Document ID: FDA-2011-N-0003-0015
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs: Enrofloxacin
Posted Date: 2011-04-22T04:00Z

[Federal Register Volume 76, Number 78 (Friday, April 22, 2011)]
[Rules and Regulations]
[Pages 22610-22611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9765]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2011-N-0003]

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 the addition of a pathogen to the indications for use of 
enrofloxacin solution in cattle, as a single injection, for the 
treatment of respiratory disease.

DATES: This rule is effective April 22, 2011.

FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8341, e-mail: 
cindy.burnsteel@fda.hhs.gov.

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), an injectable solution. 
The supplemental NADA provides for the addition of Mycoplasma bovis to 
the pathogens in the indication for use of enrofloxacin solution in 
cattle, as a single injection, for the treatment of bovine respiratory 
disease (BRD). The supplemental NADA is approved as of March 10, 2011, 
and the regulation in 21 CFR 522.812 is amended to reflect the 
approval.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and Sec.  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.
    Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), this supplemental approval 
qualifies for 3

[[Page 22611]]

years of marketing exclusivity beginning on the date of approval.
    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.

List of Subjects in 21 CFR Part 522

    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 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. In Sec.  522.812, revise paragraph (e)(2)(ii) to read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (e) * * *
    (2) * * *
    (ii) Indications for use--(A) Single-dose therapy: For the 
treatment of bovine respiratory disease (BRD) associated with 
Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and 
Mycoplasma bovis in beef and non-lactating dairy cattle.
    (B) Multiple-day therapy: For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni in beef and non-lactating dairy 
cattle.
* * * * *

    Dated: April 15, 2011.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2011-9765 Filed 4-21-11; 8:45 am]
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