Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 70673 

and software, may be considered by the 

Committee. The Committee advises the 

Commissioner of Food and Drugs 

(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. Criteria for Voting Members 

The Committee consists of a core of 

nine voting members, including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities who 

are knowledgeable in the fields of 

digital health, such as artificial 

intelligence/machine learning, 

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 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 nonvoting members 

who are identified with and represent 

industry interests. 

III. Nomination Procedures 

Any interested person may nominate 

one or more qualified individuals for 

membership on the 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 the FDA. Self-nominations are also 

accepted. Nominations must include a 

cover letter; 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 

Nomination Portal (see ADDRESSES). 

Nominations must specify the advisory 

committee for which the nominee is 

recommended. Nominations must also 

acknowledge that the nominee is aware 

of the nomination, unless selfnominated. 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. 

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. 2023–22569 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–P–1795] 

Determination That MEKINIST 

(Trametinib Dimethyl Sulfoxide) 

Tablets, 1 Milligram, Was Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined that MEKINIST (trametinib 

dimethyl sulfoxide) tablets, 1 milligram 

(mg), was not withdrawn from sale for 

reasons of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for trametinib 

dimethyl sulfoxide tablets, 1 mg, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Nikki Mueller, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6280, 

Silver Spring, MD 20993–0002, 301– 

796–3601, Nicole.Mueller@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

MEKINIST (trametinib dimethyl 

sulfoxide) tablets, 1 mg, is the subject of 

NDA 204114, held by Novartis 

Pharmaceuticals Corp., and initially 

approved on May 29, 2013. MEKINIST 

is a kinase inhibitor indicated as a 

single agent for the treatment of BRAFinhibitor treatment-naı ̈ve patients with 

unresectable or metastatic melanoma 

with BRAF V600E or V600K mutations 

as detected by an FDA-approved test. 


ddrumheller on DSK120RN23PROD with NOTICES1
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