Document ID: FDA-2010-N-0002-0011
Agency: fda
Document Type: Notice
Title: Implantation or Injectable Dosage Form New Animal Drugs; Tilmicosin
Posted Date: 2010-03-02T05:00Z

[Federal Register Volume 75, Number 40 (Tuesday, March 2, 2010)]
[Rules and Regulations]
[Pages 9333-9334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4206]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2010-N-0002]

Implantation or Injectable Dosage Form New Animal Drugs; 
Tilmicosin

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 Elanco Animal Health, A Division of Eli 
Lilly & Co. The supplemental NADA provides a dose range for use of an 
injectable solution of tilmicosin phosphate for treatment of 
respiratory disease in cattle and additional pathogens for which this 
therapy is effective.

DATES:  This rule is effective March 2, 2010.

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: Elanco Animal Health, A Division of Eli 
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285, filed a 
supplement to NADA 140-929 for MICOTIL 300 (tilmicosin injection, USP) 
Injection, available by veterinary prescription for use in the 
treatment and control of respiratory disease in cattle and the 
treatment of respiratory disease in sheep. The supplemental NADA 
establishes a dose range and adds pathogens for which this therapy is 
effective in the management of bovine respiratory disease. As a 
consequence of revising the dosage, the preslaughter withdrawal period 
has been recalculated. The supplemental NADA is approved as of December 
30, 2009, and the regulations in 21 CFR 522.2471 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 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

[[Page 9334]]

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.  522.2471, revise paragraphs (e)(1)(i), (e)(1)(ii), and 
(e)(1)(iii) to read as follows:

Sec.  522.2471  Tilmicosin.

* * * * *
    (e) * * *
    (1) * * *
    (i) Amount. 10 to 20 milligrams per kilograms (mg/kg) of body 
weight as a single subcutaneous injection.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (BRD) associated with Mannheimia haemolytica, Pasteurella 
multocida, and Histophilus somni. For the control of respiratory 
disease in cattle at high risk of developing BRD associated with M. 
haemolytica.
    (iii) Limitations. Do not use in female dairy cattle 20 months of 
age or older. Use of this antibiotic in this class of cattle may cause 
milk residues. Do not slaughter within 42 days of last treatment.
* * * * *

    Dated: February 16, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 2010-4206 Filed 3-1-10; 8:45 am]
BILLING CODE 4160-01-S