National Institute of General Medical Sciences; Notice of Closed Meeting, 65363-65364 [2010-26708]
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Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices
manufactured by SmithKline Beecham
Corp. d/b/a (doing business as)
GlaxoSmithKline and 020–180/S–034,
trade name PROSCAR (finasteride)
Tablets, manufactured by Merck & Co.,
Inc. The proposed indication (use) for
AVODART (dutasteride) is for reduction
in the risk of prostate cancer in men at
increased risk of developing the disease.
The population at increased risk of
prostate cancer includes men with an
elevated serum prostate-specific antigen
(PSA) or men otherwise determined to
be at increased risk based on other
associated risk factors such as age, race,
and family history. There is no
proposed expansion of the indication
for PROSCAR (finasteride); however, in
light of the Prostate Cancer Prevention
Trial (PCPT) which demonstrated a
statistically significant reduction in the
7-year period prevalence of prostate
cancer with finasteride (PROSCAR)
treatment, and which reported an
imbalance in high Gleason grade
prostate cancers (indicating more
aggressive cancers) in the finasteride
treatment arm vs. placebo, the efficacy
and safety of both products for use in
prostate cancer risk reduction will be
examined.
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 November 16, 2010.
Oral presentations from the public will
be scheduled between approximately
2:30 p.m. to 3:30 p.m. Those desiring to
make 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 November 8, 2010. 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,
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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
November 9, 2010.
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 Nicole
Vesely 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: October 13, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–26651 Filed 10–21–10; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Basic Behavioral and Social Science
Opportunity Network (OppNet)
ACTION:
Notice.
A two-day meeting
highlighting OppNet’s activities and
future goals is scheduled for Thursday,
October 28, and Friday, October 29,
2010, at the Hyatt Regency Washington
on Capitol Hill, 400 New Jersey Avenue,
NW., Washington DC 20001. This is the
first public meeting to promote and
publicize the Basic Behavioral and
Social Science Opportunity Network
(OppNet) initiative. Attendance is
limited to prior registration via https://
www.regonline.com/oppnet.
Background: The Basic Behavioral
and Social Science Opportunity
Network (OppNet) is a trans-NIH
initiative to expand the agency’s
funding of basic behavioral and social
sciences research (b-BSSR). OppNet
prioritizes activities and initiatives that
focus on basic mechanisms of behavior
SUMMARY:
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and social processes that are relevant to
the missions and public health
challenges of multiple NIH Institutes,
Centers, and Offices (ICOs) and that
build upon existing NIH investments
without replicating them. https://
www.oppnet.nih.gov.
Participating: The meeting will take
place on October 28, from 9 a.m. to 4:30
p.m., and October 29, from 8:30 a.m. to
2:30 p.m., at the Hyatt Regency
Washington on Capitol Hill, 400 New
Jersey Avenue, NW., Washington DC
20001.
FOR FURTHER INFORMATION CONTACT: To
register, visit the registration Web site at
https://regonline.com/oppnet, call
William Elwood at 301–402–0116, or email elwoodwi@od.nih.gov.
Dated: October 15, 2010.
Lawrence A. Tabak,
Principal Deputy Director, National Institutes
of Health.
[FR Doc. 2010–26709 Filed 10–21–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
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.
Name of Committee: National Institute of
General Medical Sciences Special Emphasis
Panel; Review of Minority Biomedical
Research Neuro Grant Applications.
Date: December 6, 2010.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency-Bethesda, 7400
Wisconsin Avenue, One Bethesda Metro
Center, Bethesda, MD 20814.
Contact Person: John J. Laffan, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN18J, Bethesda,
MD 20892, 301–594–2773,
laffanjo@mail.nih.gov.
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Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices
(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: October 18, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–26708 Filed 10–21–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
emcdonald on DSK2BSOYB1PROD with NOTICES
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 Cancer
Institute Special Emphasis Panel; EDRN
Biomarker Development Labs (U01) J1.
Date: November 2, 2010.
Time: 8 a.m. to 10:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 116
Executive Blvd., Room 8146, Rockville, MD
20852 (Teleconference Meeting).
Contact Person: Sherwood Githens, PhD,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Blvd., Room 8146, Bethesda, MD
20892, 301/435–1822, githenss@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to scheduling
conflicts.
Name of Committee: National Cancer
Institute Special Emphasis Panel; EDRN
Biomarker Development Labs (U01) J2.
Date: November 2, 2010.
Time: 10:30 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6116
Executive Blvd., Room 8146, Rockville, MD
20852 (Teleconference Meeting).
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Contact Person: Sherwood Githens, PhD,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Blvd., Room 8146, Bethesda, MD
20892, 301/435–1822, githenss@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to scheduling
conflicts.
Name of Committee: National Cancer
Institute Special Emphasis Panel; EDRN
Biomarker Development Labs (U01) J3.
Date: November 2, 2010.
Time: 2 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6116
Executive Blvd., Room 8146, Rockville, MD
20852 (Teleconference Meeting).
Contact Person: Sherwood Githens, PhD,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Blvd., Room 8146, Bethesda, MD
20892, 301/435–1822, githenss@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to scheduling
conflicts.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: October 18, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–26706 Filed 10–21–10; 8:45 am]
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; Conferences and Scientific
Meetings Support.
Date: November 16, 2010.
Time: 1 p.m. to 4 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 (Telephone
Conference Call).
Contact Person: Teresa Nesbitt, PhD, DVM,
Chief, Scientific Review Branch, Division of
Extramural Research and Training, Nat’l
Institute of Environmental Health Sciences,
P.O. Box 12233, MD EC–30, Research
Triangle Park, NC 27709, (919) 541–7571,
nesbittt@mail.nih.gov.
(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
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Dated: October 15, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–26704 Filed 10–21–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–P
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Cancer Institute; Notice of
Closed Meeting
National Institutes of Health
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 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 contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
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.
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Name of Committee: National Cancer
Institute Special Emphasis Panel; Epitope
Mapping Technologies.
Date: December 14, 2010.
Time: 1 p.m. to 4 p.m.
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Agencies
[Federal Register Volume 75, Number 204 (Friday, October 22, 2010)]
[Notices]
[Pages 65363-65364]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26708]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of General Medical 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.
Name of Committee: National Institute of General Medical
Sciences Special Emphasis Panel; Review of Minority Biomedical
Research Neuro Grant Applications.
Date: December 6, 2010.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency-Bethesda, 7400 Wisconsin Avenue, One
Bethesda Metro Center, Bethesda, MD 20814.
Contact Person: John J. Laffan, PhD, Scientific Review Officer,
Office of Scientific Review, National Institute of General Medical
Sciences, National Institutes of Health, Natcher Building, Room
3AN18J, Bethesda, MD 20892, 301-594-2773, laffanjo@mail.nih.gov.
[[Page 65364]]
(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: October 18, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-26708 Filed 10-21-10; 8:45 am]
BILLING CODE 4140-01-P