Document ID: FDA-2009-N-0665-0005
Agency: fda
Document Type: Notice
Title: Oral Dosage Form New Animal Drugs: Tiamulin
Posted Date: 2009-02-13T05:00Z

[Federal Register: February 13, 2009 (Volume 74, Number 29)]
[Rules and Regulations]               
[Page 7180]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13fe09-2]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2009-N-0665]

 
Oral Dosage Form New Animal Drugs; Tiamulin

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 Novartis Animal Health US, Inc. The 
supplemental NADA provides for removal of a 250-pound weight 
restriction and the addition of a reproductive caution statement to 
labeling of tiamulin concentrate solution used in drinking water for 
the treatment of certain bacterial respiratory and enteric diseases in 
swine.

DATES: This rule is effective February 13, 2009.

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: Novartis Animal Health US, Inc., 3200 
Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to 
NADA 140-916 for DENAGARD (tiamulin) Liquid Concentrate used for the 
treatment of certain bacterial respiratory and enteric diseases in 
swine. The supplemental NADA provides for removal of a 250-pound weight 
restriction and the addition of a reproductive caution statement to 
labeling. The supplemental NADA is approved as of January 27, 2009, and 
21 CFR 520.2455 is amended to reflect the approval.
    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(d)(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 520

    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 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

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

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

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2. In Sec.  520.2455, remove paragraph (d), redesignate paragraph (e) 
as paragraph (d), and revise newly redesignated paragraph (d)(2) to 
read as follows:

Sec.  520.2455  Tiamulin.

* * * * *
    (d) * * *
    (2) Limitations. Use as only source of drinking water. Prepare 
fresh medicated water daily. Withdraw medication 3 days before 
slaughter following treatment at 3.5 mg/lb and 7 days before slaughter 
following treatment at 10.5 mg/lb of body weight. Swine being treated 
with tiamulin should not have access to feeds containing polyether 
ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or 
semduramycin) as adverse reactions may occur. The effects of tiamulin 
on swine reproductive performance, pregnancy, and lactation have not 
been determined.

    Dated: February 10, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-3131 Filed 2-12-09; 8:45 am]

BILLING CODE 4160-01-S