[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Notices]
[Page 51450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18236]


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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 
document that appeared in the Federal Register of July 7, 2020. The 
document announced the dates that support and requirement will begin 
for version 1.7 of the Clinical Data Interchange Standards Consortium 
(CDISC) for Study Data Tabulation Model (SDTM) Implementation Guide 
(IG) 3.3, and for version 2.1 of the Define-Extensible Markup Language 
(Define-XML). The document provided the 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, cderdatastandards@fda.hhs.gov, or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 7, 2020 (85 
FR 40658), in FR Doc. 2020-14512, the following correction is made:
    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 IG 3.3 and version 2.1 of the Define-XML will begin on 
March 15, 2021, and the date that the requirement begins for CDISC 
version 1.7 SDTM IG 3.3 and version 2.1 of the Define-XML for new drug 
applications, abbreviated new drug applications, certain biologics 
license applications, and noncommercial investigational new drug 
applications will be March 15, 2022. Support and requirement for 
version 1.3 of the CDISC SDTM IG 3.1.3 will end on March 15, 2021.''

    Dated: August 13, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-18236 Filed 8-19-20; 8:45 am]
BILLING CODE 4164-01-P


