Patient-Focused Drug Development for Vitiligo; Public Meeting; Request for Comments, 8004-8006 [2020-02767]
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which they promote as a resource for
consumers in search of financial
products such as loans and insurance.
In numerous instances, Respondents
have described the content on the
website, including their rate tables, star
ratings, and rankings of the companies
offering these financial products, as
‘‘objective,’’ ‘‘honest,’’ ‘‘accurate,’’ and
‘‘unbiased.’’ Contrary to their claims,
Respondents have provided financial
services companies with higher
numerical rankings or star ratings and
higher positions on rate tables based on
compensation. Respondents also have
added or removed companies from their
content based on compensation.
In addition, Respondents have touted
positive consumer reviews about their
company and website that, in fact, were
written by LendEDU employees or their
friends, family members, and associates.
Of 126 reviews of LendEDU on the
third-party review platform Trustpilot,
90% were written or made up by
LendEDU employees or their family,
friends, or other associates. Respondents
also have reposted and touted the
Trustpilot reviews on LendEDU’s
website, as well as fake reviews written
by LendEDU employees who purport to
be, but are not, actual users.
The proposed order will prevent
Proposed Respondents from engaging in
similar acts or practices. Part I would
prohibit Proposed Respondents from
making the challenged and related
misrepresentations. Part II would
require Proposed Respondents to
disclose the influence of compensation
on representations made on its website
and to disclose material connections
among the Proposed Respondents and
the various parties represented on the
website. Part III would require Proposed
Respondents, jointly and severally, to
pay to the Commission $350,000 within
8 days of the effective date of the Order.
Part IV sets out additional
requirements related to the monetary
relief. Part V requires Proposed
Respondents to provide sufficient
customer information to enable the
Commission to efficiently administer
consumer redress. Part VI is an order
distribution provision that requires
Proposed Respondents to provide the
order to current and future principals,
officers, directors, and LLC managers
and members, as well as current and
future managers, agents and
representatives who participate in
certain duties related to the subject
matter of the proposed complaint and
order, and to secure statements
acknowledging receipt of the order. Part
VII requires Proposed Respondents to
submit a compliance report one year
after the order is entered. It also requires
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Proposed Respondents to notify the
Commission of corporate changes that
may affect compliance obligations
within 14 days of such a change.
Part VIII requires Proposed
Respondents to maintain and upon
request make available certain
compliance-related records, including
accounting records and unique
websites. Part IX requires Proposed
Respondents to submit additional
compliance reports within 10 business
days of a written request by the
Commission. Part X is a provision
‘‘sunsetting’’ the order after twenty (20)
years, with certain exceptions.
The purpose of this analysis is to aid
public comment on the proposed order.
It is not intended to constitute an
official interpretation of the complaint
or proposed order, or to modify in any
way the proposed order’s terms.
By direction of the Commission.
April J. Tabor,
Acting Secretary.
[FR Doc. 2020–02798 Filed 2–11–20; 8:45 am]
BILLING CODE 6750–01–P
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.
Notice of public meeting;
request for comments.
ACTION:
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
SUMMARY:
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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
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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-201509-18/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,
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Jkt 250001
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 FDAapproved 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-eventshuman-drugs/public-meeting-patientfocused-drug-development-vitiligo03302020-03302020.
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.)
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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, overthe-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://vitiligopfdd.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, firstserved 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
VerDate Sep<11>2014
17:03 Feb 11, 2020
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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/publicmeeting-patient-focused-drugdevelopment-vitiligo-0330202003302020.
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR Panel:
Alzheimer’s Clinical Trials.
Date: March 10, 2020.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Dr., Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Unja Hayes, Ph.D.,
Scientific Review Officer, National Institutes
of Health, Center for Scientific Review, 6701
Rockledge Drive, Bethesda, MD 20892, 301–
827–6830, unja.hayes@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; SBIR Small
Business: Computational, Modeling, and
Biodata Management.
Date: March 11, 2020.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
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Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW,
Washington, DC 20015.
Contact Person: Allen Richon, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6184,
MSC 7892, Bethesda, MD 20892, 301–379–
9351, allen.richon@nih.hhs.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Psycho/Neuropathology Lifespan
Development, STEM Education.
Date: March 12–13, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Pentagon City, 550
Army Navy Drive, Arlington, VA 22202.
Contact Person: Elia K. Ortenberg, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108,
Bethesda, MD 20892, 301–827–7189,
femiaee@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Medical Imaging.
Date: March 12–13, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Holiday Inn Bayside, 4875 North
Harbor Drive, San Diego, CA 92106.
Contact Person: Leonid V. Tsap, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5128,
MSC 7854, Bethesda, MD 20892, (301) 435–
2507, tsapl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Neuroscience Assay, Diagnostics
and Animal Model Development.
Date: March 12–13, 2020.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Washington, DC
Downtown, 1199 Vermont Ave. NW,
Washington, DC 20005.
Contact Person: Joseph G. Rudolph, Ph.D.,
Chief and Scientific Review Officer, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5186,
MSC 7844, Bethesda, MD 20892, 301–408–
9098, josephru@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–17–
190: Maximizing Investigators’ Research
Award for Early Stage Investigators (R35).
Date: March 12, 2020.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, Metro
Center, 1, Bethesda, MD 20814.
Contact Person: Baishali Maskeri, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2022,
Bethesda, MD 20892, 301–827–2864,
maskerib@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Oncology.
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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: 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, [email protected].
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 [email protected] 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
