[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Draft Guidance for Industry on Development of Target Animal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availability of the draft guidance for industry (123) entitled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 This draft guidance is intended to provide specific advice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ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Communications Staff (HFV-12), Center for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Submit written comments on the draft guidance document to the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identified with the full title of the draft guidance document and the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SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.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This draft guidance document provides information on approaches to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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