4036 Federal Register / Vol. 87, No. 17 / Wednesday, January 26, 2022 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–3846] 

Patient Engagement in the Design and 

Conduct of Medical Device Clinical 

Studies; Guidance for Industry, Food 

and Drug Administration Staff, and 

Other Stakeholders; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Patient Engagement 

in the Design and Conduct of Medical 

Device Clinical Studies.’’ The Patient 

Engagement Advisory Committee 

(PEAC) recommended that FDA and 

industry develop a framework to clarify 

how patient advisors can engage in the 

clinical investigation process. This 

guidance focuses on the applications, 

perceived barriers, and common 

challenges of patient engagement in the 

design and conduct of medical device 

clinical studies. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 26, 2022. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2019–D–3846 for ‘‘Patient Engagement 

in the Design and Conduct of Medical 

Device Clinical Studies.’’ Received 

comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

An electronic copy of the guidance 

document is available for download 

from the internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the guidance 

document entitled ‘‘Patient Engagement 

in the Design and Conduct of Medical 

Device Clinical Studies’’ to the Office of 

Policy, Guidance and Policy 

Development, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002 or the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Tarver, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5608, Silver Spring, 

MD 20993–0002, 301–796–6884 or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On October 11 and 12, 2017, the 

PEAC met to discuss and make 

recommendations regarding patient 

engagement into medical device clinical 

studies. The PEAC stated that some 

framework should be developed by FDA 

and industry to clarify how patient 

advisors can engage in the clinical study 

process. Based on this recommendation, 

FDA is pursuing various efforts of 


khammond on DSKJM1Z7X2PROD with NOTICES
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