Document ID: FDA-2017-N-4302-0001
Agency: fda
Document Type: Notice
Title: Electronic Study Data Submission; Data Standards; Support End Date for Study Data Tabulation Model Version 1.2, Implementation Guide Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1
Posted Date: 2017-09-01T04:00Z

[Federal Register Volume 82, Number 169 (Friday, September 1, 2017)]
[Notices]
[Pages 41624-41625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18566]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4302]

Electronic Study Data Submission; Data Standards; Support End 
Date for Study Data Tabulation Model Version 1.2, Implementation Guide 
Version 3.1.2, and Implementation Guide Version 3.1.2, Amendment 1

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Biologics Evaluation and Research (CBER) and Center for Drug Evaluation 
and Research (CDER) are announcing the end of support for Version 1.2 
of Clinical Data Interchange Standards Consortium Study Data Tabulation 
Model (SDTM) and an

[[Page 41625]]

update to the FDA Data Standards Catalog. FDA will continue its support 
of the newer SDTM Version 1.3 and Version 1.4, which have been listed 
in the FDA Data Standards Catalog since December 2012 and August 2015, 
respectively. FDA support for SDTM Version 1.2 will end for studies 
that start 12 months after March 15, 2018.

DATES: Submit either electronic or written comments at any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-4302 for ``Electronic Study Data Submission; Data Standards, 
Support End Date for Study Data Tabulation Model Version 1.2, 
Implementation Guide Version 3.1.2, and Implementation Guide Version 
3.1.2, Amendment 1.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Fatima Frye, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-0002, 301-
796-4863, email: cder-edata@fda.hhs.gov; or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 
240-402-7911, email: Stephen.Ripley@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    On December 17, 2014, FDA published final guidance for industry 
``Providing Regulatory Submissions in Electronic Format--Standardized 
Study Data'' (eStudy Data guidance) posted on FDA's Study Data 
Standards Resources Web page at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data guidance 
implements the electronic submission requirements of section 745A(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k-1(a)) for 
study data contained in new drug applications, abbreviated new drug 
applications, biologics license applications, and investigational new 
drug applications submitted to CDER or CBER by specifying the format 
for electronic submissions. The eStudy Data guidance states that a 
Federal Register notice will specify the transition date for updates to 
standards (with the month and day for the transition date corresponding 
to March 15).
    The transition date for the end of FDA support for SDTM Version 
1.2, Implementation Guide Version 3.1.2, and Implementation Guide 
Version 3.1.2, Amendment Version 1.2 is March 15, 2018. Therefore, FDA 
support for SDTM Version 1.2, Implementation Guide Version 3.1.2, and 
Implementation Guide Version 3.1.2, Amendment 1.2 will end for studies 
that start after March 15, 2019. The FDA Data Standards Catalog (see 
https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm) will be updated to list March 15, 2019, as the ``date 
support ends.''

II. Electronic Access

    Persons with access to the internet may obtain the referenced 
material at https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.

    Dated: August 29, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-18566 Filed 8-31-17; 8:45 am]
 BILLING CODE 4164-01-P