[Federal Register Volume 72, Number 2 (Thursday, January 4, 2007)]
[Rules and Regulations]
[Pages 264-265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-22514]


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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

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 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: 
[email protected].

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.

[[Page 265]]


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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, 21 CFR part 524 is 
amended as follows:

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

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2. Revise Sec.  524.402 to read as follows:


Sec.  524.402   Chlorhexidine.

    (a) Specifications. Each gram of ointment contains 10 milligrams 
chlorhexidine acetate.
    (b) Sponsors. See Nos. 000856 and 058829 in Sec.  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.
[FR Doc. E6-22514 Filed 1-3-07; 8:45 am]
BILLING CODE 4160-01-S