[Federal Register Volume 67, Number 248 (Thursday, December 26, 2002)]
[Rules and Regulations]
[Pages 78684-78685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32442]


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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; Imidacloprid 
and Ivermectin

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 Bayer Corp., Agriculture Division, Animal Health. The 
NADA provides for veterinary prescription use in dogs of an 
imidacloprid and ivermectin topical solution for the prevention of 
heartworm disease caused by Dirofilaria immitis and treatment of flea 
infestations (Ctenocephalides felis).

DATES: This rule is effective December 26, 2002.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl.,

[[Page 78685]]

Rockville, MD 20855, 301-827-7543, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Bayer Corp., Agriculture Division, Animal 
Health, P.O. Box 390, Shawnee Mission, KS 66201, filed NADA 141-208 
that provides for veterinary prescription use in dogs of ADVANTAGE DUO 
(imidacloprid and ivermectin) Topical Solution for the prevention of 
heartworm disease caused by D. immitis and treatment of flea 
infestations (C. felis). The NADA is approved as of September 27, 2002, 
and the regulations are amended by adding 21 CFR 524.1140 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 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 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 qualifies for 
3 years of marketing exclusivity beginning September 27, 2002.
    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 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 524.1140 is added to read as follows:


Sec.  524.1140  Imidacloprid and ivermectin.

    (a) Specifications. The product is available in unit applicator 
tubes containing 0.4, 1.0, 2.5, or 4.0 milliliters (mL). Each mL of 
solution contains 100 milligrams (mg) imidacloprid and 800 micrograms 
([mu]g) ivermectin.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Conditions of Use in Dogs--(1) Amount. The recommended minimum 
dosage is 4.5 mg/pound (lb) (10 mg/kilogram (kg)) of imidacloprid and 
36.4 [mu]g/lb (80 [mu]g/kg) of ivermectin, topically once a month.
    (2) Indications for Use. For the prevention of heartworm disease 
caused by Dirofilaria immitis; kills adult fleas and is indicated for 
the treatment of flea infestations (Ctenocephalides felis).
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.

    Dated: December 17, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-32442 Filed 12-24-02; 8:45 am]
BILLING CODE 4160-01-S