Document ID: FDA-2009-D-0052-0004
Agency: fda
Document Type: Notice
Title: Guidance for Industry: Documenting Statistical Analysis Programs and Data Files; Availability
Posted Date: 2010-05-05T04:00Z

[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]               
[Page 24718]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my10-103]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Guidance for Industry on Documenting Statistical Analysis 
Programs and Data Files; 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 197 entitled 
``Documenting Statistical Analysis Programs and Data Files.'' This 
guidance is provided to inform study statisticians of recommendations 
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 encompass the most complex data submissions to CVM, 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.

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.
    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.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Anna Nevius, Center for Veterinary 
Medicine (HFV-163), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 240-276-8170, anna.nevius@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 16, 2009 (74 FR 11118), FDA 
published the notice of availability for a draft guidance entitled 
``Draft Guidance for Industry on Documenting Statistical Analysis 
Programs and Data Files; Availability'' giving interested persons until 
June 1, 2009, to comment on the draft guidance. FDA received no 
comments on the draft guidance. Minor editorial changes were made to 
improve clarity. The guidance announced in this notice finalizes the 
draft guidance dated April 27, 2009.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking on the 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 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

    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.
    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 guidance at 
either http://www.fda.gov/AnimalVeterinary/default.htm or http://
www.regulations.gov.

    Dated: April 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10582 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-01-S