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HHS/FDA RIN: 0910-AH21 Publication ID: Fall 2015 
Title: Revocation of the General Safety Test Regulations That Are Duplicative of Requirements in Biologic License Applications 
Abstract:

The Food and Drug Administration (FDA) is amending its regulations by removing the general safety test (GST) requirements for biological products. FDA is taking this action because these regulations are duplicative and obsolete.

 
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 
CFR Citation: 21 CFR 610.11    21 CFR 610.11a    21 CFR 680.3   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 351    21 U.S.C. 352    21 U.S.C. 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 360c    21 U.S.C. 360d    21 U.S.C. 360h    21 U.S.C. 360i    21 U.S.C. 371    21 U.S.C. 372    21 U.S.C. 374    21 U.S.C. 381    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   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/22/2014  79 FR 49727   
NPRM Comment Period End  11/20/2014 
Final Action  07/02/2015  80 FR 37971   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Lori Jo Churchyard
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Building 71, Room 7301,
Silver Spring, MD 20993
Phone:240 402-7911
Email: lori.olsenchurchyard@fda.hhs.gov