[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55905-55906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24465]


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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) Vanguard Data and Sample Archive and Access System (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 National Institutes of Health Eunice Kennedy 
Shriver National Institute of Child Health and Human Development 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: Jack Moye, 
Jr., MD, Bldg. 6710B Rm. 2130 MSC 7002, 9000 Rockville Pike, Bethesda, 
MD, 20892-7002, or call non-toll-free number (301) 594-8624 or Email 
your request, including your address to: 3.net">NCSArchive@s-3.net. 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 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: National Children's Study (NCS) Vanguard 
Data and Sample Archive and Access System, 0925-0730 exp., date 2/28/
2019--EXTENSION Eunice Kennedy Shriver National Institute of Child 
Health and Human Development (NICHD), National Institutes of Health 
(NIH).
    Need and Use of Information Collection: NICHD requires 
institutional and investigator contact information from users of the 
NCS Data and Sample Archive and Access System (NCS Archive). This 
information collected from potential data users is necessary to fulfill 
the requirements of their proposed research projects, ensure compliance 
with Department of Health and Human Services regulations for the 
protection of human subjects in research (45 CFR 46) and the Common 
Rule (45 CFR 46 Subpart A), and to document, track, and monitor the use 
of the NCS Archive, which provides opportunities for qualified 
researchers to use data and samples collected by the NCS Vanguard 
phase, for approved research projects. The information in addition will 
help NIH better understand the use of archived data and samples by the 
research community. There is no plan to publish the data collected 
under this request other than to post on the NCS Archive website the 
titles of approved research projects together with project 
investigators' institutional affiliations. The data otherwise are for 
internal monitoring purposes only, to assess the archive resource 
requirements and for quality improvement.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 109.

                                                            Estimated Annualized Burden Hours
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                                                                                                                           Average time
               Type of respondent                                  Form                      Number of     Frequency of    per response    Total annual
                                                                                            respondents      response         (hours)      burden hours
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Research scientists............................  NCS Vanguard Data User Agreement.......             300               1           10/60              50
Research scientists............................  NCS Vanguard Data Request Form.........              50               1           20/60              17
Research scientists............................  NCS Vanguard Data and Sample Request                 50               1           30/60              25
                                                  Form.
Research scientists............................  Research Materials Distribution                     100               1           10/60              17
                                                  Agreement.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             500             500  ..............             109
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[[Page 55906]]

    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. 2018-24465 Filed 11-7-18; 8:45 am]
 BILLING CODE 4140-01-P