Document ID: FDA-2010-N-0002-0092
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs: Oxytetracycline and Flunixin
Posted Date: 2011-01-20T05:00Z

[Federal Register Volume 76, Number 13 (Thursday, January 20, 2011)]
[Rules and Regulations]
[Pages 3488-3489]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1040]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2010-N-0002]

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

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 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.

[[Page 3489]]

DATES: This rule is effective January 20, 2011.

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.

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.

List of Subjects in 21 CFR Part 522

    Animal drugs.

    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:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:

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

0
2. Add Sec.  522.1664 to read as follows:

Sec.  522.1664  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 Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec. Sec.  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.

    Dated: January 11, 2011.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2011-1040 Filed 1-19-11; 8:45 am]
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