83 FR 18575 - Proposed Collection; 60-Day Comment Request Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 82 (April 27, 2018)

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, 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.

[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)]
[Notices]
[Pages 18575-18576]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-08901]


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

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 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: 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]. 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 clarity of the information to be collected; and (4) Ways 
to minimizes 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 06/30/2019, 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 de-identified study data and 
biospecimen inventories--a list of biospecimens available at the NICHD 
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 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 study data archived in NICHD DASH 
without creating an account. Users who wish to submit or request 
research data and/or

[[Page 18576]]

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
----------------------------------------------------------------------------------------------------------------
                                                                                   Average time
                  Type of form                       Number of     Frequency of    per response    Total annual
                                                    respondents      response       (in hours)      burden hour
----------------------------------------------------------------------------------------------------------------
User Registration...............................             200               1            5/60              17
Data and Biospecimen Inventory Submission.......              36               1               2              72
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
----------------------------------------------------------------------------------------------------------------


    Dated: April 17, 2018.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver, National Institute 
of Child Health and Human Development, National Institutes of Health.
[FR Doc. 2018-08901 Filed 4-26-18; 8:45 am]
 BILLING CODE 4140-01-P