[Federal Register Volume 66, Number 48 (Monday, March 12, 2001)]
[Rules and Regulations]
[Page 14316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5681]


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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 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 Phoenix Scientific, Inc. The supplemental 
NADA provides for oral use of a 200-milligram (mg) strength 
phenylbutazone tablet for relief of inflammatory conditions associated 
with the musculoskeletal system in dogs and horses.

DATES: This rule is effective March 12, 2001.

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.

SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th 
Street Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed a 
supplement to approved NADA 094-170 for Phenylbutazone Tablets, USP. 
The supplemental NADA provides for use of a 200-mg strength 
phenylbutazone tablet for relief of inflammatory conditions associated 
with the musculoskeletal system in dogs and horses. The supplemental 
NADA is approved as of January 12, 2001, and the regulations are 
amended in 21 CFR 520.1720a 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 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 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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


Sec.  520.1720a  [Amended]

    2. Section 520.1720a Phenylbutazone tablets and boluses is amended 
in paragraph (b)(2) by removing ``No. 000010'' and by adding in its 
place ``Nos. 000010 and 059130''; and in paragraph (b)(3) by removing 
``015579, 059130'' and by adding in its place ``015579''.

    Dated: February 26, 2001.
Claire M. Lathers,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 01-5681 Filed 3-9-01; 8:45 am]
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