[Federal Register Volume 63, Number 31 (Tuesday, February 17, 1998)] [Rules and Regulations] [Page 7701] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-3897] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin Phosphate Injection 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 Elanco Animal Health, A Division of Eli Lilly and Co. The supplemental NADA provides for removal of the label warnings concerning subcutaneous use of tilmicosin phosphate injection in preruminating (veal) calves. Removal of the warning is based on a tissue residue depletion study in calves less than 1 month of age. EFFECTIVE DATE: February 17, 1998. FOR FURTHER INFORMATION CONTACT: Naba K. Das, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1659. SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285, is sponsor of NADA 140-929 that provides for the subcutaneous use of Micotil300 (tilmicosin phosphate) Injection for the treatment of cattle with bovine respiratory disease (BRD) associated with Pasteurella haemolytica. The drug is limited to use by or on the order of a licensed veterinarian. The firm filed a supplemental NADA providing for removal of the warning statements regarding use of the product in preruminating (veal) calves. The supplemental NADA is approved as of December 23, 1997, and the regulations are amended in 21 CFR 522.2471(d)(1)(iii) 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 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 522 Animal drugs. 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 522 is amended as follows: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 522.2471 [Amended] 2. Section 522.2471 Tilmicosin phosphate injection is amended in paragraph (d)(1)(iii) by removing the 13th and 14th sentences. Dated: January 30, 1998. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 98-3897 Filed 2-13-98; 8:45 am] BILLING CODE 4160-01-F