Fed Regist. 2006 May 12;71(92):27606-10.
The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are amending their regulations to consider as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products (HCT/Ps) (FDA regulation). We (HRSA and FDA) are taking this action to provide that blood vessels recovered with organs and intended for use in organ transplantation are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We believe that this change will eliminate the unnecessary burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). We are issuing these amendments directly as a final rule because they are noncontroversial, and there is little likelihood that we will receive any significant adverse comments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule under our usual procedures for notice and comment in the event that we receive any significant adverse comments on the direct final rule. If we receive any significant adverse comments that warrant terminating the direct final rule, we will consider such comments on the proposed rule in developing the final rule.
卫生资源与服务管理局（HRSA）和食品药品监督管理局（FDA）正在修订其法规，将与器官一同回收且拟用于器官移植的血管视为器官的一部分（HRSA法规）；并将此类血管排除在人类细胞、组织及基于细胞和组织的产品（HCT/Ps）的定义范围之外（FDA法规）。我们（HRSA和FDA）采取这一行动是为了规定，与器官一同回收且拟用于器官移植的血管受有关器官的法规管辖。对其他回收血管的监管保持不变。我们认为，这一变化将消除器官采购组织在遵守FDA和HRSA关于血管（FDA管辖）和器官（HRSA管辖）的规则方面所付出努力带来的不必要负担。我们直接将这些修订作为最终规则发布，因为它们没有争议，而且我们不太可能收到任何重大负面意见。在本期《联邦公报》的其他地方，我们正在按照我们通常的通知和评论程序发布一项配套的拟议规则，以防我们收到对直接最终规则的任何重大负面意见。如果我们收到任何足以终止直接最终规则的重大负面意见，我们将在制定最终规则时考虑对拟议规则的此类意见。
