[Federal Register Volume 60, Number 188 (Thursday, September 28, 1995)] [Rules and Regulations] [Pages 50097-50098] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-24159] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 520 and 556 Animal Drugs, Feeds, and Related Products; Sarafloxacin Hydrochloride 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 Abbott Laboratories. The NADA provides for use of sarafloxacin hydrochloride in turkey and broiler chicken drinking water for control of mortality associated with Escherichia coli organisms susceptible to sarafloxacin. EFFECTIVE DATE: September 28, 1995. FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for Veterinary Medicine (HFV-133), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1644. SUPPLEMENTARY INFORMATION: Abbott Laboratories, 1401 Sheridan Rd., North Chicago, IL 60064-4000, filed NADA 141-017, which provides for use of sarafloxacin hydrochloride (SaraFloxWSP) water soluble powder to make turkey and broiler chicken medicated drinking water used for control of mortality associated with E. coli organisms susceptible to sarafloxacin. The NADA is approved as of August 18, 1995, and the regulations are amended by adding new Sec. 520.2095 to reflect the approval. The basis of approval is discussed in the freedom of information summary. In addition, part 556 (21 CFR part 556) is amended by adding new Sec. 556.594 to reflect that a tolerance for residues of sarafloxacin in edible turkey and broiler chicken tissues is not required. At zero withdrawal, the total residue of sarafloxacin HC1 in the target tissue (liver) is less than half the safe concentration (5.25 ppm). The marker compound, parent sarafloxacin HC1, represents 20 to 80 percent of the total residue in liver of turkeys and 60 to 80 percent of the total residue in liver of chickens, depending upon the extraction procedure. 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, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 5 years of marketing exclusivity beginning August 18, 1995, because no active ingredient (including any ester or salt thereof) has been previously approved in any other application filed under section 512(b)(1) of the act. 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 21 CFR Part 520 Animal drugs. 21 CFR Part 556 Animal drugs, foods. 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 parts 520 and 556 are 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: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b). 2. New Sec. 520.2095 is added to read as follows: Sec. 520.2095 Sarafloxacin soluble powder. (a) Specifications. Each 145 grams (5.1 ounces) pouch contains sarafloxacin hydrochloride equivalent to 14.5 grams of sarafloxacin base. (b) Sponsor. See No. 000074 in Sec. 510.600(c) of this chapter. (c) Related tolerances. See Sec. 556.594 of this chapter. [[Page 50098]] (d) Conditions of use. Used in drinking water as follows: (1) Amount. Chickens--20 to 40 parts per million for 5 consecutive days as the only source of drinking water. Turkeys--30 to 50 parts per million for 5 consecutive days as the only source of drinking water. (2) Indications for use. For control of mortality in growing turkeys and broiler chickens associated with Escherichia coli organisms susceptible to sarafloxacin. (3) Limitations. No preslaughter drug withdrawal period is required when the product is used as directed. Use in a manner other than that indicated or with a dose in excess of that recommended may result in drug residues in edible tissues. Do not use in laying hens producing eggs for human consumption. The effects of sarafloxacin on the reproductive function of treated fowl have not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian. PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD 3. The authority citation for 21 CFR part 556 continues to read as follows: Authority: Secs. 402, 512, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342, 360b, 371). 4. New Sec. 556.594 is added to subpart B to read as follows: Sec. 556.594 Sarafloxacin. A tolerance for residues of sarafloxacin in edible turkey and broiler chickens tissues is not required. Dated: September 21, 1995. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 95-24159 Filed 9-27-95; 8:45 am] BILLING CODE 4160-01-F