Federal Register / Vol. 87, No. 17 / Wednesday, January 26, 2022 / Notices 4037 

encouraging voluntary patient 

engagement in clinical studies, 

including guidance. FDA believes 

medical device clinical studies designed 

with patient input may help to address 

common challenges faced in medical 

device clinical studies. 

While FDA acknowledges that patient 

engagement may be beneficial across the 

total product lifecycle, this guidance 

focuses on the applications of patient 

engagement in the design and conduct 

of medical device clinical studies. The 

guidance will: (1) Help sponsors 

understand how they can voluntarily 

use patient engagement to elicit 

experience, perspectives, and other 

relevant information from patient 

advisors (see definition in section IV) to 

improve the design and conduct of 

medical device clinical studies; (2) 

highlight the benefits of engaging with 

patient advisors early in the medical 

device development process; (3) 

illustrate which patient engagement 

activities are generally not considered 

by FDA to constitute research or an 

activity subject to FDA’s regulations, 

including regulations regarding 

institutional review boards (IRBs); and 

(4) address common questions and 

misconceptions about collecting and 

submitting to FDA patient engagement 

information regarding the design and 

conduct of a medical device clinical 

study. 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of September 24, 2019 (84 FR 

50047). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including clarifying 

terminology, adding additional 

background on patient engagement 

efforts at FDA, and clarifying how 

sponsors can obtain specific feedback 

from FDA on patient engagement plans 

and patient-centered study designs. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on patient engagement 

in the design and conduct of medical 

device clinical studies. It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

at https://www.fda.gov/medical-devices/ 

device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This 

guidance document is also available at 

https://www.regulations.gov and at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments or https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances. Persons 

unable to download an electronic copy 

of ‘‘Patient Engagement in the Design 

and Conduct of Medical Device Clinical 

Studies’’ may send an email request to 

CDRH-Guidance@fda.hhs.gov to receive 

an electronic copy of the document. 

Please use the document number 18040 

and complete title to identify the 

guidance you are requesting. 

III. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

regulations, guidance, and forms have 

been approved by OMB as listed in the 

following table: 

21 CFR part or guidance Topic OMB control 

No. 

807, subpart E .............................................................................................................. Premarket Notification .............................. 0910–0120 

814, subparts A through E ........................................................................................... Premarket Approval .................................. 0910–0231 

814, subpart H .............................................................................................................. Humanitarian Device Exemption .............. 0910–0332 

812 ................................................................................................................................ Investigational Device Exemption ............. 0910–0078 

‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’ ... De Novo Classification Process ............... 0910–0844 

‘‘FDA and Industry Procedures for Section 513(g) Requests for Information under 

the Federal Food, Drug, and Cosmetic Act’’.

513(g) Request for Information ................ 0910–0705 

‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’.Q-submissions .......................................... 0910–0756 

56 .................................................................................................................................. Institutional Review Boards ...................... 0910–0130 

Dated: January 19, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–01374 Filed 1–25–22; 8:45 am] 

BILLING CODE 4164–01–P 

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 in the U.S. to achieve 

expeditious commercialization of 

results of federally-funded research and 

development. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information may be obtained 

by emailing the indicated licensing 

contact at the National Heart, Lung, and 

Blood, Office of Technology Transfer 

and Development Office of Technology 

Transfer, 31 Center Drive, Room 4A29, 

MSC2479, Bethesda, MD 20892–2479; 

Michael Shmilovich; shmilovm@

nih.gov; telephone: 301–435–5019. A 

signed Confidential Disclosure 

Agreement may be required to receive 

any unpublished information. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Sulfur and Selenium Containing 

Cannabinoid Receptor Modulating 

Compounds 

Available for licensing and 

commercial development are sulfur- and 

selenium-containing pyrazole molecules 

for potentially treating metabolic 

disorders, psychiatric disorders, 

neurological disorders, pain disorders, 


khammond on DSKJM1Z7X2PROD with NOTICES
4038 Federal Register / Vol. 87, No. 17 / Wednesday, January 26, 2022 / Notices 

gastrointestinal disorders, cancers, 

inflammation-related disorders, 

substance abuse associated pathologies, 

and other conditions using the same. 

The filed provisional patent application 

includes extensive descriptions of the 

exemplary molecules and their various 

constituents. Therapeutic targets of said 

molecules include but are not limited to 

the cannabinoids 1 receptor, the 

cannabinoid 2 receptor, GPR55, GPR18, 

or GPR119. The rights pursued claim 

compounds, pharmaceutical 

compositions, and methods of use. 

Potential Commercial Applications: 

• Pharmaceuticals 

• Cancer therapy 

• Inflammatory and autoimmune 

disease 

Development Stage: 

• Early stage 

Inventors: Malliga R. Iyer, Ph.D. 

(NIAAA). 

Intellectual Property: HHS Reference 

No. E–190–2021–0; U.S. Provisional 

Patent Application No. 63/265,225 filed 

December 10, 2021. 

Licensing Contact: Michael 

Shmilovich; 301–435–5019; 

michael.shmilovich@nih.gov. 

Dated: January 20, 2022. 

Michael A. Shmilovich, 

Senior Licensing and Patenting Manager, 

National Heart, Lung, and Blood Institute, 

Office of Technology Transfer and 

Development. 

[FR Doc. 2022–01517 Filed 1–25–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[Docket ID FEMA–2008–0010] 

Board of Visitors for the National Fire 

Academy 

AGENCY: Federal Emergency 

Management Agency, Department of 

Homeland Security. 

ACTION: Committee management; notice 

of open Federal Advisory Committee 

meeting. 

SUMMARY: The Board of Visitors for the 

National Fire Academy (Board) will 

meet virtually on Tuesday, March 15, 

2022. The meeting will be open to the 

public. 

DATES: The meeting will take place on 

Tuesday, March 15, 2022, 1 p.m. to 3 

p.m. ET. Please note that the meeting 

may close early if the Board has 

completed its business. 

ADDRESSES: Members of the public who 

wish to participate in the virtual 

conference should contact Deborah 

Gartrell-Kemp as listed in the FOR

FURTHER INFORMATION CONTACT section 

by 5 p.m. ET on March 2, 2022, to 

obtain the call-in number and access 

code for the March 15, 2022, virtual 

meeting. For more information on 

services for individuals with disabilities 

or to request special assistance, contact 

Deborah Gartrell-Kemp as soon as 

possible. 

To facilitate public participation, we 

are inviting public comment on the 

issues to be considered by the Board as 

listed in the SUPPLEMENTARY

INFORMATION section. Participants 

seeking to have their comments 

considered during the meeting should 

submit them in advance or during the 

public comment segment. Comments 

submitted up to 30 days after the 

meeting will be included in the public 

record and may be considered at the 

next meeting. Comments submitted in 

advance must be identified by Docket ID 

FEMA–2008–0010 and may be 

submitted by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Electronic Delivery: Email Deborah 

Gartrell-Kemp at 

Deborah.GartrellKemp@fema.dhs.gov no 

later than March 2, 2022, for 

consideration at the March 15, 2022 

meeting. 

Instructions: All submissions received 

must include the words ‘‘Federal 

Emergency Management Agency’’ and 

the Docket ID for this action. Comments 

received will be posted without 

alteration at http://www.regulations.gov, 

including any personal information 

provided. 

Docket: For access to the docket and 

to read background documents or 

comments received by the National Fire 

Academy Board of Visitors, go to http:// 

www.regulations.gov, click on 

‘‘Advanced Search,’’ then enter 

‘‘FEMA–2008–0010’’ in the ‘‘By Docket 

ID’’ box, then select ‘‘FEMA’’ under ‘‘By 

Agency,’’ and then click ‘‘Search.’’ 

FOR FURTHER INFORMATION CONTACT: 

Alternate Designated Federal Officer: 

Stephen Dean, telephone (301) 447– 

1271, email Stephen.Dean@

fema.dhs.gov. 

Logistical Information: Deborah 

Gartrell-Kemp, telephone (301) 447– 

7230, email Deborah.GartrellKemp@

fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: The Board 

will meet virtually on Tuesday, March 

15, 2022. The meeting will be open to 

the public. Notice of this meeting is 

given under the Federal Advisory 

Committee Act, 5 U.S.C. Appendix. 

Purpose of the Board 

The purpose of the Board is to review 

annually the programs of the National 

Fire Academy (Academy) and advise the 

Administrator of the Federal Emergency 

Management Agency (FEMA), through 

the United States Fire Administrator, on 

the operation of the Academy and any 

improvements therein that the Board 

deems appropriate. In carrying out its 

responsibilities, the Board examines 

Academy programs to determine 

whether these programs further the 

basic missions that are approved by the 

Administrator of FEMA, examines the 

physical plant of the Academy to 

determine the adequacy of the 

Academy’s facilities, and examines the 

funding levels for Academy programs. 

The Board submits a written annual 

report through the United States Fire 

Administrator to the Administrator of 

FEMA. The report provides detailed 

comments and recommendations 

regarding the operation of the Academy. 

Agenda 

On Tuesday, March 15, 2022, there 

will be four sessions, with deliberations 

and voting at the end of each session as 

necessary: 

1. The Board will discuss United 

States Fire Administration Data, 

Research, Prevention and Response. 

2. The Board will discuss deferred 

maintenance and capital improvements 

on the National Emergency Training 

Center campus and Fiscal Year 2022 

and beyond Budget Request/Budget 

Planning. 

3. The Board will deliberate and vote 

on recommendations on Academy 

program activities to include 

developments, deliveries, staffing, 

admissions and strategic plan. 

4. There will also be an update on the 

Board of Visitors Subcommittee Groups 

for the Professional Development 

Initiative Update and the National Fire 

Incident Report System. 

There will be a 10-minute comment 

period after each agenda item and each 

speaker will be given no more than 2 

minutes to speak. Please note that the 

public comment period may end before 

the time indicated following the last call 

for comments. Contact Deborah GartrellKemp to register as a speaker. Meeting 

materials will be posted by March 10, 


khammond on DSKJM1Z7X2PROD with NOTICES