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HHS/FDA RIN: 0910-AI41 Publication ID: Fall 2021 
Title: Revocation for the Regulation for Human Tissue Intended for Transplantation and Human Dura Mater 
Abstract:

The regulations under 21 CFR 882.5975 for Human Dura Mater and 21 CFR part 1270 for Human Tissue Intended For Transplantation apply only 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 Therefore, the regulations under this section and part are outdated and obsolete.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 revoking 21 CFR 882.5975 and 21 CFR part 1270.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 1270    21 CFR 882.5975   
Legal Authority: 42 U.S.C. 216    42 U.S.C. 243    42 U.S.C. 264    42 U.S.C. 271    21 U.S.C. 351    21 U.S.C. 360    21 U.S.C. 360(c)    21 U.S.C. 360(e)    21 U.S.C. 360(l)    21 U.S.C. 360(j)    21 U.S.C. 371    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/21/2020  85 FR 82990   
NPRM Comment Period End  03/08/2021 
Final Rule  12/00/2021 
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