Government Owned Inventions Available for Licensing or Collaboration: Improved Methods for Cryopreservation of Cells, Tissues, and Organs, 90300-90301 [2024-26661]
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khammond on DSKJM1Z7X2PROD with NOTICES
90300
Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices
not promiscuous kinase inhibitors. The
subject kinase inhibitors have broad
potential commercial applicability’s for
cancer, immune suppression,
preventing organ rejection, treating
diabetic neuropathic pain, malaria, or
protozoa infection. To date, there are no
approved therapeutics targeting
DNAJB1–PRKCA, an oncogenic gene
fusion, which is ubiquitously and
exclusively detected in the tumors of
patients with ultra-rare fibrolamellar
hepatocellular carcinoma FLHCC.
This Notice is in accordance with 35
U.S.C. 209 and 37 CFR part 404.
NIH Reference Number: E–044–2022.
Related Technologies: E–202–2023
and E–162–2024.
Product Type: Therapeutic.
Therapeutic Area(s): Oncology,
Infectious Disease, Rare/Neglected
Diseases.
Potential Commercial Applications:
• Gastric cancer.
• Ultra-rare adolescent liver cancer.
• Solid cancers susceptible to kinase
inhibitors.
• Cushing’s Disease.
• Transplantation.
• Diabetic neuropathic pain.
• Malaria.
• Protozoa infection.
Competitive Advantages:
• Applicability to numerous
clinically relevant kinases, including:
Æ Oncogenic gene fusion DNAJB1–
PRKACA (PKADJ).
Æ Wild type protein kinase A (PKA).
Æ Protein kinase G (PKG).
Æ Ccdc2-like kinases (CLK) 1 and 2.
Æ DYRK family of kinases.
• Applicable to a range of kinases, but
are not promiscuous kinase inhibitors.
• Broad potential commercial
applicability for several blockbuster
indications including:
Æ cancer, immune suppression,
transplantation, diabetic neuropathic
pain, malaria, and protozoa infection.
• No approved therapeutics targeting
DNAJB1–PRKCA.
Publications:
• O’Keefe BR, et al. Biochemical
Discovery, Intracellular Evaluation, and
Crystallographic Characterization of
Synthetic and Natural Product
Adenosine 3′,5′-Cyclic MonophosphateDependent Protein Kinase A (PKA)
Inhibitors. PMID: 37082750, https://
pubmed.ncbi.nlm.nih.gov/37082750/.
• O’Keefe BR, et al. Discovery and
Synthesis of a Naturally Derived Protein
Kinase Inhibitor that Selectively Inhibits
Distinct Classes of Serine/Threonine
Kinases. PMID: 37843072, https://
pubmed.ncbi.nlm.nih.gov/37843072/.
Patent Status:
• E–044–2022: PCT/US2023/070304.
• E–202–2023: PCT/US2024/038376.
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• E–162–2024: 63/672,577.
Development Stage: Pre-clinical (in
vivo validation).
Dated: November 12, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–26663 Filed 11–14–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government Owned Inventions
Available for Licensing or
Collaboration: Improved Methods for
Cryopreservation of Cells, Tissues,
and Organs
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Center for Complementary &
Integrative Health; Notice of Closed
Meeting
Pursuant to section 1009 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 Center for
Complementary and Integrative Health
Special Emphasis Panel; NCCIH Conference
Grant (R13 Clinical Trial Not Allowed).
Date: December 10, 2024
Time: 2:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Address: National Center for
Complementary and Integrative, Democracy
II, 6707 Democracy Blvd., Bethesda, MD
20892.
Meeting Format: Virtual Meeting.
Contact Person: Michael E. Authement,
Ph.D., Scientific Review Officer, Office of
Scientific Review, Division of Extramural
Activities, 6707 Democracy Boulevard,
Bethesda, MD 20817, michael.authement@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.213, Research and Training
in Complementary and Alternative Medicine,
National Institutes of Health, HHS)
Dated: November 8, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2024–26562 Filed 11–14–24; 8:45 am]
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ACTION:
Notice.
The National Eye Institute
(NEI), an institute of the National
Institutes of Health (NIH), Department
of Health and Human Services (HHS), is
giving notice of licensing and/or
collaboration opportunities for the
inventions listed below, which are
owned by an agency of the U.S.
Government and are available for
licensing and/or collaboration to
achieve expeditious commercialization
of results of federally-funded research
and development.
FOR FURTHER INFORMATION CONTACT:
Inquiries related to these licensing and/
or collaboration opportunities should be
directed to: Hiba Alsaffar, Ph.D.,
Technology Transfer Manager, NCI,
Technology Transfer Center, Email:
hiba.alsaffar@nih.gov or Phone: 240–
276–7489.
SUPPLEMENTARY INFORMATION:
Researchers at the NEI seek licensing
and/or co-development research
collaborations for improved methods of
cryopreservation of cells, tissues, and
organs via FOXO1 activation. The
cornea is a critical part of the eye that
helps prevent debris from entering and
refracts light for proper vision. Corneal
disorders such as keratoconus, Fuchs
dystrophy, and infectious keratitis
require corneal transplantation to
restore vision. Approximately 185,000
corneal transplants are performed
annually worldwide to treat corneal
disorders. Corneas for those transplants
are supplied by donor eyes that are
stored at eye banks in select countries.
Currently, Optisol-GSTM is the corneal
preservation solution that is most
widely used to store donated corneas at
eye banks. Per NEI guidelines, corneas
preserved in Optisol-GSTM have a 12day shelf life. With the high demand for
corneal transplantations worldwide, a
12-day shelf life cannot meet the
requirement for long term cryogenic
storage of corneas at large eye banks.
Scientists at the NEI have developed
improved methods for cryopreservation
of cells, tissues, and organs (with focus
of corneal tissue/cells) that increases
SUMMARY:
National Institutes of Health
BILLING CODE 4140–01–P
National Institutes of Health,
HHS.
E:\FR\FM\15NON1.SGM
15NON1
90301
Federal Register / Vol. 89, No. 221 / Friday, November 15, 2024 / Notices
cold storage shelf life 2.5 times longer
than current market products.
This Notice is in accordance with 35
U.S.C. 209 and 37 CFR part 404.
NIH Reference Number: E–013–2021.
Related Technologies: E–073–2018.
Product Type: Medical/Research Tool.
Therapeutic Area(s): Eye, Ear, Nose or
Throat.
Potential Commercial Applications:
• Corneal biobanks.
• Transplantation to remedy a wide
range of corneal disorders.
• Improved method of cryopreserving
corneal cells and other cell types.
Competitive Advantages:
• Superior corneal shelf life: 16-day
compared to 12-day maximum shelf-life
of current market products.
• Better meets requirement for larger
eye bank cryopreservation.
• 95% endothelial cell survival after
4 weeks in cold storage.
Patent Status: National Stage Filings
in the US, CA, AU, CN, EP.
Development Stage: Discovery.
Dated: November 12, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–26661 Filed 11–14–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer at (240) 276–
0361.
Comments are invited on: (a) whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Regulations To
Implement SAMHSA’s Charitable
Choice Statutory Provisions—42 CFR
Parts 54 and 54a (OMB No. 0930–
0242)—Revision
Section 1955 of the Public Health
Service Act (42 U.S.C. 300x–65), as
amended by the Children’s Health Act
of 2000 (Pub. L. 106–310) and sections
581–584 of the Public Health Service
Act (42 U.S.C. 290kk et seq., as added
by the Consolidated Appropriations Act
(Pub. L. 106–554)), set forth various
provisions which aim to ensure that
religious organizations are able to
Number of
respondents
42 CFR citation and purpose
Responses
per
respondent
compete on an equal footing for federal
funds to provide substance use services.
These provisions allow religious
organizations to offer substance use
services to individuals without
impairing the religious character of the
organizations or the religious freedom of
the individuals who receive the
services. The provisions apply to the
Substance Use Prevention, Treatment,
and Recovery Services Block Grant
(SUBG), to the Projects for Assistance in
Transition from Homelessness (PATH)
formula grant program, and to certain
Substance Abuse and Mental Health
Services Administration (SAMHSA)
discretionary grant programs (programs
that pay for substance use treatment and
prevention services, not for certain
infrastructure and technical assistance
activities). Every effort has been made to
assure that the reporting, recordkeeping
and disclosure requirements of the
proposed regulations allow maximum
flexibility in implementation and
impose minimum burden.
No changes are being made to the
regulations or the information collection
provisions. A minor change reflecting
current state reporting has been made to
the annual burden estimates in
54.8(c)(4) resulting in total burden costs
reported decreasing.
Information on how states comply
with the requirements of 42 CFR part 54
was approved by OMB as part of the
Substance Use Prevention and
Treatment Block Grant FY 2019–2021
annual application and reporting
requirements approved under OMB
control number 0930–0168.
Total
responses
Hours per
response
Total hours
khammond on DSKJM1Z7X2PROD with NOTICES
Part 54—States Receiving SUBG and/or Projects for Assistance in Transition from Homelessness
Reporting:
96.122(f)(5) Annual report of activities the state undertook to comply with 42 CFR part 54 ....................
54.8(c)(4) Total number of referrals to alternative
service providers reported by program participants
to States (respondents).
SUBG .....................................................................
PATH .....................................................................
54.8 (e) Annual report by PATH grantees on activities
undertaken to comply with 42 CFR part 54 ..............
Disclosure:
54.8(b) Program participant notice to program beneficiaries of rights to referral to an alternative service
provider.
SUBG .....................................................................
PATH .....................................................................
Recordkeeping:
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]]>Agencies
[Federal Register Volume 89, Number 221 (Friday, November 15, 2024)]
[Notices]
[Pages 90300-90301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26661]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government Owned Inventions Available for Licensing or
Collaboration: Improved Methods for Cryopreservation of Cells, Tissues,
and Organs
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Eye Institute (NEI), an institute of the National
Institutes of Health (NIH), Department of Health and Human Services
(HHS), is giving notice of licensing and/or collaboration opportunities
for the inventions listed below, which are owned by an agency of the
U.S. Government and are available for licensing and/or collaboration to
achieve expeditious commercialization of results of federally-funded
research and development.
FOR FURTHER INFORMATION CONTACT: Inquiries related to these licensing
and/or collaboration opportunities should be directed to: Hiba
Alsaffar, Ph.D., Technology Transfer Manager, NCI, Technology Transfer
Center, Email: [email protected] or Phone: 240-276-7489.
SUPPLEMENTARY INFORMATION: Researchers at the NEI seek licensing and/or
co-development research collaborations for improved methods of
cryopreservation of cells, tissues, and organs via FOXO1 activation.
The cornea is a critical part of the eye that helps prevent debris from
entering and refracts light for proper vision. Corneal disorders such
as keratoconus, Fuchs dystrophy, and infectious keratitis require
corneal transplantation to restore vision. Approximately 185,000
corneal transplants are performed annually worldwide to treat corneal
disorders. Corneas for those transplants are supplied by donor eyes
that are stored at eye banks in select countries. Currently, Optisol-
GSTM is the corneal preservation solution that is most
widely used to store donated corneas at eye banks. Per NEI guidelines,
corneas preserved in Optisol-GSTM have a 12-day shelf life.
With the high demand for corneal transplantations worldwide, a 12-day
shelf life cannot meet the requirement for long term cryogenic storage
of corneas at large eye banks. Scientists at the NEI have developed
improved methods for cryopreservation of cells, tissues, and organs
(with focus of corneal tissue/cells) that increases
[[Page 90301]]
cold storage shelf life 2.5 times longer than current market products.
This Notice is in accordance with 35 U.S.C. 209 and 37 CFR part
404.
NIH Reference Number: E-013-2021.
Related Technologies: E-073-2018.
Product Type: Medical/Research Tool.
Therapeutic Area(s): Eye, Ear, Nose or Throat.
Potential Commercial Applications:
Corneal biobanks.
Transplantation to remedy a wide range of corneal
disorders.
Improved method of cryopreserving corneal cells and other
cell types.
Competitive Advantages:
Superior corneal shelf life: 16-day compared to 12-day
maximum shelf-life of current market products.
Better meets requirement for larger eye bank
cryopreservation.
95% endothelial cell survival after 4 weeks in cold
storage.
Patent Status: National Stage Filings in the US, CA, AU, CN, EP.
Development Stage: Discovery.
Dated: November 12, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2024-26661 Filed 11-14-24; 8:45 am]
BILLING CODE 4140-01-P
