[Federal Register Volume 86, Number 9 (Thursday, January 14, 2021)]
[Notices]
[Pages 3160-3162]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00636]


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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 propose 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: 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: 
<a href="/cdn-cgi/l/email-protection#afe1e6ece7eb81ebeefce7efc2cec6c381c1c6c781c8c0d9"><span class="__cf_email__" data-cfemail="37797e747f73197376647f775a565e5b19595e5f19505841">[email 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

[[Page 3161]]

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 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 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:
    <bullet> Communicate with the Users regarding data submission, 
study catalog submission, data collection catalog submission, data 
requests and biospecimen requests;
    <bullet> Monitor data submissions, study catalog submission, data 
collection catalog submission, data requests and biospecimen requests;
    <bullet> Notify interested Users of updates to data and biospecimen 
inventories stored in NICHD DASH; and
    <bullet> 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
                  Type of form                       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

[[Page 3162]]

 
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: January 5, 2021.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2021-00636 Filed 1-13-21; 8:45 am]
BILLING CODE 4140-01-P


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