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HHS/FDA

RIN: 0910-AG94

Publication ID: Spring 2016

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 application (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.
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 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 352 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 371 42 U.S.C. 262 ...

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	11/13/2013	78 FR 67985
NPRM Comment Period Extended	12/27/2013	78 FR 78796
NPRM Comment Period End	01/13/2014
NPRM Comment Period Extended End	03/13/2014
NPRM Comment Period Reopened	02/18/2015	80 FR 8577
NPRM Comment Period Reopened End	04/27/2015
Final Rule	04/00/2017

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 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