Notice2026-01903
FDA Rare Disease Innovation Hub Future Programming; Request for Comments
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
January 30, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is announcing the following request for comments for a future public workshop series entitled "Rare disease Innovation, Science, and Exploration (RISE) Workshop." The purpose of the public workshops is to focus on challenges that are common to multiple diseases or a class of diseases, and for which evolving science offers innovative solutions. The workshops will primarily focus on cross-cutting or common issues and will not be focused on any specific product under review by the Agency. The Agency further welcomes comments that highlight general rare disease-related issues of potential interest for the FDA Rare Disease Innovation Hub (Hub) to inform its future activities.
Full Text
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<title>Federal Register, Volume 91 Issue 20 (Friday, January 30, 2026)</title>
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[Federal Register Volume 91, Number 20 (Friday, January 30, 2026)]
[Notices]
[Pages 4084-4085]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-01903]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-0131]
FDA Rare Disease Innovation Hub Future Programming; 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 the Agency) is
announcing the following request for comments for a future public
workshop series entitled ``Rare disease Innovation, Science, and
Exploration (RISE) Workshop.'' The purpose of the public workshops is
to focus on challenges that are common to multiple diseases or a class
of diseases, and for which evolving science offers innovative
solutions. The workshops will primarily focus on cross-cutting or
common issues and will not be focused on any specific product under
review by the Agency. The Agency further welcomes comments that
highlight general rare disease-related issues of potential interest for
the FDA Rare Disease Innovation Hub (Hub) to inform its future
activities.
DATES: Submit either electronic or written comments by December 31,
2026. See the SUPPLEMENTARY INFORMATION section for comment deadlines
corresponding to specific workshop sessions.
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 December 31, 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 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-0131 for ``FDA Rare Disease Innovation Hub Future
Programming; 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 <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: Philipa Friedman, Center for Biologics
Evaluation and Research, 10903 New Hampshire Ave., Silver Spring, MD
20993, 240-402-7911, <a href="/cdn-cgi/l/email-protection#90c2d4d9fefeffe6f1e4f9fffed8e5f2d0f6f4f1bef8f8e3bef7ffe6"><span class="__cf_email__" data-cfemail="6735232e0909081106130e08092f120527010306490f0f1449000811">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The FDA is publishing this request for comments to obtain
suggestions for topics for future RISE Workshops. The Hub supports the
RISE Workshop series pursuant to its commitment to further advance
regulatory science of rare disease therapies and the Agency's PDUFA VII
commitments to enhance regulatory science and expedite drug development
and rare disease product review under the Food, Drug, and Cosmetic Act.
The Hub-sponsored RISE workshop series focuses on challenges that
are common to multiple diseases or a class of diseases, and for which
evolving science offers innovative solutions. The workshops are open to
the public and designed for interaction and discourse between the
various rare disease community members and perspectives, including drug
developers, patient and disease organizations, academics, FDA
regulators and reviewers, and relevant staff from other federal
agencies. All workshops include coordination of the relevant medical
product Centers and
[[Page 4085]]
address the Centers' approaches to the relevant issues. The workshops
also include a discussion of the role of patients and patient/disease
organizations in the design and implementation of innovative solutions.
The workshops primarily focus on cross-cutting or common issues and
will not be focused on any specific product under review by the Agency.
Preference will be given to submissions that are germane to multiple
disease states and/or that are submitted jointly by two or more
entities.
For consideration for the summer RISE Workshop, FDA requests
comments by February 28, 2026. For consideration for the fall RISE
Workshop, FDA requests comments by May 31, 2026. The Agency requests
that submissions include:
<bullet> A description of the proposed topic;
<bullet> Suggested speakers and/or subject matter experts;
<bullet> A description of the impact of the topic on the
development and regulatory science of rare disease therapies;
<bullet> The disease state(s) affected by the challenge highlighted
in the submission;
<bullet> If relevant, related FDA guidances or existing programs
addressing the challenge highlighted in the submission.
Notice of this meeting series is given pursuant to 21 CFR 10.65.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-01903 Filed 1-29-26; 8:45 am]
BILLING CODE 4164-01-P
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