
[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: ronald.fitzmartin@fda.hhs.gov.

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]
 BILLING CODE 4164-01-P


