Notice2023-24212
Advisory Committee; Patient Engagement Advisory Committee; Renewal
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
November 2, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is announcing the renewal of the Patient Engagement Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Patient Engagement Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 6, 2025, expiration date.
Full Text
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<title>Federal Register, Volume 88 Issue 211 (Thursday, November 2, 2023)</title>
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[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75290-75291]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-24212]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2809]
Advisory Committee; Patient Engagement Advisory Committee;
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the renewal of the Patient Engagement Advisory Committee by
the Commissioner of Food and Drugs (the Commissioner). The Commissioner
has determined that it is in the public interest to renew the Patient
Engagement Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until the
October 6, 2025, expiration date.
DATES: Authority for the Patient Engagement Advisory Committee would
have expired on October 6, 2025, unless the Commissioner had formally
determined that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Letise Williams, Office of the Center
Director, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5407, Silver
Spring, MD 20993-0002, 301-796-8398, <a href="/cdn-cgi/l/email-protection#b0fcd5c4d9c3d59ee7d9dcdcd9d1ddc3f0d6d4d19ed8d8c39ed7dfc6"><span class="__cf_email__" data-cfemail="9dd1f8e9f4eef8b3caf4f1f1f4fcf0eeddfbf9fcb3f5f5eeb3faf2eb">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Patient Engagement
Advisory Committee (the Committee). The Committee is a discretionary
Federal advisory committee established to provide advice to the
Commissioner. The Patient Engagement Advisory Committee advises the
Commissioner or designee in discharging responsibilities as they relate
to helping to ensure safe and effective devices for human use and, as
required, any other product for which FDA has regulatory
responsibility.
The Committee provides advice to the Commissioner of Food and Drugs
or designee on complex scientific, issues relating to medical devices,
the regulation of devices, and their use by patients. Agency guidance
and policies, clinical trial or registry design, patient preference
study design, benefit-risk determinations, device labeling, unmet
clinical needs, available alternatives, patient reported outcomes, and
device-related quality of life measures or health status issues are
among the topics that may be considered by the Committee. The Committee
provides relevant skills and perspectives to improve communication of
benefits, risks, and clinical outcomes, and increase integration of
patient perspectives into the regulatory process for medical devices.
It performs its duties by identifying new approaches, promoting
innovation, recognizing unforeseen risks or barriers, and identifying
unintended consequences that could result from FDA policy.
Pursuant to its Charter, the Committee shall consist of a core of
nine voting members, including the Chair. Members and the Chair are
selected by the Commissioner or designee from among authorities who are
knowledgeable in areas such as clinical research, patient experience,
and healthcare needs of patient groups in the United States, or who are
experienced in the work of patient and health professional
organizations, methodologies for patient reported outcomes and
eliciting patient preferences, and strategies for communicating
benefits, risks, and clinical outcomes to patients and research
subjects, as well as other relevant areas. Members will be invited to
serve for overlapping terms of up to 4 years. Non-Federal members of
this committee will serve as either as Special Government Employees or
non-voting representatives. Federal members will serve as Regular
Government Employees. The core of voting members may include one
technically qualified member, selected by the Commissioner or designee,
who serves as an individual, but who is identified with consumer
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons. The Commissioner or
designee shall also have the authority to select from a group of
individuals nominated by industry to serve temporarily as nonvoting
members who are identified with industry interests. The number of
temporary members selected for a particular meeting will depend on the
meeting topic.
The Commissioner or designee shall also have the authority to
select members of other scientific and technical FDA advisory
committees (normally not to exceed 10 members) to serve temporarily as
voting members and to designate consultants to serve temporarily as
voting members when: (1) expertise is required that is not available
among current voting standing members of the Committee (when additional
voting members are added to the Committee to provide needed expertise,
a quorum will be based on the combined total of regular and added
members); or (2) to comprise a quorum when, because of unforeseen
circumstances, a quorum is or will be lacking. Because of the size of
the Committee and the variety in the types of issues that it will
consider, FDA may, in connection with a particular committee meeting,
specify a quorum that is less than a majority of the current voting
members. The Agency's regulations (21 CFR 14.22(d)) authorize a
committee charter to specify quorum requirements.
Further information regarding the most recent charter and other
information can be found at <a href="https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee">https://www.fda.gov/advisory-committees/committees-and-meeting-materials/patient-engagement-advisory-committee</a>
or by contacting the Designated Federal Officer (see FOR FURTHER
INFORMATION CONTACT). In light of the fact that no change has been made
to the committee name or description of duties, no amendment will be
made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees,
[[Page 75291]]
please visit us at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: October 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24212 Filed 11-1-23; 8:45 am]
BILLING CODE 4164-01-P
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