[Federal Register Volume 89, Number 51 (Thursday, March 14, 2024)]
[Notices]
[Pages 18650-18652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05404]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 within 60 days of the date of 
this publication.

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 call non-toll-free number 301-827-4602, 
or email your request, including your address to: 
[email protected]. 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

[[Page 18651]]

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 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 three-year 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.

[[Page 18652]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                          Annual burden hours estimate
-----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total annual
                    Form name                       respondents    responses per   response  (in    burden hour
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
User Registration...............................             900               1            5/60              75
Data and Biospecimen Catalog Submission.........              36               1               2              72
Institutional Certification Template............              36               1            5/60               3
Data Request....................................             150               1               1             150
Biospecimen Request.............................               4               1               1               4
Data Request Annual Progress Report.............             240               1           30/60             120
Study Catalog Submission........................               2               1           30/60               1
External Resource Catalog Submission............               4               1           15/60               1
Data Request Renewal............................              42               1           10/60               7
                                                 ---------------------------------------------------------------
    Total.......................................           1,414           1,414  ..............             433
----------------------------------------------------------------------------------------------------------------


    Dated: March 6, 2024.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2024-05404 Filed 3-13-24; 8:45 am]
BILLING CODE 4140-01-P