05-23295. Implantation or Injectable Dosage Form New Animal Drugs; Boldenone

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 a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health. The supplemental NADA provides for revised labeling for the veterinary prescription use of injectable boldenone solution in horses.

DATES:

This rule is effective November 25, 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:

Fort Dodge Animal Health, A Division of Wyeth Holdings Corp., P.O. Box 1339, Fort Dodge, IA 50501, filed a supplement to NADA 34-705 that provides for veterinary prescription use of EQUIPOISE (boldenone undecylenate) by injection in horses. The supplemental NADA provides for a revised indication and food safety warning on labeling. The supplemental NADA is approved as of October 7, 2005, and the regulations are amended in 21 CFR 522.204 to reflect the approval and a current format.

Approval of this supplemental NADA did not require review of additional safety or effectiveness data. Therefore, a freedom of information summary is not required.

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 the 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 522.204 is revised to read as follows:

§ 522.204

Boldenone.

(a) Specifications. Each milliliter of solution contains 25 or 50 milligrams (mg) boldenone undecylenate.

(b) Sponsor. See No. 053501 in § 510.600(c) of this chapter.

(c) Conditions of use in horses—(1) Amount. 0.5 mg per pound body weight by intramuscular injection. Treatment may be repeated at 3-week intervals.

(2) Indications for use. As an aid for treating debilitated horses when an improvement in weight, hair coat, or general physical condition is desired.

(3) Limitations. Do not administer to horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dated: November 15, 2005.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.