Notice2024-07254
Request for Nominations for Voting Members for the Patient Engagement Advisory Committee
Primary source
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Published
April 5, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is requesting nominations for voting members, excluding consumer and industry representatives, to serve on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Full Text
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<title>Federal Register, Volume 89 Issue 67 (Friday, April 5, 2024)</title>
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[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Notices]
[Page 24013]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-07254]
[[Page 24013]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0008]
Request for Nominations for Voting Members for the Patient
Engagement Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
requesting nominations for voting members, excluding consumer and
industry representatives, to serve on the Patient Engagement Advisory
Committee (the Committee) in the Center for Devices and Radiological
Health. Nominations will be accepted for upcoming vacancies effective
with this notice. FDA seeks to include the views of members of all
gender groups, members of all racial and ethnic groups, and individuals
with and without disabilities on its advisory committees and,
therefore, encourages nominations of appropriately qualified candidates
from these groups.
DATES: Nominations received on or before June 4, 2024, will be given
first consideration for membership on the Committee. Nominations
received after June 4, 2024, will be considered for nomination to the
Committee as later vacancies occur.
ADDRESSES: All nominations for membership should be submitted
electronically, by logging into the FDA Advisory Committee Membership
Nomination Portal (<a href="https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm">https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm</a>) and selecting Academician/Practitioner from the
dropdown menu (regardless of whether Academician/Practitioner
accurately describes the nominee), or by mail to Advisory Committee
Oversight and Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002.
Information about becoming a member on an FDA advisory committee can
also be obtained by visiting FDA's website at <a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.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, 301-
796-8398, email: <a href="/cdn-cgi/l/email-protection#0f436a7b667c6a2158666363666e627c4f696b6e2167677c21686079"><span class="__cf_email__" data-cfemail="5c103928352f39720b353030353d312f1c3a383d7234342f723b332a">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members to fill upcoming vacancies on the Patient Engagement Advisory
Committee. This notice does not include consumer and industry
representative nominations. The Agency will publish two separate
notices announcing the vacancy of a representative of consumer
interests and vacancy of representatives of interests of the device
manufacturing industry.
I. General Description of the Committee Duties
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. The Committee performs its duties by identifying new
approaches, promoting innovation, recognizing unforeseen risks or
barriers, and identifying unintended consequences that could result
from FDA policy. The Committee provides advice on complex scientific
issues related 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, device-related quality of life
measures, or health status issues are among the topics that may be
considered by the Committee.
II. Criteria for Voting Members
The Committee consists 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 or caregiver experience, healthcare needs of
patient groups in the United States, or are experienced in the work of
patient and health professional organizations, scientific methodologies
for patient-reported outcomes and other clinical outcome assessments,
scientific methodologies for 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. Prospective members should also have an understanding of the
broad spectrum of patients in a particular disease area. Almost all
non-Federal members of this Committee serve as Special Government
Employees, with the exception of the representatives from industry.
III. Nomination Procedures
Any interested person may nominate one or more qualified
individuals for membership on the Committee. Self-nominations are also
accepted. Nominations must include a cover letter; a current, complete
r[eacute]sum[eacute] or curriculum vitae for each nominee, including
current business and/or home address, telephone number, and email
address if available; and a signed copy of the Acknowledgement and
Consent form available at the FDA Advisory Nomination Portal (see
ADDRESSES). Nominations must specify the advisory committee for which
the nominee is recommended. Nominations must also acknowledge that the
nominee is aware of the nomination unless self-nominated. FDA will ask
potential candidates to provide detailed information concerning such
matters related to financial holdings, employment, and research grants
and/or contracts to permit evaluation of possible sources of conflicts
of interest.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. 1001 et seq.) and 21 CFR part 14, relating to advisory
committees.
Dated: April 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07254 Filed 4-4-24; 8:45 am]
BILLING CODE 4164-01-P
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