Patient-Focused Drug Development on Chronic Pain; Public Meeting; Request for Comments, 22491-22493 [2018-10284]
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22491
Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
Unaccompanied Alien Children,
renamed to Sponsorship Review
Procedures for Approval of
Unaccompanied Alien Children. The
information collection will allow ACF
to conduct suitability assessments to vet
potential sponsors of unaccompanied
alien children in accordance with a
Memorandum of Agreement (MOA)
between ORR and the Department of
Homeland Security. Specifically, the
information collection allows ORR to
obtain biometric and biographical
information from sponsors, adult
members of their household, and adult
care givers identified in a sponsor care
plan, where applicable. ORR in turn
shares the information collected with
other federal departments to conduct
background checks. ORR intends the
instruments used in this submission to
be available for use by mid-May 2018.
ACF cannot reasonably comply with
the normal clearance procedures
because the use of normal clearance
procedures is reasonably likely to
prevent the collection of needed
information in a timely manner.
Number of
respondents
Instrument
daltland on DSKBBV9HB2PROD with NOTICES
Family reunification application .......................................................................
Authorization for Release of Information .........................................................
Fingerprint Instructions ....................................................................................
Letter of Designation .......................................................................................
Estimated Total Annual Burden per
Respondent: 143,750.
Additional Information:
ACF is requesting that OMB grant
approval for this information collection
under procedures for emergency
processing through October 31, 2018,
the expiration date for the already
approved information collection. ACF
requests approval of the expanded
information collection by May 11, 2018.
Although ACF is seeking immediate
approval of the specific aspects of the
information collection described above,
ACF is also soliciting public comment
on these aspects of the information
collection and on the information
collection more generally.
Copies of the proposed collection of
information for emergency processing
and public comment can be obtained at
reginfo.gov by searching for OMB
Control No. 0970–0278. Comments may
be forwarded by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington DC 20201. Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
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Dated: May 11, 2018.
Naomi Goldstein,
Deputy Assistant Secretary for Planning,
Research, and Evaluation.
[FR Doc. 2018–10452 Filed 5–11–18; 4:15 pm]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1621]
Patient-Focused Drug Development on
Chronic Pain; Public Meeting; Request
for Comments
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
Chronic Pain.’’ The public meeting will
provide patients (including adult and
pediatric patients) with an opportunity
to present to FDA their perspectives on
the impacts of chronic pain, views on
treatment approaches for chronic pain,
and challenges or barriers to accessing
treatments. FDA is particularly
interested in hearing from patients who
SUMMARY:
PO 00000
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Sfmt 4703
Number of
responses per
respondent
50,000
90,000
90,000
25,000
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
AGENCY:
Complying with the normal clearance
procedures would delay or disrupt
ORR’s ability to expand the background
checks in order to more
comprehensively evaluate the suitability
of potential sponsors of unaccompanied
alien children, and to ensure safe and
appropriate placement of children. The
information collection is essential to the
mission of the agency.
Respondents: Sponsors, adult
household members, parents or legal
guardians of unaccompanied alien
children.
1
1
1
1
Average
burden hours
per response
0.5
0.25
1
0.25
Total
burden hours
25,000
22,500
90,000
6,250
experience chronic pain that is managed
with analgesic medications such as
opioids, acetaminophen, nonsteroidal
anti-inflammatory drugs (NSAIDs),
antidepressants; other medications; and
non-pharmacologic interventions or
therapies.
DATES: The public meeting will be held
on July 9, 2018, from 10 a.m. to 4 p.m.
Submit either electronic or written
comments on this public workshop by
September 10, 2018. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public meeting will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before September 10, 2018. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of September 10, 2018. 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.
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22492
Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / 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’’).
daltland on DSKBBV9HB2PROD with NOTICES
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–
2018–N–1621 for ‘‘Patient-Focused Drug
Development on Chronic Pain; Public
Meeting; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
VerDate Sep<11>2014
20:27 May 14, 2018
Jkt 244001
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.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.
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:
pain, including prescription and nonprescription medications, invasive and
non-invasive medical devices, and
behavioral and physical therapies. FDA
is particularly interested in patients’
(including adult and pediatric patients)
perspectives on types of chronic pain
that are managed with analgesic
medications such as opioids,
acetaminophen, NSAIDs,
antidepressants; other medications; and
non-pharmacologic interventions or
therapies.
At the meeting, patients and patient
representatives will provide patient
perspectives on the symptoms and daily
impacts of chronic pain and on
treatment approaches for chronic pain.
The questions that will be asked of
patients and patient representatives at
the meeting are listed in the following
section and organized by topic. For each
topic, a brief initial patient panel
discussion will begin the dialogue. This
will be followed by a facilitated
discussion inviting comments from
other patient and patient representative
participants. In addition to input
generated through this public meeting,
FDA is interested in receiving patient
and patient representative input
addressing these questions through
written comments, which can be
submitted to the public docket (see
ADDRESSES). When submitting
comments, if you are commenting on
behalf of a patient, please indicate that
you are doing so and answer the
following questions as much as possible
from the patient’s perspective.
FDA will post the agenda and other
meeting materials approximately 5 days
before the meeting at: https://
www.fda.gov/Drugs/NewsEvents/
ucm603093.htm.
II. Topics for Discussion at the Public
Meeting
I. Background
Topic 1: Symptoms and Daily Impacts
of Chronic Pain That Matter Most to
Patients
This meeting will provide FDA the
opportunity to better understand
patients’ perspectives on the impacts of
chronic pain, patient views on treatment
approaches for chronic pain, and
challenges or barriers to accessing
treatments. Chronic pain is defined as
either pain that persists for more than 3
months or pain that lasts more than 1
month beyond the normal healing time.
Chronic pain is diverse and can include
primary pain, cancer pain, postsurgical
and posttraumatic pain, neuropathic
pain, headache and orofacial pain,
visceral pain, and musculoskeletal pain.
There are a number of therapeutic
approaches for the treatment of chronic
1. How would you describe your
chronic pain? (Characteristics could
include location, radiation, intensity,
duration, constancy or intermittency,
triggers etc.)
2. What are the most significant
symptoms that you experience resulting
from your condition? (Examples may
include restricted range of motion,
muscle spasms, changes in sensation,
etc.)
3. 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 chronic pain?
(Examples of activities may include
work or school activities, sleeping
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Federal Register / Vol. 83, No. 94 / Tuesday, May 15, 2018 / Notices
through the night, daily hygiene,
participation in sports or social
activities, intimacy with a spouse or
partner, etc.)
4. How has your chronic pain
changed over time? (Considerations
include severity and frequency of your
chronic pain and the effects of chronic
pain on your daily activities.)
daltland on DSKBBV9HB2PROD with NOTICES
Topic 2: Patients’ Perspectives on
Current Approaches to Treatment of
Chronic Pain
1. What are you currently doing to
help treat your chronic pain? (Examples
may include prescription medicines,
over-the-counter products, and nondrug therapies.)
a. How has your treatment regimen
changed over time, and why? (Examples
may include change in your condition,
change in dose, or treatment side
effects.)
b. What factors do you take into
account when making decisions about
selecting a course of treatment?
2. How well does your current
treatment regimen manage your chronic
pain? (Considerations include severity
and frequency of your chronic pain and
the effects of chronic pain on your daily
activities.)
3. What are the most significant
downsides to your current treatments,
and how do they affect your daily life?
4. What challenges or barriers to
accessing or using medical treatments
for chronic pain have you or do you
encounter?
5. What specific things would you
look for in an ideal treatment for your
chronic pain?
III. Participating in the Public Meeting
Registration: To register for the public
meeting, visit https://chronicpainpfdd.eventbrite.com. Please register by
July 2, 2018. Persons without access to
the internet can call 240–402–6525 to
register. If you are unable to attend the
meeting in person, you can register to
view a live webcast of the meeting. You
will be asked to indicate in your
registration if you plan to attend in
person or via the webcast.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public meeting must
register by July 2, 2018. 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. If time and space permit,
onsite registration on the day of the
public meeting will be provided
beginning at 9 a.m. If you need special
VerDate Sep<11>2014
20:27 May 14, 2018
Jkt 244001
accommodations because of a disability,
please contact Meghana Chalasani (see
FOR FURTHER INFORMATION CONTACT) no
later than July 2, 2018.
Panelist Selection: Patients or patient
representatives who are interested in
presenting comments as part of the
initial panel discussions will be asked
to indicate in their registration which
topic(s) they wish to address. These
patients or patient representatives also
will be asked to send PatientFocused@
fda.hhs.gov a brief summary of
responses to the topic questions by June
25, 2018. Panelists will be notified of
their selection approximately 7 days
before the public meeting. We will try
to accommodate all patients and patient
stakeholders who wish to speak, either
through the panel discussion or
audience participation; however, the
duration of comments may be limited by
time constraints.
Open Public Comment: There will be
time allotted during the meeting for
open public comment. Signup for this
session will be on a first-come, firstserve basis on the day of the workshop.
Individuals and organizations with
common interests are urged to
consolidate or coordinate and request
time for a joint presentation. No
commercial or promotional material
will be permitted to be presented or
distributed at the public workshop.
Streaming Webcast of the Public
Meeting: This public meeting will also
be webcast. Please register for the
webcast by visiting https://chronicpainpfdd.eventbrite.com.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the website addresses in this
document, as of the date this document
publishes in the Federal Register, but
websites are subject to change over time.
Transcripts: Please be advised that as
soon as a transcript of the public
meeting is available, it will be accessible
at https://www.regulations.gov. It may
be viewed at the Dockets Management
Staff (see ADDRESSES). A link to the
transcript will also be available on the
internet at https://www.fda.gov/Drugs/
NewsEvents/ucm603093.htm.
Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10284 Filed 5–14–18; 8:45 am]
BILLING CODE 4164–01–P
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22493
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–1837]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Electronic User
Fee Payment Request Forms
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on electronic user fee
payment request forms.
DATES: Submit either electronic or
written comments on the collection of
information by July 16, 2018.
ADDRESSES: 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 July 16, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 16, 2018. 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:
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
E:\FR\FM\15MYN1.SGM
15MYN1
]]>Agencies
[Federal Register Volume 83, Number 94 (Tuesday, May 15, 2018)]
[Notices]
[Pages 22491-22493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10284]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1621]
Patient-Focused Drug Development on Chronic Pain; 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 Chronic Pain.'' The public
meeting will provide patients (including adult and pediatric patients)
with an opportunity to present to FDA their perspectives on the impacts
of chronic pain, views on treatment approaches for chronic pain, and
challenges or barriers to accessing treatments. FDA is particularly
interested in hearing from patients who experience chronic pain that is
managed with analgesic medications such as opioids, acetaminophen,
nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other
medications; and non-pharmacologic interventions or therapies.
DATES: The public meeting will be held on July 9, 2018, from 10 a.m. to
4 p.m. Submit either electronic or written comments on this public
workshop by September 10, 2018. See the SUPPLEMENTARY INFORMATION
section for registration date and information.
ADDRESSES: The public meeting will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before September 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of September 10, 2018. 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.
[[Page 22492]]
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-2018-N-1621 for ``Patient-Focused Drug Development on Chronic Pain;
Public Meeting; Request for Comments.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.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.
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, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
This meeting will provide FDA the opportunity to better understand
patients' perspectives on the impacts of chronic pain, patient views on
treatment approaches for chronic pain, and challenges or barriers to
accessing treatments. Chronic pain is defined as either pain that
persists for more than 3 months or pain that lasts more than 1 month
beyond the normal healing time. Chronic pain is diverse and can include
primary pain, cancer pain, postsurgical and posttraumatic pain,
neuropathic pain, headache and orofacial pain, visceral pain, and
musculoskeletal pain. There are a number of therapeutic approaches for
the treatment of chronic pain, including prescription and non-
prescription medications, invasive and non-invasive medical devices,
and behavioral and physical therapies. FDA is particularly interested
in patients' (including adult and pediatric patients) perspectives on
types of chronic pain that are managed with analgesic medications such
as opioids, acetaminophen, NSAIDs, antidepressants; other medications;
and non-pharmacologic interventions or therapies.
At the meeting, patients and patient representatives will provide
patient perspectives on the symptoms and daily impacts of chronic pain
and on treatment approaches for chronic pain. The questions that will
be asked of patients and patient representatives at the meeting are
listed in the following section and organized by topic. For each topic,
a brief initial patient panel discussion will begin the dialogue. This
will be followed by a facilitated discussion inviting comments from
other patient and patient representative participants. In addition to
input generated through this public meeting, FDA is interested in
receiving patient and patient representative input addressing these
questions through written comments, which can be submitted to the
public docket (see ADDRESSES). When submitting comments, if you are
commenting on behalf of a patient, please indicate that you are doing
so and answer the following questions as much as possible from the
patient's perspective.
FDA will post the agenda and other meeting materials approximately
5 days before the meeting at: https://www.fda.gov/Drugs/NewsEvents/ucm603093.htm.
II. Topics for Discussion at the Public Meeting
Topic 1: Symptoms and Daily Impacts of Chronic Pain That Matter Most to
Patients
1. How would you describe your chronic pain? (Characteristics could
include location, radiation, intensity, duration, constancy or
intermittency, triggers etc.)
2. What are the most significant symptoms that you experience
resulting from your condition? (Examples may include restricted range
of motion, muscle spasms, changes in sensation, etc.)
3. 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
chronic pain? (Examples of activities may include work or school
activities, sleeping
[[Page 22493]]
through the night, daily hygiene, participation in sports or social
activities, intimacy with a spouse or partner, etc.)
4. How has your chronic pain changed over time? (Considerations
include severity and frequency of your chronic pain and the effects of
chronic pain on your daily activities.)
Topic 2: Patients' Perspectives on Current Approaches to Treatment of
Chronic Pain
1. What are you currently doing to help treat your chronic pain?
(Examples may include prescription medicines, over-the-counter
products, and non-drug therapies.)
a. How has your treatment regimen changed over time, and why?
(Examples may include change in your condition, change in dose, or
treatment side effects.)
b. What factors do you take into account when making decisions
about selecting a course of treatment?
2. How well does your current treatment regimen manage your chronic
pain? (Considerations include severity and frequency of your chronic
pain and the effects of chronic pain on your daily activities.)
3. What are the most significant downsides to your current
treatments, and how do they affect your daily life?
4. What challenges or barriers to accessing or using medical
treatments for chronic pain have you or do you encounter?
5. What specific things would you look for in an ideal treatment
for your chronic pain?
III. Participating in the Public Meeting
Registration: To register for the public meeting, visit https://chronicpain-pfdd.eventbrite.com. Please register by July 2, 2018.
Persons without access to the internet can call 240-402-6525 to
register. If you are unable to attend the meeting in person, you can
register to view a live webcast of the meeting. You will be asked to
indicate in your registration if you plan to attend in person or via
the webcast.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
meeting must register by July 2, 2018. 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. If time and space permit,
onsite registration on the day of the public meeting will be provided
beginning at 9 a.m. If you need special accommodations because of a
disability, please contact Meghana Chalasani (see FOR FURTHER
INFORMATION CONTACT) no later than July 2, 2018.
Panelist Selection: Patients or patient representatives who are
interested in presenting comments as part of the initial panel
discussions will be asked to indicate in their registration which
topic(s) they wish to address. These patients or patient
representatives also will be asked to send [email protected] a
brief summary of responses to the topic questions by June 25, 2018.
Panelists will be notified of their selection approximately 7 days
before the public meeting. We will try to accommodate all patients and
patient stakeholders who wish to speak, either through the panel
discussion or audience participation; however, the duration of comments
may be limited by time constraints.
Open Public Comment: There will be time allotted during the meeting
for open public comment. Signup for this session will be on a first-
come, first-serve basis on the day of the workshop. Individuals and
organizations with common interests are urged to consolidate or
coordinate and request time for a joint presentation. No commercial or
promotional material will be permitted to be presented or distributed
at the public workshop.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. Please register for the webcast by visiting https://chronicpain-pfdd.eventbrite.com.
If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/Drugs/NewsEvents/ucm603093.htm.
Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10284 Filed 5-14-18; 8:45 am]
BILLING CODE 4164-01-P
