Notice2023-22569
Request for Nominations for Voting Members for the Digital Health Advisory Committee
Primary source
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Published
October 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is requesting nominations for voting members, excluding consumer and industry representatives, to serve on the Digital Health Advisory Committee (the Committee) in the Center for Devices and Radiological Health. 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.
Full Text
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<title>Federal Register, Volume 88 Issue 196 (Thursday, October 12, 2023)</title>
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[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70672-70673]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22569]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0008]
Request for Nominations for Voting Members 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 voting members, excluding consumer and industry
representatives, to serve on the Digital Health Advisory Committee (the
Committee) in the Center for Devices and Radiological Health.
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: Nominations received on or before December 11, 2023 will be
given first consideration for membership on the Committee. Nominations
received after December 11, 2023 will be considered for nomination to
the committee as later vacancies occur.
ADDRESSES: All nominations for membership should be sent 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: James Swink, Office of Management,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver
Spring, MD 20993-0002, 301-796-6313, <a href="/cdn-cgi/l/email-protection#c882a9a5adbbe69bbfa1a6a388aeaca9e6a0a0bbe6afa7be"><span class="__cf_email__" data-cfemail="d49eb5b9b1a7fa87a3bdbabf94b2b0b5fabcbca7fab3bba2">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members to fill current vacancies on the Digital Health 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 a vacancy of representatives of interests of the device
manufacturing industry.
I. General Description of the Committee 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,
[[Page 70673]]
and software, may be considered by the Committee. The Committee advises
the Commissioner of Food and Drugs (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. 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 the fields of
digital health, such as artificial intelligence/machine learning,
augmented reality, virtual reality, digital therapeutics, wearables,
remote patient monitoring, software development, user experience, real-
world data, real-world evidence, patient-generated health data,
interoperability, personalized medicine/genetics, decentralized
clinical trials, cybersecurity, and implementation in clinical practice
of and patient experience with digital health, 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
either as Special Government Employees or nonvoting 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 and represent
industry interests.
III. Nomination Procedures
Any interested person may nominate one or more qualified
individuals for membership on the Committee with the exception of the
following: Individuals who are not U.S. citizens or nationals cannot be
appointed as Advisory Committee Members (42 U.S.C. 217(a)) in the FDA.
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. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22569 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P
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