Government-Owned Inventions; Availability for Licensing, 71912-71913 [2024-19719]

Download as PDF ddrumheller on DSK120RN23PROD with NOTICES1 71912 Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices Name of Committee: National Cancer Institute Special Emphasis Panel; Metastasis Research Network (U01). Date: October 8, 2024. Time: 11:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute, Shady Grove 9609 Medical Center Drive, Room 7W266 Rockville, Maryland 20850 (Virtual Meeting). Contact Person: Lei Fang, Ph.D., Scientific Review Officer, Program Coordination and Referral Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W266, Rockville, Maryland 20850, 240–760–6821, fangl@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Early-Stage Development of Informatics Technologies for Cancer Research and Management. Date: October 17–18, 2024. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W254, Rockville, Maryland 20850 (Virtual Meeting). Contact Person: Susan Lynn Spence, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W254, Rockville, Maryland 20850, 240–620–0819, susan.spence@ nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; SEP 13: NCI Clinical and Translational R21 and Omnibus R03 Review. Date: October 22, 2024. Time: 10:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute at Shady Grove, 9609 Medical Center Drive, Room 7W542, Rockville, Maryland 20850 (Virtual Meeting). Contact Person: Biman Chandra Paria, Ph.D., Scientific Review Officer, Program Coordination and Referral Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W542, Rockville, Maryland 20850, 240–858–3814, pariab@mail.nih.gov. Name of Committee: National Cancer Institute Initial Review Group; Institutional Training and Education Study Section (F). Date: October 23–24, 2024. Time: 4:00 p.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington/Rockville, 1750 Rockville Pike, Rockville, Maryland 20852 (In-Person Meeting). Contact Person: Adriana Stoica, Ph.D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W234, Rockville, Maryland 20850, 240–276–6368, Stoicaa2@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI VerDate Sep<11>2014 21:26 Sep 03, 2024 Jkt 262001 Pathway to Independence Award for Outstanding Early-Stage Postdoctoral Researchers (K99/R00) and Mentored Research Scientist Development Award (K01). Date: October 30–31, 2024. Time: 10:00 a.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute at Shady Grove, 9609 Medical Center Drive, Room 7W238, Rockville, Maryland 20850 (Virtual Meeting). Contact Person: Byeong-Chel Lee, Ph.D., Scientific Review Officer, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W238, Rockville, Maryland 20850, 240–276–7755, byeong-chel.lee@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; SEP–2: NCI Clinical and Translational Cancer Research. Date: October 31, 2024. Time: 10:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W242, Rockville, Maryland 20850 (Virtual Meeting). Contact Person: Zhiqiang Zou, M.D., Ph.D., Scientific Review Officer, Special Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W242, Rockville, Maryland 20850, 240–276–6372, zouzhiq@ mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; NCI Cancer Epidemiology Cohorts Special Emphasis Panel. Date: November 1, 2024. Time: 10:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Cancer Institute Shady Grove, 9609 Medical Center Drive, Room 7W236, Rockville, Maryland 20850 (Virtual Meeting). Contact Person: Shuli Xia, Ph.D., Scientific Review Officer, Research Technology and Contract Review Branch, Division of Extramural Activities, National Cancer Institute, NIH, 9609 Medical Center Drive, Room 7W236, Rockville, Maryland 20850, 240–276–5256, shuli.xia@nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: August 28, 2024. David W. Freeman, Supervisory Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2024–19742 Filed 9–3–24; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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 inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research for the benefit of the public health. FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained by emailing the indicated licensing contact Michael Shmilovich, Esq, MS, CLP; 301–435–5019; michael.shmilovich@nih.gov at the National Heart, Lung, and Blood, Office of Technology Transfer and Development, 31 Center Drive Room 4A25, MSC2479, Bethesda, MD 20892– 2479; NHLBI_TechTransfer@ mail.nih.gov. A signed Confidential Disclosure Agreement may be required to receive any unpublished information. SUPPLEMENTARY INFORMATION: This notice is in accordance with 35 U.S.C. 209 and 37 CFR part 404. Technology description follows. SUMMARY: PET Imaging Agents for Fungal Infections Available for licensing and commercial development are patent rights covering PET imaging agents, methods of their synthesis, and their uses in imaging specific fungal infections. Fungal infections remain a global health problem resulting in over 1.5 million annual deaths. Immunocompromised patients, especially those undergoing cancer treatments or transplantation, are particularly vulnerable and the fungus, Aspergillus fumigatus, is of particular concern. To date, no fungal-specific imaging agents are available—existing imaging agents cannot discern fungal pathogens from bacteria or viruses and generally cannot differentiate between infection and inflammation. One naturally-occurring disaccharide, cellobiose, is selectively hydrolyzed by Aspergillus fumigatus and not by bacteria or human cells. The fluorinated version of the disaccharide, 18FFluorodeoxycellobiose ([18F]-FCB), has been synthesized and tested. [18F]-FCB is particularly useful as it is not metabolized by human enzymes and hydrolyzed only by fungal beta- E:\FR\FM\04SEN1.SGM 04SEN1 Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices glucosidases. Both in vitro and in vivo testing in animal models (see publications below) of different infections and inflammation confirmed radioactivity accumulation only in live pathogenic fungi. Imaging with [18F]FCB in mice infected with Aspergillus, for example, showed that the imaging agent can detect whether there has been a response to antifungal therapy. One major advantage is that synthesis of [18F]-FCB is simple and efficient using readily commercially available reagents. The radiolabeled agent can then be administered intravenously, and imaging performed 90–120 minutes after injection. A radiosynthesis kit has also been developed and can be used at ambient temperature to produce [18F]FCB from a commercially acquired kit in less than two hours without the need for a cyclotron. [18F]Fluorocellobiose Using Trasis AllInOne Module. Journal of labelled compounds & radiopharmaceuticals, 67(9), 308–313. https://doi.org/10.1002/ jlcr.4116. Potential Commercial Applications • Imaging of live infections. Dated: August 28, 2024. Michael A. Shmilovich, Senior Licensing and Patenting Manager, National Heart, Lung, and Blood Institute, Office of Technology Transfer and Development. Development Stage • In vitro data • Preclinical in vivo data (mouse models) Intellectual Property • NIH Reference No. E–163–2019; U.S. Provisional Patent Application 62/ 882,023 filed August 2, 2019; International Patent Application PCT/ US2020/044446 filed July 31, 2020 (published as WIPO publication WO 2021/025984); and national stage patent applications filed in Europe (20757180.3) and the United States (17/ 631,600). • NIH Reference No. E–080–2023; U.S. Provisional Patent Application 63/ 492,302 filed March 27, 2023, and International Patent Application PCT/ US2024/021440 filed March 26, 2024. [FR Doc. 2024–19719 Filed 9–3–24; 8:45 am] BILLING CODE 4140–01–P ddrumheller on DSK120RN23PROD with NOTICES1 Related Publications • Zhang X, Basuli F, Shi Z–D, Shah S, Shi J, Mitchell A, Lai J, Wang Z, Hammoud DA, Swenson RE. Synthesis and Evaluation of Fluorine-18-Labeled L-Rhamnose Derivatives. Molecules. 2023; 28(9):3773. https://doi.org/ 10.3390/molecules28093773. • Shah, S., Lai, J., Basuli, F., Martinez-Orengo, N., Patel, R., Turner, M.L., Wang, B., Shi, Z.D., Sourabh, S., Peiravi, M., Lyndaker, A., Liu, S., Seyedmousavi, S., Williamson, P.R., Swenson, R.E., & Hammoud, D.A. (2024). Development and preclinical validation of 2-deoxy 2[18F]fluorocellobiose as an Aspergillusspecific PET tracer. Science translational medicine, 16(760), eadl5934. https://doi.org/10.1126/ scitranslmed.adl5934. • Basuli, F., Shi, J., Shah, S., Lai, J., Hammoud, D.A., & Swenson, R.E. (2024). Fully Automated Cassette-Based Synthesis of 2-Deoxy-2- DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Strategic Preparedness and Response Statement of Organization, Functions, and Delegations of Authority Administration for Strategic Preparedness and Response, HHS. ACTION: Notice. AGENCY: This notice announces revisions to the organizations within the Administration for Strategic Preparedness and Response (ASPR). DATES: These revisions were approved by the Administrator and Assistant Secretary of ASPR on July 2, 2024, and became effective on July 2, 2024. SUPPLEMENTARY INFORMATION: Part A, Office of the Secretary, Statement of Organization, Functions, and SUMMARY: 71913 Delegations of Authority of the U.S. Department of Health and Human Services (HHS) is being amended at Chapter AN, Office of the Assistant Secretary for Preparedness and Response (ASPR), as last amended at 88 FR 10125 (Feb. 16, 2023), 85 FR 8302 (Feb. 13, 2020), 83 FR 33941 (July 18, 2018), 79 FR 70.535 (Nov. 26, 2014), 78 FR 25277 (April 30, 2013), 78 FR 7784 (Feb. 4, 2013), 75 FR 35.035 (June 21, 2010) to refine the functions within ASPR to more closely align with ASPR’s Operating Division status and expansion of mission which includes preparing for and responding to ever-increasing manmade and naturally occurring threats which have the potential to degrade public health, access to healthcare, access to emergency medical services, and national security. In 2023, ASPR underwent a major reorganization that was designed to recognize the Agency’s expanded scope of work as a new Operating Division, simplify the organizational structure, provide greater role clarity, and increase collaboration across teams. These changes were targeted in nature and focused on areas where the mission had recently expanded. Since the implementation of ASPR’s 2023 reorganization, the Agency has undergone additional, modest adjustments to its organizational structure to better clarify missions, roles, and responsibilities at the Deputy Assistant Secretary (DAS)-level, Officelevel, and Division level. Substantive changes to ASPR organizations are noted below. The changes are as follows: Global Change: Naming Conventions for ASPR Components To more closely align with the maturation of ASPR’s Operating Division status and mission of the organization, the titles for the ASPR component overseen by an ASPR Deputy Assistant Secretary (DAS) are now called ‘‘Centers’’ instead of ‘‘Offices.’’ The chart below provides the previous title and the new title. Previous title New title Immediate Office of the ASPR ................................................................. Office of Administration ............................................................................ Office of Preparedness ............................................................................. Office of Response ................................................................................... Office of Biomedical Advanced Research Development Authority .......... Office of HHS Coordination, Operations, and Response Element .......... Office of Industrial Base Management and Supply Chain ....................... Office of the Strategic National Stockpile ................................................ Immediate Office of the ASPR (no change). Center for Administration. Center for Preparedness. Center for Response. Center for the Biomedical Advanced Research Development Authority. Center for the HHS Coordination Operations and Response Element. Center for Industrial Base Management and Supply Chain. Center for the Strategic National Stockpile. VerDate Sep<11>2014 21:26 Sep 03, 2024 Jkt 262001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\04SEN1.SGM 04SEN1

Agencies

[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71912-71913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19719]


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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 inventions listed below are owned by an agency of the U.S. 
Government and are available for licensing to achieve expeditious 
commercialization of results of federally-funded research for the 
benefit of the public health.

FOR FURTHER INFORMATION CONTACT: Licensing information may be obtained 
by emailing the indicated licensing contact Michael Shmilovich, Esq, 
MS, CLP; 301-435-5019; [email protected] at the National 
Heart, Lung, and Blood, Office of Technology Transfer and Development, 
31 Center Drive Room 4A25, MSC2479, Bethesda, MD 20892-2479; 
[email protected]. A signed Confidential Disclosure 
Agreement may be required to receive any unpublished information.

SUPPLEMENTARY INFORMATION: This notice is in accordance with 35 U.S.C. 
209 and 37 CFR part 404. Technology description follows.

PET Imaging Agents for Fungal Infections

    Available for licensing and commercial development are patent 
rights covering PET imaging agents, methods of their synthesis, and 
their uses in imaging specific fungal infections. Fungal infections 
remain a global health problem resulting in over 1.5 million annual 
deaths. Immunocompromised patients, especially those undergoing cancer 
treatments or transplantation, are particularly vulnerable and the 
fungus, Aspergillus fumigatus, is of particular concern. To date, no 
fungal-specific imaging agents are available--existing imaging agents 
cannot discern fungal pathogens from bacteria or viruses and generally 
cannot differentiate between infection and inflammation. One naturally-
occurring disaccharide, cellobiose, is selectively hydrolyzed by 
Aspergillus fumigatus and not by bacteria or human cells. The 
fluorinated version of the disaccharide, \18\F-Fluorodeoxycellobiose 
([18F]-FCB), has been synthesized and tested. [18F]-FCB is particularly 
useful as it is not metabolized by human enzymes and hydrolyzed only by 
fungal beta-

[[Page 71913]]

glucosidases. Both in vitro and in vivo testing in animal models (see 
publications below) of different infections and inflammation confirmed 
radioactivity accumulation only in live pathogenic fungi. Imaging with 
[18F]-FCB in mice infected with Aspergillus, for example, showed that 
the imaging agent can detect whether there has been a response to 
antifungal therapy. One major advantage is that synthesis of [18F]-FCB 
is simple and efficient using readily commercially available reagents. 
The radiolabeled agent can then be administered intravenously, and 
imaging performed 90-120 minutes after injection. A radiosynthesis kit 
has also been developed and can be used at ambient temperature to 
produce [18F]-FCB from a commercially acquired kit in less than two 
hours without the need for a cyclotron.

Potential Commercial Applications

     Imaging of live infections.

Development Stage

     In vitro data
     Preclinical in vivo data (mouse models)

Related Publications

     Zhang X, Basuli F, Shi Z-D, Shah S, Shi J, Mitchell A, Lai 
J, Wang Z, Hammoud DA, Swenson RE. Synthesis and Evaluation of 
Fluorine-18-Labeled L-Rhamnose Derivatives. Molecules. 2023; 
28(9):3773. https://doi.org/10.3390/molecules28093773.
     Shah, S., Lai, J., Basuli, F., Martinez-Orengo, N., Patel, 
R., Turner, M.L., Wang, B., Shi, Z.D., Sourabh, S., Peiravi, M., 
Lyndaker, A., Liu, S., Seyedmousavi, S., Williamson, P.R., Swenson, 
R.E., & Hammoud, D.A. (2024). Development and preclinical validation of 
2-deoxy 2-[18F]fluorocellobiose as an Aspergillus-specific PET tracer. 
Science translational medicine, 16(760), eadl5934. https://doi.org/10.1126/scitranslmed.adl5934.
     Basuli, F., Shi, J., Shah, S., Lai, J., Hammoud, D.A., & 
Swenson, R.E. (2024). Fully Automated Cassette-Based Synthesis of 2-
Deoxy-2-[18F]Fluorocellobiose Using Trasis AllInOne Module. Journal of 
labelled compounds & radiopharmaceuticals, 67(9), 308-313. https://doi.org/10.1002/jlcr.4116.

Intellectual Property

     NIH Reference No. E-163-2019; U.S. Provisional Patent 
Application 62/882,023 filed August 2, 2019; International Patent 
Application PCT/US2020/044446 filed July 31, 2020 (published as WIPO 
publication WO 2021/025984); and national stage patent applications 
filed in Europe (20757180.3) and the United States (17/631,600).
     NIH Reference No. E-080-2023; U.S. Provisional Patent 
Application 63/492,302 filed March 27, 2023, and International Patent 
Application PCT/US2024/021440 filed March 26, 2024.

    Dated: August 28, 2024.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager, National Heart, Lung, and Blood 
Institute, Office of Technology Transfer and Development.
[FR Doc. 2024-19719 Filed 9-3-24; 8:45 am]
BILLING CODE 4140-01-P

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