46858 Federal Register / Vol. 86, No. 159 / Friday, August 20, 2021 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; 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 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: NIGMS Initial Review 

Group Training and Workforce Development 

Study Section–C; Review of MARC and U– 

RISE T34 Applications. 

Date: October 21–22, 2021. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, Bethesda, 

MD 20892 (Video Meeting). 

Contact Person: Lee Warren Slice, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Institutes of General 

Medical Sciences, National Institutes of 

Health, 45 Center Drive, Room 3AN18A, 

Bethesda, MD 20814, 301–435–0807, 

slicelw@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives; 93.859, 

Biomedical Research and Research Training, 

National Institutes of Health, HHS) 

Dated: August 17, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–17875 Filed 8–19–21; 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: The Development of an 

Epidermal Growth Factor Receptor 

Variant III (EGFRvIII) Antibody-Drug 

Conjugate (ADC) for the Treatment of 

EGFRvIII-Expressing Human Cancers 

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 ADC Therapeutics 

Ltd (ADCT), located in Lausanne, 

Switzerland. 

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 7, 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: Abritee Dhal, Ph.D., 

Technology Transfer Manager, NCI 

Technology Transfer Center, Telephone: 

(240) 276–6154; Email: abritee.dhal@

nih.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

U.S. Provisional Patent Application 

62/869,956 entitled ‘‘Monoclonal 

Antibodies that Bind EGFRvIII and 

Their Use’’ [HHS Ref. E–103–2019–0– 

US–01], PCT Patent Application PCT/ 

US2020/040544 entitled ‘‘Monoclonal 

Antibodies that Bind EGFRvIII and 

Their Use’’ [HHS Ref. E–103–2019–0– 

PCT–02], and U.S. and foreign patent 

applications claiming priority to the 

aforementioned applications. 

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 use, development, manufacturing 

and commercialization of an antibodydrug conjugate (ADC) having: 

(1) The CDR sequences of the 40H3 

monoclonal antibody 

(2) a DNA-damaging or 

immunostimulant payload including, 

but not limited to, 

pyrrolobenzodiazepines, camptothecins, 

ecteinascidins, TLR/STING agonists, 

for the treatment of EGFRoverexpressing tumors including, but 

not limited to glioblastoma, head and 

neck cancer, non-small cell lung cancer 

(NSCLC) and colorectal cancer. The 

license field of use excludes any (a) 

non-specified immunoconjugates, 

including, but not limited to, chimeric 

antigen receptors (CARs) and variants 

thereof, ADCs with payloads that are not 

DNA-damaging, and (b) unconjugated 

antibodies.’’ 

Epidermal growth factor receptor 

(EGFR) is a transmembrane receptor for 

members of the epidermal growth factor 

(EGF) family of extracellular protein 

ligands. There is substantial evidence 

that aberrant EGFR activity is involved 

in the pathogenesis and progression of 

various types of cancers including 

glioblastoma multiforme (GBM). 

Aberrant EGFR activity is frequently 

associated with genetic alterations in 

EGFR expression (such as gene 

amplification) or activity (such as 

activating mutations). A particularly 

prominent activating mutation is caused 

by the loss of exons 2–7 to produce 

EGFR variant III (EGFRvIII). This 

constitutively active variant of EGFR is 

expressed in cancer cells only. 

Currently, there for no effective therapy 

for patients with GBM. The EGFRvIII 

ADC can potentially be used for the 

treatment of GBM and other EGFR 

expressing cancers such as head and 

neck cancer, NSCLC and colorectal 

cancer, the ADCs can lead to the 

selective destruction of the cancerous 

cells. The development of a new 

therapeutic targeting EGFR will benefit 

public health by providing an effective 

treatment for patients with GBM and 

other solid tumors. 

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. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 159 / Friday, August 20, 2021 / Notices 46859 

License applications submitted in 

response to this Notice will be 

presumed to contain business 

confidential information and any release 

of information in 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: August 16, 2021. 

Richard U. Rodriguez, 

Associate Director, Technology Transfer 

Center, National Cancer Institute. 

[FR Doc. 2021–17849 Filed 8–19–21; 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; 

Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Diabetes and 

Digestive and Kidney Diseases Advisory 

Council, September 09, 2021, 10:00 a.m. 

to September 10, 2021, 12:45 p.m., 

National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD, 20892 which 

was published in the Federal Register 

on August 09, 2021, FR Doc 2021– 

16952, 86 FR 43557. 

The meeting notice is amended to 

change and adjust the Opening and 

Closing times on the Subcommittees 

and Executive Sessions. The meeting is 

partially Closed to the public. 

Dated: August 17, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–17876 Filed 8–19–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Arthritis and 

Musculoskeletal and Skin Diseases; 

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 Institute of 

Arthritis and Musculoskeletal and Skin 

Diseases Special Emphasis Panel; AMP AIM 

Technology and Analytic Cores Review. 

Date: September 15, 2021. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Arthritis and 

Musculoskeletal and Skin Diseases, 6701 

Democracy Blvd, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Kan Ma, Ph.D., Scientific 

Review Officer, Scientific Review Branch, 

National Institute of Arthritis, 

Musculoskeletal and Skin Diseases, NIH, 

6701 Democracy Boulevard, Suite 814, 

Bethesda, MD 20892, 301–451–4838, mak2@

mail.nih.gov. 

Name of Committee: National Institute of 

Arthritis and Musculoskeletal and Skin 

Diseases Special Emphasis Panel; AMP–AIM 

Disease Team Review. 

Date: September 17, 2021. 

Time: 10:30 a.m. to 2:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute of Arthritis and 

Musculoskeletal and Skin Diseases, 6701 

Democracy Blvd., Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Yin Liu, Ph.D., MD 

Scientific Review Officer, Scientific Review 

Branch, National Institute of Arthritis, and 

Musculoskeletal and Skin Diseases, National 

Institute of Health, Bethesda, MD 20892, 

301–496–0505 liuy@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.846, Arthritis, 

Musculoskeletal and Skin Diseases Research, 

National Institutes of Health, HHS) 

Dated: August 17, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–17873 Filed 8–19–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Council of Councils. 

The meeting will be held as a virtual 

meeting and will be open to the public 

as indicated below. Individuals who 

plan to view the virtual meeting and 

need special assistance or other 

reasonable accommodations to view the 

meeting, should notify the Contact 

Person listed below in advance of the 

meeting. The open sessions will be 

videocast and can be accessed from the 

NIH Videocasting and Podcasting 

website (http://videocast.nih.gov). 

A portion of 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 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: Council of Councils. 

Open: September 17, 2021. 

Time: 10:00 a.m. to 12:10 p.m. 

Agenda: Call to Order and Introductions; 

Announcements and Updates; NIH Program 

Updates; Scientific Talks and Other Business 

of the Committee. 

Place: National Institutes of Health, 

Building 1, One Center Drive, Bethesda, MD 

20892 (Virtual Meeting). 

Name of Committee: Council of Councils. 

Closed: September 17, 2021. 

Time: 12:10 p.m. to 1:10 p.m. 

Agenda: Review of Grant Applications. 

Place: National Institutes of Health, 

Building 1, One Center Drive, Bethesda, MD 

20892 (Virtual Meeting). 

Open: September 17, 2021. 

Time: 1:30 p.m. to 5:10 p.m. 

Agenda: NIH Program Updates; Scientific 

Talks and Other Business of the Committee. 

Place: National Institutes of Health, 

Building 1, One Center Drive, Bethesda, MD 

20892 (Virtual Meeting). 

Contact Person: Robert W. Eisinger, Ph.D., 

Executive Secretary, Council of Councils, 

Senior Scientific Advisor, Division of 

Program Coordination, Planning, and 

Strategic Initiatives, Office of the Director, 

NIH, Building 1, Room 258, One Center 

Drive, Bethesda, MD 20892, robert.eisinger@

nih.gov, 301–451–0455. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Council of Council’s home page at http://

dpcpsi.nih.gov/council/ where an agenda 

will be posted before the meeting date. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 


khammond on DSKJM1Z7X2PROD with NOTICES