[Federal Register Volume 91, Number 138 (Tuesday, July 21, 2026)]
[Notices]
[Pages 45820-45821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-14672]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-4699]
Expedited Investigational New Drug Pilot Program; Request for
Information; Extension of the Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information; establishment of a public
docket; extension of the comment period.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
extending the comment period for the notice that appeared in the
Federal Register of June 24, 2026, to open a public docket to solicit
input and comments on a proposal to establish a pilot program, the
Expedited Investigational New Drug (IND) pilot program, to shorten the
time it takes from drug identification to first-in-human (FIH) study,
while protecting clinical trial participants.
DATES: FDA is extending the comment period on the notice published on
June 24, 2026 (91 FR 37996). Either electronic or written comments,
data, or information must be received by August 24, 2026.
ADDRESSES: You may submit comments, data, and information as follows.
Please note that late, untimely filed comments
[[Page 45821]]
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 August 24, 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:
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 identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include Docket No. FDA-
2026-N-4699 for ``Expedited Investigational New Drug 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
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: Benjamin Cook, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 2, Rm. 2114, Silver Spring, MD 20993-0002, 240-338-4685,
[email protected].
SUPPLEMENTARY INFORMATION: In the Federal Register of June 24, 2026 (91
FR 37996), FDA published a notice to open a public docket to solicit
input and comments on a proposal to establish a pilot program, the
Expedited IND pilot program, to shorten the time it takes from drug
identification to FIH study, while protecting clinical trial
participants. FDA is extending the comment period until August 24,
2026. The Agency is taking this action to allow interested persons
additional time to submit comments.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-14672 Filed 7-20-26; 8:45 am]
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