[Federal Register Volume 60, Number 200 (Tuesday, October 17, 1995)] [Rules and Regulations] [Pages 53701-53702] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-25623] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use In Animal Feeds; Decoquinate 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 Rhone-Poulenc, Inc. The supplemental NADA provides for use of decoquinate Type A medicated articles to make Type C medicated feeds for young sheep for the prevention of certain forms of coccidiosis. EFFECTIVE DATE: October 17, 1995. FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for Veterinary [[Page 53702]] Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1643. SUPPLEMENTARY INFORMATION: Rhone-Poulenc, Inc., 500 Northridge Rd., suite 620, Atlanta, GA 30350, filed supplemental NADA 39-417, which provides for use of Deccox(decoquinate) Type A medicated article to make a Type C medicated feed for young sheep for the prevention of coccidiosis caused by Eimeria bakuensis, E. crandallis, E. ovinoidalis, and E. parva. The supplemental NADA is approved as of August 28, 1995, and the regulations are amended in 21 CFR 558.195 to reflect the approval. The basis of 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, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for food- producing animals qualifies for 3 years of marketing exclusivity beginning August 28, 1995, because the supplemental NADA contains reports of new clinical or field investigations (other than bioequivalence or residue studies) essential to approval and conducted or sponsored by the applicant. Marketing exclusivity applies only to the use for which the supplemental NADA is approved. The agency has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. The agency's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday. 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 558.195 is amended in paragraph (d) in the table by numerically adding a new entry to read as follows: Sec. 558.195 Decoquinate. -* * * * * (d) * * * ---------------------------------------------------------------------------------------------------------------- Combination in grams Decoquinate in grams per ton per ton Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- * * * * * * * 13.6 (0.0015 pct).............. ....................... Young sheep; for Feed Type C feed at 011526 the prevention of a rate to provide coccidiosis caused 22.7 mg per 100 lb by Eimeria of body weight ovinoidalis, E. (0.5 mg per kg) crandallis, E. per day. Feed at parva, E. least 28 days bakuensis. during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for food. * * * * * * * ---------------------------------------------------------------------------------------------------------------- Dated: October 5, 1995. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 95-25623 Filed 10-16-95; 8:45 am] BILLING CODE 4160-01-F