[Federal Register Volume 82, Number 160 (Monday, August 21, 2017)]
[Notices]
[Page 39589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17567]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2363]


Electronic Study Data Submission; Data Standards; Support for 
Standard for Exchange of Nonclinical Data Implementation Guide Version 
3.1

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) is announcing support for the 3.1 
version of Clinical Data Interchange Standards Consortium (CDISC) 
Standard for Exchange of Nonclinical Data (SEND IG 3.1), the end of 
support for the 3.0 version of SEND IG, and an update to the FDA Data 
Standards Catalog (Catalog). (See http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.) SEND IG 3.1 has been 
available from CDISC (www.cdisc.org) since July 2016. FDA is 
encouraging sponsors and applicants to use SEND IG 3.1 in 
investigational study data provided in regulatory submissions 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. 1115, Silver Spring, MD 20993-0002, 301-
796-5333, email: [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    On December 17, 2014, FDA published 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 https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data guidance 
implements the electronic submission requirements of section 745A(a) of 
the Food, Drug and Cosmetic Act (21 U.S.C. 379k-1(a)) 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 FDA's Center for 
Biologics Evaluation and Research or CDER by specifying the format for 
electronic submissions. The initial timetable for implementing 
electronic submission requirements for study data was 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 of version 3.1 of CDISC SEND IG is 
March 15, 2018. Although SEND IG version 3.1 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, 2019. The Catalog will list 
March 15, 2019, 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.
    The transition date for the end of FDA support for SEND IG 3.0 is 
March 15, 2018. Therefore, FDA support for SEND IG 3.0 will end for 
studies that start after March 15, 2019. The Catalog 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/ectd.

    Dated: August 15, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17567 Filed 8-18-17; 8:45 am]
 BILLING CODE 4164-01-P