded the initial OPTN contract on September 30, 1986, and has continued to administer the OPTN more than 16 years and four successive contract renewals.

Effective March 16, 2000, HHS implemented a Final Rule establishing a regulatory framework for the structure and operations of the OPTN. Under the terms of the Final Rule, policies intended to be binding upon OPTN members are developed through the OPTN committees and Board of Directors and then submitted to the Secretary of HHS for final approval.

For more information on the Final Rule, please see the Federal Registration Notice for the OPTN. (Requires Adobe Acrobat Reader.)