[Federal Register Volume 71, Number 129 (Thursday, July 6, 2006)]
[Rules and Regulations]
[Page 38261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-10496]


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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.

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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 Altana Inc. The ANADA provides for 
veterinary prescription use of gentamicin sulfate, betamethasone 
valerate, clotrimazole ointment for the treatment of canine otitis 
externa.

DATES: This rule is effective July 6, 2006.

FOR FURTHER INFORMATION CONTACT: Daniel A. Benz, Center for Veterinary 
Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0223, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Altana Inc., 60 Baylis Rd., Melville, NY 
11747, filed ANADA 200-283 that provides for veterinary prescription 
use of VETRO-MAX (gentamicin sulfate, USP; betamethasone valerate, USP; 
and clotrimazole, USP, ointment) for the treatment of canine otitis 
externa associated with yeast (Malassezia pachydermatis, formerly 
Pityrosporum canis) and/or bacteria susceptible to gentamicin. Altana 
Inc.'s VETRO-MAX Otic Ointment is approved as a generic copy of 
Schering-Plough Animal Health Corp.'s OTOMAX Ointment approved under 
NADA 140-896. The ANADA is approved as of June 1, 2006, and the 
regulations are amended in 21 CFR 524.1044g 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 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, add paragraph (b)(4) to read as follows:


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

* * * * *
    (b) * * *
    (4) No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.
* * * * *

    Dated: June 22, 2006.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E6-10496 Filed 7-5-06; 8:45 am]
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