Notice2022-15248
Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Versions 1.2 and 1.3 of the Analysis Data Model Implementation Guide
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Published
July 18, 2022
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 the date that support begins for versions 1.2 and 1.3 of the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model Implementation Guide (ADaMIG) and the date that this version update is required in certain submissions. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect these changes.
Full Text
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<title>Federal Register, Volume 87 Issue 136 (Monday, July 18, 2022)</title>
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[Federal Register Volume 87, Number 136 (Monday, July 18, 2022)]
[Notices]
[Pages 42729-42730]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15248]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1366]
Data Standards; Requirement Begins for the Clinical Data
Interchange Standards Consortium Versions 1.2 and 1.3 of the Analysis
Data 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 the date that support begins for
versions 1.2 and 1.3 of the Clinical Data Interchange Standards
Consortium (CDISC) Analysis Data Model Implementation Guide (ADaMIG)
and the date that this version update is required in certain
submissions. The Agency will update the FDA Data Standards Catalog
(Catalog) to reflect these changes.
DATES: Support for versions 1.2 and 1.3 of the CDISC ADaMIG begins July
18, 2022. The requirement for electronic submissions to be submitted
using versions 1.2 and 1.3 of the CDISC ADaMIG begins March 15, 2024,
for new drug applications (NDAs), abbreviated new drug applications
(ANDAs), certain biologics license applications (BLAs), and certain
investigational new drug applications (INDs).
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.
[[Page 42730]]
<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-2022-N-1366 for ``Data Standards; Requirement Begins for the
Clinical Data Interchange Standards Consortium Versions 1.2 and 1.3 of
the Analysis Data 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 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#afcccbcaddcbcedbcedcdbcec1cbceddcbdcefc9cbce81c7c7dc81c8c0d9"><span class="__cf_email__" data-cfemail="82e1e6e7f0e6e3f6e3f1f6e3ece6e3f0e6f1c2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>.
CBER: 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: FDA's CBER and CDER are issuing this Federal
Register notice to announce the date that support begins for versions
1.2 and 1.3 of the CDISC ADaMIG and the date that this version update
is required in certain submissions. The FDA guidance for industry
``Providing Regulatory Submissions in Electronic Format--Standardized
Study Data'' (June 2021) (eStudy Data guidance), posted on FDA's Study
Data Standards Resources web page at <a href="https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm">https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm</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 CDER or CBER
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 versions 1.2 and 1.3 of the CDISC ADaMIG begins July
18, 2022. The transition date for this version update is March 15,
2023. The requirement for electronic submissions to be submitted using
versions 1.2 and 1.3 of the CDISC ADaMIG is March 15, 2024, for NDAs,
ANDAs, certain BLAs, and certain INDs.
Dated: July 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15248 Filed 7-15-22; 8:45 am]
BILLING CODE 4164-01-P
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