70674 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 

MEKINIST (trametinib dimethyl 

sulfoxide) tablets, 1 mg, is currently 

listed in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. Apotex Inc., submitted a citizen 

petition dated May 4, 2023 (Docket No. 

FDA–2023–P–1795), under 21 CFR 

10.30, requesting that the Agency 

determine whether MEKINIST 

(trametinib dimethyl sulfoxide) tablets, 

1 mg, was withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that MEKINIST (trametinib 

dimethyl sulfoxide) tablets, 1 mg, was 

not withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that MEKINIST (trametinib 

dimethyl sulfoxide) tablets, 1 mg, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

MEKINIST (trametinib dimethyl 

sulfoxide) tablets, 1 mg, from sale. We 

have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list MEKINIST (trametinib 

dimethyl sulfoxide) tablets, 1 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to MEKINIST (trametinib dimethyl 

sulfoxide) tablets, 1 mg, may be 

approved by the Agency as long as they 

meet all other legal and regulatory 

requirements for the approval of 

ANDAs. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the Agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: October 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22464 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 Consumer 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 a voting 

consumer representative to serve on the 

Digital Health Advisory Committee. 

FDA is also requesting that any 

consumer organizations interested in 

participating in the selection of a voting 

consumer representative to serve on the 

Digital Health Advisory Committee 

notify FDA in writing. Nominees 

recommended to serve as a voting 

consumer representative may either be 

self-nominated or may be nominated by 

a consumer organization. Nominations 

will be accepted for the current vacancy 

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 consumer organization 

interested in participating in the 

selection of an appropriate voting 

member to represent consumer interests 

on the Digital Health Advisory 

Committee may send a letter or email 

stating that interest to FDA (see 

ADDRESSES) by November 27, 2023 for 

vacancy listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA (see ADDRESSES) by November 27, 

2023. Nominations will be accepted for 

current vacancy. 

ADDRESSES: All statements of interest 

from consumer organizations interested 

in participating in the selection process 

should be submitted electronically to 

ACOMSSubmissions@fda.hhs.gov or by 

mail to Advisory Committee and 

Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5122, Silver Spring, 

MD 20993–0002. 

Consumer representative nominations 

should be submitted electronically by 

logging into the FDA 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, 10903 New Hampshire Ave., Bldg. 

32, Rm. 5122, Silver Spring, MD 20993– 

0002. Additional information about 

becoming a member of 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: 

For questions relating to participation 

in the selection process: Kimberly 

Hamilton, Advisory Committee 

Oversight and Management Staff, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 5122, 

Silver Spring, MD 20993–0002, 301– 

796–8220, Kimberly.Hamilton@

fda.hhs.gov. 

For questions relating to the Digital 

Health Advisory Committee: James 

Swink, 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, 

James.Swink@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

requesting nominations for a voting 

consumer representative on the Digital 

Health 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 on a Public Advisory 

Committee: Digital Health Advisory 

Committee 

3. Request for Nominations of 

Individuals and Industry 

Organizations for the Digital Health 

Advisory Committee 

I. Function and General Description of 

the Committee Duties 

Digital Health Advisory Committee 

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, 


ddrumheller on DSK120RN23PROD with NOTICES1
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