Proposed Collection; 60-Day Comment Request; Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development), 18650-18652 [2024-05404]
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Federal Register / Vol. 89, No. 51 / Thursday, March 14, 2024 / Notices
Deadlines: Public Comment Due Date:
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Dated: March 11, 2024.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–05438 Filed 3–13–24; 8:45 am]
BILLING CODE 4140–01–P
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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
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development (NICHD), 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.
SUMMARY:
To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Rebecca F. Rosen, Ph.D.,
Director of the Office of Data Science
and Sharing, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development (NICHD), National
Institutes of Health, 6710B Rockledge
Drive, Bethesda, MD 20817, or call nontoll-free number 301–827–4602, or
email your request, including your
address to: NICHD.DASH@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
FOR FURTHER INFORMATION CONTACT:
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\14MRN1.SGM
14MRN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 51 / Thursday, March 14, 2024 / Notices
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.
Proposed Collection Title: Data and
Specimen Hub (DASH)–0925–0744
expiration date 06/30/2024, 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 (OMB
number: 0925–0744) to add the
collection of additional information
from Users who wish to extend their
data access beyond the standard threeyear period, remove a Biospecimen
Annual Report form that is no longer in
use, extend the information collection
in Institutional Certifications to cover
both data and biospecimen submissions,
and implement minor revisions on
previously approved forms, including
additional field options and language
revisions that do not impact the nature
of information being collected or its
associated burden.
DASH has been established by NICHD
as a data sharing mechanism for
biomedical research investigators. It
serves as a centralized resource for
investigators to share and access deidentified study data from studies
funded by NICHD. DASH also serves as
a portal for requesting biospecimens
from select DASH studies.
NICHD also supports other public
archives, data collections, and
resources, such as Data Sharing for
Demographic Research (DSDR), NICHD/
DIPHR Biospecimen Repository Access
and Data Sharing (BRADS), the Down
Syndrome Registry (DS–Connect),
Zebrafish Information Network (ZFIN),
etc. In addition to these NICHD-funded
public archives, many collaborative
studies funded through NICHD are
dispersed across other NIH designated
archives, including the National Heart,
Lung, and Blood Institute (NHLBI)
Biologic Specimen and Data Repository
Information Coordinating Center
(BioLINCC), and other NIH-wide
repositories, such as the Database of
Genotypes and Phenotypes (dbGaP).
VerDate Sep<11>2014
16:47 Mar 13, 2024
Jkt 262001
In an effort to link these data
resources and increase the visibility of
NICHD-funded studies and data
collections, DASH enables Users to
catalog studies and data collections
stored in other external archives to
facilitate their discovery through DASH.
Users submitting studies or external
resources for cataloging in DASH will
provide descriptive information about
the study required to populate the Study
Overview Page in DASH. This
cataloging process closely mirrors the
existing study data submission process
in DASH; however, no study
documentation or data will be uploaded
to DASH. Requesters will be directed to
the external archive via a URL link to
obtain access to the data stored in the
external archives and resources.
The potential for public benefit to be
achieved through sharing study data
and/or biospecimen inventories through
DASH for secondary analysis is
significant. Additionally, the ability to
centralize information regarding where
to find, and how to access, studies, and
data collections funded by NICHD
stored across various public archives
(i.e., cataloged studies and data
collections) further helps to promote
information discovery and reuse of data.
NICHD DASH supports NICHD’s
mission to lead research and training to
understand human development,
improve reproductive health, enhance
the lives of children and adolescents,
and optimize abilities for all. Study data
and biospecimen sharing and reuse will
promote testing of new hypotheses from
data and biospecimens 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
collections without creating an account.
Users who wish to submit studies or
request data (stored in DASH) and/or
biospecimens (stored in NICHD
contracted Biorepository) must register
for an account. Users who wish to
submit a study catalog and/or external
resource catalog must also register for an
account.
Information will be collected from
those wishing to create an account,
sufficient to identify them as unique
PO 00000
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18651
Users. Those submitting or requesting
data and/or biospecimens will be
required to provide additional
supporting information to ensure proper
use and security of NICHD DASH study
data and biospecimens. For data and/or
biospecimen requests, information is
collected both for initial data and/or
biospecimen access and then
throughout the request duration to
maintain access. This includes research
objectives and analysis plans, research
teams, and institution information, as
well as significant findings details for
annual progress reports or extension
justification for data request renewals.
The information collected throughout
these processes 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 and aligns with DASH data
sharing policies. The primary uses of
the information collected from Uses by
NICHD will be to:
• Communicate with the Users
regarding data submission, study catalog
submission, external resource catalog
submission, data requests, and
biospecimen requests;
• Monitor data submissions, study
catalog submission, external resource
catalog submission, data requests, and
biospecimen requests;
• Notify interested Users of updates
to data and biospecimens available
through NICHD DASH; and
• Help NICHD understand the use of
NICHD DASH study data and
biospecimens by the research
community.
All the data collected from use of
NICHD DASH are for the purposes of
internal administrative management of
NICHD DASH, with the exception of the
Recipient’s approved use of DASH data
and/or biospecimens, Recipient name
and institution, and significant findings
reporting in the Data Request Annual
Use Report, which may be shared on the
DASH website or in publications
describing the performance and value of
the DASH system for the broader
scientific community.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
433.
E:\FR\FM\14MRN1.SGM
14MRN1
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Federal Register / Vol. 89, No. 51 / Thursday, March 14, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Annual burden hours estimate
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total annual
burden hour
User Registration ..............................................................................................................................
Data and Biospecimen Catalog Submission ....................................................................................
Institutional Certification Template ....................................................................................................
Data Request ....................................................................................................................................
Biospecimen Request .......................................................................................................................
Data Request Annual Progress Report ............................................................................................
Study Catalog Submission ................................................................................................................
External Resource Catalog Submission ...........................................................................................
Data Request Renewal .....................................................................................................................
900
36
36
150
4
240
2
4
42
1
1
1
1
1
1
1
1
1
5/60
2
5/60
1
1
30/60
30/60
15/60
10/60
75
72
3
150
4
120
1
1
7
Total ...........................................................................................................................................
1,414
1,414
........................
433
Dated: March 6, 2024.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy
Shriver National Institute of Child Health and
Human Development, National Institutes of
Health.
[FR Doc. 2024–05404 Filed 3–13–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Meeting
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
responses per
respondent
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory
General Medical Sciences Council.
The meeting will be open to the
public as indicated below, with a short
public comment period at the end.
Attendance is limited by the space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
submit a request using the NIGMS
contact us form https://www.nigms.nih.
gov/Pages/ContactUs.aspx at least 5
days prior to the event. The open
session will also be videocast, closed
captioned, and can be accessed from the
NIH Videocasting and Podcasting
website (https://videocast.nih.gov).
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
VerDate Sep<11>2014
16:47 Mar 13, 2024
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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
General Medical Sciences Council.
Date: May 16, 2024.
Open: 9:30 a.m. to 12:10 p.m.
Agenda: For the discussion of program
policies and issues; opening remarks; report
of the Director, NIGMS; and other business
of the Council.
Place: National Institutes of Health,
Natcher Building, Conference Rooms E1 &
E2, 45 Center Drive, Bethesda, MD 20892.
Closed: 1:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, Conference Rooms E1 &
E2, 45 Center Drive, Bethesda, MD 20892.
Contact Person: Erica L. Brown, Ph.D.,
Director, Division of Extramural Activities,
National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 2AN24C, Bethesda,
MD 20892, 301–594–4499, erica.brown@
nih.gov.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Electronic
copies are requested for the record.
In the interest of security, NIH has
procedures at https://www.nih.gov/aboutnih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors attending a meeting on
campus or at an off-campus federal facility
will be asked to show one form of
identification (for example, a governmentissued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
Information is also available on the
Institute’s/Center’s home page: https://www.
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nigms.nih.gov/About/Council, where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program No. 93.859, Biomedical Research
and Research Training, National Institutes of
Health, HHS)
Dated: March 11, 2024.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–05439 Filed 3–13–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, 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
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RC2—NIDDK High
Impact, Interdisciplinary Science Review.
Date: March 27, 2024.
Time: 10:30 a.m. to 12:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
NIDDK, Democracy II, Suite 7000A, 6707
Democracy Boulevard, Bethesda, MD 20892.
E:\FR\FM\14MRN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 51 (Thursday, March 14, 2024)]
[Notices]
[Pages 18650-18652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05404]
-----------------------------------------------------------------------
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 Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD), 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: Rebecca F.
Rosen, Ph.D., Director of the Office of Data Science and Sharing,
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD), National Institutes of Health, 6710B Rockledge
Drive, Bethesda, MD 20817, or call non-toll-free number 301-827-4602,
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
[[Page 18651]]
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.
Proposed Collection Title: Data and Specimen Hub (DASH)-0925-0744
expiration date 06/30/2024, 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 (OMB number: 0925-0744) to add the
collection of additional information from Users who wish to extend
their data access beyond the standard three-year period, remove a
Biospecimen Annual Report form that is no longer in use, extend the
information collection in Institutional Certifications to cover both
data and biospecimen submissions, and implement minor revisions on
previously approved forms, including additional field options and
language revisions that do not impact the nature of information being
collected or its associated burden.
DASH has been established by NICHD as a data sharing mechanism for
biomedical research investigators. It serves as a centralized resource
for investigators to share and access de-identified study data from
studies funded by NICHD. DASH also serves as a portal for requesting
biospecimens from select DASH studies.
NICHD also supports other public archives, data collections, and
resources, such as Data Sharing for Demographic Research (DSDR), NICHD/
DIPHR Biospecimen Repository Access and Data Sharing (BRADS), the Down
Syndrome Registry (DS-Connect), Zebrafish Information Network (ZFIN),
etc. In addition to these NICHD-funded public archives, many
collaborative studies funded through NICHD are dispersed across other
NIH designated archives, including the National Heart, Lung, and Blood
Institute (NHLBI) Biologic Specimen and Data Repository Information
Coordinating Center (BioLINCC), and other NIH-wide repositories, such
as the Database of Genotypes and Phenotypes (dbGaP).
In an effort to link these data resources and increase the
visibility of NICHD-funded studies and data collections, DASH enables
Users to catalog studies and data collections stored in other external
archives to facilitate their discovery through DASH. Users submitting
studies or external resources for cataloging in DASH will provide
descriptive information about the study required to populate the Study
Overview Page in DASH. This cataloging process closely mirrors the
existing study data submission process in DASH; however, no study
documentation or data will be uploaded to DASH. Requesters will be
directed to the external archive via a URL link to obtain access to the
data stored in the external archives and resources.
The potential for public benefit to be achieved through sharing
study data and/or biospecimen inventories through DASH for secondary
analysis is significant. Additionally, the ability to centralize
information regarding where to find, and how to access, studies, and
data collections funded by NICHD stored across various public archives
(i.e., cataloged studies and data collections) further helps to promote
information discovery and reuse of data. NICHD DASH supports NICHD's
mission to lead research and training to understand human development,
improve reproductive health, enhance the lives of children and
adolescents, and optimize abilities for all. Study data and biospecimen
sharing and reuse will promote testing of new hypotheses from data and
biospecimens 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 collections without creating an
account. Users who wish to submit studies or request data (stored in
DASH) and/or biospecimens (stored in NICHD contracted Biorepository)
must register for an account. Users who wish to submit a study catalog
and/or external resource catalog must also 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 biospecimens will be required to provide
additional supporting information to ensure proper use and security of
NICHD DASH study data and biospecimens. For data and/or biospecimen
requests, information is collected both for initial data and/or
biospecimen access and then throughout the request duration to maintain
access. This includes research objectives and analysis plans, research
teams, and institution information, as well as significant findings
details for annual progress reports or extension justification for data
request renewals.
The information collected throughout these processes 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 and aligns with DASH data sharing policies.
The primary uses of the information collected from Uses by NICHD will
be to:
Communicate with the Users regarding data submission,
study catalog submission, external resource catalog submission, data
requests, and biospecimen requests;
Monitor data submissions, study catalog submission,
external resource catalog submission, data requests, and biospecimen
requests;
Notify interested Users of updates to data and
biospecimens available through NICHD DASH; and
Help NICHD understand the use of NICHD DASH study data and
biospecimens by the research community.
All the data collected from use of NICHD DASH are for the purposes
of internal administrative management of NICHD DASH, with the exception
of the Recipient's approved use of DASH data and/or biospecimens,
Recipient name and institution, and significant findings reporting in
the Data Request Annual Use Report, which may be shared on the DASH
website or in publications describing the performance and value of the
DASH system for the broader scientific community.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 433.
[[Page 18652]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Annual burden hours estimate
-----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total annual
Form name respondents responses per response (in burden hour
respondent hours)
----------------------------------------------------------------------------------------------------------------
User Registration............................... 900 1 5/60 75
Data and Biospecimen Catalog Submission......... 36 1 2 72
Institutional Certification Template............ 36 1 5/60 3
Data Request.................................... 150 1 1 150
Biospecimen Request............................. 4 1 1 4
Data Request Annual Progress Report............. 240 1 30/60 120
Study Catalog Submission........................ 2 1 30/60 1
External Resource Catalog Submission............ 4 1 15/60 1
Data Request Renewal............................ 42 1 10/60 7
---------------------------------------------------------------
Total....................................... 1,414 1,414 .............. 433
----------------------------------------------------------------------------------------------------------------
Dated: March 6, 2024.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2024-05404 Filed 3-13-24; 8:45 am]
BILLING CODE 4140-01-P
