E7-14950. Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline Hydrochloride Injection

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 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: [e-mail].

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

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

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

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

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

§ 522.1662a

Oxytetracycline hydrochloride injection.

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(h) * * *

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

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Dated: July 17, 2007.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.