Government Owned Inventions Available for Licensing or Collaboration: Single Source-Detector Separation Approach To Calculate Tissue Oxygen Saturation, 90019-90020 [2024-26451]
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Federal Register / Vol. 89, No. 220 / Thursday, November 14, 2024 / Notices
FOR FURTHER INFORMATION CONTACT:
Ethan Gabbour, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6306,
Silver Spring, MD 20993, 301–796–
8112, Ethan.Gabbour@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under the seventh iteration of the
Prescription Drug User Fee Act,
incorporated as part of the FDA User
Fee Reauthorization Act of 2022, FDA
committed to facilitate the advancement
and use of systematic approaches to
collect and utilize robust and
meaningful patient and caregiver input
that can more consistently inform drug
development and, as appropriate,
regulatory decision making. This
included issuing a Request for
Information (RFI) available at https://
www.federalregister.gov/documents/
2023/05/02/2023-09265/
methodological-challenges-related-topatient-experience-data-request-forinformation-and-comments to elicit
public input on methodologic
challenges related to patient experience
data, and other areas of greatest interest
or concern to public stakeholders.1 The
RFI was published on May 2, 2023, and
the public comment period was open
until July 3, 2023. A summary of the
comments was published on December
12, 2023, and is available at https://
www.regulations.gov by entering the
following docket number: FDA–2023–
N–1506. The input received in response
to the RFI helped inform the topics for
this public workshop. This public
workshop together with the input
received in response to the RFI will also
help inform a subsequent workshop
focused on methodological challenges
and will help FDA identify priorities for
future work.
II. Topics for Discussion at the Public
Workshop
The purpose of this virtual public
workshop is to highlight and discuss
methodological issues related to patient
experience data, including the
submission and evaluation of patient
experience data in the context of the
benefit-risk assessment and product
labeling, as well as other areas of
greatest interest or concern to
stakeholders. This workshop will
explore the different types of patient
experience data and how FDA utilizes
such data for regulatory decisionmaking, along with considerations for
submitting patient experience data to
FDA. In addition, this workshop will
feature presentations and panel
discussions with experts on selected
methodologies and the challenges and
opportunities they present.
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
website: https://fda.zoomgov.com/
webinar/register/WN_Jb5xMhbVS1wYhLn6fwMng#/registration. Please
provide complete contact information
for each attendee, including name,
organization, email, and affiliation.
Registration is free and persons
interested in attending this public
workshop must register to receive a link
to the meeting. Registrants will receive
a confirmation email after they register.
If you need special accommodations
due to a disability, please contact
Ethan.Gabbour@fda.hhs.gov no later
than December 6, 2024. Closed
captioning will be available.
Dated: November 6, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–26399 Filed 11–13–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government Owned Inventions
Available for Licensing or
Collaboration: Single Source-Detector
Separation Approach To Calculate
Tissue Oxygen Saturation
AGENCY:
National Institutes of Health,
ddrumheller on DSK120RN23PROD with NOTICES1
HHS.
1 The Federal Food, Drug, and Cosmetic Act, as
amended by the 21st Century Cures Act (Pub. L.
114–255) and the FDA Reauthorization Act of 2017
(Pub. L. 115–52), defines patient experience data as
data that are collected by any persons (including
patients, family members and caregivers of patients,
patient advocacy organizations, disease research
foundations, researchers and drug manufacturers)
and are intended to provide information about
patients’ experiences with a disease or condition,
including the impact (including physical and
psychosocial impacts) of such disease or condition
or a related therapy or clinical investigation and
patient preferences with respect to treatment of the
disease or condition.
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ACTION:
Notice.
The National Institute of
Child Health and Human Development
(NICHD), an institute of the National
Institutes of Health (NIH), Department
of Health and Human Services (HHS), is
giving notice of the licensing or
collaboration opportunities for the
inventions listed below, which are
owned by an agency of the U.S.
Government and are available for
SUMMARY:
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Fmt 4703
Sfmt 4703
90019
licensing and collaboration to achieve
expeditious commercialization of
results of federally-funded research and
development.
FOR FURTHER INFORMATION CONTACT:
Inquiries related to these licensing or
collaboration opportunities should be
directed to: Zarpheen Jinnah, Ph.D.,
Technology Transfer Manager, NCI,
Technology Transfer Center, Email:
zarpheen.jinnah@nih.gov or Phone:
240–620–0586.
SUPPLEMENTARY INFORMATION: Tissue
oxygen saturation (StO2) is an important
parameter to assess oxygen delivery and
uptake. Hypoxia, a term used to indicate
inadequate StO2, is often seen in
patients with cardiac problems,
respiratory infections or pulmonary
diseases. Prolonged hypoxia can damage
vital organs such as the brain, lungs,
and heart and can be fatal. Currently
available tissue oximeters to monitor
StO2 are expensive and cumbersome.
NICHD has developed a novel
method, which uses a single sourcedetector separation to calculate StO2.
With this technique, a simple tissue
oximeter can be made with just a LED
and a photodetector, which enables the
development of a miniaturized device.
As a result, it can be used
independently or implemented on
existing technologies to measure StO2
without any hardware modifications. It
can be applied in wearable devices,
implantable medicines or endoscopies
to measure tissue oxygenation in
different tissues such as muscle, brain,
spinal cord, internal organs, fetus and
placenta.
This Notice is in accordance with 35
U.S.C. 209 and 37 CFR part 404.
NIH Reference Number: E–037–2023–
0.
Product Type: Device.
Therapeutic Area(s): Respiratory,
Neurology or Cardiac.
Potential Commercial Applications:
• Miniaturized tissue oximeter for
implantation or endoscopy.
• Measure tissue oxygen saturation.
• Multilayer tissue oximeter.
Competitive Advantages:
• Simpler and more compact as it
only requires a single light source such
as LED and a single photodetector such
as a photodetector to build a tissue
oximeter.
• Multilayer measurement.
• Implementation with existing
technologies without any hardware
modifications.
Publication: Nguyen, T., et al.
Application of the Single Source—
Detector Separation Algorithm in
Wearable Neuroimaging Devices: A Step
toward Miniaturized Biosensor for
Hypoxia Detection. (PMID 38671806).
E:\FR\FM\14NON1.SGM
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90020
Federal Register / Vol. 89, No. 220 / Thursday, November 14, 2024 / Notices
Patent Status: PCT Application PCT/
US2023/085725 filed on December 22,
2023.
Development Stage: Clinical Phase I.
Dated: November 8, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–26451 Filed 11–13–24; 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: Methods of Detecting
Loss of Heterozygosity and Damaging
Mutations in Immune-Related Genes
Using Liquid Biopsies
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The National Cancer Institute
(NCI), an institute of the National
Institutes of Health (NIH), Department
of Health and Human Services (HHS), is
giving notice of the licensing or
collaboration opportunities for the
inventions listed below, which are
owned by an agency of the U.S.
Government and are available for
licensing or collaboration to achieve
expeditious commercialization of
results of federally funded research and
development.
FOR FURTHER INFORMATION CONTACT:
Inquiries related to these licensing and
collaboration opportunities should be
directed to: Suna Gulay French, Ph.D.,
Technology Transfer Manager, NCI,
Technology Transfer Center, Email:
suna.gulay@nih.gov or Phone: 240–276–
7424.
SUPPLEMENTARY INFORMATION: The
technology is a liquid biopsy diagnostic
assay capable of detecting loss of
heterozygosity (LOH) and somatic
mutations in genes important for
antigen processing and presentation and
interferon-g (IFN) response pathways.
Immunotherapy is an effective cancer
treatment utilizing T cells to recognize
and eliminate cancer cells. Antigen
processing and presentation machinery
(APM) and IFN response pathways play
an important role for T cells to target
cancer cells. To evade immunotherapy,
cancer cells can develop somatic
mutations in genes important for APM
and IFN.
Liquid biopsy is a non-invasive tool
that can diagnose and monitor cancer by
analyzing circulating tumor DNA. The
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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20:16 Nov 13, 2024
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ability to detect somatic mutations and
predict response to immunotherapies
using liquid biopsy would be critical to
provide more personalized cancer
treatment. However, currently marketed
liquid biopsies cannot predict response
to cellular immunotherapies. As a
result, patients with relapsed or
recurrent disease lose valuable time and
resources on ineffective treatments.
The inventors at the NCI developed a
novel method to detect somatic
mutations from liquid biopsy samples.
Combined with NCI’s method to detect
loss of heterozygosity in HLA genes—
another mechanism for immunotherapy
evasion—this invention allows for
improved patient selection and noninvasive prediction of response. This
novel precision medicine method will
allow patient-tailored treatment by
targeting treatment based on genetic
mutations and prediction of
immunotherapy response. This
invention could potentially deliver
better patient satisfaction, lower
healthcare costs and better outcomes.
This invention will be used to select
optimal patients and monitor efficacy of
treatments—such as TCR–T cell
therapy. There are no liquid biopsy
assays on the market designed as
companion diagnostics for cellular
immunotherapy—such as TCR–T cell
therapy. Therefore, this technology may
be particularly appealing to codevelopment partners who are
developing proprietary cellular
immunotherapies.
This Notice is in accordance with 35
U.S.C. 209 and 37 CFR part 404.
NIH Reference Number: E–027–2024–
0.
Related Technologies: E–045–2022–0.
Product Type: Diagnostic.
Therapeutic Area(s): Oncology or
Immunology.
Potential Commercial Applications:
• Companion diagnostic for cellular
immunotherapies.
• Companion diagnostic for
monitoring the effectiveness of TCRbased immunotherapies.
• Companion diagnostic for T cellbased immunotherapies, including
certain immune checkpoint inhibitors.
• Research use in labs studying and
developing new pre-clinical therapeutic
candidates.
• Research use in basic research labs
studying immunotherapy resistance
mechanisms, antigen processing and
presentation, IFN response pathways,
mutations in cancer cells, basic
immunology and basic oncology.
damaging mutations using liquid biopsy
samples.
• Non-invasive test not requiring
surgery.
• Easy to administer.
• Allows patient-tailored treatment
and monitor the effectiveness of TCRbased immunotherapies in a simple and
cost-effective manner.
• Potential improvement in patient
survival.
• Potential time and money savings
for patients, physicians and hospitals.
Patent Status: US Provisional
Application 63/572,760 filed on April 4,
2024.
Development Stage: Prototype.
Dated: November 8, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
[FR Doc. 2024–26446 Filed 11–13–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Integrative Health; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the National Advisory
Council for Complementary and
Integrative Health, January 24, 2025,
10:00 a.m. to January 24, 2025, 4:00
p.m., National Institutes of Health, DEM
2, 6707 Democracy Boulevard,
Bethesda, MD, 20892 which was
published in the Federal Register on
September 25, 2024, 89 FR 78318.
The notice is being amended to
change the start and end times of the
open session portion of the meeting.
The open session start time has changed
from 12:30 p.m. to 1:00 p.m. and the
end time has changed from 4:00 p.m. to
5:00 p.m. This meeting is partially
closed to the public.
Dated: November 8, 2024.
David W Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2024–26527 Filed 11–13–24; 8:45 am]
BILLING CODE 4140–01–P
Competitive Advantages
• First method to predict response to
immunotherapies by detecting
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]]>Agencies
[Federal Register Volume 89, Number 220 (Thursday, November 14, 2024)]
[Notices]
[Pages 90019-90020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26451]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government Owned Inventions Available for Licensing or
Collaboration: Single Source-Detector Separation Approach To Calculate
Tissue Oxygen Saturation
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Child Health and Human Development
(NICHD), an institute of the National Institutes of Health (NIH),
Department of Health and Human Services (HHS), is giving notice of the
licensing 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 collaboration to achieve expeditious
commercialization of results of federally-funded research and
development.
FOR FURTHER INFORMATION CONTACT: Inquiries related to these licensing
or collaboration opportunities should be directed to: Zarpheen Jinnah,
Ph.D., Technology Transfer Manager, NCI, Technology Transfer Center,
Email: [email protected] or Phone: 240-620-0586.
SUPPLEMENTARY INFORMATION: Tissue oxygen saturation (StO2) is an
important parameter to assess oxygen delivery and uptake. Hypoxia, a
term used to indicate inadequate StO2, is often seen in patients with
cardiac problems, respiratory infections or pulmonary diseases.
Prolonged hypoxia can damage vital organs such as the brain, lungs, and
heart and can be fatal. Currently available tissue oximeters to monitor
StO2 are expensive and cumbersome.
NICHD has developed a novel method, which uses a single source-
detector separation to calculate StO2. With this technique, a simple
tissue oximeter can be made with just a LED and a photodetector, which
enables the development of a miniaturized device. As a result, it can
be used independently or implemented on existing technologies to
measure StO2 without any hardware modifications. It can be applied in
wearable devices, implantable medicines or endoscopies to measure
tissue oxygenation in different tissues such as muscle, brain, spinal
cord, internal organs, fetus and placenta.
This Notice is in accordance with 35 U.S.C. 209 and 37 CFR part
404.
NIH Reference Number: E-037-2023-0.
Product Type: Device.
Therapeutic Area(s): Respiratory, Neurology or Cardiac.
Potential Commercial Applications:
Miniaturized tissue oximeter for implantation or
endoscopy.
Measure tissue oxygen saturation.
Multilayer tissue oximeter.
Competitive Advantages:
Simpler and more compact as it only requires a single
light source such as LED and a single photodetector such as a
photodetector to build a tissue oximeter.
Multilayer measurement.
Implementation with existing technologies without any
hardware modifications.
Publication: Nguyen, T., et al. Application of the Single Source--
Detector Separation Algorithm in Wearable Neuroimaging Devices: A Step
toward Miniaturized Biosensor for Hypoxia Detection. (PMID 38671806).
[[Page 90020]]
Patent Status: PCT Application PCT/US2023/085725 filed on December
22, 2023.
Development Stage: Clinical Phase I.
Dated: November 8, 2024.
Richard U. Rodriguez,
Associate Director, Technology Transfer Center, National Cancer
Institute.
[FR Doc. 2024-26451 Filed 11-13-24; 8:45 am]
BILLING CODE 4140-01-P
