[Federal Register Volume 71, Number 2 (Wednesday, January 4, 2006)]
[Notices]
[Page 350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-8223]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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://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: [email protected].

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published a notice of availability for a draft guidance entitled 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://www.fda.gov/cvm or 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]
BILLING CODE 4160-01-S