[Federal Register Volume 68, Number 167 (Thursday, August 28, 2003)]
[Rules and Regulations]
[Pages 51704-51705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21835]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Etodolac

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 Fort Dodge Animal Health, Division of 
American Cyanamid Co. The supplemental NADA provides for a 500-
milligram (mg) tablet size of etodolac for oral use in dogs.

DATES:  This rule is effective August 28, 2003.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, (301) 827-7540, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of 
American Cyanamid Co., P.O. Box 1339, Fort Dodge, IA 50501, filed a 
supplement to NADA 141-108 that provides for a 500-mg tablet size of 
ETOGESIC (etodolac) Tablets used for the management of pain and 
inflammation associated with osteoarthritis in dogs. The supplemental 
application is approved as of May 8, 2003, and the regulations are 
amended in 21 CFR 520.870 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 21 CFR 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.

[[Page 51705]]

1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through 
Friday.
    FDA 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 520

    Animal drugs.

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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

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1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority:  21 U.S.C. 360b.


Sec.  520.870  [Amended]

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2. Section 520.870 Etodolac is amended in paragraph (a) by removing 
``150 or 300'' and by adding in its place ``150, 300, or 500''.

    Dated: August 13, 2003.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 03-21835 Filed 8-27-03; 8:45 am]
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