Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 70679 

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. 

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 https://

www.regulations.gov 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: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov 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 https://www.regulations.gov. 

• 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: 

• 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. 

• 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 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• 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 https://

www.regulations.gov. 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: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov 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, James.Swink@

fda.hhs.gov. 

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, realworld 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 


ddrumheller on DSK120RN23PROD with NOTICES1
70680 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 

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 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 consumeroriented 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. 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: 

• Transparency and bias management 

considerations, including promoting 

health equity in DHTs 

• Augmented reality and virtual reality 

technical and clinical questions 

• Transparency and labeling 

considerations for ‘‘opaque box’’ 

algorithms 

• Digital therapeutics 

• AI/ML 

• Input on regulation of AI/ML-enabled 

devices 

• Real-world data and real-world 

evidence 

• Patient-generated health data 

• Postmarket monitoring considerations 

for a total product lifecycle approach 

to DHTs 

• Interoperability 

• Personalized medicine/genetics 

• Wearables, remote patient monitoring, 

and internet of things 

• Postmarket monitoring of DHTs 

• Technologies to enable decentralized 

clinical trials 

• 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Commission 

on Childhood Vaccines 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Advisory 

Commission on Childhood Vaccines 

(ACCV) will hold public meetings for 

the 2024 calendar year (CY). 

Information about ACCV, agendas, and 

materials for these meetings can be 

found on the ACCV website at https:// 

www.hrsa.gov/advisory-committees/ 

vaccines/index.html. 

DATES: ACCV meetings will be held on 

March 7, 2024, 10:00 a.m.–4:00 p.m. 

Eastern Time (ET); March 8, 2024, 10:00 

a.m.–4:00 p.m. ET; September 5, 2024, 

10:00 a.m.–4:00 p.m. ET; September 6, 

2024, 10:00 a.m.–4:00 p.m. ET. 

ADDRESSES: Meetings may be held inperson or by Zoom webinar. For updates 

on how the meeting will be held, visit 

the ACCV website meeting page 

included below 30 business days before 

the date of the meeting, where 

instructions for joining meetings either 

in-person or remotely will be posted. Inperson ACCV meetings will be held at 

5600 Fishers Lane, Rockville, MD 

20857. For meeting information 

updates, go to the ACCV website 

meeting page at https://www.hrsa.gov/ 

advisory-committees/vaccines/ 

meetings.html. 

FOR FURTHER INFORMATION CONTACT: Pita 

Gomez, Principal Staff Liaison, Division 

of Injury Compensation Programs, 

HRSA, 5600 Fishers Lane, 8W–25A, 

Rockville, MD 20857; 800–338–2382; or 

ACCV@hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACCV 

provides advice and recommendations 

to the Secretary of HHS (Secretary) on 

policy, program development, and other 

issues related to implementation of the 

National Vaccine Injury Compensation 

Program and concerning other matters 

as described under section 2119 of the 

Public Health Service Act (42 U.S.C. 

300aa–19). 

Since priorities dictate meeting times, 

be advised that start times, end times, 

and agenda items are subject to change. 

For CY 2024 meetings, agenda items 

may include, but are not limited to: 

updates from the Division of Injury 

Compensation Programs, Department of 

Justice, Office of Infectious Disease and 

HIV/AIDS Policy (HHS), Immunization 

Safety Office (Centers for Disease 

Control and Prevention), National 

Institute of Allergy and Infectious 

Diseases (National Institutes of Health) 

and Center for Biologics Evaluation and 

Research (Food and Drug 

Administration). Refer to the ACCV 

website listed above for all current and 

updated information concerning the CY 

2024 ACCV meetings, including draft 

agendas and meeting materials that will 

be posted 5 calendar days before the 

meeting. 

These meetings are open to the 

public. Meetings held by Zoom webinar 

will require registration. Registration 

details will be provided on our ACCV 

website at https://www.hrsa.gov/ 

advisory-committees/vaccines/ 

meetings.html. All registrants will be 

asked to provide their name, affiliation, 

and email address. After registration, 

individuals will receive personalized 

Zoom information via email. 

Members of the public will have the 

opportunity to provide comments. 

Public participants may submit written 

statements in advance of the scheduled 

meeting(s). Oral comments will be 

honored in the order they are requested 

and may be limited as time allows. 

Requests to submit a written statement 

or make oral comments to ACCV should 


ddrumheller on DSK120RN23PROD with NOTICES1