02-4595. Ophthalmic and Topical Dosage Form New Animal Drugs; Chlorhexidine Ointment

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 an abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for topical use of chlorhexidine ointment for surface wounds on dogs, cats, and horses.

DATES:

This rule is effective February 27, 2002.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION:

First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123, filed ANADA 200-301 for PRIVASAN (chlorhexidine acetate) Antiseptic Ointment. The application provides for topical use of a 1-percent chlorhexidine acetate ointment for surface wounds on dogs, cats, and horses. First Priority's PRIVASAN Antiseptic Ointment is approved as a generic copy of Ft. Dodge Animal Health's NOLVASAN Antiseptic Ointment, approved under NADA 9-872. ANADA 200-301 is approved as of November 6, 2001, and 21 CFR 524.402 is amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

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. Section 524.402 is revised to read as follows:

§ 524.402

Chlorhexidine ointment.

(a) Specifications. The product contains 1-percent chlorhexidine acetate in an ointment base.

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

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

(2) Limitations. Not for use in horses intended for food.

Dated: January 30, 2002.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.