Patient-Focused Drug Development for Functional Gastrointestinal Disorders; Public Meeting; Request for Comments, 7616-7617 [2015-02804]
Download as PDF
<![CDATA[
7616
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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/
ucm430885.htm.
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT:
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/
PMAApprovals/default.htm.
Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–02783 Filed 2–10–15; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2015–N–0244]
Patient-Focused Drug Development for
Functional Gastrointestinal Disorders;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
tkelley on DSK3SPTVN1PROD with NOTICES
I. Background on Patient-Focused Drug
Development
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
functional gastrointestinal (GI)
disorders, including irritable bowel
syndrome, gastroparesis, chronic
persistent symptomatic
gastroesophageal reflux despite standard
therapeutic interventions, and chronic
idiopathic constipation. 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 functional
GI disorders on daily life and patient
views on treatment approaches.
DATES: The public meeting will be held
on May 11, 2015, from 1 p.m. to 5 p.m.
Registration to attend the meeting must
be received by May 1, 2015 (see
SUPPLEMENTARY INFORMATION for
instructions). Submit electronic or
written comments to the public docket
by July 13, 2015.
ADDRESSES: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Participants must enter through
Building 1 and undergo security
screening. For more information on
parking and security procedures, please
refer to https://www.fda.gov/AboutFDA/
SUMMARY:
VerDate Sep<11>2014
17:07 Feb 10, 2015
Jkt 235001
Pegah Mariani, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146,
Silver Spring, MD 20993–0002, 240–
402–4513, FAX: 301–847–8443,
Sayyedeh.Mariani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
FDA has selected functional GI
disorders 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 20 disease areas during
the course of PDUFA V. For each
disease area, the Agency will conduct a
public meeting to discuss the disease
and its impact on patients’ daily lives,
the types of treatment benefit that
matter most to patients, and patients’
perspectives on the adequacy of the
available therapies. These meetings will
include participation of FDA review
divisions, the relevant patient
communities, and other interested
stakeholders.
On April 11, 2013, FDA published a
document in the Federal Register (78
FR 21613) announcing the disease areas
for meetings in fiscal years (FYs) 2013–
2015, the first 3 years of the 5-year
PDUFA V timeframe. The Agency used
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
several criteria outlined in that
document 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 has
initiated a second 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 at https://
www.fda.gov/ForIndustry/UserFees/
PrescriptionDrugUserFee/
ucm326192.htm.
II. Public Meeting Information
A. Purpose and Scope of the Meeting
The purpose of this Patient-Focused
Drug Development meeting is to obtain
input on the symptoms and other
impacts of functional GI disorders, such
as irritable bowel syndrome,
gastroparesis, chronic persistent
symptomatic gastroesophageal reflux
despite standard therapeutic
interventions, and chronic idiopathic
constipation, that matter most to
patients, as well as perspectives on
current approaches to treating these
conditions. Functional GI disorders are
common disorders that are
characterized by persistent and
recurring GI symptoms and occur as a
result of abnormal functioning of the GI
tract. These disorders are not caused by
structural abnormalities, thus routine
medical tests may be normal, and
diagnosis is based primarily on
symptoms. Functional GI disorders can
affect any part of the GI tract, including
the esophagus, bile duct, and intestines.
Treatment for functional GI disorders
focuses on management of different
symptoms over a period of time.
Treatments may include dietary
management as well as over-the-counter
and prescription medications (e.g.,
antispasmodics, pro-motility agents,
antidiarrheals, and antidepressants). In
addition, psychological treatments, such
as relaxation therapy or cognitive
behavioral therapy, may help manage
the symptoms of functional GI
disorders.
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
E:\FR\FM\11FEN1.SGM
11FEN1
Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices
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).
tkelley on DSK3SPTVN1PROD with NOTICES
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
• Have you received a diagnosis of a
functional GI disorder from a health
care provider? If so, please state the
condition.
• Of all the symptoms that you
experience because of your condition,
which one to three symptoms have the
most significant impact on your life?
(Examples may include pain, bloating,
constipation, vomiting)
• 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)
Æ How do your symptoms and their
negative impacts affect your daily life
on the best days? On the worst days?
• How has your condition and its
symptoms changed over time?
Æ Do your symptoms come and go or
are they ongoing? If so, do you know of
anything that worsens your symptoms?
• What worries you most about your
condition?
Topic 2: Patients’ Perspectives on
Current Approaches To Treating
Functional GI Disorders
• 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 nondrug therapies such as
diet modification.)
Æ What specific symptoms do your
treatments address?
Æ How has your treatment regimen
changed over time, and why?
• How well does your current
treatment regimen treat the most
significant symptoms of your disease?
Æ How well do these treatments stop
or slow the progression of your
condition?
Æ How well do these therapies
improve your ability to do specific
activities that are important to you in
your daily life?
Æ How well have these treatments
worked for you as your condition has
changed over time?
• 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.)
VerDate Sep<11>2014
17:07 Feb 10, 2015
Jkt 235001
• Assuming there is no complete cure
for your condition, what specific things
would you look for in an ideal treatment
for your condition?
Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
B. Meeting Attendance and
Participation
BILLING CODE 4164–01–P
If you wish to attend this meeting,
visit https://pfddfunctionalgi
disorders.eventbrite.com. Please register
by May 1, 2015. 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
Pegah Mariani (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 April 24, 2015. Panelists
will be notified of their selection
approximately 7 days before the public
meeting. We will try to accommodate all
patients and patient stakeholders who
wish to speak, either through the panel
discussion or audience participation;
however, the duration of comments may
be limited by time constraints.
7617
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
III. 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
July 13, 2015. Received comments may
be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://
www.regulations.gov.
IV. Transcripts
As soon as a transcript is available,
FDA will post it at https://www.fda.gov/
ForIndustry/UserFees/Prescription
DrugUserFee/ucm430885.htm.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
[FR Doc. 2015–02804 Filed 2–10–15; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2004–N–0451]
Food and Drug Administration
Modernization Act of 1997:
Modifications to the List of Recognized
Standards, Recognition List Number:
039
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing a
publication containing modifications
the Agency is making to the list of
standards FDA recognizes for use in
premarket reviews (‘‘FDA Recognized
Consensus Standards’’). Specifically,
this publication announces the addition
of a list of recognized standards that are
relevant to safety considerations to
mitigate the risks of misconnections
with small-bore connectors intended for
enteral applications. This publication,
entitled ‘‘Modifications to the List of
Recognized Standards, Recognition List
Number: 039’’ (‘‘Recognition List
Number: 039’’), will assist
manufacturers who elect to declare
conformity with consensus standards to
meet certain requirements for medical
devices.
SUMMARY:
Submit either electronic or
written comments concerning this
document at any time. See section VI for
the effective date of the recognition of
standards announced in this document.
ADDRESSES: An electronic copy of
Recognition List Number: 039 is
available on the Internet at https://
www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
V for electronic access to the searchable
database for the current list of FDA
recognized consensus standards,
including Recognition List Number: 039
modifications and other standards
related information.
Submit written requests for single
copies of the document entitled
‘‘Modifications to the List of Recognized
Standards, Recognition List Number:
039’’ to the Division of Industry and
Consumer Education, Center for Devices
and Radiological Health, Food and Drug
DATES:
E:\FR\FM\11FEN1.SGM
11FEN1
]]>Agencies
[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7616-7617]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02804]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0244]
Patient-Focused Drug Development for Functional Gastrointestinal
Disorders; 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 or Agency) is announcing
a public meeting and an opportunity for public comment on Patient-
Focused Drug Development for functional gastrointestinal (GI)
disorders, including irritable bowel syndrome, gastroparesis, chronic
persistent symptomatic gastroesophageal reflux despite standard
therapeutic interventions, and chronic idiopathic constipation.
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 functional GI
disorders on daily life and patient views on treatment approaches.
DATES: The public meeting will be held on May 11, 2015, from 1 p.m. to
5 p.m. Registration to attend the meeting must be received by May 1,
2015 (see SUPPLEMENTARY INFORMATION for instructions). Submit
electronic or written comments to the public docket by July 13, 2015.
ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993-0002. Participants must enter through
Building 1 and undergo security screening. For more information on
parking and security procedures, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Submit electronic comments to 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/ucm430885.htm.
FOR FURTHER INFORMATION CONTACT: Pegah Mariani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-4513, FAX: 301-847-8443, Sayyedeh.Mariani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background on Patient-Focused Drug Development
FDA has selected functional GI disorders 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 20 disease areas
during the course of PDUFA V. For each disease area, the Agency will
conduct a public meeting to discuss the disease and its impact on
patients' daily lives, the types of treatment benefit that matter most
to patients, and patients' perspectives on the adequacy of the
available therapies. These meetings will include participation of FDA
review divisions, the relevant patient communities, and other
interested stakeholders.
On April 11, 2013, FDA published a document in the Federal Register
(78 FR 21613) announcing the disease areas for meetings in fiscal years
(FYs) 2013-2015, the first 3 years of the 5-year PDUFA V timeframe. The
Agency used several criteria outlined in that document 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
has initiated a second 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 at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.
II. Public Meeting Information
A. Purpose and Scope of the Meeting
The purpose of this Patient-Focused Drug Development meeting is to
obtain input on the symptoms and other impacts of functional GI
disorders, such as irritable bowel syndrome, gastroparesis, chronic
persistent symptomatic gastroesophageal reflux despite standard
therapeutic interventions, and chronic idiopathic constipation, that
matter most to patients, as well as perspectives on current approaches
to treating these conditions. Functional GI disorders are common
disorders that are characterized by persistent and recurring GI
symptoms and occur as a result of abnormal functioning of the GI tract.
These disorders are not caused by structural abnormalities, thus
routine medical tests may be normal, and diagnosis is based primarily
on symptoms. Functional GI disorders can affect any part of the GI
tract, including the esophagus, bile duct, and intestines. Treatment
for functional GI disorders focuses on management of different symptoms
over a period of time. Treatments may include dietary management as
well as over-the-counter and prescription medications (e.g.,
antispasmodics, pro-motility agents, antidiarrheals, and
antidepressants). In addition, psychological treatments, such as
relaxation therapy or cognitive behavioral therapy, may help manage the
symptoms of functional GI disorders.
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
[[Page 7617]]
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
Have you received a diagnosis of a functional GI disorder
from a health care provider? If so, please state the condition.
Of all the symptoms that you experience because of your
condition, which one to three symptoms have the most significant impact
on your life? (Examples may include pain, bloating, constipation,
vomiting)
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)
[cir] How do your symptoms and their negative impacts affect your
daily life on the best days? On the worst days?
How has your condition and its symptoms changed over time?
[cir] Do your symptoms come and go or are they ongoing? If so, do
you know of anything that worsens your symptoms?
What worries you most about your condition?
Topic 2: Patients' Perspectives on Current Approaches To Treating
Functional GI Disorders
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 nondrug therapies
such as diet modification.)
[cir] What specific symptoms do your treatments address?
[cir] How has your treatment regimen changed over time, and why?
How well does your current treatment regimen treat the
most significant symptoms of your disease?
[cir] How well do these treatments stop or slow the progression of
your condition?
[cir] How well do these therapies improve your ability to do
specific activities that are important to you in your daily life?
[cir] How well have these treatments worked for you as your
condition has changed over time?
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.)
Assuming there is no complete cure for your condition,
what specific things would you look for in an ideal treatment for your
condition?
B. Meeting Attendance and Participation
If you wish to attend this meeting, visit https://pfddfunctionalgidisorders.eventbrite.com. Please register by May 1,
2015. 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 Pegah
Mariani (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 April 24, 2015. Panelists will be notified of
their selection approximately 7 days before the public meeting. We will
try to accommodate all patients and patient stakeholders who wish to
speak, either through the panel discussion or audience participation;
however, the duration of comments may be limited by time constraints.
III. 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 July 13, 2015. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday, and will be posted to the
docket at https://www.regulations.gov.
IV. Transcripts
As soon as a transcript is available, FDA will post it at https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm430885.htm.
Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02804 Filed 2-10-15; 8:45 am]
BILLING CODE 4164-01-P
