Proposed Collection; 60-Day Comment Request; Progress Reports for Center for Global Health's Low and Mid-Income Countries; (LMICs) Global Health Collaborations, 43755-43756 [2014-17684]
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Federal Register / Vol. 79, No. 144 / Monday, July 28, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Cardiovascular and Renal Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Cardiovascular
and Renal Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 9, 2014, from 12
noon to 5 p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center (rm. 1503), 10903
New Hampshire Ave., Silver Spring, MD
20993–0002. 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: Kristina Toliver,
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: CRDAC@
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 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: The committee will discuss
new drug application (NDA) 206302,
VerDate Mar<15>2010
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nebivolol/valsartan fixed-dose
combination tablets (5/80 milligrams
(mg), 5/160 mg, 10/160 mg, 10/320 mg
and 20/320 mg), submitted by Forrest
Laboratories, Inc., for the proposed
indication of the treatment of
hypertension.
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
person on or before August 25, 2014.
Oral presentations from the public will
be scheduled between approximately
2:30 p.m. and 3:30 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 August 15, 2014. 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 August 18, 2014.
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 Kristina
Toliver 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/
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43755
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: July 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–17665 Filed 7–25–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Progress Reports for Center
for Global Health’s Low and MidIncome Countries; (LMICs) Global
Health Collaborations
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI),
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Teri Brown, Center for
Global Health, National Cancer Institute,
9609 Medical Center Dr., RM 3W530,
Rockville, MD 20850 or call non-tollfree number 240–276–5810 or Email
SUMMARY:
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43756
Federal Register / Vol. 79, No. 144 / Monday, July 28, 2014 / Notices
your request, including your address to:
brownte@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Progress Reports
for Center for Global Health’s Low and
Mid-Income Countries (LMICs) Global
Health Collaborations, 0925–NEW,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The Center for Global
Health’s (CGH) Low and Mid-Income
Countries (LMICs) Global Health
Collaborations is proposing new
program specific progress report
guidelines. The CGH LMIC Global
is needed to monitor the performance of
this special program within NCI, funded
through three Request for Proposals
(RFPs); the first was released April 18,
2013 and CGH expects to release
another in 2014 and the final one in
2015. The respondents are the Principal
Investigators of the awards. The
information will be used to monitor
individual award performance and the
effectiveness of the program as a whole.
Since these projects are funded through
the contract mechanism, the PIs will not
be required to submit interim and final
progress reports like other National
Institutes of Health grantees must.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
83.
Health Collaborations are part of a pilot
initiative and partnership, between the
NCI CGH and the Office of Cancer
Centers (OCC), to promote
collaborations between the NCI
designated Cancer Centers and foreign
institutions from Low and Middle
Income Countries (LMICs). This
collaboration is designed to develop and
implement mutually beneficial global
cancer research programs by increasing
the capability of these countries to
participate and partner in cancer
research. The proposed guidelines
request information about award
performance related to objectives,
accomplishments, barriers and
challenges, collaborators, and findings.
The information is gathered six months
into the award and 12 months after the
award (upon expiry). This information
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Principal Investigators .......................
Principal Investigators .......................
6 Month Report ................................
12 Month Report ..............................
Dated: July 22, 2014.
Karla Bailey,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2014–17684 Filed 7–25–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with NOTICES
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.
Dated: July 22, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–17671 Filed 7–25–14; 8:45 am]
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
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15
15
Business: HIV/AIDS Innovative Research
Applications.
Date: August 1, 2014.
Time: 9:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting)
Contact Person: Mark P Rubert, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1775, rubertm@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(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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Number of
responses per
respondent
1
1
Average
time per
response
(in hours)
Total annual
burden hours
90/60
4
23
60
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; 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
Neurological Disorders and Stroke Special
Emphasis Panel; Fellowship Review.
Date: August 7, 2014.
Time: 2:00 p.m. to 3:00 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).
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]]>Agencies
[Federal Register Volume 79, Number 144 (Monday, July 28, 2014)]
[Notices]
[Pages 43755-43756]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17684]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Progress Reports for
Center for Global Health's Low and Mid-Income Countries; (LMICs) Global
Health Collaborations
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NCI), National Institutes of Health (NIH), will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited on one or more of the following points: (1)
Whether the proposed collection of information is necessary for the
proper performance of the function of the agency, including whether the
information will have practical utility; (2) The accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to minimize the burden of the
collection of information on those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
To Submit Comments and For Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Teri
Brown, Center for Global Health, National Cancer Institute, 9609
Medical Center Dr., RM 3W530, Rockville, MD 20850 or call non-toll-free
number 240-276-5810 or Email
[[Page 43756]]
your request, including your address to: brownte@mail.nih.gov. Formal
requests for additional plans and instruments must be requested in
writing.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Proposed Collection: Progress Reports for Center for Global
Health's Low and Mid-Income Countries (LMICs) Global Health
Collaborations, 0925-NEW, National Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information Collection: The Center for Global
Health's (CGH) Low and Mid-Income Countries (LMICs) Global Health
Collaborations is proposing new program specific progress report
guidelines. The CGH LMIC Global Health Collaborations are part of a
pilot initiative and partnership, between the NCI CGH and the Office of
Cancer Centers (OCC), to promote collaborations between the NCI
designated Cancer Centers and foreign institutions from Low and Middle
Income Countries (LMICs). This collaboration is designed to develop and
implement mutually beneficial global cancer research programs by
increasing the capability of these countries to participate and partner
in cancer research. The proposed guidelines request information about
award performance related to objectives, accomplishments, barriers and
challenges, collaborators, and findings. The information is gathered
six months into the award and 12 months after the award (upon expiry).
This information is needed to monitor the performance of this special
program within NCI, funded through three Request for Proposals (RFPs);
the first was released April 18, 2013 and CGH expects to release
another in 2014 and the final one in 2015. The respondents are the
Principal Investigators of the awards. The information will be used to
monitor individual award performance and the effectiveness of the
program as a whole. Since these projects are funded through the
contract mechanism, the PIs will not be required to submit interim and
final progress reports like other National Institutes of Health
grantees must.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 83.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondents Form name Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Principal Investigators....... 6 Month Report.. 15 1 90/60 23
Principal Investigators....... 12 Month Report. 15 1 4 60
----------------------------------------------------------------------------------------------------------------
Dated: July 22, 2014.
Karla Bailey,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2014-17684 Filed 7-25-14; 8:45 am]
BILLING CODE 4140-01-P
