Submission for OMB Review; 30-Day Comment Request; Autism Spectrum Disorder (ASD) Research Portfolio Analysis, NIMH, 66685-66686 [2019-26294]
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Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
and pandemic-potential influenza
viruses.
This technology is available for
licensing for commercial development
in accordance with 35 U.S.C. 209 and 37
CFR part 404.
Potential Commercial Applications:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The invention listed below is
owned by an agency of the U.S.
Government and is available for
licensing to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Jenish Patel, Ph.D., 240–669–2894;
jenish.patel@nih.gov. Licensing
information and copies of the U.S.
patent application listed below may be
obtained by communicating with the
indicated licensing contact at the
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD, 20852; tel.
301–496–2644. A signed Confidential
Disclosure Agreement will be required
to receive copies of unpublished patent
applications.
SUPPLEMENTARY INFORMATION:
Technology description follows.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
Broadly Protective Influenza Vaccine
Comprising a Cocktail of Inactivated
Avian Influenza Viruses
Description of Technology: There is a
great need for broadly protective,
‘‘universal’’ influenza virus vaccines
given the antigenic drift and shift of
influenza viruses and the variable
protective efficacy of the current
influenza vaccines. This technology
relates to a broadly protective,
‘‘universal’’ influenza vaccine candidate
composed of a cocktail of different low
pathogenicity avian influenza virus
subtypes inactivated by
betapropiolactone (BPL). Vaccinating
animals with BPL-inactivated whole
virus vaccine comprising influenza
virus strains belonging to four or more
different low pathogenicity avian
influenza hemagglutinin subtypes,
intranasally or intramuscularly,
provided extremely broad protection
and heterosubtypic protection to lethal
challenge with influenza viruses in both
mice and ferrets. This influenza vaccine
technology has a great potential to offer
broad protection against both seasonal
VerDate Sep<11>2014
17:38 Dec 04, 2019
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• Vaccine against viruses
• Vaccines against influenza virus
• Universal influenza virus vaccine
Competitive Advantages:
• Broad protection to both seasonal and
pandemic-potential influenza viruses
• Easy and cost-effective inactivation
method
• Effective immune response due to the
use of authentic viral antigens
• Animal data available
Development Stage:
• In vivo (animal)
Inventors: Jeffery K. Taubenberger,
M.D., Ph.D., (NIAID) and Louis Merican
Schwartzman, Ph.D. (NIAID).
Publications: None.
Intellectual Property: HHS Reference
No. E–033–2018/0—PCT Application
filed January 18, 2019—PCT/US2019/
014220.
Licensing Contact: To license this
technology, please contact Jenish Patel,
Ph.D., 240–669–2894; jenish.patel@
nih.gov.
Collaborative Research Opportunity:
The National Institute of Allergy and
Infectious Diseases is also seeking
statements of capability or interest from
parties interested in collaborative
research. NIAID would like a
prospective collaborator to have the
capacity to generate clinical grade
materials and perform clinical studies.
NIAID will consider executing a
Confidentiality Agreement with a
prospective collaborator to facilitate
receipt of a Capability Statement if
requested. For collaboration
opportunities, please contact Jenish
Patel, Ph.D., 240–669–2894;
jenish.patel@nih.gov.
Dated: November 27, 2019.
Wade W. Green,
Acting Deputy Director, Technology Transfer
and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases.
[FR Doc. 2019–26278 Filed 12–4–19; 8:45 am]
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66685
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Autism Spectrum
Disorder (ASD) Research Portfolio
Analysis, NIMH
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
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: The Office of
Autism Research Coordination, NIMH,
NIH, Neuroscience Center, 6001
Executive Boulevard, MSC 9663, Room
6184, Bethesda, Maryland 20892 or can
email your request, including your
address to: iaccpublicinquiries@
mail.nih.gov or
nimhprapubliccomments@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
ADDRESSES:
This
proposed information collection was
previously published in the Federal
Register on October 3, 2019, page 52888
(84 FR 52888) 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
SUPPLEMENTARY INFORMATION:
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66686
Federal Register / Vol. 84, No. 234 / Thursday, December 5, 2019 / Notices
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: Autism
Spectrum Disorder (ASD) Research
Portfolio Analysis, NIMH, 0925–0682,
expiration date 12/31/2019,
EXTENSION, National Institute of
Mental Health (NIMH), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The purpose of the ASD
research portfolio analysis is to collect
research funding data from U.S. and
international ASD research funders, to
assist the Interagency Autism
Coordinating Committee (IACC) in
fulfilling the requirements of the Autism
Collaboration, Accountability, Research,
Education and Support (CARES) Act of
2019, and to inform the committee and
interested stakeholders of the funding
landscape and current directions for
ASD research. Specifically, these
analyses will continue to examine the
extent to which current funding and
research topics align with the IACC
Strategic Plan for ASD Research. The
findings will help guide future funding
priorities by outlining current gaps and
opportunities in ASD research as well as
serving to highlight annual activities
and research progress.
OMB approval is requested for three
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
714.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Average time
per response
(in hours)
Total burden
hours
U.S. Federal .....................................................................................................
U.S. Private ......................................................................................................
Individuals/households—International Government ........................................
Individuals/households—International Private .................................................
25
9
1
2
88
63
61
13
15/60
15/60
15/60
15/60
550
142
15
7
Total ..........................................................................................................
37
2854
........................
714
Dated: December 2, 2019.
Melba O. Rojas,
Project Clearance Liaison, National Institute
of Mental Health, National Institutes of
Health.
[FR Doc. 2019–26294 Filed 12–4–19; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2019–0002]
Federal Emergency
Management Agency, DHS.
ACTION: Notice.
AGENCY:
Flood hazard determinations,
which may include additions or
modifications of Base Flood Elevations
(BFEs), base flood depths, Special Flood
Hazard Area (SFHA) boundaries or zone
designations, or regulatory floodways on
the Flood Insurance Rate Maps (FIRMs)
and where applicable, in the supporting
Flood Insurance Study (FIS) reports
have been made final for the
communities listed in the table below.
The FIRM and FIS report are the basis
of the floodplain management measures
that a community is required either to
adopt or to show evidence of having in
effect in order to qualify or remain
qualified for participation in the Federal
SUMMARY:
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Emergency Management Agency’s
(FEMA’s) National Flood Insurance
Program (NFIP). In addition, the FIRM
and FIS report are used by insurance
agents and others to calculate
appropriate flood insurance premium
rates for buildings and the contents of
those buildings.
DATES: The date of April 17, 2020 has
been established for the FIRM and,
where applicable, the supporting FIS
report showing the new or modified
flood hazard information for each
community.
The FIRM, and if
applicable, the FIS report containing the
final flood hazard information for each
community is available for inspection at
the respective Community Map
Repository address listed in the tables
below and will be available online
through the FEMA Map Service Center
at https://msc.fema.gov by the date
indicated above.
FOR FURTHER INFORMATION CONTACT: Rick
Sacbibit, Chief, Engineering Services
Branch, Federal Insurance and
Mitigation Administration, FEMA, 400
C Street SW, Washington, DC 20472,
(202) 646–7659, or (email)
patrick.sacbibit@fema.dhs.gov; or visit
the FEMA Map Information eXchange
(FMIX) online at https://
www.floodmaps.fema.gov/fhm/fmx_
main.html.
ADDRESSES:
Final Flood Hazard Determinations
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Number of
projects per
respondent
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The
Federal Emergency Management Agency
SUPPLEMENTARY INFORMATION:
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(FEMA) makes the final determinations
listed below for the new or modified
flood hazard information for each
community listed. Notification of these
changes has been published in
newspapers of local circulation and 90
days have elapsed since that
publication. The Deputy Associate
Administrator for Insurance and
Mitigation has resolved any appeals
resulting from this notification.
This final notice is issued in
accordance with section 110 of the
Flood Disaster Protection Act of 1973,
42 U.S.C. 4104, and 44 CFR part 67.
FEMA has developed criteria for
floodplain management in floodprone
areas in accordance with 44 CFR part
60.
Interested lessees and owners of real
property are encouraged to review the
new or revised FIRM and FIS report
available at the address cited below for
each community or online through the
FEMA Map Service Center at https://
msc.fema.gov.
The flood hazard determinations are
made final in the watersheds and/or
communities listed in the table below.
(Catalog of Federal Domestic Assistance No.
97.022, ‘‘Flood Insurance.’’)
Michael M. Grimm,
Assistant Administrator for Risk
Management, Department of Homeland
Security, Federal Emergency Management
Agency.
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[Federal Register Volume 84, Number 234 (Thursday, December 5, 2019)]
[Notices]
[Pages 66685-66686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26294]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Autism
Spectrum Disorder (ASD) Research Portfolio Analysis, NIMH
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: The Office of Autism Research Coordination, NIMH,
NIH, Neuroscience Center, 6001 Executive Boulevard, MSC 9663, Room
6184, Bethesda, Maryland 20892 or can email your request, including
your address to: [email protected] or
[email protected]. Formal requests for additional
plans and instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on October 3, 2019, page
52888 (84 FR 52888) 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
[[Page 66686]]
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: Autism Spectrum Disorder (ASD) Research
Portfolio Analysis, NIMH, 0925-0682, expiration date 12/31/2019,
EXTENSION, National Institute of Mental Health (NIMH), National
Institutes of Health (NIH).
Need and Use of Information Collection: The purpose of the ASD
research portfolio analysis is to collect research funding data from
U.S. and international ASD research funders, to assist the Interagency
Autism Coordinating Committee (IACC) in fulfilling the requirements of
the Autism Collaboration, Accountability, Research, Education and
Support (CARES) Act of 2019, and to inform the committee and interested
stakeholders of the funding landscape and current directions for ASD
research. Specifically, these analyses will continue to examine the
extent to which current funding and research topics align with the IACC
Strategic Plan for ASD Research. The findings will help guide future
funding priorities by outlining current gaps and opportunities in ASD
research as well as serving to highlight annual activities and research
progress.
OMB approval is requested for three years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 714.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondents Number of projects per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
U.S. Federal.................................... 25 88 15/60 550
U.S. Private.................................... 9 63 15/60 142
Individuals/households--International Government 1 61 15/60 15
Individuals/households--International Private... 2 13 15/60 7
---------------------------------------------------------------
Total....................................... 37 2854 .............. 714
----------------------------------------------------------------------------------------------------------------
Dated: December 2, 2019.
Melba O. Rojas,
Project Clearance Liaison, National Institute of Mental Health,
National Institutes of Health.
[FR Doc. 2019-26294 Filed 12-4-19; 8:45 am]
BILLING CODE 4140-01-P
