[Federal Register Volume 72, Number 148 (Thursday, August 2, 2007)]
[Rules and Regulations]
[Pages 42290-42291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14950]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Oxytetracycline Hydrochloride Injection

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 an abbreviated new animal drug 
application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA 
provides for use of an oxytetracycline hydrochloride injectable 
solution in beef cattle, beef calves, nonlactating dairy cattle, and 
dairy calves for the treatment of various bacterial diseases.

DATES: This rule is effective August 2, 2007.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Norbrook Laboratories, Ltd., Station Works, 
Newry BT35 6JP, Northern Ireland, filed ANADA 200-452 that provides for 
use of OXYTET 10 (oxytetracycline hydrochloride) Injection in beef 
cattle, beef calves, nonlactating dairy cattle, and dairy calves for 
the treatment of various bacterial diseases. Norbrook Laboratories, 
Ltd.'s OXYTET 10 Injection is approved as a generic copy of Boehringer 
Ingelheim Vetmedica, Inc.'s, MEDAMYCIN Injectable approved under NADA 
108-963. The ANADA is approved as of June 27, 2007, and the regulations 
are amended in 21 CFR 522.1662a to reflect the approval.
    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.
    FDA has determined under 21 CFR 25.33(a)(1) 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.

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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:

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

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


[[Page 42291]]


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

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2. Section 522.1662a is amended by revising paragraph (h)(2) to read as 
follows:


Sec.  522.1662a  Oxytetracycline hydrochloride injection.

* * * * *
    (h) * * *
    (2) Sponsors. See No. 000010 in Sec.  510.600(c) of this chapter 
for use of 50 and 100 milligrams per milliliter solution; and Nos. 
055529 and 059130 in Sec.  510.600(c) for use of 100 milligrams per 
milliliter solution.
* * * * *

    Dated: July 17, 2007.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. E7-14950 Filed 8-1-07; 8:45 am]
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