Patient-Focused Drug Development for Alopecia Areata; Public Meeting; Request for Comments, 28665-28667 [2017-13194]
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Federal Register / Vol. 82, No. 120 / Friday, June 23, 2017 / Notices
Submit written requests for single
copies of the Engineering Research
Center for Structured Organic
Particulate Systems (C-SOPS) document
to the Division of Drug Information,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2201, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the C-SOPS
document.
Sau
(Larry) Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2128, Silver Spring,
MD 20993–0002, 301–796–2905,
Sau.Lee@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. Background
During a May 7, 2015, workshop on
the Future of Pharmaceutical
Manufacturing, FDA agreed that
interested parties could submit for
Agency consideration draft guidance or
other materials discussing the science,
technology, and best practices related to
continuous manufacturing. On June 13,
2016, C-SOPS submitted to FDA an
industry-coordinated best practices
document on continuous
manufacturing. FDA is interested in
public comments about the science,
technology, and practices discussed in
the C-SOPS document and is opening
this docket for that purpose. In addition,
FDA is seeking comments on other
recommendations regarding continuous
manufacturing that have already been
published, including ‘‘Regulatory and
Quality Considerations for Continuous
Manufacturing: May 20–21, 2014,
Continuous Manufacturing
Symposium.’’ FDA invites comment on
control strategy, facility, and process
validation considerations for continuous
manufacturing of solid oral dosage
forms. This request is not limited to
comments on the proposal described in
the C-SOPS submission.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
II. Electronic Access
Persons with access to the Internet
may obtain the C-SOPS document at
https://www.regulations.gov.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13195 Filed 6–22–17; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–3067]
Patient-Focused Drug Development for
Alopecia Areata; 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 a public meeting and
an opportunity for public comment on
‘‘Patient-Focused Drug Development for
Alopecia Areata.’’ Patient-Focused Drug
Development is part of FDA’s
performance commitments under the
fifth authorization of the Prescription
Drug User Fee Act (PDUFA V). The
public meeting is intended to allow
FDA to obtain patients’ perspectives on
the impact of alopecia areata, including
on daily life. FDA is also seeking
patients’ views on treatment approaches
and decision factors taken into account
when selecting a treatment.
DATES: The public meeting will be held
on September 11, 2017, from 1 p.m. to
5 p.m. Submit either electronic or
written comments on this public
meeting by November 13, 2017. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For more information on
parking and security procedures, 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 November 13, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of November 13, 2017. 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.
SUMMARY:
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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–
2017–N–3067 for ‘‘Patient-Focused Drug
Development for Alopecia Areata.’’
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
E:\FR\FM\23JNN1.SGM
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Federal Register / Vol. 82, No. 120 / Friday, June 23, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FDA will post the agenda
approximately 5 days before the meeting
at: https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm554443.htm.
FOR FURTHER INFORMATION CONTACT:
Meghana Chalasani, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993–0002, 240–
402–6525, FAX: 301–847–8443,
Meghana.Chalasani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug
Development
FDA has selected alopecia areata as
the focus of a public meeting under the
Patient-Focused Drug Development
initiative. This initiative involves
obtaining a better understanding of
patients’ perspectives on the severity of
a disease and the available therapies for
that condition. Patient-Focused Drug
Development is being conducted to
fulfill FDA performance commitments
that are part of the PDUFA
reauthorization under Title I of the Food
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19:21 Jun 22, 2017
Jkt 241001
and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112–
144). The full set of performance
commitments is available on the FDA
Web site at https://www.fda.gov/
downloads/forindustry/userfees/
prescriptiondruguserfee/
ucm270412.pdf.
FDA committed to obtain the patient
perspective on at least 20 disease areas
during the course of PDUFA V. For each
disease area, the Agency is conducting
a public meeting to discuss the disease
and its impact on patients’ daily lives,
the types of treatment benefits that
matter most to patients, and patients’
perspectives on the adequacy of the
available therapies. These meetings will
include participation of FDA review
divisions, the relevant patient
communities, and other interested
stakeholders.
On April 11, 2013, FDA published a
notice in the Federal Register (78 FR
21613), announcing the disease areas for
meetings in fiscal years (FYs) 2013–
2015, the first 3 years of the 5-year
PDUFA V timeframe. The Agency used
several criteria outlined in that notice to
develop the list of disease areas. FDA
obtained public comment on the
Agency’s proposed criteria and potential
disease areas through a public docket
and a public meeting that was convened
on October 25, 2012. In selecting the set
of disease areas, FDA carefully
considered the public comments
received and the perspectives of review
divisions at FDA. FDA initiated a
second public process for determining
the disease areas for FY 2016–2017, and
published a notice in the Federal
Register on July 2, 2015 (80 FR 38216),
announcing the selection of eight
disease areas. More information,
including the list of disease areas and a
general schedule of meetings, is posted
at https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm347317.htm.
II. Purpose and Scope of the Meeting
As part of Patient-Focused Drug
Development, FDA will obtain patient
and patient stakeholder input on the
symptoms of alopecia areata that matter
most to patients and on current
approaches to treating alopecia areata.
Alopecia areata is an autoimmune
disease that causes hair loss. The hair
loss usually occurs on the scalp but can
also affect the beard, eyebrows, and
other areas of the body. While there is
currently no cure, there are available
treatments, such as corticosteroids or
non-drug therapies, which may help
hair regrowth. FDA is interested in the
perspectives of patients with alopecia
areata on: (1) The impact of their
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condition, (2) treatment approaches, and
(3) decision factors taken into account
when selecting a treatment.
The questions that will be asked of
patients and patient stakeholders at the
meeting are listed in this section and
organized by topic. For each topic, a
brief initial patient panel discussion
will begin the dialogue. This will be
followed by a facilitated discussion
inviting comments from other patient
and patient stakeholder participants. In
addition to input generated through this
public meeting, FDA is interested in
receiving patient input addressing these
questions through electronic or written
comments, which can be submitted to
the Dockets Management Staff (see
ADDRESSES).
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
1. Of all the symptoms or disease
manifestations that you experience
because of your condition, which one to
three symptoms or manifestations have
the most significant impact on your life?
Examples may include location or type
of hair loss (i.e. loss of hair on scalp,
loss of eyebrows, loss of all hair on body
patchy hair loss), nail changes, hair
quality upon regrowth.
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 condition? Examples of
activities may include daily hygiene,
engagement in personal relationships,
participation in sports or social
activities, completion of school or work
activities, etc.
3. How do your symptoms and their
negative impacts affect your daily life
on the best days? On the worst days?
4. How has your condition changed
over time?
• Would you define your condition
today as being well-managed?
5. What worries you most about your
condition?
Topic 2: Patients’ Perspectives on
Current Approaches to Treatment
1. What are you currently doing to
help treat your condition or its
symptoms? Examples may include
prescription medicines, over-thecounter products, and 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 control your
condition?
• How well have these treatments
worked for you as your condition has
changed over time?
3. What are the most significant
downsides to your current treatments,
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Federal Register / Vol. 82, No. 120 / Friday, June 23, 2017 / Notices
UserFees/PrescriptionDrugUserFee/
ucm554443.htm.
III. Meeting Attendance and
Participation
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and how do they affect your daily life?
Examples of downsides may include
going to the clinic for treatment, time
devoted to treatment, side effects of
treatment, route of administration, etc.
4. What specific things would you
look for in an ideal treatment for your
condition?
• What would you consider to be a
meaningful improvement in your
condition that a treatment could
provide?
5. What factors do you take into
account when making decisions about
selecting a course of treatment?
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Federal Tort
Claims Act (FTCA) Program Deeming
Applications for Free Clinics, OMB No.
0915–0293—Extension
If you wish to attend this meeting,
visit https://
alopeciaareata.eventbrite.com. Persons
interested in attending this public
meeting must register by August 28,
2017. 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. Early
registration is recommended because
seating is limited; therefore, FDA may
limit the number of participants from
each organization. Registrants will
receive confirmation once they have
been accepted. Onsite registration on
the day of the meeting will be based on
space availability. If you need special
accommodations due to a disability,
please contact Meghana Chalasani (see
FOR FURTHER INFORMATION CONTACT) no
later than September 1, 2017.
Patients 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 also must send to
PatientFocused@fda.hhs.gov a brief
summary of responses to the topic
questions by August 21, 2017. 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.
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 at
https://www.fda.gov/ForIndustry/
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Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13194 Filed 6–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, the Health Resources and
Services Administration (HRSA)
announces plans to submit an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB). Prior
to submitting the ICR to OMB, HRSA
seeks comments from the public
regarding the burden estimate, below, or
any other aspect of the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than August 22, 2017.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Federal Tort Claims Act (FTCA)
SUMMARY:
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28667
Program Deeming Applications for Free
Clinics, OMB No. 0915–0293—
Extension.
Abstract: Section 224(o) of the Public
Health Service (PHS) Act (42 U.S.C.
233(o)), as amended, authorizes the
‘‘deeming’’ of certain individuals as
PHS employees for the purposes of
receiving Federal Tort Claims Act
(FTCA) coverage. Section 224(o) relates
to employees, officers, and contractors
at qualifying free clinics. The Free
Clinics FTCA Program is administered
by HRSA’s Bureau of Primary Health
Care (BPHC). Sponsoring free clinics are
required by law to submit deeming
applications in the specified form and
manner on behalf of named individuals
for review and approval, resulting in a
‘‘deeming determination’’ that includes
associated FTCA coverage for these
individuals.
Need and Proposed Use of the
Information: Deeming applications must
address certain specified criteria
required by law for deeming
determinations to be issued, and FTCA
application forms are critical to BPHC’s
deeming determination process. These
forms provide BPHC with the
information necessary to evaluate an
application and determine whether an
individual meets the requirements for
deemed PHS employee status for the
purposes of FTCA coverage. FTCA
application forms for free clinics do not
require any changes with this extension
other than to update the applicable
dates.
Likely Respondents: Respondents
include free clinics seeking deemed
PHS employee status on behalf of their
sponsored individuals for purposes of
FTCA coverage.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
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Agencies
[Federal Register Volume 82, Number 120 (Friday, June 23, 2017)]
[Notices]
[Pages 28665-28667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13194]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-3067]
Patient-Focused Drug Development for Alopecia Areata; 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 a public meeting and an opportunity for public comment on
``Patient-Focused Drug Development for Alopecia Areata.'' Patient-
Focused Drug Development is part of FDA's performance commitments under
the fifth authorization of the Prescription Drug User Fee Act (PDUFA
V). The public meeting is intended to allow FDA to obtain patients'
perspectives on the impact of alopecia areata, including on daily life.
FDA is also seeking patients' views on treatment approaches and
decision factors taken into account when selecting a treatment.
DATES: The public meeting will be held on September 11, 2017, from 1
p.m. to 5 p.m. Submit either electronic or written comments on this
public meeting by November 13, 2017. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public
meeting participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For more
information on parking and security procedures, 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 November 13, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 13, 2017. 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-2017-N-3067 for ``Patient-Focused Drug Development for Alopecia
Areata.'' 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
[[Page 28666]]
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.gpo.gov/fdsys/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.
FDA will post the agenda approximately 5 days before the meeting
at: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm554443.htm.
FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, FAX: 301-847-8443, Meghana.Chalasani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug Development
FDA has selected alopecia areata as the focus of a public meeting
under the Patient-Focused Drug Development initiative. This initiative
involves obtaining a better understanding of patients' perspectives on
the severity of a disease and the available therapies for that
condition. Patient-Focused Drug Development is being conducted to
fulfill FDA performance commitments that are part of the PDUFA
reauthorization under Title I of the Food and Drug Administration
Safety and Innovation Act (FDASIA) (Pub. L. 112-144). The full set of
performance commitments is available on the FDA Web site at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
FDA committed to obtain the patient perspective on at least 20
disease areas during the course of PDUFA V. For each disease area, the
Agency is conducting a public meeting to discuss the disease and its
impact on patients' daily lives, the types of treatment benefits that
matter most to patients, and patients' perspectives on the adequacy of
the available therapies. These meetings will include participation of
FDA review divisions, the relevant patient communities, and other
interested stakeholders.
On April 11, 2013, FDA published a notice in the Federal Register
(78 FR 21613), announcing the disease areas for meetings in fiscal
years (FYs) 2013-2015, the first 3 years of the 5-year PDUFA V
timeframe. The Agency used several criteria outlined in that notice to
develop the list of disease areas. FDA obtained public comment on the
Agency's proposed criteria and potential disease areas through a public
docket and a public meeting that was convened on October 25, 2012. In
selecting the set of disease areas, FDA carefully considered the public
comments received and the perspectives of review divisions at FDA. FDA
initiated a second public process for determining the disease areas for
FY 2016-2017, and published a notice in the Federal Register on July 2,
2015 (80 FR 38216), announcing the selection of eight disease areas.
More information, including the list of disease areas and a general
schedule of meetings, is posted at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm347317.htm.
II. Purpose and Scope of the Meeting
As part of Patient-Focused Drug Development, FDA will obtain
patient and patient stakeholder input on the symptoms of alopecia
areata that matter most to patients and on current approaches to
treating alopecia areata. Alopecia areata is an autoimmune disease that
causes hair loss. The hair loss usually occurs on the scalp but can
also affect the beard, eyebrows, and other areas of the body. While
there is currently no cure, there are available treatments, such as
corticosteroids or non-drug therapies, which may help hair regrowth.
FDA is interested in the perspectives of patients with alopecia areata
on: (1) The impact of their condition, (2) treatment approaches, and
(3) decision factors taken into account when selecting a treatment.
The questions that will be asked of patients and patient
stakeholders at the meeting are listed in this section and organized by
topic. For each topic, a brief initial patient panel discussion will
begin the dialogue. This will be followed by a facilitated discussion
inviting comments from other patient and patient stakeholder
participants. In addition to input generated through this public
meeting, FDA is interested in receiving patient input addressing these
questions through electronic or written comments, which can be
submitted to the Dockets Management Staff (see ADDRESSES).
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
1. Of all the symptoms or disease manifestations that you
experience because of your condition, which one to three symptoms or
manifestations have the most significant impact on your life? Examples
may include location or type of hair loss (i.e. loss of hair on scalp,
loss of eyebrows, loss of all hair on body patchy hair loss), nail
changes, hair quality upon regrowth.
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
condition? Examples of activities may include daily hygiene, engagement
in personal relationships, participation in sports or social
activities, completion of school or work activities, etc.
3. How do your symptoms and their negative impacts affect your
daily life on the best days? On the worst days?
4. How has your condition changed over time?
Would you define your condition today as being well-
managed?
5. What worries you most about your condition?
Topic 2: Patients' Perspectives on Current Approaches to Treatment
1. What are you currently doing to help treat your condition or its
symptoms? Examples may include prescription medicines, over-the-counter
products, and 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 control your
condition?
How well have these treatments worked for you as your
condition has changed over time?
3. What are the most significant downsides to your current
treatments,
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and how do they affect your daily life? Examples of downsides may
include going to the clinic for treatment, time devoted to treatment,
side effects of treatment, route of administration, etc.
4. What specific things would you look for in an ideal treatment
for your condition?
What would you consider to be a meaningful improvement in
your condition that a treatment could provide?
5. What factors do you take into account when making decisions
about selecting a course of treatment?
III. Meeting Attendance and Participation
If you wish to attend this meeting, visit https://alopeciaareata.eventbrite.com. Persons interested in attending this
public meeting must register by August 28, 2017. 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. Early registration is
recommended because seating is limited; therefore, FDA may limit the
number of participants from each organization. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on space availability. If you need
special accommodations due to a disability, please contact Meghana
Chalasani (see FOR FURTHER INFORMATION CONTACT) no later than September
1, 2017.
Patients 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 also
must send to PatientFocused@fda.hhs.gov a brief summary of responses to
the topic questions by August 21, 2017. 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.
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 at
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm554443.htm.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13194 Filed 6-22-17; 8:45 am]
BILLING CODE 4164-01-P