Proposed Collection; 60-Day Comment Request Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development), 18575-18576 [2018-08901]
Download as PDF
<![CDATA[
Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices
meeting, see the DMICC website,
www.diabetescommittee.gov, or contact
Dr. B. Tibor Roberts, Executive
Secretary of the Diabetes Mellitus
Interagency Coordinating Committee,
National Institute of Diabetes and
Digestive and Kidney Diseases, 31
Center Drive, Building 31A, Room
9A19, MSC 2560, Bethesda, MD 20892–
2560, telephone: 301–496–6623; FAX:
301–480–6741; email: dmicc@
mail.nih.gov.
The
DMICC, chaired by the National
Institute of Diabetes and Digestive and
Kidney Diseases (NIDDK) comprising
members of the Department of Health
and Human Services and other federal
agencies that support diabetes-related
activities, facilitates cooperation,
communication, and collaboration on
diabetes among government entities.
DMICC meetings, held several times a
year, provide an opportunity for
Committee members to learn about and
discuss current and future diabetes
programs in DMICC member
organizations and to identify
opportunities for collaboration. The
May 29, 2018 DMICC meeting will focus
on fostering research on older adults
with diabetes receiving long term care.
Any member of the public interested
in presenting oral comments to the
Committee should notify the contact
person listed on this notice at least 10
days in advance of the meeting.
Interested individuals and
representatives or organizations should
submit a letter of intent, a brief
description of the organization
represented, and a written copy of their
oral presentation in advance of the
meeting. Only one representative of an
organization will be allowed to present;
oral comments and presentations will be
limited to a maximum of 5 minutes.
Printed and electronic copies are
requested for the record. In addition,
any interested person may file written
comments with the Committee by
forwarding their statement to the
contact person listed on this notice. The
statement should include the name,
address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Because of time constraints for the
meeting, oral comments will be allowed
on a first-come, first-serve basis.
Members of the public who would
like to receive email notification about
future DMICC meetings should register
for the listserv available on the DMICC
website, www.diabetescommittee.gov.
daltland on DSKBBV9HB2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:18 Apr 26, 2018
Jkt 244001
Dated: April 18, 2018.
Bruce T. Roberts,
Executive Secretary, DMICC, Office of
Scientific Program and Policy Analysis,
National Institute of Diabetes and Digestive
and Kidney Diseases, National Institutes of
Health.
[FR Doc. 2018–08900 Filed 4–26–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request Data and Specimen Hub
(DASH) (Eunice Kennedy Shriver
National Institute of Child Health and
Human Development)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, 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,
6710B Rockledge Drive, Room 2113,
Bethesda, MD 20817, or call non-tollfree number (301)–435–6868 or Email
your request, including your address to:
rohan.hazra@nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and/or suggestions from the
public and affected agencies are invited
to address 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
SUMMARY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
18575
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 minimizes
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.
Proposed Collection Title: Data and
Specimen Hub (DASH)–0925–0744
expiration date 06/30/2019, REVISION,
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), National
Institutes of Health (NIH).
Need and Use of Information Collection
This is a request to revise the
previously approved submission to add
the collection of additional information
from Users who will request
biospecimens, submit the Institutional
Certification for data/biospecimen
inventory, and submit DASH data/
biospecimen Annual Progress Report for
the NICHD Data and Specimen Hub
(DASH). DASH has been established by
NICHD as a data sharing mechanism for
biomedical research investigators. It
serves as a centralized resource for
investigators to store and access deidentified study data and biospecimen
inventories—a list of biospecimens
available at the NICHD Biorepository—
from studies funded by NICHD. The
potential for public benefit to be
achieved through sharing study data
and/or biospecimen inventories 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. Study data and
biospecimen sharing and reuse will
promote testing of new hypotheses from
data already collected, facilitate transdisciplinary 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 study
data archived in NICHD DASH without
creating an account. Users who wish to
submit or request research data and/or
E:\FR\FM\27APN1.SGM
27APN1
18576
Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices
biospecimen inventories 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 and/or biospecimen inventories
will be required to provide additional
supporting information to ensure proper
use and security of NICHD DASH study
data and biospecimen inventories. The
information collected is limited to the
essential data required to ensure the
management of Users in NICHD DASH
is efficient and the sharing of data and
All the data collected from use of
NICHD DASH except for information
provided in the annual progress reports
are for the purposes of internal
administrative management of NICHD
DASH. Information gathered through
the annual progress reports may be used
in publications describing performance
of the DASH system.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
204.
biospecimens 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, data
requests and biospecimen requests
• Monitor data submissions, data
requests and biospecimen requests
• Notify interested recipients of updates
to data and biospecimen inventories
stored in NICHD DASH
• Help NICHD understand the use of
NICHD DASH study data and
biospecimen inventories by the
research community
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of form
Frequency of
response
Average time
per response
(in hours)
Total annual
burden hour
User Registration .............................................................................................
Data and Biospecimen Inventory Submission .................................................
Data Request ...................................................................................................
Biospecimen Request ......................................................................................
Data Use Annual Progress Report ..................................................................
Biospecimen Use Annual Progress Report .....................................................
Institutional Certification Template ..................................................................
200
36
60
36
60
36
36
1
1
1
1
1
1
1
5/60
2
1
1
10/60
10/60
5/60
17
72
60
36
10
6
3
Total ..........................................................................................................
200
200
........................
204
Dated: April 17, 2018.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy
Shriver, National Institute of Child Health
and Human Development, National Institutes
of Health.
[FR Doc. 2018–08901 Filed 4–26–18; 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
CTEP Branch and Support Contracts
Forms and Surveys (National Cancer
Institute)
AGENCY: National Institutes of Health,
HHS.
ACTION: Notice.
In compliance with 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.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:18 Apr 26, 2018
Jkt 244001
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: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Michael Montello,
Pharm.D., Shanda Finnigan, MPH, RN,
CCRC or Jacquelyn Goldberg, JD, Cancer
Therapy Evaluation Program, Division
of Cancer Treatment and Diagnosis,
9609 Medical Center Drive, Rockville,
MD 20850 or call non-toll-free number
(240–276–6080) or email your request,
including your address to: ctsucontact@
westat.com.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on February 21, 2018, page
7483 (83 FR 7483) and allowed 60 days
for public comment. No public
comments were received. 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,
ADDRESSES:
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
revised, or implemented on or after
October 1, 1995, unless it displays a
currently valid OMB control number.
In compliance with 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.
Proposed Collection: CTEP Branch
and Support Contracts Forms and
Surveys, 0925–0753 Expiration Date 06/
30/2020, REVISION, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Cancer
Institute (NCI) Cancer Therapy
Evaluation Program (CTEP) and the
Division of Cancer Prevention (DCP)
fund an extensive national program of
cancer research, sponsoring clinical
trials in cancer prevention, symptom
management and treatment for qualified
clinical investigators. As part of this
effort, CTEP implements programs to
register clinical site investigators and
clinical site staff, and to oversee the
conduct of research at the clinical sites.
CTEP and DCP also oversee two support
programs, the NCI Central Institutional
Review Board (CIRB) and the Cancer
Trial Support Unit (CTSU). The
combined systems and processes for
E:\FR\FM\27APN1.SGM
27APN1
]]>Agencies
[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)]
[Notices]
[Pages 18575-18576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08901]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request Data and Specimen Hub
(DASH) (Eunice Kennedy Shriver National Institute of Child Health and
Human Development)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Institutes of Health will publish
periodic summaries of proposed projects to be submitted to the Office
of Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, 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, 6710B
Rockledge Drive, Room 2113, Bethesda, MD 20817, or call non-toll-free
number (301)-435-6868 or Email your request, including your address to:
[email protected]. Formal requests for additional plans and
instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written comments and/or suggestions
from the public and affected agencies are invited to address 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 minimizes 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.
Proposed Collection Title: Data and Specimen Hub (DASH)-0925-0744
expiration date 06/30/2019, REVISION, Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD), National
Institutes of Health (NIH).
Need and Use of Information Collection
This is a request to revise the previously approved submission to
add the collection of additional information from Users who will
request biospecimens, submit the Institutional Certification for data/
biospecimen inventory, and submit DASH data/biospecimen Annual Progress
Report for the NICHD Data and Specimen Hub (DASH). DASH has been
established by NICHD as a data sharing mechanism for biomedical
research investigators. It serves as a centralized resource for
investigators to store and access de-identified study data and
biospecimen inventories--a list of biospecimens available at the NICHD
Biorepository--from studies funded by NICHD. The potential for public
benefit to be achieved through sharing study data and/or biospecimen
inventories 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. Study data and biospecimen
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 study data archived in NICHD DASH
without creating an account. Users who wish to submit or request
research data and/or
[[Page 18576]]
biospecimen inventories 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 and/or biospecimen inventories will be required to
provide additional supporting information to ensure proper use and
security of NICHD DASH study data and biospecimen inventories. The
information collected is limited to the essential data required to
ensure the management of Users in NICHD DASH is efficient and the
sharing of data and biospecimens 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, data requests and biospecimen requests
Monitor data submissions, data requests and biospecimen
requests
Notify interested recipients of updates to data and
biospecimen inventories stored in NICHD DASH
Help NICHD understand the use of NICHD DASH study data and
biospecimen inventories by the research community
All the data collected from use of NICHD DASH except for
information provided in the annual progress reports are for the
purposes of internal administrative management of NICHD DASH.
Information gathered through the annual progress reports may be used in
publications describing performance of the DASH system.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 204.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Type of form Number of Frequency of per response Total annual
respondents response (in hours) burden hour
----------------------------------------------------------------------------------------------------------------
User Registration............................... 200 1 5/60 17
Data and Biospecimen Inventory Submission....... 36 1 2 72
Data Request.................................... 60 1 1 60
Biospecimen Request............................. 36 1 1 36
Data Use Annual Progress Report................. 60 1 10/60 10
Biospecimen Use Annual Progress Report.......... 36 1 10/60 6
Institutional Certification Template............ 36 1 5/60 3
---------------------------------------------------------------
Total....................................... 200 200 .............. 204
----------------------------------------------------------------------------------------------------------------
Dated: April 17, 2018.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver, National Institute
of Child Health and Human Development, National Institutes of Health.
[FR Doc. 2018-08901 Filed 4-26-18; 8:45 am]
BILLING CODE 4140-01-P
