E8-12160. Implantation or Injectable Dosage Form New Animal Drugs; Butorphanol

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

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 Lloyd, Inc. The ANADA provides for the veterinary prescription use of butorphanol tartrate injectable solution in horses for the relief of pain.

DATES:

This rule is effective June 2, 2008.

FOR FURTHER INFORMATION CONTACT:

John K. Harshman, Center for Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Lloyd, Inc., 604 West Thomas Ave., Shenandoah, IA 51601, filed ANADA 200-332 that provides for the veterinary prescription use of BUTORPHIC (butorphanol tartrate) Injection in horses for the relief of pain associated with colic and postpartum pain. Lloyd, Inc.'s BUTORPHIC Injection is approved as a generic copy of TORBUGESIC, sponsored by Fort Dodge Animal Health, Division of Wyeth, under NADA 135-780. The ANADA is approved as of May 1, 2008, and 21 CFR 522.246 is amended 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.

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.

§ 522.246

[Amended]

2. In paragraph (b)(3) of § 522.246, remove “057926 and 059130” and in its place add “057926, 059130, and 061690”.

Dated: May 21, 2008.

Bernadette Dunham,

Director, Center for Veterinary Medicine.