[Federal Register Volume 74, Number 49 (Monday, March 16, 2009)]
[Notices]
[Pages 11118-11119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-5650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0052]


Draft Guidance for Industry on Documenting Statistical Analysis 
Programs and Data Files; 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availability of a draft guidance for industry 197 entitled 
``Draft Guidance for Industry on Documenting Statistical Analysis 
Programs and Data Files.'' The purpose of this draft guidance is to 
simplify the preparation and evaluation of submissions in support of 
new animal drug applications by providing a uniform system for 
documenting statistical analysis programs and data files.

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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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 June 1, 2009.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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    Submit written comments on the draft guidance to the Division of 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section for electronic access to the draft guidance document.

[[Page 11119]]


FOR FURTHER INFORMATION CONTACT: Robert Abugov, Center for Veterinary 
Medicine (HFV-105), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8168, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
197 entitled ``Draft Guidance for Industry on Documenting 
Statistical Analysis Programs and Data Files.'' This draft guidance 
provides recommendations to study statisticians for documenting 
statistical analyses and data files submitted to the Center for 
Veterinary Medicine (CVM) for the evaluation of safety and 
effectiveness in new animal drug applications. These recommendations 
are intended to reduce the number of revisions that may be required for 
CVM to effectively review statistical analyses and to simplify 
submission preparation by providing a uniform documentation system.

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 in 21 CFR part 514 have been approved under 
OMB control no. 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.

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: March 10, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-5650 Filed 3-13-09; 8:45 am]
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