[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 782-783]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-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 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: 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.

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on November 8, 2018, page 
55905 (83 FR 55905) 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: 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                 300               1           10/60              50
                                 Data User
                                 Agreement.
Research scientists...........  NCS Vanguard                  50               1           20/60              17
                                 Data Request
                                 Form.
Research scientists...........  NCS Vanguard                  50               1           30/60              25
                                 Data and Sample
                                 Request Form.
Research scientists...........  Research                     100               1           10/60              17
                                 Materials
                                 Distribution
                                 Agreement.
                                                 ---------------------------------------------------------------
    Total.....................  ................             500             500  ..............             109
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[[Page 783]]

    Dated: January 24, 2019.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy Shriver National Institute of 
Child Health and Human Development, National Institutes of Health.
[FR Doc. 2019-00437 Filed 1-30-19; 8:45 am]
BILLING CODE 4140-01-P