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Rule

Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline and Flunixin

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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.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Norbrook Laboratories, Ltd. The NADA provides for veterinary prescription use of a combination drug injectable solution containing oxytetracycline and flunixin meglumine in cattle.

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DATES:

This rule is effective January 20, 2011.

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FOR FURTHER INFORMATION CONTACT:

Cindy L. Burnsteel, Center for Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: cindy.burnsteel@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

Norbrook Laboratories, Ltd., Station Works, Newry, BT35 6JP, Northern Ireland, filed NADA 141-312 that provides for veterinary prescription use of HEXASOL (oxytetracycline and flunixin meglumine) Injection for the treatment of bacterial pneumonia associated with Pasteurella spp. and for the control of associated pyrexia in beef and non-lactating dairy cattle. The application is approved as of November 29, 2010, and the regulations in part 522 (21 CFR part 522) are revised by adding 21 CFR 522.1664.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(ii) of the act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning on the date of approval.

The Agency 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.

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List of Subjects in 21 CFR Part 522

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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 522 is amended as follows:

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PART 522—IMPLANTATION OR INJECTABLE 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. Add § 522.1664 to read as follows:

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Oxytetracycline and flunixin.

(a) Specifications. Each milliliter (mL) of solution contains 300 milligrams (mg) oxytetracycline base as amphoteric oxytetracycline and 20 mg flunixin base as flunixin meglumine.

(b) Sponsor. See No. 055529 in § 510.600(c) of this chapter.

(c) Related tolerances. See §§ 556.286 and 556.500 of this chapter.

(d) Conditions of use cattle—(1) Amount. Administer once as an intramuscular or subcutaneous injection of 1 mL per 22 pounds (lb) body weight (BW) (13.6 mg oxytetracycline and 0.9 mg flunixin per lb BW) where retreatment of calves and yearlings for bacterial pneumonia is impractical due to husbandry conditions, such as cattle on range, or where their repeated restraint is inadvisable.

(2) Indications for use. For the treatment of bacterial pneumonia associated with Pasteurella spp. and for the control of associated pyrexia in beef and nonlactating dairy cattle.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Discontinue treatment at least 21 days prior to slaughter of cattle. Do not use in female dairy cattle 20 months of age or older. Use in this class of cattle may cause milk residues. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Use of dosages other than those indicated may result in residue violations.

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Dated: January 11, 2011.

Bernadette Dunham,

Director, Center for Veterinary Medicine.

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[FR Doc. 2011-1040 Filed 1-19-11; 8:45 am]

BILLING CODE 4160-01-P