Public Meeting on Patient-Focused Drug Development for Neuropathic Pain Associated With Peripheral Neuropathy, 22606-22608 [2016-08881]
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22606
Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices
use in assessing their work to improve
patient understanding, navigation,
engagement, and self care.
The planned environmental scan
interviews will provide the information
needed to:
• Identify and document the
characteristics of relevant quality
improvement measures that are already
in use; and
• identify additional measures that
would be useful to stakeholders in the
field.
The findings from these interviews
will be used, along with the results from
other activities (i.e., input from a
Technical Expert Panel, literature
review, a Request for Information
published in the Federal Register, and
focus groups with patients), to identify
and document a set of quality
improvement measures that can be
recommended for rigorous testing and
validation. Measures that are assessed to
be valid and reliable will be eligible to
be disseminated by AHRQ to support
health care organizations in their efforts
to improve patient understanding of
health information, navigation of the
health care system, engagement in
medical decision making, and
management of their health.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in
Environmental Scan Interviews. The
Environmental Scan Interviews will be
completed by 50 respondents (2
representatives from each of the 25
organizations targeted for participation).
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Hours per
response
Total burden
hours
Environmental Scan Interviews .......................................................................
50
1
2
100
Total ..........................................................................................................
50
1
2
100
Exhibit 2 shows the estimated annual
cost burden associated with the
respondents’ time to participate in this
information collection. The annual cost
burden for the Environmental Scan
Interviews is estimated to be $4,984.
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents
Form name
Environmental Scan Interviews .......................................................................
Total burden
hours
Total cost
burden
100
50
a $49.84
$4,984
100
50
Total ..........................................................................................................
Average
hourly wage
rate *
a 49.84
4,984
* National Compensation Survey: Occupational wages in the United States May 2014, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
a Based on the mean wages for Medical and Health Services Managers 11–9111.
mstockstill on DSK4VPTVN1PROD with NOTICES
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
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17:54 Apr 15, 2016
Jkt 238001
comments will become a matter of
public record.
ACTION:
Sharon B. Arnold,
Acting Director.
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
neuropathic pain associated with
peripheral neuropathies. PatientFocused 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
neuropathic pain associated with
peripheral neuropathies, patient views
on treatment approaches, and decision
factors taken into account when
selecting a treatment.
DATES: The public meeting will be held
on June 10, 2016, from 10 a.m. to 4 p.m.
Registration to attend the meeting must
be received by June 3, 2016 (see
SUPPLEMENTARY INFORMATION for
instructions). Submit electronic or
SUMMARY:
1. U.S. Department of Health and
Human Services. Healthy people 2010:
Understanding and Improving Health.
2nd ed: U.S. Government Printing
Office; 2000.
[FR Doc. 2016–08856 Filed 4–15–16; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1110]
Public Meeting on Patient-Focused
Drug Development for Neuropathic
Pain Associated With Peripheral
Neuropathy
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
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Fmt 4703
Notice of public meeting;
request for comments.
Sfmt 4703
E:\FR\FM\18APN1.SGM
18APN1
Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices
written comments to the public docket
by August 10, 2016.
ADDRESSES: You may submit comments
as follows:
mstockstill on DSK4VPTVN1PROD with NOTICES
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–N–1110 for ‘‘Public Meeting on
Patient-Focused Drug Development for
Neuropathic Pain Associated with
Peripheral Neuropathy.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management 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
VerDate Sep<11>2014
17:54 Apr 15, 2016
Jkt 238001
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 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/
ucm470608.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 neuropathic pain
associated with peripheral neuropathy
as the focus of a public meeting under
Patient-Focused Drug Development, an
initiative that involves obtaining a better
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
22607
understanding of patient 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 reauthorization of the PDUFA
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 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 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 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 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. 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/
ucm326192.htm.
II. Public Meeting Information
A. Purpose and Scope of the Meeting
As part of Patient-Focused Drug
Development, FDA will obtain patient
and patient stakeholder input on the
impacts of neuropathic pain associated
with peripheral neuropathies.
Peripheral neuropathy is a neurological
disorder that develops as a result of
damage to the peripheral nerves and is
E:\FR\FM\18APN1.SGM
18APN1
22608
Federal Register / Vol. 81, No. 74 / Monday, April 18, 2016 / Notices
associated with both a physical and
psychological burden. Nerve damage
can be caused by diseases such as
diabetes, physical injury, or exposure to
drugs or toxins. The pain associated
with neuropathies of sensory nerves
may be characterized as a pins and
needles sensation, as sharp, jabbing, or
burning, or as an exaggeratedly intense
or distorted pain response to typically
nonpainful touch. While there is
currently no cure, treatments for the
pain associated with peripheral
neuropathy include prescription
medications and other approaches such
as transcutaneous electrical nerve
stimulation, braces, and behavioral
therapies. FDA is interested in the
perspectives of patients with peripheral
neuropathy on specifically: (1) The
impact of neuropathic pain associated
with peripheral neuropathy and (2)
treatment approaches for the
neuropathic pain associated with
peripheral neuropathy.
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).
mstockstill on DSK4VPTVN1PROD with NOTICES
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
1. How would you describe your
neuropathic pain associated with
peripheral neuropathy? What terms
would you use to describe the most
bothersome aspects of pain? (Examples
may include stabbing sensations,
electric shocks, burning or tingling, 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 neuropathic pain?
(Examples of activities may include
sleeping through the night, daily
hygiene, participation in sports or social
activities, intimacy with a spouse or
partner, etc.)
3. How do your neuropathic pain and
its negative impacts affect your daily life
on the best days? On the worst days?
4. How has your neuropathic pain
changed over time?
5. What worries you most about your
condition?
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Jkt 238001
Topic 2: Patients’ Perspectives on
Current Approaches to Treatment
1. What are you currently doing to
help treat your neuropathic pain
associated with peripheral neuropathy?
(Examples may include prescription
medicines, over-the-counter products,
and other therapies including non-drug
therapies). How has your treatment
regimen changed over time, and why?
2. How well does your current
treatment regimen control your
neuropathic pain?
a. How well have these treatments
worked for you as your condition has
changed over time?
b. Would you define your condition
today as being well managed?
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, going to the
hospital or clinic for treatment, time
devoted to treatment, restrictions on
driving, etc.)
4. Assuming there is no complete cure
for your neuropathic pain, what specific
things would you look for in an ideal
treatment for your neuropathic pain?
What would you consider to be a
meaningful improvement in your
condition (for example, specific
symptom improvements or functional
improvements) that a treatment could
provide?
5. If you had the opportunity to
consider participating in a clinical trial
studying experimental treatments for
neuropathic pain, what things would
you consider when deciding whether or
not to participate? (Examples may
include how severe your neuropathic
pain is, how well current treatments are
working for you, your concern about
risks, etc.)
you need special accommodations
because of a disability, please contact
Meghana Chalasani (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 Patient
Focused@fda.hhs.gov a brief summary
of responses to the topic questions by
May 27, 2016. 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.
Docket Comments: Regardless of
whether you attend the public meeting,
you can submit electronic or written
responses to the questions pertaining to
topics 1 and 2 to the public docket (see
ADDRESSES) by August 10, 2016.
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.
Transcripts: As soon as a transcript is
available, FDA will post it at https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm470608.htm.
Dated: April 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–08881 Filed 4–15–16; 8:45 am]
BILLING CODE 4164–01–P
B. Meeting Attendance and
Participation
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
If you wish to attend this meeting,
visit https://peripheralneuropathypfdd.
eventbrite.com. Please register by June
3, 2016. 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. 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
Food and Drug Administration
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[Docket No. FDA–2016–N–1097]
AbbVie Inc.; Withdrawal of Approval of
New Drug Applications for ADVICOR
and SIMCOR
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of the new drug
applications (NDAs) for ADVICOR
(niacin extended-release (ER) and
lovastatin) tablets and SIMCOR (niacin
ER and simvastatin) tablets. The holder
of these two applications, AbbVie Inc.,
SUMMARY:
E:\FR\FM\18APN1.SGM
18APN1
]]>Agencies
[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22606-22608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08881]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1110]
Public Meeting on Patient-Focused Drug Development for
Neuropathic Pain Associated With Peripheral Neuropathy
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 neuropathic pain associated with
peripheral neuropathies. 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
neuropathic pain associated with peripheral neuropathies, patient views
on treatment approaches, and decision factors taken into account when
selecting a treatment.
DATES: The public meeting will be held on June 10, 2016, from 10 a.m.
to 4 p.m. Registration to attend the meeting must be received by June
3, 2016 (see SUPPLEMENTARY INFORMATION for instructions). Submit
electronic or
[[Page 22607]]
written comments to the public docket by August 10, 2016.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-1110 for ``Public Meeting on Patient-Focused Drug
Development for Neuropathic Pain Associated with Peripheral
Neuropathy.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 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/ucm470608.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 neuropathic pain associated with peripheral
neuropathy 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 that condition. Patient-Focused Drug
Development is being conducted to fulfill FDA performance commitments
that are part of the reauthorization of the PDUFA 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 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 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 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 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. 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/ucm326192.htm.
II. Public Meeting Information
A. Purpose and Scope of the Meeting
As part of Patient-Focused Drug Development, FDA will obtain
patient and patient stakeholder input on the impacts of neuropathic
pain associated with peripheral neuropathies. Peripheral neuropathy is
a neurological disorder that develops as a result of damage to the
peripheral nerves and is
[[Page 22608]]
associated with both a physical and psychological burden. Nerve damage
can be caused by diseases such as diabetes, physical injury, or
exposure to drugs or toxins. The pain associated with neuropathies of
sensory nerves may be characterized as a pins and needles sensation, as
sharp, jabbing, or burning, or as an exaggeratedly intense or distorted
pain response to typically nonpainful touch. While there is currently
no cure, treatments for the pain associated with peripheral neuropathy
include prescription medications and other approaches such as
transcutaneous electrical nerve stimulation, braces, and behavioral
therapies. FDA is interested in the perspectives of patients with
peripheral neuropathy on specifically: (1) The impact of neuropathic
pain associated with peripheral neuropathy and (2) treatment approaches
for the neuropathic pain associated with peripheral neuropathy.
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).
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
1. How would you describe your neuropathic pain associated with
peripheral neuropathy? What terms would you use to describe the most
bothersome aspects of pain? (Examples may include stabbing sensations,
electric shocks, burning or tingling, 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
neuropathic pain? (Examples of activities may include sleeping through
the night, daily hygiene, participation in sports or social activities,
intimacy with a spouse or partner, etc.)
3. How do your neuropathic pain and its negative impacts affect
your daily life on the best days? On the worst days?
4. How has your neuropathic pain changed over time?
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 neuropathic pain
associated with peripheral neuropathy? (Examples may include
prescription medicines, over-the-counter products, and other therapies
including non-drug therapies). How has your treatment regimen changed
over time, and why?
2. How well does your current treatment regimen control your
neuropathic pain?
a. How well have these treatments worked for you as your condition
has changed over time?
b. Would you define your condition today as being well managed?
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, going to the hospital or
clinic for treatment, time devoted to treatment, restrictions on
driving, etc.)
4. Assuming there is no complete cure for your neuropathic pain,
what specific things would you look for in an ideal treatment for your
neuropathic pain? What would you consider to be a meaningful
improvement in your condition (for example, specific symptom
improvements or functional improvements) that a treatment could
provide?
5. If you had the opportunity to consider participating in a
clinical trial studying experimental treatments for neuropathic pain,
what things would you consider when deciding whether or not to
participate? (Examples may include how severe your neuropathic pain is,
how well current treatments are working for you, your concern about
risks, etc.)
B. Meeting Attendance and Participation
If you wish to attend this meeting, visit https://peripheralneuropathypfdd.eventbrite.com. Please register by June 3,
2016. 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. 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 Meghana
Chalasani (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 May 27, 2016. 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.
Docket Comments: Regardless of whether you attend the public
meeting, you can submit electronic or written responses to the
questions pertaining to topics 1 and 2 to the public docket (see
ADDRESSES) by August 10, 2016. 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.
Transcripts: As soon as a transcript is available, FDA will post it
at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm.
Dated: April 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08881 Filed 4-15-16; 8:45 am]
BILLING CODE 4164-01-P
