
[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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]
BILLING CODE 4164-01-P


