Pulmonary Arterial Hypertension Public Meeting on Patient-Focused Drug Development, 7464-7465 [2014-02629]
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Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Notices
submissions to FDA in electronic format
for INDs, pre-market applications,
including new drug applications
(NDAs), ANDAs, biologics license
applications (BLAs), and amendments
and supplements to these applications,
master files (MFs), postapproval studies
(whether submitted as supplements to
approved applications or otherwise),
submissions related to products
marketed without an approved
application, and adverse event reports.
The information collection discussed in
the guidance is contained in our IND
regulations (21 CFR part 312) and
approved under OMB control number
0910–0014, our NDA regulations
(including ANDAs) (21 CFR part 314)
and approved under OMB control
number 0910–0001, and our BLA
regulations (21 CFR part 601) and
approved under OMB control number
0910–0338.
III. Comments
Interested persons may submit either
electronic comments to https://
www.regulations.gov or written
comments regarding this document to
the Division of Dockets Management
(see ADDRESSES). It is only necessary to
send one set of comments. Identify
comments with the docket number
found in brackets in the heading of this
document. 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. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Development
ApprovalProcess/FormsSubmission
Requirements/ElectronicSubmissions/
ucm253101.htm, https://
www.regulations.gov, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: February 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
mstockstill on DSK4VPTVN1PROD with NOTICES
[FR Doc. 2014–02654 Filed 2–6–14; 8:45 am]
BILLING CODE 4160–01–P
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Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0967]
Pulmonary Arterial Hypertension
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 pulmonary
arterial hypertension. 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 pulmonary arterial
hypertension on daily life, as well as
their perspectives on the available
therapies for pulmonary arterial
hypertension.
DATES: The public meeting will be held
on May 13, 2014, from 1 p.m. to 5 p.m.
Registration to attend the meeting must
be received by April 30, 2014. See the
SUPPLEMENTARY INFORMATION section for
information on how to register for the
meeting. Submit electronic or written
comments by July 14, 2014.
ADDRESSES: The meeting will be held at
the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503A), 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 more information on
parking and security procedures, please
refer to https://www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Submit electronic comments to
https://www.regulations.gov. Submit
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
All comments should be identified with
the docket number found in brackets in
the heading of this document.
FDA will post the agenda
approximately 5 days before the meeting
at https://www.fda.gov/ForIndustry/
UserFees/PrescriptionDrugUserFee/
ucm379694.htm.
SUMMARY:
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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 pulmonary arterial
hypertension 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 (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 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
community, and other interested
stakeholders.
On April 11, 2013, FDA published a
notice (78 FR 21613) in the Federal
Register announcing the disease areas
for meetings in fiscal years (FYs) 2013
through 2015, the first 3 years of the 5year PDUFA V time frame. 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 58849), 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 FYs 2016 through
2017. More information, including the
list of disease areas and a general
E:\FR\FM\07FEN1.SGM
07FEN1
Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Notices
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 pulmonary arterial
hypertension that matter most to
patients and on current approaches to
treating pulmonary arterial
hypertension. Pulmonary arterial
hypertension is a rare, progressive
condition that affects the heart and
lungs. It is characterized by abnormally
high blood pressure in the pulmonary
artery and may be accompanied by
shortness of breath, chest pain, fatigue,
dizziness, fainting, lightheadedness, and
swollen ankles and legs. There are
several treatment options for pulmonary
arterial hypertension, including
medications, surgery, and lifestyle
changes.
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
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).
mstockstill on DSK4VPTVN1PROD with NOTICES
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
1. Of all the symptoms that you
experience because of your condition,
which one to three symptoms have the
most significant impact on your life?
(Examples may include symptoms such
as chest pain, shortness of breath,
difficulty concentrating, and others.)
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
may include activities such as
household chores, walking up the
stairs.)
• 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?
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17:17 Feb 06, 2014
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Topic 2: Patients’ Perspectives on
Current Approaches to Treating
Pulmonary Arterial Hypertension
1. What are you currently doing to
help treat your condition or its
symptoms? (Examples may include
prescription medicines, over-thecounter products, other therapies
including non-drug therapies such as
diet modification.)
• 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?
• Have the medications for
pulmonary arterial hypertension made a
difference to you? If so, in what ways?
2. What are the most significant
downsides to your current treatments,
and how do they affect your daily life?
(Examples may include downsides such
as bothersome side effects, going to the
hospital for treatment, and others.)
3. Assuming there is no complete cure
for your condition, what specific things
would you look for in an ideal treatment
for your condition?
Fmt 4703
Sfmt 4703
Dated: January 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
BILLING CODE 4160–01–P
If you wish to attend this meeting,
visit https://patientfocusedpulmonary
arterialhypertension.eventbrite.com.
Please register by April 30, 2014. 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@
Frm 00044
fda.hhs.gov. We will notify panelists of
their selection soon after the close of
registration on April 30, 2014. 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.
Comments: Regardless of attendance
at 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 14, 2014. 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/
ucm379694.htm.
[FR Doc. 2014–02629 Filed 2–6–14; 8:45 am]
B. Meeting Attendance and
Participation
PO 00000
7465
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences Initial Review
Group; Training and Workforce Development
Subcommittee—C.
Date: March 3, 2014.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Mona R. Trempe, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 79, Number 26 (Friday, February 7, 2014)]
[Notices]
[Pages 7464-7465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02629]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0967]
Pulmonary Arterial Hypertension 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 pulmonary arterial hypertension. 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 pulmonary arterial hypertension on daily
life, as well as their perspectives on the available therapies for
pulmonary arterial hypertension.
DATES: The public meeting will be held on May 13, 2014, from 1 p.m. to
5 p.m. Registration to attend the meeting must be received by April 30,
2014. See the SUPPLEMENTARY INFORMATION section for information on how
to register for the meeting. Submit electronic or written comments by
July 14, 2014.
ADDRESSES: The meeting will be held at the FDA White Oak Campus, 10903
New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm.
1503A), 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 more information on
parking and security procedures, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Submit electronic comments to https://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. All comments should be identified with the docket number found
in brackets in the heading of this document.
FDA will post the agenda approximately 5 days before the meeting at
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm379694.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 pulmonary arterial hypertension 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
(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 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 community, and other interested
stakeholders.
On April 11, 2013, FDA published a notice (78 FR 21613) in the
Federal Register announcing the disease areas for meetings in fiscal
years (FYs) 2013 through 2015, the first 3 years of the 5-year PDUFA V
time frame. 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 58849), 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 FYs 2016 through
2017. More information, including the list of disease areas and a
general
[[Page 7465]]
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 pulmonary arterial
hypertension that matter most to patients and on current approaches to
treating pulmonary arterial hypertension. Pulmonary arterial
hypertension is a rare, progressive condition that affects the heart
and lungs. It is characterized by abnormally high blood pressure in the
pulmonary artery and may be accompanied by shortness of breath, chest
pain, fatigue, dizziness, fainting, lightheadedness, and swollen ankles
and legs. There are several treatment options for pulmonary arterial
hypertension, including medications, surgery, and lifestyle changes.
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
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 one to three symptoms have the most significant impact
on your life? (Examples may include symptoms such as chest pain,
shortness of breath, difficulty concentrating, and others.)
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 may include activities such as household chores,
walking up the stairs.)
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?
Topic 2: Patients' Perspectives on Current Approaches to Treating
Pulmonary Arterial Hypertension
1. What are you currently doing to help treat your condition or its
symptoms? (Examples may include prescription medicines, over-the-
counter products, other therapies including non-drug therapies such as
diet modification.)
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?
Have the medications for pulmonary arterial hypertension
made a difference to you? If so, in what ways?
2. What are the most significant downsides to your current
treatments, and how do they affect your daily life? (Examples may
include downsides such as bothersome side effects, going to the
hospital for treatment, and others.)
3. 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://patientfocusedpulmonaryarterialhypertension.eventbrite.com. Please
register by April 30, 2014. 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. We will notify panelists of
their selection soon after the close of registration on April 30, 2014.
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.
Comments: Regardless of attendance at 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 14, 2014.
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/ucm379694.htm.
Dated: January 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02629 Filed 2-6-14; 8:45 am]
BILLING CODE 4160-01-P
