Notice2024-19323
Patient Engagement Advisory Committee; Notice of Meeting-Patient-Centered Informed Consent in Clinical Study
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
August 28, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Full Text
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<title>Federal Register, Volume 89 Issue 167 (Wednesday, August 28, 2024)</title>
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[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Pages 68908-68909]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-19323]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0008]
Patient Engagement Advisory Committee; Notice of Meeting--
Patient-Centered Informed Consent in Clinical Study
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) announces a
forthcoming public advisory committee meeting of the Patient Engagement
Advisory Committee (the Committee). The general function of the
Committee is to provide advice and recommendations to the Agency on
FDA's regulatory issues. The meeting will be open to the public.
DATES: The meeting will be held on October 30, 2024, from 10 a.m. to 5
p.m. Eastern Time.
ADDRESSES: All meeting participants will be heard, viewed, captioned,
and recorded for this advisory committee meeting via an online
teleconferencing and/or video conferencing platform.
Answers to commonly asked questions about FDA advisory committee
meetings may be accessed at: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
FOR FURTHER INFORMATION CONTACT: Letise Williams, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5407, Silver Spring, MD 20993-0002,
<a href="/cdn-cgi/l/email-protection#b6fad3c2dfc5d398e1dfdadadfd7dbc5f6d0d2d798dedec598d1d9c0"><span class="__cf_email__" data-cfemail="8dc1e8f9e4fee8a3dae4e1e1e4ece0fecdebe9eca3e5e5fea3eae2fb">[email protected]</span></a>, 301-796-8398, or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). A notice in the Federal Register about last-minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before the
meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing and/or video
conferencing platform. On October 30, 2024, the Committee will discuss
and make recommendations on ``Patient-Centered Informed Consent in
Clinical Study of FDA-Regulated Medical Products.'' The individuals who
volunteer to participate in clinical research play an integral role in
advancing scientific knowledge and supporting the development of
potentially life-saving therapies for patients in need. Informed
consent is a key element in clinical studies and can be one of a
patient's first interactions with the clinical community. Too often,
however, informed consent forms are lengthy and difficult for potential
research participants to understand. FDA has worked to improve informed
consent over the years, including several recent activities such as
developing a draft guidance in identifying key information in informed
consent.
The Committee will provide recommendations on the informed consent
process and the areas of focus of the informed consent. The Committee
will also provide recommendations on factors to consider when
communicating informed consent to clinical study participants to
increase the likelihood of participants understanding the key elements
of research.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting, and the background material
will be posted on FDA's website after the meeting. Background material
and the link to the online teleconference and/or video conference
meeting will be available at <a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. Scroll down and select the appropriate advisory
committee meeting link. The meeting will include slide presentations
with audio and video components to allow the presentation of materials
in a manner that most closely resembles an in-person advisory committee
meeting.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the Committee.
Written submissions may be made to the contact person (see FOR FURTHER
INFORMATION CONTACT) on or before October 3, 2024. Oral presentations
from the public will be scheduled between approximately 2 p.m. and 3
p.m. Eastern Time. Those individuals interested in making formal oral
presentations should notify the contact person (see FOR FURTHER
INFORMATION CONTACT) and submit a brief statement of the general nature
of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
September 25, 2024. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. If the number of registrants
requesting to speak during the open public hearing is greater than can
be reasonably accommodated during the scheduled open hearing portion of
the advisory committee meeting, FDA may conduct a lottery to determine
the speakers who will be invited to participate. The contact person
will notify interested persons regarding their request to speak by
September 26, 2024.
Virtual Breakout Session: Individuals interested in participating
in the virtual breakout scenario discussions will need to sign up to
participate on or before October 16, 2024. The signup sheet, as well as
additional information pertaining to the virtual scenario discussions,
will be available at <a href="https://www.fdalive.com/peac">https://www.fdalive.com/peac</a>. Everyone who signs
up in advance and provides a valid email address will receive an
[[Page 68909]]
email at least 2 days prior to the meeting with information on how to
access the virtual platform that will host the virtual breakout
scenario discussions. Please note due to limited technology capacity,
participation in the virtual breakout scenario discussions will be
limited to 150 participants. Once capacity reaches 150 participants,
the breakout session will be closed to additional participants.
Additional information regarding the virtual breakout scenario
discussions will be provided at <a href="https://www.fdalive.com/peac">https://www.fdalive.com/peac</a>.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#e38587828c8e82a3858782cd8b8b90cd848c95"><span class="__cf_email__" data-cfemail="abcdcfcac4c6caebcdcfca85c3c3d885ccc4dd">[email protected]</span></a> or 301-796-4540.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact AnnMarie Williams at <a href="/cdn-cgi/l/email-protection#9fdef1f1f2feedf6fab1c8f6f3f3f6fef2ecdff9fbfeb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="eeaf8080838f9c878bc0b9878282878f839dae888a8fc086869dc0898198">[email protected]</span></a>, or 240-507-
6496 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. 1001 et seq.). This meeting notice also serves
as notice that, pursuant to 21 CFR 10.19, the requirements in 21 CFR
14.22(b), (f), and (g) relating to the location of advisory committee
meetings are hereby waived to allow for this meeting to take place
using an online meeting platform. This waiver is in the interest of
allowing greater transparency and opportunities for public
participation, in addition to convenience for advisory committee
members, speakers, and guest speakers. The conditions for issuance of a
waiver under 21 CFR 10.19 are met.
Dated: August 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19323 Filed 8-27-24; 8:45 am]
BILLING CODE 4164-01-P
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