Food and Drug Administration, HHS.
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.
This rule is effective June 8, 2006.Start Further Info
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@example.com.End Further Info End Preamble Start Supplemental 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.Start List of Subjects
List of Subjects in 21 CFR Part 520End List of Subjects Start Amendment Part
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,End Amendment Part Start Part
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. Amend paragraph (c)(3) of § 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.”.End Amendment Part Start Signature
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