Notice2023-22566
Advisory Committee; Digital Health Committee; Establishment
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
Under the Federal Advisory Committee Act, the Food and Drug Administration (FDA or Agency) is announcing the establishment of the Digital Health Advisory Committee. The Commissioner of Food and Drugs (Commissioner) has determined that it is in the public interest to establish such a committee. Duration of this committee is 2 years from the date the Charter is filed, unless the Commissioner formally determines that renewal is in the public interest.
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 70679-70680]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22566]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3941]
Advisory Committee; Digital Health Committee; Establishment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of establishment.
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SUMMARY: Under the Federal Advisory Committee Act, the Food and Drug
Administration (FDA or Agency) is announcing the establishment of the
Digital Health Advisory Committee. The Commissioner of Food and Drugs
(Commissioner) has determined that it is in the public interest to
establish such a committee. Duration of this committee is 2 years from
the date the Charter is filed, unless the Commissioner formally
determines that renewal is in the public interest.
DATES: Either electronic or written comments on the notice must be
submitted by December 11, 2023. FDA is establishing a docket for public
comment on this document. The docket number is FDA-2023-N-3941. The
docket will close on December 11, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 11, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-N-3941 for ``Advisory Committee; Digital Health Committee;
Establishment.'' Received comments, those filed in a timely manner,
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
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, 301-796-6313, <a href="/cdn-cgi/l/email-protection#baf0dbd7dfc994e9cdd3d4d1fadcdedb94d2d2c994ddd5cc"><span class="__cf_email__" data-cfemail="d19bb0bcb4a2ff82a6b8bfba91b7b5b0ffb9b9a2ffb6bea7">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The Digital Health Advisory Committee
(Committee) provides advice to the Commissioner or designee, 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 (AI/ML), 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.
The Committee shall consist of a core of nine voting members
including the Chair. Members and the Chair are
[[Page 70680]]
selected by the Commissioner or designee from among authorities
knowledgeable in the fields of digital health, such as AI/ML, 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 non-voting 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 non-voting members who are identified with and represent
industry interests. The number of temporary members selected for a
particular meeting will depend on the meeting topic.
In announcing the establishment of this Advisory Committee under
the Federal Advisory Committee Act (5 U.S.C. 1001 et seq.), FDA is also
soliciting public feedback on potential topics for this committee to
discuss and upon which to advise the Agency. The following topics may
include, but are not limited to:
<bullet> Transparency and bias management considerations, including
promoting health equity in DHTs
<bullet> Augmented reality and virtual reality technical and clinical
questions
<bullet> Transparency and labeling considerations for ``opaque box''
algorithms
<bullet> Digital therapeutics
<bullet> AI/ML
<bullet> Input on regulation of AI/ML-enabled devices
<bullet> Real-world data and real-world evidence
<bullet> Patient-generated health data
<bullet> Postmarket monitoring considerations for a total product
lifecycle approach to DHTs
<bullet> Interoperability
<bullet> Personalized medicine/genetics
<bullet> Wearables, remote patient monitoring, and internet of things
<bullet> Postmarket monitoring of DHTs
<bullet> Technologies to enable decentralized clinical trials
<bullet> Cybersecurity best practices in software development for
cloud-based software
Elsewhere in this issue of the Federal Register, FDA is publishing
separate documents regarding: (1) Digital Health Advisory Committee:
Request for Nominations for Voting Members on a Public Advisory
Committee: Digital Health Advisory Committee; (2) Request for
Nomination of Individuals and Consumer Organizations for the Digital
Health Advisory Committee; and (3) Request for Nomination of
Individuals and Industry Organizations for the Digital Health Advisory
Committee.
FDA intends to publish in the Federal Register a final rule adding
the Digital Health Advisory Committee to 21 CFR 14.100.
Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22566 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P
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