Regulatory Counsel

0910-AH49 201704 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Removal of Time of Inspection and Duties of Inspector Regulations for Biological Products

The Food and Drug Administration is amending the general biologics regulations by removing mandatory inspection requirements for biologics. FDA is taking this action to remove outdated requirements and allow inspection frequency based on risk. This action is part of FDA’s retrospective review of its regulations and better target Agency resources.

]]> Substantive, Nonsignificant First Time Published in The Unified Agenda Final Rule Stage Undetermined No 21 CFR 600.21 21 CFR 600.22 42 U.S.C. 216 42 U.S.C. 262 42 U.S.C. 263 42 U.S.C. 263a 42 U.S.C. 264 42 U.S.C. 300aa-25 21 U.S.C. 321 21 U.S.C. 351 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 356c 21 U.S.C. 356e 21 U.S.C. 360 21 U.S.C. 360i 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 379k-l No Direct Final Rule 06/00/2017 No No None No No No No Melissa Segal Regulatory Counsel 0910 Food and Drug Administration FDA 240 402-7911 melissa.segal@fda.hhs.gov Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301, Silver Spring MD 20993