Health Resources and Services Administration March 12, 2007 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E7-4412
Type: Notice
Date: 2007-03-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E7-4411
Type: Notice
Date: 2007-03-12
Agency: Department of Health and Human Services, Health Resources and Services Administration
Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
Document Number: 07-1131
Type: Rule
Date: 2007-03-12
Agency: Food and Drug Administration, Department of Health and Human Services, Health Resources and Services Administration
The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are amending their regulations to include 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, or cellular or tissue- based products (HCT/Ps) (FDA regulation). The purpose of this final rule is to amend the regulations so that blood vessels recovered with organs and intended for use in organ transplantation, and labeled as such, are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We (HRSA and FDA) believe that this change will eliminate the 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).
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