[Federal Register Volume 68, Number 143 (Friday, July 25, 2003)]
[Rules and Regulations]
[Pages 43925-43926]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-18910]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Phenylbutazone Paste

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 Bioniche Animal Health USA, Inc. The ANADA 
provides for oral use of phenylbutazone paste in horses for relief of 
inflammatory conditions associated with the musculoskeletal system.

DATES:  This rule is effective July 25, 2003.

FOR FURTHER INFORMATION CONTACT:  Lonnie W. Luther, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-8549, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Bioniche Animal Health USA, Inc., 119 Rowe 
Rd., Athens, GA 30601, filed ANADA 200-266 for the oral use of 
BUTEQUINE (phenylbutazone) Paste in horses for relief of inflammatory 
conditions associated with the musculoskeletal system. Bioniche Animal 
Health's BUTEQUINE Paste is approved as a generic copy of Schering-
Plough Animal Health's PHENYLZONE (phenylbutazone) Paste, approved 
under NADA 116-087. The ANADA is approved as of February 21, 2003, and 
the regulations are amended in 21 CFR 520.1720c to reflect the approval 
and current format. 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

[[Page 43926]]

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.
    FDA 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 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.

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2. Section 520.1720c is amended by revising paragraphs (a) and (b), by 
removing paragraph (c), and by redesignating paragraph (d) as new 
paragraph (c) to read as follows:


Sec.  520.1720c   Phenylbutazone paste.

    (a) Specifications--(1) Each gram of paste contains 0.2 grams 
phenylbutazone.
    (2) Each gram of paste contains 0.35 grams phenylbutazone.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter.
    (1) Nos. 000061 and 010797 for use of product described in 
paragraph (a)(1) of this section.
    (2) No. 064847 for use of product described in paragraph (a)(2) of 
this section.
* * * * *

    Dated: July 3, 2003.
Andrew J. Beaulieu,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 03-18910 Filed 7-24-03; 8:45 am]
BILLING CODE 4160-01-S