Submission for OMB Review; 30-Day Comment Request Division of Cancer Epidemiology and Genetics (DCEG) Fellowship Program and Summer Student Applications (NCI), 10127-10128 [2015-03789]
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Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices
Administration, Office of Minority
Health, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 2382, Silver Spring, MD
20993, 301–796–8453, FAX: 301–847–
8601, email: Christine.merenda@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
I. Background
FDA’s Office of Minority Health
(OMH) was established in 2010, as
mandated by the Patient Protection and
Affordable Care Act (Pub. L. 111–148).
OMH serves as the principal advisor to
the Commissioner on minority health
and health disparities. OMH provides
leadership and direction in identifying
Agency actions that can help reduce
health disparities, including the
coordination of efforts across the
Agency.
OMH advances FDA’s regulatory
mission in addressing the reduction of
racial and ethnic health disparities and
in achieving the highest standard of
health for all. To achieve this mission,
OMH has committed to identifying gaps
in existing knowledge to shape further
research projects intended to lead to
better understanding of medical product
clinical outcomes in racial/ethnic
demographic subgroups. A guiding
principle for FDA in meeting the health
needs of patients across the
demographic spectrum is the
importance of encouraging diversity in
clinical trials. Thus, FDA is also
interested in gaining input for
improving clinical trials in therapeutic
areas impacted by low rates of inclusion
of racial/ethnic demographic subgroup
populations, ranging from issues
surrounding recruitment and
participation in clinical trials to clinical
outcome analysis of demographic
subgroup populations. Of particular
note in this regard is FDA’s ‘‘Action
Plan to Enhance the Collection and
Availability of Demographic Subgroup
Data’’ at https://www.fda.gov/downloads/
RegulatoryInformation/Legislation/
FederalFoodDrugand
CosmeticActFDCAct/Significant
AmendmentstotheFDCAct/FDASIA/
UCM410474.pdf.
Research in regulatory science is
distinctive for developing new tools,
standards, and approaches for assessing
the safety, efficacy, quality, and
performance of all FDA-regulated
products. The results can help to
transform the way medical products are
developed, evaluated, and
manufactured. Health disparities
research with a regulatory focus seeks to
expand and strengthen knowledge of,
and the availability of data on, medical
product clinical outcomes in racial/
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18:05 Feb 24, 2015
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ethnic demographic subgroups, to
inform healthcare decisions by
providers and patients.
II. Request for Comments and
Information
OMH seeks comments and
information to identify specific areas of
public health concern involving racial/
ethnic demographic subgroups that can
be addressed through regulatory science
research, including new or emerging
areas of concern. We encourage
comments to include supporting
information regarding the topic
addressed, such as previously published
peer-reviewed literature or new research
findings. These comments and
information will support OMH in its
development of a research agenda that
will inform funding decisions for the
next fiscal year. (This notice is not a
request for specific research or grant
proposals from outside entities.) In
addition to input on improving clinical
trial inclusion and outcome analysis,
requested comments and information
identifying disease areas with outcome
differences for further study may
include, but are not limited to, the
following:
• An area of study that could lead to
a diagnostic or screening test based on
the development and evaluation of
biomarkers for a disease or condition
that disproportionately impacts racial/
ethnic demographic subgroups.
• An area of study that could lead to
changes in labeled indications, or
dosages, for a single or class of drug(s)
or biologic(s) used to treat a disease or
condition that disproportionately
impacts racial/ethnic demographic
subgroups.
• An area of study that could lead to
changes in the design or use of a device
to treat a disease or condition that
disproportionately impacts racial/ethnic
demographic subgroups.
• Research to identify effective ways
to communicate with patients and
consumers from racial/ethnic
subgroups, including those with low
health literacy and limited English
proficiency, so they are informed about
FDA actions (new approvals, warnings,
recalls, etc.) that impact their health.
• Research evaluating methods to
accommodate cultural and language
differences that can improve health
communications to racial/ethnic
subgroups, and assess the cost of these
methods to the Government.
• Research evaluating the impact of
different formats and amounts of
numerical information in FDA
communications for patients, health
care providers, health educators, and
informal caregivers.
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10127
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: February 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–03846 Filed 2–24–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request Division of Cancer
Epidemiology and Genetics (DCEG)
Fellowship Program and Summer
Student Applications (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on April 9, 2014
(Vol. 79, P. 19632) and allowed 60-days
for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
SUMMARY:
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10128
Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project
contact: Jackie Lavigne, Office of
Education, Division of Cancer
Epidemiology and Genetics, 9609
Medical Center Drive, MSC 9776,
Bethesda, MD 20892–9776 or call nontoll-free number 240–376–7237 or Email
your request, including your address to:
lavignej@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Proposed Collection: Division of
Cancer Epidemiology and Genetics
(DCEG) Fellowship Program and
Summer Student Applications (NCI),
Existing Collection in Use without OMB
Control Number, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
applications are essential to the
administration of these training
programs as they enable OE to
determine the eligibility and quality of
potential awardees; to assess their
potential as future scientists; to
determine where mutual research
interests exist; and to make decisions
regarding which applicants will be
proposed and approved for traineeship
awards. In each case, completing the
application is voluntary, but in order to
receive due consideration, the
prospective trainee is encouraged to
complete all relevant fields. The
information is for internal use to make
decisions about prospective fellows and
students that could benefit from the
DCEG program.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
175.
Need and Use of Information
Collection: The Division of Cancer
Epidemiology and Genetics (DCEG)
Office of Education (OE) administers a
variety of programs and initiatives to
recruit pre-college through post-doctoral
educational level individuals into the
Intramural Research Program to
facilitate their development into future
biomedical scientists. DCEG trains postdoctoral, doctoral candidates, graduate
and baccalaureate students, through full
time fellowships, summer fellowships,
and internships in preparation for
research careers in cancer epidemiology
and genetics. The proposed information
collection involves brief online
applications completed by applicants to
the full time and the summer fellowship
programs. Full-time fellowships
include: Full-time Equivalents (FTE)
and non-FTE fellowships for US
citizens, permanent residents and
international fellows. These
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Type of respondent
Fellowship Program Application ...................
Summer Program Application .......................
Full-time Fellows ...................
Summer Students .................
Dated: February 19, 2015.
Karla Bailey,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2015–03789 Filed 2–24–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Assessment of
Oncology Nursing Education and
Training in Low and Middle Income
Countries (NCI)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on July 8, 2014,
Vol. 79, page 38542 and allowed 60days for public comment. One public
comment was received on July 9, 2014.
The purpose of this notice is to allow an
additional 30 days for public comment.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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18:05 Feb 24, 2015
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150
300
The National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments or request more
information on the proposed project,
contact: Annette Galassi, Center for
Global Health, National Cancer Institute,
9609 Medical Center Dr., Rm. 3W250,
Rockville, MD 20850 or call non-tollfree number 240–276–6632 or Email
your request, including your address to:
PO 00000
Frm 00085
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
Average
burden per
response
(in hours)
30/60
20/60
Total annual
burden hours
75
100
agalassi@mail.nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Proposed Collection: Assessment of
Oncology Nursing Education and
Training in Low and Middle Income
Countries, 0925–NEW, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: This submission is a request
for OMB to approve the Assessment of
Oncology Nursing Education and
Training in Low and Middle Income
Countries (LMICs). NCI-Designated
Cancer Centers have a range of
international activities, some of which
are funded by NCI, but many of which
are not. These international activities
may include oncology nursing
education and training in LMICs, but
the extent of these activities across
cancer centers is unknown. The
proposed assessment requests
information about oncology nursing
education and training projects
including: descriptions of projects,
partner organizations, types of activities,
cost, and impact. The information will
be collected annually. NCI’s Center for
Global Health (CGH) is in the process of
developing its strategic plan for
oncology nursing education in LMICs.
E:\FR\FM\25FEN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10127-10128]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03789]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Division of
Cancer Epidemiology and Genetics (DCEG) Fellowship Program and Summer
Student Applications (NCI)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH), has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on April 9, 2014 (Vol. 79, P. 19632) and allowed 60-days for
public comment. No public comments were received. The purpose of this
notice is to allow an additional 30 days for public comment. The
National Cancer Institute (NCI), National Institutes of Health, may not
conduct or sponsor, and the respondent is not required to respond to,
an information collection that has been extended, revised, or
implemented on or after October 1, 1995, unless it displays a currently
valid OMB control number.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments regarding this information collection
are best assured of having their full effect if
[[Page 10128]]
received within 30-days of the date of this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: Jackie Lavigne, Office of Education, Division
of Cancer Epidemiology and Genetics, 9609 Medical Center Drive, MSC
9776, Bethesda, MD 20892-9776 or call non-toll-free number 240-376-7237
or Email your request, including your address to:
lavignej@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
Proposed Collection: Division of Cancer Epidemiology and Genetics
(DCEG) Fellowship Program and Summer Student Applications (NCI),
Existing Collection in Use without OMB Control Number, National Cancer
Institute (NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Division of Cancer
Epidemiology and Genetics (DCEG) Office of Education (OE) administers a
variety of programs and initiatives to recruit pre-college through
post-doctoral educational level individuals into the Intramural
Research Program to facilitate their development into future biomedical
scientists. DCEG trains post-doctoral, doctoral candidates, graduate
and baccalaureate students, through full time fellowships, summer
fellowships, and internships in preparation for research careers in
cancer epidemiology and genetics. The proposed information collection
involves brief online applications completed by applicants to the full
time and the summer fellowship programs. Full-time fellowships include:
Full-time Equivalents (FTE) and non-FTE fellowships for US citizens,
permanent residents and international fellows. These applications are
essential to the administration of these training programs as they
enable OE to determine the eligibility and quality of potential
awardees; to assess their potential as future scientists; to determine
where mutual research interests exist; and to make decisions regarding
which applicants will be proposed and approved for traineeship awards.
In each case, completing the application is voluntary, but in order to
receive due consideration, the prospective trainee is encouraged to
complete all relevant fields. The information is for internal use to
make decisions about prospective fellows and students that could
benefit from the DCEG program.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 175.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Fellowship Program Application Full-time 150 1 30/60 75
Fellows.
Summer Program Application.... Summer Students. 300 1 20/60 100
----------------------------------------------------------------------------------------------------------------
Dated: February 19, 2015.
Karla Bailey,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2015-03789 Filed 2-24-15; 8:45 am]
BILLING CODE 4140-01-P
