Government-Owned Inventions; Availability for Licensing, 25003-25004 [2023-08642]
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Name of Committee: National Advisory
Mental Health Council.
Date: May 16–17, 2023.
Open: May 16, 2023, 12:00 p.m. to 4:30
p.m.
Agenda: Presentation of the NIMH
Director’s Report and discussion of NIMH
programs.
Place: National Institutes of Health,
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160, Bethesda, MD 20892.
Closed: May 17, 2023, 12:00 p.m. to 4:00
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Agenda: To review and evaluate grant
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Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive, Room
160, Bethesda, MD 20892.
Contact Person: Tracy L. Waldeck, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Mental Health, National
Institutes of Health, Neuroscience Center,
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20892, (301) 480–6833, tracy.waldeck@
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(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: April 19, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–08631 Filed 4–24–23; 8:45 am]
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Staff,’ National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, Building 33, Room 1N24, 33 North
Drive, Bethesda, MD 20892, 301–761–6362,
Laurie.Lewallen@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: April 19, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–08626 Filed 4–24–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
25003
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:
Licensing information may be obtained
by communicating with the Technology
Transfer and Intellectual Property
Office, National Institute of Allergy and
Infectious Diseases, 5601 Fishers Lane,
Rockville, MD 20852 by contacting Dr.
Benjamin Hurley at 240–669–5092 or
benjamin.hurley@nih.gov. A signed
Confidential Disclosure Agreement will
be required to receive copies of
unpublished information related to the
invention.
SUPPLEMENTARY INFORMATION:
Technology description follows:
SUMMARY:
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Division of Intramural
Research Board of Scientific Counselors,
NIAID.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
National Institute of Allergy and
Infectious Diseases, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Division of Intramural
Research Board of Scientific Counselors,
NIAID.
Date: June 12–14, 2023.
Time: 7:45 a.m. to 10:55 a.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, Building 50, Conference Room 1227/
1233, 50 Center Drive, Bethesda, MD 20892.
Contact Person: Laurie Lewallen, Division
of Intramural Research Program Support
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Engineered Cell-Penetrating
Monoclonal Antibody for Universal
Influenza Immunotherapy
Description of Technology:
Influenza remains a burden on public
health, as current treatments of viral
infections remain ineffective due to
frequent virus mutations. Many current
influenza treatments rely on targeting
surface viral glycoproteins.
Unfortunately, these glycoproteins are
primary targets of the immune system,
which results in increased selection
E:\FR\FM\25APN1.SGM
25APN1
lotter on DSK11XQN23PROD with NOTICES1
25004
Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices
pressure and mutational rate, leading to
the well-known seasonal variation of
influenza virus. In contrast, the
nucleocapsid viral protein (NP), located
in the interior of the virus, is more
conserved and an ideal antibody target;
however, NP is inaccessible to
extracellular antibodies produced in
response to infection. To circumvent the
challenge of targeting NP, scientists at
NIAID have developed an antibody
genetically fused with a cell penetrating
peptide (CPP-mAb) that targets NP
within infected cells to effectively
inhibit viral replication. By targeting NP
rather than the surface glycoproteins,
this CPP-mAb can treat more influenza
variants, potentially across flu seasons,
and is an improvement upon current
influenza treatments.
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:
• Clinical Treatment: CPP-mAbs
against influenza NP may be a reliable
and effective method to treat patients
infected with varying subtypes of
influenza, by targeting a functionally
conserved protein.
• CPP-mAbs could be a viable
alternative to the treatment of influenza
when other treatments are ineffective,
potentially lowering the mortality and
morbidity rates in populations
susceptible to influenza infection.
Competitive Advantages:
• Current vaccines remain effective
for a short time period, due to the everchanging nature of the viral surface
glycoproteins. CPP-mAbs could remain
effective for a longer time period by
targeting the interior NP of influenza,
which is more conserved across
influenza subtypes.
• Other attempts to produce vaccines
against conserved portions of the
surface viral glycoproteins have failed to
produce a robust and reliable vaccine.
CPP-mAbs could be a more reliable
therapeutic agent compared to
alternatives, potentially effective across
flu seasons.
• In vivo efficacy: CPP-mAbs against
NP increase survivorship in mice
infected with mouse Influenza A virus,
demonstrating therapeutic protection.
Development Stage:
• Pre-Clinical.
Inventors: Jonathon Yewdell, MD,
Ph.D. and Ivan Kosik, Ph.D., both from
NIAID.
Publications: Publication pending.
Intellectual Property: HHS Reference
No. E–193–2021; US Provisional
VerDate Sep<11>2014
16:47 Apr 24, 2023
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Application No. 63/365,841, filed on
June 3rd, 2022.
Licensing Contact: To license this
technology, please contact Benjamin
Hurley at 240–669–5092 or
benjamin.hurley@nih.gov, and reference
E–193–2021.
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 this invention. For
collaboration opportunities, please
contact Benjamin Hurley; 240–669–
5092, benjamin.hurley@nih.gov.
Dated: April 19, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2023–08642 Filed 4–24–23; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2023–0011; OMB No.
1660–0015]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Revisions to
National Flood Insurance Program
Maps: Application Forms and
Instructions for (C)LOMAs and
(C)LOMR–Fs
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: 60-Day notice of revision and
request for comments.
AGENCY:
The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public to take this
opportunity to comment on an
extension, with change of a currently
approved information collection. In
accordance with the Paperwork
Reduction Act of 1995, this notice seeks
comments concerning information
required by FEMA to amend or revise
National Flood Insurance Program
(NFIP) maps to remove certain property
from the one-percent annual chance
floodplain.
DATES: Comments must be submitted on
or before June 26, 2023.
ADDRESSES: To avoid duplicate
submissions to the docket, please
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
submit comments at
www.regulations.gov under Docket ID
FEMA–2023–0011. Follow the
instructions for submitting comments.
All submissions received must
include the agency name and Docket ID.
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
change, to the Federal eRulemaking
Portal at https://www.regulations.gov,
and will include any personal
information you provide. Therefore,
submitting this information makes it
public. You may wish to read the
Privacy and Security Notice that is
available via a link on the homepage of
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Bryan Anderson, FEMA, Federal
Insurance & Mitigation Administration,
at (202) 577–2397 or Bryanb.Anderson@
fema.dhs.gov. You may contact the
Information Management Division for
copies of the proposed collection of
information at email address: FEMAInformation-Collections-Management@
fema.dhs.gov.
The
National Flood Insurance Program
(NFIP) is authorized by the National
Flood Insurance Act of 1968, as
amended, 42 U.S.C. 4001 et seq. The
Federal Emergency Management Agency
(FEMA) administers the NFIP and
maintains the maps that depict flood
hazard information. The land area
covered by the floodwaters of the base
flood is the Special Flood Hazard Area
(SFHA) on NFIP maps. The SFHA is the
area where the NFIP’s floodplain
management regulations must be
enforced and the area where the
mandatory purchase of flood insurance
applies. If a SFHA has been determined
to exist for property and the owner or
lessee of the property believes his/her
property has been incorrectly included
in a SFHA, information can be provided
to support removal of the SFHA
designation. NFIP regulations, at 44 CFR
parts 65 and 70, outline the data that
must be submitted by an owner or lessee
of property who believes their property
has been incorrectly included in a
SFHA. In order to remove an area from
a SFHA, the owner or lessee of the
property must submit scientific or
technical data demonstrating that the
area is ‘‘reasonably safe from flooding’’
and not in the SFHA.
This information collection is set to
expire on July 31, 2023. FEMA is
requesting a revision to the currently
approved information collection.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\25APN1.SGM
25APN1
Agencies
[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 25003-25004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08642]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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: Licensing information may be obtained
by communicating with the Technology Transfer and Intellectual Property
Office, National Institute of Allergy and Infectious Diseases, 5601
Fishers Lane, Rockville, MD 20852 by contacting Dr. Benjamin Hurley at
240-669-5092 or [email protected]. A signed Confidential
Disclosure Agreement will be required to receive copies of unpublished
information related to the invention.
SUPPLEMENTARY INFORMATION: Technology description follows:
Engineered Cell-Penetrating Monoclonal Antibody for Universal Influenza
Immunotherapy
Description of Technology:
Influenza remains a burden on public health, as current treatments
of viral infections remain ineffective due to frequent virus mutations.
Many current influenza treatments rely on targeting surface viral
glycoproteins. Unfortunately, these glycoproteins are primary targets
of the immune system, which results in increased selection
[[Page 25004]]
pressure and mutational rate, leading to the well-known seasonal
variation of influenza virus. In contrast, the nucleocapsid viral
protein (NP), located in the interior of the virus, is more conserved
and an ideal antibody target; however, NP is inaccessible to
extracellular antibodies produced in response to infection. To
circumvent the challenge of targeting NP, scientists at NIAID have
developed an antibody genetically fused with a cell penetrating peptide
(CPP-mAb) that targets NP within infected cells to effectively inhibit
viral replication. By targeting NP rather than the surface
glycoproteins, this CPP-mAb can treat more influenza variants,
potentially across flu seasons, and is an improvement upon current
influenza treatments.
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:
Clinical Treatment: CPP-mAbs against influenza NP may be a
reliable and effective method to treat patients infected with varying
subtypes of influenza, by targeting a functionally conserved protein.
CPP-mAbs could be a viable alternative to the treatment of
influenza when other treatments are ineffective, potentially lowering
the mortality and morbidity rates in populations susceptible to
influenza infection.
Competitive Advantages:
Current vaccines remain effective for a short time period,
due to the ever-changing nature of the viral surface glycoproteins.
CPP-mAbs could remain effective for a longer time period by targeting
the interior NP of influenza, which is more conserved across influenza
subtypes.
Other attempts to produce vaccines against conserved
portions of the surface viral glycoproteins have failed to produce a
robust and reliable vaccine. CPP-mAbs could be a more reliable
therapeutic agent compared to alternatives, potentially effective
across flu seasons.
In vivo efficacy: CPP-mAbs against NP increase
survivorship in mice infected with mouse Influenza A virus,
demonstrating therapeutic protection.
Development Stage:
Pre-Clinical.
Inventors: Jonathon Yewdell, MD, Ph.D. and Ivan Kosik, Ph.D., both
from NIAID.
Publications: Publication pending.
Intellectual Property: HHS Reference No. E-193-2021; US Provisional
Application No. 63/365,841, filed on June 3rd, 2022.
Licensing Contact: To license this technology, please contact
Benjamin Hurley at 240-669-5092 or [email protected], and
reference E-193-2021.
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 this invention. For collaboration
opportunities, please contact Benjamin Hurley; 240-669-5092,
[email protected].
Dated: April 19, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-08642 Filed 4-24-23; 8:45 am]
BILLING CODE 4140-01-P