[Federal Register: February 18, 1998 (Volume 63, Number 32)] [Rules and Regulations] [Page 8122-8123] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr18fe98-25] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Difloxacin Tablets 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 new animal drug application (NADA) filed by Fort Dodge Animal Health. The NADA provides for oral use of difloxacin tablets for management of diseases in dogs associated with bacteria susceptible to difloxacin. EFFECTIVE DATE: February 18, 1998. FOR FURTHER INFORMATION CONTACT: Tania D. Woerner, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1617. SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of American Home Products, 800 Fifth St. NW., P.O. Box 518, Fort Dodge, IA 50501, filed NADA 141-096 that provides for oral use of Dicural (difloxacin) tablets for management of diseases in dogs associated with bacteria susceptible to difloxacin. The drug is limited to use by or on the order of a licensed veterinarian. The NADA is approved as of November 20, 1997, and the regulations are amended by adding new Sec. 520.645 to reflect the approval. 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, 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)(iv) of the Federal Food, Drug, and Cosmetic Act [[Page 8123]] (the act), this approval, which is solely for nonfood-producing animals qualifies for 3 years of marketing exclusivity beginning November 20, 1997, because the applicant has elected to waive section 512(c)(2)(F)(i) of the act. FDA has determined under 21 CFR 25.33(d) 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 the 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. 2. Section 520.645 is added to read as follows: Sec. 520.645 Difloxacin. (a) Specifications. Each tablet contains 11.4, 45.4, or 136 milligrams (mg) of difloxacin hydrochloride. (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use--(1) Dogs--(i) Amount. 5 to 10 mg per kilogram (2.3 to 4.6 mg/pound) of body weight. (ii) Indications for use. For management of diseases in dogs associated with bacteria susceptible to difloxacin. (iii) Limitations. Use once a day for 2 to 3 days beyond cessation of clinical signs of disease up to a maximum of 30 days. Federal law prohibits the extra-label use of this drug in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] Dated: January 21, 1998. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 98-3984 Filed 2-17-98; 8:45 am] BILLING CODE 4160-01-F