[Federal Register Volume 83, Number 216 (Wednesday, November 7, 2018)]
[Notices]
[Pages 55729-55730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24313]


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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/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden and associated response time, should be directed to the: Office 
of Management and Budget, Office of Regulatory Affairs, 
[email protected] or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

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: Rohan Hazra, M.D., Eunice Kennedy Shriver 
National Institute of Child Health and Human Development (NICHD), 
National Institutes of Health, 6710B Rockledge Drive, Room 2113, 
Bethesda, MD 20817, or call non-toll-free number (301)-435-6868 or 
Email your request, including your address to: [email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on April 27, 2018, page 
18576 (Vol 83) 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) 0925-0774 exp. 
date 6/30/19--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 to 
add the collection of additional information from Users who will 
request biospecimens, submit the Institutional Certification for data/
biospecimen inventory, and submit DASH data/biospecimen Annual Progress 
Report for the NICHD Data and Specimen Hub (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 store and access deidentified study data and 
biospecimen inventories--a list of biospecimens available at the NICHD

[[Page 55730]]

Biorepository--from studies funded by NICHD. The potential for public 
benefit to be achieved through sharing study data and/or biospecimen 
inventories for secondary analysis is significant. 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, and 
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 
already collected, facilitate transdisciplinary 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 study data archived in NICHD DASH 
without creating an account. Users who wish to submit or request 
research data and/or biospecimen inventories must 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 biospecimen inventories will be required to 
provide additional supporting information to ensure proper use and 
security of NICHD DASH study data and biospecimen inventories. 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 Users by NICHD will be 
to:

 Communicate with the Users with regards to their data 
submission, data requests and biospecimen requests
 Monitor data submissions, data requests and biospecimen 
requests
 Notify interested recipients of updates to data and 
biospecimen inventories stored in NICHD DASH
 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 204.

                                        Estimated Annualized Burden Hours
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                                                                     Number of     Average time
                      Form                           Number of    responses  per   per response    Total annual
                                                    respondents      respondent     (in hours)      burden hour
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User Registration...............................             200               1            5/60              17
Data Submission and Biospecimen Inventory                     36               1               2              72
 Submissions....................................
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  ..............             204
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    Dated: November 1, 2018.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2018-24313 Filed 11-6-18; 8:45 am]
 BILLING CODE 4140-01-P