[Federal Register Volume 86, Number 10 (Friday, January 15, 2021)]
[Notices]
[Pages 4085-4086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00832]



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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.

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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 ``Patient-Focused 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, [email protected].

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 FDA-approved 
treatment for repigmentation, there are available therapies, such as 
prescription medications or non-drug therapies, which may be used to 
manage

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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-events-human-drugs/public-meeting-patient-focused-drug-development-vitiligo-03082021-03082021.

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, over-the-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/public-meeting-patient-focused-drug-development-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/46a8899c50914665b27d134db530bd421d. 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/public-meeting-patient-focused-drug-development-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