02-32750. Implantation or Injectable Dosage Form New Animal Drugs; Trenbolone Acetate and Estradiol Benzoate

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 use of an implant containing 100 milligrams (mg) trenbolone acetate and 14 mg estradiol benzoate for increased rate of weight gain in steers fed in confinement for slaughter.

DATES:

This rule is effective December 27, 2002.

FOR FURTHER INFORMATION CONTACT:

Daniel A. Benz, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0223, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Fort Dodge Animal Health, Division of Wyeth, 800 Fifth St. NW., Fort Dodge, IA 50501, filed a supplement to NADA 141-043 for SYNOVEX (trenbolone acetate and estradiol benzoate) implants. The supplemental NADA provides for use of SYNOVEX Choice, an implant containing 100 mg trenbolone acetate and 14 mg estradiol benzoate, for increased rate of weight gain in steers fed in confinement for slaughter. The supplemental NADA is approved as of October 3, 2002, and the regulations are amended in 21 CFR 522.2478 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 § 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this supplemental 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.

Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval qualifies for 3 years of marketing exclusivity beginning October 3, 2002.

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.

2. Section 522.2478 is revised to read as follows:

§ 522.2478

Trenbolone acetate and estradiol benzoate.

(a) Specifications. Each implant dose consists of:

(1) 8 pellets, each pellet containing 25 milligrams (mg) trenbolone acetate and 3.5 mg estradiol benzoate.

(2) 4 pellets, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate.

(b) Sponsor. See No. 000856 in § 510.600(c) of this chapter.

(c) Related tolerances. See §§ 556.240 and 556.739 of this chapter.

(d) Conditions of use—(1) Steers fed in confinement for slaughter. (i) For an implant as described in paragraph (a)(1) of this section:

(A) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate.

(B) Indications for use. For increased rate of weight gain and improved feed efficiency.

(C) Limitations. Implant subcutaneously in ear only.

(ii) For an implant as described in paragraph (a)(2) of this section:

(A) Amount. 100 mg trenbolone acetate and 14 mg estradiol benzoate.

(B) Indications for use. For increased rate of weight gain.

(C) Limitations. Implant subcutaneously in ear only.

(2) Heifers fed in confinement for slaughter—(i) Amount. 200 mg trenbolone acetate and 28 mg estradiol benzoate (as described in paragraph (a)(1) of this section).

(ii) Indications for use. For increased rate of weight gain.

(iii) Limitations. Implant subcutaneously in ear only. Not for dairy or beef replacement heifers.

Dated: December 17, 2002.

Steven D. Vaughn,

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