Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 70675 

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. 

II. Criteria for Members 

Persons nominated for membership as 

a consumer representative on this 

committee should meet the following 

criteria: (1) demonstrate an affiliation 

with and/or active participation in in 

consumer or community-based 

organizations, (2) be able to analyze 

technical data, (3) understand research 

design, (4) discuss benefits and risks, 

and (5) evaluate the safety and efficacy 

of products under review. The 

consumer representative should be able 

to represent the consumer perspective 

on issues and actions before the 

advisory committee; serve as a liaison 

between the committee and interested 

consumers, associations, coalitions, and 

consumer organizations; and facilitate 

dialogue with the advisory committees 

on scientific issues that affect 

consumers. 

III. Selection Procedures 

Selection of members representing 

consumer interests is conducted 

through procedures that include the use 

of organizations representing the public 

interest and public advocacy groups. 

These organizations recommend 

nominees for the Agency’s selection. 

Representatives from the consumer 

health branches of Federal, State, and 

local governments also may participate 

in the selection process. Any consumer 

organization interested in participating 

in the selection of an appropriate voting 

member to represent consumer interests 

should send a letter stating that interest 

to FDA (see ADDRESSES) within 30 days 

of publication of this document. 

Within the subsequent 45 days, FDA 

will compile a list of consumer 

organizations that will participate in the 

selection process and will forward to 

each such organization a ballot listing at 

least two qualified nominees selected by 

the Agency based on the nominations 

received, together with each nominee’s 

current curriculum vitae or re ́sume ́. 

Ballots are to be filled out and returned 

to FDA within 30 days. The nominee 

receiving the highest number of votes 

ordinarily will be selected to serve as 

the member representing consumer 

interests for that particular advisory 

committee. 

IV. Nomination Procedures 

Any interested person or organization 

may nominate one or more qualified 

persons to represent consumer interests 

on the Digital Health Advisory 

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 FDA. 

Self-nominations are also accepted. 

Nominations must include a current, 

complete re ́sume ́ or curriculum vitae for 

each nominee, including current 

business and/or home address, 

telephone number, and email address if 

available; a signed copy of the 

Acknowledgment and Consent form 

available at the FDA Advisory 

Nomination Portal (see ADDRESSES), and 

a list of consumer or community-based 

organizations for which the candidate 

can demonstrate active participation. 

Nominations should also specify the 

advisory committee for which the 

nominee is recommended. In addition, 

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. 

Members will be invited to serve for 

terms up to 4 years. 

FDA will review all nominations 

received within the specified 

timeframes and prepare a ballot 

containing the names of qualified 

nominees. Names not selected will 

remain on a list of eligible nominees 

and be reviewed periodically by FDA to 

determine continued interest. After 

selecting qualified nominees for the 

ballot, FDA will provide those 

consumer organizations that are 

participating in the selection process 

with the opportunity to vote on the 

listed nominees. Only organizations 

vote in the selection process. Persons 

who nominate themselves to serve as 

voting consumer 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. 2023–22567 Filed 10–11–23; 8:45 am] 

BILLING CODE 4164–01–P 

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 


ddrumheller on DSK120RN23PROD with NOTICES1
70676 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 

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: 

margaret.ames@fda.hhs.gov. 

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, 

James.swink@fda.hhs.gov. 

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, 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. 

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 re ́sume ́ 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4181] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Cattle Materials 

Prohibited From Use in Animal Food or 

Feed 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 


ddrumheller on DSK120RN23PROD with NOTICES1