[Federal Register Volume 71, Number 188 (Thursday, September 28, 2006)]
[Rules and Regulations]
[Pages 56867-56868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15888]


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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; Gentamicin 
Sulfate, Betamethasone Valerate, Clotrimazole Ointment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental abbreviated new 
animal drug application (ANADA) filed by IVX Animal Health, Inc. The 
supplemental ANADA provides for a new container size, a 40-gram dropper 
bottle, from which gentamicin sulfate, betamethasone valerate, 
clotrimazole ointment may be administered for the treatment of acute 
and chronic canine otitis externa.

DATES: This rule is effective September 28, 2006.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-287 
for use of TRIPLEMAX (gentamicin sulfate, USP; betamethasone valerate, 
USP; and clotrimazole, USP ointment) for the treatment of acute and 
chronic canine otitis externa. The supplemental ANADA provides for a 
new container size, a 40-gram dropper bottle. The supplemental ANADA is 
approved as of August 23, 2006, and the regulations are amended in 21 
CFR 524.1044g to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 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 Division of Dockets Management 
(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.

0
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. In Sec.  524.1044g, revise paragraph (b)(3), paragraph (c)(1) 
introductory text, and paragraph (c)(1)(ii) to read as follows:


Sec.  524.1044g  Gentamicin sulfate, betamethasone valerate, 
clotrimazole ointment.

* * * * *
    (b) * * *
    (3) No. 059130 for use of 10-, 20-, 40-, or 215-g bottles.
    (c) * * *
    (1) Amount. Instill ointment twice daily into the ear canal for 7 
consecutive days.
* * * * *
    (ii) From 20-, 40-, or 215-g bottles: 2 drops for dogs weighing 
less than 30 lb or 4 drops for dogs weighing 30 lb or more.
* * * * *


[[Page 56868]]


    Dated: September 15, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-15888 Filed 9-27-06; 8:45 am]
BILLING CODE 4160-01-S