[Federal Register Volume 62, Number 44 (Thursday, March 6, 1997)] [Rules and Regulations] [Pages 10219-10220] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-5452] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 522 Implantation or Injectable Dosage Form New Animal Drugs; 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 supplemental new animal drug application (NADA) filed by Abbott Laboratories. The supplement provides for use of sarafloxacin hydrochloride solution for injection in 18-day embryonated broiler eggs for control of early chick mortality associated with Escherichia coli organisms susceptible to sarafloxacin. EFFECTIVE DATE: March 6, 1997. 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 a supplement to NADA 141-018 that provides for use of sarafloxacin hydrochloride solution for injection (SaraFloxInjection) in 18-day embryonated broiler eggs in addition to approved use in day-old broiler chickens for control of early chick mortality associated with E. coli organisms susceptible to sarafloxacin. The supplement is approved as of January 21, 1997, and the regulations are amended by revising 21 CFR 522.2095(d) 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 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)(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 beginning January 21, 1997, because this supplement contains substantial evidence of the effectiveness of the drug involved, studies of animal safety, or human food safety studies (other than bioequivalence or residue studies), required for approval and conducted or sponsored by the applicant. Marketing exclusivity applies only to use in 18-day embryonated broiler eggs. 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 522 Animal drugs. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner [[Page 10220]] of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is amended as follows: PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 522 continues to read as follows: Authority: Sec. 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b). 2. Section 522.2095 is amended by revising paragraph (d) to read as follows: Sec. 522.2095 Sarafloxacin solution for injection. * * * * * (d) Conditions of use. 18-day embryonated broiler eggs and day-old broiler chickens: (1) Amount--(i) 18-day embryonated broiler eggs: 0.05 milligram sarafloxacin in 0.1 milliliter dose in single in ovo injection. (ii) Day-old broiler chickens: 0.1 milligrams sarafloxacin per 0.2 milliliter dose in single subcutaneous injection in the neck. (2) Indications for use. For control of early chick mortality associated with Escherichia coli organisms susceptible to sarafloxacin. (3) Limitations. Dilute 1 milliliter with 99 milliliters of sterile water or physiologic saline for use. Use entire contents of diluted solution within 24 hours. No preslaughter drug withdrawal period is required when the product is used as directed. Use in a manner other than that indicated or with dosages in excess of that recommended may result in illegal drug residues in edible tissues. Do not use in laying hens producing eggs for human consumption. Do not use in eggs intended 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. Dated: February 7, 1997. Stephen F. Sundlof, Director, Center for Veterinary Medicine. [FR Doc. 97-5452 Filed 3-5-97; 8:45 am] BILLING CODE 4160-01-F