Document ID: FDA-2008-N-0039-0026
Agency: fda
Document Type: Rule
Title: Implantation or Injectable Dosage Form New Animal Drugs; Enrofloxacin
Posted Date: 2008-04-02T04:00Z

[Federal Register: April 2, 2008 (Volume 73, Number 64)]
[Rules and Regulations]               
[Page 17890]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap08-5]                         

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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 the use of enrofloxacin injectable solution in female 
dairy cattle less than 20 months of age.

DATES: This rule is effective April 2, 2008.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8342, e-mail: 
joan.gotthardt@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) injectable solution used 
for the treatment of bovine respiratory disease associated with several 
bacterial pathogens. The supplemental NADA provides for the use of 
enrofloxacin injectable solution in female dairy cattle less than 20 
months of age. The supplemental NADA is approved as of February 13, 
2008, and the regulations in 21 CFR 522.812 are amended to reflect the 
approval.
    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.
    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 years of marketing exclusivity beginning on the date of 
approval.
    The agency has determined under 21 CFR 25.33(a)(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 522

    Animal drugs.

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 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 paragraphs (e)(2)(i) through (e)(2)(iii) to 
read as follows:

Sec.  522.812  Enrofloxacin.

* * * * *
    (e) * * *
    (2) * * *
    (i) Amount. Single-dose therapy: 7.5 to 12.5 mg/kg of body weight 
by subcutaneous injection. Multiple-day therapy: 2.5 to 5.0 mg/kg of 
body weight by subcutaneous injection. Treatment should be repeated at 
24-hour intervals for 3 days. Additional treatments may be given on 
days 4 and 5 to animals that have shown clinical improvement but not 
total recovery.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni (previously Haemophilus somnus) in 
beef and non-lactating dairy cattle.
    (iii) Limitations. Animals intended for human consumption must not 
be slaughtered within 28 days from the last treatment. Do not use in 
female dairy cattle 20 months of age or older. Use of enrofloxacin in 
this class of cattle may cause milk residues. A withdrawal period has 
not been established for this product in pre-ruminating calves. Do not 
use in calves to be processed for veal.

    Dated: March 21, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-6706 Filed 4-1-08; 8:45 am]

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