Document ID: FDA-2009-N-0665-0009
Agency: fda
Document Type: Rule
Title: Other Dosage Form New Animal Drugs: Sevoflurane
Posted Date: 2009-03-11T04:00Z

[Federal Register: March 11, 2009 (Volume 74, Number 46)]
[Rules and Regulations]               
[Page 10484]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11mr09-11]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

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

 
Other Dosage Form New Animal Drugs; Sevoflurane

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 Abbott Laboratories, Inc. The supplemental 
NADA provides for a revised induction dose of sevoflurane inhalant 
anesthetic in dogs.

DATES: This rule is effective March 11, 2009.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail: 
melanie.berson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Abbott Laboratories, North Chicago, IL 
60064, has filed a supplement to NADA 141-103 for SEVOFLO (sevoflurane) 
used for induction and maintenance of general anesthesia in dogs. The 
supplemental NADA provides for a revised induction dose of sevoflurane. 
The supplemental NADA is approved as of July 27, 2006, and the 
regulations are amended in 21 CFR 529.2150 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 529

    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 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

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1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

Sec.  529.2150  [Amended]

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2. In Sec.  529.2150, in the first sentence in paragraph (c)(1), remove 
``5 to 7 percent sevoflurane'' and in its place add ``Up to 7 percent 
sevoflurane''.

    Dated: March 3, 2009.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. E9-4879 Filed 3-10-09; 8:45 am]

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