Document ID: FDA-2010-N-0002-0061
Agency: fda
Document Type: Rule
Title: Oral Dosage Form New Animal Drugs: Tiamulin
Posted Date: 2010-09-08T04:00Z

[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Rules and Regulations]               
[Page 54492]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se10-5]                         

[[Page 54492]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

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

 
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 use of an increased strength of tiamulin 
concentrate solution in the drinking water of swine for the treatment 
of certain bacterial respiratory and enteric diseases.

DATES: This rule is effective September 8, 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: 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 administered in 
drinking water for the treatment of certain bacterial respiratory and 
enteric diseases in swine. The supplemental NADA provides for use of a 
12.5 percent tiamulin concentrate solution. The supplemental NADA is 
approved as of June 14, 2010, 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 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.

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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 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, revise paragraphs (a) and (b) to read as follows:

Sec.  520.2455  Tiamulin.

    (a) Specifications. (1) Each gram of soluble powder contains 450 
milligrams (mg) tiamulin hydrogen fumarate.
    (2) Each milliliter (mL) of solution contains 125 mg (12.5 percent) 
tiamulin hydrogen fumarate.
    (3) Each mL of solution contains 123 mg (12.3 percent) tiamulin 
hydrogen fumarate.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this 
chapter for use as in paragraph (d) of this section.
    (1) No. 058198 for products described in paragraphs (a)(1) and 
(a)(2) of this section.
    (2) No. 059130 for products described in paragraphs (a)(1) and 
(a)(3) of this section.
* * * * *

    Dated: September 1, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 2010-22277 Filed 9-7-10; 8:45 am]
BILLING CODE 4160-01-S