Notice2024-13715
Submission for OMB Review; 30-Day Comment Request; Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 24, 2024
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 121 (Monday, June 24, 2024)</title>
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[Federal Register Volume 89, Number 121 (Monday, June 24, 2024)]
[Notices]
[Pages 52481-52483]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13715]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-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.
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SUMMARY: 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.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
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: 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, call non-toll-free
number 301-827-4602, or email your request, including your address to:
<a href="/cdn-cgi/l/email-protection#f0beb9b3b8b4deb4b1a3b8b09d91999cde9e9998de979f86"><span class="__cf_email__" data-cfemail="e7a9aea4afa3c9a3a6b4afa78a868e8bc9898e8fc9808891">[email protected]</span></a>. Formal requests for additional plans and
instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on March 14, 2024, page
18650-18652, (Vol. 89 FR 18650-18652) 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 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.
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.
[[Page 52482]]
Proposed Collection: 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:
<bullet> Communicate with the Users regarding data submission,
study catalog submission, external resource catalog submission, data
requests, and biospecimen requests;
<bullet> Monitor data submissions, study catalog submission,
external resource catalog submission, data requests, and biospecimen
requests;
<bullet> Notify interested Users of updates to data and
biospecimens available through NICHD DASH; and
<bullet> 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.
Estimated Annualized Burden Hours
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Annual burden hours estimate
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Number of Average burden
Form name Number of responses per per response Total annual
respondents respondent (in hours) burden hour
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User Registration............................... 900 1 5/60 75
[[Page 52483]]
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
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Total....................................... 1,414 1,414 .............. 433
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Dated: June 17, 2024.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2024-13715 Filed 6-21-24; 8:45 am]
BILLING CODE 4140-01-P
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