[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:
john.harshman@fda.hhs.gov.
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]
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