[Federal Register Volume 59, Number 100 (Wednesday, May 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12664]


[[Page Unknown]]

[Federal Register: May 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 520

 

Oral Dosage Form New Animal Drugs; Proban (Cythioate) 
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 supplemental new animal drug 
application (NADA) filed by Miles, Inc. The supplemental NADA provides 
for the oral use of a 90-milligram (mg) Proban (cythioate) 
Tablet in addition to the currently approved use of the 30-mg tablet.

EFFECTIVE DATE: May 25, 1994.

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: Miles, Inc., Agriculture Division, Animal 
Health Products, P.O. Box 390, Shawnee Mission, KS 66201, filed 
supplemental NADA 132-337, which provides for the use of a 90-mg 
Proban (cythioate) tablet in addition to the approved 30-mg 
tablet for control of fleas on dogs. The supplemental NADA is approved 
as of April 25, 1994, and the regulations are amended in 21 CFR 520.531 
to reflect the approval.
    Approval of this supplement does not require submission of new 
safety or effectiveness data. This supplement provides for use of a 
larger tablet with increased drug concentration to be given at the 
currently approved use level. However, in accordance with the freedom 
of information provisions of part 20 (21 CFR part 20) and 
Sec. 514.11(e)(2)(ii) (21 CFR 514.11(e)(2)(ii)), a freedom of 
information summary is provided for the revised labeling.
    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 does not 
qualify for marketing exclusivity. The additional studies submitted 
with the supplement were conducted as requested by FDA to correct 
deficiencies in the original data supporting safety and effectiveness 
of the 1968 approval, and they were not essential to the approval of 
this supplement.
    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 520.531 is amended by removing and reserving paragraph 
(a) and by revising paragraph (b) to read as follows:


Sec. 520.531  Cythioate tablets.

    (a) [Reserved]
    (b) Sponsors. See No. 000859 in Sec. 510.600(c) of this chapter for 
use of 30- and 90-milligram (mg) tablets and see No. 010042 in 
Sec. 510.600(c) of this chapter for use of 30-mg tablet.
* * * * *

    Dated: May 16, 1994.
Robert C. Livingston,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 94-12664 Filed 5-24-94; 8:45 am]
BILLING CODE 4160-01-F