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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 [www.gpo.gov]
[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: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm 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 https://www.fda.gov/AdvisoryCommittees/default.htm.

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: [email protected].

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:

 Cybersecurity
 Communication of Benefit & Risk Information to Patients; 
Medical Device Labeling
 Digital Health Technology/Artificial Intelligence
 Health Equity
 Patient Engagement
 Patient Preference Elicitation
 Patient-Reported Outcomes Development, Validation, and Use in 
Regulatory Studies or Clinical Practice
 Postmarket Studies, Including Observational and Registry-Based 
Studies
 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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