Regulatory Counsel

0910-AI41 202104 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Revocation for the Regulation for Human Tissue Intended For Transplantation and Human Dura Mater

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 Therefore, the regulations under this section and part are outdated and obsolete.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.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage Undetermined No 21 CFR 1270 21 CFR 882.5975 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 ... No NPRM 12/21/2020 85 FR 82990 NPRM Comment Period End 03/08/2021 Final Rule 12/00/2021 Undetermined None No No No Shruti Modi Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 shruti.modi@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Silver Spring MD 20993