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HHS/FDA RIN: 0910-AF31 Publication ID: 2012 
Title: Over-the-Counter (OTC) Drug Review--Cough/Cold (Antihistamine) Products 
Abstract: FDA will be proposing a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients. This proposed rule is the result of collaboration under the U.S.-Canada Regulatory Cooperation Council (RCC). The objectives of the RCC monograph alignment working group are to conduct a pilot program to develop aligned monograph elements for a selected over-the-counter (OTC) drug category (e.g., aligned directions, warnings, indications, and conditions of use) and subsequently, develop recommendations to determine the feasibility of an ongoing mechanism for alignment in review and adoption of these OTC drug monograph elements. 
Agency: Department of Health and Human Services(HHS)  Priority: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201    21 CFR 310    21 CFR 330 to 358   
Legal Authority: 21 USC 321p    21 USC 331    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Reopening of Administrative Record  08/25/2000  65 FR 51780   
Comment Period End  11/24/2000    
NPRM (Amendment) (Common Cold)  06/00/2013 
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: Split from 0910-AA01 
Agency Contact:
Mary Chung
Regulatory Health Project Manager
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 22, Room 5488, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-0260
Fax:301 796-9899
Email: mary.chung@fda.hhs.gov