Notice2023-27310
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 238 (Wednesday, December 13, 2023)</title>
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[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86336-86337]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#395a5d5c4b5d584d584a4d58575d584b5d4a795f5d581751514a175e564f"><span class="__cf_email__" data-cfemail="0b686f6e796f6a7f6a787f6a656f6a796f784b6d6f6a25636378256c647d">[email protected]</span></a>.
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, <a href="/cdn-cgi/l/email-protection#83c0c1c6d1aee6c7c2d7c2c3e5e7e2adebebf0ade4ecf5"><span class="__cf_email__" data-cfemail="f3b0b1b6a1de96b7b2a7b2b3959792dd9b9b80dd949c85">[email protected]</span></a>.
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
<a href="https://www.fda.gov/media/82716/download">https://www.fda.gov/media/82716/download</a>), 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
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