[Federal Register Volume 70, Number 120 (Thursday, June 23, 2005)]
[Rules and Regulations]
[Page 36338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12402]


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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, Mometasone Furoate, Clotrimazole Otic Suspension; Technical 
Amendment

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 new animal drug 
application (NADA) filed by Schering-Plough Animal Health Corp. The 
supplemental NADA provides for a new container size, a 7.5-gram dropper 
bottle, from which gentamicin sulfate, mometasone furoate, clotrimazole 
otic suspension may be administered for the treatment of otitis externa 
in dogs. The regulations are also being amended to correct the 
description of a previously approved container size. This action is 
being taken to improve the accuracy of the regulations.

DATES: This rule is effective June 23, 2005.

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: Schering-Plough Animal Health Corp., 1095 
Morris Ave., Union, NJ 07083, filed a supplement to NADA 141-177 for 
use of MOMETAMAX (gentamicin sulfate, U.S.P.; mometasone furoate 
monohydrate; and clotrimazole, U.S.P.) Otic Suspension for the 
treatment of otitis externa in dogs. The supplement provides for a new 
container size, a 7.5-gram dropper bottle. The supplemental NADA is 
approved as of June 1, 2005, and the regulations are amended in 21 CFR 
524.1044h to reflect the approval.
    The regulations are also being amended to correct the description 
of a previously approved container size. This action is being taken to 
improve the accuracy of the regulations.
    The agency has determined under 21 CFR 25.33(a)(4) 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 Subject in 21 CFR Part 524

    Animal drugs.

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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. Section 524.1044h is amended by revising paragraphs (b) and (c)(1) 
to read as follows:


Sec.  524.1044h  Gentamicin sulfate, mometasone furoate, clotrimazole 
otic suspension.

* * * * *
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. For dogs weighing less 
than 30 pounds (lb), instill 4 drops from the 7.5-, 15-, or 30-gram (g) 
bottle into the ear canal (2 drops from the 215-g bottle) or, for dogs 
weighing 30 lb or more, instill 8 drops from the 7.5-, 15-, or 30-g 
bottle into the ear canal (4 drops from the 215-g bottle), once or 
twice daily for 7 days.
* * * * *

    Dated: June 15, 2005.
Steven D. Vaugh,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-12402 Filed 6-22-05; 8:45 am]
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