Document ID: FDA-2008-N-0039-0041
Agency: fda
Document Type: Rule
Title: Certain Other Dosage Form New Animal Drugs; Sevoflurane
Posted Date: 2008-05-07T04:00Z

[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Rules and Regulations]               
[Page 25507-25508]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07my08-6]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 529

 
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 Minrad, Inc. The ANADA provides for the 
use of sevoflurane inhalant anesthetic in dogs.

DATES:  This rule is effective May 7, 2008.

FOR FURTHER INFORMATION CONTACT:  John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8197, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Minrad, Inc., 836 Main St., 2nd floor, 
Buffalo, NY 14202, filed ANADA 200-438 that provides for use of PETREM 
(sevoflurane) inhalant anesthetic in dogs. Minrad, Inc.'s PETREM is 
approved as a generic copy of SEVOFLO, sponsored by Abbott 
Laboratories, under NADA 141-103. The ANADA is approved as of April 3, 
2008, 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

[[Page 25508]]

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(a)(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.

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 529 is 
amended as follows:

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 529 continues to read as 
follows:

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

0
2. In Sec.  529.2150, revise paragraphs (a) and (b) to read as follows:

Sec.  529.2150   Sevoflurane.

    (a) Specifications. Sevoflurane liquid.
    (b) Sponsors. See Nos. 000074 and 060307 in Sec.  510.600(c) of 
this chapter.
* * * * *

    Dated: April 28, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-10153 Filed 5-6-08; 8:45 am]

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