Document ID: FDA-2008-N-0039-0094
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Phenylbutazone Tablets and Boluses
Posted Date: 2009-01-12T05:00Z

[Federal Register: January 12, 2009 (Volume 74, Number 7)]
[Rules and Regulations]               
[Page 1146]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja09-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2008-N-0039]

 
Oral Dosage Form New Animal Drugs; Phenylbutazone Tablets and 
Boluses

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 First Priority, Inc. The supplemental 
application provides for revising the description of a 1-gram oral 
dosage form of phenylbutazone from tablet to bolus.

DATES:  This rule is effective January 12, 2009.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: First Priority, Inc., 1585 Todd Farm Dr., 
Elgin, IL 60123, filed a supplement to NADA 48-647 for the veterinary 
prescription use of PRIBUTAZONE (phenylbutazone) Tablets in horses for 
the relief of inflammatory conditions associated with the 
musculoskeletal system. The supplemental application provides for 
revising the description of this 1-gram oral dosage form of 
phenylbutazone from tablet to bolus. The supplemental NADA is approved 
as of December 10, 2008, and 21 CFR 520.1720a is amended to reflect the 
approval.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    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 520

    Animal drugs.

0
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.

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2. In Sec.  520.1720a, revise paragraphs (a) and (b)(3); and add 
paragraph (b)(6) to read as follows:

Sec.  520.1720a  Phenylbutazone tablets and boluses.

    (a) Specifications. Each tablet contains 100, 200, or 400 
milligrams (mg), or 1 gram (g) of phenylbutazone. Each bolus contains 
1, 2, or 4 gram g of phenylbutazone.
    (b) * * *
    (3) Nos. 000856 and 061623 for use of 100-mg or 1-g tablets in dogs 
and horses.
* * * * *
    (6) No. 058829 for use of 100-mg or 1-g tablets in dogs and horses, 
or 1-g boluses in horses.
* * * * *

    Dated: January 5, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-265 Filed 1-9-09; 8:45 am]

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