02-30782. Implantation or Injectable Dosage Form New Animal Drugs; Oxytetracycline 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 original abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the administration of an oxytetracycline injectable solution to cattle and swine for the treatment of various bacterial diseases.

DATES:

This rule is effective December 5, 2002.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary Medicine (HFV-101), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Norbrook Laboratories, Ltd., Station Works, Newry BT35 6JP, Northern Ireland, filed original ANADA 200-306 that provides for the use of Oxytetracycline Injection (200 milligrams per milliliter (mg/mL)) as a treatment for various bacterial diseases in cattle and swine. Norbrook's Oxytetracycline Injection (200 mg/mL) is approved as a generic copy of Pfizer's LIQUAMYCIN LA-200, approved under NADA 113-232. The application is approved as of June 18, 2002, and the regulations are amended in 21 CFR 522.1660 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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 Dockets Management Branch (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.

The agency 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.

§ 522.1660

[Amended]

2. Section 522.1660 Oxytetracycline injection is amended in paragraph (b) by removing “Sponsor” and by adding in its place “Sponsors”, and by numerically adding “055529”; in paragraph (d)(1)(iii) in the second and ninth sentences by numerically adding “055529”; and in paragraph (d)(2)(iii) in the third sentence by removing “when provided by 000010, 000069, 011722, 053389, 059130, and 061623”.

Dated: November 15, 2002.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.