44028 Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Notices 

medical physicists; and determining the 

costs and benefits of compliance with 

these requirements. 

K. Patient Engagement Advisory 

Committee 

The Patient Engagement Advisory 

Committee advises the Agency on 

complex issues relating to medical 

devices, the regulation of devices, and 

their use by patients. The Committee 

may consider topics such as Agency 

guidance and policies, clinical trial or 

registry design, patient preference study 

design, benefit-risk determinations, 

device labeling, unmet clinical needs, 

available alternatives, patient reported 

outcomes and device-related quality of 

life or health status issues, and other 

patient-related topics. The Committee 

will provide relevant skills and 

perspectives to improve communication 

of benefits, risks, and clinical outcomes 

and increase integration of patient 

perspectives into the regulatory process 

for medical devices. The Committee will 

perform its duties by discussing and 

providing advice and recommendation 

in ways such as identifying new 

approaches, promoting innovation, 

recognizing unforeseen risks or barriers, 

and identifying unintended 

consequences that could result from 

FDA policy. 

II. Criteria for Members 

Persons nominated for membership as 

consumer representatives on 

committees or panels should meet the 

following criteria: (1) Demonstrate an 

affiliation with and/or active 

participation in consumer or 

community-based organizations, (2) be 

able to analyze technical data, (3) 

understand research design, (4) discuss 

benefits and risks, and (5) evaluate the 

safety and efficacy of products under 

review. The consumer representative 

should be able to represent the 

consumer perspective on issues and 

actions before the advisory committee; 

serve as a liaison between the 

committee and interested consumers, 

associations, coalitions, and consumer 

organizations; and facilitate dialogue 

with the advisory committees on 

scientific issues that affect consumers. 

III. Selection Procedures 

Selection of members representing 

consumer interests is conducted 

through procedures that include the use 

of organizations representing the public 

interest and public advocacy groups. 

These organizations recommend 

nominees for the Agency’s selection. 

Representatives from the consumer 

health branches of Federal, State, and 

local governments also may participate 

in the selection process. Any consumer 

organization interested in participating 

in the selection of an appropriate voting 

or nonvoting member to represent 

consumer interests should send a letter 

stating that interest to FDA (see 

ADDRESSES) within 30 days of 

publication of this document. 

Within the subsequent 30 days, FDA 

will compile a list of consumer 

organizations that will participate in the 

selection process and will forward to 

each such organization a ballot listing at 

least two qualified nominees selected by 

the Agency based on the nominations 

received, together with each nominee’s 

current curriculum vitae or re ́sume ́. 

Ballots are to be filled out and returned 

to FDA within 30 days. The nominee 

receiving the highest number of votes 

ordinarily will be selected to serve as 

the member representing consumer 

interests for that particular advisory 

committee or panel. 

IV. Nomination Procedures 

Any interested person or organization 

may nominate one or more qualified 

persons to represent consumer interests 

on the Agency’s advisory committees or 

panels. Self-nominations are also 

accepted. Nominations must include a 

current, complete re ́sume ́ or curriculum 

vitae for each nominee and a signed 

copy of the Acknowledgement and 

Consent form available at the FDA 

Advisory Nomination Portal (see 

ADDRESSES), and a list of consumer or 

community-based organizations for 

which the candidate can demonstrate 

active participation. 

Nominations must also specify the 

advisory committee(s) or panel(s) for 

which the nominee is recommended. In 

addition, nominations must also 

acknowledge that the nominee is aware 

of the nomination unless selfnominated. FDA will ask potential 

candidates to provide detailed 

information concerning such matters as 

financial holdings, employment, and 

research grants and/or contracts to 

permit evaluation of possible sources of 

conflicts of interest. Members will be 

invited to serve for terms of up to 4 

years. 

FDA will review all nominations 

received within the specified 

timeframes and prepare a ballot 

containing the names of qualified 

nominees. Names not selected will 

remain on a list of eligible nominees 

and be reviewed periodically by FDA to 

determine continued interest. Upon 

selecting qualified nominees for the 

ballot, FDA will provide those 

consumer organizations that are 

participating in the selection process 

with the opportunity to vote on the 

listed nominees. Only organizations 

vote in the selection process. Persons 

who nominate themselves to serve as 

voting or nonvoting consumer 

representatives will not participate in 

the selection process. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: August 5, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–17066 Filed 8–10–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0008] 

Patient Engagement Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

forthcoming public advisory committee 

meeting of the 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 October 6, 2021, from 10 

a.m. to 5 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@


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 152 / Wednesday, August 11, 2021 / Notices 44029 

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. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On October 

6, 2021, the committee will discuss and 

make recommendations on the topic 

‘‘Medical Device Recalls.’’ Once a 

medical device is available in the U.S. 

marketplace and in widespread use, 

unforeseen problems can sometimes 

lead to a recall. When a device is 

defective or potentially harmful, 

recalling that product—removing it from 

the market or correcting the problem— 

is the most effective means for 

protecting the public. A company may 

recall a device after discovering a 

problem on its own, or after FDA raises 

concerns. In rare cases, FDA may 

require a company to recall a device. 

When a device is recalled, FDA reviews 

the company’s strategy for resolving the 

problem by assessing the relative degree 

of risk associated with the product and 

making sure the strategy effectively 

resolves the problem with the device. 

FDA provides transparency and 

communicates information when the 

public needs to be alerted to a serious 

hazard, as well as once the recall has 

been appropriately resolved. The 

recommendations provided by the 

committee will address factors FDA and 

industry should consider to effectively 

communicate medical device recall 

information to patients and the public, 

including but not limited to content, 

format, methods used to disseminate the 

message, and timing of communication. 

The committee will also consider 

concerns patients have about changes to 

their device in response to a recall and 

will discuss ways patient perspectives 

could be incorporated in FDA and 

industry benefit-risk decision making, 

as well as the healthcare provider and 

patient decision-making process related 

to a recalled medical device, including 

implanted devices. 

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 2021 

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 

October 6, 2021, between approximately 

2 p.m. to 3 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 

September 8, 2021. 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 September 10, 2021. 

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 September 16, 2021. 

Virtual Breakout Session: Individuals 

interested in participating in the virtual 

breakout scenario discussions will need 

to sign up to participate on or before 

September 22, 2021. 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 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 

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: August 6, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–17118 Filed 8–10–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 


jbell on DSKJLSW7X2PROD with NOTICES