Government-Owned Inventions; Availability for Licensing, 10906-10907 [2023-03595]

Download as PDF 10906 Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / Notices stem cell transplantation and donation. The ACBSCT may also review the state of the science using adult stem cells and birthing tissues to develop new types of therapies for patients, for the purpose of considering the potential inclusion of such new types of therapies in the C.W. Bill Young Cell Transplantation Program. The recharter for ACBSCT was approved on February 15, 2023. Recharter of the ACBSCT charter gives authorization for the ACBSCT to operate until February 19, 2025. A copy of the ACBSCT charter is available on the ACBSCT website at https://bloodstemcell.hrsa.gov/about/ advisory-council. A copy of the charter can also be obtained by accessing the FACA database that is maintained by the Committee Management Secretariat under the General Services Administration. The website address for the FACA database is https:// www.facadatabase.gov/. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2023–03604 Filed 2–21–23; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Amended Notice of Meeting lotter on DSK11XQN23PROD with NOTICES1 Notice is hereby given of a change in the meeting of the Center for Scientific Review Special Emphasis Panel, PAR– 19–367: Maximizing Investigators’ Research Award, February 23–24, 2023, 10:00 a.m. to 8:00 p.m., National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting), which was published in the Federal Register on January 31, 2023, 88 FR 6288, Doc 2023–01953. This meeting is being amended to change the panel name to ‘‘PAR–20– 117: Maximizing Investigators’ Research Award for Early-Stage Investigators’’. The meeting is closed to the public. Dated: February 15, 2023. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–03572 Filed 2–21–23; 8:45 am] BILLING CODE 4140–01–P VerDate Sep<11>2014 19:42 Feb 21, 2023 Jkt 259001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; 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 on Aging Special Emphasis Panel; Healthcare Inequities in ADRD. Date: March 14, 2023. Time: 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Sandhya Sanghi, Ph.D., Scientific Review Officer, National Institutes of Health, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, (2N230) NIA/SRB, Bethesda, MD 20892, (301) 496–2879, sandhya.sanghi@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. 93.866, Aging Research, National Institutes of Health, HHS) Dated: February 15, 2023. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–03645 Filed 2–21–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Minority Health and Health Disparities; 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 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 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 on Minority Health and Health Disparities Special Emphasis Panel; John Lewis NIMHD Research Endowment Program. Date: March 22, 2023. Time: 10:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, NIMHD DEM II, Suite 800, 6707 Democracy Boulevard, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Xinli Nan, M.D., Ph.D., Scientific Review Officer, Office of Extramural Research Activities, National Institute on Minority Health and Health Disparities, National Institutes of Health, 6707 Democracy Boulevard, Suite 800, Bethesda, MD 20892, (301) 594–7784, Xinli.Nan@nih.gov. Dated: February 15, 2023. David W. Freeman, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–03571 Filed 2–21–23; 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: Dr. Maryann Puglielli at (240)–627–3723, or maryann.puglielli@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– SUMMARY: E:\FR\FM\22FEN1.SGM 22FEN1 Federal Register / Vol. 88, No. 35 / Wednesday, February 22, 2023 / Notices 2644. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to the invention. SUPPLEMENTARY INFORMATION: Technology description follows: lotter on DSK11XQN23PROD with NOTICES1 Replicating RNA Vaccine for CrimeanCongo Hemorrhagic Fever Virus Description of Technology: Crimean-Congo hemorrhagic fever (CCHF) is a deadly hemorrhagic fever having a high mortality rate. The disease results from infection of an individual by Crimean-Congo hemorrhagic fever virus (CCHFV), which is a tick-borne bunyavirus endemic in Southern and Eastern Europe, Africa, the Middle East, and Asia. Geographically, case distribution is consistent with the range of Hyalomma genus ticks, the main reservoir of CCHFV, and is likely to expand due to climate change. Humans may be infected from tick bites, through contact with infected animals or animal tissue. Nosocomial human-to-human transmission has also been described primarily for healthcare workers. Initial symptoms of CCHF include acute onset of a non-specific febrile illness consisting of sudden fever, myalgia, diarrhea, nausea, and vomiting. The hemorrhagic phase is characterized by large areas of severe bruising and uncontrolled bleeding throughout the body; among hospitalized patients, case fatality rates have ranged from 9–50%. Currently, there is no approved specific antiviral or vaccine for CCHFV infection. Scientists at NIAID in collaboration with HDT Bio have developed a replicating RNA (repRNA) vaccine based on Venezuelan Equine Encephalitis Virus replicon RNA expressing either the nucleoprotein (repNP) or the glycoprotein precursor (repGPC) from CCHFV alone or in combination. In mice, the repNP vaccine primarily elicited a robust but non-neutralizing antibody response while repGPC elicited primarily cellular immunity against epitopes in the CCHFV NSm and Gc proteins. Vaccination with repNP or repNP + repGPC resulted in protection against challenge with a heterologous strain of CCHFV in mice. 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: • Prophylactic usage against CCHFV infections in normal or high-risk populations. VerDate Sep<11>2014 19:42 Feb 21, 2023 Jkt 259001 • Therapeutic treatment, alone or in combination, in patients with CCHFV infection. • Assay development for surveillance, diagnostic, and prevention measures. Competitive Advantages: • Uses a cell-free system to express antigens thereby increasing safety of the vaccine. • RepRNA as a platform can drive high-level protein expression and mimics viral replication in a single round of replication resulting in a more robust immune response in comparison to DNA and mRNA platforms. Development Stage: Pre-clinical. Inventors: Heinz Feldmann (NIAID); David Hawman, (NIAID); and Jesse Erasmus (HDT Bio). Publications: Leventhal, S. et al., ‘‘Replicating RNA Vaccination Elicits an Unexpected Immune Response that Efficiently Protects Mice Against Lethal Crimean-Congo Hemorrhagic Fever Virus Challenge’’, EBioMedicine 82:104188 (2022). Intellectual Property: U.S. provisional patent application 63/365,015 filed May 19, 2022. Licensing Contact: To license this technology, please contact Dr. Maryann Puglielli at (240)–627–3723, or maryann.puglielli@nih.gov, and reference E–103–2022. 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 this technology. For collaboration opportunities, please contact Dr. Maryann Puglielli at (240)– 627–3723, or maryann.puglielli@ nih.gov. Dated: February 8, 2023. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2023–03595 Filed 2–21–23; 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 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 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 10907 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; Specialized Centers of Research Excellence (SCORE) on Sex Differences. Date: March 21–22, 2023. Time: 10:00 a.m. to 7:00 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: Elaine Sierra-Rivera, Ph.D., IRG Chief, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 6182, Bethesda, MD 20892, (301) 435–2514, riverase@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fertility Status as a Marker for Overall Health. Date: March 21, 2023. Time: 10:00 a.m. to 7:00 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: Anthony Wing Sang Chan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 809K, Bethesda, MD 20892, (301) 496–9392, chana3@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Fellowships: Endocrine and Metabolic Systems. Date: March 23, 2023. Time: 9:00 a.m. to 7:00 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: Victoria Martinez Virador, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892, (301) 594–4703, victoria.virador@ nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Cancer Diagnostics and Treatments (CDT). Date: March 23–24, 2023. Time: 9:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Washington Marriott Georgetown, 1221 22nd Street NW, Washington, DC 20037. Contact Person: Victor A. Panchenko, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 802B2, E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[Federal Register Volume 88, Number 35 (Wednesday, February 22, 2023)]
[Notices]
[Pages 10906-10907]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03595]


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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: Dr. Maryann Puglielli at (240)-627-
3723, or [email protected]. 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-

[[Page 10907]]

2644. A signed Confidential Disclosure Agreement will be required to 
receive copies of unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Replicating RNA Vaccine for Crimean-Congo Hemorrhagic Fever Virus

    Description of Technology:
    Crimean-Congo hemorrhagic fever (CCHF) is a deadly hemorrhagic 
fever having a high mortality rate. The disease results from infection 
of an individual by Crimean-Congo hemorrhagic fever virus (CCHFV), 
which is a tick-borne bunyavirus endemic in Southern and Eastern 
Europe, Africa, the Middle East, and Asia. Geographically, case 
distribution is consistent with the range of Hyalomma genus ticks, the 
main reservoir of CCHFV, and is likely to expand due to climate change. 
Humans may be infected from tick bites, through contact with infected 
animals or animal tissue. Nosocomial human-to-human transmission has 
also been described primarily for healthcare workers. Initial symptoms 
of CCHF include acute onset of a non-specific febrile illness 
consisting of sudden fever, myalgia, diarrhea, nausea, and vomiting. 
The hemorrhagic phase is characterized by large areas of severe 
bruising and uncontrolled bleeding throughout the body; among 
hospitalized patients, case fatality rates have ranged from 9-50%. 
Currently, there is no approved specific antiviral or vaccine for CCHFV 
infection.
    Scientists at NIAID in collaboration with HDT Bio have developed a 
replicating RNA (repRNA) vaccine based on Venezuelan Equine 
Encephalitis Virus replicon RNA expressing either the nucleoprotein 
(repNP) or the glycoprotein precursor (repGPC) from CCHFV alone or in 
combination. In mice, the repNP vaccine primarily elicited a robust but 
non-neutralizing antibody response while repGPC elicited primarily 
cellular immunity against epitopes in the CCHFV NSm and Gc proteins. 
Vaccination with repNP or repNP + repGPC resulted in protection against 
challenge with a heterologous strain of CCHFV in mice.
    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:
     Prophylactic usage against CCHFV infections in normal or 
high-risk populations.
     Therapeutic treatment, alone or in combination, in 
patients with CCHFV infection.
     Assay development for surveillance, diagnostic, and 
prevention measures.
    Competitive Advantages:
     Uses a cell-free system to express antigens thereby 
increasing safety of the vaccine.
     RepRNA as a platform can drive high-level protein 
expression and mimics viral replication in a single round of 
replication resulting in a more robust immune response in comparison to 
DNA and mRNA platforms.
    Development Stage: Pre-clinical.
    Inventors: Heinz Feldmann (NIAID); David Hawman, (NIAID); and Jesse 
Erasmus (HDT Bio).
    Publications: Leventhal, S. et al., ``Replicating RNA Vaccination 
Elicits an Unexpected Immune Response that Efficiently Protects Mice 
Against Lethal Crimean-Congo Hemorrhagic Fever Virus Challenge'', 
EBioMedicine 82:104188 (2022).
    Intellectual Property: U.S. provisional patent application 63/
365,015 filed May 19, 2022.
    Licensing Contact: To license this technology, please contact Dr. 
Maryann Puglielli at (240)-627-3723, or [email protected], and 
reference E-103-2022.
    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 this technology. For collaboration 
opportunities, please contact Dr. Maryann Puglielli at (240)-627-3723, 
or [email protected].

    Dated: February 8, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-03595 Filed 2-21-23; 8:45 am]
BILLING CODE 4140-01-P
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