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Notice2026-10517

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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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
May 27, 2026
Effective
July 27, 2026

Issuing agencies

Health and Human Services DepartmentNational Institutes of Health

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.

Full Text

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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&#160;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
----------------------------------------------------------------------------------------------------------------
                                                                      Number      Average burden   Total annual
                    Form name                        Number of     responses per   per response     burden (in
                                                    respondents     respondent      (in hours)        hours)
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    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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Indexed from Federal Register on May 27, 2026.

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