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HHS/FDA RIN: 0910-AG12 Publication ID: Spring 2018 
Title: Over-the-Counter (OTC) Drug Review--Pediatric Dosing for Cough/Cold Products 
Abstract:

The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. This action will propose changes to the final monograph to address safety and efficacy issues associated with pediatric cough and cold products.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: No  Unfunded Mandates: Private Sector 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 201    21 CFR 310    21 CFR 330 to 358   
Legal Authority: 21 U.S.C. 331    21 U.S.C. 351 to 353    21 U.S.C. 355    21 U.S.C. 360    21 U.S.C. 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  To Be Determined 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Local, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Related RINs: Related to 0910-AF31, Related to 0910-AF32, Related to 0910-AF33, Related to 0910-AF34 
Agency Contact:
Janice Adams-King
Regulatory Health Project Manager
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3713
Fax:301 796-9899
Email: janice.adams-king@fda.hhs.gov