National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 42967-42968 [2013-17185]
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TKELLEY on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices
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: On September 25, 2013, the
committee will discuss optimal
strategies for the evaluation,
interpretation, and communication of
drug-drug interaction (DDI) information.
FDA will seek input on: (1) Best
practices in DDI communication
through prescription drug product
labels (i.e., ‘‘package inserts’’), namely:
(a) Appropriate format for presentation
(e.g. tables, graphs, text) of DDI
information; (b) level of detail of DDI
study results; and (c) appropriate
wording for clinical recommendations
based on empirical data versus
anticipated interactions; (2) appropriate
criteria for determining whether or not
to describe DDI information derived
from the literature in product labels;
and (3) how package insert information
on DDIs is used by various end-users
(e.g., prescribers, dispensers, DDI
database curators) in decision making
and/or communication.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before September 11, 2013.
Oral presentations from the public will
be scheduled between approximately
12:45 p.m. and 1:45 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
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or before September 3, 2013. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
September 4, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Yvette
Waples at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Research Dissemination and Implementation
& Sleep Education Projects.
Date: August 26, 2013.
Time: 12:30 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crystal Gateway Marriott, 1700
Jefferson Davis Highway, Arlington, VA
22202.
Contact Person: Keith A. Mintzer, Ph.D.,
Scientific Review Officer, Office of Review
Branch/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7186, Bethesda, MD 20892–7924, 301–594–
7947 mintzerk@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: July 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
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 meeting.
The meeting 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.
[FR Doc. 2013–17212 Filed 7–17–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
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 meeting.
The meeting 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.
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Dated: July 12, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–17183 Filed 7–17–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Pediatric Pulmonary Vascular Disease
Bioinformatics Clinical Coordinating Center.
Date: August 29, 2013.
Time: 9:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 7182,
6701 Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Susan Wohler Sunnarborg,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
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Federal Register / Vol. 78, No. 138 / Thursday, July 18, 2013 / Notices
Drive, Room 7182, Bethesda, MD 20892 ,
sunnarborgsw@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: July 12, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–17185 Filed 7–17–13; 8:45 am]
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
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 meeting.
The meeting 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.
TKELLEY on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2013–17189 Filed 7–17–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Center for Scientific Review; Amended
Notice of Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; NIEHS Microbiome Review
Meeting.
Date: August 6, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Contact Person: Janice B. Allen, Ph.D.,
Scientific Review Administrator, Scientific
Review Branch, Division of Extramural
Research and Training, Nat. Institute of
Environmental Health Science, P.O. Box
12233, MD EC–30/Room 3170 B, Research
Triangle Park, NC 27709, 919/541–7556.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
17:20 Jul 17, 2013
Dated: July 11, 2013.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
National Institutes of Health
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Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
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Notice is hereby given of a change in
the meeting of the Center for Scientific
Review Special Emphasis Panel, July 18,
2013, 8:00 a.m. to July 19, 2013, 6:00
p.m., National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD, 20892
which was published in the Federal
Register on June 18, 2013, 78 FR 36553–
36554.
The meeting will be held on July 17–
July 18, 2013. The meeting location and
time remain the same. The meeting is
closed to the public.
Dated: July 12, 2013.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–17184 Filed 7–17–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; RFA: Pilot
Projects on Sports-Related Brain and Spinal
Cord Injury.
Date: August 12–13, 2013.
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Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Suzan Nadi, Ph.D., MD,
FAAP, MSC, Scientific Review Officer,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 5217B, MSC 7846, Bethesda, MD
20892, 301–435–1259, nadis@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Brain and
Eye Disorders.
Date: August 12, 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,
(Telephone Conference Call).
Contact Person: Samuel C Edwards, Ph.D.,
IRG CHIEF, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5210, MSC 7846, Bethesda, MD
20892, (301) 435–1246,
edwardss@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Project: Protease Inhibitor Resistance.
Date: August 13, 2013.
Time: 1:00 p.m. to 4:00 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: Eduardo A Montalvo,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5108,
MSC 7852, Bethesda, MD 20892, (301) 435–
1168, montalve@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Vascular
Biology.
Date: August 13, 2013.
Time: 1:30 p.m. to 2:00 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: Larry Pinkus, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4132,
MSC 7802, Bethesda, MD 20892, (301) 435–
1214, pinkusl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Vascular Biology.
Date: August 13, 2013.
Time: 1:50 p.m. to 2:15 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: Larry Pinkus, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4132,
MSC 7802, Bethesda, MD 20892, (301) 435–
1214, pinkusl@csr.nih.gov.
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Agencies
[Federal Register Volume 78, Number 138 (Thursday, July 18, 2013)]
[Notices]
[Pages 42967-42968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17185]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed
Meeting
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
meeting.
The meeting 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 Heart, Lung, and Blood Institute
Special Emphasis Panel; Pediatric Pulmonary Vascular Disease
Bioinformatics Clinical Coordinating Center.
Date: August 29, 2013.
Time: 9:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 7182, 6701 Rockledge
Drive, Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Susan Wohler Sunnarborg, Ph.D., Scientific
Review Officer, Office of Scientific Review/DERA, National Heart,
Lung, and Blood Institute, 6701 Rockledge
[[Page 42968]]
Drive, Room 7182, Bethesda, MD 20892 , sunnarborgsw@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: July 12, 2013.
Michelle Trout,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2013-17185 Filed 7-17-13; 8:45 am]
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