National Institute of Allergy and Infectious Diseases Notice of Closed Meeting, 783-784 [2022-00008]
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TKELLEY on DSK125TN23PROD with NOTICE
Federal Register / Vol. 87, No. 4 / Thursday, January 6, 2022 / Notices
NIH ref No.
Patent No. or application
No.
Issue date
Filing date
E–282–2012–0–US–01 ......
E–282–2012–0–PCT–02 ....
E–282–2012–0–US–03 ......
E–282–2012–0–CA–04 ......
E–282–2012–0–EP–05 .......
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E–282–2012–0–DE–13 ......
E–282–2012–0–FR–14 .......
E–282–2012–0–GB–15 ......
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E–282–2012–0–IN–06 ........
E–282–2012–0–JP–07 .......
E–282–2012–0–CN–08 ......
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E–282–2012–1–US–01 ......
E–282–2012–1–PCT–02 ....
E–282–2012–1–US–08 ......
E–282–2012–1–US–09 ......
E–140–2014–0–US–01 ......
E–140–2014–0–PCT–02 ....
E–140–2014–0–AU–03 ......
E–140–2014–0–CA–04 ......
E–140–2014–0–CN–05 ......
E–140–2014–0–EP–06 .......
E–140–2014–0–IN–07 ........
E–140–2014–0–JP–08 .......
E–140–2014–0–US–09 ......
E–140–2014–0–HK–10 ......
61/725,949 ........................
PCT/US2013/069686 ........
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PCT/US2016/035291 ........
15/579,123 ........................
16/438,850 ........................
61/991,333 ........................
PCT/US2015/029946 ........
2015255765 ......................
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The patent rights in these inventions
have been assigned to the Government
of the United States of America. The
prospective exclusive patent license
territory may be worldwide and in a
field of use limited to human
therapeutics for fibrotic disease.
The invention covered by the patents
and patent applications pertaining to
NIH Ref. No. E–282–2012–0 and –1
pertain to cannabinoid receptor 1 (CB1R)
inverse agonists. CB1R activation plays
a key role in appetitive behavior and
metabolism. Of importance as a
therapeutic target here is that the
receptor is expressed in both peripheral
tissue as well as the CNS. The invention
is a class of pyrazole compounds that
act as CB1 receptor inverse agonists and
have been shown effective at reducing
obesity and its associated metabolic
consequences, and for fibrotic disease,
while having no experimentally
discernable neuropsychotropic side
effects that are considered adverse such
as the earlier antagonists rimonabant.
These CB1R receptor compounds were
developed with the goals of limiting
their brain penetrance without losing
their metabolic efficacy due to CB1
inverse agonism, and having a primary
metabolite directly targeting enzymes
involved in inflammatory and fibrotic
processes associated with metabolic
disorders. The patents are both
compositions of matter and methods of
use.
The inventions covered by HHS Ref.
E–140–2014–0 also pertain to pyrazole
CB1R receptor inverse agonists. In
VerDate Sep<11>2014
18:13 Jan 05, 2022
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addition, some of these compounds also
have a direct inhibitory effect on
inducible nitric oxide synthase (iNOS),
whereas another group of the
compounds directly activates AMP
kinase. There is evidence that the
metabolic effects of endocannabinoids
are mediated by CB1 receptors in
peripheral tissues. These dual-target
compounds may be useful for treating
metabolic disease and related
conditions such as obesity and diabetes
and their complications, and includes
various fibrotic disorders, without the
dangerous the side effects.
This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive patent license
will be royalty bearing and may be
granted unless within fifteen (15) days
from the date of this published notice,
the NHLBI receives written evidence
and argument that establishes that the
grant of the license would not be
consistent with the requirements of 35
U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in
the prospective field of use that are
timely filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive patent
license. Comments and objections
submitted to this notice will not be
made available for public inspection
and, to the extent permitted by law, will
not be released under the Freedom of
Information Act, 5 U.S.C. 552.
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Title
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Cannabinoid
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Receptor
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Mediating
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Compounds.
Dated: January 3, 2022.
Michael Shmilovich,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute,
Office of Technology Transfer and
Development.
[FR Doc. 2022–00022 Filed 1–5–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Research Topic No.
051 Inhaled Delivery of Clofazimine (CFZ)—
An Important Anti-Tuberculosis Drug Phase
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784
Federal Register / Vol. 87, No. 4 / Thursday, January 6, 2022 / Notices
II Proposal Title: Optimized Dry Powder
Formulation and Delivery for Inhaled
Clofazimine (N01).
Date: January 27, 2022.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Cynthia L. De La Fuente,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G31,
Rockville, MD 20852, 240–669–2740,
delafuentecl@niaid.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: December 30, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–00008 Filed 1–5–22; 8:45 am]
BILLING CODE 4140–01–P
National Institute of Allergy and
Infectious Diseases Notice of Closed
Meeting
TKELLEY on DSK125TN23PROD with NOTICE
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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; HHS–NIH–CDC–SBIR PHS
2022–1: Development of Diagnostics to
Differentiate HIV Infection from Vaccine
Induced Seropositivity (Topic 103).
Date: February 2, 2022.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G22B,
Rockville, MD 20892 (Virtual Meeting).
Jkt 256001
[FR Doc. 2022–00009 Filed 1–5–22; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID FEMA–2020–0016]
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: Announcement of meetings.
AGENCY:
National Institutes of Health
18:13 Jan 05, 2022
Dated: December 30, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
Meetings To Implement Pandemic
Response Voluntary Agreement Under
Section 708 of the Defense Production
Act
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
Contact Person: Kristina S. Wickham,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G22B,
Rockville, MD 20852, 301–761–5390,
kristina.wickham@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)
The Federal Emergency
Management Agency (FEMA) is holding
a series of meetings, under the Plan of
Action to Establish a National Strategy
for the Coordination of National
Multimodal Healthcare Supply Chains
to Respond to COVID–19, to implement
the Voluntary Agreement for the
Manufacture and Distribution of Critical
Healthcare Resources Necessary to
Respond to a Pandemic.
DATES:
• Wednesday, January 5, 2022, from 1
p.m. to 3 p.m. Eastern Time (ET).
• Wednesday, January 12, 2022, from
1 p.m. to 3 p.m. ET.
• Wednesday, January 19, 2022, from
1 p.m. to 3 p.m. ET.
• Wednesday, January 26, 2022, from
1 p.m. to 3 p.m. ET.
FOR FURTHER INFORMATION CONTACT:
Robert Glenn, Office of Business,
Industry, Infrastructure Integration, via
email at OB3I@fema.dhs.gov or via
phone at (202) 212–1666.
SUPPLEMENTARY INFORMATION: Notice of
these meetings is provided as required
by section 708(h)(8) of the Defense
Production Act (DPA), 50 U.S.C.
4558(h)(8), and consistent with 44 CFR
part 332.
SUMMARY:
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The DPA authorizes the making of
‘‘voluntary agreements and plans of
action’’ with representatives of industry,
business, and other interests to help
provide for the national defense.1 The
President’s authority to facilitate
voluntary agreements with respect to
responding to the spread of COVID–19
within the United States was delegated
to the Secretary of Homeland Security
in Executive Order 13911.2 The
Secretary of Homeland Security further
delegated this authority to the FEMA
Administrator.3
On August 17, 2020, after the
appropriate consultations with the
Attorney General and the Chairman of
the Federal Trade Commission, FEMA
completed and published in the Federal
Register a ‘‘Voluntary Agreement,
Manufacture and Distribution of Critical
Healthcare Resources Necessary to
Respond to a Pandemic’’ (Voluntary
Agreement).4 Unless terminated earlier,
the Voluntary Agreement is effective
until August 17, 2025, and may be
extended subject to additional approval
by the Attorney General after
consultation with the Chairman of the
Federal Trade Commission. The
Agreement may be used to prepare for
or respond to any pandemic, including
COVID–19, during that time.
On December 7, 2020, the first plan of
action under the Voluntary
Agreement—the Plan of Action to
Establish a National Strategy for the
Manufacture, Allocation, and
Distribution of Personal Protective
Equipment (PPE) to Respond to COVID–
19 (PPE Plan of Action)—was finalized.5
The PPE Plan of Action established
several sub-committees under the
Voluntary Agreement, focusing on
different aspects of the PPE Plan of
Action.
On May 24, 2021, four additional
plans of action under the Voluntary
Agreement—the Plan of Action to
Establish a National Strategy for the
Manufacture, Allocation, and
Distribution of Diagnostic Test Kits and
other Testing Components to respond to
COVID–19, the Plan of Action to
1 50
U.S.C. 4558(c)(1).
FR 18403 (Apr. 1, 2020).
3 DHS Delegation 09052, Rev. 00.1 (Apr. 1, 2020);
DHS Delegation Number 09052 Rev. 00 (Jan. 3,
2017).
4 85 FR 50035 (Aug. 17, 2020). The Attorney
General, in consultation with the Chairman of the
Federal Trade Commission, made the required
finding that the purpose of the voluntary agreement
may not reasonably be achieved through an
agreement having less anticompetitive effects or
without any voluntary agreement and published the
finding in the Federal Register on the same day. 85
FR 50049 (Aug. 17, 2020).
5 See 85 FR 78869 (Dec. 7, 2020). See also 85 FR
79020 (Dec. 8, 2020).
2 85
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]]>Agencies
[Federal Register Volume 87, Number 4 (Thursday, January 6, 2022)]
[Notices]
[Pages 783-784]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00008]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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 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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel; NIAID Research Topic No. 051
Inhaled Delivery of Clofazimine (CFZ)--An Important Anti-
Tuberculosis Drug Phase
[[Page 784]]
II Proposal Title: Optimized Dry Powder Formulation and Delivery for
Inhaled Clofazimine (N01).
Date: January 27, 2022.
Time: 1:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G31,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Cynthia L. De La Fuente, Ph.D., Scientific
Review Officer, Scientific Review Program, Division of Extramural
Activities, National Institute of Allergy and Infectious Diseases,
National Institutes of Health, 5601 Fishers Lane, Room 3G31,
Rockville, MD 20852, 240-669-2740, [email protected].
(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: December 30, 2021.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2022-00008 Filed 1-5-22; 8:45 am]
BILLING CODE 4140-01-P
