Center for Scientific Review; Notice of Closed Meeting, 16757-16758 [2022-06215]
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Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices
certification to ORI at the conclusion of
the Supervision Period that his
participation was not proposed on a
research project for which an
application for PHS support was
submitted and that he has not
participated in any capacity in PHSsupported research.
(5) During the Exclusion and
Supervision Periods, Respondent will
exclude himself voluntarily from
serving in any advisory or consultant
capacity to PHS including, but not
limited to, service on any PHS advisory
committee, board, and/or peer review
committee.
Dated: March 21, 2022.
Wanda K. Jones,
Acting Director, Office of Research Integrity,
Office of the Assistant Secretary for Health.
[FR Doc. 2022–06246 Filed 3–23–22; 8:45 am]
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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.
SUMMARY:
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FOR FURTHER INFORMATION CONTACT:
Peter Tung at 240–669–5483 or
peter.tung@nih.gov. Licensing
information and copies of the patent
applications 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to receive copies of unpublished patent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:
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Novel Compositions of Matter
Comprising Stabilized Coronavirus
Antigens and Their Use
• Computational method of designing
vaccine antigens.
Description of Technology
• Pre-clinical testing of the novel
immunogens in non-human primates.
Inventors: Dr. Niraj Tolia and Dr.
Thayne Dickey, both of NIAID.
Publications: ‘‘Design of the SARSCoV–2 RBD vaccine antigen improves
neutralizing antibody response’’,
https://doi.org/10.1101/2021.05.09.
443238.
Intellectual Property: HHS Reference
No. E–045–2021–0–US–01—U.S.
Provisional Application No. 63/200,194,
filed February 18, 2021; PCT/US2022/
070744, filed February 1, 2022
Licensing Contact: To license this
technology, please contact Peter Tung at
240–669–5483 or peter.tung@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 the invention. For
collaboration opportunities, please
contact Peter Tung at 240–669–5483;
peter.tung@nih.gov.
Using a computational design
methodology, SARS-CoV–2 spike
proteins containing engineered amino
acid changes to the receptor binding
domain (RBD) were designed. These
engineered spike proteins improved the
immune response upon immunization
of animals. An engineered RBD was also
expressed at greater yield, had increased
temperature stability, and improved the
immune response upon immunization
of animals. Specifically, the disclosed
RBD designs can be produced
approximately 7 times more efficiently
than the native sequence, facilitating
vaccine manufacturing on a global scale.
The disclosed designs also have up to
10 °C higher thermal stability than the
native sequence, suggesting enhanced
stability during storage and when in the
body. Finally, immunization of animals
with the disclosed antigens produces up
to 10-fold higher levels of blocking
antibodies than the native sequence and
30-fold higher levels of pseudoviral
neutralizing antibodies. An additional
RBD protein has been engineered to
eliminate the need for glycosylation,
facilitating production and singlecomponent nanoparticle display of the
antigen. The engineered receptor
binding domain (RBD) and spike protein
antigens produce significant
improvements in pre-clinical animal
models and may be used to develop
improved coronavirus vaccines.
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
• Novel SARS-CoV–2 vaccine.
• Improved SARS-CoV–2 diagnostics
using stabilized antigens.
• Method of designing vaccine
candidates or stabilized antigens by
computational. optimization of amino
acid identity, followed by additional
sequence comparison and selection
(Stabilizer for Protein Expression and
Epitope Design (SPEEDesign)).
Competitive Advantages
• Novel SARS-CoV–2 spike vaccine
with improved breadth and duration of
protection.
• Novel RBD monomer and
nanoparticle designs that are more
immunogenic and stable than the
naturally occurring RBD sequence.
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Development Stage
Dated: March 17, 2022.
Surekha Vathyam,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2022–06174 Filed 3–23–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Antimicrobial Resistant Infections.
Date: April 19, 2022.
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Federal Register / Vol. 87, No. 57 / Thursday, March 24, 2022 / Notices
Time: 1:30 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Pauline Cupit, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 827–3275, cupitcunninghpm@
mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 18, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–06215 Filed 3–23–22; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket Number USCG–2020–0093]
Port Access Route Study: Seacoast of
North Carolina Including Offshore
Approaches to the Cape Fear River
and Beaufort Inlet, North Carolina
Coast Guard, DHS.
Notice of availability of draft
report; request for comments.
AGENCY:
ACTION:
On March 18, 2020, the Coast
Guard published a notice of study and
request for comments announcing a Port
Access Route Study (PARS) for the
Seacoast of North Carolina Including
Offshore Approaches to the Cape Fear
River and Beaufort Inlet, North Carolina.
This notice announces the availability
of a draft report for public review and
comment. We seek your comments on
the content, proposed routing measures,
and development of the report. The
recommendations of the study may lead
to future rulemakings or appropriate
international agreements.
DATES: Your comments and related
material must reach the Coast Guard on
or before April 25, 2022.
ADDRESSES: You may submit comments
identified by docket number USCG–
2020–0093 using the Federal portal at
https://www.regulations.gov. See the
‘‘Public Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
FOR FURTHER INFORMATION CONTACT: If
you have questions about this notice or
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SUMMARY:
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study, call or email Mr. Matthew
Creelman, Fifth Coast Guard District
(dpw), U.S. Coast Guard; telephone
(757) 398–6225, email
Matthew.K.Creelman2@uscg.mil.
SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
AIS Automated Information System
DHS Department of Homeland Security
FR Federal Register
PARS Port Access Route Study
ACPARS Atlantic Coast Ports Access Route
Study
U.S.C. United States Code
II. Background and Purpose
The Ports and Waterways Safety Act
(46 U.S.C. 70003(c)) requires the Coast
Guard to conduct a PARS, i.e., a study
of potential traffic density and the need
for safe access routes for vessels.
Through the study process, the Coast
Guard coordinates with Federal, State,
local, tribal and foreign state agencies
(as appropriate) to consider the views of
maritime community representatives,
environmental groups, and other
interested stakeholders. The primary
purpose of this coordination is, to the
extent practicable, to reconcile the need
for safe access routes with other
reasonable waterway uses such as
construction and operation of renewable
energy facilities and other uses of the
Atlantic Ocean in the study area.
In 2019, the Coast Guard announced
a supplemental study of routes used by
all vessels to access ports on the
Atlantic Coast of the United States (84
FR 9541, March 15, 2019). This posting
announced PARS for specific port
approaches and international transit
areas along the Atlantic Coast. The
purpose of the supplemental studies is
to align the Atlantic Coast Port Access
Route Study (ACPARS) (81 FR 13307,
March 14, 2016) with port approaches.
The ACPARS analyzed the Atlantic
Coast waters seaward of existing port
approaches within the U.S. Exclusive
Economic Zone and was finalized in
2017 (82 FR 16510, April 5, 2017).
The purpose of this notice is to
announce the availability of the draft
PARS examining the seacoast of North
Carolina and the offshore approaches to
the Cape Fear River and Beaufort Inlet,
North Carolina. We encourage you to
participate in the study process by
submitting comments in response to this
notice. This PARS used Automated
Information System (AIS) data and
information from stakeholders to
identify and verify customary
navigation routes as well as potential
conflicts involving alternative activities,
such as wind energy generation and
offshore mineral exploitation and
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exploration, off the seacoast of North
Carolina and in the offshore approaches
to the Cape Fear River and Beaufort
Inlet, North Carolina.
The study area extends approximately
200 nautical miles seaward of Cape Fear
including the offshore area of North and
South Carolina used by commercial and
public vessels transiting to and from
these ports. An illustration showing the
study area is available in the docket
where indicated under ADDRESSES.
Additionally, the study area is available
for viewing on the Mid-Atlantic Ocean
Data Portal at https://portal.midatlantic
ocean.org/visualize/. See the
‘‘Maritime’’ portion of the Data Layers
section.
On March 18, 2020, the Coast Guard
published a Notice of Study; request for
comments entitled ‘‘Port Access Route
Study: Seacoast of North Carolina
Including Offshore Approaches to the
Cape Fear River and Beaufort Inlet,
North Carolina’’ in the Federal Register
(85 FR 15487). The initial comment
period closed on May 18, 2020.
III. Information Requested
PARS are the means by which the
Coast Guard determines the need to
establish traffic routing measures or
shipping safety fairways to reduce the
risk of collision, allision, and
grounding, and their impact on the
environment; increase the efficiency
and predictability of vessel traffic; and
preserve the paramount right of
navigation while continuing to allow for
other reasonable waterway uses. The
study analyzes current routing measures
around the approaches to the Cape Fear
River and Beaufort Inlet, North Carolina,
and proposes an adequate way to
manage forecasted maritime traffic
growth and to promote navigation
safety. The study also reviewed coastal
port access from the seacoasts of North
and South Carolina within the study
area and the co-dependent use of the
waters in support of future
development.
The Coast Guard received two
discrete comments in response to our
Federal Register notice and other
outreach efforts. We received one
additional comment, which was a
duplicate of a previously submitted
comment. All comments and supporting
documents are available in a public
docket and can be viewed at https://
www.regulations.gov. To do so, go to
https://www.regulations.gov, type
USCG–2020–0093 in the ‘‘SEARCH’’
box and click ‘‘SEARCH.’’ Next, look for
this document in the Search Results
column, and click on it.
As a result of the data analysis within
this study, and considering the
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Agencies
[Federal Register Volume 87, Number 57 (Thursday, March 24, 2022)]
[Notices]
[Pages 16757-16758]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-06215]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Antimicrobial Resistant Infections.
Date: April 19, 2022.
[[Page 16758]]
Time: 1:30 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Pauline Cupit, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892, (301) 827-3275,
[email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: March 18, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-06215 Filed 3-23-22; 8:45 am]
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