Notice2025-16514
Patient-Focused Drug Development: Workshop #2 To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop; Request for Comments
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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
August 28, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Patient-Focused Drug Development: Workshop #2 to Discuss Methodologic and Other Challenges Related to Patient Experience Data." The purpose of the public workshop is to discuss methodological challenges related to patient experience data, and other areas of greatest interest or concern to public stakeholders.
Full Text
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<title>Federal Register, Volume 90 Issue 165 (Thursday, August 28, 2025)</title>
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[Federal Register Volume 90, Number 165 (Thursday, August 28, 2025)]
[Notices]
[Pages 42017-42018]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-16514]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-2368]
Patient-Focused Drug Development: Workshop #2 To Discuss
Methodologic and Other Challenges Related to Patient Experience Data;
Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Patient-Focused
Drug Development: Workshop #2 to Discuss Methodologic and Other
Challenges Related to Patient Experience Data.'' The purpose of the
public workshop is to discuss methodological challenges related to
patient experience data, and other areas of greatest interest or
concern to public stakeholders.
DATES: The public workshop will be held virtually on September 18,
2025, from 12:30 p.m. to 5 p.m. Eastern Time, and September 19, 2025,
from 12:30 p.m. to 4 p.m. Eastern Time. Either electronic or written
comments on this public workshop must be submitted by November 18,
2025. See the SUPPLEMENTARY INFORMATION section for registration date
and information.
ADDRESSES: The public workshop will be held virtually using the Zoom
platform. The link for the public workshop will be sent to registrants
upon registration.
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 18, 2025. 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-2025-N-2368 for ``Patient-Focused Drug Development: Workshop #2 to
Discuss Methodologic and Other Challenges Related to Patient Experience
Data.'' 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
[[Page 42018]]
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: Ethan Gabbour, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6306, Silver Spring, MD 20993, 301-796-
8112, <a href="/cdn-cgi/l/email-protection#c683b2aea7a8e881a7a4a4a9b3b486a0a2a7e8aeaeb5e8a1a9b0"><span class="__cf_email__" data-cfemail="baffced2dbd494fddbd8d8d5cfc8fadcdedb94d2d2c994ddd5cc">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Under the seventh iteration of the Prescription Drug User Fee Act,
incorporated as part of the FDA User Fee Reauthorization Act of 2022,
FDA committed to facilitate the advancement and use of systematic
approaches to collect and utilize robust and meaningful patient and
caregiver input that can more consistently inform drug development and,
as appropriate, regulatory decision making. This included issuing a
Request for Information (RFI) available at <a href="https://www.federalregister.gov/documents/2023/05/02/2023-09265/methodological-challenges-related-to-patient-experience-data-request-for-information-and-comments">https://www.federalregister.gov/documents/2023/05/02/2023-09265/methodological-challenges-related-to-patient-experience-data-request-for-information-and-comments</a> to elicit public input on methodologic challenges related
to patient experience data, and other areas of greatest interest or
concern to public stakeholders.\1\ The RFI was published on May 2,
2023, and the public comment period was open until July 3, 2023. A
summary of the comments was published on December 12, 2023, and is
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> by entering the following
docket number: FDA-2023-N-1506. The input received in response to the
RFI helped inform the topics for the first public workshop in this
series, Patient-Focused Drug Development: Workshop to Discuss
Methodologic and Other Challenges Related to Patient Experience Data,
held on December 13, 2024. The discussions from the first workshop
helped to inform the topics for this second workshop. These workshops,
together with the input received in response to the RFI, will help FDA
identify priorities for future work.
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\1\ The Federal Food, Drug, and Cosmetic Act, as amended by the
21st Century Cures Act (Pub. L. 114-255) and the FDA Reauthorization
Act of 2017 (Pub. L. 115-52), defines patient experience data as
data that are collected by any persons (including patients, family
members and caregivers of patients, patient advocacy organizations,
disease research foundations, researchers and drug manufacturers)
and are intended to provide information about patients' experiences
with a disease or condition, including the impact (including
physical and psychosocial impacts) of such disease or condition or a
related therapy or clinical investigation and patient preferences
with respect to treatment of the disease or condition.
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II. Topics for Discussion at the Public Workshop
The purpose of this virtual public workshop is to highlight and
discuss methodological issues related to patient experience data,
including the submission and evaluation of patient experience data in
the context of the benefit-risk assessment and product labeling, as
well as other areas of greatest interest or concern to stakeholders.
This workshop will build upon the previous workshop and will feature
presentations and panel discussions with experts on selected
methodologies and the challenges and opportunities they present. In
addition, this workshop will present a draft version of an updated
evidence dossier template to facilitate the submission of evidence to
FDA to support a Clinical Outcome Assessment.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: <a href="https://fda.zoomgov.com/webinar/register/WN_8FiAJfirS3W2WpC_8K0Zww#/registration">https://fda.zoomgov.com/webinar/register/WN_8FiAJfirS3W2WpC_8K0Zww#/registration</a>. Please provide complete
contact information for each attendee, including name, organization,
email, and affiliation.
Registration is free. Persons interested in attending this public
workshop must register to receive a link to the meeting. Registrants
will receive a confirmation email after they register.
If you need special accommodations due to a disability, please
contact <a href="/cdn-cgi/l/email-protection#c782b3afa6a9e980a6a5a5a8b2b587a1a3a6e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="5316273b323d7d143231313c2621133537327d3b3b207d343c25">[email protected]</span></a> no later than September 11, 2025.
Please note, closed captioning will be available automatically.
Transcript: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may also be viewed at the Dockets Management
Staff (see ADDRESSES).
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-16514 Filed 8-27-25; 8:45 am]
BILLING CODE 4164-01-P
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