80 FR 50014 - Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.2

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 159 (August 18, 2015)

The Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) are announcing support for the 3.2 version (see section II. Exceptions) of Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model Implementation Guide (SDTM IG 3.2), an update to the FDA Data Standards Catalog (Catalog), and availability of validation rules for the 3.2 version. SDTM IG 3.2 has been available from CDISC since December 2013. FDA is encouraging sponsors and applicants to use SDTM IG 3.2 (see section II. Exceptions) in investigational study data provided in regulatory submissions to CBER and to CDER.

[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50014-50015]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-20316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2853]


Electronic Study Data Submission; Data Standards; Support for 
Study Data Tabulation Model Implementation Guide Version 3.2

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Center for Biologics Evaluation and Research (CBER) and 
the Center for Drug Evaluation and Research (CDER) are announcing 
support for the 3.2 version (see section II. Exceptions) of Clinical 
Data Interchange Standards Consortium (CDISC) Study Data Tabulation 
Model Implementation Guide (SDTM IG 3.2), an update to the FDA Data 
Standards Catalog (Catalog), and availability of validation rules for 
the 3.2 version. SDTM IG 3.2 has been available from CDISC since 
December 2013. FDA is encouraging sponsors and applicants to use SDTM 
IG 3.2 (see section II. Exceptions) in investigational study data 
provided in regulatory submissions to CBER and to CDER.

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,

[[Page 50015]]

MD 20993-002, 301-796-5333, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On December 17, 2014, FDA published a final guidance for industry 
entitled ``Providing Regulatory Submissions in Electronic Format--
Standardized Study Data'' (eStudy Data) posted on FDA's Study Data 
Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data guidance 
implements the electronic submission requirements of section 745A(a) of 
the FD&C Act (21 U.S.C. 379k-1) for study data contained in new drug 
applications (NDAs), abbreviated new drug applications (ANDAs), 
biologics license applications (BLAs), and investigational new drug 
applications (INDs) to CBER or CDER by specifying the format for 
electronic submissions. The initial timetable for the implementation of 
electronic submission requirements for study data is December 17, 2016 
(24 months after issuance of final guidance for NDAs, BLAs, ANDAs, and 
36 months for INDs). The eStudy Data guidance states that a Federal 
Register notice will specify the transition date for all version 
updates (with the month and day for the transition date corresponding 
to March 15).
    The transition date for support (see section II. Exceptions) of the 
3.2 version of CDISC STDM IG is March 15, 2017. Although SDTM IG 
version 3.2 is supported as of this Federal Register notice and 
sponsors or applicants are encouraged to begin using it, the new 
version will only be required in submissions for studies that start 
after March 15, 2018. The Catalog will list March 15, 2018, as the 
``date requirement begins.'' When multiple versions of an FDA-supported 
standard are listed in the Catalog, sponsors or applicants can select a 
version to use.

II. Exceptions

    The following SDTM IG 3.2 domains have not completed testing and 
acceptance and are not supported at this time: Death Details and 
Exposure as Collected. The therapeutic area (TA) standards (http://www.cdisc.org/) that are included in SDTM IG 3.2 have not completed 
testing and acceptance and are not supported at this time. The specific 
domain and the TA standard are listed in the table that follows:

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        SDTM IG 3.2 Domain                      TA User guide
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1. Healthcare Encounters..........  Cardiovascular Studies, 1.0;
                                     Polycystic Kidney Disease, 1.0;
                                     Asthma, 1.0.
2. Microscopic Findings...........  Tuberculosis, 1.0; Parkinson's, 1.0.
3. Morphology.....................  Cardiovascular Studies, 1.0;
                                     Parkinson's, 1.0; Polycystic Kidney
                                     Disease, 1.0; Alzheimer's, 1.0;
                                     Multiple Sclerosis, 1.0.
4. Procedures.....................  Cardiovascular Studies, 1.0;
                                     Polycystic Kidney Disease, 1.0;
                                     Alzheimer's, 1.0.
5. Reproductive System............  Polycystic Kidney Disease, 1.0.
6. Disease Response...............  Tuberculosis, 1.0.
7. Skin Response..................  Asthma, 1.0.
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    Sponsors and applicants with questions on how to implement the FDA-
supported study data standards should contact and work with FDA 
technical staff. For questions, contact CDER at [email protected] 
or CBER at [email protected].

III. 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.

IV. 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: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20316 Filed 8-17-15; 8:45 am]
 BILLING CODE 4164-01-P