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HHS/FDA RIN: 0910-AI27 Publication ID: Fall 2018 
Title: ●Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products 
Abstract:

FDA 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  FDA is taking this action to remove outdated requirements and allow inspection frequency based on risk.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 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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Deregulatory 
CFR Citation: 21 CFR 600   
Legal Authority: 42 U.S.C. 216    42 U.S.C. 262 to 264    42 U.S.C. 300    21 U.S.C. 321    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 356    21 U.S.C. 360    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 379   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  01/26/2018  83 FR 3631   
NPRM Comment Period End  04/11/2018 
Final Action  03/00/2019 
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 
Related RINs: Previously reported as 0910-AH49 
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