[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70675-70676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22568]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0008]
Request for Nominations of Individuals and Industry Organizations
for the Digital Health Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is requesting
nominations for temporary nonvoting industry representatives to be
included in a pool of individuals to serve on the Digital Health
Advisory Committee. FDA is also requesting that industry organizations
interested in participating in the selection of a pool of nonvoting
industry representatives to serve as temporary nonvoting members on the
Digital Health Advisory Committee (the Committee) in the Center for
Devices and Radiological Health notify FDA in writing. 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 of different medical
device areas based on areas of expertise relevant to the topics being
considered by the Committee. Nominations will be accepted for current
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: 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
November 13, 2023, (see sections I and II of this document for
details). Concurrently, nomination materials for prospective candidates
should be sent to FDA by November 13, 2023.
ADDRESSES: All statements of interest from interested 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 may be submitted
electronically by accessing the FDA
[[Page 70676]]
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].
For questions relating to the Digital Health Advisory Committee,
contact James Swink, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Room 5211,
Silver Spring, MD 20993-0002, 301-796-6313, [email protected].
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a pool of
nonvoting industry representatives for the Digital Health Advisory
Committee (this position may be filled by representatives of different
medical device areas based on areas of expertise relevant to the topics
being considered by the Advisory Committee).
Elsewhere in this Federal Register, FDA is publishing separate
documents regarding:
1. Digital Health Advisory Committee; Notice of Establishment
2. Request for Nominations for Voting Members for the Digital Health
Advisory Committee
3. Request for Nominations of Individuals and Consumer Organizations
for the Digital Health Advisory Committee
I. General Description of the Committee's Duties
The Committee provides advice on complex scientific and technical
issues related to Digital Health Technologies (DHTs). This also may
include advice on the regulation of DHTs, and/or their use, including
use of DHTs in clinical trials or postmarket studies subject to FDA
regulation. Topics relating to DHTs, such as artificial intelligence/
machine learning, augmented reality, virtual reality, digital
therapeutics, wearables, remote patient monitoring, and software, may
be considered by the Committee. The Committee advises the Commissioner
on issues related to DHTs, including, for example, real-world data,
real-world evidence, patient-generated health data, interoperability,
personalized medicine/genetics, decentralized clinical trials, use of
DHTs in clinical trials for medical products, cybersecurity, DHT user
experience, and Agency policies and regulations regarding these
technologies. The Committee provides relevant expertise and perspective
to improve Agency understanding of the benefits, risks, and clinical
outcomes associated with use of DHTs. The Committee performs its duties
by providing advice and recommendations on new approaches to develop
and evaluate DHTs and to promote innovation of DHTs, as well as
identifying risks, barriers, or unintended consequences that could
result from proposed or established Agency policy or regulation for
topics related to DHTs.
II. Qualifications
Persons nominated for the Digital Health 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 45 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 resumes 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). Nominations should also
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. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22568 Filed 10-11-23; 8:45 am]
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