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HHS/FDA | RIN: 0910-AI41 | Publication ID: Fall 2019 |
Title: ●Human Tissue Intended For Transplantation | |
Abstract:
The regulations under 21 CFR part 1270 for Human Tissue Intended For Transplantation apply to certain tissues recovered prior to May 25, 2005. We do not believe there are currently any tissues intended for transplantation remaining in inventory that were recovered prior to this date and that would be subject to these regulations. Therefore, the regulations under this part are outdated and obsolete. All Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) recovered after May 25, 2005, are subject to the regulations under 21 CFR part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Therefore, FDA is proposing to revoke 21 CFR part 1270. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
CFR Citation: 21 CFR 1270 | |
Legal Authority: 42 U.S.C. 216 42 U.S.C. 243 42 U.S.C. 264 42 U.S.C. 271 |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: Undetermined | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Shruti Modi Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Silver Spring, MD 20993 Phone:240 402-7911 Email: shruti.modi@fda.hhs.gov |