Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4085 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0255] 

Patient-Focused Drug Development for 

Vitiligo; Public Meeting; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: In the Federal Register notice 

published on March 19, 2020, the Food 

and Drug Administration (FDA, Agency, 

or we) announced the cancellation of 

the public meeting entitled ‘‘PatientFocused Drug Development for Vitiligo’’ 

originally scheduled to occur on March 

30, 2020, as announced in the Federal 

Register on February 12, 2020. FDA is 

announcing a new date for the meeting, 

to occur in a virtual format. The purpose 

of the public meeting is to allow FDA 

to obtain patient perspectives on the 

impact of vitiligo on daily life, patient 

views on treatment approaches, and 

decision factors considered when 

selecting a treatment. 

DATES: The public meeting will be held 

on March 8, 2021, from 10 a.m. to 2:30 

p.m. Eastern Time. Submit either 

electronic or written comments on this 

public meeting by May 10, 2021. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: Please note that due to the 

impact of the COVID–19 pandemic, all 

meeting participants will be joining this 

public meeting via an online 

conferencing platform. 

You may submit comments as 

follows. The docket number to submit 

comments is FDA–2020–N–0255. Please 

note that late, untimely filed comments 

will not be considered. Electronic 

comments must be submitted on or 

before May 10, 2021. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

May 10, 2021. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is 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– 

2020–N–0255 for ‘‘Patient-Focused Drug 

Development for Vitiligo; Public 

Meeting; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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.’’ The 

Agency 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 to 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 this 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: 

Shannon Cole, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave, Bldg. 51, Rm. 6306, 

Silver Spring, MD 20993–0002, 301– 

796–9208, PatientFocused@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 19, 2020, FDA announced 

in the Federal Register (85 FR 15789) 

the cancellation of the meeting entitled 

‘‘Patient-Focused Drug Development for 

Vitiligo,’’ originally scheduled to occur 

on March 30, 2020, as announced in the 

Federal Register on February 12, 2020 

(85 FR 8004). The meeting has been 

rescheduled in a virtual format. 

This meeting will provide FDA with 

the opportunity to obtain patient and 

patient representative input on the 

aspects of vitiligo, including how it 

affects daily life, what matters most to 

patients, and on current approaches to 

treating vitiligo. Vitiligo is an 

autoimmune disease that causes the loss 

of skin color. The loss of color can affect 

skin, hair, and other areas of the body. 

The area affected by color loss can range 

in individual patients from small 

discrete areas to near total involvement. 

Although there is no cure or FDAapproved treatment for repigmentation, 

there are available therapies, such as 

prescription medications or non-drug 

therapies, which may be used to manage 

4086 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

aspects of vitiligo. FDA is interested in 

patients’ (including adult and pediatric 

patients) perspectives on: (1) The 

impact of their vitiligo; (2) treatment 

approaches; and (3) decision factors 

considered when selecting a treatment. 

The questions that will be asked of 

patients and patient representatives at 

the meeting are listed in the following 

section and organized by topic. For each 

topic, a brief initial patient panel 

discussion will begin the dialogue. This 

discussion will be followed by a 

facilitated discussion inviting comments 

from other patients and patient 

representatives. In addition to input 

generated through this public meeting, 

FDA is interested in receiving patient 

and patient representative input 

addressing these questions through 

written comments, which can be 

submitted to the public docket (see 

ADDRESSES). When submitting 

comments, if you are commenting on 

behalf of a patient, please indicate that 

you are doing so and answer the 

following questions as much as possible 

from the patient’s perspective. 

FDA will post the agenda and other 

meeting materials approximately 5 days 

before the meeting at: https://

www.fda.gov/drugs/news-eventshuman-drugs/public-meeting-patientfocused-drug-development-vitiligo03082021-03082021. 

II. Topics for Discussion at the Public 

Meeting 

Topic 1: Health Effects and Daily 

Impacts That Matter Most to Patients 

1. Which aspects of vitiligo have the 

most significant impact on your life? 

(Examples may include depigmentation, 

itching, sensitivity to sunlight, etc.) 

2. Are there specific activities that are 

important to you but that you cannot do 

at all or as fully as you would like 

because of your vitiligo? (Examples of 

activities may include participating in 

social events, playing sports, being 

outside in the sunlight, etc.) 

a. How does your vitiligo and its 

impacts affect your daily life on the best 

days? On the worst days? 

3. How has your vitiligo changed over 

time? 

a. How has your vitiligo changed from 

childhood to adulthood (such as vitiligo 

severity, disease acceptance)? 

b. Would you define your vitiligo 

today as being well-managed? 

4. What worries you most about your 

vitiligo? 

a. Is there a particular body area 

affected by vitiligo (such as face, hands, 

limbs) that is of most concern to you? 

Topic 2: Patients’ Perspectives on 

Current Approaches to Treatment 

1. What are you currently doing to 

help treat your vitiligo? (Examples may 

include prescription medicines, overthe-counter products, and other 

therapies, including non-drug therapies 

such as diet modification.) 

a. How has your treatment regimen 

changed over time, and why? 

2. How well does your current 

treatment regimen treat the most 

significant aspects of your vitiligo? For 

example, how well do your treatments 

improve your ability to do specific 

activities? 

3. What are the most significant 

downsides to your current treatments, 

and how do they affect your daily life? 

(Examples of downsides may include 

bothersome side effects, depigmentation 

of affected area is more noticeable, 

hospital treatments, etc.) 

4. Assuming there is no complete cure 

for your vitiligo, what specific things 

would you look for in an ideal treatment 

for your vitiligo? 

a. Is there a particular body area 

affected by vitiligo (such as face, hands, 

limbs) that you would prioritize for 

treatment? 

5. What factors do you consider when 

making decisions about selecting a 

course of treatment? 

III. Participating in the Public Meeting 

Registration: Persons interested in 

attending this public meeting via 

webcast must register online at https:// 

vitiligopfdd.eventbrite.com. Persons 

without access to the internet can call 

301–796–9208 to register. Contact 

information provided during 

registration will remain confidential and 

will only be used to send meeting 

updates to participants. 

Registration for this virtual event is 

free, although there may be limited 

space for attendance based on 

bandwidth availability. Webcast 

information will be provided upon 

completion of registration. Closed 

captioning will be provided. Please 

check the meeting website for the latest 

information: https://www.fda.gov/drugs/ 

news-events-human-drugs/publicmeeting-patient-focused-drugdevelopment-vitiligo-03082021- 

03082021. 

If you need special accommodations 

due to a disability, please contact 

Shannon Cole (see FOR FURTHER

INFORMATION CONTACT) no later than 

March 1, 2021. 

Streaming Webcast of the Public 

Meeting: This public meeting will be 

streamed via webcast only. The 

recording and presentation slides, along 

with a meeting transcript and summary 

report, will also be made publicly 

available after the meeting. To register 

for the webcast, please visit https://

vitiligopfdd.eventbrite.com. The webcast 

can also be accessed via: https://

fda.yorkcast.com/webcast/Play/ 

46a8899c50914665b27d134db

530bd421d. Simply click on the link 

and hit the ‘‘play’’ button and it will 

start. The webcast link will be activated 

30 minutes prior to the start of the 

meeting. 

FDA has verified the website 

addresses in this document, as of the 

date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

meeting website at https://www.fda.gov/ 

drugs/news-events-human-drugs/publicmeeting-patient-focused-drugdevelopment-vitiligo-03082021- 

03082021. 

Dated: January 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00832 Filed 1–14–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–4337] 

Prescription Drug User Fee Act of 

2017; Electronic Submissions and Data 

Standards; Public Meeting; Request 

for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the following virtual public 

meeting entitled ‘‘Prescription Drug 

User Fee Act of 2017; Electronic 

Submissions and Data Standards.’’ The 

purpose of the virtual public meeting 

and the request for comments is to 

fulfill FDA’s commitment to seek 

stakeholder input related to data 

standards and the electronic submission 

system’s past performance, future 

targets, emerging industry needs, and 

technology initiatives. FDA will use the 

information from the public meeting as