[Federal Register Volume 70, Number 33 (Friday, February 18, 2005)]
[Rules and Regulations]
[Pages 8290-8291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3179]


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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; 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 abbreviated new 
animal drug application (ANADA) filed by Phoenix Scientific, Inc. The 
supplemental ANADA provides for a new container size, a 20-gram dropper 
bottle, from which gentamicin sulfate, betamethasone valerate, 
clotrimazole ointment may be administered for the treatment of acute 
and chronic canine otitis externa. The regulations are also being 
amended to correct the indications for use to agree with approved 
product labeling. This action is being taken to improve the accuracy of 
the regulations.

DATES: This rule is effective February 18, 2005.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV 104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
St. Ter., St. Joseph, MO 64503, filed a supplement to ANADA 200-287 for 
use of TRIPLEMAX (gentamicin sulfate, U.S.P.; betamethasone valerate, 
U.S.P.; and clotrimazole, U.S.P. ointment) for the treatment of acute 
and chronic canine otitis externa. The supplement provides for a new 
container size, a 20-gram dropper bottle. The supplemental ANADA is 
approved as of January 21, 2005, 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.
    The regulations are also being amended to correct the indications 
for use to agree with approved product labeling. 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

[[Page 8291]]

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 Subject 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

0
1. The authority citation for 21 CFR part 524 continues to read as 
follows:

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

0
2. Section 524.1044g is amended by revising paragraphs (b)(3), 
(c)(1)(ii), and (c)(2) to read as follows.


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

* * * * *
    (b) * * *
    (3) No. 059130 for use of 10-, 20-, or 215-g bottles.
    (c) * * *
    (1) * * *
    (ii) From 20- or 215-g bottles: 2 drops for dogs weighing less than 
30 lb or 4 drops for dogs weighing 30 lb or more.
    (2) Indications for use. For the treatment of acute and chronic 
canine otitis externa associated with yeast (Malassezia pachydermatis, 
formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
* * * * *

    Dated: February 8, 2005.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 05-3179 Filed 2-17-05; 8:45 am]
BILLING CODE 4160-01-S