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HHS/FDA RIN: 0910-AH49 Publication ID: Fall 2017 
Title: Removal of Time of Inspection and Duties of Inspector Regulations for Biological Products 
Abstract:

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 FDA is taking this action to remove outdated requirements and allow inspection frequency based on risk.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 will better target Agency resources.

 
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: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 600.21    21 CFR 600.22   
Legal Authority: 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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Direct Final Rule  12/00/2017 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Melissa Segal
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301,
Silver Spring, MD 20993
Phone:240 402-7911
Email: melissa.segal@fda.hhs.gov