[Federal Register Volume 85, Number 29 (Wednesday, February 12, 2020)]
[Notices]
[Pages 8004-8006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02767]


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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: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public meeting entitled ``Patient-Focused Drug 
Development for Vitiligo.'' 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 30, 2020, from 1 p.m. 
to 5 p.m. Submit either electronic or written comments on this public 
meeting by June 1, 2020. See the SUPPLEMENTARY INFORMATION section for 
registration date and information.

ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room 
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting 
participants (non-FDA employees) is through Building 1 where routine 
security check procedures will be performed. For parking and security 
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before June 1, 2020. The https://www.regulations.gov 
electronic filing system will accept comments until 11:59 p.m. Eastern 
Time at the end of June 1, 2020. 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

[[Page 8005]]

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 on 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.
     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.

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

    This meeting will provide FDA the opportunity to obtain patient and 
patient representative input on the aspects of vitiligo that matter 
most to patients, including how it affects daily life, 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 often be used to manage 
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-03302020-03302020.

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.)
    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?
    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.)
    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?
    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: To register for the public meeting, visit https://vitiligo_pfdd.eventbrite.com">https://vitiligo_pfdd.eventbrite.com. Please register by March 23, 2020. 
Persons without access to the internet can call 301-796-9208 to 
register. If you are unable to attend the meeting in person, you can 
register to view a live webcast of the meeting. You will be asked to 
indicate in your registration if you plan to attend in person or via 
the webcast. Please

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provide complete contact information for each attendee, including name, 
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
meeting must register by March 23, 2020, 11:59 p.m. Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. If time 
and space permit, onsite registration on the day of the public meeting 
will be provided beginning at 12 p.m.
    If you need special accommodations due to a disability, please 
contact Shannon Cole (see FOR FURTHER INFORMATION CONTACT) no later 
than March 23, 2020.
    Panelist Selection: Patients or patient representatives who are 
interested in presenting comments as part of the initial panel 
discussions will be asked to indicate in their registration which 
topic(s) they wish to address. These patients or patient 
representatives also will be asked to send PatientFocused@fda.hhs.gov a 
brief summary of responses to the topic questions by March 9, 2020. 
Panelists will be notified of their selection approximately 7 days 
before the public meeting. We will try to accommodate all patients and 
patient stakeholders who wish to speak, either through the panel 
discussion or audience participation; however, the duration of comments 
may be limited by time constraints.
    Open Public Comment: There will be time allotted during the meeting 
for open public comment. Signup for this session will be on a first-
come, first-served basis on the day of the meeting. Individuals and 
organizations with common interests are urged to consolidate or 
coordinate and request time for a joint presentation. No commercial or 
promotional material will be permitted to be presented or distributed 
at the public meeting.
    Persons attending FDA's meetings are advised that FDA is not 
responsible for providing access to electrical outlets.
    Streaming Webcast of the Public Meeting: This public meeting will 
also be webcast. Please register for the webcast by visiting https://vitiligo_pfdd.eventbrite.com.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. 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 
internet at https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-patient-focused-drug-development-vitiligo-03302020-03302020.

    Dated: February 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02767 Filed 2-11-20; 8:45 am]
 BILLING CODE 4164-01-P


