[Federal Register Volume 63, Number 177 (Monday, September 14, 1998)]
[Rules and Regulations]
[Pages 49002-49003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24497]


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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.

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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 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 filed NADA 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. 98-24497 Filed 9-11-98; 8:45 am]
BILLING CODE 4160-01-F