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HHS/FDA | RIN: 0910-AF65 | Publication ID: Spring 2006 |
Title: Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation | |
Abstract: FDA and Health Resources and Services Administration (HRSA) are issuing a direct final rule and companion proposed rule to amend the regulations to consider as part of an organ (and regulated by HRSA) those blood vessels recovered with vascularized human organs that are intended for use in organ transplantation; and to exclude such blood vessels from the definition of human cells, tissues, and cellular and tissue-based products (regulated by FDA). We 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. We believe this change will eliminate unnecessary burden resulting from an organ procurement organizations efforts to comply with both FDA and HRSA requirements with respect to vascular tissue (FDA jurisdiction) and organs (HRSA jurisdiction). | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 21 CFR 1271 42 CFR 121 | |
Legal Authority: 42 USC 216 42 USC 243 42 USC 263a 42 USC 264 42 USC 271 42 USC 273 to 274d 42 USC 1302 42 USC 1306 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
Related Agencies: Joint: HHS/HRSA; | |
Agency Contact: Paula S. McKeever Senior Scientific Policy Analyst Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45, Rockville, MD 20857-0001 Phone:301 827-1520 Fax:301 443-9718 Email: paula.mckeever@fda.hhs.gov |