[Federal Register Volume 72, Number 46 (Friday, March 9, 2007)]
[Rules and Regulations]
[Page 10595]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4204]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Fenbendazole Paste

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 two supplemental new animal 
drug applications (NADAs) filed by Intervet, Inc. The supplemental 
NADAs provide for a revised human food safety warning for fenbendazole 
paste, used for the control of various internal parasites in horses and 
cattle.

DATES: This rule is effective March 9, 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, Millsboro, DE 19966, filed a supplement to NADA 120-648 that 
provides for use of PANACUR (fenbendazole) Paste in horses for the 
control of various internal parasites, and to NADA 132-872 that 
provides for use of SAFE-GUARD (fenbendazole) Paste in cattle for the 
control of various internal parasites. The supplemental NADAs provide 
for a revised human food safety warning on product labeling. The 
supplemental NADAs are approved as of February 8, 2007, and the 
regulations are amended in 21 CFR 520.905c to reflect the approval and 
a current format.
    Approval of these supplemental NADAs 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 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.


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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

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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. Amend Sec.  520.905c as follows:
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a. Revise paragraph (a);
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b. Redesignate paragraph (d) as paragraph (e);
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c. Add new paragraph (d); and
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d. Revise newly redesignated paragraph (e).
    The revisions, redesignation, and addition read as follows:


Sec.  520.905c  Fenbendazole paste.

    (a) Specifications. Each gram of paste contains 100 milligrams (mg) 
fenbendazole (10 percent).
    (d) Special considerations. See Sec.  500.25 of this chapter.
    (e) Conditions of use--(1) Horses--(i) Indications for use and 
amounts--(A) For control of large strongyles (Strongylus edentatus, S. 
equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and 
ascarids (Parascaris equorum): 2.3 mg per pound (/lb) of body weight, 
or for foals and weanlings (less than 18 months of age), 4.6 mg/lb of 
body weight. Retreatment at intervals of 6 to 8 weeks may be required.
    (B) For control of arteritis caused by the fourth-stage larvae of 
S. vulgaris: 4.6 mg/lb of body weight daily for 5 days. Treatment 
should be initiated in the spring and repeated in 6 months.
    (C) For treatment of encysted mucosal cyathostome (small strongyle) 
larvae including early third-stage (hypobiotic), late third-stage, and 
fourth-stage larvae: 4.6 mg/lb of body weight daily for 5 consecutive 
days.
    (D) Fenbendazole paste 10 percent may be used concomitantly with 
approved forms of trichlorfon for the indications provided in paragraph 
(e)(1)(i)(A) of this section and for treating infections of stomach 
bots as provided in Sec.  520.2520.
    (ii) Limitations. Do not use in horses intended for human 
consumption.
    (2) Cattle--(i) Amount. 2.3 mg/lb of body weight. Re-treatment may 
be needed after 4 to 6 weeks.
    (ii) Indications for use. For the removal and control of lungworms 
(Dictyocaulus viviparus), stomach worms (Haemonchus contortus, 
Ostertagia ostertagi, Trichostrongylus axei), and intestinal worms 
(Bunostomum phlebotomum, Nematodirus helvetianus, Cooperia punctata, C. 
oncophora, Trichostrongylus colubriformis, and Oesophagostomum 
radiatum).
    (iii) Limitations. Cattle must not be slaughtered within 8 days 
following last treatment.

    Dated: February 28, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E7-4204 Filed 3-8-07; 8:45 am]
BILLING CODE 4160-01-S