[Federal Register Volume 62, Number 58 (Wednesday, March 26, 1997)]
[Rules and Regulations]
[Page 14301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7549]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520


Oral Dosage Form New Animal Drugs; Lufenuron 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 Ciba-Geigy Animal Health Corp. The NADA provides for 
oral administration of lufenuron tablets to cats and kittens 6 weeks of 
age and older for the control of flea populations.

EFFECTIVE DATE: March 26, 1997.

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

SUPPLEMENTARY INFORMATION: Ciba-Geigy Animal Health Corp., P.O. Box 
18300, Greensboro, NC 27419-8300, filed NADA 141-062, which provides 
for oral administration of Program (Lufenuron) Cat Flavor 
Tablets for cats and kittens 6 weeks of age or older, for the control 
of flea populations. The drug is given orally, once a month, at a 
minimum of 13.6 milligrams (mg) of lufenuron per pound of body weight 
(30 mg/kilogram), in tablets containing 135 or 270 mg lufenuron each. 
Lufenuron has no deleterious effect on adult fleas, but it prevents 
most flea eggs from hatching or maturing into adults. The NADA is 
approved as of March 3, 1997, and the regulations are amended in 21 CFR 
520.1288(a) and (d) 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, 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)(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 March 3, 1997, because the 
NADA contains substantial evidence of effectiveness of the drug 
involved or any studies of animal safety, 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 paragraphs (a), (d) (1), 
and (d) (3) to read as follows:

Sec. 520.1288  Lufenuron tablets.

    (a) Specifications--(1) Dogs. Each tablet contains either 45, 90, 
204.9, or 409.8 milligrams (mg) lufenuron.
    (2) Cats. Each regular tablet contains either 90 or 204.9 mg 
lufenuron, each flavor tablet contains 135 or 270 mg lufenuron.
* * * * *
    (d) Conditions of use in cats--(1) Amount. Minimum of 13.6 mg 
lufenuron per pound (lb) of body weight (30 mg per kilogram). 
Recommended 90 mg regular tablet for cats up to 6 lb of body weight, 
204.9 mg regular tablet for 7 to 15 lb, 135 mg flavor tablet for up to 
10 lb, 270 mg flavor tablet for 11 to 20 lb. Cats over 15 lb (regular 
tablet) or over 20 lb (flavor tablet) are provided the appropriate 
combination of tablets.
* * * * *
    (3) Limitations. For oral use in cats or kittens 6 weeks of age or 
older, once a month, directly or broken and mixed with 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: March 17, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-7549 Filed 3-25-97; 8:45 am]
BILLING CODE 4160-01-F