Document ID: FDA-2020-N-1206-0004
Agency: fda
Document Type: Notice
Title: Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.7 Implementation Guide 3.3 and for Define-Extensible Markup Language Version 2.1; Requirement Ends for Study Data Tabulation Model Version 1.3 Implementation Guide 3.1.3; Correction
Posted Date: 2022-12-16T05:00Z

[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Pages 77126-77127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27346]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1206]

Electronic Study Data Submission; Data Standards; Support and 
Requirement Begin for Study Data Tabulation Model Version 1.7 
Implementation Guide 3.3 and for Define-Extensible Markup Language 
Version 2.1; Requirement Ends for Study Data Tabulation Model Version 
1.3 Implementation Guide 3.1.3; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
correction that appeared in the Federal Register of August 20, 2020. 
The document announced the correction dates that the support and 
requirement were to begin for version 1.7 of the Clinical Data 
Interchange Standards Consortium (CDISC) Study Data Tabulation Model 
(SDTM), and version 3.3 of the SDTM Implementation Guide (SDTMIG), and 
for version 2.1 of the Define-Extensible Markup Language (Define-XML). 
The document erroneously provided the

[[Page 77127]]

incorrect dates for these electronic study data standards. This 
document corrects those errors.

FOR FURTHER INFORMATION CONTACT: Chenoa Conley, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 301-
796-0035, [email protected], or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 20, 2020 
(85 FR 51450), in FR Doc. 2020-18236, the following correction is made:
    On page 51450, in the second and third columns, the last paragraph 
of the document is corrected to read as follows: ``On page 40659, in 
the first column, the last three sentences of the document are 
corrected to read as follows: Support for version 1.7 of the CDISC 
SDTM, version 3.3 of the SDTMIG, and version 2.1 of the Define-XML will 
begin on March 15, 2021, and the date that the requirement begins will 
be on March 15, 2022, for new drug applications, abbreviated new drug 
applications, and certain biologics license applications. For certain 
investigational new drug applications, the date that requirement begins 
will be March 15, 2023. Support and requirement for version 1.3 of the 
CDISC SDTM and version 3.1.3 of the SDTMIG will end on March 15, 
2021.''

    Dated: December 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27346 Filed 12-15-22; 8:45 am]
BILLING CODE 4164-01-P