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HHS/FDA RIN: 0910-AH21 Publication ID: Fall 2014 
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 proposing to amend 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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 610.11    21 CFR 610.11a    21 CFR 680.3   
Legal Authority: 21 USC 321    21 USC 331    21 USC 351    21 USC 352    21 USC 353    21 USC 355    21 USC 360    21 USC 360c    21 USC 360d    21 USC 360h    21 USC 360i    21 USC 371    21 USC 372    21 USC 374    21 USC 381    42 USC 216    42 USC 262    42 USC 263    42 USC 263a    42 USC 264   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/22/2014  79 FR 49727   
NPRM Comment Period End  11/20/2014 
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