E9-5650. Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry #197 entitled “Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files.” The purpose of this draft guidance is to simplify the preparation and evaluation of submissions in support of new animal drug applications by providing a uniform system for documenting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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by June 1, 2009.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Submit written requests for single copies of the draft guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.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Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

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, [e-mail].

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FDA is announcing the availability of a draft guidance for industry #197 entitled “Draft Guidance for Industry on Documenting Statistical Analysis Programs and Data Files.” This draft guidance provides recommendations to study statisticians for documenting statistical analyses and data files submitted to the Center for Veterinary Medicine (CVM) for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This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115).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.