Government-Owned Inventions; Availability for Licensing, 25003-25004 [2023-08642]

Download as PDF Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices lotter on DSK11XQN23PROD with NOTICES1 such as sign language interpretation or other reasonable accommodations, must notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (https://videocast. nih.gov/). 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/or 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 grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Advisory Mental Health Council. Date: May 16–17, 2023. Open: May 16, 2023, 12:00 p.m. to 4:30 p.m. Agenda: Presentation of the NIMH Director’s Report and discussion of NIMH programs. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Room 160, Bethesda, MD 20892. Closed: May 17, 2023, 12:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications and/or contract proposals. Place: National Institutes of Health, Rockledge II, 6701 Rockledge Drive, Room 160, Bethesda, MD 20892. Contact Person: Tracy L. Waldeck, Ph.D., Director, Division of Extramural Activities, National Institute of Mental Health, National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Bethesda, MD 20892, (301) 480–6833, tracy.waldeck@ nih.gov. Any member of the public interested in presenting oral comments to the committee must notify the Contact Person listed on this notice at least 10 days in advance of the meeting. Interested individuals and representatives of organizations may submit a letter of intent, a brief description of the organization represented, and a short description of the oral presentation. Only one representative of an organization may be allowed to present oral comments and if accepted by the committee, presentations may be limited to five minutes. Both printed and electronic copies are requested for the record. In addition, any interested person may file written comments with the committee by forwarding their statement to the Contact Person listed on this notice at least 10 days in advance of the meeting. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has procedures at https://www.nih.gov/about- VerDate Sep<11>2014 16:47 Apr 24, 2023 Jkt 259001 nih/visitor-information/campus-accesssecurity for entrance into on-campus and offcampus facilities. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors attending a meeting on campus or at an off-campus federal facility will be asked to show one form of identification (for example, a governmentissued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program No. 93.242, Mental Health Research Grants, National Institutes of Health, HHS) Dated: April 19, 2023. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–08631 Filed 4–24–23; 8:45 am] BILLING CODE 4140–01–P Staff,’ National Institute of Allergy and Infectious Diseases, National Institutes of Health, Building 33, Room 1N24, 33 North Drive, Bethesda, MD 20892, 301–761–6362, Laurie.Lewallen@nih.gov. (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: April 19, 2023. Tyeshia M. Roberson-Curtis, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2023–08626 Filed 4–24–23; 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: DEPARTMENT OF HEALTH AND HUMAN SERVICES 25003 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: 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 by contacting Dr. Benjamin Hurley at 240–669–5092 or benjamin.hurley@nih.gov. A signed Confidential Disclosure Agreement will be required to receive copies of unpublished information related to the invention. SUPPLEMENTARY INFORMATION: Technology description follows: SUMMARY: National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Division of Intramural Research Board of Scientific Counselors, NIAID. The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Allergy and Infectious Diseases, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Division of Intramural Research Board of Scientific Counselors, NIAID. Date: June 12–14, 2023. Time: 7:45 a.m. to 10:55 a.m. Agenda: To review and evaluate personnel qualifications and performance, and competence of individual investigators. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, Building 50, Conference Room 1227/ 1233, 50 Center Drive, Bethesda, MD 20892. Contact Person: Laurie Lewallen, Division of Intramural Research Program Support PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Engineered Cell-Penetrating Monoclonal Antibody for Universal Influenza Immunotherapy Description of Technology: Influenza remains a burden on public health, as current treatments of viral infections remain ineffective due to frequent virus mutations. Many current influenza treatments rely on targeting surface viral glycoproteins. Unfortunately, these glycoproteins are primary targets of the immune system, which results in increased selection E:\FR\FM\25APN1.SGM 25APN1 lotter on DSK11XQN23PROD with NOTICES1 25004 Federal Register / Vol. 88, No. 79 / Tuesday, April 25, 2023 / Notices pressure and mutational rate, leading to the well-known seasonal variation of influenza virus. In contrast, the nucleocapsid viral protein (NP), located in the interior of the virus, is more conserved and an ideal antibody target; however, NP is inaccessible to extracellular antibodies produced in response to infection. To circumvent the challenge of targeting NP, scientists at NIAID have developed an antibody genetically fused with a cell penetrating peptide (CPP-mAb) that targets NP within infected cells to effectively inhibit viral replication. By targeting NP rather than the surface glycoproteins, this CPP-mAb can treat more influenza variants, potentially across flu seasons, and is an improvement upon current influenza treatments. 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: • Clinical Treatment: CPP-mAbs against influenza NP may be a reliable and effective method to treat patients infected with varying subtypes of influenza, by targeting a functionally conserved protein. • CPP-mAbs could be a viable alternative to the treatment of influenza when other treatments are ineffective, potentially lowering the mortality and morbidity rates in populations susceptible to influenza infection. Competitive Advantages: • Current vaccines remain effective for a short time period, due to the everchanging nature of the viral surface glycoproteins. CPP-mAbs could remain effective for a longer time period by targeting the interior NP of influenza, which is more conserved across influenza subtypes. • Other attempts to produce vaccines against conserved portions of the surface viral glycoproteins have failed to produce a robust and reliable vaccine. CPP-mAbs could be a more reliable therapeutic agent compared to alternatives, potentially effective across flu seasons. • In vivo efficacy: CPP-mAbs against NP increase survivorship in mice infected with mouse Influenza A virus, demonstrating therapeutic protection. Development Stage: • Pre-Clinical. Inventors: Jonathon Yewdell, MD, Ph.D. and Ivan Kosik, Ph.D., both from NIAID. Publications: Publication pending. Intellectual Property: HHS Reference No. E–193–2021; US Provisional VerDate Sep<11>2014 16:47 Apr 24, 2023 Jkt 259001 Application No. 63/365,841, filed on June 3rd, 2022. Licensing Contact: To license this technology, please contact Benjamin Hurley at 240–669–5092 or benjamin.hurley@nih.gov, and reference E–193–2021. 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 invention. For collaboration opportunities, please contact Benjamin Hurley; 240–669– 5092, benjamin.hurley@nih.gov. Dated: April 19, 2023. Surekha Vathyam, Deputy Director, Technology Transfer and Intellectual Property Office, National Institute of Allergy and Infectious Diseases. [FR Doc. 2023–08642 Filed 4–24–23; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA–2023–0011; OMB No. 1660–0015] Agency Information Collection Activities: Proposed Collection; Comment Request; Revisions to National Flood Insurance Program Maps: Application Forms and Instructions for (C)LOMAs and (C)LOMR–Fs Federal Emergency Management Agency, Department of Homeland Security. ACTION: 60-Day notice of revision 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 an extension, with change of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this notice seeks comments concerning information required by FEMA to amend or revise National Flood Insurance Program (NFIP) maps to remove certain property from the one-percent annual chance floodplain. DATES: Comments must be submitted on or before June 26, 2023. ADDRESSES: To avoid duplicate submissions to the docket, please SUMMARY: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 submit comments at www.regulations.gov under Docket ID FEMA–2023–0011. Follow the instructions for submitting comments. All submissions received must include the agency name and Docket ID. Regardless of the method used for 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 wish to read the Privacy and Security Notice that is available via a link on the homepage of www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Bryan Anderson, FEMA, Federal Insurance & Mitigation Administration, at (202) 577–2397 or Bryanb.Anderson@ fema.dhs.gov. You may contact the Information Management Division for copies of the proposed collection of information at email address: FEMAInformation-Collections-Management@ fema.dhs.gov. The National Flood Insurance Program (NFIP) is authorized by the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4001 et seq. The Federal Emergency Management Agency (FEMA) administers the NFIP and maintains the maps that depict flood hazard information. The land area covered by the floodwaters of the base flood is the Special Flood Hazard Area (SFHA) on NFIP maps. The SFHA is the area where the NFIP’s floodplain management regulations must be enforced and the area where the mandatory purchase of flood insurance applies. If a SFHA has been determined to exist for property and the owner or lessee of the property believes his/her property has been incorrectly included in a SFHA, information can be provided to support removal of the SFHA designation. NFIP regulations, at 44 CFR parts 65 and 70, outline the data that must be submitted by an owner or lessee of property who believes their property has been incorrectly included in a SFHA. In order to remove an area from a SFHA, the owner or lessee of the property must submit scientific or technical data demonstrating that the area is ‘‘reasonably safe from flooding’’ and not in the SFHA. This information collection is set to expire on July 31, 2023. FEMA is requesting a revision to the currently approved information collection. SUPPLEMENTARY INFORMATION: E:\FR\FM\25APN1.SGM 25APN1

Agencies

[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 25003-25004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08642]


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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: 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 by contacting Dr. Benjamin Hurley at 
240-669-5092 or [email protected]. A signed Confidential 
Disclosure Agreement will be required to receive copies of unpublished 
information related to the invention.

SUPPLEMENTARY INFORMATION: Technology description follows:

Engineered Cell-Penetrating Monoclonal Antibody for Universal Influenza 
Immunotherapy

    Description of Technology:
    Influenza remains a burden on public health, as current treatments 
of viral infections remain ineffective due to frequent virus mutations. 
Many current influenza treatments rely on targeting surface viral 
glycoproteins. Unfortunately, these glycoproteins are primary targets 
of the immune system, which results in increased selection

[[Page 25004]]

pressure and mutational rate, leading to the well-known seasonal 
variation of influenza virus. In contrast, the nucleocapsid viral 
protein (NP), located in the interior of the virus, is more conserved 
and an ideal antibody target; however, NP is inaccessible to 
extracellular antibodies produced in response to infection. To 
circumvent the challenge of targeting NP, scientists at NIAID have 
developed an antibody genetically fused with a cell penetrating peptide 
(CPP-mAb) that targets NP within infected cells to effectively inhibit 
viral replication. By targeting NP rather than the surface 
glycoproteins, this CPP-mAb can treat more influenza variants, 
potentially across flu seasons, and is an improvement upon current 
influenza treatments.
    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:
     Clinical Treatment: CPP-mAbs against influenza NP may be a 
reliable and effective method to treat patients infected with varying 
subtypes of influenza, by targeting a functionally conserved protein.
     CPP-mAbs could be a viable alternative to the treatment of 
influenza when other treatments are ineffective, potentially lowering 
the mortality and morbidity rates in populations susceptible to 
influenza infection.
    Competitive Advantages:
     Current vaccines remain effective for a short time period, 
due to the ever-changing nature of the viral surface glycoproteins. 
CPP-mAbs could remain effective for a longer time period by targeting 
the interior NP of influenza, which is more conserved across influenza 
subtypes.
     Other attempts to produce vaccines against conserved 
portions of the surface viral glycoproteins have failed to produce a 
robust and reliable vaccine. CPP-mAbs could be a more reliable 
therapeutic agent compared to alternatives, potentially effective 
across flu seasons.
     In vivo efficacy: CPP-mAbs against NP increase 
survivorship in mice infected with mouse Influenza A virus, 
demonstrating therapeutic protection.
    Development Stage:
     Pre-Clinical.
    Inventors: Jonathon Yewdell, MD, Ph.D. and Ivan Kosik, Ph.D., both 
from NIAID.
    Publications: Publication pending.
    Intellectual Property: HHS Reference No. E-193-2021; US Provisional 
Application No. 63/365,841, filed on June 3rd, 2022.
    Licensing Contact: To license this technology, please contact 
Benjamin Hurley at 240-669-5092 or [email protected], and 
reference E-193-2021.
    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 invention. For collaboration 
opportunities, please contact Benjamin Hurley; 240-669-5092, 
[email protected].

    Dated: April 19, 2023.
Surekha Vathyam,
Deputy Director, Technology Transfer and Intellectual Property Office, 
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2023-08642 Filed 4-24-23; 8:45 am]
BILLING CODE 4140-01-P


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