Document ID: FDA-2009-N-0665-0013
Agency: fda
Document Type: Notice
Title: Oral Dosage Form New Animal Drugs: Fenbendazole Suspension - Notices of Final Rule
Posted Date: 2009-04-17T04:00Z

[Federal Register: April 17, 2009 (Volume 74, Number 73)]
[Rules and Regulations]               
[Page 17770]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17ap09-4]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2009-N-0665]

 
Oral Dosage Form New Animal Drugs; Fenbendazole 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 Intervet, Inc. The supplemental NADA 
provides for a revised human food safety warning for use of 
fenbendazole suspension in horses.

DATES:  This rule is effective April 17, 2009.

FOR FURTHER INFORMATION CONTACT:  Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Intervet, Inc., P.O. Box 318, 29160 Intervet 
Lane, Millsboro, DE 19966, filed a supplement to NADA 104-494 that 
provides for use of PANACUR (fenbendazole) Suspension 10% in horses for 
the control of various internal parasites. The supplemental NADA 
provides for a revised human food safety warning on product labeling. 
The supplemental NADA is approved as of March 25, 2009, and the 
regulations are amended in 21 CFR 520.905a to reflect the approval and 
a current format.
    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

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

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

0
2. Amend Sec.  520.905a as follows:
0
a. Revise paragraph (a);
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b. Remove paragraph (e);
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c. Redesignate paragraph (d) as paragraph (e);
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d. Add new paragraph (d); and
0
e. Revise newly redesignated paragraphs (e)(1)(i), (e)(1)(iii), 
(e)(2)(i), (e)(2)(iii), (e)(3)(i), (e)(3)(ii) , and (e)(4)(i).
    The revisions and addition are to read as follows:

Sec.  520.905a  Fenbendazole suspension.

    (a) Specifications. Each milliliter of suspension contains 100 
milligrams (mg) fenbendazole.
* * * * *
    (d) Special considerations--(1) See Sec.  500.25 of this chapter.
    (2) Fenbendazole suspension 10 percent and approved forms of 
trichlorfon, when used concomitantly for treating the indications 
provided in paragraph (e) of this section and for treating infections 
of stomach bot as provided in Sec.  520.2520, have been shown to be 
compatible and not to interfere with one another.
    (e) * * *
    (1) * * *
    (i) Amount. Administer orally 5 mg per kilogram (/kg) (2.3 mg per 
pound (/lb)) for the control of large strongyles, small strongyles, and 
pinworms; 10 mg/kg for the control of ascarids.
* * * * *
    (iii) Limitations. Administer by dose syringe or suitable plastic 
syringe. Do not use in horses intended for human consumption.
    (2) * * *
    (i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb).
* * * * *
    (iii) Limitations. Retreatment may be needed after 4 to 6 weeks. 
Cattle must not be slaughtered within 8 days following last treatment.
    (3) * * *
    (i) Amount. Administer orally 10 mg/kg of body weight.
    (ii) Indications for use. For the removal and control of stomach 
worm (4th stage inhibited larvae/type II ostertagiasis), Ostertagia 
ostertagi, and tapeworm, Moniezia benedeni.
* * * * *
    (4) * * *
    (i) Amount. Administer orally 5 mg/kg of body weight (2.3 mg/lb).
* * * * *

    Dated: April 9, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-8822 Filed 4-16-09; 8:45 am]

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