[Federal Register Volume 63, Number 147 (Friday, July 31, 1998)] [Rules and Regulations] [Pages 40824-40825] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-20466] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; 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 supplemental new animal drug application (NADA) filed by Alpharma Inc. The supplemental NADA provides for using approved bacitracin methylene disalicylate (BMD) Type A medicated articles to make a Type C medicated feed for replacement chickens. EFFECTIVE DATE: July 31, 1998. FOR FURTHER INFORMATION CONTACT: William T. Flynn, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1652. SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, filed supplemental NADA 46-592 that provides for using approved BMD(10, 25, 30, 40, 50, 60, or 75 grams (g) per pound BMD) Type A medicated articles to make Type C medicated replacement chicken feed. A Type C feed containing 50 g per ton (/t) BMD is fed continuously as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to BMD. A Type C feed containing 100 to 200 g/t BMD is fed for 5 to 7 days, or as long as clinical signs persist, as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to BMD. The supplemental NADA is approved as of June 22, 1998, and the regulations in 21 CFR 558.76(d)(1) are amended in the table in items (vi) and (ix) to add new entries 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 the 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. FDA has determined under 21 CFR 25.33(a)(1) that these actions are of a type that do 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 in paragraph (d)(1) in the table in items (vi) and (ix) by adding new entries to read as follows: Sec. 558.76 Bacitracin methylene disalicylate. * * * * * (d) * * * (1) * * * [[Page 40825]] ---------------------------------------------------------------------------------------------------------------- Bacitracin methylene Combination in Indications for disalicylate in grams per ton grams per ton use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * (vi) * * *.................... .................. Replacement Feed continuously 046573 chickens; as an as sole ration.. aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. * * * * * * * (ix) * * *.................... .................. Replacement Feed continuously 046573 chickens; as an as sole ration. aid in the Start at first control of clinical signs of necrotic disease, vary enteritis caused dosage based on or complicated by severity of Clostridium spp. infection, or other administer organisms continuously for susceptible to 5 to 7 days or as bacitracin. long as clinical signs persist, then reduce medication to prevention level (50 g/t). * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * Dated: July 10, 1998. Margaret Ann Miller, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 98-20466 Filed 7-30-98; 8:45 am] BILLING CODE 4160-01-F