Proposed Collection; 60-Day Comment Request; Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development)
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Abstract
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.
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<title>Federal Register, Volume 91 Issue 101 (Wednesday, May 27, 2026)</title>
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[Federal Register Volume 91, Number 101 (Wednesday, May 27, 2026)]
[Notices]
[Pages 31471-31473]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10517]
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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.
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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 by July 27, 2026.
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 Email your request, including your
address to: <a href="/cdn-cgi/l/email-protection#03507673736c71774742504b436e626a6f2d6d6a6b2d646c75"><span class="__cf_email__" data-cfemail="c794b2b7b7a8b5b38386948f87aaa6aeabe9a9aeafe9a0a8b1">[email protected]</span></a>. 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 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 07/31/2027, REVISION, 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
[[Page 31472]]
Specimen Hub (DASH) is in the process of moving its existing data
repository to the Biomedical Research Informatics Computing System
(BRICS) data repository platform operated by the NIH Center for
Information Technology (CIT). This requires changes to the existing OMB
approved DASH forms to meet the CIT BRICS platform structure and also
to incorporate NIH Requirements for Controlled-Access Data Repositories
(CADRs) from the Required Security and Operational Standards for NIH
Controlled-Access Data Repositories (NOT-OD-25-159) Guidebook.
Specifically, we will revise the Data and Biospecimen Catalog
Submission form to add items required for study milestone tracking and
remove outdated policy compliance items. In addition, we will add new
data collection, submission, and sharing assurances to the
Institutional Certification Template and reduce the number of items on
the User Registration form. The Data Request, Biospecimen Request, and
Data Request Annual Progress Report forms will have minor revisions to
add field options and update language that does not impact the nature
of information being collected or its associated burden. Finally, we
are removing three forms that are no longer in use by DASH: the Data
Request Renewal Form, External Resource Catalog Submission form, and
Study Catalog Submission form.
DASH was established by NICHD as a data and biospecimen sharing
mechanism for biomedical research investigators. It serves as a
centralized resource for investigators to share and access de-
identified clinical and population health data from studies funded by
NICHD. DASH also serves as a portal for requesting biospecimens from
select DASH studies. NICHD researchers may generate other types of
scientific data that cannot be shared in DASH. Investigators submitting
data to DASH can indicate in their submissions if related study data
are shared in other NIH data repositories and where those data are
shared, for investigators to find and request access as needed.
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 study data shared across other
public archives 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.
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 and to comply with NIH
Requirements for CADRs. 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 by
NICHD will be to:
<bullet> Communicate with the Users regarding data and biospecimen
catalog submission, data requests, and biospecimen requests;
<bullet> Monitor data and biospecimen catalog submissions, 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 Progress 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 is 1,010. The proposed difference is a 6-hour reduction in
the annualized burden.
Estimated Annualized Burden Hours
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Number Average burden Total annual
Form name Number of responses per per response burden (in
respondents respondent (in hours) hours)
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1. User Registration............................ 1,482 1 5/60 124
2. Institutional Certification Template......... 37 1 10/60 6
3. Data Request Annual Progress Report.......... 313 1 30/60 157
4. Data Request................................. 637 1 1 637
5. Data and Biospecimen Catalog Submission...... 37 1 2 74
6. Biospecimen Request.......................... 12 1 1 12
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Total....................................... 2,518 2,518 .............. 1,010
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[[Page 31473]]
Dated: May 21, 2026.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2026-10517 Filed 5-26-26; 8:45 am]
BILLING CODE 4140-01-P
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