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HHS/FDA | RIN: 0910-AF65 | Publication ID: Fall 2006 |
Title: Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation | |
Abstract: FDA and Health Resources and Services Administration (HRSA) issued 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 took 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 blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction). We received significant adverse comments in response to the direct final rule. Therefore, the direct final rule is being withdrawn. FDA and HRSA intend to finalize the proposed rule after considering comments. | |
Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final 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: Denise Sanchez Regulatory Policy Analyst Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research (HFM-17), 1401 Rockville Pike, Rockville, MD 20852-1448 Phone:301 827-6210 Fax:301 827-9434 |