E6-22514. Ophthalmic and Topical Dosage Form New Animal Drugs; Chlorhexidine

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

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.

DATES:

This rule is effective January 4, 2007.

FOR FURTHER INFORMATION CONTACT:

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

SUPPLEMENTARY INFORMATION:

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.

List of Subjects in 21 CFR Part 524

• Animal drugs

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, 21 CFR part 524 is amended as follows:

PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 524 continues to read as follows:

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

2. Revise § 524.402 to read as follows:

§ 524.402

Chlorhexidine.

(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.

Dated: December 19, 2006.

Steven D. Vaughn,

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