Center for Scientific Review; Notice of Closed Meetings, 735-736 [2012-31740]
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Federal Register / Vol. 78, No. 3 / Friday, January 4, 2013 / Notices
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ACRHD@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee link, or call the advisory
committee information line to learn
about possible modifications before
coming to the meeting.
Agenda: On March 4, 2013, during the
morning session, the committee will
discuss new drug application (NDA)
022506, gabapentin 600 milligram (mg)
tablets, submitted by Depomed, Inc., for
the proposed indication of treatment of
moderate to severe vasomotor symptoms
due to menopause.
During the afternoon session, the
committee will discuss NDA 204516,
paroxetine mesylate 7.5 mg capsules,
submitted by Noven Therapeutics, LLC,
for the proposed indication of treatment
of moderate to severe vasomotor
symptoms associated with menopause.
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 meeting
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
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person on or before February 15, 2013.
Oral presentations from the public will
be scheduled between approximately
10:30 a.m. to 11 a.m. and 3:30 p.m. to
4 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
or before February 7, 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 sessions,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing sessions. The contact
person will notify interested persons
regarding their request to speak by
February 8, 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 Kalyani
Bhatt 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).
Dated: December 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–31675 Filed 1–3–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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735
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 Institute of
Allergy and Infectious Diseases Special
Emphasis Panel U.S.-China Program for
Biomedical Collaborative Research (R01)—2.
Date: January 24–25, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Room 3139, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Barney Duane Price, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DHHS/NIH/NIAID/DEA, Room
3139, 6700B Rockledge Drive, MSC 7616,
Bethesda, MD 20892–7616, 301–451–2592,
pricebd@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: December 28, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–31631 Filed 1–3–13; 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.
E:\FR\FM\04JAN1.SGM
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736
Federal Register / Vol. 78, No. 3 / Friday, January 4, 2013 / Notices
Name of Committee: Center for Scientific
Review Special Emphasis Panel, PSE:
Member Conflict Applications.
Date: January 30–31, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Karin F Helmers, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3166,
MSC 7770, Bethesda, MD 20892, 301–254–
9975, helmersk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Thrombosis and Hypertension.
Date: January 31–February 1, 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,
(Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6183,
MSC 7804, Bethesda, MD 20892, 301–495–
1213, espinozala@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Systemic
Injury by Environmental Exposure.
Date: February 5–6, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, Bethesda, MD 20814.
Contact Person: Patricia Greenwel, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2178,
MSC 7818, Bethesda, MD 20892, 301–435–
1169, greenwep@csr.nih.gov.
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group, Neurobiology of
Motivated Behavior Study Section.
Date: February 6, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sheraton Delfina Santa Monica
Hotel, 530 West Pico Boulevard, Santa
Monica, CA 90405.
Contact Person: Nicholas Gaiano, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5178, MSC 7844, Bethesda, MD
20892–7844, 301–435–1033,
gaianonr@csr.nih.gov.
Name of Committee: Oncology 1—Basic
Translational Integrated Review Group,
Tumor Progression and Metastasis Study
Section.
Date: February 6–7, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Courtyard Long Beach, 500 East
First Street, Long Beach, CA 90802.
Contact Person: Rolf Jakobi, Ph.D.,
Scientific Review Officer, Center for
VerDate Mar<15>2010
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Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6187,
MSC 7806, Bethesda, MD 20892, 301–495–
1718, jakobir@mail.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group, Cardiovascular Differentiation and
Development Study Section.
Date: February 6, 2013.
Time: 8:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Sara Ahlgren, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, RM 4136,
BETHESDA, MD 20817–7814, 301–435–0904,
sara.ahlgren@nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group, Lung Cellular, Molecular, and
Immunobiology Study Section.
Date: February 6–7, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Admiral Fell Inn, 888 South
Broadway, Baltimore, MD 21231.
Contact Person: George M Barnas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2180,
MSC 7818, Bethesda, MD 20892, 301–435–
0696, barnasg@csr.nih.gov.
Name of Committee: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group, Surgery,
Anesthesiology and Trauma Study Section.
Date: February 6–7, 2013.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Hotel, 1750 Rockville Pike,
Rockville, MD 20892.
Contact Person: Weihua Luo, MD, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5114,
MSC 7854, Bethesda, MD 20892, (301) 435–
1170, luow@csr.nih.gov.
Name of Committee: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group, Clinical Molecular
Imaging and Probe Development.
Date: February 6–7, 2013.
Time: 7:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Serrano Hotel, 405 Taylor Street,
San Francisco, CA 94102.
Contact Person: Eileen W Bradley, DSC,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5100,
MSC 7854, Bethesda, MD 20892, (301) 435–
1179, bradleye@csr.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)
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Dated: December 31, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–31740 Filed 1–3–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Clinical Center; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the NIH
Advisory Board for Clinical Research.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended to
discuss personnel matters, the
disclosure of which would constitute a
clearly unwarranted invasion of privacy.
Name of Committee: NIH Advisory Board
for Clinical Research.
Date: January 28, 2013.
Time: 10:00 a.m. to 1:15 p.m.
Agenda: To review the 2013 Clinical
Center Strategic and Annual Operating Plan
and provide updates on selected
organizational initiatives.
Place: National Institutes of Health,
Building 10, CRC Medical Board Room 4–
2551, 10 Center Drive, Bethesda, MD 20892.
Closed: 1:15 p.m. to 2:00 p.m.
Agenda: To discuss personnel matters.
Place: National Institutes of Health,
Building 10, 10 Center Drive, CRC Medical
Board Room 4–2551, Bethesda, MD 20892.
Contact Person: Maureen E Gormley,
Executive Secretary, Mark O. Hatfield
Clinical Research Center, National Institutes
of Health, Building 10, Room 6–2551,
Bethesda, MD 20892, (301) 496–2897.
Any interested person may file
written comments with the committee
by forwarding the statement to the
Contact Person listed on this notice. The
statement should include the name,
address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for
entrance onto the NIH campus. All
visitor vehicles, including taxicabs,
hotel, and airport shuttles will be
inspected before being allowed on
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]]>Agencies
[Federal Register Volume 78, Number 3 (Friday, January 4, 2013)]
[Notices]
[Pages 735-736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31740]
-----------------------------------------------------------------------
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.
[[Page 736]]
Name of Committee: Center for Scientific Review Special Emphasis
Panel, PSE: Member Conflict Applications.
Date: January 30-31, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Karin F Helmers, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3166, MSC 7770, Bethesda, MD
20892, 301-254-9975, helmersk@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Member Conflict: Thrombosis and Hypertension.
Date: January 31-February 1, 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, (Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6183, MSC 7804, Bethesda, MD 20892, 301-495-
1213, espinozala@mail.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel, Systemic Injury by Environmental Exposure.
Date: February 5-6, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center,
Bethesda, MD 20814.
Contact Person: Patricia Greenwel, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2178, MSC 7818, Bethesda, MD
20892, 301-435-1169, greenwep@csr.nih.gov.
Name of Committee: Integrative, Functional and Cognitive
Neuroscience Integrated Review Group, Neurobiology of Motivated
Behavior Study Section.
Date: February 6, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Sheraton Delfina Santa Monica Hotel, 530 West Pico
Boulevard, Santa Monica, CA 90405.
Contact Person: Nicholas Gaiano, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5178, MSC 7844, Bethesda, MD 20892-7844, 301-
435-1033, gaianonr@csr.nih.gov.
Name of Committee: Oncology 1--Basic Translational Integrated
Review Group, Tumor Progression and Metastasis Study Section.
Date: February 6-7, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Courtyard Long Beach, 500 East First Street, Long Beach,
CA 90802.
Contact Person: Rolf Jakobi, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6187, MSC 7806, Bethesda, MD 20892, 301-495-
1718, jakobir@mail.nih.gov.
Name of Committee: Cardiovascular and Respiratory Sciences
Integrated Review Group, Cardiovascular Differentiation and
Development Study Section.
Date: February 6, 2013.
Time: 8:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Sara Ahlgren, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, RM 4136, BETHESDA, MD 20817-7814, 301-435-0904,
sara.ahlgren@nih.gov.
Name of Committee: Cardiovascular and Respiratory Sciences
Integrated Review Group, Lung Cellular, Molecular, and Immunobiology
Study Section.
Date: February 6-7, 2013.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Admiral Fell Inn, 888 South Broadway, Baltimore, MD
21231.
Contact Person: George M Barnas, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2180, MSC 7818, Bethesda, MD
20892, 301-435-0696, barnasg@csr.nih.gov.
Name of Committee: Surgical Sciences, Biomedical Imaging and
Bioengineering Integrated Review Group, Surgery, Anesthesiology and
Trauma Study Section.
Date: February 6-7, 2013.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Hotel, 1750 Rockville Pike, Rockville, MD 20892.
Contact Person: Weihua Luo, MD, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5114, MSC 7854, Bethesda, MD
20892, (301) 435-1170, luow@csr.nih.gov.
Name of Committee: Surgical Sciences, Biomedical Imaging and
Bioengineering Integrated Review Group, Clinical Molecular Imaging
and Probe Development.
Date: February 6-7, 2013.
Time: 7:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Serrano Hotel, 405 Taylor Street, San Francisco, CA
94102.
Contact Person: Eileen W Bradley, DSC, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5100, MSC 7854, Bethesda, MD
20892, (301) 435-1179, bradleye@csr.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: December 31, 2012.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-31740 Filed 1-3-13; 8:45 am]
BILLING CODE 4140-01-P
