[Federal Register Volume 62, Number 224 (Thursday, November 20, 1997)] [Rules and Regulations] [Pages 61911-61912] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-30408] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs for Use in Animal Feeds; Clopidol and Bacitracin Zinc 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 an abbreviated new animal drug application (ANADA) filed by Alpharma Inc. The ANADA provides for using approved clopidol and bacitracin zinc Type A medicated articles to make Type C medicated broiler chicken feeds used for prevention of coccidiosis, improved feed efficiency, and increased rate of weight gain. EFFECTIVE DATE: November 20, 1997. FOR FURTHER INFORMATION CONTACT: Jeffrey M. Gilbert, Center for Veterinary Medicine (HFV-128), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1602. SUPPLEMENTARY INFORMATION: Alpharma Inc., One Executive Dr., P.O. Box 1399, Fort Lee, NJ 07024, is sponsor of ANADA 200-218 that provides for combining approved clopidol and bacitracin zinc Type A medicated articles to make Type C medicated feeds for broilers containing clopidol 113.5 grams per ton (g/t) and bacitracin zinc 5 to 25 g/t. The Type C medicated feed is used as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency. Alpharma Inc.'s ANADA 200-218 is approved as a generic copy of Rhone- [[Page 61912]] Poulenc, Inc.'s NADA 49-934. The ANADA is approved as of November 20, 1997 and the regulations are amended in Sec. 558.175 (21 CFR 558.175) to reflect the approval. The basis for approval is discussed in the freedom of information summary. In addition, Sec. 558.175 is amended to reflect the approval by redesignating paragraph (c) as paragraph (d), by reserving paragraph (c), and by amending newly redesignated paragraph (d)(1)(iv)(b). 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, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. The agency has determined under 21 CFR 25.33(a)(1) 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 The authority citation for 21 CFR part 558 continues to read as follows: Authority: 21 U.S.C. 360b, 371. Sec. 558.175 [Amended] 2. Section 558.175 Clopidol is amended by redesignating paragraph (c) as paragraph (d), by reserving paragraph (c), and in newly redesignated paragraph (d)(1)(iv)(b) by removing ``No. 000061'' and adding in its place ``Nos. 000061 and 046573''. Dated: October 30, 1997. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 97-30408 Filed 11-19-97; 8:45 am] BILLING CODE 4160-01-F