[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70674-70675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm 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 https://www.fda.gov/AdvisoryCommittees/default.htm.

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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