Notice2026-18191
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
September 8, 2026
Effective
October 8, 2026
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 91 Issue 172 (Tuesday, September 8, 2026)</title>
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[Federal Register Volume 91, Number 172 (Tuesday, September 8, 2026)]
[Notices]
[Pages 57157-57159]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18191]
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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 by October 8, 2026.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent
[[Page 57158]]
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 240-447-7723, or email your request, including your address to:
<a href="/cdn-cgi/l/email-protection#87d4f2f7f7e8f5f3c3c6d4cfc7eae6eeeba9e9eeefa9e0e8f1"><span class="__cf_email__" data-cfemail="b0e3c5c0c0dfc2c4f4f1e3f8f0ddd1d9dc9eded9d89ed7dfc6">[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 May 27, 2026, pages
31471-31473, (Vol. 91 FR 31471) and allowed 60 days for public comment.
One request for information was received for the data collection plan
and tools to be provided. This was sent to the requester on June 29,
2026. There were no public comments. 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.
Proposed Collection: 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: NICHD DASH was established
by NICHD as a data sharing mechanism for clinical and population health
research studies. It serves as a centralized resource for investigators
to share and access de-identified study data funded by NICHD. DASH also
serves as a portal for requesting biospecimens from select DASH
studies.
NICHD is in the process of migrating DASH data to a new instance of
the Biomedical Research Informatics Computing System (BRICS) platform
operated by the NIH Center for Information Technology (CIT). This
requires changes to the existing Office of Management and Budget (OMB)-
approved DASH forms to align with the BRICS platform structure and to
incorporate new NIH Requirements for Controlled-Access Data
Repositories (CADRs) from the Required Security and Operational
Standards for NIH Controlled-Access Data Repositories (NIH CADR
Guidebook), hereinafter referred to as ``NOT-OD-25-159'' (<a href="https://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-25-159.html">https://www.grants.nih.gov/grants/guide/notice-files/NOT-OD-25-159.html</a>).
Six (6) NICHD DASH information collection forms have been updated
and three (3) forms have been removed. No (0) forms have been added.
Information collected from Users wishing to create an account will
be sufficient to identify them as unique Users in the NICHD DASH system
and to comply with user access requirements in NOT-OD-25-159. Users
submitting or requesting data and/or biospecimens will be required to
provide information to ensure proper use and secure handling of NICHD
DASH study data and biospecimens, in alignment with the standard data
submission and access processes and security standards and practices in
NOT-OD-25-159. Users submitting data will be required to provide an
institutional attestation that the data and biospecimen catalog being
submitted are appropriate for sharing in NICHD DASH, following the
standard language in NOT-OD-25-159. Users with approved data and
biospecimen requests will be required to submit an annual progress or
closeout report to provide data and/or biospecimen usage information
and comply with data access process and security standards in NOT-OD-
25-159 and biospecimen access terms. The information collected from
Users who register in NICHD DASH and submit or request data and/or
biospecimens will be used to monitor submissions and requests, oversee
Users' experiences with DASH, notify interested recipients of updates
to study data or biospecimen catalogs available through NICHD DASH, and
maintain User and NICHD DASH compliance with NOT-OD-25-159.
The potential for public benefit to be achieved through sharing
study data and/or biospecimens through DASH for secondary analysis is
significant. 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 promotes 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.
This revised information collection package is being submitted to
OMB to revise NICHD DASH clearance for use of the forms indicated in
the Table (Estimated Annualized Burden Hours) below. OMB approval is
requested for 3 years. There are no costs to respondents other than
their time.
The total User burden increased from 2024 to 2026 as a result of:
(a) Additional attestation information and data collection required to
comply with NOT-OD-25-159, and (b) NICHD DASH supporting a significant
increase in User numbers due to NIH-wide data sharing expectations
under the NIH DMS Policy. The estimated annualized burden is 1,361
hours. See details in the Table below.
Estimated Annualized Burden Hours
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............................... 1,500 1 5/60 125
Data and Biospecimen Catalog Submission......... 100 1 2 200
Institutional Certification Template............ 100 1 5/60 8
[[Page 57159]]
Data Access Request (New Request)............... 500 1 1 500
Data Access Request (Renewal)................... 380 1 10/60 63
Biospecimen Access Request (New Request)........ 60 1 1 60
Biospecimen Access Request (Renewal)............ 3 1 10/60 1
Annual Progress Report/Closeout Report (Data & 606 1 40/60 404
Biospecimen Access)............................
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Total....................................... 3,249 3,249 .............. 1,361
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Dated: September 2, 2026.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2026-18191 Filed 9-4-26; 8:45 am]
BILLING CODE 4140-01-P
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