Notice2023-22567
Request for Nominations of Individuals and Consumer Organizations for the Digital Health 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
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 a voting consumer representative to serve on the Digital Health Advisory Committee. FDA is also requesting that any consumer organizations interested in participating in the selection of a voting consumer representative to serve on the Digital Health Advisory Committee notify FDA in writing. Nominees recommended to serve as a voting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for the current vacancy 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 70674-70675]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22567]
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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 Consumer 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 a voting consumer representative to serve on the
Digital Health Advisory Committee. FDA is also requesting that any
consumer organizations interested in participating in the selection of
a voting consumer representative to serve on the Digital Health
Advisory Committee notify FDA in writing. Nominees recommended to serve
as a voting consumer representative may either be self-nominated or may
be nominated by a consumer organization. Nominations will be accepted
for the current vacancy 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 consumer organization interested in participating in the
selection of an appropriate voting member to represent consumer
interests on the Digital Health Advisory Committee may send a letter or
email stating that interest to FDA (see ADDRESSES) by November 27, 2023
for vacancy listed in this notice. Concurrently, nomination materials
for prospective candidates should be sent to FDA (see ADDRESSES) by
November 27, 2023. Nominations will be accepted for current vacancy.
ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process should be
submitted electronically to <a href="/cdn-cgi/l/email-protection#7c3d3f33312f2f091e11150f0f1513120f3c1a181d5214140f521b130a"><span class="__cf_email__" data-cfemail="09484a46445a5a7c6b64607a7a6066677a496f6d682761617a276e667f">[email protected]</span></a> or by mail to
Advisory Committee and Management Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002.
Consumer representative nominations 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> or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver
Spring, MD 20993-0002. Additional information about becoming a member
of 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:
For questions relating to participation in the selection process:
Kimberly Hamilton, Advisory Committee Oversight and Management Staff,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm.
5122, Silver Spring, MD 20993-0002, 301-796-8220,
<a href="/cdn-cgi/l/email-protection#377c5e5a5552455b4e197f565a5e5b43585977515356195f5f4419505841"><span class="__cf_email__" data-cfemail="377c5e5a5552455b4e197f565a5e5b43585977515356195f5f4419505841">[email protected]</span></a>.
For questions relating to the Digital Health Advisory Committee:
James Swink, 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#89c3e8e4ecfaa7dafee0e7e2c9efede8a7e1e1faa7eee6ff"><span class="__cf_email__" data-cfemail="175d767a72643944607e797c57717376397f7f6439707861">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: FDA is requesting nominations for a voting
consumer representative on the Digital Health 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 on a Public Advisory
Committee: Digital Health Advisory Committee
3. Request for Nominations of Individuals and Industry Organizations
for the Digital Health Advisory Committee
I. Function and General Description of the Committee Duties
Digital Health Advisory Committee
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,
[[Page 70675]]
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.
II. Criteria for Members
Persons nominated for membership as a consumer representative on
this committee should meet the following criteria: (1) demonstrate an
affiliation with and/or active participation in in consumer or
community-based organizations, (2) be able to analyze technical data,
(3) understand research design, (4) discuss benefits and risks, and (5)
evaluate the safety and efficacy of products under review. The consumer
representative should be able to represent the consumer perspective on
issues and actions before the advisory committee; serve as a liaison
between the committee and interested consumers, associations,
coalitions, and consumer organizations; and facilitate dialogue with
the advisory committees on scientific issues that affect consumers.
III. Selection Procedures
Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
member to represent consumer interests should send a letter stating
that interest to FDA (see ADDRESSES) within 30 days of publication of
this document.
Within the subsequent 45 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA
within 30 days. The nominee receiving the highest number of votes
ordinarily will be selected to serve as the member representing
consumer interests for that particular advisory committee.
IV. Nomination Procedures
Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Digital Health
Advisory 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 FDA. Self-nominations are also
accepted. Nominations must include 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; a signed copy of the Acknowledgment and Consent
form available at the FDA Advisory Nomination Portal (see ADDRESSES),
and a list of consumer or community-based organizations for which the
candidate can demonstrate active participation.
Nominations should also specify the advisory committee for which
the nominee is recommended. In addition, 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. Members will be invited
to serve for terms up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
After selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting consumer 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. 2023-22567 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P
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