[Federal Register: February 2, 1999 (Volume 64, Number 21)] [Rules and Regulations] [Page 4965-4966] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr02fe99-4] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use In Animal Feeds; Narasin and Nicarbazin With Bacitracin Methylene Disalicylate 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 new animal drug application (NADA) filed by Elanco Animal Health, a Division of Eli Lilly & Co. The NADA provides for combining approved narasin/nicarbazin (1:1 fixed ratio) and bacitracin methylene disalicylate (BMD) Type A medicated articles to make combination drug Type C medicated broiler chicken feeds for prevention of certain forms of coccidiosis and for increased rate of weight gain and improved feed efficiency. EFFECTIVE DATE: February 2, 1999. FOR FURTHER INFORMATION CONTACT: Charles J. Andres, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-1600. SUPPLEMENTARY INFORMATION: Elanco Animal Health, a Division of Eli Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed NADA 140-926 that provides for combining approved narasin/nicarbazin (1:1 fixed ratio) Maxiban and BMD Type A medicated articles to make combination drug Type C medicated broiler chicken feeds. The feeds contain 27 to 45 grams per ton (g/t) each of narasin and nicarbazin and 4 to 50 g/t BMD. The feeds are used for the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency. The NADA is approved as of January 4, 1999, and the regulations are amended in 21 CFR 558.76, 558.363, and 558.366 to reflect the approval. [[Page 4966]] 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. This approval is for use of approved Type A medicated articles to make combination drug Type C medicated feeds. One ingredient, nicarbazin, is a Category II drug as defined in 21 CFR 558.3(b)(1)(ii). As provided in 21 CFR 558.4(b), an approved form FDA 1900 is required for making a Type B or C medicated feed as in this application. Under 21 U.S.C. 360b(m), as amended by the Animal Drug Availability Act of 1996 (Pub. L. 104-250), medicated feed applications have been replaced by a requirement for manufacture in a licensed feed mill. Therefore, use of narasin/nicarbazin and BMD Type A medicated articles to make Type C medicated feeds as in NADA 140-926 requires manufacture in a licensed feed mill. The agency has determined under 21 CFR 25.33(a)(2) 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 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: 21 U.S.C. 360b, 371. 2. Section 558.76 is amended by adding paragraph (d)(3)(xix) to read as follows: Sec. 558.76 Bacitracin methylene disalicylate. * * * * * (d) * * * (3) * * * (xix) Narasin and nicarbazin as in Sec. 558.366. 3. Section 558.363 is amended by adding paragraph (d)(2)(ii) to read as follows: Sec. 558.363 Narasin. * * * * * (d) * * * (2) * * * (ii) Nicarbazin and bacitracin methylene disalicylate as in Sec. 558.366. 4. Section 558.366 is amended in the table in paragraph (c) under entry ``27 to 45'' by alphabetically adding an entry for ``Narasin 27 to 45 and bacitracin methylene disalicylate 4 to 50'' to read as follows: Sec. 558.366 Nicarbazin. * * * * * (c) * * * ---------------------------------------------------------------------------------------------------------------- Nicarbazin in grams Combination in grams per ton per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- 27 to 45 Narasin 27 to 45 and Broiler chickens; Feed continuously as 000986 bacitracin methylene prevention of sole ration. disalicylate 4 to 50 coccidiosis caused Withdraw 5 days by Eimeria tenella, before slaughter. Do E. necatrix, E. not allow turkeys, acervulina, E. horses, or other maxima, E. brunetti, equines access to E. mivati; for formulations increased rate of containing narasin. weight gain and Ingestion of narasin improved feed by these species has efficiency. been fatal. Do not feed to laying hens. Narasin and nicarbazin as provided by 000986, bacitracin methylene disalicylate by 046573. * * * * * * * ---------------------------------------------------------------------------------------------------------------- Dated: January 22, 1999. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 99-2411 Filed 2-1-99; 8:45 am] BILLING CODE 4160-01-F