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HHS/FDA RIN: 0910-AF97 Publication ID: Spring 2013 
Title: Abbreviated New Drug Applications and 505(b)(2) Applications 
Abstract: This proposed rule would make changes to certain procedures for Abbreviated New Drug Applications and 505(b)(2) applications relating to patent certifications, provision of notice to patent owners and application holders, the availability of a 30-month stay of approval, amendments and supplements and the types of bioavailability and bioequivalence data that can be used to support these applications. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
CFR Citation: 21 CFR 314.3; 21 CFR 314.50; 21 CFR 314.52; 21 CFR 314.53; 21 CFR 314.54; 21 CFR 314.60; 21 CFR 314.70; 21 CFR 314.90; 21 CFR 314.93; 21 CFR 314.94; 21 CFR 314.95; 21 CFR 314.96; 21 CFR 314.97; 21 CFR 314.99; 21 CFR 314.101; 21 CFR 314.105; 21 CFR 314.107; 21 CFR 314.108; 21 CFR 314.125; 21 CFR 314.127; 21 CFR 320.1; 21 CFR 320.23 
Legal Authority: PL 108-173, title XI; 21 USC 355; 21 USC 371 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/00/2013   
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
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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