Document ID: FDA-2008-D-0623-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry on Anesthetics for Companion Animals; Availability
Posted Date: 2008-12-17T05:00Z

[Federal Register: December 17, 2008 (Volume 73, Number 243)]
[Notices]               
[Page 76657-76658]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17de08-90]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Draft Guidance for Industry on Anesthetics for Companion Animals; 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availability of a draft guidance for industry 192 entitled 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: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by March 2, 2009.

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    Submit written comments on the draft guidance to the Division of 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section for electronic access to the draft guidance document.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    FDA is announcing the availability of a draft guidance for industry 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.

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent 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 draft 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 number 
0910-0032.

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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management

[[Page 76658]]

System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 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

    Dated: December 11, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29953 Filed 12-16-08; 8:45 am]

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