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
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 70681 

be sent to Pita Gomez using the contact 

information listed above at least 5 

business days before the meeting 

date(s). 

Individuals who need special 

assistance or another reasonable 

accommodation should notify Pita 

Gomez using the contact information 

listed above at least 10 business days 

before the meeting(s) they wish to 

attend. Since all in-person meetings will 

occur in a federal government building, 

attendees must go through a security 

check to enter the building. Non-U.S. 

Citizen attendees must notify HRSA of 

their planned attendance at least 20 

business days prior to the meeting to 

facilitate their entry into the building. 

All attendees are required to present 

government-issued identification prior 

to entry. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–22584 Filed 10–11–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Heritable Disorders in Newborns and 

Children 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Advisory 

Committee on Heritable Disorders in 

Newborns and Children (ACHDNC or 

Committee) has scheduled a public 

meeting to be held on Thursday, 

November 2, 2023, and Friday, 

November 3, 2023. Information about 

the ACHDNC and the agenda for this 

meeting can be found on the ACHDNC 

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

advisory-committees/heritabledisorders/index.html. 

DATES: Thursday, November 2, 2023, 

from 10:00 a.m. to 4:00 p.m. Eastern 

Time (ET) and Friday, November 3, 

2023, from 10:00 a.m. to 2:00 p.m. ET. 

ADDRESSES: This meeting will be held 

via webinar. While this meeting is open 

to the public, advance registration is 

required. 

Please visit the ACHDNC website for 

information on registration: https://

www.hrsa.gov/advisory-committees/ 

heritable-disorders/index.html by the 

deadline of 12:00 p.m. ET on November 

1, 2023. Instructions on how to access 

the meeting via webcast will be 

provided upon registration. 

FOR FURTHER INFORMATION CONTACT: 

Alaina Harris, Maternal and Child 

Health Bureau, HRSA, 5600 Fishers 

Lane, Room 18W66, Rockville, 

Maryland 20857; 301–443–0721; or 

ACHDNC@hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACHDNC 

provides advice and recommendations 

to the Secretary of Health and Human 

Services (Secretary) on the development 

of newborn screening activities, 

technologies, policies, guidelines, and 

programs for effectively reducing 

morbidity and mortality in newborns 

and children having, or at risk for, 

heritable disorders. ACHDNC reviews 

and reports regularly on newborn and 

childhood screening practices, 

recommends improvements in the 

national newborn and childhood 

screening programs, and fulfills 

requirements stated in the authorizing 

legislation. In addition, ACHDNC’s 

recommendations regarding inclusion of 

additional conditions for screening on 

the Recommended Uniform Screening 

Panel, following adoption by the 

Secretary, are evidence-informed 

preventive health services provided for 

in the comprehensive guidelines 

supported by HRSA pursuant to section 

2713 of the Public Health Service Act 

(42 U.S.C. 300gg–13). Under this 

provision, non-grandfathered group 

health plans and health insurance 

issuers offering non-grandfathered 

group or individual health insurance are 

required to provide insurance coverage 

without cost-sharing (a co-payment, coinsurance, or deductible) for preventive 

services for plan years (i.e., policy years) 

beginning on or after the date that is 1 

year from the Secretary’s adoption of the 

condition for screening. 

During the November 2–3, 2023, 

meeting, ACHDNC will hear from 

experts in the fields of public health, 

medicine, heritable disorders, rare 

disorders, and newborn screening. 

Agenda items include the following: 

(1) An update on the Krabbe disease 

expedited evidence review update; 

(2) An update on the Duchenne 

Muscular Dystrophy evidence review 

update; 

(3) An update by the ACHDNC 

Decision Matrix ad hoc topic group and 

potential vote on revisions to the 

ACHDNC Decision Matrix; 

(4) A presentation and discussion on 

the ACHDNC’s conflict of interest 

procedures; 

(5) Ad hoc topic group updates; and 

(6) A possible presentation on the 

National Academies of Sciences, 

Engineering, and Medicine Workshop 

on Next Generation Screening. 

ACHDNC will not vote on 

recommending conditions for inclusion 

in the Recommended Uniform 

Screening Panel during this meeting; 

however, Krabbe disease and Duchenne 

Muscular Dystrophy evidence review 

updates along with a discussion and a 

potential vote on revisions to the 

ACHDNC Decision Matrix may inform 

such potential future recommendations. 

Agenda items are subject to change as 

priorities dictate. Information about 

ACHDNC, including a roster of members 

and past meeting summaries, is 

available on the ACHDNC website. 

Members of the public will have the 

opportunity to provide comments on 

any or all of the above agenda items. 

Public participants may request to 

provide general oral comments and may 

submit written statements in advance of 

the scheduled meeting. Oral comments 

will be honored in the order they are 

requested and may be limited as time 

allows. Members of the public registered 

to provide oral public comments on all 

other newborn screening related topics 

are tentatively scheduled to provide 

their statements on Thursday, 

November 2, 2023. Requests to provide 

a written statement or make oral 

comments to ACHDNC must be 

submitted via the registration website by 

12:00 p.m. ET on Friday, October 20, 

2023. Written comments will be shared 

with the Committee, so that they have 

an opportunity to consider them prior to 

the meeting. 

Individuals who need special 

assistance or another reasonable 

accommodation should notify Alaina 

Harris at the address and phone number 

listed above at least 10 business days 

prior to the meeting. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–22493 Filed 10–11–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the Advisory Committee on 

Infant and Maternal Mortality 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Advisory 


ddrumheller on DSK120RN23PROD with NOTICES1