Public Meeting on Patient-Focused Drug Development for Huntington's and Parkinson's Diseases, 42503-42505 [2015-17556]
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Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
information via the internet at https://
www.regulations.gov. Submit written
comments on the collection of
information to the Dockets Management
Branch (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
SUPPLEMENTARY INFORMATION:
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on: (1) Whether the proposed
collection of information is necessary
for the proper performance of FDA’s
functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Industry on Questions
and Answers Regarding the Labeling of
Nonprescription Human Drug Products
Marketed Without an Approved
Application as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act
OMB Control Number 0910–0641—
Extension
Section 502(x) of the FD&C Act (21
U.S.C. 352(x)), which was added by the
Dietary Supplement and
Nonprescription Drug Consumer
Protection Act (Pub. L. 109–462),
requires the label of a nonprescription
drug product marketed without an
approved application in the United
States to include a domestic address or
domestic telephone number through
which a manufacturer, packer, and
distributor may receive a report of a
serious adverse event associated with
the product. The guidance document
contains questions and answers relating
to this labeling requirement and
provides guidance to industry on the
following topics: (1) The meaning of
‘‘domestic address’’ for purposes of the
labeling requirements of section 502(x)
of the FD&C Act; (2) FDA’s
recommendation for the use of an
introductory statement before the
domestic address or phone number that
is required to appear on the product
label under section 502(x) of the FD&C
Act; and (3) FDA’s intent regarding
enforcing the labeling requirements of
section 502(x) of the FD&C Act.
Description of Respondents:
Respondents to this collection of
information are manufacturers, packers,
and distributors whose name (pursuant
to section 502(b)(1) of the FD&C Act)
appears on the label of a
nonprescription drug product marketed
in the United States without an
approved application.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity
Number
of respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Including a domestic address or phone number and a
statement of its purpose on OTC drug labeling (21
U.S.C. 502(x)) ..................................................................
300
3
900
4
3,600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17558 Filed 7–16–15; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0967]
BILLING CODE 4164–01–P
srobinson on DSK5SPTVN1PROD with NOTICES
Public Meeting on Patient-Focused
Drug Development for Huntington’s
and Parkinson’s Diseases
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing a public meeting and an
opportunity for public comment on
SUMMARY:
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Patient-Focused Drug Development for
Huntington’s disease and Parkinson’s
disease. Patient-Focused Drug
Development is part of FDA’s
performance commitments made as part
of the fifth authorization of the
Prescription Drug User Fee Act (PDUFA
V). The public meeting is intended to
allow FDA to obtain patient
perspectives on the impact of
Huntington’s disease and Parkinson’s
disease on daily life and patient views
on treatment approaches. Although
these are both neurological diseases,
since they are quite distinct, FDA will
structure this public meeting into two
distinct sessions. The morning session,
scheduled from 9 a.m. to 1 p.m., will be
E:\FR\FM\17JYN1.SGM
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Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
srobinson on DSK5SPTVN1PROD with NOTICES
devoted to hearing patient perspectives
on the impact of Huntington’s disease
on daily life and their views on
currently available treatment
approaches. The afternoon session,
scheduled from 1 p.m. to 5 p.m., will be
devoted to obtaining patient
perspectives on the impact of
Parkinson’s disease on daily life and
patient views on currently available
treatment approaches.
DATES: The public meeting will be held
on September 22, 2015, from 9 a.m. to
5 p.m. Registration to attend the meeting
must be received by September 14, 2015
(see SUPPLEMENTARY INFORMATION for
instructions). Register here to attend the
meeting: https://
pfddhuntingtonparkinson.
eventbrite.com. Submit electronic or
written comments to the public docket
by November 23, 2015.
ADDRESSES: The 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.
Participants must enter through
Building 1 and undergo security
screening. For more information on
parking and security procedures, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
All comments should be identified with
the docket number found in brackets in
the heading of this document.
FDA will post the agenda
approximately 5 days before the meeting
at: https://www.fda.gov/Drugs/
NewsEvents/ucm451807.htm.
FOR FURTHER INFORMATION CONTACT:
Graham Thompson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993, 301–796–
5003, FAX: 301–847–8443,
graham.thompson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug
Development
FDA has selected Huntington’s
disease (HD) and Parkinson’s disease
(PD) as the focus of a public meeting
under Patient-Focused Drug
Development, an initiative that involves
obtaining a better understanding of
patient perspectives on the severity of a
disease and the available therapies for
VerDate Sep<11>2014
20:59 Jul 16, 2015
Jkt 235001
these conditions. Patient-Focused Drug
Development is being conducted to
fulfill FDA performance commitments
that are part of the reauthorization of
PDUFA under Title I of the Food and
Drug Safety and Innovation Act (Pub. L.
112–144). The full set of performance
commitments is available at https://
www.fda.gov/downloads/forindustry/
userfees/prescriptiondruguserfee/
ucm270412.pdf.
FDA committed to obtain the patient
perspective on 20 disease areas during
the course of PDUFA V. For each
disease area, the Agency will conduct a
public meeting to discuss the disease
and its impact on patients’ daily lives,
the types of treatment benefit 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 (78 FR 21613) in the Federal
Register announcing the disease areas
for meetings in fiscal years (FY) 2013 to
2015, the first 3 years of the 5-year
PDUFA V time frame. 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. By the end of FY
2015, FDA will initiate a second public
process for determining the disease
areas for FYs 2016 to 2017. More
information, including the list of disease
areas and a general schedule of
meetings, is posted at https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm326192.htm.
II. Public Meeting Information
A. Purpose and Scope of the Meeting
The purpose of this Patient-Focused
Drug Development meeting is to obtain
input on the symptoms and other
impacts of HD and PD that matter most
to patients, as well as perspectives on
current approaches to treating these
conditions. HD is a fatal genetic
disorder that causes the progressive
degeneration of nerve cells in the brain,
resulting in uncontrolled movements,
loss of intellectual faculties, and
emotional disturbance. Each child of an
HD parent has a 50–50 chance of
inheriting the HD gene, and a person
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
who inherits the HD gene will
eventually develop the disease.
Physicians may prescribe a number of
medications to help control emotional
and movement problems associated
with HD. While medicines may help
keep these clinical symptoms under
control, there is no current treatment to
stop or reverse the course of the disease.
PD belongs to a group of conditions
called motor system disorders, which
are the result of the loss of dopamineproducing brain cells. As nerve cells
become impaired or die, individuals
begin to experience tremor, muscle
rigidity or stiffness, slowing of
movement, and impaired balance and
coordination. The cause of PD is
unknown, but factors such as genetics
and environmental triggers may play a
role. Although there is no cure for PD,
medications can help manage the levels
of dopamine and other
neurotransmitters in the brain to
improve symptoms. Deep brain
stimulation is a surgery that may also be
used to manage symptoms if
medications are not effective.
The questions that will be asked of
patients and patient stakeholders at the
meeting are listed in this section,
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 written comments,
which can be submitted to the public
docket (see ADDRESSES).
B. Huntington’s Disease Discussion
Questions
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
1. Of all the symptoms that you
experience because of your condition,
which one to three symptoms have the
most significant impact on your life?
(Examples may include: ability to
control movements, balance/
coordination, difficulty concentrating,
sleeping, mood/behavior, 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 condition? (Examples of
activities may include sleeping through
the night, daily bathing/showering,
cooking, eating, dressing, shopping, etc.)
• How do your symptoms affect your
daily life on the best days? On the worst
days?
3. How has your condition and its
symptoms changed over time?
E:\FR\FM\17JYN1.SGM
17JYN1
Federal Register / Vol. 80, No. 137 / Friday, July 17, 2015 / Notices
• Do your symptoms come and go? If
so, do you know of anything that makes
your symptoms better? Worse?
4. How has your condition affected
your social interactions, including
relationships with family and friends?
5. How has your condition affected
your mood (for example: depression,
apathy, patience/tolerance for
frustration)?
3. How has your ability to cope with
symptoms changed over time?
• Do your symptoms come and go? If
so, do you know of anything that makes
your symptoms better? Worse?
4. What worries you most about your
condition?
5. How has your condition affected
your social interactions, including
relationships with family and friends?
Topic 2: Patients’ Perspectives on
Current Approaches To Treating HD
Topic 2: Patients’ Perspectives on
Current Approaches To Treating PD
1. What are you currently doing to
help treat your condition or its
symptoms? (Examples may include
prescription medicines, over-thecounter products, and other therapies
including non-drug therapies such as
diet modification and exercise.)
• What specific symptoms do your
treatments address (for example:
depression, constipation, memory
difficulty, sleepiness, ability to move)?
2. How well does your current
treatment regimen treat the most
significant symptoms of your disease?
• How well do these treatments
improve your ability to do specific
activities that are important to you in
your daily life?
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, need to visit
your doctor or take medications
frequently, cause sleepiness, etc.)
4. Assuming there is no complete cure
for your condition, what would you
look for in an ideal treatment for your
condition or a specific aspect of your
condition?
1. What are you currently doing to
help treat your condition or its
symptoms? (Examples may include
prescription medicines, over-thecounter products, and other therapies
including non-drug therapies such as
diet modification and exercise.)
(a) What specific symptoms do your
treatments address?
(b) How has your treatment regimen
changed over time, and why?
2. How well does your current
treatment regimen treat the most
significant symptoms of your disease?
(a) How well do these treatments
improve your ability to do specific
activities that are important to you in
your daily life?
(b) 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,
and how do they affect your daily life?
(Examples of downsides may include
bothersome side effects, interacts with
other medications, need to visit your
doctor more frequently, etc.)
4. Assuming there is no complete cure
for your condition, what would you
look for in an ideal treatment for your
condition or a specific aspect of your
condition?
C. Parkinson’s Disease Discussion
Questions
srobinson on DSK5SPTVN1PROD with NOTICES
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
1. Of all the symptoms that you
experience because of your condition,
which one to three symptoms have the
most significant impact on your life?
(Examples may include difficulty
moving, pain, constipation, difficulty
concentrating or remembering, daytime
sleepiness, 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 condition? (Examples of
activities may include daily hygiene,
feeding, dressing, etc.)
• How do your symptoms affect your
daily life on the best days? On the worst
days?
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Jkt 235001
III. Meeting Attendance and
Participation
If you wish to attend this meeting,
visit https://pfddhuntingtonparkinson.
eventbrite.com. Please register by
September 14, 2015. If you are unable to
attend the meeting in person, you can
register to view a live webcast of the
meeting. When you register, you can
indicate whether you plan to attend the
morning session on HD, the afternoon
session on PD, or both. You will also be
asked to indicate in your registration if
you plan to attend in person or via the
webcast. Seating will be limited, so
early registration is recommended.
Registration is free and will be on a firstcome, first-served basis. However, FDA
may limit the number of participants
from each organization based on space
limitations. 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
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42505
accommodations because of a disability,
please contact Graham Thompson (see
FOR FURTHER INFORMATION CONTACT) at
least 7 days before the meeting.
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 September 8, 2015.
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.
IV. Comments
Regardless if you attend the public
meeting, you can submit electronic or
written responses to the questions
pertaining to HD Topics 1 and 2 and PD
Topics 1 and 2 to the public docket (see
ADDRESSES) by November 23, 2015.
Received comments may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to
the docket at https://
www.regulations.gov.
V. Transcripts
As soon as a transcript is available,
FDA will post it at https://www.fda.gov/
Drugs/NewsEvents/ucm451807.htm.
Dated: July 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–17556 Filed 7–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
E:\FR\FM\17JYN1.SGM
17JYN1
]]>Agencies
[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Notices]
[Pages 42503-42505]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17556]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0967]
Public Meeting on Patient-Focused Drug Development for
Huntington's and Parkinson's Diseases
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public meeting and an opportunity for public comment on Patient-
Focused Drug Development for Huntington's disease and Parkinson's
disease. Patient-Focused Drug Development is part of FDA's performance
commitments made as part of the fifth authorization of the Prescription
Drug User Fee Act (PDUFA V). The public meeting is intended to allow
FDA to obtain patient perspectives on the impact of Huntington's
disease and Parkinson's disease on daily life and patient views on
treatment approaches. Although these are both neurological diseases,
since they are quite distinct, FDA will structure this public meeting
into two distinct sessions. The morning session, scheduled from 9 a.m.
to 1 p.m., will be
[[Page 42504]]
devoted to hearing patient perspectives on the impact of Huntington's
disease on daily life and their views on currently available treatment
approaches. The afternoon session, scheduled from 1 p.m. to 5 p.m.,
will be devoted to obtaining patient perspectives on the impact of
Parkinson's disease on daily life and patient views on currently
available treatment approaches.
DATES: The public meeting will be held on September 22, 2015, from 9
a.m. to 5 p.m. Registration to attend the meeting must be received by
September 14, 2015 (see SUPPLEMENTARY INFORMATION for instructions).
Register here to attend the meeting: https://pfddhuntingtonparkinson.eventbrite.com. Submit electronic or written
comments to the public docket by November 23, 2015.
ADDRESSES: The 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. Participants must enter through
Building 1 and undergo security screening. For more information on
parking and security procedures, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Submit electronic comments to https://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.
FDA will post the agenda approximately 5 days before the meeting
at: https://www.fda.gov/Drugs/NewsEvents/ucm451807.htm.
FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-
5003, FAX: 301-847-8443, graham.thompson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug Development
FDA has selected Huntington's disease (HD) and Parkinson's disease
(PD) as the focus of a public meeting under Patient-Focused Drug
Development, an initiative that involves obtaining a better
understanding of patient perspectives on the severity of a disease and
the available therapies for these conditions. Patient-Focused Drug
Development is being conducted to fulfill FDA performance commitments
that are part of the reauthorization of PDUFA under Title I of the Food
and Drug Safety and Innovation Act (Pub. L. 112-144). The full set of
performance commitments is available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
FDA committed to obtain the patient perspective on 20 disease areas
during the course of PDUFA V. For each disease area, the Agency will
conduct a public meeting to discuss the disease and its impact on
patients' daily lives, the types of treatment benefit 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 (78 FR 21613) in the
Federal Register announcing the disease areas for meetings in fiscal
years (FY) 2013 to 2015, the first 3 years of the 5-year PDUFA V time
frame. 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. By
the end of FY 2015, FDA will initiate a second public process for
determining the disease areas for FYs 2016 to 2017. More information,
including the list of disease areas and a general schedule of meetings,
is posted at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.
II. Public Meeting Information
A. Purpose and Scope of the Meeting
The purpose of this Patient-Focused Drug Development meeting is to
obtain input on the symptoms and other impacts of HD and PD that matter
most to patients, as well as perspectives on current approaches to
treating these conditions. HD is a fatal genetic disorder that causes
the progressive degeneration of nerve cells in the brain, resulting in
uncontrolled movements, loss of intellectual faculties, and emotional
disturbance. Each child of an HD parent has a 50-50 chance of
inheriting the HD gene, and a person who inherits the HD gene will
eventually develop the disease. Physicians may prescribe a number of
medications to help control emotional and movement problems associated
with HD. While medicines may help keep these clinical symptoms under
control, there is no current treatment to stop or reverse the course of
the disease.
PD belongs to a group of conditions called motor system disorders,
which are the result of the loss of dopamine-producing brain cells. As
nerve cells become impaired or die, individuals begin to experience
tremor, muscle rigidity or stiffness, slowing of movement, and impaired
balance and coordination. The cause of PD is unknown, but factors such
as genetics and environmental triggers may play a role. Although there
is no cure for PD, medications can help manage the levels of dopamine
and other neurotransmitters in the brain to improve symptoms. Deep
brain stimulation is a surgery that may also be used to manage symptoms
if medications are not effective.
The questions that will be asked of patients and patient
stakeholders at the meeting are listed in this section, 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 written comments, which can be submitted to the
public docket (see ADDRESSES).
B. Huntington's Disease Discussion Questions
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
1. Of all the symptoms that you experience because of your
condition, which one to three symptoms have the most significant impact
on your life? (Examples may include: ability to control movements,
balance/coordination, difficulty concentrating, sleeping, mood/
behavior, 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
condition? (Examples of activities may include sleeping through the
night, daily bathing/showering, cooking, eating, dressing, shopping,
etc.)
How do your symptoms affect your daily life on the best
days? On the worst days?
3. How has your condition and its symptoms changed over time?
[[Page 42505]]
Do your symptoms come and go? If so, do you know of
anything that makes your symptoms better? Worse?
4. How has your condition affected your social interactions,
including relationships with family and friends?
5. How has your condition affected your mood (for example:
depression, apathy, patience/tolerance for frustration)?
Topic 2: Patients' Perspectives on Current Approaches To Treating HD
1. What are you currently doing to help treat your condition or its
symptoms? (Examples may include prescription medicines, over-the-
counter products, and other therapies including non-drug therapies such
as diet modification and exercise.)
(a) What specific symptoms do your treatments address?
(b) How has your treatment regimen changed over time, and why?
2. How well does your current treatment regimen treat the most
significant symptoms of your disease?
(a) How well do these treatments improve your ability to do
specific activities that are important to you in your daily life?
(b) 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, and how do they affect your daily life? (Examples of
downsides may include bothersome side effects, interacts with other
medications, need to visit your doctor more frequently, etc.)
4. Assuming there is no complete cure for your condition, what
would you look for in an ideal treatment for your condition or a
specific aspect of your condition?
C. Parkinson's Disease Discussion Questions
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
1. Of all the symptoms that you experience because of your
condition, which one to three symptoms have the most significant impact
on your life? (Examples may include difficulty moving, pain,
constipation, difficulty concentrating or remembering, daytime
sleepiness, 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
condition? (Examples of activities may include daily hygiene, feeding,
dressing, etc.)
How do your symptoms affect your daily life on the best
days? On the worst days?
3. How has your ability to cope with symptoms changed over time?
Do your symptoms come and go? If so, do you know of
anything that makes your symptoms better? Worse?
4. What worries you most about your condition?
5. How has your condition affected your social interactions,
including relationships with family and friends?
Topic 2: Patients' Perspectives on Current Approaches To Treating PD
1. What are you currently doing to help treat your condition or its
symptoms? (Examples may include prescription medicines, over-the-
counter products, and other therapies including non-drug therapies such
as diet modification and exercise.)
What specific symptoms do your treatments address (for
example: depression, constipation, memory difficulty, sleepiness,
ability to move)?
2. How well does your current treatment regimen treat the most
significant symptoms of your disease?
How well do these treatments improve your ability to do
specific activities that are important to you in your daily life?
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, need to visit your
doctor or take medications frequently, cause sleepiness, etc.)
4. Assuming there is no complete cure for your condition, what
would you look for in an ideal treatment for your condition or a
specific aspect of your condition?
III. Meeting Attendance and Participation
If you wish to attend this meeting, visit https://pfddhuntingtonparkinson.eventbrite.com. Please register by September
14, 2015. If you are unable to attend the meeting in person, you can
register to view a live webcast of the meeting. When you register, you
can indicate whether you plan to attend the morning session on HD, the
afternoon session on PD, or both. You will also be asked to indicate in
your registration if you plan to attend in person or via the webcast.
Seating will be limited, so early registration is recommended.
Registration is free and will be on a first-come, first-served basis.
However, FDA may limit the number of participants from each
organization based on space limitations. 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 because of a disability, please contact Graham
Thompson (see FOR FURTHER INFORMATION CONTACT) at least 7 days before
the meeting.
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 September 8, 2015. 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.
IV. Comments
Regardless if you attend the public meeting, you can submit
electronic or written responses to the questions pertaining to HD
Topics 1 and 2 and PD Topics 1 and 2 to the public docket (see
ADDRESSES) by November 23, 2015. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov.
V. Transcripts
As soon as a transcript is available, FDA will post it at https://www.fda.gov/Drugs/NewsEvents/ucm451807.htm.
Dated: July 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-17556 Filed 7-16-15; 8:45 am]
BILLING CODE 4164-01-P
