[Federal Register Volume 62, Number 50 (Friday, March 14, 1997)]
[Rules and Regulations]
[Page 12085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6412]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520


Oral Dosage Form New Animal Drugs; Lufenuron Tablet

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 Ciba-Geigy Animal Health, Ciba-Geigy Corp. 
The supplemental NADA provides for oral administration of lufenuron 
tablets at a minimum dose of 30 milligrams per kilogram (mg/kg) for the 
control of flea populations on cats.

EFFECTIVE DATE: March 14, 1997.

FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for 
Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 
Standish P1., Rockville, MD 20855, 301-594-0614.

SUPPLEMENTARY INFORMATION: Ciba-Geigy Animal Health, Ciba-Geigy Corp., 
P.O. Box 18300, Greensboro, NC 27419-8300, filed supplemental NADA 141-
035, which provides for oral administration of Program<Register> 
(lufenuron) tablets to cats 6 weeks of age or older. The drug is 
approved in 90- or 204.9-mg tablets, given once a month, directly or 
broken and mixed into wet food, for the control of flea populations. 
Lufenuron has no deleterious effect on adult fleas but it prevents most 
flea eggs from hatching or maturing into adults. The supplemental NADA 
is approved as of January 23, 1997, and the regulations are amended in 
21 CFR 520.1288 by revising the heading for paragraph (c) and by adding 
new paragraph (d) to reflect the approval. The basis for 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, 
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 qualifies 
for 3 years of marketing exclusivity beginning January 23, 1997, 
because the application contains substantial evidence of effectiveness 
of the drug involved, studies of animal safety or, in the case of food-
producing animals, human food safety studies (other than bioequivalence 
or residue studies) required for approval and conducted or sponsored by 
the applicant.
    The agency has determined under 21 CFR 25.24(d)(1)(iii) 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.

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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360b).

    2. Section 520.1288 is amended by revising the heading for 
paragraph (c) and by adding new paragraph (d) to read as follows:

Sec. 520.1288  Lufenuron tablets.

* * * * *
    (c) Conditions of use in dogs--
* * * * *
    (d) Conditions of use in cats--(1) Amount. 90-milligram tablet for 
cats up to 6 pounds of body weight, 204.9-milligram tablet for cats 7 
to 15 pounds, a combination of tablets for cats over 15 pounds (a 
minimum of 13.6 milligrams per pound (30 milligrams per kilogram)).
    (2) Indications for use. For control of flea populations.
    (3) Limitations. For oral use in cats 6 weeks of age or older, once 
a month, directly or broken and mixed into wet food. Administer in 
conjunction with a full meal to ensure adequate absorption. Treat all 
cats in the household to ensure maximum benefits. Because the drug has 
no affect on adult fleas, the concurrent use of insecticides that kill 
adults may be necessary depending on the severity of the infestation.

    Dated: February 11, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-6412 Filed 3-13-97; 8:45 am]
BILLING CODE 4160-01-F