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HHS/FDA RIN: 0910-AG94 Publication ID: Spring 2014 
Title: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 
Abstract: This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (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. This rule would describe the process by which information regarding "changes being effected" (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA's review of the labeling 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 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 314.70    21 CFR 314.97    21 CFR 314.150    21 CFR 601.12   
Legal Authority: 21 USC 321    21 USC 331    21 USC 352    21 USC 353    21 USC 355    21 USC 371    42 USC 262    ...   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  11/13/2013  78 FR 67985   
NPRM Comment Period End  01/13/2014 
Final Rule  12/00/2014 
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
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Building 51, Room 6270, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3475
Fax:301 847-8440
Email: janice.weiner@fda.hhs.gov