[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28275-28276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11846]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-1377]
Electronic Study Data Submission; Data Standards; Study Data
Standardization Plan Recommendations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of draft recommendations for preparing a Study Data
Standardization Plan (Standardization Plan). The Standardization Plan
is referenced in the Study Data Technical Conformance Guide (Guide).
The Guide supplements the guidance for industry ``Providing Regulatory
Submissions in Electronic Format--Standardized Study Data'' and
provides specifications, recommendations, and general considerations on
submitting standardized study data using FDA-supported data standards.
The Guide recommends that, for clinical and nonclinical studies,
sponsors include a plan that describes the submission of standardized
study data to FDA. The proposed recommendations describe the
information that should be included in the Standardization Plan. The
proposed recommendations for creating a Standardization Plan are posted
on FDA's Study Data Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.
DATES: Although you can comment on these recommendations at any time,
to ensure that the Agency considers your comments, please submit either
electronic or written comments by July 2, 2015.
ADDRESSES: Submit written requests for single copies of the
recommendations to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002; or the Office of Communication, Outreach, and Development,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your requests.
Submit electronic comments to http://www.regulations.gov. Submit
[[Page 28276]]
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. See the SUPPLEMENTARY INFORMATION section for electronic access
to the draft recommendations for preparing the Standardization Plan.
FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-002, 301-
796-5333, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of draft recommendations for
preparing the Standardization Plan. The Standardization Plan is
referenced in the Guide. The Guide supplements the guidance for
industry ``Providing Regulatory Submissions in Electronic Format--
Standardized Study Data'' and provides specifications, recommendations,
and general considerations on submitting standardized study data using
FDA-supported data standards; it is posted on FDA's Study Data
Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.
The Guide recommends that, for clinical and nonclinical studies,
sponsors include a plan that describes the submission of standardized
study data to FDA. The Standardization Plan will assist FDA in
identifying potential data standardization issues early in the
development program (e.g., pre-investigational new drug application
stage). The draft recommendations describe the information that should
be included in the Standardization Plan. The recommendations include,
but are not limited to, the following: (1) General sponsor information,
(2) product information, (3) list of completed studies and standards,
and (4) list of planned studies and standards.
II. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the proposed
recommendations at either http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm or http://www.regulations.gov.
Dated: May 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11846 Filed 5-15-15; 8:45 am]
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