Document ID: FDA-2009-N-0665-0078
Agency: fda
Document Type: Notice
Title: Certain Other Dosage Form New Animal Drugs; Sevoflurane
Posted Date: 2010-01-08T05:00Z

[Federal Register Volume 75, Number 5 (Friday, January 8, 2010)]
[Rules and Regulations]
[Page 1021]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: X10-10108]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

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

Certain 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 an abbreviated new animal drug 
application (ANADA) filed by Halocarbon Products Corp. The ANADA 
provides for the use of sevoflurane inhalant anesthetic in dogs.

DATES: This rule is effective January 8, 2010.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-170), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Halocarbon Products Corp., 887 Kinderkamack 
Rd., River Edge, NJ 07661, filed ANADA 200-467 that provides for use of 
Sevoflurane, an inhalant anesthetic, in dogs. Halocarbon Products 
Corp.'s Sevoflurane is approved as a generic copy of SEVOFLO 
(sevoflurane), sponsored by Abbott Laboratories, under NADA 141-103. 
The ANADA is approved as of November 27, 2009, and the regulations are 
amended in Sec.  529.2150 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.
    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 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 paragraph (b) of Sec.  529.2150, remove ``Nos. 000074 and 
060307'' and in its place add ``Nos. 000074, 012164, and 060307''.

    Dated: January 4, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-47 Filed 1-7-10; 8:45 am]
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