90018 Federal Register / Vol. 89, No. 220 / Thursday, November 14, 2024 / Notices 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

In 2024, that threshold is approximately 

$183 million. This notice would not 

impose a mandate that will result in the 

expenditure by state, local, and Tribal 

Governments, in the aggregate, or by the 

private sector, of more than $183 

million in any 1 year. 

F. Federalism 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on state and local 

governments, preempts state law, or 

otherwise has federalism implications. 

This notice will not have a substantial 

direct effect on state or local 

governments, preempt state law, or 

otherwise have federalism implications. 

G. Congressional Review 

This notice is subject to the 

Congressional Review Act and has been 

transmitted to the Congress and the 

Government Accountability Office’s 

Comptroller General for review. 

Chiquita Brooks-LaSure, 

Administrator of the Centers for 

Medicare & Medicaid Services, 

approved this document on October 31, 

2024. 

Xavier Becerra, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2024–26473 Filed 11–8–24; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4815] 

Patient-Focused Drug Development: 

Workshop To Discuss Methodologic 

and Other Challenges Related to 

Patient Experience Data; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following virtual 

public workshop entitled ‘‘PatientFocused Drug Development: Workshop 

to Discuss Methodologic and Other 

Challenges Related to Patient 

Experience Data.’’ The purpose of the 

public workshop is to discuss 

methodological challenges related to 

patient experience data, and other areas 

of greatest interest or concern to public 

stakeholders. 

DATES: The public workshop will be 

held virtually on December 13, 2024, 

from 10 a.m. to 5 p.m. Eastern Time. 

Either electronic or written comments 

on this public meeting must be 

submitted by February 11, 2025. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public workshop will 

be held virtually using the Zoom 

platform. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 11, 2025. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are received on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–N–4815 for ‘‘Patient-Focused Drug 

Development: Workshop to Discuss 

Methodologic and Other Challenges 

Related to Patient Experience Data.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 


ddrumheller on DSK120RN23PROD with NOTICES1
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