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HHS/FDA RIN: 0910-AF97 Publication ID: Spring 2014 
Title: Abbreviated New Drug Applications and 505(b)(2) 
Abstract: This proposed rule would make changes to certain procedures for Abbreviated New Drug Applications and related applications to patent certifications, 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: No  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 to 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  05/00/2014 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
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
Email: janice.weiner@fda.hhs.gov