[Federal Register: January 4, 2006 (Volume 71, Number 2)]
[Notices]
[Page 350]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja06-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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 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 a guidance for industry (123) entitled
``Development of Target Animal Safety and Effectiveness Data to Support
Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals.''
This guidance provides recommendations regarding the development of
target animal safety and effectiveness data to support approval of
veterinary non-steroidal anti-inflammatory drugs (NSAIDs), specifically
cyclooxygenase (COX) inhibitors.
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. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Comments should be identified with the
full title of the guidance and the docket number found in brackets in
the heading of this 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: lwilmot@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November 10, 2004 (69 FR 65202), FDA
published a notice of availability for a draft guidance entitled
``Development of Target Animal Safety and Effectiveness Data to Support
Approval of Non-Steroidal Anti-Inflammatory Drugs for Use in Animals''
giving interested persons until January 24, 2005, to comment on the
draft guidance. This final guidance reflects changes in response to
comments received on the draft guidance. In addition, FDA provided
further clarification regarding recommendations on the generation of
pharmacokinetic (PK) data. In particular, FDA included several examples
of the type of PK information that would be recommended for certain
types of products including those involving repeated administration or
multiple dosage forms.
II. 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 addressed in this guidance have been
approved under OMB control number 0910-0032.
III. Significance of Guidance
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This 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. 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.
IV. Comments
As with all FDA guidances, the public is encouraged to submit
written or electronic comments with new data or other new information
pertinent to this guidance. FDA periodically will review the comments
in the docket, and where appropriate, will amend the guidance. The
agency will notify the public of any such amendments through a notice
in the Federal Register.
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 should be identified with the docket number found in brackets
in the heading of this document. A copy of the 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
Persons with access to the Internet may obtain the guidance at
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/default
.htm.
Dated: December 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-8223 Filed 1-3-06; 8:45 am]
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