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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
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 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