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HHS/FDA RIN: 0910-AG94 Publication ID: Spring 2016 
Title: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 

This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs)., and biologics license application (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 314.70    21 CFR 314.97    21 CFR 314.150    21 CFR 601.12   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 352    21 U.S.C. 353    21 U.S.C. 355    21 U.S.C. 371    42 U.S.C. 262    ...   
Legal Deadline:  None
Action Date FR Cite
NPRM  11/13/2013  78 FR 67985   
NPRM Comment Period Extended  12/27/2013  78 FR 78796   
NPRM Comment Period End  01/13/2014 
NPRM Comment Period Extended End  03/13/2014 
NPRM Comment Period Reopened  02/18/2015  80 FR 8577   
NPRM Comment Period Reopened End  04/27/2015 
Final Rule  04/00/2017 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
Agency Contact:
Janice L. Weiner
Principal Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270,
Silver Spring, MD 20993-0002
Phone:301 796-3475
Fax:301 847-8440