[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70672-70673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22569]


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

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.

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

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 
(https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm) 
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 https://www.fda.gov/AdvisoryCommittees/default.htm.

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


</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>