Government-Owned Inventions; Availability for Licensing, 60894-60895 [2021-24028]

Download as PDF 60894 Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices and Hematology Research, National Institutes of Health, HHS) Dated: October 29, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–24029 Filed 11–3–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings lotter on DSK11XQN23PROD with NOTICES1 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: Center for Scientific Review Special Emphasis Panel; PAR Panel: Fogarty HIV Research Training Program for Low- and Middle-Income Country Institutions. Date: December 2–3, 2021. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Maureen Shuh, Ph.D., Scientific Review Officer, Center for Scientific Review, 6701 Rockledge Drive, Bethesda, MD 20892, 301–480–4097, maureen.shuh@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Genes, Genomes and Genetics. Date: December 6, 2021. Time: 12:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Elena Smirnova, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5187, MSC 7840, Bethesda, MD 20892, 301–357– 9112, smirnove@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Topics Focused on Alzheimer’s Disease and Alzheimer’s-Related Dementia. VerDate Sep<11>2014 17:57 Nov 03, 2021 Jkt 256001 Date: December 7–8, 2021. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Tara Roshell Earl, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1007C, Bethesda, MD 20892, (301) 451–3946, earltr@ mail.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Respiratory Sciences. Date: December 13–14, 2021. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Ghenima Dirami, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4122, MSC 7814, Bethesda, MD 20892, (240) 498– 7546, diramig@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: October 31, 2021. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–24053 Filed 11–3–21; 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. 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., 301–496–2644; peter.soukas@nih.gov. Licensing information and copies of the patent applications listed below may be obtained by communicating with the SUMMARY: PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 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. Recombinant Chimeric Bovine/Human Parainfluenza Virus 3 Expressing SARS–CoV–2 Spike Protein and Its Use Description of Technology Vaccines for SARS–CoV–2 are increasingly available under emergency use authorizations; however, indications are currently limited to individuals twelve (12) years or older. They also involve intramuscular immunization, which does not directly stimulate local immunity in the respiratory tract, the primary site of SARS–CoV–2 infection, shedding and spread. While the major burden of COVID–19 disease is in adults, infection and disease also occur in infants and young children, contributing to viral transmission. Therefore, the development of safe and effective pediatric COVID–19 vaccines is important. Ideally, a vaccine should be effective as a single dose, should induce mucosal immunity with the ability to restrict SARS–CoV–2 infection and respiratory shedding, and should easily coordinate with vaccines for other illnesses, such as HPIV3. The live-attenuated vaccine candidates are based on a recombinant chimeric bovine/human parainfluenza virus 3 (rB/HPIV3) vector expressing prefusion-stabilized versions of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS–CoV–2) Spike (S) protein. The B/HPIV3–SARS CoV–2 vaccine candidates are designed to be administered intranasally by drops or spray to infants and young children. The vaccines are expected to induce durable and broad systemic and respiratory mucosal immunity against SARS–CoV–2 and HPIV3. Immunogenicity and protective efficacy against SARS–CoV–2 challenge was confirmed in experimental animals including non-human primates. Based on experience with this B/HPIV3 platform and other live-attenuated PIV vaccine candidates in previous pediatric clinical studies, the present candidates are anticipated to be well-tolerated in humans, including infants and young children, and are available for clinical evaluation. The National Institute of Allergy and Infectious Diseases has extensive experience and capability in E:\FR\FM\04NON1.SGM 04NON1 Federal Register / Vol. 86, No. 211 / Thursday, November 4, 2021 / Notices evaluating live-attenuated respiratory virus vaccine candidates in pediatric clinical studies, including PIV vaccine candidates, and opportunity for collaboration exists. This technology is available for nonexclusive 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 • Vaccine research Competitive Advantages • Ease of manufacture • B cell and T cell activation • Low-cost vaccines • Intranasal administration/needlefree delivery Development Stage • In vivo data assessment (animal) Inventors: Ursula Buchholz (NIAID), Shirin Munir (NIAD), Cyril Le Nouen (NIAID), Xueqiao Liu (NIAID), Cindy Luongo (NIAID), Peter Collins (NIAID). Intellectual Property: HHS Reference No. E–239–2020–0—U.S. Provisional Application No. 63/180,534, filed April 27, 2021. Licensing Contact: Peter Soukas, J.D., 301–496–2644; 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., 301–496–2644; peter.soukas@nih.gov. Dated: October 29, 2021. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2021–24028 Filed 11–3–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES lotter on DSK11XQN23PROD with NOTICES1 National Institutes of Health Center for Scientific Review; 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. VerDate Sep<11>2014 17:57 Nov 03, 2021 Jkt 256001 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: Center for Scientific Review Special Emphasis Panel; Member Conflict: Risk Prevention and Health Behavior. Date: November 30, 2021. Time: 12:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Pamela Jeter, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 10J08, Bethesda, MD 20892, (301) 435–2591, pamela.jeter@nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR–19– 222: Small Grants for New Investigators to Promote Diversity in Health-Related Research (R21 Clinical Trial Optional). Date: December 6, 2021. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Jonathan K. Ivins, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 2190, MSC 7850, Bethesda, MD 20892, (301) 594– 1245, ivinsj@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Neuropharmacology and Physiology. Date: December 8, 2021. Time: 12:00 p.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Christine Jean DiDonato, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 1014J, Bethesda, MD 20892, (301) 435–1042, didonatocj@csr.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) PO 00000 Frm 00105 Fmt 4703 Sfmt 9990 60895 Dated: October 29, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–24027 Filed 11–3–21; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Library of Medicine; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the meeting of the Biomedical Informatics, Library and Data Sciences Review Committee. 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 materials, 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: Biomedical Informatics, Library and Data Sciences Review Committee (BILDS). Date: March 3, 2022. Time: 10:00 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Contact Person: Zoe E. Huang, MD, Chief Scientific Review Officer, Scientific Review Office, Extramural Programs, National Library of Medicine, National Institutes of Health (NIH), 6705 Rockledge Drive, Suite 500, Bethesda, MD 20892–7968, 301–594– 4937, huangz@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program No. 93.879, Medical Library Assistance, National Institutes of Health, HHS) Dated: October 29, 2021. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2021–24033 Filed 11–3–21; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\04NON1.SGM 04NON1

Agencies

[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Notices]
[Pages 60894-60895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24028]


-----------------------------------------------------------------------

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., 301-496-2644; 
[email protected]. 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.

Recombinant Chimeric Bovine/Human Parainfluenza Virus 3 Expressing 
SARS-CoV-2 Spike Protein and Its Use

Description of Technology

    Vaccines for SARS-CoV-2 are increasingly available under emergency 
use authorizations; however, indications are currently limited to 
individuals twelve (12) years or older. They also involve intramuscular 
immunization, which does not directly stimulate local immunity in the 
respiratory tract, the primary site of SARS-CoV-2 infection, shedding 
and spread. While the major burden of COVID-19 disease is in adults, 
infection and disease also occur in infants and young children, 
contributing to viral transmission. Therefore, the development of safe 
and effective pediatric COVID-19 vaccines is important. Ideally, a 
vaccine should be effective as a single dose, should induce mucosal 
immunity with the ability to restrict SARS-CoV-2 infection and 
respiratory shedding, and should easily coordinate with vaccines for 
other illnesses, such as HPIV3.
    The live-attenuated vaccine candidates are based on a recombinant 
chimeric bovine/human parainfluenza virus 3 (rB/HPIV3) vector 
expressing prefusion-stabilized versions of the Severe Acute 
Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Spike (S) protein. The 
B/HPIV3-SARS CoV-2 vaccine candidates are designed to be administered 
intranasally by drops or spray to infants and young children. The 
vaccines are expected to induce durable and broad systemic and 
respiratory mucosal immunity against SARS-CoV-2 and HPIV3. 
Immunogenicity and protective efficacy against SARS-CoV-2 challenge was 
confirmed in experimental animals including non-human primates. Based 
on experience with this B/HPIV3 platform and other live-attenuated PIV 
vaccine candidates in previous pediatric clinical studies, the present 
candidates are anticipated to be well-tolerated in humans, including 
infants and young children, and are available for clinical evaluation. 
The National Institute of Allergy and Infectious Diseases has extensive 
experience and capability in

[[Page 60895]]

evaluating live-attenuated respiratory virus vaccine candidates in 
pediatric clinical studies, including PIV vaccine candidates, and 
opportunity for collaboration exists.
    This technology is available for nonexclusive 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
     Vaccine research

Competitive Advantages

     Ease of manufacture
     B cell and T cell activation
     Low-cost vaccines
     Intranasal administration/needle-free delivery

Development Stage

     In vivo data assessment (animal)

    Inventors: Ursula Buchholz (NIAID), Shirin Munir (NIAD), Cyril Le 
Nouen (NIAID), Xueqiao Liu (NIAID), Cindy Luongo (NIAID), Peter Collins 
(NIAID).
    Intellectual Property: HHS Reference No. E-239-2020-0--U.S. 
Provisional Application No. 63/180,534, filed April 27, 2021.
    Licensing Contact: Peter Soukas, J.D., 301-496-2644; 
[email protected].
    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., 301-496-2644; [email protected].

    Dated: October 29, 2021.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2021-24028 Filed 11-3-21; 8:45 am]
BILLING CODE 4140-01-P
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