Document ID: FDA-2008-N-0039-0061
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs; Oxfendazole Suspension
Posted Date: 2008-08-06T04:00Z

[Federal Register: August 6, 2008 (Volume 73, Number 152)]
[Rules and Regulations]               
[Page 45610]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06au08-5]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. 2008-N-0039]

 
Oral Dosage Form New Animal Drugs; Oxfendazole Suspension

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 Fort Dodge Animal Health, Division of 
Wyeth. The supplemental NADA provides for revised scientific 
nomenclature for an internal parasite for which oxfendazole suspension 
is used orally in cattle.

DATES: This rule is effective August 6, 2008.

FOR FURTHER INFORMATION CONTACT: Donald A. Prater, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8343, e-mail: 
donald.prater@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth, 
800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 
140-854 for SYNANTHIC (oxfendazole) Bovine Dewormer Suspension, 
approved for oral use in cattle for the removal of various internal 
parasites. The supplemental NADA provides for revised scientific 
nomenclature for a parasite. The supplemental application is approved 
as of July 7, 2008, and the regulations are amended in 21 CFR 520.1630 
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(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 520

    Animal drugs.

0
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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

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2. In Sec.  520.1630, in paragraph (e)(2)(ii), remove ``C. mcmasteri'' 
and in its place add ``C. surnabada''; and revise paragraph (e)(2)(iii) 
to read as follows:

Sec.  520.1630  Oxfendazole suspension.

* * * * *
    (e) * * *
    (2) * * *
    (iii) Limitations. Cattle must not be slaughtered until 7 days 
after treatment. Because a withdrawal time in milk has not been 
established, do not use in female dairy cattle of breeding age.

    Dated: July 24, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-18092 Filed 8-5-08; 8:45 am]

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