Federal Register / Vol. 87, No. 4 / Thursday, January 6, 2022 / Notices 783 

NIH ref No. Patent No. or application 

No. Issue date Filing date Title 

E–282–2012–0–US–01 ...... 61/725,949 ........................ ........................................... November 13, 2012 .......... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–PCT–02 .... PCT/US2013/069686 ........ ........................................... November 12, 2013 .......... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–US–03 ...... 9,765,031 .......................... September 19, 2017 ......... November 12, 2013 .......... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–CA–04 ...... 2889697 ............................ ........................................... April 27, 2015 ................... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–EP–05 ....... 2919779 ............................ January 6, 2021 ................ June 01, 2015 ................... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–CH–12 ...... 2919779 ............................ January 6, 2021 ................ November 12, 2013 .......... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–DE–13 ...... 2919779 ............................ January 6, 2021 ................ November 12, 2013 .......... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–FR–14 ....... 2919779 ............................ January 6, 2021 ................ November 12, 2013 .......... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–GB–15 ...... 2919779 ............................ January 6, 2021 ................ November 12, 2013 .......... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–IE–16 ........ 2919779 ............................ January 6, 2021 ................ November 12, 2013 .......... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–IN–06 ........ 354301 .............................. December 23, 2020 .......... May 1, 2015 ...................... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–JP–07 ....... 6272626 ............................ January 12, 2018 .............. May 11, 2015 .................... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–CN–08 ...... ZL201380069389.9 ........... August 20, 2019 ............... July 3, 2015 ...................... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–US–09 ...... 10,683,270 ........................ June 16, 2020 ................... August 10, 2017 ............... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–US–10 ...... 10,787,419 ........................ September 29, 2020 ......... August 10, 2017 ............... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–0–US–11 ...... 16/870,093 ........................ ........................................... May 8, 2020 ...................... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–1–US–01 ...... 62/171,179 ........................ ........................................... June 4, 2015 ..................... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–1–PCT–02 .... PCT/US2016/035291 ........ ........................................... June 1, 2016 ..................... Cannabinoid Receptor Mediating Compounds. 

E–282–2012–1–US–08 ...... 15/579,123 ........................ ........................................... December 1, 2017 ............ Cannabinoid Receptor Mediating Compounds. 

E–282–2012–1–US–09 ...... 16/438,850 ........................ ........................................... June 12, 2019 ................... Cannabinoid Receptor Mediating Compounds. 

E–140–2014–0–US–01 ...... 61/991,333 ........................ ........................................... May 9, 2014 ...................... Cannabinoid Receptor Mediating Compounds. 

E–140–2014–0–PCT–02 .... PCT/US2015/029946 ........ ........................................... May 8, 2015 ...................... Cannabinoid Receptor Mediating Compounds. 

E–140–2014–0–AU–03 ...... 2015255765 ...................... ........................................... November 7, 2016 ............ Cannabinoid Receptor Mediating Compounds. 

E–140–2014–0–CA–04 ...... 2948349 ............................ ........................................... May 8, 2015 ...................... Cannabinoid Receptor Mediating Compounds. 

E–140–2014–0–CN–05 ...... 201580028788.X .............. February 7, 2020 .............. May 8, 2015 ...................... Cannabinoid Receptor Mediating Compounds. 

E–140–2014–0–EP–06 ....... 15728668.3 ....................... ........................................... May 8, 2015 ...................... Cannabinoid Receptor Mediating Compounds. 

E–140–2014–0–IN–07 ........ 201637038171 .................. ........................................... November 8, 2016 ............ Cannabinoid Receptor Mediating Compounds. 

E–140–2014–0–JP–08 ....... 6762930 ............................ September 11, 2020 ......... May 8, 2015 ...................... Cannabinoid Receptor Mediating Compounds. 

E–140–2014–0–US–09 ...... 10,329,259 ........................ June 25, 2019 ................... November 8, 2016 ............ Cannabinoid Receptor Mediating Compounds. 

E–140–2014–0–HK–10 ...... 17105705.6 ....................... ........................................... June 9, 2017 ..................... Cannabinoid Receptor Mediating Compounds. 

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 

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. 

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 


TKELLEY on DSK125TN23PROD with NOTICE 
784 Federal Register / Vol. 87, No. 4 / Thursday, January 6, 2022 / Notices 

1 50 U.S.C. 4558(c)(1). 

2 85 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). 

5See 85 FR 78869 (Dec. 7, 2020). See also 85 FR 

79020 (Dec. 8, 2020). 

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 

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; 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). 

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) 

Dated: December 30, 2021. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–00009 Filed 1–5–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID FEMA–2020–0016] 

Meetings To Implement Pandemic 

Response Voluntary Agreement Under 

Section 708 of the Defense Production 

Act 

AGENCY: Federal Emergency 

Management Agency, Department of 

Homeland Security. 

ACTION: Announcement of meetings. 

SUMMARY: 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. 

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 


TKELLEY on DSK125TN23PROD with NOTICE