Document ID: FDA-2008-D-0623-0009
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Anesthetics for Companion Animals; Availability
Posted Date: 2010-03-26T04:00Z

[Federal Register: March 26, 2010 (Volume 75, Number 58)]
[Notices]               
[Page 14604]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr10-60]                         

[[Page 14604]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0623]

 
Guidance for Industry on Anesthetics for Companion Animals; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of Guidance for Industry 192 entitled 
``Anesthetics for Companion Animals.'' This guidance makes 
recommendations for the development of anesthetic new animal drug 
products for companion animals. The guidance discusses the contents of 
the target animal safety, effectiveness, and labeling technical 
sections of a new animal drug application (NADA) for general 
anesthetics.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your requests.
    Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Germaine Connolly, Center for 
Veterinary Medicine, (HFV-116), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 240-276-8331, e-mail: 
germaine.connolly@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a Guidance for Industry 
192 entitled ``Anesthetics for Companion Animals.'' This 
guidance document makes recommendations to assist developers of general 
anesthetic drugs (injectable or inhalational) for use in companion 
animals (dogs, cats, and horses). The guidance specifically describes 
what should be considered while planning and executing safety and field 
studies for the proposed anesthetic. In addition, the guidance includes 
recommendations on how to analyze and package the collected data for 
submission to the Center for Veterinary Medicine (CVM).
    In the Federal Register of December 17, 2008, (73 FR 76657), FDA 
published the notice of availability for a draft guidance entitled 
``Anesthetics for Companion Animals'' which gave interested persons 
until March 2, 2009, to comment on the draft guidance. FDA received a 
few comments on the draft guidance and those comments were considered 
as the guidance was finalized. In addition to some of the changes based 
on the comments received, CVM made a few minor changes to the guidance 
to add clarity and accuracy. The guidance announced in this notice 
finalizes the draft guidance dated December 17, 2008.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking on this topic. It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information have been approved under OMB Control No. 
0910-0032 (expiration date 04/30/2010).

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/AnimalVeterinary/default.htm or http://
www.regulations.gov.

    Dated: March 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6700 Filed 3-25-10; 8:45 am]
BILLING CODE 4160-01-S