Center for Scientific Review; Notice of Closed Meetings, 2223-2224 [2016-00650]
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Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices
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of safety-related drug marketing
withdrawals over the past 50 years and
that hepatotoxicity has both limited the
use of many drugs that have been
approved and prevented the approval of
others. Second, this guidance discusses
methods of detecting DILI by periodic
tests of serum enzyme activities and of
bilirubin concentration and how
changes in the results of these
laboratory tests over time, along with
symptoms and physical findings, may
be used to estimate the severity of the
injury. Third, this guidance suggests
some ‘‘stopping rules’’ for interrupting
drug treatment and mentions the need
to obtain sufficient clinical information
to assess causation. FDA published a
draft of this guidance in 2006, and
comments on that draft were taken into
consideration when issuing the final
guidance in July 2009.
II. Conference Information
The purpose of the 2016 conference is
to invite participants to present their
data and views and to hold an open
discussion. The meetings in recent years
have been attended by members of
industry, regulatory bodies, and
academic consultants, and the topics
discussed have included several
unresolved issues on which consensus
was sought.
Registration: A registration fee ($650
for industry registrants and $325 for
Federal government and academic
registrants) will be charged to help
defray the cost of renting the meeting
space, providing meals and snacks, and
covering the travel fees incurred by
invited academic (but not government
or industry) speakers, as well as any
other expenses. The registration process
will be handled by C-Path, an
independent, nonprofit organization
established in 2005 with public and
private philanthropic support from the
southern Arizona community, Science
Foundation Arizona, and FDA.
Additional information on the
conference, program, and registration
procedures may be obtained on the
Internet at https://www.c-path.org, and at
https://www.fda.gov by typing ‘‘liver
toxicity’’ into the search box. (FDA has
verified the Web site addresses but is
not responsible for any subsequent
changes to the Web sites after this
document publishes in the Federal
Register.)
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management,
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD.
A transcript will also be available in
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either hardcopy or on CD–ROM, after
submission of a Freedom of Information
request. The Freedom of Information
office address is available on the
Agency’s Web site at https://
www.fda.gov.
Materials presented at past programs
(from 2007 to 2015) (including copies of
slides shown, comments made about the
slides, and discussions following the
slides) may be accessed at https://
www.aasld.org/events-professionaldevelopment/drug-induced-liver-injury2015-program. (FDA has verified this
Web site address but is not responsible
for any subsequent changes to it after
this document publishes in the Federal
Register.)
Dated: January 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–00690 Filed 1–14–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting Notice for the President’s
Advisory Council on Faith-Based and
Neighborhood Partnerships
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the President’s
Advisory Council on Faith-based and
Neighborhood Partnerships announces
the following meetings:
Name: President’s Advisory Council
on Faith-based and Neighborhood
Partnerships Council Meetings.
Time and Date: Monday, February
1st, 2016 1:00 p.m.–5:00 p.m. (EST) and
Tuesday, February 2nd, 2016 10:00
a.m.–1:00 p.m. (EST).
Place: Meeting will be held at a
location to be determined in the White
House complex, 1600 Pennsylvania Ave
NW., Washington, DC. Space is
extremely limited. Photo ID and RSVP
by January 25, 2016 are required to
attend the event. Please RSVP to Ben
O’Dell at partnerships@hhs.gov.
The meeting will be available to the
public through a conference call line.
Register to participate in the conference
call on Monday, February 1st at the Web
site https://attendee.gotowebinar.com/
register/7321886895235169026. Register
to participate in the conference call on
Tuesday, February 2nd at the Web site
https://attendee.gotowebinar.com/
register/4788059050490531842.
Status: Open to the public, limited
only by space available. Conference call
limited only by lines available.
Purpose: The Council brings together
leaders and experts in fields related to
the work of faith-based and
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2223
neighborhood organizations in order to:
Identify best practices and successful
modes of delivering social services;
evaluate the need for improvements in
the implementation and coordination of
public policies relating to faith- based
and other neighborhood organizations;
and make recommendations for changes
in policies, programs, and practices.
Contact Person for Additional
Information: Please contact Ben O’Dell
for any additional information about the
President’s Advisory Council meeting at
partnerships@hhs.gov.
Agenda: For February 1, the agenda
will begin with an Opening and
Welcome from the Chairperson and
Executive Director for the President’s
Advisory Council for Faith-based and
Neighborhood Partnership. Then there
will be presentation of any
Recommendations for deliberation and
vote. Lastly, there will be a discussion
of subgroup deliberation as well as
elements being considered for
recommendations. For February 2, there
will presentations on work to address
poverty and income inequality after a
welcome and opening from the
Chairperson and Executive Director for
the President’s Advisory Council.
Public Comment: There will be an
opportunity for public comment at the
end of the meeting. Comments and
questions can be sent in advance to
partnerships@hhs.gov.
Dated: January 11, 2016.
Ben O’Dell,
Associate Director for Center for Faith-based
and Neighborhood Partnerships at U.S.
Department of Health and Human Services.
[FR Doc. 2016–00767 Filed 1–14–16; 8:45 am]
BILLING CODE 4154–07–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
E:\FR\FM\15JAN1.SGM
15JAN1
2224
Federal Register / Vol. 81, No. 10 / Friday, January 15, 2016 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–15–
319 Biomedical and Behavioral Research
Innovations to Ensure Equity (BRITE).
Date: February 3, 2016.
Time: 1:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: San Diego Marriott Mission Valley,
8757 Rio San Diego Drive, San Diego, CA
92108.
Contact Person: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
MSC 7770, Bethesda, MD 20892, 301–435–
0684, olufokunbisamd@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–15–
279 Strategies to Increase Delivery of
Guideline-Based Care to Populations with
Health Disparities.
Date: February 3, 2016.
Time: 2:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: San Diego Marriott Mission Valley,
8757 Rio San Diego Drive, San Diego, CA
90108.
Contact Person: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
MSC 7770, Bethesda, MD 20892, 301–435–
0684, olufokunbisamd@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Health Disparities and Equity Promotion
Study Section.
Date: February 4–5, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: San Diego Marriott Mission Valley,
8757 Rio San Diego Drive, San Diego, CA
92108.
Contact Person: Delia Olufokunbi Sam,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
MSC 7770, Bethesda, MD 20892, 301–435–
0684, olufokunbisamd@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Physical
Activity and Weight Control Interventions
Among Cancer Survivors: Effects on
Biomarkers of Prognosis.
Date: February 4, 2016.
Time: 1:30 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Denise Wiesch, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3138,
MSC 7770, Bethesda, MD 20892, (301) 437–
3478, wieschd@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Academic
Research Enhancement Award.
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Date: February 9, 2016.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bahia Resort Hotel, 998 West
Mission Bay Drive, San Diego, CA 92109.
Contact Person: Inna Gorshkova, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, 301–435–1784, gorshkoi@csr.nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Modeling and Analysis of Biological
Systems Study Section.
Date: February 10–11, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Long Beach Hotel, 111
East Ocean Blvd., Long Beach, CA 90802.
Contact Person: Craig Giroux, Ph.D.,
Scientific Review Officer, BST IRG, Center
for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5150,
Bethesda, MD 20892, 301–435–2204,
girouxcn@csr.nih.gov.
Name of Committee: Digestive, Kidney and
Urological Systems Integrated Review Group;
Xenobiotic and Nutrient Disposition and
Action Study Section.
Date: February 10, 2016.
Time: 8:00 a.m. to 6:00 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: Martha Garcia, Ph.D.,
Scientific Reviewer Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2186,
Bethesda, MD 20892, 301–435–1243,
garciamc@nih.gov.
Name of Committee: Digestive, Kidney and
Urological Systems Integrated Review Group;
Kidney Molecular Biology and Genitourinary
Organ Development.
Date: February 10, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Crowne Plaza National Airport, 1480
Crystal Drive, Arlington, VA 22202.
Contact Person: Ryan G. Morris, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4205,
MSC 7814, Bethesda, MD 20892, 301–435–
1501, morrisr@csr.nih.gov.
Name of Committee: Infectious Diseases
and Microbiology Integrated Review Group;
Vector Biology Study Section.
Date: February 10, 2016.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Marines Memorial Club & Hotel, 609
Sutter Street, San Francisco, CA 94102.
Contact Person: Liangbiao Zheng, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214,
MSC 7808, Bethesda, MD 20892, 301–402–
5671, zhengli@csr.nih.gov.
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Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Musculoskeletal, Oral and Skin Sciences
AREA review.
Date: February 10, 2016.
Time: 9:00 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: Yanming Bi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892, 301–451–
0996, ybi@csr.nih.gov.
Name of Committee: Oncology 1-Basic
Translational Integrated Review Group;
Tumor Cell Biology Study Section.
Date: February 11–12, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Nikko San Francisco, 222
Mason Street, San Francisco, CA 94102.
Contact Person: Charles Morrow, MD,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6202,
MSC 7804, Bethesda, MD 20892, 301–408–
9850, morrowcs@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: January 11, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–00650 Filed 1–14–16; 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 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: Center for Scientific
Review Special Emphasis Panel; PAR–14–
E:\FR\FM\15JAN1.SGM
15JAN1
]]>Agencies
[Federal Register Volume 81, Number 10 (Friday, January 15, 2016)]
[Notices]
[Pages 2223-2224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00650]
-----------------------------------------------------------------------
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
[[Page 2224]]
would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; RFA-15-319 Biomedical and Behavioral Research Innovations to
Ensure Equity (BRITE).
Date: February 3, 2016.
Time: 1:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant applications.
Place: San Diego Marriott Mission Valley, 8757 Rio San Diego
Drive, San Diego, CA 92108.
Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD
20892, 301-435-0684, olufokunbisamd@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; RFA-15-279 Strategies to Increase Delivery of Guideline-Based
Care to Populations with Health Disparities.
Date: February 3, 2016.
Time: 2:30 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: San Diego Marriott Mission Valley, 8757 Rio San Diego
Drive, San Diego, CA 90108.
Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD
20892, 301-435-0684, olufokunbisamd@csr.nih.gov.
Name of Committee: Healthcare Delivery and Methodologies
Integrated Review Group; Health Disparities and Equity Promotion
Study Section.
Date: February 4-5, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: San Diego Marriott Mission Valley, 8757 Rio San Diego
Drive, San Diego, CA 92108.
Contact Person: Delia Olufokunbi Sam, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158, MSC 7770, Bethesda, MD
20892, 301-435-0684, olufokunbisamd@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Physical Activity and Weight Control Interventions Among
Cancer Survivors: Effects on Biomarkers of Prognosis.
Date: February 4, 2016.
Time: 1:30 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Denise Wiesch, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3138, MSC 7770, Bethesda, MD 20892, (301) 437-
3478, wieschd@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Academic Research Enhancement Award.
Date: February 9, 2016.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Bahia Resort Hotel, 998 West Mission Bay Drive, San
Diego, CA 92109.
Contact Person: Inna Gorshkova, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD 20892, 301-435-1784,
gorshkoi@csr.nih.gov.
Name of Committee: Bioengineering Sciences & Technologies
Integrated Review Group; Modeling and Analysis of Biological Systems
Study Section.
Date: February 10-11, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Renaissance Long Beach Hotel, 111 East Ocean Blvd., Long
Beach, CA 90802.
Contact Person: Craig Giroux, Ph.D., Scientific Review Officer,
BST IRG, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5150, Bethesda, MD 20892, 301-
435-2204, girouxcn@csr.nih.gov.
Name of Committee: Digestive, Kidney and Urological Systems
Integrated Review Group; Xenobiotic and Nutrient Disposition and
Action Study Section.
Date: February 10, 2016.
Time: 8:00 a.m. to 6:00 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: Martha Garcia, Ph.D., Scientific Reviewer
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2186, Bethesda, MD 20892, 301-
435-1243, garciamc@nih.gov.
Name of Committee: Digestive, Kidney and Urological Systems
Integrated Review Group; Kidney Molecular Biology and Genitourinary
Organ Development.
Date: February 10, 2016.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Crowne Plaza National Airport, 1480 Crystal Drive,
Arlington, VA 22202.
Contact Person: Ryan G. Morris, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4205, MSC 7814, Bethesda, MD
20892, 301-435-1501, morrisr@csr.nih.gov.
Name of Committee: Infectious Diseases and Microbiology
Integrated Review Group; Vector Biology Study Section.
Date: February 10, 2016.
Time: 8:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Marines Memorial Club & Hotel, 609 Sutter Street, San
Francisco, CA 94102.
Contact Person: Liangbiao Zheng, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3214, MSC 7808, Bethesda, MD
20892, 301-402-5671, zhengli@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Musculoskeletal, Oral and Skin Sciences AREA review.
Date: February 10, 2016.
Time: 9:00 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: Yanming Bi, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301-451-
0996, ybi@csr.nih.gov.
Name of Committee: Oncology 1-Basic Translational Integrated
Review Group; Tumor Cell Biology Study Section.
Date: February 11-12, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hotel Nikko San Francisco, 222 Mason Street, San
Francisco, CA 94102.
Contact Person: Charles Morrow, MD, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6202, MSC 7804, Bethesda, MD
20892, 301-408-9850, morrowcs@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: January 11, 2016.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-00650 Filed 1-14-16; 8:45 am]
BILLING CODE 4140-01-P
