Notice2024-31272
Request for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committee
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
December 30, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) is requesting that any industry organizations interested in participating in the selection of a pool of nonvoting industry representatives to serve as temporary nonvoting members on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the Committee. Nominees recommended to serve as a temporary nonvoting industry representative may either be self- nominated or nominated by an industry organization. This position may be filled by representatives from different medical device areas based on expertise relevant to the topics being considered by the Committee. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of women and men, 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 249 (Monday, December 30, 2024)</title>
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[Federal Register Volume 89, Number 249 (Monday, December 30, 2024)]
[Notices]
[Pages 106513-106514]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-31272]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0008]
Request for Nominations of Individuals and Industry Organizations
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 that any industry organizations interested in participating
in the selection of a pool of nonvoting industry representatives to
serve as temporary nonvoting members on the Patient Engagement Advisory
Committee (the Committee) in the Center for Devices and Radiological
Health notify FDA in writing. FDA is also requesting nominations for
temporary nonvoting industry representatives to be included in a pool
of individuals to serve on the Committee. Nominees recommended to serve
as a temporary nonvoting industry representative may either be self-
nominated or nominated by an industry organization. This position may
be filled by representatives from different medical device areas based
on expertise relevant to the topics being considered by the Committee.
Nominations will be accepted for upcoming vacancies effective with this
notice. FDA seeks to include the views of women and men, 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: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interest must send a letter stating that interest to the FDA by January
29, 2025, (see sections I and II of this document for details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by January 29, 2025.
ADDRESSES: All statements of interest from industry organizations
interested in participating in the selection process of a pool of
nonvoting industry representatives should be sent electronically to
Margaret Ames (see FOR FURTHER INFORMATION CONTACT). All nominations
for nonvoting industry representatives should be submitted
electronically by accessing 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> 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: Margaret Ames, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5213, Silver Spring, MD 20993-0002, 301-796-5960,
email: <a href="/cdn-cgi/l/email-protection#c4a9a5b6a3a5b6a1b0eaa5a9a1b784a2a0a5eaacacb7eaa3abb2"><span class="__cf_email__" data-cfemail="81ece0f3e6e0f3e4f5afe0ece4f2c1e7e5e0afe9e9f2afe6eef7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a pool of
nonvoting industry representatives for the Committee. The list of
needed expertise on May 1, 2025, is identified below:
<bullet> Cybersecurity
<bullet> Communication of Benefit & Risk Information to Patients;
Medical Device Labeling
<bullet> Digital Health Technology/Artificial Intelligence
<bullet> Health Equity
<bullet> Patient Engagement
<bullet> Patient Preference Elicitation
<bullet> Patient-Reported Outcomes Development, Validation, and Use in
Regulatory Studies or Clinical Practice
<bullet> Postmarket Studies, Including Observational and Registry-Based
Studies
<bullet> Human Factors
FDA is publishing separate documents regarding:
1. Request for Nominations for Voting Members for the Patient
Engagement Advisory Committee
2. Request for Nominations for Consumer Representative for the Patient
Engagement Advisory Committee
I. General Description of the Committee's Duties
The Committee provides advice on complex 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 or
[[Page 106514]]
health status issues are among the topics that may be considered by the
Committee. Members are knowledgeable in areas such as clinical
research, primary care patient experience, healthcare needs of patient
groups in the United States or are experienced in the work of patient
and health professional organizations, methodologies for eliciting
patient preferences, and strategies for communicating benefits, risks
and clinical outcomes to patients and research subjects. The
Commissioner of Food and Drugs (the Commissioner), or designee, shall
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(s).
II. Qualifications
Persons nominated for the Patient Engagement Advisory Committee
should be full-time employees of firms that manufacture medical device
products, or consulting firms that represent manufacturers or have
similar appropriate ties to industry.
III. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interest must send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of
this document (see DATES). Within the subsequent 30 days, FDA will send
a letter to each organization that has expressed an interest, attaching
a complete list of all such organizations; and a list of all nominees
along with their current r[eacute]sum[eacute]s or curriculum vitae. The
letter will also state that it is the responsibility of the interested
organizations to confer with one another and to select a candidate or
candidates (to serve in a pool of individuals with varying areas of
expertise) to represent industry interest for the Committee, within 60
days after the receipt of the FDA letter. The interested organizations
are not bound by the list of nominees in selecting a candidate or
candidates. However, if no individual is selected within 60 days, the
Commissioner will select temporary nonvoting members (or pool of
individuals) to represent industry interests.
IV. Nomination Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a temporary nonvoting industry
representative. Nominations must include a cover letter and 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 Committee Membership
Nomination Portal (see ADDRESSES). Nominations should specify the
advisory committee for which the nominee is recommended within 30 days
of publication of this document (see DATES). In addition, nominations
should acknowledge that the nominee is aware of the nomination, unless
self-nominated. FDA will forward all nominations to the organizations
expressing interest in participating in the selection process for the
Committee. Only interested industry organizations participate in the
selection process. Persons who nominate themselves as nonvoting
industry representatives will not participate in the selection process.
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: December 20, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-31272 Filed 12-27-24; 8:45 am]
BILLING CODE 4164-01-P
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