Submission for OMB Review; 30-Day Comment Request: A Clearance for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Data and Specimen Hub (DASH), 9865-9866 [2016-04178]
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Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request The Sister Study: A
Prospective Study of the Genetic and
Environmental Risk Factors for Breast
Cancer (NIEHS)
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 02 December
2015, Vol. 80, page 75465 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
Institute of Environmental Health
Sciences (NIEHS), 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
SUMMARY:
complex, with both genetic and
environmental factors likely playing a
role. Environmental risk factors,
however, have been difficult to identify.
By focusing on genetically susceptible
subgroups, more precise estimates of the
contribution of environmental and other
non-genetic factors to disease risk may
be possible. Sisters of women with
breast cancer are one group at increased
risk for breast cancer; we would expect
at least 2 times as many breast cancers
to accrue in a cohort of sisters as would
accrue in a cohort identified through
random sampling or other means. In
addition, a cohort of sisters should be
enriched with regard to the prevalence
of relevant genes and/or exposures,
further enhancing the ability to detect
gene-environment interactions. Sisters
of women with breast cancer will also
be at increased risk for ovarian cancer
and possibly for other hormonallymediated diseases. From August 2003
through July 2009, we enrolled a cohort
of 50,884 women who had not had
breast cancer. We estimated that after
the cohort was fully enrolled,
approximately 300 new cases of breast
cancer will be diagnosed during each
year of follow-up. Thus far 2,904
participants have reported being
diagnosed with breast cancer.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
16,350.
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.
DATES: 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: Dr. Dale P. Sandler, Chief,
Epidemiology Branch, NIEHS, Rall
Building A3–05, P.O. Box 12233,
Research Triangle Park, NC 27709, or
call non-toll free number (919)–541–
4668 or Email your request, including
your address to: sandler@niehs.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Proposed Collection: Revision: The
Sister Study: A Prospective Study of the
Genetic and Environmental Risk Factors
for Breast Cancer, 0925–0522, National
Institute of Environmental Health
Sciences (NIEHS), National Institutes of
Health (NIH).
Need and Use of Information
Collection: This is to continue the longterm follow-up of the Sister Study—a
study of genetic and environmental risk
factors for the development of breast
cancer in a high-risk cohort of sisters of
women who have had breast cancer.
The etiology of breast cancer is
ESTIMATED ANNUALIZED BURDEN HOURS
Annual
number of
respondents
Activity
Number of
reponses per
respondent
Average
burden per
response
(hours)
Total
burden hours
per year
Annual Update .................................................................................................
Follow-Up III (triennial) .....................................................................................
Follow-Up III Telephone Prompting Script .......................................................
32,215
16,108
4,832 *
1
1
1
10/60
40/60
3/60
5,369
10,739
242
Total per year ...........................................................................................
48,323
........................
........................
16,350
* These Respondents are included in the 16,108 for Follow-Up III, thus not added into Total Respondents per year.
Dated: February 19, 2016.
Jane Lambert,
Project Clearance Liaison, NIEHS.
[FR Doc. 2016–04179 Filed 2–25–16; 8:45 am]
mstockstill on DSK4VPTVN1PROD with NOTICES
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request: A Clearance for the
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development Data and Specimen Hub
(DASH)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Eunice
SUMMARY:
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Kennedy Shriver National Institute of
Child Health and Human Development
(NICHD), the National Institutes of
Health, 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 October 30, 2015 on pages
66913–4 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
E:\FR\FM\26FEN1.SGM
26FEN1
9866
Federal Register / Vol. 81, No. 38 / Friday, February 26, 2016 / Notices
comment. The Eunice Kennedy Shriver
National Institute of Child Health and
Human Development (NICHD), 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.
DATES: 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: Rohan Hazra, M.D., Eunice
Kennedy Shriver National Institute of
Child Health and Human Development
(NICHD), National Institutes of Health,
6100 Executive Blvd., Room 4B11,
Bethesda, MD 20892–7510, or call nontoll-free number (301)-435–6868 or
Email your request, including your
address to: hazrar@mail.nih.gov. Formal
requests for additional plans and
information about the studies and data
archived in NICHD DASH without
creating an account. Users who wish to
submit or request research study data
must register for an account.
Information will be collected from
those wishing to create an account,
sufficient to identify them as unique
Users. Those submitting or requesting
data will be required to provide
additional supporting information to
ensure proper use and security of
NICHD DASH data. The information
collected is limited to the essential data
required to ensure that the management
of Users in NICHD DASH is efficient
and the sharing of data among
investigators is effective. The primary
uses of the information collected from
Users by NICHD will be to:
• Communicate with the Users with
regards to their data submission or
requests
• Monitor data submissions and data
requests
• Notify interested recipients of
updates to data stored in NICHD DASH
• Help NICHD understand the use of
NICHD DASH data by the research
community
There is no plan to publish the data
collected under this request.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
142.
instruments must be requested in
writing.
Proposed Collection: Data and
Specimen Hub (DASH), 0925–NEW,
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The NICHD Data and
Specimen Hub (DASH) is being
established by NICHD as a data sharing
mechanism for biomedical research
investigators. It will serve as a
centralized resource for investigators to
store and access de-identified data from
studies funded by NICHD. The potential
for public benefit to be achieved
through sharing research study data for
secondary analysis is significant. NICHD
DASH supports NICHD’s mission to
ensure that every person is born healthy
and wanted, that women suffer no
harmful effects from reproductive
processes, and that all children have the
chance to achieve their full potential for
healthy and productive lives, free from
disease or disability, and to ensure the
health, productivity, independence, and
well-being of all people through optimal
rehabilitation. Data sharing and reuse
will promote testing of new hypotheses
from data already collected, facilitate
trans-disciplinary collaboration,
accelerate scientific findings and enable
NICHD to maximize the return on its
investments in research.
Anyone can access NICHD DASH to
browse and view descriptive
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form
Frequency of
response
Average time
per response
(in hours)
Total annual
burden hour
User Registration .............................................................................................
Data Submission ..............................................................................................
Data Request ...................................................................................................
120
36
60
1
1
1
5/60
2
1
10
72
60
Total ..........................................................................................................
120
216
........................
142
Dated: February 17, 2016.
Sarah L. Glavin,
Project Clearance Liaison, NICHD, NIH.
[FR Doc. 2016–04178 Filed 2–25–16; 8:45 am]
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BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
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amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Cancer Institute Board of
Scientific Advisors. The meeting will be
open to the public, 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 also be
videocast and can be accessed from the
NIH Videocasting and Podcasting Web
site (https://videocast.nih.gov/).
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Name of Committee: National Cancer
Institute Board of Scientific Advisors.
Date: March 29, 2016.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: Director’s Report: Ongoing and
New Business; Reports of Program Review
Group(s); Budget Presentations; Reports of
Special Initiatives; RFA and RFP Concept
Reviews; and Scientific Presentations.
Place: National Institutes of Health, 31
Center Drive, Building 31, C-Wing, 6th Floor,
Room 10, Bethesda, MD 20892.
Contact Person: Paulette S. Gray, Ph.D.,
Director, Division of Extramural Activities,
National Cancer Institute—Shady Grove,
National Institutes of Health, 9609 Medical
Center Drive, 7th Floor, Rm. 7W444,
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]]>Agencies
[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Pages 9865-9866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04178]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request: A Clearance
for the Eunice Kennedy Shriver National Institute of Child Health and
Human Development Data and Specimen Hub (DASH)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD), the National Institutes of
Health, 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 October 30, 2015 on pages 66913-4 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
[[Page 9866]]
comment. The Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD), 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.
DATES: 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: Rohan Hazra, M.D., Eunice Kennedy Shriver
National Institute of Child Health and Human Development (NICHD),
National Institutes of Health, 6100 Executive Blvd., Room 4B11,
Bethesda, MD 20892-7510, or call non-toll-free number (301)-435-6868 or
Email your request, including your address to: hazrar@mail.nih.gov.
Formal requests for additional plans and instruments must be requested
in writing.
Proposed Collection: Data and Specimen Hub (DASH), 0925-NEW, Eunice
Kennedy Shriver National Institute of Child Health and Human
Development (NICHD), National Institutes of Health (NIH).
Need and Use of Information Collection: The NICHD Data and Specimen
Hub (DASH) is being established by NICHD as a data sharing mechanism
for biomedical research investigators. It will serve as a centralized
resource for investigators to store and access de-identified data from
studies funded by NICHD. The potential for public benefit to be
achieved through sharing research study data for secondary analysis is
significant. NICHD DASH supports NICHD's mission to ensure that every
person is born healthy and wanted, that women suffer no harmful effects
from reproductive processes, and that all children have the chance to
achieve their full potential for healthy and productive lives, free
from disease or disability, and to ensure the health, productivity,
independence, and well-being of all people through optimal
rehabilitation. Data sharing and reuse will promote testing of new
hypotheses from data already collected, facilitate trans-disciplinary
collaboration, accelerate scientific findings and enable NICHD to
maximize the return on its investments in research.
Anyone can access NICHD DASH to browse and view descriptive
information about the studies and data archived in NICHD DASH without
creating an account. Users who wish to submit or request research study
data must register for an account.
Information will be collected from those wishing to create an
account, sufficient to identify them as unique Users. Those submitting
or requesting data will be required to provide additional supporting
information to ensure proper use and security of NICHD DASH data. The
information collected is limited to the essential data required to
ensure that the management of Users in NICHD DASH is efficient and the
sharing of data among investigators is effective. The primary uses of
the information collected from Users by NICHD will be to:
Communicate with the Users with regards to their data
submission or requests
Monitor data submissions and data requests
Notify interested recipients of updates to data stored in
NICHD DASH
Help NICHD understand the use of NICHD DASH data by the
research community
There is no plan to publish the data collected under this request.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 142.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Form Number of Frequency of per response Total annual
respondents response (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
User Registration............................... 120 1 5/60 10
Data Submission................................. 36 1 2 72
Data Request.................................... 60 1 1 60
---------------------------------------------------------------
Total....................................... 120 216 .............. 142
----------------------------------------------------------------------------------------------------------------
Dated: February 17, 2016.
Sarah L. Glavin,
Project Clearance Liaison, NICHD, NIH.
[FR Doc. 2016-04178 Filed 2-25-16; 8:45 am]
BILLING CODE 4140-01-P
