Proposed Collection; 60-Day Comment Request: National Children's Study (NCS) Data Archive and Repository (NICHD), 22543 [2015-09359]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Page 22543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09359]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request: National Children's 
Study (NCS) Data Archive and Repository (NICHD)

SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of 
the Paperwork Reduction Act of 1995, for 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 (NIH) will publish periodic summaries of 
proposed projects to be submitted to the Office of Management and 
Budget (OMB) for review and approval.
    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) the quality, utility, and clarity of the information to be 
collected; and (4) 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.
    To Submit Comments and for Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: Dr. Jack 
Moye, 6100 Executive Boulevard, Rockville Pike, MD 20891 or call 301-
594-8624 or Email your request, including your address to: 
moyej@mail.nih.gov. Formal requests for additional plans and 
instruments must be requested in writing.

DATES: Comment Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 60 days 
of the date of this publication.
    Proposed Collection: National Children's Study (NCS) Data Archive 
and Repository, 0925-NEW, National Institute of Child Health and Human 
Development (NICHD), National Institutes of Health (NIH).
    Need and Use of Information Collection: The primary use of this 
data archive and repository is to facilitate, document, track, monitor, 
and evaluate the access of NCS Vanguard Study data previously 
collected. There are two planned levels of data access associated with 
NCS Vanguard Study data: (1) Through a de-identified dataset containing 
key variables. Access requirements for the de-identified dataset would 
be modest, requiring that the investigators, promise not to attempt to 
re-identify participants, agree to cite the NCS as the source of the 
data, and submit a copy of any paper submitted or published using the 
data; (2) through a secure, virtual data enclave wherein users could 
access and analyze data, provided that they describe their research 
plan, submit IRB approval documentation, complete a Data User Agreement 
(DUA) DUA, and agree to submit a copy of any paper submitted or 
published using the data. In the planned virtual data enclave, the 
investigator cannot download any participant-level data for use outside 
of the protected analytic environment. Upon approval of the research 
project the data files specified in the DUA would be placed in the 
investigator's project space within the data enclave by the enclave 
staff. Final analytic results would be screened by the enclave staff 
for identifiable information prior to release back to the investigator.
    There is no plan to publish the data collected under this request. 
These data are for internal monitoring purposes to assess the enclave 
resource requirements.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 154.

                                        Estimated Annualized Burden Hours
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                                                                                   Average time
                      Form                           Number of     Frequency of   per response (   Total annual
                                                    respondents      response        in hours)      burden hour
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De-identified data access.......................             300               1           10/60              50
Enclave data access.............................             100               1               1             100
Additional data access..........................              50               1            5/60               4
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    Dated: April 10, 2015.
Sarah L. Glavin,
Project Clearance Officer, Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, Deputy Director, Office of Science 
Policy, Analysis, and Communications, Eunice Kennedy Shriver National 
Institute of Child Health and Human Development, National Institutes of 
Health.
[FR Doc. 2015-09359 Filed 4-21-15; 8:45 am]
BILLING CODE 4140-01-P