Notice2026-15887
Establishment of a Quantitative Medicine Innovation Network: Scope, Feasibility, and Opportunities; Request for Information
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Published
August 5, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Center for Drug Evaluation and Research (CDER) within the Food and Drug Administration (FDA or Agency), through its Quantitative Medicine Center of Excellence (QM CoE), is announcing a request for information to inform the development of a Quantitative Medicine Innovation Network (QMIN). The vision for the QMIN is to create a cross-sector collaborative platform that accelerates the translation of quantitative medicine approaches to transform drug development, regulatory science, and clinical decision-making for patient benefit. The purpose of this request is to obtain feedback from industry, academia, healthcare providers, patient groups, and other interested parties on identifying critical community needs and establishing mechanisms for continuous engagement, supporting collaborative demonstration projects or research on innovative approaches aimed at addressing high priority areas through the application of QM approaches, and exploring mechanisms to leverage community expertise and capacity to promote QM innovation and adoption. Information submitted in response to this request will be considered in shaping the structure, priorities, and activities of the QMIN.
Full Text
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<title>Federal Register, Volume 91 Issue 149 (Wednesday, August 5, 2026)</title>
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[Federal Register Volume 91, Number 149 (Wednesday, August 5, 2026)]
[Notices]
[Pages 50553-50555]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-15887]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-7605]
Establishment of a Quantitative Medicine Innovation Network:
Scope, Feasibility, and Opportunities; Request for Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for information.
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SUMMARY: The Center for Drug Evaluation and Research (CDER) within the
Food and Drug Administration (FDA or Agency), through its Quantitative
Medicine Center of Excellence (QM CoE), is announcing a request for
information to inform the development of a Quantitative Medicine
Innovation Network (QMIN). The vision for the QMIN is to create a
cross-sector collaborative platform that accelerates the translation of
quantitative medicine approaches to transform drug development,
regulatory science, and clinical decision-making for patient benefit.
The purpose of this request is to obtain feedback from industry,
academia, healthcare providers, patient groups, and other interested
parties on identifying critical community needs and establishing
mechanisms for continuous engagement, supporting collaborative
demonstration projects or research on innovative approaches aimed at
addressing high priority areas through the application of QM
approaches, and exploring mechanisms to leverage community expertise
and capacity to promote QM innovation and adoption. Information
submitted in response to this request will be considered in shaping the
structure, priorities, and activities of the QMIN.
DATES: Either electronic or written comments on the notice must be
submitted by November 3, 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 November 3, 2026. Comments
received
[[Page 50554]]
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-7605 for ``Establishment of a Quantitative Medicine
Innovation Network: Scope, Feasibility, and Opportunities; 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: Daphne Guinn, Office of Clinical
Pharmacology, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Silver Spring, MD
20993-0002, 301-837-7122, <a href="/cdn-cgi/l/email-protection#cb8faabba3a5aee58cbea2a5a58badafaae5a3a3b8e5aca4bd"><span class="__cf_email__" data-cfemail="480c293820262d660f3d212626082e2c296620203b662f273e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing a request for information titled ``Establishment
of a Quantitative Medicine Innovation Network: Scope, Feasibility, and
Opportunities.'' Information submitted in response to this notice will
be used by CDER's Quantitative Medicine Center of Excellence (QM CoE)
to inform the development and implementation of a cross-sector
innovation network.
The proposed mission for the QMIN is to connect FDA scientists,
academia, industry, healthcare providers, patient groups, and other
regulatory partners in driving the development and application of
quantitative medicine to tackle critical unmet needs of the community
by fundamentally transforming drug development and clinical care.
Quantitative medicine approaches integrate mathematical and
computational models with biological, clinical, and statistical data to
inform drug development, regulatory, and clinical decisions. These
approaches have the potential to improve the efficiency of drug
development, optimize treatment strategies, and ultimately improve
patient outcomes.
The QM CoE seeks to establish a collaborative ecosystem that brings
together diverse stakeholders to advance the science and application of
quantitative medicine toward transformative capabilities. The QMIN is
envisioned as a multi-stakeholder network to accelerate the translation
of quantitative approaches across the drug discovery, development,
regulation, and utilization continuum, fundamentally transforming how
safe and effective therapies reach patients. This request for
information is designed to gather input on how best to structure and
implement the QMIN to maximize its impact on public health.
II. Request for Information
FDA is interested in detailed comments on the topics listed in this
section to inform the establishment of the QMIN. The topics identified
in this section are not meant to be exhaustive. FDA is also interested
in any other pertinent information that interested parties would like
to share related to advancing quantitative medicine through
collaborative networks. The Agency encourages interested parties to
provide specific rationale and basis for their comments, including any
available supporting data and information.
The QM CoE seeks to understand the current landscape of
quantitative medicine capabilities, challenges, and opportunities
across different stakeholder groups. We are interested in establishing
mechanisms for problem-solving that leverage community expertise and
collaborative capacity.
Specific areas of interest include the following:
A. Scope
1. Priority Domains
<bullet> What areas of quantitative medicine (e.g., disease
modeling, trial simulation, New Approach Methodologies (NAMs)
integration) would most benefit from a coordinated, cross-sector
network?
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<bullet> Where currently are the greatest gaps in tools, standards,
or infrastructure?
2. Depth vs. Breadth
<bullet> Should the QMIN prioritize a limited number of high-impact
domains (e.g., therapeutic area specific needs, methodology
development) for deep investment, or a broader set of activities (e.g.,
improved adoption and integration of QM approaches across therapeutic
areas)?
3. Boundaries of Activity
<bullet> What activities are most appropriate for a precompetitive
network versus those better addressed within individual development
programs or regulatory submissions?
<bullet> How should the QMIN define its role relative to existing
efforts, including those led by FDA and external stakeholders?
B. Operating Model
1. Structure and Governance
<bullet> What governance structures would best support a multi-
stakeholder network involving FDA, industry, academia, and patient
groups?
<bullet> What roles should different stakeholders play in setting
priorities, developing outputs, and ensuring scientific rigor?
2. Modes of Collaboration
<bullet> What mechanisms (e.g., working groups, pilot projects,
public workshops, shared platforms) would most effectively support the
QMIN's objectives?
<bullet> How should collaboration be structured to enable both
innovation and broad participation?
3. Sustainability and Incentives
<bullet> What incentives would encourage sustained participation
from stakeholders?
<bullet> What funding or resourcing models (e.g., public-private
partnerships) should be considered?
C. Priority Use Cases
1. Selection of Use Cases
<bullet> What types of use cases are most appropriate for initial
QMIN focus?
<bullet> What criteria should be used to select and evaluate use
cases?
2. Demonstration of Value
<bullet> How should the QMIN's use cases be designed to demonstrate
clear impact?
<bullet> What metrics (e.g., reduced development time, improved
decision confidence, reduced animal use) are most appropriate?
(Authority: 21 U.S.C. 355)
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-15887 Filed 8-4-26; 8:45 am]
BILLING CODE 4164-01-P
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