Animal drugs, feeds, and related products: Enrofloxacin solution,

[Federal Register: September 14, 1998 (Volume 63, Number 177)]

[Rules and Regulations]

[Page 49002-49003]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr14se98-6]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556

Animal Drugs, Feeds, and Related Products; Enrofloxacin 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 new animal drug application (NADA) filedby Bayer Corp., Agriculture Division, Animal Health. The NADA provides for subcutaneous use of enrofloxacin solution in cattle for the treatment of bovine respiratory disease.

EFFECTIVE DATE: September 14, 1998. 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: Bayer Corp., Agriculture Division, Animal Health, P.O. Box 390, Shawnee Mission, KS 66201, has filedNADA 141-068 Baytril 100 Injectable Solution (100 milligrams enrofloxacin per milliliter) for subcutaneous injection for the treatment of cattle for bovine respiratory disease associated with Pasteurella haemolytica, P. multocida, and Haemophilus somnus. The NADA is approved as of July 24, 1998, and the regulations are amended by revising 21 CFR 522.812 to reflect the approval. The regulations are also amended to provide for a tolerance for enrofloxacin residues in cattle by revising 21 CFR 556.228. 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, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval for food- producing animals qualifies for 3 years of marketing exclusivity beginning July 24, 1998, because the NADA contains substantial evidence of the effectiveness of the drug

[[Page 49003]]

involved, studies of animal safety or, in the case of food-producing animals, human food safety studies (other than bioequivalence or residue studies) required for approval and conducted or sponsored by the applicant.

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 522

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 522 and 556 are 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: 21 U.S.C. 360b.

2. Section 522.812 is amended by revising paragraph (a), by redesignating paragraphs (d)(1), (d)(2), and (d)(3) as paragraphs (d)(1)(i), (d)(1)(ii), and (d)(1)(iii), respectively, by adding a new heading to paragraph (d)(1), and by adding paragraphs (c) and (d)(2) to read as follows:

   Sec. 522.812 Enrofloxacin solution.

   (a) Specifications. Each milliliter of sterile solution contains either 22.7 milligrams of enrofloxacin when intended for use in dogs or 100 milligrams of enrofloxacin when intended for use in cattle. * * * * *

   (c) Related tolerance. See Sec. 556.228 of this chapter.

   (d) Conditions of use--(1) Dogs--(i) Amount. * * * * * * * *

   (2) Cattle--(i) Amount. Single-dose therapy: 7.5 to 12.5 milligrams enrofloxacin per kilogram of body weight (3.4 to 5.7 milliliters per 100 pounds). Multiple-day therapy: 2.5 to 5.0 milligrams per kilogram of body weight (1.1 to 2.3 milliliters per 100 pounds) administered once daily for 3 to 5 days.

   (ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica, P. multocida, and Haemophilus somnus.

   (iii) Limitations. For subcutaneous use in cattle only. Do not inject more than 20 milliliters at each site. Do not slaughter within 28 days of last treatment. Do not use in cattle intended for dairy production. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. The effect of enrofloxacin on bovine reproductive performance, pregnancy, and lactation have not been determined. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra-label use of this drug in food-producing animals.

   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: 21 U.S.C. 342, 360b, 371.

4. Section 556.228 is amended by redesignating the text as paragraph (a), by adding a heading to the newly redesignated paragraph (a), and by adding an introductory text and paragraph (b) to read as follows:

   Sec. 556.228 Enrofloxacin.

   The acceptable daily intake for enrofloxacin is 3 micrograms per kilogram of body weight per day.

   (a) Chickens and turkeys. * * *

   (b) Cattle. A tolerance of 0.1 part per million for desethylene ciprofloxacin (marker residue) has been established in liver (target tissue) of cattle.

   Dated: August 25, 1998. Stephen F. Sundlof, Director, Center for Veterinary Medicine.

   [FR Doc. 98-24497Filed9-11-98; 8:45 am]

   BILLING CODE 4160-01-F