[Federal Register Volume 61, Number 166 (Monday, August 26, 1996)] [Rules and Regulations] [Page 43654] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-21728] [[Page 43654]] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Milbemycin Oxime 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 Ciba-Geigy Animal Health, Ciba-Geigy Corp. The supplemental NADA provides for expanding the indications for use of milbemycin oxime tablets in dogs and puppies to include removal and control of adult roundworm infections caused by Toxascaris leonina. EFFECTIVE DATE: August 26, 1996. FOR FURTHER INFORMATION CONTACT: Marcia K. Larkins, Center for Veterinary Medicine (HFV-112), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-0614. SUPPLEMENTARY INFORMATION: Ciba-Geigy Animal Health, Ciba-Geigy Corp., P.O. Box 18300, Greensboro, NC 27419-8300, is the sponsor of NADA 140- 915, which covers Interceptor(milbemycin oxime) tablets. The product is currently approved for the prevention of heartworm disease caused by Dirofilaria immitis, control of hookworm infections caused by Ancylostoma caninum, and removal and control of adult roundworm infections caused by Toxocara canis and whipworm infections caused by Trichuris vulpis in dogs and in puppies 4 weeks of age or greater and 2 pounds of body weight or greater. The supplemental NADA provides for expanding the indications for use in both dogs and puppies by adding removal and control of the adult roundworm T. leonina. The drug is available by veterinary prescription. The supplemental NADA 140-915 is approved as of July 9, 1996, and the regulations are amended in 21 CFR 520.1445(c)(2) 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, 12420 Parklawn Dr., rm. 1-23, 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 qualifies for 3 years of marketing exclusivity for the new indications beginning on July 9,1996, because the application includes reports of new clinical or field investigations (other than bioequivalence or residue studies) essential to the approval and conducted by the sponsor. 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 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 The authority citation for 21 CFR part 520 continues to read as follows: Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b). Sec. 520.1445 [Amended] 2. Section 520.1445 Milbemycin oxime tablets is amended in paragraph (c)(2) by adding the phrase ``and Toxascaris leonina'' after ``Toxocara canis''. Dated: August 14, 1996. Robert C. Livingston, Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 96-21728 Filed 8-23-96; 8:45 am] BILLING CODE 4160-01-F