Document ID: FDA-2022-N-1366-0001
Agency: fda
Document Type: Notice
Title: Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Versions 1.2 and 1.3 of the Analysis Data Model Implementation Guide
Posted Date: 2022-07-18T04:00Z

[Federal Register Volume 87, Number 136 (Monday, July 18, 2022)]
[Notices]
[Pages 42729-42730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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.

[[Page 42730]]

     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 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 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: 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 https://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm, 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