9520 Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 

2. Effective Time Period, Section XII, 

Add to the End of the Section: 

Liability protections for Qualified 

Persons under sections V(f) and V(d) of 

the declaration begin on February 8, 

2021 and last through October 1, 2024. 

Authority: 42 U.S.C. 247d–6d. 

Norris Cochran, 

Acting Secretary, Department of Health and 

Human Services. 

[FR Doc. 2021–03106 Filed 2–11–21; 4:15 pm] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Peter Soukas, J.D., 301–594–8730; 

peter.soukas@nih.gov. Licensing 

information and copies of the patent 

applications listed below may be 

obtained by communicating with the 

indicated licensing contact at the 

Technology Transfer and Intellectual 

Property Office, National Institute of 

Allergy and Infectious Diseases, 5601 

Fishers Lane, Rockville, MD, 20852; tel. 

301–496–2644. A signed Confidential 

Disclosure Agreement will be required 

to receive copies of unpublished patent 

applications. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Epstein-Barr Virus Antibody That 

Blocks Fusion And Neutralizes Virus 

Infection of B Cells 

Description of Technology 

Epstein-Barr virus (EBV) is the most 

common cause of infectious 

mononucleosis and is associated with 

nearly 200,000 cancers and 140,000 

deaths each year. EBV-associated 

cancers include Hodgkin’s lymphoma, 

non-Hodgkin’s lymphoma, Burkitt B cell 

lymphoma, and EBV post-transplant 

lymphoproliferative disease. The latent 

reservoir for EBV in the body is the B 

lymphocyte. Thus, blocking B cell 

infection is important for reducing EBVrelated disease. 

EBV can infect both B cells and 

epithelial cells; however, the method of 

entry differs between these two cell 

types. To initiate B cell infection, EBV 

glycoprotein 350 (gp350) binds to 

compliment receptor 2 (CR2; also 

known as CD21), followed by binding of 

glycoprotein 42 (gp42) to HLA class II 

molecules, which triggers fusion of EBV 

with the B cell, allowing virus entry into 

the cell. Fusion also requires the EBV 

proteins gH/gL, which are found 

complexed with gp42 as a heterotrimer, 

and gB. Infection of epithelial cells is 

initiated by the binding of the EBV 

protein BMRF2 to cellular integrins, 

followed by binding of gH/gL to ephrin 

receptor A2 and integrins, which 

triggers fusion by EBV gB. 

Monoclonal antibodies that 

specifically bind EBV gp42 are 

described by this invention. The gp42- 

specific antibodies are capable of 

neutralizing EBV infection and 

inhibiting fusion of EBV with B cells. 

The monoclonal antibodies can be used 

for the treatment or prophylaxis of EBV 

infection, prevention of EBV-associated 

disease or infection in 

immunocompromised subjects, 

diagnosis of EBV infection, and 

detection of EBV in a biological sample. 

This technology is available for 

licensing for commercial development 

in accordance with 35 U.S.C. 209 and 37 

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration. 

Potential Commercial Applications 

• Viral diagnostics 

• Viral therapeutics 

• Viral prophylaxis 

• Vaccine research 

Competitive Advantages 

• Ease of manufacture 

• Strongly neutralizing antibodies 

• Alternative to EBV vaccines 

Development Stage 

• In vivo data assessment (animal) 

Inventors: Jeffrey Cohen (NIAID), Wei 

Bu (NIAID), Nathan Board (NIAID), 

Kennichi Dowdell (NIAID). 

Intellectual Property: HHS Reference 

No. E–020–2020–0—U.S. Provisional 

Application No. 62/979,070, filed 

February 20, 2020. 

Licensing Contact: Peter Soukas, J.D., 

301–594–8730; peter.soukas@nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate, or 

commercialize for development of a 

vaccine for respiratory or other 

infections. For collaboration 

opportunities, please contact Peter 

Soukas, J.D., 301–594–8730; 

peter.soukas@nih.gov. 

Dated: January 28, 2021. 

Surekha Vathyam, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2021–03045 Filed 2–12–21; 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; 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: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Renal RC2 

Applications. 

Date: March 19, 2021. 

Time: 3:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Ryan G. Morris, Ph.D., 

Scientific Review Officer, Review Branch, 

Division of Extramural Activities, NIDDK, 

National Institutes of Health, 6707 

Democracy Boulevard, Room 7015, Bethesda, 

MD 20892–2542, 301–594–4721, 

ryan.morris@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices 9521 

Dated: February 9, 2021. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–03015 Filed 2–12–21; 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 

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 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; HHS–NIH–CDC–SBIR PHS 

2021–1 Phase I: Pediatric Formulations of 

Select Second Line Drugs for Treating 

Tuberculosis (Topic 97). 

Date: February 22, 2021. 

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

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F58, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Mario Cerritelli, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F58, 

Rockville, MD 20892, 240–669–5199, 

cerritem@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; HHS–NIH–CDC–SBIR PHS 

2021–1 Phase I: Pediatric Formulations of 

Select Second Line Drugs for Treating 

Tuberculosis (Topic 96). 

Date: February 24, 2021. 

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

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F58, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Mario Cerritelli, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F58, 

Rockville, MD 20892, 240–669–5199, 

cerritem@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; HHS–NIH–CDC–SBIR PHS 

2021–1 Phase II: Pediatric Formulations of 

Select Second Line Drugs for Treating 

Tuberculosis (Topic 97). 

Date: February 24, 2021. 

Time: 4:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F58, 

Rockville, MD 20892 (Virtual Meeting). 

Contact Person: Mario Cerritelli, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, National Institute of Allergy and 

Infectious Diseases, National Institutes of 

Health, 5601 Fishers Lane, Room 3F58, 

Rockville, MD 20892, 240–669–5199, 

cerritem@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: February 9, 2021. 

Tyeshia M. Roberson, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–03016 Filed 2–12–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

Chris Kornak at 240–627–3705 or 

Chris.Kornak@nih.gov. Licensing 

information may be obtained by 

communicating with the Technology 

Transfer and Intellectual Property 

Office, National Institute of Allergy and 

Infectious Diseases, 5601 Fishers Lane, 

Rockville, MD 20852; tel. 301–496– 

2644. A signed Confidential Disclosure 

Agreement will be required to receive 

copies of unpublished information 

related to the invention. 

SUPPLEMENTARY INFORMATION: 

Technology description follows: 

Replication-Competent Adenovirus 

Type 4 SARS–CoV–2 Vaccines and 

Their Use 

Description of Technology 

NIAID has produced recombinant 

adenovirus type 4 (Ad4), SARS–CoV–2 

spike, vectors for administration to 

humans. These recombinant vaccines 

permit rapid development of high levels 

of neutralizing antibodies to SARS– 

CoV–2 in experimental animals. This 

vaccine is designed to improve the 

durability of the immune response by 

inducing mucosal and systemic 

immunity. Further, this system should 

be incredibly simple and efficient when 

producing vaccine at scale. This 

technology is available for licensing for 

commercial development in accordance 

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

as well as for further development and 

evaluation under a research 

collaboration. 

Potential Commercial Applications 

• Vaccine composition(s) 

Competitive Advantages 

• Stimulates a durable immune 

response; 

• Induction of mucosal and systemic 

immunity; 

• Potential for transmission 

interruption; 

• Intranasal administration minimizes 

the impact of pre-existing immunity; 

• Notable improvement for 

manufacturing yield and cost, ease of 

administration, and distribution as 

compared to current candidates. 

Inventor: Mark Connors, M.D. (NIAID) 

Publications: Matsuda et al. Journal of 

Clinical Investigation, 2021. (https://

doi.org/10.1172/JCI140794). Matsuda et 

al., Science Immunology 2019 (https:// 

doi.org/10.1126/sciimmunol.aau2710). 

Intellectual Property: HHS Reference 

E–055–2021; Application No. 63/ 

138,221. 

Licensing Contact: To license this 

technology, please contact Chris Kornak 

at chris.kornak@nih.gov. 


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