[Federal Register Volume 64, Number 151 (Friday, August 6, 1999)]
[Rules and Regulations]
[Page 42831]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-20254]


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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; Nystatin, 
Neomycin, Thiostrepton, and Triamcinolone Acetonide Ointment

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 an abbreviated new animal drug 
application (ANADA) filed by Med-Pharmex, Inc. The ANADA provides for 
use of nystatin, neomycin, thiostrepton, and triamcinolone acetonide 
vanishing cream base ointment for topical management of dermatologic 
disorders of dogs and cats.

EFFECTIVE DATE: August 6, 1999.

FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0209.

SUPPLEMENTARY INFORMATION: Med-Pharmex, Inc., 2727 Thompson Creek Rd., 
Pomona, CA 91767-1861, filed ANADA 200-245 that provides for veterinary 
prescription use of Derma-Vet Cream (nystatin, neomycin, thiostrepton, 
and triamcinolone acetonide) for topical management of dermatologic 
disorders in dogs and cats characterized by inflammation and dry or 
exudative dermatitis, particularly those caused, complicated, or 
threatened by bacterial or candidal (Candida albicans) infections.
     Med-Pharmex's ANADA 200-245 is approved as a generic copy of 
Solvay's NADA 96-676 for Panalog Cream. The ANADA is approved 
as of June 7, 1999. The basis for approval is discussed in the freedom 
of information summary.
    The regulation in Sec. 524.1600a (21 CFR 524.1600a) does not 
designate which approvals are for petrolatum base products (ointments) 
and which are for vanishing cream base products (creams). The 
regulation in Sec. 524.1600a(b) is amended at this time to designate 
the base of each sponsor's product and to reflect this approval.
    In addition, due to enactment of the Generic Animal Drug and Patent 
Term Restoration Act of 1988, the footnote concerning the National 
Academy of Sciences/National Research Council review is outdated. At 
this time, the footnote and the footnote references are removed.
    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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    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 524.1600a is amended by revising paragraph (b) and by 
removing the footnote of paragraphs (c)(1)(i), (c)(1)(ii), (c)(1)(iii), 
(c)(2)(i), and (c)(2)(ii) to read as follows:


Sec. 524.1600a  Nystatin, neomycin, thiostrepton, and triamcinolone 
acetonide ointment.

* * * * *
    (b) Sponsors. For petrolatum base ointments see 000031, 000069, 
000332, 025463, 051259, and 053501 in Sec. 510.600(c) of this chapter. 
For vanishing cream base ointments see 051259 and 053501.
* * * * *

    Dated: June 29, 1999
George A. Mitchell,
Acting Deputy Director, Center for Veterinary Medicine.
[FR Doc. 99-20254 Filed 8-5-99; 8:45 am]
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