National Institute of General Medical Sciences; Notice of Closed Meetings, 7465-7466 [2014-02584]
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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).
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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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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?
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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
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7466
Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Notices
Sciences, National Institutes of Health, 45
Center Drive, Room 3An.12A, Bethesda, MD
20892–4874, 301–594–3998, trempemo@
mail.nih.gov.
Name of Committee: National Institute of
General Medical Sciences Initial Review
Group; Training and Workforce Development
Subcommittee—D.
Date: March 13–14, 2014.
Time: 8:00 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: Rebecca H. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3An.18C, Bethesda, MD
20892–4874, 301–594–2771, JohnsoRe@
nigms.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS).
Dated: February 3, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–02584 Filed 2–6–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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National Cancer Institute; 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/
contract proposals 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 Cancer
Institute Special Emphasis Panel; Omnibus
R03/R21: Tumor Immunology.
Date: March 5–6, 2014.
Time: 6:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
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17:17 Feb 06, 2014
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Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Robert Bird, Ph.D., Chief,
Resources and Training Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W110, Bethesda, MD 20892–
8328, 240–276–6344, birdr@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI
Omnibus—Cancer Biology 1.
Date: March 6–7, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center, 5701 Marinelli Road,
Bethesda, MD 20852.
Contact Person: Zhiqiang Zou, MD, Ph.D.,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W242,
Bethesda, MD 20892–9750, 240–276–6372,
zouzhiq@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Collaborative Research in Integrative Cancer
Biology.
Date: March 13, 2014.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W242, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Zhiqiang Zou, MD, Ph.D.,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W242,
Bethesda, MD 20892–9750, 240–276–6372,
zouzhiq@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Awards for
Research on Imaging and Biomarkers for
Early Cancer Detection.
Date: March 17, 2014.
Time: 9:00 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
2W914, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Thomas A. Winters, Ph.D.,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W412,
Rockville, MD 20892–2750, 240–276–6386,
twinters@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Cancer
Prevention.
Date: March 19, 2014.
Time: 7:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda North Marriott Hotel &
Conference Center 5701, Marinelli Road,
Bethesda, MD 20852.
Contact Person: Clifford Schweinfest,
Ph.D., Scientific Review Officer, Special
PO 00000
Frm 00045
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Review and Logistics Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W108, Bethesda, MD 20892–9750,
240–276–6343, schweinfestcw@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; BiosensorBased Core Needles for Tumor Biopsy.
Date: March 19, 2014.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
4W032, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Donald L. Coppock, Ph.D.,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center, Room 7W260,
Bethesda, MD 20892, 240–276–6382,
donald.coppock@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Omnibus—
Drug Delivery/Imaging/Biotechnology.
Date: March 20–21, 2014.
Time: 7:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard Marriott Washingtonian
Center, 204 Boardwalk Place, Gaithersburg,
MD 20878.
Contact Person: Gerald G. Lovinger, Ph.D.,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 7W266,
Rockville, MD 20850–9750, 240–276–6385,
lovingeg@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel, Cancer
Therapy (Omnibus).
Date: March 27–28, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Gaithersburg Marriott
Washingtonian Center, 9751 Washingtonian
Boulevard, Gaithersburg, MD 20878.
Contact Person: Caron A Lyman, Ph.D.,
Chief, Research Programs Review Branch,
Division of Extramural Activities, National
Cancer Institute, NIH, 9609 Medical Center
Drive, Room 7W126, Bethesda, MD 20892–
9750, 240–276–6348, lymanc@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Drug
Reformulation.
Date: March 27, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Hilton Garden Inn Washington DC/
Bethesda, 7301 Waverly Street, Bethesda, MD
20814.
Contact Person: Thomas M. Vollberg,
Ph.D., Scientific Review Officer, Special
Review and Logistics Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W412, Bethesda, MD 20892–9750,
240–276–6341, vollbert@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Career
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Agencies
[Federal Register Volume 79, Number 26 (Friday, February 7, 2014)]
[Notices]
[Pages 7465-7466]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02584]
-----------------------------------------------------------------------
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
[[Page 7466]]
Sciences, National Institutes of Health, 45 Center Drive, Room
3An.12A, Bethesda, MD 20892-4874, 301-594-3998,
trempemo@mail.nih.gov.
Name of Committee: National Institute of General Medical
Sciences Initial Review Group; Training and Workforce Development
Subcommittee--D.
Date: March 13-14, 2014.
Time: 8:00 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: Rebecca H. Johnson, Ph.D., Scientific Review
Officer, Office of Scientific Review, National Institute of General
Medical Sciences, National Institutes of Health, 45 Center Drive,
Room 3An.18C, Bethesda, MD 20892-4874, 301-594-2771,
JohnsoRe@nigms.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.375,
Minority Biomedical Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology, Physiology, and
Biological Chemistry Research; 93.862, Genetics and Developmental
Biology Research; 93.88, Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National Institutes of Health, HHS).
Dated: February 3, 2014.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-02584 Filed 2-6-14; 8:45 am]
BILLING CODE 4140-01-P