[Federal Register Volume 62, Number 37 (Tuesday, February 25, 1997)]
[Rules and Regulations]
[Page 8371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4513]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520
Oral Dosage Form New Animal Drugs; Lufenuron Suspension and
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 two supplemental new animal
drug applications (NADA's) filed by Ciba-Geigy Animal Health, Ciba-
Geigy Corp. The supplements provide that veterinary prescriptions are
no longer required for use of lufenuron tablets for dogs and oral
suspension for cats.
EFFECTIVE DATE: February 25, 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-
026 that provides for oral administration of Program
(lufenuron) suspension for cats and kittens for control of flea
populations and supplemental NADA 141-035 that provides for oral
administration of Program (lufenuron) tablets for dogs and
puppies for prevention and control of flea populations. The
supplemental NADA's provide that veterinary prescriptions are no longer
required. The supplemental NADA's are approved as of December 31, 1996,
and the regulations are amended by revising 21 CFR 520.1288(c)(3) and
520.1289(c)(3) to remove the limitation for veterinary prescription
use.
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.
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
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).
Sec. 520.1288 [Amended]
2. Section 520.1288 Lufenuron tablets is amended in paragraph
(c)(3) by removing the last sentence.
Sec. 520.1289 [Amended]
3. Section 520.1289 Lufenuron suspension is amended in paragraph
(c)(3) by removing the last sentence.
Dated: February 3, 1997.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 97-4513 Filed 2-24-97; 8:45 am]
BILLING CODE 4160-01-F
