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
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Abstract
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 incorrect dates for these electronic study data standards. This document corrects those errors.
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<title>Federal Register, Volume 87 Issue 241 (Friday, December 16, 2022)</title>
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[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Notices]
[Pages 77126-77127]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#d1b2b5b4a3b5b0a5b0a2a5b0bfb5b0a3b5a291b7b5b0ffb9b9a2ffb6bea7"><span class="__cf_email__" data-cfemail="d7b4b3b2a5b3b6a3b6a4a3b6b9b3b6a5b3a497b1b3b6f9bfbfa4f9b0b8a1">[email protected]</span></a>, 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
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