[Federal Register Volume 65, Number 62 (Thursday, March 30, 2000)]
[Rules and Regulations]
[Page 16817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7931]


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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; 
Triamcinolone Acetonide Cream

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 
veterinary prescription use of triamcinolone acetonide cream on dogs 
for topical treatment of allergic dermatitis and summer eczema.

DATES: This rule is effective March 30, 2000.

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 200-275 that provides for veterinary 
prescription use of triamcinolone acetonide cream on dogs for topical 
treatment of allergic dermatitis and summer eczema. Med-Pharmex's ANADA 
200-275 MEDALOG cream is approved as a generic copy of Fort Dodge 
Animal Health's NADA 46-146 VETALOG cream. ANADA 200-275 is 
approved as of February 4, 2000, and 21 CFR 524.2481(b) is amended 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, 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(a)(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.


Sec. 524.2481  [Amended]

    2. Section 524.2481 Triamcinolone acetonide cream is amended in 
paragraph (b) by adding after ``No.'' the phrase ``051259 and''.

    Dated: March 20, 2000.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 00-7931 Filed 3-29-00; 8:45 am]
BILLING CODE 4160-01-F