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HHS/FDA RIN: 0910-AF97 Publication ID: Fall 2016 
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, 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: Completed Actions 
Major: No  Unfunded Mandates: No 
EO 13771 Designation:  
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: Pub. L. 108-173, title XI    21 U.S.C. 355    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  02/06/2015  80 FR 6802   
NPRM Comment Period End  05/07/2015 
NPRM Comment Period Extended  04/24/2015  80 FR 22953   
NPRM Comment Period Extended End  06/08/2015 
Final Action  10/16/2016  81 FR 69580   
Final Action Effective  12/05/2016 
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
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, Building 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