[Federal Register Volume 72, Number 46 (Friday, March 9, 2007)]
[Rules and Regulations]
[Pages 10596-10597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4206]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522


Implantation or Injectable Dosage Form New Animal Drugs; 
Enrofloxacin

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 Bayer HealthCare LLC. The supplemental NADA 
provides for changing scientific nomenclature for a bovine respiratory 
pathogen on labeling for enrofloxacin injectable solution.

DATES: This rule is effective March 9, 2007.

FOR FURTHER INFORMATION CONTACT:  Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail:  
<a href="/cdn-cgi/l/email-protection#ea80858b84c48d859e9e828b988e9eaa8c8e8bc4828299c48d859c"><span class="__cf_email__" data-cfemail="e78d888689c9808893938f86958393a7818386c98f8f94c9808891">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Bayer HealthCare LLC, Animal Health 
Division, P.O. Box 390, Shawnee Mission, KS 66201, filed a supplement 
to NADA 141 068 for BAYTRIL 100 (enrofloxacin) Injectable Solution used 
for the treatment of bovine respiratory disease associated with several 
bacterial pathogens. The supplemental NADA provides for changing a 
pathogen name from Pasteurella haemolytica to Mannheimia haemolytica on 
product labeling. The supplemental NADA is approved as of February 15, 
2007, and the regulations in 21 CFR 522.812 are amended to reflect the 
approval and a current format.
    Approval of this supplemental NADA did not require review of 
additional safety or effectiveness data or information. Therefore, a 
freedom of information summary is not required.
    The agency has determined under 21 CFR 25.33 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.

[[Page 10597]]

List of Subjects in 21 CFR Part 522

    Animal drugs.


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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 522 is 
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as 
follows:


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

0
2. Revise Sec.  522.812 to read as follows:


Sec.  522.812  Enrofloxacin.

    (a) Specifications. Each milliliter (mL) of solution contains:
    (1) 22.7 milligrams (mg) enrofloxacin or
    (2) 100 mg enrofloxacin.
    (b) Sponsor. See No. 000859 in Sec.  510.600(c) of this chapter.
    (c) Related tolerance. See Sec.  556.228 of this chapter.
    (d) Special considerations. 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.
    (e) Conditions of use--(1) Dogs. Use the product described in 
paragraph (a)(1) of this section as follows:
    (i) Amount. 2.5 mg per kilogram (/kg) of body weight (1.13 mg per 
pound) as a single, intramuscular, initial dose followed by use of 
tablets twice daily for 2 to 3 days beyond cessation of clinical signs 
to a maximum of 10 days.
    (ii) Indications for use. For the management of diseases associated 
with bacteria susceptible to enrofloxacin.
    (2) Cattle. Use the product described in paragraph (a)(2) of this 
section as follows:
    (i) Amount. Single-dose therapy: 7.5 to 12.5 mg/kg of body weight 
(3.4 to 5.7 mL per 100 pounds) by subcutaneous injection. Multiple-day 
therapy: 2.5 to 5.0 mg/kg of body weight (1.1 to 2.3 mL per 100 pounds) 
by subcutaneous injection once daily for 3 to 5 days.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Haemophilus somnus.
    (iii) Limitations. Animals intended for human consumption must not 
be slaughtered within 28 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. The effect of enrofloxacin on bovine 
reproductive performance, pregnancy, and lactation have not been 
determined.

    Dated: February 28, 2007.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E7-4206 Filed 3-8-07; 8:45 am]
BILLING CODE 4160-01-S


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