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Rule

Oral Dosage Form New Animal Drugs; Fenbendazole Paste

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Information about this document as published in the Federal Register.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

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.

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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: george.haibel@fda.hhs.gov.

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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.

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List of Subjects in 21 CFR Part 520

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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,

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PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for

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

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2. Section 520.905c is revised to read as follows:

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Fenbendazole paste.

(a) Specifications. Each gram of paste contains 100 milligrams (mg) fenbendazole (10 percent).

(b) Sponsor. See No. 057926 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.275 of this chapter.

(d) Special considerations. See § 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 § 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.

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Dated: April 24, 2007.

Bernadette Dunham,

Deputy Director, Center for Veterinary Medicine.

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[FR Doc. E7-8391 Filed 5-1-07; 8:45 am]

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