National Heart, Lung, and Blood Institute; Notice of Closed Meetings, 33852-33853 [2013-13264]
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Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Notices
any other part of the body, such as to
the brain or to bones. Available
therapies for management of lung cancer
falls into two main categories: therapies
to reduce or control the spread of
disease (including surgery, radiation
therapy, conventional chemotherapy,
and targeted therapies), and supportive
care therapies to improve or manage
symptoms of the underlying condition
(lung cancer) or the side effects of
cancer treatments. FDA is interested in
patients’ perspectives for the two main
types of lung cancer (small-cell and
non-small cell lung cancer) on the
importance of disease symptoms,
benefits of treatment approaches, and
possible cancer treatment side effects.
The draft questions that will be asked
of patients and patient stakeholders at
the meeting are provided in the
paragraphs that follow. For each of these
topics, a brief initial patient panel
discussion will begin the dialogue and
will be 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 the public docket (see
ADDRESSES).
Topic 1: Disease Symptoms and Daily
Impacts That Matter Most to Patients
1. For context, how long ago was your
diagnosis of lung cancer? Is your cancer
currently in only one area of the lung or
has it spread to other parts of the lung
or outside of the lungs?
2. Of all the symptoms that you
experience because of your lung cancer,
which one to three symptoms have the
most significant impact on your daily
life? (Examples may include pain,
cough, shortness of breath, fatigue, voice
hoarseness.)
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 lung cancer? (Examples may
include sleeping through the night,
climbing stairs, household activities.)
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Topic 2: Patients’ Perspectives on
Current Approaches To Treating Lung
Cancer
1. Are you currently undergoing any
cancer treatments to help reduce or
control the spread of your lung cancer?
Please describe.
1.1 What do you consider to be the
most significant downsides of these
treatments? (Examples of downsides
may include side effects, going to the
hospital for treatment, frequent blood
tests, etc.)
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1.2 How do these downsides affect
your daily life?
2. What supportive care treatments, if
any, are you taking to help improve or
manage the symptoms you experience
because of your lung cancer? Please
include any prescription medicines,
over-the-counter products, and other
therapies including non-drug therapies
(such as breathing techniques).
2.1 What specific symptoms do your
treatments address?
2.2 How well do these treatments
manage these symptoms?
2.3 Are there symptoms that your
current treatment regimen does not
address at all, or does not treat as well
as you would like?
3. When thinking about your overall
goals for treatment, how do you weigh
the importance of prolonging your life
versus improving the symptoms you
experience because of your lung cancer?
4. What factors do you take into
account when making decisions about
using treatments to help reduce or
control the spread of your lung cancer?
In particular:
4.1 What information on the
potential benefits of these treatments
factors most into your decision?
(Examples of potential benefits from
treatments may include shrinking the
tumor, delaying the growth of the
tumor, prolonging life, etc.)
4.2 How do you weigh the potential
benefits of these treatments versus the
common side effects of the treatments?
(Common side effects could include
nausea, loss of appetite fatigue,
diarrhea, rash.)
4.3 How do you weigh potential
benefits of these treatments versus the
less common but serious risks
associated with the treatments?
(Examples of less common but serious
risks are developing a hole in the
stomach or intestine, liver failure,
kidney failure, lung inflammation,
blood clot, stroke, heart attack, serious
infections, etc.)
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. More information
will be posted on the meeting Web site
at least 5 days before the meeting date.
Patients who are interested in
presenting comments as part of the
initial panel discussions should indicate
in their registration which topic(s) they
wish to address. They will be asked to
send a brief summary of responses to
the topic(s) questions via email to
PatientFocused@fda.hhs.gov. Panelists
will be notified of their selection soon
after the close of registration on June 19,
2013. FDA will try to accommodate all
patients and patient advocate
participants 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 Web cast, are
invited to provide electronic or written
responses to any or all of the questions
pertaining to Topics 1 and 2 to the
Division of Dockets Management (see
ADDRESSES). Comments may be
submitted until July 29, 2013.
B. Attendance and/or Participation in
the Meeting
If you wish to attend this meeting,
visit https://patientfocusedlungcancer.
eventbrite.com. Please register by June
19, 2013. Those who are unable to
attend the meeting in person can
register to view a live Web cast of the
meeting. You will be asked to indicate
in your registration if you plan to attend
in person or via the Web cast. Your
registration will 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
National Institutes of Health
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Dated: May 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–13243 Filed 6–4–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Heart, Lung, and Blood
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 and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
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Federal Register / Vol. 78, No. 108 / Wednesday, June 5, 2013 / Notices
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Trauma and Hemostasis.
Date: June 25, 2013.
Time: 7:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crystal Gateway Marriott, 1700
Jefferson Davis Highway, Arlington, VA
22202.
Contact Person: Michael P Reilly, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7200, Bethesda, MD 20892, 301–496–9659,
reillymp@nhlbi.nih.gov.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Short-term Training to Promote Diversity in
Health Research.
Date: June 27, 2013.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7189, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Stephanie L Constant,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7189, Bethesda, MD 20892, 301–
443–8784, constantsl@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: May 30, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
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: Center for Scientific
Review Special Emphasis Panel; Spinal cord
biology and bone implants.
Date: June 27, 2013.
Time: 10:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Priscilla B. Chen, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4104,
MSC 7814, Bethesda, MD 20892, (301) 435–
1787, chenp@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Molecular Genetic Mechanisms.
Date: July 3, 2013.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Dominique Lorang-Leins,
Ph.D., Scientific Review Officer, National
Institutes of Health, Center for Scientific
Review, 6701 Rockledge Drive, Room 5108,
MSC 7766, Bethesda, MD 20892,
301.326.9721, Lorangd@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: May 30, 2013.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–13263 Filed 6–4–13; 8:45 am]
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[FR Doc. 2013–13264 Filed 6–4–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
33853
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; PAR
11–109 Grand Opportunity in Medications
Development for Substance-Related
Disorders.
Date: June 20, 2013.
Time: 2:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Jose F. Ruiz, Ph.D.,
Scientific Review Officer, Office of
Extramural Affairs, National Institute on
Drug Abuse, NIH, Room 4228, MSC 9550,
6001 Executive Blvd., Bethesda, MD 20892–
9550, (301) 451–3086, ruizjf@nida.nih.gov.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel;
Exceptional Unconventional Research
Enabling Knowledge Acceleration (EUREKA)
for Neuroscience and Disorders of the
Nervous System (R01).
Date: July 22, 2013.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Minna Liang, Ph.D.,
Scientific Review Officer, Grants Review
Branch, Office of Extramural Affairs,
National Institute on Drug Abuse, NIH,
DHHS, 6001 Executive Blvd., Room 4226,
MSC 9550, Bethesda, MD 20892–9550, 301–
435–1432, liangm@nida.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: May 30, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–13265 Filed 6–4–13; 8:45 am]
BILLING CODE 4140–01–P
National Institutes of Health
National Institutes of Health
National Institute on Drug Abuse;
Notice of Closed Meetings
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Center for Scientific Review; Notice of
Closed Meetings
mstockstill on DSK4VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 USC,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable materials,
and personal information concerning
individuals associated with the grant
Substance Abuse and Mental Health
Services Administration (SAMHSA)
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,
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Announcement for the National
Registry of Evidence-Based Programs
and Practices (NREPP): Open
Submission Period for Fiscal Year
2014
SAMHSA, Health and Human
Services.
ACTION: Announcement.
AGENCY:
SUMMARY: The mission of SAMHSA is to
reduce the impact of substance abuse
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Agencies
[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33852-33853]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13264]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood 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 and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning
[[Page 33853]]
individuals associated with the grant applications, the disclosure of
which would constitute a clearly unwarranted invasion of personal
privacy.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel; Trauma and Hemostasis.
Date: June 25, 2013.
Time: 7:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Crystal Gateway Marriott, 1700 Jefferson Davis Highway,
Arlington, VA 22202.
Contact Person: Michael P Reilly, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7200, Bethesda, MD
20892, 301-496-9659, reillymp@nhlbi.nih.gov.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel; Short-term Training to Promote Diversity in
Health Research.
Date: June 27, 2013.
Time: 12:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive, Room
7189, Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Stephanie L Constant, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7189, Bethesda, MD
20892, 301-443-8784, constantsl@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.233,
National Center for Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839,
Blood Diseases and Resources Research, National Institutes of
Health, HHS)
Dated: May 30, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-13264 Filed 6-4-13; 8:45 am]
BILLING CODE 4140-01-P