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HHS/FDA RIN: 0910-AF75 Publication ID: Fall 2007 
Title: Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients(Section 610 Review) 
Abstract: Section 310.545 (21 CFR part 310.545) codifies a final rule that was issued stating certain first aid antiseptic, vaginal contraceptive, and antimicrobial diaper rash ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective and are misbranded. This rule took into consideration the reports and recommendations of various OTC drug advisory review panels and public comment on proposed Agency regulations. Based on the absence of substantive comments in opposition to the Agency’s proposed nonmonograph status for various ingredients, as well as the failure of interested parties to submit new data or information to FDA, the Agency determined that the presence of the subject ingredients in an OTC drug product would result in that product not being generally recognized as safe and effective and would result in misbranding. FDA is initiating a review under section 610 of the Regulatory Flexibility Act for the regulation in section 310.545. The purpose of this review is to determine whether the regulation in section 310.545 should be continued without change, or whether it should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities.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 will consider, and is soliciting comments on the following: (1) The continued need for the regulation in section 310.545; (2) the nature of the complaints or comments received concerning the regulation in section 310.545; (3) the complexity of the regulations in section 310.545; (4) the extent to which the regulation in section 310.545 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 regulation in section 310.545. The section 610 review will be 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: Undetermined  Unfunded Mandates: No 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 21 CFR 310.545 
Legal Authority: 5 USC 610 
Legal Deadline:  None
Timetable:
Action Date FR Cite
Begin Review of Current Regulation  12/01/2006   
End Review  12/00/2007   
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
Email: walter.ellenberg@fda.hhs.gov

 
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