[Federal Register Volume 71, Number 72 (Friday, April 14, 2006)]
[Rules and Regulations]
[Page 19429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-3586]



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  Federal Register / Vol. 71, No. 72 / Friday, April 14, 2006 / Rules 
and Regulations  

[[Page 19429]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Fenbendazole Granules

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 minor changes to the labeling of over-the-counter 
fenbendazole granules, used for the treatment and control of certain 
internal parasites in dogs.

DATES: This rule is effective April 14, 2006.

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, Millsboro, DE 19966, filed a supplement to NADA 121-473 that 
provides for over-the-counter use in dogs of SAFE-GUARD (fenbendazole) 
Canine, orally administered granules used for the treatment and control 
of certain internal parasites. The supplemental NADA provides for minor 
changes to product labeling. The supplemental NADA is approved as of 
March 17, 2006, and the regulations are amended in 21 CFR 520.905b 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.

List of Subjects in 21 CFR Part 520

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

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


Sec.  520.905b  [Amended]

0
2. In paragraph (d)(2)(ii) of Sec.  520.905b, remove the word 
``removal'' and add, in its place, the words ``treatment and control''.

    Dated: April 6, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-3586 Filed 4-13-06; 8:45 am]
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