[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Draft Guidance for Industry on Providing Submissions in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availability of a draft guidance for industry entitled ``Providing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 This draft
guidance establishes FDA's recommendation that sponsors and applicants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 The draft guidance recognizes that standardized study data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draft guidance is to promote the use of data standards for study data,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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 23, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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for electronic access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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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