[Federal Register Volume 72, Number 227 (Tuesday, November 27, 2007)]
[Rules and Regulations]
[Pages 66045-66046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22987]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs For Use in Animal Feeds; Fenbendazole

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 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: 
[email protected].

SUPPLEMENTARY INFORMATION: Intervet Inc., P.O. Box 318, 29160 Intervet 
Lane,

[[Page 66046]]

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.

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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

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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]

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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. E7-22987 Filed 11-26-07; 8:45 am]
BILLING CODE 4160-01-S