Submission for OMB Review; 30-Day Comment Request; Generic Clearance for the Research Domain Criteria (RDoC) Initiative (National Institute of Mental Health), 16378-16379 [2018-07859]
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Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
assemble into nanoparticles with
influenza antigenic proteins displayed
on the nanoparticle surface (Nature 499,
102–106 (2013)). Further engineering
these recombinant fusion proteins, the
scientists have developed nanoparticles
that simultaneously display multiple
strains of influenza viral protein
antigens (the receptor-binding domain
of hemagglutinin) on their surface. Due
to the heterogeneity of the antigenic
protein derived from multiple strains,
these nanoparticles are referred to as
mosaic nanoparticles.
Upon immunization of mice with
mosaic nanoparticles displaying
antigens from eight different H1N1
strains, the elicited antibodies
neutralized a panel of H1N1 strains
from 1918 through 2009 including the
strains that had not been displayed on
the mosaic nanoparticle. However, mice
immunized with a mixture of the eight
types of nanoparticles, each displaying
a single antigenic protein, did not elicit
a similar breadth of neutralizing
antibody response.
NIAID is continuing development of
these vaccine candidates through
animal studies and moving toward
clinical evaluation.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404, as well as for further
development and evaluation under a
research collaboration.
Potential Commercial Applications:
• Vaccine platform for seasonal
influenza with broader protection
coverage
Competitive Advantages:
• Nucleic acid or recombinant
protein-based vaccine
• Increased ease of production
compared to current seasonal influenza
vaccines
Development Stage:
• In vivo (animal studies)
Inventors: Barney S. Graham, Hadi
Yassine, Masaru Kanekiyo (all from
NIAID).
Publications: Kanekiyo, M, et al.
Manuscript under revision.
Intellectual Property: HHS Reference
Number E–060–2015 includes U.S.
Patent Application No. 15/540,898 filed
June 29, 2017 (Pending); Canada Patent
Application No. 2,974,346 filed
December 31, 2015 (Pending); China
Patent Application No. 201580076324.6
filed December 31, 2015 (Pending);
Europe Patent Application No.
15825772.5 filed July 7, 2017 (Pending);
India Patent Application No
201717026077 filed July 21, 2017
(Pending); Australia Patent Application
No. 2015373928 filed July 21, 2017;
Brazil Patent Application No.
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BR112017014219–8 filed June 29, 2017;
Israel Patent Application No. 253187
filed December 31, 2015; Japan Patent
Application No. 2017–534796 filed June
28, 2017; South Korean Patent
Application No. 10–2017–7021112 filed
July 27, 2017; Singapore Patent
Application No. 11201705264W filed
June 23, 2017.
Related Intellectual Property: HHS
Reference Number E–293–2011
Licensing Contact: Dr. Amy Petrik,
240–627–3721; amy.petrik@nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate or
commercialize influenza monoclonal
antibody technologies. For collaboration
opportunities, please contact Dr. Amy
Petrik, 240–627–3721; amy.petrik@
nih.gov.
Dated: April 5, 2018.
Suzanne M. Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2018–07821 Filed 4–13–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Generic Clearance
for the Research Domain Criteria
(RDoC) Initiative (National Institute of
Mental Health)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
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.
SUMMARY:
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,
OIRA_submission@omb.eop.gov or by
ADDRESSES:
PO 00000
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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: Melba Rojas,
NIMH Project Clearance Liaison,
Science Policy and Evaluation Branch,
Office of Science Policy, Planning and
Communications, NIMH, Neuroscience
Center, 6001 Executive Boulevard, MSC
9667, Bethesda, Maryland 20892, call
301–443–4335, or email your request,
including your mailing address, to
nimhprapubliccomments@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on January 29, 2018, pages
4062–4063 (83 FR 4062) 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
National Institute of Mental Health
(NIMH), 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: Generic
Clearance for the Research Domain
Criteria (RDoC) Initiative, 0925–NEW,
National Institute of Mental Health
(NIMH), National Institutes of Health
(NIH).
Need and Use of Information
Collection: This request serves as notice
that the National Institute of Mental
Health (NIMH) is seeking OMB approval
of a generic plan to conduct information
collections to interface with the
scientific community and promote the
RDoC Initiative. As the lead Federal
agency for research on mental illnesses,
NIMH’s mission is to transform the
understanding and treatment of mental
illnesses through basic and clinical
research, paving the way for prevention,
recovery, and cure. To this end, NIMH
launched the RDoC Initiative in 2009 to
implement Strategy 1.4 of the 2008
NIMH Strategic Plan: ‘‘Develop new
ways of classifying disorders based on
dimensions of observable behaviors and
brain functions.’’ The aim of RDoC is to
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16APN1
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Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
guide research that begins with
disruptions in neurobiological and
behavioral mechanisms, and then works
across systems to clarify connections
among such disruptions and clinical
symptoms. The information collected as
OMB approval is requested for 3
years. There are no costs to respondents’
other than their time. The total
estimated annualized burden hours are
490.
part of this generic clearance will allow
NIMH to determine success of the RDoC
Initiative, develop future directions and
endeavors, and to help guide
programmatic priorities for RDoC and
the agency.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Instrument type
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
Workshops .......................................................................................................
Interviews .........................................................................................................
Surveys ............................................................................................................
Focus Groups ..................................................................................................
Evaluation Forms .............................................................................................
50
10
100
10
100
1
1
1
1
1
8
30/60
30/60
1
15/60
400
5
50
10
25
Total ..........................................................................................................
270
270
........................
490
Dated: April 4, 2018.
Melba O. Rojas,
Project Clearance Liaison, NIMH, NIH.
[FR Doc. 2018–07859 Filed 4–13–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF THE INTERIOR
U.S. Geological Survey
[GX18DJ00COM0050]
Federal Interagency Collaborative on
Environmental Modeling and
Monitoring
U.S. Geological Survey (USGS),
Interior.
ACTION: Notice of public meeting.
AGENCY:
The annual public meeting of
the Federal Interagency Collaborative
for Environmental Modeling and
Monitoring (ICEMM) will convene to
discuss developments in environmental
modeling applications, tools and
frameworks, as well as new operational
initiatives among the participating
agencies. The meeting this year will
focus on the theme of ‘‘Monitoring and
Model Data Fusion.’’
DATES: The meeting will be held on
April 24–25, 2018, from 9:00 a.m. to
5:00 p.m.
ADDRESSES: The meeting will be held at
U.S. Nuclear Regulatory Commission,
Office of Nuclear Regulatory Research,
11555 Rockville Pike, Rockville, MD
20852.
srobinson on DSK3G9T082PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Brenda Rashleigh, Assistant Laboratory
Director for Water, U.S. Environmental
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Protection Agency by email at
Rashleigh.Brenda@epa.gov, or by
telephone at (401) 782–3014; or Pierre
Glynn, Chief, Water Cycle Branch, U.S.
Geological Survey, by email at pglynn@
usgs.gov, or by telephone at (703) 648–
5823.
SUPPLEMENTARY INFORMATION:
Background: Federal agencies have
been cooperating since 2001 under a
Memorandum of Understanding (MOU)
on the research and development of
multimedia environmental models.
(please see: https://my.usgs.gov/
confluence/display/cdi/Interagency+
Collaborative+for+Environmental+
Modeling+and+Monitoring). The MOU,
revised and reaffirmed in 2016,
establishes a framework for facilitating
cooperation and coordination among six
agencies (the specific research
organization within the agency is in
parentheses):
• National Science Foundation;
• U.S. Army Corps of Engineers
(Engineer Research and Development
Center);
• U.S. Department of Energy (Office
of Biological and Environmental
Research);
• U.S. Environmental Protection
Agency (Office of Research and
Development);
• U.S. Geological Survey; and
• U.S. Nuclear Regulatory
Commission (Office of Nuclear
Regulatory Research).
These agencies are cooperating and
coordinating in the research and
development of multimedia
environmental models, software, and
related databases. Model development
and simulation supports interagency
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interests in human and environmental
health risk assessment, uncertainty
analyses, water supply issues, and
contaminant transport.
Purpose of the Public Meeting: The
MOU calls for an annual public meeting
to provide an opportunity for other
Federal and State agencies, the scientific
community, and the public to be briefed
on ICEMM activities and initiatives and
to discuss technological advancements
in multimedia environmental modeling.
Proposed Agenda: This year’s ICEMM
public meeting will be a workshop
focusing on modeling and monitoring
data fusion. The ICEMM Chair will open
the meeting with an overview of the
goals of the MOU and current activities
of ICEMM, followed by a series of
presentations on collaborative modeling
and monitoring efforts by ICEMM and
invited speakers. During the morning of
the second day, the ICEMM agencies
will discuss their programs addressing
modeling and monitoring data fusion.
During the afternoon of the second day,
the chairs of the ICEMM Workgroups
will discuss their activities and plans
for fiscal years 2018 and 2019.
Meeting Access: The meeting will be
available for onsite attendance or
remotely through Web Meeting Services.
To obtain onsite or web access, all
interested attendees must pre-register by
providing their full contact information
and affiliation. (See FOR FURTHER
INFORMATION CONTACT).
Pierre Glynn,
U.S. Geological Survey.
[FR Doc. 2018–07764 Filed 4–13–18; 8:45 am]
BILLING CODE 4338–11–P
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]]>Agencies
[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Notices]
[Pages 16378-16379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07859]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Generic
Clearance for the Research Domain Criteria (RDoC) Initiative (National
Institute of Mental Health)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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: Melba Rojas, NIMH Project Clearance Liaison,
Science Policy and Evaluation Branch, Office of Science Policy,
Planning and Communications, NIMH, Neuroscience Center, 6001 Executive
Boulevard, MSC 9667, Bethesda, Maryland 20892, call 301-443-4335, or
email your request, including your mailing address, to
[email protected].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on January 29, 2018, pages
4062-4063 (83 FR 4062) 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 National Institute of
Mental Health (NIMH), 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: Generic Clearance for the Research Domain
Criteria (RDoC) Initiative, 0925-NEW, National Institute of Mental
Health (NIMH), National Institutes of Health (NIH).
Need and Use of Information Collection: This request serves as
notice that the National Institute of Mental Health (NIMH) is seeking
OMB approval of a generic plan to conduct information collections to
interface with the scientific community and promote the RDoC
Initiative. As the lead Federal agency for research on mental
illnesses, NIMH's mission is to transform the understanding and
treatment of mental illnesses through basic and clinical research,
paving the way for prevention, recovery, and cure. To this end, NIMH
launched the RDoC Initiative in 2009 to implement Strategy 1.4 of the
2008 NIMH Strategic Plan: ``Develop new ways of classifying disorders
based on dimensions of observable behaviors and brain functions.'' The
aim of RDoC is to
[[Page 16379]]
guide research that begins with disruptions in neurobiological and
behavioral mechanisms, and then works across systems to clarify
connections among such disruptions and clinical symptoms. The
information collected as part of this generic clearance will allow NIMH
to determine success of the RDoC Initiative, develop future directions
and endeavors, and to help guide programmatic priorities for RDoC and
the agency.
OMB approval is requested for 3 years. There are no costs to
respondents' other than their time. The total estimated annualized
burden hours are 490.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument type Number of responses per per response Total annual
respondents respondent (in hours) burden hours
----------------------------------------------------------------------------------------------------------------
Workshops....................................... 50 1 8 400
Interviews...................................... 10 1 30/60 5
Surveys......................................... 100 1 30/60 50
Focus Groups.................................... 10 1 1 10
Evaluation Forms................................ 100 1 15/60 25
---------------------------------------------------------------
Total....................................... 270 270 .............. 490
----------------------------------------------------------------------------------------------------------------
Dated: April 4, 2018.
Melba O. Rojas,
Project Clearance Liaison, NIMH, NIH.
[FR Doc. 2018-07859 Filed 4-13-18; 8:45 am]
BILLING CODE 4140-01-P
