[Federal Register Volume 69, Number 217 (Wednesday, November 10, 2004)]
[Notices]
[Pages 65202-65203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24995]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0468]


Draft Guidance for Industry on Development of Target Animal 
Safety and Effectiveness Data to Support Approval of Non-Steroidal 
Anti-Inflammatory Drugs for Use in 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availability of the draft guidance for industry (123) entitled 
``Development of Target Animal Safety and Effectiveness Data to Support 
Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) for Use in 
Animals.'' This draft guidance is intended to provide specific advice 
regarding the development of target animal safety and effectiveness 
data to support approval of veterinary NSAIDs, specifically 
cyclooxygenase (COX) inhibitors.

DATES: Submit written or electronic comments on agency guidances by 
January 24, 2005 to ensure their adequate consideration in preparation 
of the final document. General comments on agency guidance documents 
are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Communications Staff (HFV-12), Center for 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.

[[Page 65203]]

    Submit written comments on the draft guidance document to the 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.fda.gov/dockets/ecomments. Comments should be 
identified with the full title of the draft guidance document and the 
docket number found in the heading of this document. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

FOR FURTHER INFORMATION CONTACT: Linda Wilmot, Center for Veterinary 
Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-0135, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document provides information on approaches to 
the development of target animal safety and effectiveness data to 
support approval of veterinary NSAIDs--specifically, NSAIDs that reduce 
the production of prostaglandins by inhibiting the COX pathway. NSAIDs 
that inhibit lipooxygenase, or both lipooxygenase and COX, or act as 
cytokine antagonists. The Center for Veterinary Medicine (CVM) may 
recommend alternative product development strategies to complete its 
evaluation.

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 
represents the agency's current thinking on the development of target 
animal safety and effectiveness data to support approval of non-
steroidal anti-inflammatory drugs for use in animals. The document does 
not create or confer any rights for or on any person and will not 
operate to bind FDA or the public. Alternative methods may be used as 
long as they satisfy the requirements of the applicable statutes and 
regulations.

III. Paperwork Reduction Act of 1995

    The collection of information requirements are approved by the 
Office of Management and Budget (OMB) under OMB control number 0910-
0032.

IV. Comments

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit written or electronic comments to the 
Division of Dockets Management (see ADDRESSES) regarding this draft 
guidance document. Two paper copies of any mailed comments are to be 
submitted, 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. A copy of the draft guidance and received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Electronic comments may be submitted on the Internet at http://www.fda.gov/dockets/ecomments. Once on this site, select [Docket No. 
2004D-0468] ``Guidance for Industry on Development of Target Animal 
Safety and Effectiveness Data to Support Approval of Non-Steroidal 
Anti-Inflammatory Drugs (NSAIDS) for use in Animals'' and follow the 
directions. Copies of this draft guidance may be obtained on the 
Internet from the CVM home page at http://www.fda.gov/cvm.

    Dated: November 2, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24995 Filed 11-9-04; 8:45 am]
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