[Federal Register Volume 77, Number 34 (Tuesday, February 21, 2012)]
[Notices]
[Pages 9945-9946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3956]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0097]


Draft Guidance for Industry on Providing Submissions in 
Electronic Format--Standardized Study Data; 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availability of a draft guidance for industry entitled ``Providing 
Submissions in Electronic Format--Standardized Study Data.'' This draft 
guidance establishes FDA's recommendation that sponsors and applicants 
submit nonclinical and clinical study data in a standardized electronic 
format. The draft guidance recognizes that standardized study data 
promotes the efficient review of this information. The purpose of this 
draft guidance is to promote the use of data standards for study data, 
and increase the number of standardized study data submissions to the 
Center for Drug Evaluation and Research, the Center for Biologics 
Evaluation and Research, and the Center for Devices and Radiological 
Health.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 23, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002 or the 
Office of Communication, Outreach and Development (HFM-40), Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. The guidance 
may also be obtained by mail by calling CBER at 1-800-835-4709 or 301-
827-1800. Send one self-addressed adhesive label to assist that office 
in processing your requests. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kieu Pham, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 21, Rm. 4677, Silver Spring, MD 20993-0002, 301-796-1616, or

Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448, 301-827-6210, or

Terrie Reed, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3324, Silver 
Spring, MD 20993-0002, 301-796-6130.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Providing Submissions in Electronic Format--Standardized 
Study Data.'' FDA routinely receives submissions of the results of 
scientific studies, including clinical trials and animal studies. For 
many years, FDA has requested that clinical study data be submitted 
electronically because paper case report tabulations (CRTs) are 
universally recognized as being highly inefficient to support analysis 
and review. The data in paper CRTs are not machine-readable and 
therefore cannot be easily analyzed using modern analytic software. 
Although submission of clinical study data in electronic format has 
become relatively routine, these data are often submitted using 
nonstandard formats.
    FDA has long recognized the advantage of standardizing study data, 
as have many sponsors and applicants. Data submitted in a standard 
electronic format are easier to understand, analyze, and review.
    This draft guidance establishes FDA's recommendation that sponsors 
and applicants submit clinical and nonclinical study data in a standard 
electronic format. As sponsors and applicants move toward standardized 
electronic study data submissions, there is a need to understand FDA's 
expectations for such data submissions. This draft guidance provides 
FDA's current thinking on the submission of study data in a standard 
electronic format.
    The draft guidance refers submitters to FDA's Study Data Standards 
Resource Web page at http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm, where there is useful information 
describing which data standards to use and how to use them.
    This 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 submitting 
standardized study data in electronic format. 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

[[Page 9946]]

requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments 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.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information that 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 314 and 21 CFR 
part 312 have been approved under OMB control numbers 0910-0001 and 
0910-0014, respectively. The collections of information in 21 CFR part 
807, subpart E have been approved under 0910-0120; the collections of 
information in 21 CFR part 812 have been approved under 0910-0078; and 
the collections of information in 21 CFR part 814 have been approved 
under 0910-0231.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3956 Filed 2-17-12; 8:45 am]
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