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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

CFR Citation: 21 CFR Part 558

NOTICE: RULES

ACTION: Animal drugs, feeds, and related products:

DOCUMENT ACTION: Final rule.

SUBJECT CATEGORY: New Animal Drugs For Use in Animal Feeds; Fenbendazole

DATES: This rule is effective November 27, 2007.

DOCUMENT 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.

SUMMARY: Fenbendazole,

SUPPLEMENTAL INFORMATION

Intervet Inc., P.O. Box 318, 29160 Intervet Lane,
[[Page 66046]]
Millsboro, DE 19966, filed a supplement to NADA 131675 for use of SAFEGUARD (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. 801808.
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 558NEW 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.
Sec. 558.258 [Amended]
2. In Sec. 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.
[FR Doc. E722987 Filed 112607; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Melanie R. Berson, Center for Veterinary Medicine (HFV110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 3018277540, email:
melanie.berson@fda.hhs.gov.