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Oral Dosage Form New Animal Drugs; Oxibendazole Suspension

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 [Federal Register: June 8, 2006 (Volume 71, Number 110)]
[Rules and Regulations]
[Page 33237]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn06-12]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 520

Oral Dosage Form New Animal Drugs; Oxibendazole Suspension

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 Pfizer, Inc. The supplemental NADA provides 
for revised food safety labeling for oxibendazole suspension 
administered orally to horses as an antiparasitic.

DATES: This rule is effective June 8, 2006.

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: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed a supplement to NADA 109-722 for use of ANTHELCIDE EQ 
(oxibendazole) Suspension administered orally to horses as an 
antiparasitic. The supplemental NADA provides for revised food safety 
labeling. The supplemental application is approved as of April 17, 
2006, and the regulations are amended in 21 CFR 520.1640 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.

? 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.  520.1640  [Amended]

? 2. Amend paragraph (c)(3) of Sec.  520.1640 by removing ``Not for use 
in horses intended for food.'' and adding in its place ``Not for use in 
horses intended for human consumption.''.

    Dated: May 26, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E6-8953 Filed 6-7-06; 8:45 am]
BILLING CODE 4160-01-S

 
 

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