Document

Submission for OMB Review; 30-Day Comment Request Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development)

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 a...

Department of Health and Human Services
National Institutes of Health

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 by October 8, 2026.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent ( printed page 57158) 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 non-toll-free number 240-447-7723, or email your request, including your address to: . 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” ( www.grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-25-159.html).

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

Form name Number of respondents Number of responses per respondent Average burden per response (in hours) Total annual burden hour
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
( printed 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 & Biospecimen Access) 606 1 40/60 404
Total 3,249 3,249 1,361

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

Legal Citation

Federal Register Citation

Use this for formal legal and research references to the published document.

91 FR 57157

Web Citation

Suggested Web Citation

Use this when citing the archival web version of the document.

“Submission for OMB Review; 30-Day Comment Request Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development),” thefederalregister.org (September 8, 2026), https://thefederalregister.org/documents/2026-18191/submission-for-omb-review-30-day-comment-request-data-and-specimen-hub-dash-eunice-kennedy-shriver-national-institute-of.