[Federal Register Volume 63, Number 27 (Tuesday, February 10, 1998)] [Rules and Regulations] [Page 6644] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-3293] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 558 New Animal Drugs For Use In Animal Feeds; Salinomycin 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 Hoffmann-La Roche, Inc. The NADA provides for use of an alternate formulation of salinomycin Type A medicated articles to make Type C medicated feeds. EFFECTIVE DATE: February 10, 1998. FOR FURTHER INFORMATION CONTACT: Mary G. Leadbetter, Center for Veterinary Medicine (HFV-143), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1662. SUPPLEMENTARY INFORMATION: Hoffmann-La Roche, Inc., Nutley, NJ 07110- 1199, is sponsor of NADA 128-686 that provides for use of Bio- Cox(salinomycin) Type A medicated articles to make Type C medicated feeds for broiler, roaster, and replacement chickens, and quail. The firm filed a supplement to the NADA that provides for use of a 60-grams-per-pound (g/lb) salinomycin Type A medicated article in addition to the currently approved 30-g/lb product. The supplemental NADA is approved as of January 9, 1998, and the regulations are amended in 21 CFR 558.550(a)(1) to reflect the approval. Approval of this supplemental NADA does not require additional safety or effectiveness data or information. A freedom of information summary as provided under 21 CFR part 20 and 514.11(e)(2)(ii) is not required. The agency has determined under 21 CFR 25.33(a)(3) 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 the 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. Sec. 558.550 [Amended] 2. Section 558.550 Salinomycin is amended in paragraph (a)(1) by removing ``30'' and adding in its place ``30 and 60''. Dated: January 28, 1998. Andrew J. Beaulieau, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 98-3293 Filed 2-9-98; 8:45 am] BILLING CODE 4160-01-F