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[Federal Register Volume 65, Number 228 (Monday, November 27, 2000)]
[Rules and Regulations]
[Pages 70661-70662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30047]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs; Nitenpyram Tablets

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 
the oral use of nitenpyram tablets for the treatment of flea 
infestations in dogs, puppies, cats, and kittens that are 4 weeks of 
age and older and 2 pounds (lb) of body weight or greater.

DATES: This rule is effective November 27, 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., 3200 
Northline Ave., suite 300, Greensboro, NC 27408, filed NADA 141-175 
that provides for the over-the-counter use of CAPSTARTM 
(nitenpyram) tablets for the oral treatment of flea infestations on 
dogs,

[[Page 70662]]

puppies, cats, and kittens that are 4 weeks of age and older and 2 lb 
of body weight or greater. The NADA is approved as of October 20, 2000, 
and the regulations are amended in part 520 (21 CFR part 520) by adding 
Sec. 520.1510 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)(i) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360b(c)(2)(F)(i)), this approval 
qualifies for 5 years of marketing exclusivity beginning October 20, 
2000, because no active ingredient (including any ester or salt of the 
drug) has been previously approved in any other application filed under 
section 512(b)(1) of the act.
    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.

List of Subjects in 21 CFR Part 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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

    2. Section 520.1510 is added to read as follows:

Sec. 520.1510  Nitenpyram.

    (a) Specifications. Each tablet contains 11.4 or 57 milligrams of 
nitenpyram.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--Dogs and cats--(1) Amount. One tablet given 
orally, as needed.
    (2) Indications for use. For the treatment of flea infestations on 
dogs, puppies, cats, and kittens 4 weeks of age and older and 2 pounds 
of body weight or greater.

    Dated: November 8, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-30047 Filed 11-24-00; 8:45 am]
BILLING CODE 4160-01-F
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