83 FR 55905 - 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)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 83, Issue 217 (November 8, 2018)

Page Range		55905-55906
FR Document		2018-24465

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.

Federal Register, Volume 83 Issue 217 (Thursday, November 8, 2018)

[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55905-55906]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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">[email protected]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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                           Average time
               Type of respondent                                  Form                      Number of     Frequency of    per response    Total annual
                                                                                            respondents      response         (hours)      burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------



[[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

Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices 55905

seeking statements of capability or proposed data collection projects, the electronic, mechanical, or other
interest from parties interested in National Institutes of Health Eunice technological collection techniques or
collaborative research, such as from bio- Kennedy Shriver National Institute of other forms of information technology.
analytic research groups to develop Child Health and Human Development Proposed Collection Title: National
rapid influenza monitoring, diagnostic, will publish periodic summaries of Children’s Study (NCS) Vanguard Data
and surveillance devices and proposed projects to be submitted to the and Sample Archive and Access
biotechnology companies to formulate Office of Management and Budget System, 0925–0730 exp., date 2/28/
and test influenza next generation (OMB) for review and approval. 2019—EXTENSION Eunice Kennedy
sequencing kits for challenging DATES: Comments regarding this Shriver National Institute of Child
influenza infected samples, for example information collection are best assured Health and Human Development
zoonotic infections of influenza A virus of having their full effect if received (NICHD), National Institutes of Health
subtypes differing from currently within 60 days of the date of this (NIH).
circulating human influenza viruses or publication. Need and Use of Information
in mixed infections. NIAID will FOR FURTHER INFORMATION CONTACT: To Collection: NICHD requires institutional
consider executing a Confidentiality obtain a copy of the data collection and investigator contact information
Agreement with a prospective plans and instruments, submit from users of the NCS Data and Sample
collaborator to facilitate receipt of a comments in writing, or request more Archive and Access System (NCS
Capability Statement if requested. For information on the proposed project, Archive). This information collected
collaboration opportunities, please contact: Jack Moye, Jr., MD, Bldg. 6710B from potential data users is necessary to
contact Jenish Patel, Ph.D., 240–669– Rm. 2130 MSC 7002, 9000 Rockville fulfill the requirements of their
2894; jenish.patel@nih.gov. Pike, Bethesda, MD, 20892–7002, or call proposed research projects, ensure
Dated: October 19, 2018. non-toll-free number (301) 594–8624 or compliance with Department of Health
Suzanne M. Frisbie, Email your request, including your and Human Services regulations for the
Deputy Director, Technology Transfer and address to: NCSArchive@s-3.net. Formal protection of human subjects in research
Intellectual Property Office, National Institute requests for additional plans and (45 CFR 46) and the Common Rule (45
of Allergy and Infectious Diseases. instruments must be requested in CFR 46 Subpart A), and to document,
[FR Doc. 2018–24468 Filed 11–7–18; 8:45 am] writing. track, and monitor the use of the NCS
BILLING CODE 4140–01–P SUPPLEMENTARY INFORMATION: Section Archive, which provides opportunities
3506(c)(2)(A) of the Paperwork for qualified researchers to use data and
Reduction Act of 1995 requires: Written samples collected by the NCS Vanguard
DEPARTMENT OF HEALTH AND comments and/or suggestions from the phase, for approved research projects.
HUMAN SERVICES public and affected agencies are invited The information in addition will help
to address one or more of the following NIH better understand the use of
National Institutes of Health points: (1) Whether the proposed archived data and samples by the
collection of information is necessary research community. There is no plan to
Proposed Collection; 60-Day Comment publish the data collected under this
for the proper performance of the
Request; National Children’s Study request other than to post on the NCS
function of the agency, including
(NCS) Vanguard Data and Sample Archive website the titles of approved
whether the information will have
Archive and Access System (Eunice research projects together with project
practical utility; (2) The accuracy of the
Kennedy Shriver National Institute of investigators’ institutional affiliations.
agency’s estimate of the burden of the
Child Health and Human Development) The data otherwise are for internal
proposed collection of information,
AGENCY: National Institutes of Health, including the validity of the monitoring purposes only, to assess the
HHS. methodology and assumptions used; (3) archive resource requirements and for
ACTION: Notice. Ways to enhance the quality, utility, and quality improvement.
clarity of the information to be OMB approval is requested for 3
SUMMARY: In compliance with the collected; and (4) Ways to minimize the years. There are no costs to respondents
requirement of the Paperwork burden of the collection of information other than their time. The total
Reduction Act of 1995 to provide on those who are to respond, including estimated annualized burden hours are
opportunity for public comment on the use of appropriate automated, 109.

ESTIMATED ANNUALIZED BURDEN HOURS
Average time
Number of Frequency of Total annual
Type of respondent Form per response
respondents response burden hours
(hours)

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 Form 50 1 30/60 25
Research scientists ....... Research Materials Distribution Agreement ........ 100 1 10/60 17

Total ........................ .............................................................................. 500 500 ........................ 109
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55906 Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices

Dated: November 1, 2018. (Catalogue of Federal Domestic Assistance DEPARTMENT OF HEALTH AND
Jennifer M. Guimond, Program No. 93.242, Mental Health Research HUMAN SERVICES
Project Clearance Liaison, Eunice Kennedy Grants, National Institutes of Health, HHS)
Shriver National Institute of Child Health and Dated: November 5, 2018. National Institutes of Health
Human Development, National Institutes of
Health. Melanie J. Pantoja, Government-Owned Inventions;
[FR Doc. 2018–24465 Filed 11–7–18; 8:45 am] Program Analyst, Office of Federal Advisory Availability for Licensing
Committee Policy.
BILLING CODE 4140–01–P
[FR Doc. 2018–24471 Filed 11–7–18; 8:45 am]
AGENCY: National Institutes of Health,
HHS.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND ACTION: Notice.
HUMAN SERVICES SUMMARY: The invention listed below is
DEPARTMENT OF HEALTH AND owned by an agency of the U.S.
National Institutes of Health HUMAN SERVICES Government and is available for
National Institute of Mental Health; licensing to achieve expeditious
National Institutes of Health commercialization of results of
Notice of Closed Meetings
federally-funded research and
Pursuant to section 10(d) of the National Eye Institute; Notice of Closed
development. Foreign patent
Federal Advisory Committee Act, as Meeting
applications are filed on selected
amended, notice is hereby given of the inventions to extend market coverage
following meetings. Pursuant to section 10(d) of the
for companies and may also be available
The meetings will be closed to the Federal Advisory Committee Act, as
for licensing.
public in accordance with the amended, notice is hereby given of the
FOR FURTHER INFORMATION CONTACT:
provisions set forth in sections following meeting.
James M. Robinson, 301–761–7542;
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., The meeting will be closed to the James.Robinson4@nih.gov. Licensing
as amended. The grant applications and public in accordance with the information and copies of the patent
the discussions could disclose provisions set forth in sections application listed below may be
confidential trade secrets or commercial 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., obtained by communicating with the
property such as patentable material, as amended. The grant applications and indicated licensing contact at the
and personal information concerning the discussions could disclose Technology Transfer and Intellectual
individuals associated with the grant confidential trade secrets or commercial Property Office, National Institute of
applications, the disclosure of which property such as patentable material, Allergy and Infectious Diseases, 5601
would constitute a clearly unwarranted
and personal information concerning Fishers Lane, Rockville, MD, 20852; tel.
invasion of personal privacy.
individuals associated with the grant 301–496–2644. A signed Confidential
Name of Committee: National Institute of applications, the disclosure of which Disclosure Agreement will be required
Mental Health Special Emphasis Panel to receive copies of unpublished patent
would constitute a clearly unwarranted
Member Conflicts: Mental Health Services applications.
Research. invasion of personal privacy.
Date: November 26, 2018. SUPPLEMENTARY INFORMATION:
Name of Committee: National Eye Institute
Time: 4:00 p.m. to 5:30 p.m. Special Emphasis Panel; NEI Institutional Technology description follows.
Agenda: To review and evaluate grant Training Grant Applications (T32 and T35).
Methods for diagnosing and treating
applications.
Date: November 27–28, 2018. Mycobacterium tuberculosis (Mtb)
Place: National Institutes of Health, infection through detection of CD153
Neuroscience Center, 6001 Executive Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant expression level.
Boulevard, Rockville, MD 20852 (Virtual Description of Technology:
Meeting). applications.
Place: National Institutes of Health, 6700B
Mycobacterium tuberculosis (Mtb)
Contact Person: Karen Gavin-Evans, Ph.D.,
Scientific Review Officer, Division of Rockledge Drive, Ste. 3400, Bethesda, MD infection continues to be the leading
Extramural Activities, National Institute of 20817 (Virtual Meeting). cause of death due to a single infectious
Mental Health, NIH, Neuroscience Center, Contact Person: Anne E. Schaffner, Ph.D., agent and poses significant global health
6001 Executive Boulevard, Room 6153, MSC Chief, Scientific Review Branch, Division of challenges. Past research has shown that
9606, Bethesda, MD 20892, 301–451–2356, Extramural Research, National Eye Institute, CD4 T cells are essential for resistance
gavinevanskm@mail.nih.gov. to Mtb infection, and for decades it has
5635 Fishers Lane, Suite 1300, Msc 9300,
Name of Committee: National Institute of Bethesda, MD 20892–9300, (301) 451–2020, been thought that IFN(g) production is
Mental Health Special Emphasis Panel; Rare the primary mechanism of CD4 T cell-
aes@nei.nih.gov.
Genetic Disorders as a Window into the mediated protection.
Genetic Architecture of Mental Disorders. (Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
NIAID researchers have discovered
Date: November 27, 2018.
Time: 10:00 a.m. to 1:00 p.m. National Institutes of Health, HHS)
that the expression of TNF superfamily
Agenda: To review and evaluate grant molecule CD153 (TNSF8) is required for
applications. Dated: November 2, 2018. control of the pulmonary Mtb infection
Place: National Institutes of Health, Natasha M. Copeland, by CD4 T cells. The results have shown
Neuroscience Center, 6001 Executive Program Analyst, Office of Federal Advisory that, in Mtb infected mice, CD153
Boulevard, Rockville, MD 20852 (Telephone Committee Policy. expression is highest on Ag-specific Th1
daltland on DSKBBV9HB2PROD with NOTICES

Conference Call). cells in the lung tissue parenchyma. On
[FR Doc. 2018–24467 Filed 11–7–18; 8:45 am]
Contact Person: Vinod Charles, Ph.D., the contrary, CD153 deficient mice have
Scientific Review Officer, Division of BILLING CODE 4140–01–P
Extramural Activities, National Institute of
developed high pulmonary bacterial
Mental Health, NIH Neuroscience Center, loads and succumb early to Mtb
6001 Executive Blvd., Room 6151, MSC 9606, infection. In Mtb infected non-human
Bethesda, MD 20892–9606, 301–443–1606, primates, CD153 expression is much
charlesvi@mail.nih.gov. higher on Ag-specific CD4 T cells in the

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Document Created: 2018-11-08 06:23:21
Document Modified: 2018-11-08 06:23:21

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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
FR Citation		83 FR 55905

83 FR 55905 - 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)

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 83, Issue 217 (November 8, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health