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 Intervet Inc. The supplemental NADA provides for a revised food safety warning on labeling for fenbendazole Type A medicated article and Type B and Type C medicated horse feeds.
This rule is effective November 27, 2007.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: firstname.lastname@example.org.End Further Info End Preamble Start Supplemental Information
Intervet Inc., P.O. Box 318, 29160 Intervet Lane, Start Printed Page 66046Millsboro, DE 19966, filed a supplement to NADA 131-675 for use of SAFE-GUARD (fenbendazole) 20% Type A medicated article to formulate Type B and Type C medicated horse feeds. The supplemental NADA provides for a revised food safety warning on labeling. The supplemental NADA is approved as of November 5, 2007, and the regulations are amended in 21 CFR 558.258 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.Start List of Subjects
List of Subjects in 21 CFR Part 558End 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 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDSEnd Part Start Amendment Part
1. The authority citation forEnd Amendment Part
2. In § 558.258, in the table in paragraph (e)(4)(i), in the “Limitations” column, remove “Do not use in horses intended for food.” and add in its place “Do not use in horses intended for human consumption.”.End Amendment Part Start Signature
Dated: November 16, 2007.
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-22987 Filed 11-26-07; 8:45 am]
BILLING CODE 4160-01-S