[Federal Register Volume 72, Number 206 (Thursday, October 25, 2007)]
[Rules and Regulations]
[Page 60550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-21054]


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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 a supplemental new animal drug 
application (NADA) filed by Luitpold Pharmaceuticals, Inc. The 
supplemental NADA provides for a revised human food safety warning for 
phenylbutazone paste, used in horses for relief of inflammatory 
conditions associated with the musculoskeletal system.

DATES: This rule is effective October 25, 2007.

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: Luitpold Pharmaceuticals, Inc., Animal 
Health Division, Shirley, NY 11967, filed a supplement to NADA 140-958 
that provides for use of EQUIPHEN (phenylbutazone) Paste in horses for 
relief of inflammatory conditions associated with the musculoskeletal 
system. The supplemental NADA provides for a revised human food safety 
warning on product labeling. The supplemental NADA is approved as of 
September 26, 2007, and the regulations are amended in 21 CFR 520.1720c 
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.
    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.


Sec.  520.1720c  [Amended]

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2. In Sec.  520.1720c, in paragraph (c)(3), remove ``Not for use in 
horses intended for food.'' and add in its place ``Do not use in horses 
intended for human consumption.''

    Dated: October 17, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-21054 Filed 10-24-07; 8:45 am]
BILLING CODE 4160-01-S