[Federal Register Volume 90, Number 67 (Wednesday, April 9, 2025)]
[Notices]
[Pages 15251-15252]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-06051]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-0129]
Electronic Study Data Submission; Data Standards; Clinical Data
Interchange Standards Consortium Dataset-JavaScript Object Notation;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is exploring
Clinical Data Interchange Standards Consortium (CDISC) Dataset-
JavaScript Object Notation (Dataset-JSON) version 1.1 as a new exchange
standard, with the long-term potential to replace Statistical Analysis
System (SAS) version 5 XPORT Transport Format (XPT), for submission of
electronic study data to the Center for Biologics Evaluation and
Research (CBER) and the Center for Drug Evaluation and Research (CDER).
FDA is requesting comments on whether to accept Dataset-JSON to
exchange electronic study data as part of regulatory applications in
the future. In particular, FDA is requesting feedback on the risks and
benefits of industry adopting Dataset-JSON as a new exchange standard
for submitting electronic study data to FDA and any integration
challenges with existing tools and systems.
DATES: Either electronic or written comments must be submitted by June
9, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 9, 2025. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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
[[Page 15252]]
identified, as confidential, if submitted as detailed in
``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2025-N-0129 for ``Electronic Study Data Submission; Data Standards;
Clinical Data Interchange Standards Consortium Dataset-JavaScript
Object Notation; Request for Comments.'' Received comments, those filed
in a timely manner (see ADDRESSES), 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: Chenoa Conley, Center for Drug
Evaluation and Research, Food and Drug Administration,
[email protected], 10903 New Hampshire Ave., Bldg. 32, Rm.
3158, Silver Spring, MD 20993-0002, 301-796-0035; or James Myers,
Center for Biologics Evaluation and Research, Food and Drug
Administration, [email protected], 10903 New Hampshire Ave.,
Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
Background
In recent years, JSON has become a universal format within the
global web and is the preferred choice for a variety of publicly
available web services. While JSON is a standard for data exchange,
Dataset-JSON is a JSON-based schema specifically designed for
exchanging tabular datasets that is based on CDISC Dataset-JSON version
1.0 with enhancements, including smaller file sizes, additional
metadata, and simpler processing. CDISC Dataset-JSON supports file and
Application Programming Interface based data exchange, is widely
supported across technologies, and can link to Define-XML for
additional metadata.
In 2022, the Agency completed a high-level assessment on the costs
and benefits of a potential transition to a modern data exchange
format. Options evaluated included SAS version 8 XPT, Extensible Markup
Language, and JSON. The assessment findings were based on a weighted
evaluation of Agency requirements, which indicated JSON as the optimal
modern format with the potential to serve as a replacement to SAS
version 5 XPT. From September 2023 to April 2024, FDA collaborated with
the CDISC and Pharmaceutical Users Software Exchange (PHUSE) to execute
a pilot that tested the feasibility of using CDISC Dataset-JSON as a
transport format for study data submitted with regulatory applications.
The CDISC-PHUSE pilot results demonstrated that CDISC Dataset-JSON has
the potential to serve as a transport file for study data. For
additional information on the CDISC-PHUSE pilot titled ``Dataset-JSON
as an Alternative Transport Format for Regulatory Submissions: Final
Pilot Report'' can be found at: https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/WP-88+Dataset-JSON+Report.pdf.
JSON has become ubiquitous on the web and is the most commonly used
format to represent Health Level Seven/Fast Healthcare Interoperability
Resource, the standard specified for the use of electronic healthcare
records by the Assistant Secretary for Technology Policy and Office of
the National Coordinator for Health Information Technology.
Through this notice, FDA is requesting comments from industry on
adoption risks and benefits and any integration challenges with
existing tools and systems associated with the use of Dataset-JSON to
exchange electronic study data as part of regulatory applications. A
future transition to Dataset-JSON is being considered to improve the
Agency's ability to receive and process regulatory submission
information and ensure alignment with the FDA's Data Modernization
Action Plan. More information about the FDA Data Modernization Action
Plan can be found at: https://www.fda.gov/about-fda/reports/data-modernization-action-plan. FDA understands that any potential change to
the current regulatory submission requirements could have a significant
impact on the industry. As such, the Agency is open to future
engagements with industry and vendors through further testing
initiatives utilizing CDISC Dataset-JSON.
If the Agency makes the decision to adopt Dataset-JSON as the new
format for electronic submissions in the future, the Agency intends to
do so in accordance with the final guidance titled ``Providing
Regulatory Submissions in Electronic Format--Standardized Study Data''
(available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-regulatory-submissions-electronic-format-standardized-study-data), which implements 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 new drug
applications, abbreviated new drug applications, biologics license
applications, and investigational new drug applications submitted to
CDER or CBER by specifying the format for electronic submissions.
Dated: March 28, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-06051 Filed 4-8-25; 8:45 am]
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