[Federal Register: August 28, 1998 (Volume 63, Number 167)] [Rules and Regulations] [Page 45944] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr28au98-13] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Neomycin Sulfate Soluble Powder and Oral Solution 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 abbreviated new animal drug application (ANADA) filed by Phoenix Scientific, Inc. The supplemental ANADA provides for revised withdrawal times for oral solution as a drench and in drinking water for the treatment and control of colibacillosis in cattle (excluding veal calves), swine, sheep, and goats. EFFECTIVE DATE: August 28, 1998. FOR FURTHER INFORMATION CONTACT: Lonnie W. Luther, Center for Veterinary Medicine (HFV-102), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-0209. SUPPLEMENTARY INFORMATION: Phoenix Scientific, Inc., 3915 South 48th St. Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, is the sponsor of ANADA 200-118 that provides for the use of neomycin sulfate soluble powder and oral solution as a drench in milk, or in drinking water for the treatment and control of colibacillosis in cattle (excluding veal calves), swine, sheep, and goats. The sponsor filed a supplement that provides for the revised withdrawal periods for the use of the generic product to be identical to that of the pioneer product. The supplemental ANADA is approved as a generic copy of Pharmacia & Upjohn's NADA 011-315 Neomix. Supplemental ANADA 200-118 is approved as of July 14, 1998, and the regulations are amended in 21 CFR 520.1485 to reflect the approval for the neomycin sulfate solution. The basis for 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 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 520 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 520 is amended as follows: PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: Authority: 21 U.S.C. 360b. Sec. 520.1485 [Amended] 3. Section 520.1485 Neomycin sulfate oral solution is amended in paragraph (d)(3) by removing ``For sponsor 059130: 30 days for cattle and goats, and 20 days for swine and sheep; for sponsors 000009 and 050604:''. Dated: August 17, 1998. Andrew J. Beaulieu, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 98-23108 Filed 8-27-98; 8:45 am] BILLING CODE 4160-01-F