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

https://www.regulations.gov suitability 

policy will be posted without change to 

https://www.regulations.gov, including 

any personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

https://www.regulations.gov. Written 

public comments will be provided to 

ACIP members. 

FOR FURTHER INFORMATION CONTACT: 

Stephanie Thomas, ACIP Committee 

Management Specialist, Centers for 

Disease Control and Prevention, 

National Center for Immunization and 

Respiratory Diseases, 1600 Clifton Road 

NE, MSH24–8, Atlanta, GA 30329–4027; 

Telephone: 404–639–8367; Email: 

ACIP@cdc.gov. 

SUPPLEMENTARY INFORMATION: In 

accordance with 41 CFR 102–3.150(b), 

less than 15 calendar days’ notice is 

being given for this meeting due to the 

exceptional circumstances of the 

COVID–19 pandemic and rapidly 

evolving COVID–19 vaccine 

development and regulatory processes. 

The Secretary of Health and Human 

Services has determined that COVID–19 

is a Public Health Emergency. A notice 

of this ACIP meeting has also been 

posted on CDC’s ACIP website at: http:// 

www.cdc.gov/vaccines/acip/index.html. 

In addition, CDC has sent notice of this 

ACIP meeting by email to those who 

subscribe to receive email updates about 

ACIP. 

Purpose: The ACIP is charged with 

advising the Director, CDC, on the use 

of immunizing agents. In addition, 

under 42 U.S.C. 1396s, the ACIP is 

mandated to establish and periodically 

review and, as appropriate, revise the 

list of vaccines for administration to 

vaccine-eligible children through the 

Vaccines for Children program, along 

with schedules regarding dosing 

interval, dosage, and contraindications 

to administration of vaccines. Further, 

under provisions of the Affordable Care 

Act, section 2713 of the Public Health 

Service Act, immunization 

recommendations of the ACIP that have 

been approved by the CDC Director and 

appear on CDC immunization schedules 

must be covered by applicable health 

plans. 

Matters To Be Considered: The agenda 

will include discussions on COVID–19 

vaccine booster doses. A 

recommendation vote is scheduled. 

Agenda items are subject to change as 

priorities dictate. For more information 

on the meeting agenda visit https://

www.cdc.gov/vaccines/acip/meetings/ 

meetings-info.html. 

Public Participation 

Interested persons or organizations 

are invited to participate by submitting 

written views, recommendations, and 

data. Please note that comments 

received, including attachments and 

other supporting materials, are part of 

the public record and are subject to 

public disclosure. Comments will be 

posted on https://www.regulations.gov. 

Therefore, do not include any 

information in your comment or 

supporting materials that you consider 

confidential or inappropriate for public 

disclosure. If you include your name, 

contact information, or other 

information that identifies you in the 

body of your comments, that 

information will be on public display. 

CDC will review all submissions and 

may choose to redact, or withhold, 

submissions containing private or 

proprietary information such as Social 

Security numbers, medical information, 

inappropriate language, or duplicate/ 

near duplicate examples of a mass-mail 

campaign. CDC will carefully consider 

all comments submitted into the docket. 

Written Public Comment: The docket 

will be opened to receive written 

comments on January 6, 2022. Written 

comments must be received on or before 

January 12, 2022. 

Oral Public Comment: This meeting 

will include time for members of the 

public to make an oral comment. Oral 

public comment will occur before any 

scheduled votes including all votes 

relevant to the ACIP’s Affordable Care 

Act and Vaccines for Children Program 

roles. Priority will be given to 

individuals who submit a request to 

make an oral public comment before the 

meeting according to the procedures 

below. 

Procedure for Oral Public Comment: 

All persons interested in making an oral 

public comment at the January 5, 2022 

ACIP meeting must submit a request at 

http://www.cdc.gov/vaccines/acip/ 

meetings/ no later than 11:59 p.m. EST, 

January 4, 2022, according to the 

instructions provided. 

If the number of persons requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

time, CDC will conduct a lottery to 

determine the speakers for the 

scheduled public comment session. 

CDC staff will notify individuals 

regarding their request to speak by email 

by 12:00 p.m. EST, January 5, 2022. To 

accommodate the significant interest in 

participation in the oral public 

comment session of ACIP meetings, 

each speaker will be limited to 3 

minutes, and each speaker may only 

speak once per meeting. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2022–00123 Filed 1–4–22; 4:15 pm] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: Human Therapeutics for 

Fibrotic Disease 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Heart, Lung and 

Blood Institute (NHLBI), National 

Institutes of Health, Department of 

Health and Human Services, is 

contemplating the grant of an exclusive 

patent license to Inversago Pharma, Inc., 

located in Montreal, Quebec, Canada, to 

practice the inventions embodied in the 

patent applications listed in the 

Supplementary Information section of 

this notice. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NHLBI Office of 

Technology Transfer and Development 

January 21, 2022 will be considered. 

ADDRESSES: Requests for copies of the 

patent applications, inquiries, and 

comments relating to the contemplated 

exclusive patent license should be 

directed to: Michael Shmilovich, Esq., 

CLP Senior Licensing and Patenting 

Manager, phone number 301–435–5019 

or shmilovm@nih.gov. 

SUPPLEMENTARY INFORMATION: The 

following and all continuing U.S. and 

foreign patents/patent applications 

thereof are the intellectual properties to 

be licensed under the prospective 

license to Inversago Pharma, Inc.: 


TKELLEY on DSK125TN23PROD with NOTICE 
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