
[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86336-86337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27310]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-5022]


Data Standards; Support and Requirement Begins for the Clinical 
Data Interchange Standards Consortium Version 2.0 of the Study Data 
Tabulation Model, Version 3.4 of the Study Data Tabulation Model 
Implementation Guide, and Version 1.0 of the Standard for Exchange of 
Nonclinical Data Implementation Guide--Genetox; Requirement Ends for 
the Clinical Data Interchange Standards Version 3.2 of the Study Data 
Tabulation Model Implementation Guide

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 that support begins for version 2.0 
of the Clinical Data Interchange Standards Consortium (CDISC) Study 
Data Tabulation Model (SDTMv2.0), version 3.4 of the CDISC Study Data 
Tabulation Model Implementation Guide (SDTMIGv3.4), and version 1.0 of 
the Standard for Exchange of Nonclinical Data Implementation Guide--
Genetox (SENDIG-Genetoxv1.0) and announcing the date that these version 
updates are required in certain submissions. CBER and CDER are also 
announcing the date that requirement ends for version 3.2 of the CDISC 
SDTMIG (SDTMIGv3.2). The Agency will update the FDA Data Standards 
Catalog (Catalog) to reflect these changes. The Agency will publish in 
the technical specifications document entitled ``Study Data Technical 
Conformance Guide'' additional details on how to implement new 
variables.

DATES: Support for version CDISC SDTMv2.0, SDTMIGv3.4, and SENDIG-
Genetoxv1.0 begins December 13, 2023.
    The requirement for electronic submissions to be submitted using 
CDISC SDTMv2.0, SDTMIGv3.4, and SENDIG-Genetoxv1.0 begins March 15, 
2025, for new drug applications (NDAs), abbreviated new drug 
applications (ANDAs), certain biologics license applications (BLAs), 
and certain investigational new drug applications (INDs). The 
requirement for electronic submissions to be submitted using version 
CDISC SDTMIGv3.2 ends December 13, 2023.

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-2023-N-5022 for ``Data Standards; Requirement Begins for the 
Clinical Data Interchange Standards Consortium Version 2.0 of the Study 
Data Tabulation Model and Version 3.4 of the Study Data Tabulation 
Model Implementation Guide; Requirement Ends for the Clinical Data 
Interchange Standards Version 3.2 of the Study Data Tabulation Model 
Implementation Guide.'' 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, 240-
402-7500.
     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.govinfo.gov/content/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

[[Page 86337]]

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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: CDER: Helena Sviglin, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1117, Silver Spring, MD 20993-0002, 240-
402-6511, [email protected].
    CBER: Lisa Lin and Anne Taylor, 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, [email protected].

SUPPLEMENTARY INFORMATION: FDA's CBER and CDER are issuing this Federal 
Register notice to announce the date that support begins for CDISC 
SDTMv2.0, SDTMIGv3.4, and SENDIG-Genetoxv1.0 and requirement ends for 
version 3.2 of the CDISC SDTMIG. The guidance for industry entitled 
``Providing Regulatory Submissions in Electronic Format--Standardized 
Study Data,'' published June 2021 (eStudy Data guidance) (available at 
https://www.fda.gov/media/82716/download), 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 
NDAs, ANDAs, certain BLAs, and certain INDs submitted to CBER or CDER 
by specifying the format for electronic submissions. The eStudy Data 
guidance states that a Federal Register notice will specify any new 
standards and version updates to FDA-supported study data standards 
that will be added to the Catalog, when the support for such standards 
and version updates begins or ends, and when the requirement to use 
such standards and version updates in submissions begins or ends.
    Support for CDISC SDTMv2.0, SDTMIGv3.4, and SENDIG-Genetoxv1.0 
begins December 13, 2023. The transition date for these version updates 
is March 15, 2024. The requirement for electronic submissions to be 
submitted using CDISC SDTMv2.0, SDTMIGv3.4, and SENDIG-Genetoxv1.0 is 
March 15, 2025, for NDAs, ANDAs, certain BLAs, and certain INDs. The 
requirement for electronic submissions to be submitted using version 
3.2 of the CDISC SDTMIG ends December 13, 2023.

    Dated: December 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27310 Filed 12-12-23; 8:45 am]
BILLING CODE 4164-01-P


