[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.
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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