Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Notices 11451 

TOTAL ESTIMATED ANNUALIZED BURDEN HOURS

Form name Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Total burden 

hours 

NEPA EID Checklist ............................................................ 1,500 1 1,500 1 1,500 

Total .............................................................................. 1,500 ........................ 1,500 ........................ 1,500 

HRSA specifically requests comments 

on (1) the necessity and utility of the 

proposed information collection for the 

proper performance of the agency’s 

functions, (2) the accuracy of the 

estimated burden, (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and (4) the 

use of automated collection techniques 

or other forms of information 

technology to minimize the information 

collection burden. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2022–04267 Filed 2–28–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Development and 

Commercialization of Chimeric Antigen 

Receptor T-Cell Therapies (CAR–T) 

That are Specific to CD22 and Other BCell Antigens for the Treatment of BCell Malignancies 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute, 

an institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an Exclusive Patent License to 

practice the inventions embodied in the 

Patents and Patent Applications listed 

in the Supplementary Information 

section of this Notice to Syncopation 

Life Sciences Inc., (‘‘Syncopation’’), 

located in Palo Alto, California. 

DATES: Only written comments and/or 

complete applications for a license 

which are received by the National 

Cancer Institute’s Technology Transfer 

Center on or before March 16, 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: Jim Knabb, Senior 

Technology Transfer Manager, at 

Telephone: (240)–276–7856; or at email: 

jim.knabb@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

E–080–2012–0: Human Monoclonal 

Antibodies Specific for CD22 

1. US Provisional Patent Application 

61/042,329, filed April 4, 2008 (E–080– 

2008–0–US–01); 

2. International Patent Application 

PCT/US2009/039,080, Filed April 1, 

2009 (E–080–2008/0–PCT–02); 

3. US Patent Application: 12/934,214, 

filed September 23, 2010 (E–080–2008– 

0–US–03); 

4. US Patent Application 13/959,061, 

filed August 5, 2015 (E–080–2008–0– 

US–04); 

5. US Patent Application 15/012,023, 

filed February 1, 2016 (E–080–2008–0– 

US–05); 

6. US Patent Application 15/424,238, 

filed February 3, 2017 (E–080–2008–0– 

US–06). 

E–291–2012–0: M971 Chimeric Antigen 

Receptors 

1. US Provisional Patent Application 

61/717,960, filed October 24, 2012 (E– 

291–2012–0–US–01); 

2. International Patent Application 

PCT/US2013/060332, filed September 

18, 2013 (E–291–2012–0–PCT–02); 

3. Australia Application No: 

2019235926, filed September 2, 2020 

(E–291–2012–0–AU–03); 

4. Brazil Patent Application 

BR112015009003–6, filed April 22, 2015 

(E–291–2012–0–BR–04); 

5. Canada Application No: 2889055, 

filed September 18, 2013 (E–291–2012– 

0–CA–05); 

6. China Application No: 

201380061387.5, filed May 25, 2015 (E– 

291–2012–0–CN–06); 

7. European Patent Application No: 

13773468.7, filed September 18, 2013 

(E–291–2012–0–EP–07); 

8. India Patent Application No: 2344/ 

CHENP/2015, filed September 18, 2013 

(E–291–2012–0–IN–08); 

9. Japan Application No: 539602/ 

2015, filed April 24, 2015 (E–291–2012– 

0–JP–09); 

10. Russia Patent Application: 

2015117237, filed May 7, 2015 (E–291– 

2012–0–RU–10); 

11. US Patent Application: 14/ 

437,889, filed April 23, 2015 (E–291– 

2012–0–US–11); 

12. Hong Kong Patent Application: 

16101891.0, filed February 19, 2016 (E– 

291–2012–0–HK–12); 

13. Russia Patent Application: 

2018116582, filed May 4, 2018 (E–291– 

2012–0–RU–13); 

14. Japan Patent Application: 2018– 

088908, filed May 2, 2018, (E–291– 

2012–0–JP–14); 

15. Australia Patent Application: 

2018204257, filed June 14, 2018 (E– 

291–2012–0–AU–16); 

16. US Patent Application: 16/ 

107,271, filed August 21, 2018 (E–291– 

2012–0–US–17); 

17. Germany Patent Application: 

13773468.7, filed April 22, 2015 (E– 

291–2012–0–DE–18); 

18. Spain Patent Application: 

13773468.7, filed April 22, 2015 (E– 

291–2012–0–ES–19); 

19. France Patent Application: 

13773468.7, filed April 22, 2015 (E– 

291–2012–0–FR–20); 

20. Great Britain Patent Application: 

13773468.7, filed April 22, 2015 (E– 

291–2012–0–GB–21); 

21. Italy Patent Application: 

13773468.7, filed April 22, 2015 (E– 

291–2012–0–IT–22); 

22. China Patent Application: 

201910500128.7, filed June 11, 2019 (E– 

291–2012–0–CN–23); 

23. US Patent Application: 16/ 

869,792, filed May 8, 2020 (E–291– 

2012–0–US–24). 

E–017–2017–0: CD19/CD22 Bicistronic 

CAR Targeting Human B-Cell 

Malignancies 

1. US Provisional Patent Application 

No.: 62/135,442, filed May 15, 2017 (E– 

017–2017–0–US–01); 

2. International Patent Application 

PCT/US2018/032,809, filed May 15, 

2018 (E–017–2017–0–PCT–02); 

3. Australia Patent Application No.: 

2018269194, filed October 28, 2019 (E– 

017–2017–0–AU–03); 

4. Canada Patent Application No: 

3062433, filed May 15, 2018 (E–017– 

2017–0–CA–04); 


jspears on DSK121TN23PROD with NOTICES1
11452 Federal Register / Vol. 87, No. 40 / Tuesday, March 1, 2022 / Notices 

5. China Patent Application No.: 

201880032676.5, filed Date: May 15, 

2018 (E–017–2017–0–CN–05); 

6. European Patent Application No.: 

18733012.1, filed May 15, 2018 (E–017– 

2017–0–EP–06); 

7. Japan Patent Application No.: 

2019–563082, filed November 13, 2019 

(E–017–2017–0–JP–07); 

8. Korea Patent Application No.: 

2019–7017289, filed December 13, 2019, 

(E–017–2017–0–KR–08); 

9. Singapore Patent Application No.: 

11201910499V, filed November 11, 2019 

(E–017–2017–0–SG–09); 

10. United States Patent Application 

No.: 16/613,187, filed November 13, 

2019 (E–017–2017–0–US–10); 

The patent rights in these inventions 

have been assigned and/or exclusively 

licensed to the government of the 

United States of America. 

The prospective exclusive license 

territory may be worldwide, and the 

fields of use may be limited to the 

following: 

‘‘Development, manufacture and 

commercialization of chimeric antigen 

receptor T cell (CAR–T) 

immunotherapies for the treatment of B 

cell malignancies, wherein the T cells 

are: 

1. Manufactured ex vivo; 

2. Not engineered to overexpress 

CD47; 

3. Engineered to express a CAR that 

targets CD22 via the m971 scFv in 

combination with both: 

a. Binders, CARs, or other receptors 

targeting: CD19, CD20, CD79b, or any 

combination thereof; and 

b. At least one of the following: 

—A technology to activate CD2 

signaling in the CAR T cell, and/or 

—Manufacturing of the cell product 

using the Storage by Actuated 

Shuttling (StASh) 

Where ‘‘ex vivo’’ specifically means 

where the cells or tissue are removed 

from a healthy donor (in the case of 

allogeneic therapy) or the patient (in the 

case of autologous therapy), modified ex 

vivo and then, implanted, transplanted, 

infused, or transferred into the patient. 

For purposes of clarity, specifically 

excluded from these Fields of Use are 

the following: 

1. Allogeneically-derived CAR–T 

immunotherapies that have been 

engineered to overexpress CD47; 

2. CAR–T immunotherapies wherein 

the CAR–T cells are manufactured 

within the patient via gene therapy 

vectors delivered to the patient (in vivo 

CAR–T immunotherapies); 

3. Autologously-derived CAR–T 

immunotherapies that have been 

engineered to be specific for CD19, 

CD20, and CD22 (via the m971 scFv) 

absent the engineering of the CAR–T 

therapies to activate CD2 signaling and/ 

or StASh as described in the Fields of 

Use 3(b) above; 

4. CAR–T immunotherapies wherein 

the CAR–T cells are engineered to 

express a bispecific CAR that is 

engineered to bind to CD19 and CD22, 

as described in HHS Ref. E–106–2015 

and encompassing the m971 scFv and 

the CD22 CAR.’’ 

The government-owned technologies 

that are contemplated in this proposed 

license are CAR therapies that target 

CD22 by utilizing the anti-CD22 binder 

known as m971 alone. The E–080–2008 

technology encompasses the m971 

binder, while E–291–2012 describes a 

CAR encompassing the m971 binder. 

Additionally, E–017–2017 describes a 

bicistronic CAR vector that 

encompasses the CD22-targeting m971 

CAR and a CAR that targets CD19. CD22 

is expressed on the surface of B cells in 

B cell malignancies and CD22-targeting 

CAR–T has shown early promise in 

clinical trials for ALL and NHL both as 

a monospecific and multispecific 

therapy. Targeting CD22 in combination 

with other B cell antigens (CD19, CD20, 

and/or CD79b in this instance) can lead 

to more effective CAR–T cell therapies. 

This Notice is made in accordance 

with 35 U.S.C. 209 and 37 CFR part 404. 

The prospective exclusive license will 

be royalty bearing, and the prospective 

exclusive license may be granted unless 

within fifteen (15) days from the date of 

this published Notice, the National 

Cancer Institute 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. 

In response to this Notice, the public 

may file comments or objections. 

Comments and objections, other than 

those in the form of a license 

application, will not be treated 

confidentially, and may be made 

publicly available. 

License applications submitted in 

response to this Notice will be 

presumed to contain business 

confidential information and any release 

of information from these license 

applications will be made only as 

required and upon a request under the 

Freedom of Information Act, 5 U.S.C. 

552. 

Dated: February 23, 2022. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2022–04245 Filed 2–28–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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: National Cancer 

Institute Special Emphasis Panel; Research 

Projects in Cancer Systems Biology (CSBC 

Research Projects) (U01). 

Date: March 31, 2022. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute at Shady 

Grove, 9609 Medical Center Drive, Room 

7W234, Rockville, Maryland 20850 

(Telephone Conference Call). 

Contact Person: Adriana Stoica, Ph.D., 

Scientific Review Officer, Resources and 

Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, NIH, 9609 Medical Center Drive, 

7W234, Rockville, Maryland 20850, 240– 

276–6368, Stoicaa2@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; SEP–1 NCI 

Clinical and Translational R21 and Omnibus 

R03 Review. 

Date: March 31, 2022. 

Time: 11:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute at Shady 

Grove, 9609 Medical Center Drive, Room 

7W602, Rockville, Maryland 20850 

(Telephone Conference Call). 

Contact Person: Delia Tang, M.D., 

Scientific Review Officer, Resources Training 

and Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 7W602, 

Rockville, Maryland 20850, 240–276–6456, 

tangd@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Social and 

Behavioral Intervention Research to Address 

Modifiable Risk Factors for Cancer in Rural 

Populations (R01). 

Date: May 5, 2022. 

Time: 10:00 a.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute at Shady 

Grove, 9609 Medical Center Drive, Room 


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