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HHS/FDA RIN: 0910-AF74 Publication ID: Fall 2007 
Title: Over-the-Counter Drug Products Containing Analgesic/Antipyretic Active Ingredients for Internal Use: Required Alcohol Warning(Section 610 Review) 
Abstract: Section 201.322 describes a regulation that requires an alcohol warning for all over-the-counter (OTC) drug products, labeled for adult use, containing internal analgesic/antipyretic active ingredients. The required warning statements advise consumers with a history of heavy alcohol use to consult a physician for advice about the use of OTC internal analgesic/antipyretic drug products. FDA issued the final rule after considering comments on the Agency’s proposed regulation for OTC internal analgesic, antipyretic, and antirheumatic drug products: A proposed regulation to establish an alcohol warning, recommendations from its Nonprescription Drugs Advisory Committee (NDAC) and Arthritis Drugs Advisory Committee (ADAC), and data submitted to the agency. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in section 201.322. The purpose of this review is to determine whether the regulation in section 201.322 should be continued without change, or whether it should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA proposed to remove section 201.322 in the Federal Register on December 26, 2006 (71 FR 77314). FDA will consider the comments received in response to that proposal and, in addition, is soliciting comments on the following: (1) The continued need for the regulation in section 201.322; (2) the nature of the complaints or comments received concerning the regulation in section 201.322; (3) the complexity of the regulation in section 201.322; (4) the extent to which the regulation in section 201.322 overlaps, duplicates, or conflicts with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed for the products still subject to the labeling regulation in section 201.322. The section 610 review has been carried out along with a regulatory review under section 5 of Executive Order 12866, which calls for agencies to periodically review existing regulations to determine whether any should be modified or eliminated so as to make the Agency’s regulatory program more effective in achieving its goals, less burdensome, or in greater alignment with the President’s priorities and the principles set forth in the Executive order. This review concluded with the publication of proposed amendment of the tentative final monograph; required warnings and other labeling. 71 FR 77314 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 21 CFR 201.322   
Legal Authority: 5 USC 610   
Legal Deadline:  None
Action Date FR Cite
Begin Review of Current Regulation  12/01/2006    
End Review  12/26/2006    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Local, State 
Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Walter J. Ellenberg
Regulatory Project Management Officer
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:301 796-2090
Fax:301 796-9899

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