[Federal Register Volume 67, Number 249 (Friday, December 27, 2002)]
[Rules and Regulations]
[Pages 78972-78973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-32747]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 522 and 556


Implantation or Injectable Dosage Form New Animal Drugs; 
Danofloxacin

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 Pfizer, Inc. The NADA provides for the veterinary 
prescription use of danofloxacin solution in cattle, by subcutaneous 
injection, for treatment of bovine respiratory disease associated with 
Mannheimia (Pasteurella) haemolytica and Pasteurella multocida. FDA is 
also amending the regulations to add the acceptable daily intake for 
total residues of danofloxacin and tolerances for residues of 
danofloxacin in edible tissues of cattle.

DATES: This rule is effective December 27, 2002.

FOR FURTHER INFORMATION CONTACT: Thomas Letonja, Center for Veterinary 
Medicine (HFV-130), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855; 301-827-7576, e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, filed NADA 141-207 for A180 (danofloxacin mesylate) 
Injectable Solution. The NADA provides for the veterinary prescription 
use of danofloxacin solution in cattle, by subcutaneous injection, for 
treatment of bovine respiratory disease associated with Mannheimia 
(Pasteurella) haemolytica and Pasteurella multocida. The application is 
approved as of September 20, 2002, and the regulations are amended in 
21 CFR part 522 by adding new Sec.  522.522 and in 21 CFR part 556 by 
adding new Sec.  556.169 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, 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)(i) of the Federal Food, Drug, and 
Cosmetics Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for 
5 years of marketing exclusivity beginning September 20, 2002.
    The agency has carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA'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 
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

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 522.522 is added to read as follows:


Sec.  522.522  Danofloxacin.

    (a) Specifications. Each milliliter of solution contains 180 
milligrams (mg) danofloxacin as the mesylate salt.
    (b) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.169 of this chapter.
    (d) Conditions of use in cattle--(1) Amount. 6 mg per kilogram of 
body weight by subcutaneous injection. Treatment should be repeated 
approximately 48 hours following the first injection.
    (2) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia

[[Page 78973]]

(Pasteurella) haemolytica and Pasteurella multocida.
    (3) Limitations. Animals intended for human consumption should not 
be slaughtered within 4 days from the 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. 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 556.169 is added to read as follows:


Sec.  556.169  Danofloxacin.

    (a) Acceptable daily intake (ADI). The ADI for total residues of 
danofloxacin is 2.4 micrograms per kilogram of body weight per day.
    (b) Tolerances--(1) Cattle--(i) Liver (the target tissue). The 
tolerance for parent danofloxacin (the marker residue) is 0.2 part per 
million (ppm).
    (ii) Muscle. The tolerance for parent danofloxacin (the marker 
residue) is 0.2 ppm.
    (2) [Reserved].

    Dated: December 17, 2002.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 02-32747 Filed 12-26-02; 8:45 am]
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