[Federal Register Volume 66, Number 172 (Wednesday, September 5, 2001)]
[Rules and Regulations]
[Page 46369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22165]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Marbofloxacin Tablets

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 supplemental new animal drug 
application (NADA) filed by Pfizer, Inc. The supplemental NADA provides 
for the use of marbofloxacin tablets in cats for the treatment of 
infections associated with bacteria susceptible to marbofloxacin.

DATES: This rule is effective September 5, 2001.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7540.

SUPPLEMENTARY INFORMATION: Pfizer, Inc., 235 East 42d St., New York, NY 
10017-5755, is the sponsor of NADA 141-151 that provides for use of 
ZeniquinTM (marbofloxacin) Tablets for the treatment of 
infections in dogs associated with bacteria susceptible to 
marbofloxacin. Pfizer, Inc., filed a supplemental NADA which provides 
for the addition of cats to product indications. The supplemental NADA 
is approved as of August 1, 2001, and the regulations in 21 CFR 
520.1310 are amended 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)(iii) of the Federal Food, Drug, and 
Cosmetics Act (21 U.S.C. 360b(c)(2)(F)(iii)), this approval for non-
food-producing animals qualifies for 3 years of marketing exclusivity 
beginning August 1, 2001, because the application contains substantial 
evidence of effectiveness of the drug involved or any studies of animal 
safety required for approval of the application and conducted or 
sponsored by the applicant.
    The agency has determined under 21 CFR 25.33(d)(1) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    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 in 21 CFR Part 520

    Animal drugs.

    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 part 520 is 
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: 21 U.S.C. 360b.

    2. Section 520.1310 is amended by revising paragraphs (a) and (d) 
to read as follows:


Sec. 520.1310  Marbofloxacin tablets.

    (a) Specifications. Each tablet contains 25, 50, 100, or 200 
milligrams (mg) marbofloxacin.
* * * * *
    (d) Conditions of use--(1) Amount. 1.25 mg per pound (/lb) of body 
weight once daily, but may be increased to 2.5 mg/lb of body weight 
once daily.
    (2) Indications for use. For the treatment of infections in dogs 
and cats associated with bacteria susceptible to marbofloxacin.
    (3) Limitations. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian. Federal law prohibits the 
extralabel use of this drug in food-producing animals.

    Dated: August 21, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-22165 Filed 9-4-01; 8:45 am]
BILLING CODE 4160-01-S