Fibromyalgia Public Meeting on Patient-Focused Drug Development, 58313-58314 [2013-23019]
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Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices
complex issues for trial design conduct
and analysis; (3) development of
translational and regulatory science to
support rare disease drug development;
and (4) safety and dosing
considerations, including safety
exposures and assessment of dose
selection.
Topics for discussion on day 2
include: (1) Collaborative research
networks for pediatric rare diseases; (2)
safety considerations for pediatric rare
diseases; (3) pediatric rare cancers; and
(4) development of gene therapies for
rare pediatric disorders. Discussions
will help develop a report that includes
a strategic plan to encourage and
accelerate the development of new
therapies for pediatric rare diseases.
FDA encourages individuals, patients,
advocates, industry, consumer groups,
health care professionals, researchers
and other interested persons to attend
this public workshop.
Dated: September 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–22959 Filed 9–20–13; 8:45 am]
BILLING CODE 4160–01–P
FOR FURTHER INFORMATION CONTACT:
Graham Thompson, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1199,
Silver Spring, MD 20993, 301–796–
5003, FAX: 301–847–8443, email:
Graham.Thompson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1041]
Fibromyalgia Public Meeting on
Patient-Focused Drug Development
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting and an opportunity for
public comment on Patient-Focused
Drug Development for fibromyalgia.
Patient-Focused Drug Development is
part of FDA’s performance
commitments in the fifth authorization
of the Prescription Drug User Fee Act
(PDUFA V). The public meeting is
intended to allow FDA to obtain
patients’ perspectives on the impact of
fibromyalgia on daily life as well as the
available therapies for fibromyalgia.
DATES: The public meeting will be held
on December 10, 2013, from 1 p.m. to
5 p.m. Registration to attend the meeting
must be received by November 27, 2013.
See the SUPPLEMENTARY INFORMATION
section for information on how to
register for the meeting. Submit
electronic or written comments by
February 10, 2013.
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
20:16 Sep 20, 2013
The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, in Section A of the
Great Room (Rm. 1503), Silver Spring,
MD 20993. Entrance for the public
meeting participants is through Building
1, where routine security check
procedures will be performed. For more
information on parking and security
procedures, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit electronic comments to
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/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm363203.htm.
ADDRESSES:
Jkt 229001
I. Background on Patient-Focused Drug
Development
FDA has selected fibromyalgia as the
focus of a meeting under PatientFocused Drug Development, an
initiative that involves obtaining a better
understanding of patients’ perspectives
on the severity of the disease and the
available therapies for the condition.
Patient-Focused Drug Development is
being conducted to fulfill FDA’s
performance commitments made as part
of the authorization of PDUFA V under
Title I of the Food and Drug Safety and
Innovation Act (FDASIA) (Pub. L. 112–
144). The full set of performance
commitments is available on the FDA
Web site at https://www.fda.gov/
downloads/forindustry/userfees/
prescriptiondruguserfee/
ucm270412.pdf.
FDA has committed to obtain the
patient perspective in twenty 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’
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
58313
perspectives on the adequacy of the
available therapies. These meetings will
include participation of FDA review
divisions, the relevant patient
community, and other interested
stakeholders.
On April 11, 2013, FDA published a
notice (78 FR 08441) in the Federal
Register announcing the disease areas
for meetings in fiscal years (FY) 2013–
2015, the first 3 years of the 5-year
PDUFA V timeframe. To develop the list
of disease areas, the Agency used
several criteria that were outlined in the
April 11 notice. The Agency obtained
public comment on these criteria and
potential disease areas through a notice
for public comment published in the
Federal Register on September 24, 2012
(77 FR 23454, and through a public
meeting held on October 25, 2012. In
selecting the disease areas, FDA
carefully considered the public
comments received and the perspectives
of its review divisions. By the end of FY
2015, FDA will initiate another public
process for determining the disease
areas for FY 2016–2017. More
information, including the list of disease
areas and a general schedule of
meetings, is posted on FDA’s Web site
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
symptoms of fibromyalgia that matter
most to patients and on current
approaches to treating fibromyalgia.
Fibromyalgia is a chronic disorder
characterized by widespread
musculoskeletal pain and tenderness in
multiple tender points and may be
accompanied by fatigue, sleep
disturbances, irritable bowel syndrome,
headache, and mood disorders. While
there is currently no definitive cure,
treatments for fibromyalgia include
medications and lifestyle changes with
emphasis on minimizing symptoms and
improving general health and daily
function. FDA is interested in obtaining
a better understanding of fibromyalgia
patients’ perspectives on the severity of
the disease and the available therapies
used to treat fibromyalgia and its
symptoms.
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 patient panel discussion will begin
the dialogue, followed by a facilitated
discussion inviting comments from
E:\FR\FM\23SEN1.SGM
23SEN1
58314
Federal Register / Vol. 78, No. 184 / Monday, September 23, 2013 / Notices
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 that can be
submitted to the public docket (see
ADDRESSES).
emcdonald on DSK67QTVN1PROD 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 1–3 symptoms have the most
significant impact on your life?
(Examples may include chronic pain,
fatigue, difficulty concentrating, sleep
disorders, 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 hygiene, driving,
household chores, etc.)
(a) How do your symptoms and their
negative impacts affect your daily life
on the best days? On the worst days?
(3) How have your condition and its
symptoms changed over time?
(a) 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?
Topic 2: Patients’ Perspectives on
Current Approaches to Treating
Fibromyalgia
(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
exercise or acupuncture)
(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, going to the
hospital for treatment, restrictions on
driving, etc.)
(4) What specific things would you
look for in an ideal treatment for your
condition?
VerDate Mar<15>2010
20:16 Sep 20, 2013
Jkt 229001
B. Meeting Attendance and/or
Participation
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
If you wish to attend this meeting,
visit https://patientfocusedfibromyalgia.
eventbrite.com. Please register by
November 27, 2013. Those who are
unable to attend the meeting in person
can register to view a live webcast of the
meeting. You will be asked to indicate
in your registration whether you plan to
attend in person or via the webcast.
Your registration should also contain
your complete contact information,
including name, title, affiliation,
address, email address, and phone
number.
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
accommodations because of 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 will also be asked to send a
brief summary of responses to the topic
questions to PatientFocused@
fda.hhs.gov. Panelists will be notified of
their selection soon after the close of
registration on November 27, 2013. FDA
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.
Interested members of the public,
including those who attend the meeting
in person or through the webcast, are
invited to provide electronic or written
responses to the questions pertaining to
Topics 1 and 2 to the public docket (see
ADDRESSES). Comments may be
submitted until February 10, 2013.
Food and Drug Administration
Dated: September 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–23019 Filed 9–20–13; 8:45 am]
BILLING CODE 4160–01–P
PO 00000
Frm 00048
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[Docket No. FDA–2013–N–0001]
Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology; 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.
Name of Committee: Advisory
Committee for Pharmaceutical Science
and Clinical Pharmacology.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on October 30, 2013, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ACPS-CP@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: There will be two topics
presented to the committee for their
E:\FR\FM\23SEN1.SGM
23SEN1
]]>Agencies
[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58313-58314]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-23019]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1041]
Fibromyalgia Public Meeting on Patient-Focused Drug Development
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and an opportunity for public comment on Patient-Focused Drug
Development for fibromyalgia. Patient-Focused Drug Development is part
of FDA's performance commitments in the fifth authorization of the
Prescription Drug User Fee Act (PDUFA V). The public meeting is
intended to allow FDA to obtain patients' perspectives on the impact of
fibromyalgia on daily life as well as the available therapies for
fibromyalgia.
DATES: The public meeting will be held on December 10, 2013, from 1
p.m. to 5 p.m. Registration to attend the meeting must be received by
November 27, 2013. See the SUPPLEMENTARY INFORMATION section for
information on how to register for the meeting. Submit electronic or
written comments by February 10, 2013.
ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31 Conference Center, in Section A of the
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public
meeting participants is through Building 1, where routine security
check procedures will be performed. For more information on parking and
security procedures, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Submit electronic comments to 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/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm363203.htm.
FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1199, Silver Spring, MD 20993, 301-796-
5003, FAX: 301-847-8443, email: Graham.Thompson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug Development
FDA has selected fibromyalgia as the focus of a meeting under
Patient-Focused Drug Development, an initiative that involves obtaining
a better understanding of patients' perspectives on the severity of the
disease and the available therapies for the condition. Patient-Focused
Drug Development is being conducted to fulfill FDA's performance
commitments made as part of the authorization of PDUFA V under Title I
of the Food and Drug Safety and Innovation Act (FDASIA) (Pub. L. 112-
144). The full set of performance commitments is available on the FDA
Web site at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
FDA has committed to obtain the patient perspective in twenty
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 community, and other
interested stakeholders.
On April 11, 2013, FDA published a notice (78 FR 08441) in the
Federal Register announcing the disease areas for meetings in fiscal
years (FY) 2013-2015, the first 3 years of the 5-year PDUFA V
timeframe. To develop the list of disease areas, the Agency used
several criteria that were outlined in the April 11 notice. The Agency
obtained public comment on these criteria and potential disease areas
through a notice for public comment published in the Federal Register
on September 24, 2012 (77 FR 23454, and through a public meeting held
on October 25, 2012. In selecting the disease areas, FDA carefully
considered the public comments received and the perspectives of its
review divisions. By the end of FY 2015, FDA will initiate another
public process for determining the disease areas for FY 2016-2017. More
information, including the list of disease areas and a general schedule
of meetings, is posted on FDA's Web site 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 symptoms of fibromyalgia that
matter most to patients and on current approaches to treating
fibromyalgia. Fibromyalgia is a chronic disorder characterized by
widespread musculoskeletal pain and tenderness in multiple tender
points and may be accompanied by fatigue, sleep disturbances, irritable
bowel syndrome, headache, and mood disorders. While there is currently
no definitive cure, treatments for fibromyalgia include medications and
lifestyle changes with emphasis on minimizing symptoms and improving
general health and daily function. FDA is interested in obtaining a
better understanding of fibromyalgia patients' perspectives on the
severity of the disease and the available therapies used to treat
fibromyalgia and its symptoms.
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 patient panel discussion will begin the
dialogue, followed by a facilitated discussion inviting comments from
[[Page 58314]]
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 that can be submitted to the public docket (see ADDRESSES).
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 1-3 symptoms have the most significant impact on your
life? (Examples may include chronic pain, fatigue, difficulty
concentrating, sleep disorders, 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 hygiene, driving, household chores, etc.)
(a) How do your symptoms and their negative impacts affect your
daily life on the best days? On the worst days?
(3) How have your condition and its symptoms changed over time?
(a) 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?
Topic 2: Patients' Perspectives on Current Approaches to Treating
Fibromyalgia
(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 exercise or acupuncture)
(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, going to the hospital
for treatment, restrictions on driving, etc.)
(4) What specific things would you look for in an ideal treatment
for your condition?
B. Meeting Attendance and/or Participation
If you wish to attend this meeting, visit https://patientfocusedfibromyalgia.eventbrite.com. Please register by November
27, 2013. Those who are unable to attend the meeting in person can
register to view a live webcast of the meeting. You will be asked to
indicate in your registration whether you plan to attend in person or
via the webcast. Your registration should also contain your complete
contact information, including name, title, affiliation, address, email
address, and phone number.
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 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 will
also be asked to send a brief summary of responses to the topic
questions to PatientFocused@fda.hhs.gov. Panelists will be notified of
their selection soon after the close of registration on November 27,
2013. FDA 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.
Interested members of the public, including those who attend the
meeting in person or through the webcast, are invited to provide
electronic or written responses to the questions pertaining to Topics 1
and 2 to the public docket (see ADDRESSES). Comments may be submitted
until February 10, 2013.
Dated: September 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-23019 Filed 9-20-13; 8:45 am]
BILLING CODE 4160-01-P
