Notice2026-11691
Drug Repurposing for Unmet Medical Needs; 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
June 11, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the notice entitled "Drug Repurposing for Unmet Medical Needs; Request for Information" that appeared in the Federal Register of May 12, 2026 (91 FR 25897). In the notice, FDA requested comments to solicit input on FDA's efforts with respect to drug repurposing to address unmet medical needs. The Agency is taking this action to allow interested persons additional time to submit comments.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 112 (Thursday, June 11, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 112 (Thursday, June 11, 2026)]
[Notices]
[Pages 35488-35489]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11691]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-4492]
Drug Repurposing for Unmet Medical Needs; Request for
Information; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information; establishment of a public
docket.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
extending the comment period for the notice entitled ``Drug Repurposing
for Unmet Medical Needs; Request for Information'' that appeared in the
Federal Register of May 12, 2026 (91 FR 25897). In the notice, FDA
requested comments to solicit input on FDA's efforts with respect to
drug repurposing to address unmet medical needs. The Agency is taking
this action to allow interested persons additional time to submit
comments.
DATES: FDA is extending the comment period for the notice published May
12, 2026 (91 FR 25897). Submit either electronic or written comments,
data, or information by July 13, 2026.
ADDRESSES: You may submit comments, data, and information 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 July 13, 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,
[[Page 35489]]
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.
<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-4492 for ``Drug Repurposing for Unmet Medical Needs; 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: Caroline Huang, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6117, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#40243235273225303532302f33292e27002624216e2828336e272f36"><span class="__cf_email__" data-cfemail="9bffe9eefce9feebeee9ebf4e8f2f5fcdbfdfffab5f3f3e8b5fcf4ed">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 12, 2026 (91
FR 25897), FDA published a notice with a 30-day comment period to
request comments on the document entitled ``Drug Repurposing for Unmet
Medical Needs; Request for Information.'' FDA issued this request for
information to solicit input on potential priority disease areas and
potential candidates for drug repurposing, with a focus on FDA-approved
drugs for which there appears to be no commercial interest in adding a
new use through a supplement to a new drug application (supplemental
application).
FDA is extending the comment period for 30 days, until July 13,
2026. The Agency believes that a 30-day extension will allow adequate
time for interested persons to submit comments.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-11691 Filed 6-10-26; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on June 11, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.