[Federal Register Volume 67, Number 39 (Wednesday, February 27, 2002)]
[Rules and Regulations]
[Page 8860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4595]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524


Ophthalmic and Topical Dosage Form New Animal Drugs; 
Chlorhexidine Ointment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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:


Sec. 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 Sec. 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.
[FR Doc. 02-4595 Filed 2-26-02; 8:45 am]
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