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Ophthalmic and Topical Dosage Form New Animal Drugs; Chlorhexidine

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.


Final rule.


The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADA provides for a revised food safety warning on labeling for chlorhexidine ointment.


This rule is effective January 4, 2007.

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Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:

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Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 9-782 for NOLVASAN (chlorhexidine acetate) Antiseptic Ointment, approved as a topical antiseptic for superficial wounds of dogs, cats, and horses. The supplemental NADA provides for a revised food safety warning on labeling. The supplemental application is approved as of November 28, 2006, and the regulations are amended in 21 CFR 524.402 to reflect the approval and a current format.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data or information. Therefore, a freedom of information summary is not required.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

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List of Subjects in 21 CFR Part 524

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine,

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1. The authority citation for

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Authority: 21 U.S.C. 360b.

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2. Revise § 524.402 to read as follows:

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(a) Specifications. Each gram of ointment contains 10 milligrams chlorhexidine acetate.

(b) Sponsors. See Nos. 000856 and 058829 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs, cats, and horses—(1) Indications for use. For use as a topical antiseptic ointment for surface wounds.

(2) Limitations. Do not use in horses intended for human consumption.

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Dated: December 19, 2006.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.

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[FR Doc. E6-22514 Filed 1-3-07; 8:45 am]