[Federal Register Volume 63, Number 221 (Tuesday, November 17, 1998)] [Rules and Regulations] [Pages 63788-63789] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-30611] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 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, Division of American Home Products Corp. The supplemental NADA provides for the use of a trenbolone acetate and estradiol benzoate ear implant in heifers fed in confinement for slaughter for increased rate of weight gain. EFFECTIVE DATE: November 17, 1998. FOR FURTHER INFORMATION CONTACT: Jack Caldwell, Center for Veterinary Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0217. SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of American Home Products Corp., 800 Fifth St. NW., Ft. Dodge, IA 50501, filed supplemental NADA 141-043 that provides for use of an implantation containing 200 milligrams (mg) trenbolone acetate and 28 mg estradiol benzoate (SynovexPlus) in heifers fed in confinement for slaughter for increased rate of weight gain. The supplemental NADA is approved as of September 30, 1998, and the regulations are amended in 21 CFR 522.2478 by adding paragraph (c)(2) to reflect the approval. The basis for 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 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 approval for food producing animals qualifies for 3 years of marketing exclusivity beginning September 30, 1998, because the supplemental application contains substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or, in the case of food producing animals, human food safety studies (other than bioequivalence or residue studies) required for the approval of the supplement and conducted or sponsored by the applicant. The 3 years of marketing exclusivity applies only to use in confined heifers for increased rate of weight gain for which the supplemental application is approved. 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. 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 [[Page 63789]] 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 amended by adding paragraph (c)(2) to read as follows: Sec. 522.2478 Trenbolone acetate and estradiol benzoate. * * * * * (c) * * * (2) Heifers--(i) Amount. 200 milligrams of trenbolone acetate and 28 milligrams of estradiol benzoate (one implant consisting of 8 pellets, each pellet containing 25 milligrams of trenbolone acetate and 3.5 milligrams of estradiol benzoate) per animal. (ii) Indications for use. For increased rate of weight gain in heifers fed in confinement for slaughter. (iii) Limitations. Implant subcutaneously in ear only. Not for dairy or beef replacement heifers. Dated: November 3, 1998. Andrew J. Beaulieu, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 98-30611 Filed 11-16-98; 8:45 am] BILLING CODE 4160-01-F