Notice2026-10602
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information; Extension of Comment Period
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
May 28, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled "AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information" that appeared in the Federal Register of April 29, 2026. In the notice, FDA requested comments to solicit input on a proposed pilot program to assess how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision- making in early phase clinical trials. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Full Text
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<title>Federal Register, Volume 91 Issue 102 (Thursday, May 28, 2026)</title>
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[Federal Register Volume 91, Number 102 (Thursday, May 28, 2026)]
[Notices]
[Pages 31725-31726]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10602]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-4390]
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot
Program; Request for Information; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Request for information; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice entitled ``AI-Enabled
Optimization of Early-Phase Clinical Trials Pilot Program; Request for
Information'' that appeared in the Federal Register of April 29, 2026.
In the notice, FDA requested comments to solicit input on a proposed
pilot program to assess how artificial intelligence (AI)-enabled
technologies can improve efficiency, speed, and quality of decision-
making in early phase clinical trials. The Agency is taking this action
in response to a request for an extension to allow interested persons
additional time to submit comments.
DATES: FDA is extending the comment period on the request for
information published April 29, 2026 (91 FR 23100). Either electronic
or written comments must be submitted by June 29, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 29, 2026. 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:
<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
[[Page 31726]]
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-2026-N-4390 for ``AI-Enabled Optimization of Early- Phase Clinical
Trials Pilot Program; Request for Information.'' 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 <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: Mallika Mundkur, Deputy Chief Medical
Officer, Office of the Commissioner, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8800. Please
send relevant correspondence to Juliane Carvalho, Senior Advisor,
Office of the Commissioner, <a href="/cdn-cgi/l/email-protection#38524d545159565d165b594a4e59545057785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="741e01181d151a115a1715060215181c1b341210155a1c1c075a131b02">[email protected]</span></a> with ``RTCT-
Response to RFI'' in the subject line.
SUPPLEMENTARY INFORMATION: In the Federal Register of April 29, 2026,
FDA published a notice with a 30-day comment period to request comments
on the document entitled ``AI-Enabled Optimization of Early-Phase
Clinical Trials Pilot Program; Request for Information.'' FDA issued
this request for information to solicit input on a proposed pilot
program to assess how AI-enabled technologies can improve efficiency,
speed, and quality of decision-making in early phase clinical trials.
The Agency has received a request for a 30-day extension of the
comment period for the request for information.
FDA has considered the request and is extending the comment period
for the request for information for 30 days, until June 29, 2026. The
Agency believes that a 30-day extension allows adequate time for
interested persons to submit comments.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10602 Filed 5-27-26; 8:45 am]
BILLING CODE 4164-01-P
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