[Federal Register Volume 61, Number 91 (Thursday, May 9, 1996)] [Rules and Regulations] [Pages 21075-21076] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-11514] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Part 558 New Animal Drugs For Use In Animal Feeds; Halofuginone Hydrobromide, Bacitracin Methylene Disalicylate AGENCY: Food and Drug Administration, HHS. [[Page 21076]] ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Hoechst-Roussel Agri-Vet Co. The NADA provides for using approved single ingredient Type A medicated articles to make Type C medicated turkey feeds containing halofuginone hydrobromide and bacitracin methylene disalicylate. EFFECTIVE DATE: May 9, 1996 FOR FURTHER INFORMATION CONTACT: James F. McCormack, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1607. SUPPLEMENTARY INFORMATION: Hoechst-Roussel Agri-Vet Co., Route 202-206, P.O. Box 2500, Somerville, NJ 08876-1258, has filed NADA 140-919, which provides for use of approved Stenorol(2.72 grams of halofuginone hydrobromide per pound of Type A article) and approved BMD (30, 50, or 60 grams of bacitracin methylene disalicylate per pound) to make Type C medicated turkey feeds containing 1.36 to 2.72 grams per ton (g/t) halofuginone hydrobromide and 10 to 50 g/t bacitracin methylene disalicylate, for prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain. The NADA 140-919 is approved as of May 9, 1996, and the regulations are amended in Sec. 558.265(c)(2)(ii) (21 CFR 558.265(c)(2)(ii)) 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 part 20 (21 CFR part 20) and Sec. 514.11(e)(2)(ii) (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 Dockets Management Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. This approval is for use of single ingredient Type A medicated articles to make Type C medicated feeds. Halofuginone hydrobromide is a Category II drug which, as provided in Sec. 558.4, requires an approved form FDA 1900 for making a Type C medicated feed. Therefore, use of halofuginone hydrobromide and bacitracin methylene disalicylate Type A medicated articles to make a combination drug Type C medicated feed as provided in NADA 140-919 requires an approved form FDA 1900. The agency has determined under 21 CFR 25.24(d)(1)(ii) 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. 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 for use in food-producing animals qualifies for 3 years of marketing exclusivity beginning May 9, 1996, because the application contains reports of new clinical or field investigations (other than bioequivalence or residue studies) essential to the approval and conducted or sponsored by the applicant. List of Subjects in 21 CFR Part 558 Animal drugs, Animal feeds. 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 558 is amended as follows: PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS 1. The authority citation for 21 CFR part 558 continues to read as follows: Authority: Secs. 512, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b, 371). 2. Section 558.265 is amended by adding new paragraph (c)(2)(ii) to read as follows: Sec. 558.265 Halofuginone hydrobromide. * * * * * (c) * * * (2) * * * (ii) Amount per ton. Halofuginone hydrobromide 1.36 to 2.72 grams plus bacitracin methylene disalicylate 10 to 50 grams. (A) Indications for use. For prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain in growing turkeys. (B) Limitations. Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl. Keep out of lakes, ponds, and streams. Halofuginone is toxic to fish and aquatic life. Halofuginone is an irritant to eyes and skin. Avoid contact with skin, eyes, or clothing. Dated: April 26, 1996. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 96-11514 Filed 5-8-96; 8:45 am] BILLING CODE 4160-01-F