Billing Code 4140-01-P
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.
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
www.reginfo.gov/public/do/PRAMain. 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 nontoll-free number 301-827-4602, or e-mail your request, including your address to:
NICHD.DASH@mail.nih.gov. 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.
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 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 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.
Estimated Annualized Burden Hours

Form Name
User Registration

Annual Burden Hours Estimate
Number of
Average Burden
Number of
Responses
Per Response
Respondents
per
(in hours)
Respondent

Total Annual
Burden Hour

1

5/60

36

2

36

5/60

Data Request

1

150

Biospecimen
Request

1

4

Data and
Biospecimen
Catalog Submission
Institutional
Certification
Template

Data Request
Annual Progress
Report
Study Catalog
Submission
External Resource
Catalog Submission
Data Request
Renewal
Total

1

30/60

2

30/60

4

15/60

42

10/60

1414

433

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: 6/21/2024 8:45 am; Publication Date: 6/24/2024]