[Federal Register Volume 86, Number 67 (Friday, April 9, 2021)]
[Notices]
[Pages 18548-18549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07313]


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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 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: Regina Bures, Ph.D., Eunice Kennedy Shriver 
National Institute of Child Health and Human Development (NICHD), 
National Institutes of Health, 6710B Rockledge Drive, Room 2160, 
Bethesda, MD 20817, or call non-toll-free number (301)-496-9485 or 
Email your request, including your address to: [email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on January 14, 2021, page 
3160-3162 (86 FR 3160-3162) 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 01/31/2022, 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 will submit 
information to NICHD Data and Specimen Hub (DASH) about studies, and 
data collections stored in publicly accessible external archives--a 
process hereinafter referred to as `cataloging' in DASH.
    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 selected 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 
National

[[Page 18549]]

Institutes of Health (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 will 
enable Users to catalog studies and data collections stored in other 
external archives to facilitate their discovery through DASH. Users 
submitting studies or data collections 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 ensure that every person is born healthy and wanted; that 
women suffer no harmful effects from reproductive processes; that all 
children have the chance to achieve their full potential for healthy 
and productive lives, free from disease or disability; and to ensure 
the health, productivity, independence, and well-being of all people 
through optimal rehabilitation. 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 request biospecimens (stored in NICHD contracted 
Biorepository) must register for an account; Users who wish to submit a 
study catalog and/or data collection 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. The information collected 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. The primary uses of the 
information collected from Uses by NICHD will be to:
     Communicate with the Users regarding data submission, 
study catalog submission, data collection catalog submission, data 
requests and biospecimen requests;
     Monitor data submissions, study catalog submission, data 
collection catalog submission, data requests and biospecimen requests;
     Notify interested Users of updates to data and biospecimen 
inventories stored in NICHD DASH; and
     Help NICHD understand the use of NICHD DASH study data and 
biospecimen inventories by the research community.
    All the data collected from use of NICHD DASH except for 
information provided in the annual progress reports are for the 
purposes of internal administrative management of NICHD DASH. 
Information gathered through the annual progress reports may be used in 
publications describing performance of the DASH system.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 211.

                                        Estimated Annualized Burden Hours
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                                                                   Frequency of    Average time
                    Form name                        Number of     response per    per response    Total annual
                                                    respondents     respondent      (in hours)      burden hour
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User Registration...............................             200               1            5/60              17
Data and Biospecimen Inventory Submissions......              36               1               2              72
Study Catalog Submission........................              10               1           30/60               5
Data Collection Catalog Submission..............               6               1           15/60               2
Data Request....................................              60               1               1              60
Biospecimen Request.............................              36               1               1              36
Data Use Annual Progress Report.................              60               1           10/60              10
Biospecimen Use Annual Progress Report..........              36               1           10/60               6
Institutional Certification Template............              36               1            5/60               3
                                                 ---------------------------------------------------------------
    Total.......................................             200             200  ..............             211
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    Dated: April 1, 2021.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2021-07313 Filed 4-8-21; 8:45 am]
BILLING CODE 4140-01-P