[Federal Register Volume 86, Number 152 (Wednesday, August 11, 2021)]
[Notices]
[Pages 44028-44029]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17118]


-----------------------------------------------------------------------

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@

[[Page 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-advisory-committee. 
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 
[email protected] 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 [email protected], 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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-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