E7-22987. New Animal Drugs For Use in Animal Feeds; Fenbendazole

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

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 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.

DATES:

This rule is effective November 27, 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: [e-mail].

SUPPLEMENTARY INFORMATION:

Intervet Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, 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.

List of Subjects in 21 CFR Part 558

• Animal drugs
• Animal feeds

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

§ 558.258

[Amended]

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.”.

Dated: November 16, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.