[Federal Register: December 26, 2002 (Volume 67, Number 248)]
[Rules and Regulations]
[Page 78684-78685]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26de02-6]
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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: mberson@cvm.fda.gov.
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