Federal Register / Vol. 89, No. 220 / Thursday, November 14, 2024 / Notices 90019 

1The 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. 

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_Jb5xMhbVS1- 

wYhLn6fwMng#/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, 

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: 

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). 


ddrumheller on DSK120RN23PROD with NOTICES1
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. 

SUMMARY: 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 

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. 

Competitive Advantages 

• First method to predict response to 

immunotherapies by detecting 

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 


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