Health Resources and Services Administration May 12, 2006 – Federal Register Recent Federal Regulation Documents

Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Companion Document to Direct Final Rule
Document Number: 06-4370
Type: Proposed Rule
Date: 2006-05-12
Agency: Food and Drug Administration, Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) and the Food and Drug Administration (FDA) are proposing to amend 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 will be governed by the regulations pertaining to organs. The regulation of other recovered blood vessels would remain 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). This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. We are taking this action because the proposed changes are noncontroversial, and we do not anticipate any significant adverse comments. 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.
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
Document Number: 06-4369
Type: Rule
Date: 2006-05-12
Agency: Food and Drug Administration, Department of Health and Human Services, Health Resources and Services Administration
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.