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HHS/FDA RIN: 0910-AH49 Publication ID: Spring 2018 
Title: 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 FDA is taking this action to remove outdated requirements and allow inspection frequency based on risk.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 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: Completed Actions 
Major: No  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 to 263a    42 U.S.C. 264    42 U.S.C. 300aa-25    21 U.S.C. 321    21 U.S.C. 351 to 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
Action Date FR Cite
Direct Final Rule  01/26/2018  83 FR 3586   
Direct Final Rule Comment Period End  04/11/2018 
Direct Final Rule Effective  06/11/2018 
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