[Federal Register Volume 59, Number 123 (Tuesday, June 28, 1994)] [Unknown Section] [Page ] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-15672] [Federal Register: June 28, 1994] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 94N--0097] Miles, Inc., et al.; Withdrawal of Approval of NADA's AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADA's). One NADA is held by Miles, Inc., and provides for use of febantel-trichlorfon paste as an equine anthelmintic and boticide. The other NADA is held by Nutra-Blend Corp. and provides for use of a tylosin concentrate to manufacture a Type A medicated article and Type B medicated feeds. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the regulations by removing the entries which reflect approval of the NADA's. EFFECTIVE DATE: July 8, 1994. FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for Veterinary Medicine (HFV-216), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-0749. SUPPLEMENTARY INFORMATION: Miles, Inc., Agriculture Division, Animal Health Products, P.O. Box 390, Shawnee Mission, KS 66201, is the sponsor of NADA 131-412 that provides for use of Combotel/Negabot-Plus (febantel-trichlorfon) Paste in horses as an anthelmintic and boticide. In a letter dated December 20, 1993, Miles, Inc., requested that FDA withdraw approval of NADA 131-412 because it no longer manufactures or distributes the product. Nutra-Blend Corp., P.O. Box 485, Neosho, MO 64850, is the sponsor of NADA 122-158 that provides for the manufacture of Type B medicated feeds containing 4, 5, 10, and 20 grams per pound (g/lb) of tylosin and a Type A medicated article containing 40 g/lb of tylosin. Currently, Nutra-Blend Corp. is purchasing the 40-gram-per-pound article to manufacture the 10-gram-per-pound feed. Because this arrangement no longer requires that Nutra-Blend Corp. hold an approved NADA, the firm requested in its letter of December 15, 1993, that FDA withdraw approval of NADA 122-158. Therefore, under authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal of approval of applications (21 CFR 514.115), notice is given that approval of NADA's 122-158 and 131-412, and all supplements and amendments thereto is hereby withdrawn, effective July 8, 1994. In a final rule published elsewhere in this issue of the Federal Register, FDA is removing 21 CFR 520.903c and amending 21 CFR 558.625 to reflect the withdrawal of approval of these NADA's. Dated: June 15, 1994. Richard H. Teske, Acting Director, Center for Veterinary Medicine. [FR Doc. 94-15672 Filed 6-27-94; 8:45 am] BILLING CODE 4160-01-F