[Federal Register Volume 71, Number 56 (Thursday, March 23, 2006)]
[Rules and Regulations]
[Pages 14642-14643]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2791]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Orbifloxacin

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 Schering-Plough Animal Health Corp. The 
supplemental NADA provides for revised animal safety labeling for 
orbifloxacin tablets used in dogs and cats for the management of 
diseases associated with susceptible bacteria.

DATES: This rule is effective March 23, 2006.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug

[[Page 14643]]

Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7543, 
e-mail: [email protected].

SUPPLEMENTARY INFORMATION: Schering-Plough Animal Health Corp., 556 
Morris Ave., Summit, NJ 07901, filed a supplement to NADA 141-081 for 
the veterinary prescription use of ORBAX (orbifloxacin) Tablets for 
management of diseases in dogs and cats associated with bacteria 
susceptible to orbifloxacin. The supplemental NADA provides for revised 
animal safety labeling, specifically, the addition of postapproval 
adverse drug experience information and fluoroquinolone class 
statements regarding retinal toxicity in cats. The supplemental NADA is 
approved as of March 3, 2006, and the regulations are amended in 21 CFR 
520.1616 to reflect a current format. 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 21 CFR 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 Division of Dockets Management 
(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.
    The agency has determined under 21 CFR 25.33(d)(5) 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 ``articular 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

0
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

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. Revise Sec.  520.1616 to read as follows:


Sec.  520.1616  Orbifloxacin.

    (a) Specifications. Each tablet contains 5.7, 22.7, or 68 
milligrams (mg) orbifloxacin.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs and cats--(1) Amount. 2.5 to 7.5 mg 
per kilogram body weight once daily.
    (2) Indications for use. For management of diseases associated with 
bacteria susceptible to orbifloxacin.
    (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: March 14, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 06-2791 Filed 3-22-06; 8:45 am]
BILLING CODE 4160-01-S