22220 Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08025 Filed 4–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0008] 

Patient Engagement Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the CDRH Patient 

Engagement Advisory Committee. The 

general function of the committee is to 

provide advice to the Commissioner of 

Food and Drugs, or designee, on 

complex scientific issues relating to 

medical devices, the regulation of 

devices, and their use by patients. The 

meeting will be open to the public. 

DATES: The meeting will take place 

virtually on July 12, 2022, from 10 a.m. 

to 4 p.m. Eastern Time and on July 13, 

2022, from 10 a.m. to 2 p.m. Eastern 

Time. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. 

Answers to commonly asked questions 

about FDA advisory committee meetings 

may be accessed at: https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. Information on how to 

access the webcast will be made 

available no later than 2 business days 

prior to the meeting at https://

www.fdalive.com/peac. 

FOR FURTHER INFORMATION CONTACT: 

Letise Williams, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5441, Silver Spring, 

MD 20993–0002, letise.williams@

fda.hhs.gov, 301–796–8398, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last-minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/advisory-committees and 

scroll down to the appropriate advisory 

committee meeting link or call the 

advisory committee information line to 

learn about possible modifications 

before the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On July 12 

and 13, 2022, the committee will 

discuss and make recommendations on 

the topic of ‘‘Augmented Reality (AR) 

and Virtual Reality (VR) Medical 

Devices.’’ AR/VR devices are 

increasingly applied to healthcare 

settings across the patients’ care 

continuum. From diagnostics to clinical 

decision making, to surgical support, 

and to directly treating patients, AR/VR 

devices are used across multiple 

medical specialties. These devices have 

novel attributes and considerations for 

the end users that impact FDA’s 

evaluation of the device’s safety and 

effectiveness. The novel attributes of 

digital health visualization, tracking 

techniques, embedded software among 

other factors present unique challenges 

for pre- and postmarked evaluation. The 

recommendations provided by the 

committee will address factors FDA and 

industry should consider when 

evaluating the benefits, risks, and the 

extent of uncertainty in the benefit-risk 

information for AR/VR medical devices. 

The committee will also consider 

specific challenges related to specific 

populations (e.g., pediatric or 

cognitively impaired) who may use this 

technology. Additionally, the committee 

will discuss ways patient perspectives 

could be incorporated in FDA and 

industry benefit-risk decision making, 

as well as the healthcare provider 

decision-making process related to 

using or prescribing the technology. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available on FDA’s 

website at the time of the advisory 

committee meeting, and the background 

material will be posted on FDA’s 

website after the meeting. Background 

materials will be available at https://

www.fda.gov/advisory-committees/ 

committees-and-meeting-materials/ 

patient-engagement-advisorycommittee. Select the link for the 2022 

Meeting Materials. The meeting will 

include slide presentations with audio 

components to allow the presentation of 

materials in a manner that most closely 

resembles an in-person advisory 

committee meeting. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Oral presentations 

from the public will be scheduled on 

July 12, 2022, between approximately 

2:30 p.m. Eastern Time to 3:30 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person (see FOR FURTHER INFORMATION

CONTACT). The notification should 

include a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before June 10, 2022. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by June 14, 2022. 

Individuals who do not wish to speak at 

the open public hearing session but 

would like their comments to be heard 

by the committee may send written 

submissions to the contact person on or 

before June 20, 2022. 

Virtual Breakout Session: Individuals 

interested in participating in the virtual 

breakout scenario discussions will need 

to sign up to participate on or before 

June 28, 2022. The signup sheet, as well 

as additional information pertaining to 

the virtual scenario discussions, will be 

available at https://www.fdalive.com/ 

peac. Everyone who signs up in advance 

and provides a valid email address will 

receive an email at least 2 days prior to 

the meeting with information on how to 

access the virtual platform that will host 

the virtual breakout scenario 

discussions. Please note that due to 

limited technology capacity, 

participation in the virtual breakout 

scenario discussions will be limited to 

150 participants. Once capacity reaches 

150 participants, the breakout session 

will be closed to additional participants. 

Additional information regarding the 

virtual breakout scenario discussions 

will be provided at https://

www.fdalive.com/peac. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 


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Federal Register / Vol. 87, No. 72 / Thursday, April 14, 2022 / Notices 22221 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact AnnMarie 

Williams at Annmarie.Williams@

fda.hhs.gov, or 301–796–5966 at least 7 

days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. Please be advised 

that, during the virtual scenario 

breakout discussions, FDA will prepare 

a summary of the discussion in lieu of 

detailed transcripts. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: April 11, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08013 Filed 4–13–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–3324] 

Reconditioning of Fish and Fishery 

Products by Segregation; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of a 

final guidance for industry entitled 

‘‘Reconditioning of Fish and Fishery 

Products by Segregation.’’ This guidance 

is intended to provide industry with an 

explanation of two potential approaches 

to recondition fish and fishery products 

by effectively segregating adulterated 

portions of an article from portions not 

containing the adulterant to ensure that 

only safe and wholesome product 

reaches consumers. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on April 14, 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–3324 for ‘‘Reconditioning of 

Fish and Fishery Products by 

Segregation.’’ 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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)). 

Submit written requests for single 

copies of the guidance to Office of Food 

Safety, Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Steven Bloodgood, Division of Seafood 

Safety, Office of Food Safety, Center for 

Food Safety and Applied Nutrition 

(HFS–325), Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–5316; 

or Lauren Kleinman, Office of 

Regulations and Policy (HFS–024), 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled 

‘‘Reconditioning of Fish and Fishery 

Products by Segregation.’’ We are 

issuing the guidance consistent with our 


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