[Federal Register Volume 71, Number 63 (Monday, April 3, 2006)]
[Rules and Regulations]
[Page 16481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3149]


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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 Med-Pharmex, Inc. The 
supplemental ANADA provides for a new container size, a 15-gram bottle, 
from which gentamicin sulfate, betamethasone valerate, clotrimazole 
ointment may be dispensed for the treatment of acute and chronic canine 
otitis externa.

DATES: This rule is effective April 3, 2006.

FOR FURTHER INFORMATION CONTACT: Christopher Melluso, 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: Med-Pharmex, Inc., 2727 Thompson Creek Rd., 
Pomona, CA 91767-1861, filed a supplement to ANADA 200-229 that 
provides for use of TRI-OTIC (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. 
The supplement provides for a new container size, a 15-gram bottle. The 
supplemental ANADA is approved as of February 27, 2006, and the 
regulations are amended in Sec.  524.1044g (21 CFR 524.1044g) to 
reflect the approval. The basis of approval is discussed in the freedom 
of information summary.
    In addition, FDA has noticed that a 215-gram bottle size was 
approved for this product under ANADA 200-229 but not codified. At this 
time, that bottle size is being added to Sec.  524.1044g. This action 
is being taken to improve the accuracy of the regulations.
    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 paragraphs (b)(2) and (c)(1)(i) to read 
as follows:


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

* * * * *
    (b) * * *
    (2) No. 054925 for use of 7.5- or 15-g tubes; 10-, 15-, 25-, or 
215-g bottles.
* * * * *
    (c) * * *
    (1) * * *
    (i) From 7.5- or 15-g tubes; 10-, 12.5-, 15-, 25-, or 30-g bottles: 
4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs 
weighing 30 lb or more.
* * * * *

    Dated: March 24, 2006.
Bernadette A. Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 06-3149 Filed 3-31-06; 8:45 am]
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