Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Notices 65179 

COVID–19 Conduct guidance. FDA’s 

revisions include broadening the 

guidance’s scope to apply during 

disasters and PHEs, removing several 

outdated questions, clarifying 

recommendations regarding use of riskbased approaches for monitoring 

clinical investigations, clarifying 

recommendations concerning charging 

for investigational products, and making 

other editorial changes to improve 

clarity and consistency. 

FDA is issuing this guidance for 

immediate implementation in 

accordance with our good guidance 

practices regulation (21 CFR 

10.115(g)(3)) without initially seeking 

prior comment because the Agency has 

determined that prior public 

participation is not feasible or 

appropriate (see 21 CFR 10.115(g)(2) 

and section 701(h)(1)(C)(i) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

371(h)(1)(C)(i))). Specifically, we are not 

seeking prior comment because 

disasters and PHEs may occur without 

notice and, as we have learned from 

experience during the COVID–19 PHE, 

may rapidly cause major disruptions to 

clinical trial conduct. It is thus 

important to public health to provide 

guidance on approaches to assure the 

safety of trial participants and minimize 

risks to trial integrity during such major 

disruptions. Moreover, portions of the 

guidance reflect a less burdensome 

approach that is consistent with public 

health and that can be used during a 

disaster or PHE when appropriate. 

Interested parties had an opportunity to 

comment on the recommendations in 

the COVID–19 Conduct guidance, and 

FDA considered those comments when 

revising the guidance to apply those 

recommendations to disasters and 

public health emergencies more 

broadly. Although this guidance 

document is being implemented 

immediately, it remains subject to 

comment in accordance with FDA’s 

good guidance practices regulation 

(§ 10.115(g)(3)(D)). 

The guidance represents the current 

thinking of FDA on ‘‘Considerations for 

the Conduct of Clinical Trials of 

Medical Products During Major 

Disruptions Due to Disasters and Public 

Health Emergencies.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 11 have been 

approved under OMB control number 

0910–0303; the collections of 

information in 21 CFR parts 50 and 56 

have been approved under OMB control 

number 0910–0130; the collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014; the collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001; the collections of 

information in 21 CFR part 320 have 

been approved under OMB control 

number 0910–0630; the collections of 

information in 21 CFR part 812 have 

been approved under OMB control 

number 0910–0078; and the collections 

of information in 21 CFR part 814 have 

been approved under OMB control 

number 0910–0231. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: September 18, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–20474 Filed 9–20–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of an Exclusive 

Patent License: Development and 

Commercialization of Engineered T 

Cell Therapies for the Treatment of 

HPV-Positive Cancer(s) 

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 Scarlet TCR, 

Inc. (‘‘Scarlet’’), presently headquartered 

in Kingston, New Jersey. 

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 October 6, 2023 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: Andrew Burke, Ph.D., 

Senior Technology Transfer Manager, 

NCI Technology Transfer Center, 

Telephone: (240) 276–5484; Email: 

andy.burke@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

1. United States Provisional Patent 

Application No. 62/004,335 filed May 

29, 2014, entitled ‘‘Anti-Human 

Papillomavirus 16 E7 T Cell Receptors’’ 

[HHS Reference No. E–176–2014–0–US– 

01]; 

2. PCT Patent Application No. PCT/ 

US2015/033129 filed May 29, 2015, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–PCT–02]; 

3. Australian Patent No. 2015266818 

issued January 16, 2020, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell 

Receptors’’ [HHS Reference No. E–176– 

2014–0–AU–03]; 

4. Brazilian Patent Application No. 

BR112016027805–4 effective filing date 

of May 29, 2015, entitled ‘‘Anti-Human 

Papillomavirus 16 E7 T Cell Receptors’’ 

[HHS Reference No. E–176–2014–0–BR– 

04]; 

5. Canadian Patent Application No. 

2,950,192 effective filing date of May 29, 

2015, entitled ‘‘Anti-Human 

Papillomavirus 16 E7 T Cell Receptors’’ 

[HHS Reference No. E–176–2014–0– 

CA–05]; 

6. Chinese Patent No. 

ZL201580031789.X issued May 4, 2021, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–CN–06]; 

7. European Patent No. 3149031 

issued December 18, 2019, entitled 

‘‘Anti-Human Papillomavirus 16 E7 T 

Cell Receptors’’ [HHS Reference No. E– 

176–2014–0–EP–07]; 

a. Validated in: AL, AT, BE, BG, CH, 

CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, 

HR, HU, IE, IS, IT, LT, LU, LV, MK, MT, 

NL, NO, PL, PT, RO, SE, SI, SK, SM and 

TR. 

8. Israeli Patent No. 248797 issued 

September 1, 2021, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell 

Receptors’’ [HHS Reference No. E–176– 

2014–0–IL–08]; 


ddrumheller on DSK120RN23PROD with NOTICES1
65180 Federal Register / Vol. 88, No. 182 / Thursday, September 21, 2023 / Notices 

9. Japanese Patent No. 6742991 issued 

August 19, 2020, entitled ‘‘Anti-Human 

Papillomavirus 16 E7 T Cell Receptors’’ 

[HHS Reference No. E–176–2014–0–JP– 

09]; 

10. Korean Patent No. 10–2445667 

issued September 16, 2022, entitled 

‘‘Anti-Human Papillomavirus 16 E7 T 

Cell Receptors’’ [HHS Reference No. E– 

176–2014–0–KR–10]; 

11. Mexican Patent No. 375379 issued 

September 25, 2020, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell 

Receptors’’ [HHS Reference No. E–176– 

2014–0–MX–11]; 

12. Saudi Arabian Patent No. 7456 

issued January 5, 2021, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell 

Receptors’’ [HHS Reference No. E–176– 

2014–0–SA–12]; 

13. United States Patent No. 

10,174,098 issued January 8, 2019, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–US–13]; 

14. Hong Kong Patent No. HK1236203 

issued January 8, 2021, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell 

Receptors’’ [HHS Reference No. E–176– 

2014–0–HK–14]; 

15. United States Patent No. 

10,870,687 issued December 22, 2020, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–US–15]; 

16. European Patent Application No. 

19217074.4 filed December 17, 2019, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–EP–16]; 

17. Australian Patent No. 2019283892 

issued May 13, 2021, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell 

Receptors’’ [HHS Reference No. E–176– 

2014–0–AU–17]; 

18. Japanese Patent No. 6997267 

issued December 20, 2021, entitled 

‘‘Anti-Human Papillomavirus 16 E7 T 

Cell Receptors’’ [HHS Reference No. E– 

176–2014–0–JP–53]; 

19. Saudi Arabian Patent Application 

No. 520412601 filed August 10, 2020, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–SA–54]; 

20. Hong Kong Patent Application No. 

42020020661.3 filed November 24, 

2020, entitled ‘‘Anti-Human 

Papillomavirus 16 E7 T Cell Receptors’’ 

[HHS Reference No. E–176–2014–0– 

HK–55]; 

21. Mexican Patent Application No. 

MX/a/2020/010035 filed September 24, 

2020, entitled ‘‘Anti-Human 

Papillomavirus 16 E7 T Cell Receptors’’ 

[HHS Reference No. E–176–2014–0– 

MX–56]; 

22. United States Patent No. 

11,434,272 issued September 6, 2020, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–US–57]; 

23. Australian Patent No. 2021202227 

issued February 23, 2023, entitled 

‘‘Anti-Human Papillomavirus 16 E7 T 

Cell Receptors’’ [HHS Reference No. E– 

176–2014–0–AU–58]; 

24. Chinese Patent Application No. 

20210399056.9 filed April 14, 2021, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–CN–59]; 

25. Israeli Patent No. 282518 issued 

July 2, 2022, entitled ‘‘Anti-Human 

Papillomavirus 16 E7 T Cell Receptors’’ 

[HHS Reference No. E–176–2014–0–IL– 

60]; 

26. Hong Kong Patent Application No. 

42022046605.6 filed January 19, 2022, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–HK–62]; 

27. Japanese Patent No. 7291196 

issued June 6, 2023, entitled ‘‘AntiHuman Papillomavirus 16 E7 T Cell 

Receptors’’ [HHS Reference No. E–176– 

2014–0–JP–63]; 

28. Israeli Patent Application No. 

290655 filed February 16, 2022, entitled 

‘‘Anti-Human Papillomavirus 16 E7 T 

Cell Receptors’’ [HHS Reference No. E– 

176–2014–0–IL–64]; 

29. United States Patent Application 

No. 17/816,496 filed August 1, 2022, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–US–65]; 

30. Korean Patent Application No. 

2022–7032043 filed September 15, 2022, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–KR–66]; 

31. Australian Patent Application No. 

2023200608 filed February 6, 2023, 

entitled ‘‘Anti-Human Papillomavirus 

16 E7 T Cell Receptors’’ [HHS Reference 

No. E–176–2014–0–AU–01]; and 

32. Japanese Patent Application No. 

2023–091878 filed June 2, 2023, entitled 

‘‘Anti-Human Papillomavirus 16 E7 T 

Cell Receptors’’ [HHS Reference No. E– 

176–2014–0–JP–01]. 

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 

field of use may be limited to the 

following: 

‘‘Development, manufacture and 

commercialization of autologous T cell 

therapy products that are genetically 

engineered to have stable expression of 

a T cell receptor (TCR) targeting human 

papillomavirus (‘‘HPV’’)–16 E7, as 

claimed in the Licensed Patent Rights, 

for the treatment of HPV-associated 

cancers and premalignant conditions in 

humans.’’ 

The E–176–2014 patent family is 

primarily directed to an isolated TCR 

reactive to HPV 16 E7 antigen in the 

context of HLA–A*02. HPV describes a 

group of human viruses known to cause 

malignancy. Of the group, HPV–16 is 

the most prevalent strain. 

Approximately 90% of adults are 

estimated to have been exposed at some 

point in their lifetime. HPV drives 

transformation of infected cells through 

the expression of certain oncoproteins, 

chiefly E5, E6 and E7. The latter two are 

constitutively expressed in malignant 

cells and are necessary to maintain a 

transformed state, rendering them useful 

therapeutic targets. 

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: September 18, 2023. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2023–20487 Filed 9–20–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 


ddrumheller on DSK120RN23PROD with NOTICES1