[Federal Register Volume 64, Number 176 (Monday, September 13, 1999)] [Rules and Regulations] [Pages 49383-49385] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-23665] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Nicarbazin and Bambermycins AGENCY: Food and Drug Administration, HHS. [[Page 49384]] 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 Vet. The NADA provides for combining approved single ingredient nicarbazin and bambermycins Type A medicated articles to make Type C medicated broiler chicken feeds to be used as an aid in preventing outbreaks of cecal and intestinal forms of coccidiosis, and for increased rate of weight gain and improved feed efficiency. EFFECTIVE DATE: September 13, 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: Hoechst Roussel Vet, 30 Independence Blvd., P.O. Box 4915, Warren, NJ 07059, filed NADA 140-339 that provides for combining approved single ingredient Nicarb(nicarbazin) and Flavomycin (bambermycins) Type A medicated articles to make Type C medicated broiler chicken feeds containing 113.5 grams per ton (g/t) nicarbazin and 1 to 2 g/t bambermycins. The Type C medicated broiler chicken feeds are used as an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of weight gain and improved feed efficiency in broiler chickens. The NADA is approved as of August 6, 1999, and the regulations are amended in Sec. 558.95 (21 CFR 558.95) by adding paragraph (d)(5)(iv), and in 21 CFR 558.366 in the table in paragraph (c) by adding an entry, to reflect the approval. Also, the introductory text of Sec. 558.95(d)(5) is revised to better reflect the combination approvals. In accordance with the freedom of information provisions of 21 CFR parts 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 single ingredient 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 to make Type C medicated feed from a Category II drug. Under section 512(m) of the act (21 U.S.C. 360b(m)), as amended by the Animal Drug Availability Act of 1996 (Public Law 104-250), medicated feed applications have been replaced by a requirement for feed mill licenses. Therefore, use of Type A medicated articles to make Type C medicated feeds as provided in NADA 140-339 is limited to 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. 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 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 558.95 is amended by revising the introductory text of paragraph (d)(5) and by adding paragraph (d)(5)(iv) to read as follows: Sec. 558.95 Bambermycins. * * * * * (d) * * * (5) Bambermycins may be used in chickens as in paragraph (d)(1) of this section in combination with: * * * * * (iv) Nicarbazin as in Sec. 558.366. 3. Section 558.366 is amended in the table in paragraph (c) under the entry for ``113.5 (0.0125 pct)'' by alphabetically adding an item for ``Bambermycins 1 to 2'' and revising the item for ``Lincomycin 2'' to read as follows: Sec. 558.366 Nicarbazin. * * * * * (c) * * * ---------------------------------------------------------------------------------------------------------------- Nicarbazin in grams Combination in grams per ton per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * 113.5 (0.0125 pct) * * * * * * * * * * * * * * * * Bambermycins 1 to 2 Broiler chickens; aid Feed continuously as 012799 in preventing sole ration from outbreaks of cecal time chicks are (Eimeria tenella) placed on litter and intestinal (E. until past the time acervulina, E. when coccidiosis is maxima, E. necatrix, ordinarily a hazard; and E. brunetti) do not use as a coccidiosis, for treatment for increased rate of coccidiosis; do not weight gain and use in flushing improved feed mashes; do not feed efficiency. to laying hens; withdraw 4 days before slaughter. Nicarbazin as provided by 063271. [[Page 49385]] Lincomycin 2 (0.00044 Broiler chickens; aid Feed continuously as 060728 063271 pct) in preventing sole ration from outbreaks of secal time chicks are (Eimeria tenella) placed on litter and intestinal (E. until past the time acervulina, E. when coccidiosis is maxima, E. necatrix, ordinarily a hazard; and E. brunetti) do not use as a coccidiosis; for treatment for increased rate of coccidiosis; do not weight gain. use in flushing mashes; do not feed to laying hens; withdraw 4 days before slaughter. * * * * * * * ---------------------------------------------------------------------------------------------------------------- Dated: August 30, 1999. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 99-23665 Filed 9-10-99; 8:45 am] BILLING CODE 4160-01-F