05-12422. Implantation or Injectable Dosage Form New Animal Drugs; Embutramide, Chloroquine, and Lidocaine Solution

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 new animal drug application (NADA) filed by Phoenix Scientific, Inc. The NADA provides for veterinary prescription use of a solution containing embutramide, chloroquine phosphate, and lidocaine by intravenous injection for euthanasia of dogs.

DATES:

This rule is effective June 23, 2005.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7543, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Phoenix Scientific, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed NADA 141 245 that provides for veterinary prescription use of TRIBUTAME Euthanasia Solution (embutramide; chloroquine phosphate, U.S.P.; and lidocaine, USP) by intravenous injection for euthanasia of dogs. The NADA is approved as of May 20, 2005, and the regulations are amended in 21 CFR part 522 by adding § 522.810 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 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 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for 3 years of marketing exclusivity beginning May 20, 2005.

FDA has determined under 21 CFR 25.33(d)(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 Subject 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 522.810 is added to read as follows:

§ 522.810

Embutramide, chloroquine, and lidocaine solution.

(a) Specifications. Each milliliter (mL) of solution contains 135 milligrams (mg) embutramide; 45 mg chloroquine phosphate, U.S.P.; and 1.9 mg lidocaine, U.S.P.

(b) Sponsor. See No. 059130 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. One mL per 5 pounds of body weight.

(2) Indications for use. For euthanasia.

(3) Limitations. Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: June 10, 2005.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.