Fed Regist. 2013 Jul 3;78(128):40033-42.
: HHS is issuing this final rule (herein referred to as this rule'') to add vascularized composite allografts (VCAs) as specified herein to the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network (OPTN) (herein referred to as the OPTN final rule). When it enacted the National Organ Transplant Act in 1984, Congress included a definition of the term organ and authorized the Secretary to expand this definition by regulation. The Secretary has previously exercised this authority and expanded the statutory definition of organ. Prior to this rule, the OPTN final rule defined covered organs as a human kidney, liver, heart, lung, or pancreas, or intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract). Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this part if the vessels are intended for use in organ transplantation and labeled `For use in organ transplantation only.' '' This rule also includes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended (NOTA).
美国卫生与公众服务部发布本最终规则（以下简称“本规则”），将本文所述的血管化复合异体移植组织（VCA）纳入器官获取与移植网络（OPTN）运营规则所涵盖器官的定义中（以下简称“OPTN最终规则”）。1984年国会颁布《全国器官移植法》时，对“器官”一词进行了定义，并授权部长通过法规扩大这一定义。部长此前已行使该权力，扩大了器官的法定定义。在本规则发布之前，OPTN最终规则将涵盖的器官定义为“人的肾脏、肝脏、心脏、肺、胰腺或肠（包括食管、胃、小肠和/或大肠，或胃肠道的任何部分）。在器官获取过程中从器官捐献者身上获取的血管，如果这些血管 intended for use in organ transplantation 且标有‘仅用于器官移植’，则在本部分中视为与获取它们的器官的一部分。”本规则还对经修订的1984年《全国器官移植法》（NOTA）第301节所涵盖的人体器官定义进行了相应修改。 （注：原文中“intended for use in organ transplantation”表述不太完整准确，推测可能是“intended to be used in organ transplantation”之类的，但按要求未做修改。）
