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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 
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, WO 51, Room 6268, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: janice.weiner@fda.hhs.gov

 
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