[Federal Register Volume 66, Number 46 (Thursday, March 8, 2001)]
[Rules and Regulations]
[Pages 13848-13849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5684]


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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; Milbemycin 
Oxime Solution

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 a supplemental new animal drug 
application (NADA) filed by Novartis Animal Health US, Inc. The 
supplemental NADA provides for veterinary prescription use of 
milbemycin oxime solution to treat ear mite infestations in cats and 
kittens 4 weeks of age and older and for a repeat treatment, if 
necessary.

DATES: This rule is effective March 8, 2001.

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.

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200 
Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to 
approved NADA 141-163 that provides for the veterinary prescription use 
of Milbemite \TM\ Otic Solution (0.1% milbemycin oxime) for 
the treatment of ear mite infestations in cats and kittens. The 
supplemental NADA provides for reducing the lower age limit from 8 
weeks of age to 4 weeks of age and for repeating treatment one time, if 
necessary. The NADA is approved as of December 13, 2000, and the 
regulations are amended in 21 CFR 524.1446 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 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 Dockets Management Branch (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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for nonfood-
producing animals qualifies for 3 years of marketing exclusivity 
beginning December 13, 2000, because the application contains 
substantial evidence of effectiveness of the drug involved or any 
studies of animal safety required for approval of the application and 
conducted or sponsored by the applicant.
    The agency has determined under 21 CFR 25.33(d)(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.

[[Page 13849]]

List of Subjects in 21 CFR Part 524

    Animal drugs.

    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

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

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


Sec. 524.1446  [Amended]

    2. Section 524.1446 Milbemycin oxime solution is amended in 
paragraph (c)(1) by removing ``as a single treatment'' and in paragraph 
(c)(2) in the first sentence by removing ``8'' and adding in its place 
``4''.

    Dated: January 5, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-5684 Filed 3-7-01; 8:45 am]
BILLING CODE 4160-01-S