[Federal Register Volume 72, Number 84 (Wednesday, May 2, 2007)]
[Rules and Regulations]
[Page 24185]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-8391]


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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; technical amendment.

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SUMMARY:  The Food and Drug Administration (FDA) is amending the animal 
drug regulations to correct an inadvertent error in the conditions of 
use of fenbendazole paste in horses and cattle. This action is being 
taken to improve the accuracy of the animal drug regulations.

DATES: This rule is effective May 2, 2007.

FOR FURTHER INFORMATION CONTACT:  George K. Haibel, Center for 
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9019, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is amending the animal drug regulations 
in 21 CFR 558.95 to correct an inadvertent error in the conditions of 
use of fenbendazole paste in horses and cattle. The error in the 
agency's regulations was introduced in a final rule reflecting the 
approval of a supplemental new animal drug application that published 
in the Federal Register on March 9, 2007 (72 FR 10595). This action is 
being taken to improve the accuracy of the animal drug regulations.
    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. Section 520.905c is revised to read as follows:


Sec.  520.905c  Fenbendazole paste.

    (a) Specifications. Each gram of paste contains 100 milligrams (mg) 
fenbendazole (10 percent).
    (b) Sponsor. See No. 057926 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.275 of this chapter.
    (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. Retreatment 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: April 24, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-8391 Filed 5-1-07; 8:45 am]
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