[Federal Register Volume 65, Number 51 (Wednesday, March 15, 2000)]
[Rules and Regulations]
[Pages 13904-13905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-6284]


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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 new animal drug application 
(NADA) filed by Novartis Animal Health US, Inc. The NADA provides for 
veterinary prescription use of milbemycin oxime solution to treat ear 
mite infestations in cats and kittens 8 weeks of age and older.

DATES: This rule is effective March 15, 2000.

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., P.O. Box 
18300, Greensboro, NC 27419-8300, filed NADA 141-163 that provides for 
veterinary prescription use of MILBEMITETM Otic Solution 
(0.1 percent milbemycin oxime) for the treatment of ear mite (Otodectes 
cynotis) infestations in cats and kittens 8 weeks of age and older. 
Effectiveness is maintained throughout the life cycle of the ear mite. 
The NADA provides for use of one 0.25-milliliter tube per ear as a 
single treatment. NADA 141-163 is approved as of February 2, 2000, and 
the regulations are amended in 21 CFR part 524 by adding new 
Sec. 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)(ii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval for non-food-
producing animals qualifies for 3 years of marketing exclusivity 
beginning February 2, 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.
    FDA 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 13905]]

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.

    2. Section 524.1446 is added to read as follows:


Sec. 524.1446  Milbemycin oxime solution.

    (a) Specifications. Each tube contains 0.25 milliliter of a 0.1 
percent solution of milbemycin oxime.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. One tube administered topically 
into each external ear canal as a single treatment.
    (2) Indications for use. For the treatment of ear mite (Otodectes 
cynotis) infestations in cats and kittens 8 weeks of age and older. 
Effectiveness is maintained throughout the life cycle of the ear mite.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: March 2, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-6284 Filed 3-14-00; 8:45 am]
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