Government-Owned Inventions; Availability for Licensing, 85895-85896 [2023-27112]

Download as PDF Federal Register / Vol. 88, No. 236 / Monday, December 11, 2023 / Notices 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: Theodoric Mattes at 240–627–3827, or theodoric.mattes@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 A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to the invention.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: lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: Recombinant IgG Monoclonal Antibody-Based Detection of Taenia Antigen In Humans And Pigs Description of Technology: The pork tapeworm, Taenia solium, is endemic in most of Asia, Latin America, and SubSaharan Africa. The risk of infection is increased in regions where pigs are raised in closed proximity to humans, with migration from endemic regions being directly proportional to the prevalence of infection in high-income countries. Human infection by T. solium occurs following oral ingestion of eggs passed in human feces from an infected carrier. The larvae can travel anywhere in the human body. Neurocysticercosis (NCC) occurs when the larvae traverse the blood-brain barrier and penetrate the central nervous system. Diagnosis of NCC is typically made through radiological imaging studies (such as computed tomography or magnetic resonance imaging) to visualize the morphology, stage, and location of the cysts. Investigators at NIAID have developed the recombinant IgG monoclonal antibody known as TsG10, which can target T. solium circulating antigens. An expression vector to produce TsG10 is available for expression in mammalian cell lines. The resulting construct allows for a scalable, repeatable, and broadly accessible production of monoclonal antibodies for both human and veterinary use. The TsG10 monoclonal antibodies are adaptable for plate-based diagnostic assays like ELISAs, to support a diagnosis of NCC. VerDate Sep<11>2014 17:35 Dec 08, 2023 Jkt 262001 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: • Plate-based diagnostic immunoassays, both human and veterinary, for the detection of T. solium circulating antigen • Production of TsG10 recombinant monoclonal antibodies Competitive Advantages: • Detection of active T. solium infection • Scalable and repeatable production of a monoclonal antibody targeting T. solium • Materials available for development or licensing Development Stage: • Research Material Inventors: Drs. Thomas B. Nutman, Elise O’Connell, Theodore E. Nash, Siddhartha Mahanty, Hector Garcia, Adriana Paredes, all of NIAID Intellectual Property: HHS Reference No. E–043–2022–0 Licensing Contact: To license this technology, please contact Theodoric Mattes at 240–627–3827, or theodoric.mattes@nih.gov., and reference E–043–2022–0. 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 Theodoric Mattes at 240–627– 3827, or theodoric.mattes@nih.gov. Dated: December 5, 2023. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2023–27114 Filed 12–8–23; 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 SUMMARY: PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 85895 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: Brian Bailey, Ph.D.; 240–669–5128 or 301–201–9217; bbailey@mail.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: Enhanced Immune Response With Stabilized Norovirus VLPs: A NextGeneration Vaccine Approach Description of Technology: This technology includes a novel advancement in developing vaccines targeting norovirus, tailored specifically for a more robust and effective response. It centers around an improved version of Virus-Like Particles (VLPs) uniquely engineered for greater stability and efficacy. These enhanced VLPs are designed to remain intact even when faced with the body’s immune responses, overcoming a key limitation of previous vaccine designs. This stability is crucial in ensuring the vaccine’s effectiveness, particularly in individuals with more robust immune systems who have shown limited response to traditional vaccines. Additionally, the modified VLPs are likely more resistant to degradation, making them a more reliable and durable solution in vaccination campaigns. This innovation could be a significant step in offering a more effective vaccine option for widespread use. 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: • Enhanced Norovirus Vaccination: Specially designed to improve the effectiveness of vaccines against norovirus, particularly in individuals with previously low response rates to traditional vaccines. • Broad-Scale Immunization Programs: Suitable for large-scale public health initiatives due to its increased E:\FR\FM\11DEN1.SGM 11DEN1 lotter on DSK11XQN23PROD with NOTICES1 85896 Federal Register / Vol. 88, No. 236 / Monday, December 11, 2023 / Notices stability and durability, potentially reducing the frequency of booster shots. • Platform for Future Vaccine Development: The stabilization techniques used in this technology could be applied to other vaccine formulations, paving the way for more robust and effective vaccines against various pathogens. Competitive Advantages: • Provides enhanced stability and efficacy in norovirus VLP vaccines, ensuring effectiveness even in individuals with strong immune responses who have previously shown limited vaccine response. • Its innovative design increases the VLPs’ resistance to degradation, offering a more durable and reliable option for large-scale immunization programs. Development Stage: • Pre-Clinical. Inventors: Lisa Lindesmith, Ralph Baric, George Georgiou, Peter Kwong, Raffaello Veradi, Yaroslav Tsybovsky, Jason Gorman, Gwo-Yu Chuang and Li Ou, all of NIAID. Publications: Lu, Yuan et al. ‘‘Assessing sequence plasticity of a virus-like nanoparticle by evolution toward a versatile scaffold for vaccines and drug delivery.’’ Proceedings of the National Academy of Sciences of the United States of America vol. 112,40 (2015): 12360–5. DOI: 10.1073/ pnas.1510533112 at https://doi.org/ 10.1073/pnas.1510533112; Porta, Claudine et al. ‘‘Rational engineering of recombinant picornavirus capsids to produce safe, protective vaccine antigen.’’ PLoS pathogens vol. 9,3 (2013): e1003255. DOI: 10.1371/ journal.ppat.1003255 at https://doi.org/ 10.1371/journal.ppat.1003255; Mateo, Roberto et al. ‘‘Engineering viable footand-mouth disease viruses with increased thermostability as a step in the development of improved vaccines.’’ Journal of virology vol. 82,24 (2008): 12232–40. DOI: 10.1128/JVI.01553–08 at https://doi.org/10.1128/jvi.01553-08; Bertolotti-Ciarlet, Andrea et al. ‘‘Structural requirements for the assembly of Norwalk virus-like particles.’’ Journal of virology vol. 76,8 (2002): 4044–55. DOI: 10.1128/ jvi.76.8.4044–4055.2002 at https:// doi.org/10.1128/jvi.76.8.40444055.2002; Prasad, B V et al. ‘‘X-ray crystallographic structure of the Norwalk virus capsid.’’ Science (New York, N.Y.) vol. 286,5438 (1999): 287– 90. DOI: 10.1126/science.286.5438.287 at https://doi.org/10.1126/ science.286.5438.287. Intellectual Property: HHS Reference No. E–178–2019–0; U.S. Provisional Patent Application No. 63/091,824, filed on October 14, 2020; PCT Patent VerDate Sep<11>2014 17:35 Dec 08, 2023 Jkt 262001 Application No. PCT/US2021/55018, filed October 14, 2021; U.S. National Stage patent application, U.S. 18/ 031,602, filed April 12, 2023. Licensing Contact: To license this technology, please contact Brian Bailey, Ph.D.; 240–669–5128 or 301–201–9217; bbailey@mail.nih.gov, and reference E– 178–2019. 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 Brian Bailey, Ph.D.; 240–669– 5128 or 301–201–9217; bbailey@ mail.nih.gov. Dated: December 5, 2023. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2023–27112 Filed 12–8–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis, Panel SEP– 1: NCI Clinical and Translational Cancer Research, February 7, 2024, 9:00 a.m. to February 7, 2024, 5:00 p.m., National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W108, Rockville, Maryland, 20850 which was published in the Federal Register on November 17, 2023, FR Doc. 2023– 25490, 88 FR 80322. This notice is being amended to change the meeting date from February 7, 2024, to February 20, 2024. The meeting location and time will stay the same. The meeting is closed to the public. Dated: December 5, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–27069 Filed 12–8–23; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA–2023–0033; OMB No. 1660–NW171] Agency Information Collection Activities: Proposed Collection, Comment Request; Generic Clearance for FEMA’s Collection of Feedback on Customer Satisfaction and Disaster Recovery Federal Emergency Management Agency, Department of Homeland Security. ACTION: 60-Day notice of new collection and request for comments. AGENCY: The Federal Emergency Management Agency (FEMA), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on a new information collection. In accordance with the requirements of the Paperwork Reduction Act of 1995, this notice seeks comments concerning a generic clearance to collect feedback from applicants on service delivery and their subsequent disaster recovery. DATES: Comments must be submitted on or before February 9, 2024. ADDRESSES: To avoid duplicate submissions to the docket, please submit comments at www.regulations.gov under Docket ID FEMA–2023–0033. Follow the instructions for submitting comments. All submissions received must include the agency name and Docket ID. Regardless of the method used to submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at https://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wisht to read the Privacy and Security Notice that is available via a link on the homepage of www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Kristin Brooks, Statistician, FEMA’s Recovery Reporting and Analytics Division, Customer Survey and Analysis Section, at (202) 826–6291 or Kristin.Brooks@fema.dhs.gov. You may contact the Information Management Division for copies of the proposed collection of information at email address: FEMA-Information-CollectionsManagement@fema.dhs.gov. SUPPLEMENTARY INFORMATION: Executive Order 12862, ‘‘Setting Customer Service SUMMARY: E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 88, Number 236 (Monday, December 11, 2023)]
[Notices]
[Pages 85895-85896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27112]


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

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: Brian Bailey, Ph.D.; 240-669-5128 or 
301-201-9217; [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. 301-496-2644. A signed 
Confidential Disclosure Agreement will be required to receive copies of 
unpublished information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Enhanced Immune Response With Stabilized Norovirus VLPs: A Next-
Generation Vaccine Approach

    Description of Technology: This technology includes a novel 
advancement in developing vaccines targeting norovirus, tailored 
specifically for a more robust and effective response. It centers 
around an improved version of Virus-Like Particles (VLPs) uniquely 
engineered for greater stability and efficacy. These enhanced VLPs are 
designed to remain intact even when faced with the body's immune 
responses, overcoming a key limitation of previous vaccine designs. 
This stability is crucial in ensuring the vaccine's effectiveness, 
particularly in individuals with more robust immune systems who have 
shown limited response to traditional vaccines. Additionally, the 
modified VLPs are likely more resistant to degradation, making them a 
more reliable and durable solution in vaccination campaigns. This 
innovation could be a significant step in offering a more effective 
vaccine option for widespread use.
    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:
     Enhanced Norovirus Vaccination: Specially designed to 
improve the effectiveness of vaccines against norovirus, particularly 
in individuals with previously low response rates to traditional 
vaccines.
     Broad-Scale Immunization Programs: Suitable for large-
scale public health initiatives due to its increased

[[Page 85896]]

stability and durability, potentially reducing the frequency of booster 
shots.
     Platform for Future Vaccine Development: The stabilization 
techniques used in this technology could be applied to other vaccine 
formulations, paving the way for more robust and effective vaccines 
against various pathogens.
    Competitive Advantages:
     Provides enhanced stability and efficacy in norovirus VLP 
vaccines, ensuring effectiveness even in individuals with strong immune 
responses who have previously shown limited vaccine response.
     Its innovative design increases the VLPs' resistance to 
degradation, offering a more durable and reliable option for large-
scale immunization programs.
    Development Stage:
     Pre-Clinical.
    Inventors: Lisa Lindesmith, Ralph Baric, George Georgiou, Peter 
Kwong, Raffaello Veradi, Yaroslav Tsybovsky, Jason Gorman, Gwo-Yu 
Chuang and Li Ou, all of NIAID.
    Publications: Lu, Yuan et al. ``Assessing sequence plasticity of a 
virus-like nanoparticle by evolution toward a versatile scaffold for 
vaccines and drug delivery.'' Proceedings of the National Academy of 
Sciences of the United States of America vol. 112,40 (2015): 12360-5. 
DOI: 10.1073/pnas.1510533112 at https://doi.org/10.1073/pnas.1510533112; Porta, Claudine et al. ``Rational engineering of 
recombinant picornavirus capsids to produce safe, protective vaccine 
antigen.'' PLoS pathogens vol. 9,3 (2013): e1003255. DOI: 10.1371/
journal.ppat.1003255 at https://doi.org/10.1371/journal.ppat.1003255; 
Mateo, Roberto et al. ``Engineering viable foot-and-mouth disease 
viruses with increased thermostability as a step in the development of 
improved vaccines.'' Journal of virology vol. 82,24 (2008): 12232-40. 
DOI: 10.1128/JVI.01553-08 at https://doi.org/10.1128/jvi.01553-08; 
Bertolotti-Ciarlet, Andrea et al. ``Structural requirements for the 
assembly of Norwalk virus-like particles.'' Journal of virology vol. 
76,8 (2002): 4044-55. DOI: 10.1128/jvi.76.8.4044-4055.2002 at https://doi.org/10.1128/jvi.76.8.4044-4055.2002; Prasad, B V et al. ``X-ray 
crystallographic structure of the Norwalk virus capsid.'' Science (New 
York, N.Y.) vol. 286,5438 (1999): 287-90. DOI: 10.1126/
science.286.5438.287 at https://doi.org/10.1126/science.286.5438.287.
    Intellectual Property: HHS Reference No. E-178-2019-0; U.S. 
Provisional Patent Application No. 63/091,824, filed on October 14, 
2020; PCT Patent Application No. PCT/US2021/55018, filed October 14, 
2021; U.S. National Stage patent application, U.S. 18/031,602, filed 
April 12, 2023.
    Licensing Contact: To license this technology, please contact Brian 
Bailey, Ph.D.; 240-669-5128 or 301-201-9217; [email protected], and 
reference E-178-2019.
    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 Brian Bailey, Ph.D.; 240-669-5128 or 301-
201-9217; [email protected].

    Dated: December 5, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-27112 Filed 12-8-23; 8:45 am]
BILLING CODE 4140-01-P

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