[Federal Register Volume 75, Number 173 (Wednesday, September 8, 2010)]
[Rules and Regulations]
[Page 54492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22277]
[[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:
[email protected].
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.
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, 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]
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