[Federal Register Volume 62, Number 53 (Wednesday, March 19, 1997)] [Rules and Regulations] [Pages 12951-12952] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-6876] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Bacitracin Methylene Disalicylate and Chlortetracycline 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 Alpharma Inc. The NADA provides for using currently approved, single ingredient, Type A medicated articles in making combination drug, Types B and C medicated, swine feeds containing bacitracin methylene disalicylate and chlortetracycline. The Type C medicated feed is used for increased rate of weight gain and improved feed efficiency due to the activity of bacitracin, and treatment of enteritis and pneumonia caused by certain bacteria susceptible to chlortetracycline. EFFECTIVE DATE: March 19, 1997. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1644. SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024, filed NADA 141-059, which provides for combining separately approved, Type A medicated articles containing BMD(bacitracin methylene disalicylate (bacitracin MD)) and CTC (chlortetracycline) in making combination drug, Type C medicated swine feed. The Type C medicated feed [[Page 12952]] contains 10 to 30 grams (g) of bacitracin MD and approximately 400 g of CTC per ton varying with body weight and food consumption to provide 10 milligrams of CTC per pound of body weight per day. The feed is indicated for increased rate of weight gain and improved feed efficiency due to the activity of bacitracin, and treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to CTC. The NADA is approved as of September 18, 1996, and the regulations are amended by revising 21 CFR 558.76(d)(1) and by adding 21 CFR 558.128(c)(3)(xiv) 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 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. Under section 512(c)(2)(ii) of the Federal Food, Drug, and Cosmetic Act, this approval does not qualify for marketing exclusivity because the application contains no new clinical or field investigations (other than bioequivalence or residue studies) essential to the approval of the application and conducted or sponsored by the applicant. 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. 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 558.76 is amended in the table in paragraph (d)(1) under entry (iv) by adding a new item for Chlortetracycline approximately 400 to read as follows: Sec. 558.76 Bacitracin methylene disalicylate. * * * * * (d) * * * (1) * * * ---------------------------------------------------------------------------------------------------------------- Bacitracin methylene disalicylate in grams per Combination in grams Indications for use Limitations Sponsor ton per ton ---------------------------------------------------------------------------------------------------------------- * * * * * * * (iv) 10 to 30 * * * * * * * * * * * * Chlortetracycline Swine; for increased Feed for not more 046573 approximately 400, rate of weight gain than 14 days to varying with body and improved feed provide 10 weight and food efficiency; for milligrams of consumption to treatment of chlortetracycline provide 10 bacterial enteritis per pound of body milligrams per pound caused by weight per day; as of body weight per Escherichia coli and chlortetracycline day. Salmonella provided by No. choleraesuis and 046573 in Sec. bacterial pneumonia 510.600(c) of this caused by chapter. Pasteurella multocida susceptible to chlortetracycline. * * * * * * * ---------------------------------------------------------------------------------------------------------------- * * * * * 3. Section 558.128 is amended by adding new paragraph (c)(3)(xiv) to read as follows: Sec. 558.128 Chlortetracycline. * * * * * (c) * * * (3) * * * (xiv) Bacitracin methylene disalicylate in accordance with Sec. 558.76. Dated: February 6, 1997. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 97-6876 Filed 3-18-97; 8:45 am] BILLING CODE 4160-01-F