Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 50897 

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: September 7, 2021. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2021–19618 Filed 9–10–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Division of Extramural 

Research and Training (DERT) 

Extramural Grantee Data Collection 

National Institute of Environmental 

Health Science (NIEHS) 

AGENCY: National Institutes of Health, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, to provide 

opportunity for public comment on 

proposed data collection projects, the 

National Institute of Environmental 

Health Sciences (NIEHS), will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 60 days of the date of this 

publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments, submit 

comments in writing, or request more 

information on the proposed project, 

contact: Dr. Kristianna Pettibone, 

Evaluator, Program Analysis Branch, 

NIEHS, NIH, 530 Davis Dr., Room 3055, 

Morrisville, NC 20560, or call non-tollfree number (984) 287–3303 or Email 

your request, including your address to: 

pettibonekg@niehs.nih.gov. Formal 

requests for additional plans and 

instruments must be requested in 

writing. 

SUPPLEMENTARY INFORMATION: Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 requires: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

to address one or more of the following 

points: (1) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

function of the agency, including 

whether the information will have 

practical utility; (2) The accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

Ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Ways to minimize the 

burden of the collection of information 

on those who are to respond, including 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology. 

Proposed Collection Title: Division of 

Extramural Research and Training 

(DERT) Extramural Grantee Data 

Collection, 0925–0757, Expiration Date 

11/30/2021—REVISION, National 

Institute of Environmental Health 

Sciences (NIEHS), National Institutes of 

Health (NIH). 

Need and Use of Information 

Collection: In order to make informed 

management decisions about its 

research programs and to demonstrate 

the outputs, outcomes and impacts of its 

research programs NIEHS will collect, 

analyze and report on data from 

extramural grantees who are currently 

receiving funding or who have received 

funding in the past on topics such as: (1) 

Key scientific outcomes achieved 

through the research and the impact on 

the field of environmental health 

science; (2) Contribution of research 

findings to program goals and 

objectives; (3) Satisfaction with the 

program support received; (4) 

Challenges and benefits of the funding 

mechanism used to support the science; 

and (5) Emerging research areas and 

gaps in the research. 

Information gained from this primary 

data collection will be used in 

conjunction with data from grantee 

progress reports and presentations at 

grantee meetings to inform internal 

programs and new funding initiatives. 

Outcome information to be collected 

includes measures of agency-funded 

research resulting in dissemination of 

findings, investigator career 

development, grant-funded knowledge 

and products, commercial products and 

drugs, laws, regulations and standards, 

guidelines and recommendations, 

information on patents and new drug 

applications and community outreach 

and public awareness relevant to 

extramural research funding and 

emerging areas of research. 

OMB approval is requested for 3 

years. There are no costs to respondents, 

other than their time. The total 

estimated annualized burden hours are 

700. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Number of 

respondents 

Number of 

responses 

per 

respondent 

Average time 

per response 

(in hours) 

Total annual 

burden hour 

NICHD Grantee ............................................................................................... 200 1 30/60 100 

NIDCD Grantee ............................................................................................... 200 1 30/60 100 

NIMH Grantee .................................................................................................. 200 1 30/60 100 

NINDS Grantee ................................................................................................ 200 1 30/60 100 

NCI Grantee ..................................................................................................... 400 1 30/60 200

NIEHS Grantee ................................................................................................ 200 1 30/60 100 

Total .......................................................................................................... 1,400 1,400 ........................ 700 


lotter on DSK11XQN23PROD with NOTICES1
50898 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 

Jane M. Lambert, 

Project Clearance Liaison, National Institute 

of Environmental Health Sciences, National 

Institutes of Health. 

[FR Doc. 2021–19693 Filed 9–10–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Development and 

Commercialization of Cell Therapies 

for Cancer 

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 Athenex, Inc. 

(‘‘Athenex’’) headquartered in Buffalo, 

NY. 

DATES: Only written comments and/or 

applications for a license which are 

received by the National Cancer 

Institute’s Technology Transfer Center 

on or before September 28, 2021 will be 

considered. 

ADDRESSES: Requests for copies of the 

patent application, inquiries, and 

comments relating to the contemplated 

an Exclusive Patent License should be 

directed to: Suna Gulay French, Ph.D., 

Technology Transfer Manager, NCI 

Technology Transfer Center, Telephone: 

(240)–276–5530; Email: suna.gulay@

nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

GROUP A: 

E–237–2017–0/2: T Cell Receptors 

Recognizing Mutated P53 

1. US Provisional Patent Application 

62/565,383, filed September 29, 2017 

(E–237–2017–0–US–01); 

2. International Patent Application 

PCT/US2018/051285, filed September 

17, 2018 (E–237–2017–2–PCT–01); 

3. Australian Patent Application 

2018342246, filed September 17, 2018 

(E–237–2017–2–AU–02); 

4. Brazilian Patent Application 

BR112020006012–7, filed September 17, 

2018 (E–237–2017–2–BR–03); 

5. Canadian Patent Application 

3977024, filed September 17, 2018 (E– 

237–2017–2–CA–04); 

6. Chinese Patent Application 

201880074539.8, filed September 17, 

2018 (E–237–2017–2–CN–05); 

7. Costa Rica Patent Application 

2020–0170, filed September 17, 2018 

(E–237–2017–2–CR–06); 

8. Eurasian Patent Application 

202090757, filed September 17, 2018 

(E–237–2017–2–EA–07); 

9. European Patent Application 

18780006.5, filed September 17, 2018 

(E–237–2017–2–EP–08); 

10. Israeli Patent Application 273515, 

filed September 17, 2018 (E–237–2017– 

2–IL–09); 

11. India Patent Application 

202047013911, filed September 17, 2018 

(E–237–2017–2–IN–10); 

12. Japanese Patent Application 2020– 

517556, filed September 17, 2018 (E– 

237–2017–2–JP–11); 

13. Korean Patent Application 2020– 

7012344, filed September 17, 2018 (E– 

237–2017–2–KR–12); 

14. Mexico Patent Application MX/a/ 

2020/003504, filed September 17, 2018 

(E–237–2017–2–MX–13); 

15. New Zealand Patent Application 

763023, filed September 17, 2018 (E– 

237–2017–2–NZ–14); 

16. Singapore Patent Application 

11202002636P, filed September 17, 

2018 (E–237–2017–2–SG–15); 

17. United States Utility Patent 

Application 16/651,242, filed 

September 17, 2018 (E–237–2017–2– 

US–16); and 

18. Hong Kong Patent Application 

62020021272.3, filed November 30, 

2020 (E–237–2017–2–HK–17). 

E–135–2019: T Cell Receptors 

Recognizing R175H or Y220C Mutation 

in P53 

1. US Provisional Patent Application 

62/867,619, filed June 27, 2019 (E–135– 

2019–0–US–01); 

2. International Patent Application 

PCT/US2020/039785, filed June 26, 

2020 (E–135–2019–0–PCT–02); and 

3. Taiwanese Patent Application 

109121744, filed June 26, 2020 (E–135– 

2019–0–TW–03). 

E–173–2020: T Cell Receptors 

Recognizing R273C or Y220C Mutation 

in P53 

1. US Provisional Patent Application 

63/074,747, filed September 4, 2020 (E– 

173–2020–0–US–01). 

E–098–2018: T Cell Receptors Which 

Recognize Mutated EGFR 

1. US Provisional Patent Application 

62/665,234, filed May 1, 2018 (E–098– 

2018–0–US–01); 

2. International Patent Application 

PCT/US2019/030108, filed May 1, 2019 

(E–098–2018–0–PCT–02); 

3. Australian Patent Application 

2019263233, filed May 1, 2019 (E–098– 

2018–0–AU–03); 

4. Canadian Patent Application 

3,099,106, filed May 1, 2019 (E–098– 

2018–0–CA–04); 

5. European Patent Application 

19723615.1, filed May 1, 2019 (E–098– 

2018–0–EP–05); and 

6. United States Utility Patent 

Application 17/051,860, filed May 1, 

2019 (E–098–2018–0–US–06). 

E–165–2020: HLA Class II-Restricted 

DRB T Cell Receptors Against RAS With 

G12D Mutation 

1. US Provisional Application 63/ 

050,9131, filed July 13, 2020 (E–165– 

2020–0–US–01); and 

2. International Patent Application 

PCT/US2021/041375, filed July 13, 2021 

(E–165–2020–0–PCT–02). 

E–172–2020: HLA Class II-Restricted 

DRB T Cell Receptors Against RAS With 

G12V Mutation 

1. US Provisional Application 63/ 

052,502, filed July 16, 2020 (E–172– 

2020–0–US–01); and 

2. International Patent Application 

PCT/US2021/041737, filed July 15, 2021 

(E–172–2020–0–PCT–02). 

E–189–2020: HLA Class II-Restricted DQ 

T Cell Receptors Against RAS With 

G13D Mutation 

1. US Provisional Application 63/ 

086,674, filed October 2, 2020 (E–189– 

2020–0–US–01). 

E–190–2020: HLA Class I-Restricted T 

Cell Receptors Against RAS With G12V 

Mutation 

1. US Provisional Application 63/ 

060,340, filed August 3, 2020 (E–190– 

2020–0–US–01) and U.S., PCT and 

foreign patent applications claiming 

priority to the aforementioned 

application. 

GROUP B: 

E–237–2017–1: Methods of Isolating T 

Cells Having Antigenic Specificity for a 

P53 Cancer-Specific Mutation 

1. US Provisional Patent Application 

62/565,464, filed September 29, 2017 

(E–237–2017–1–US–01); 

2. International Patent Application 

PCT/US2018/051280, filed September 

17, 2018 (E–237–2017–1–PCT–02); 

3. Australian Patent Application 

2018342245, filed September 17, 2018 

(E–237–2017–1–AU–03); 

4. Canadian Patent Application 

3080274, filed September 17, 2018 (E– 

237–2017–1–CA–04); 


lotter on DSK11XQN23PROD with NOTICES1