[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9513-9514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03066]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]


General and Plastic Surgery Devices Panel of the Medical Devices 
Advisory Committee, Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) announces 
a forthcoming public advisory committee meeting of the General and 
Plastic Surgery Devices Panel of the Medical Devices Advisory 
Committee. The general function of the committee is to provide advice 
and recommendations to the Agency on FDA's regulatory issues. The 
meeting will be open to the public.

DATES: The meeting will take place virtually on March 23, 2021, from 9 
a.m. Eastern Time to 6 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.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5216, Silver Spring, MD 20993-0002, 
<a href="/cdn-cgi/l/email-protection#07576673756e646e6829406675646e6647616366296f6f7429606871"><span class="__cf_email__" data-cfemail="70201104021913191f5e371102131911301614115e1818035e171f06">[email protected]</span></a>, 301-796-6875, 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/AdvisoryCommittees/default.htm 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 March 23, 
2021, the committee will discuss and make recommendations regarding the 
benefits and risks of dermal fillers concerning the following topics: 
(1) Risks associated with intravascular injection of dermal fillers and 
(2) patient preference and informed decision making. FDA is convening 
this meeting to seek expert opinion on the clinical evaluation and 
regulation of dermal filler products.
    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

[[Page 9514]]

material will be posted on FDA's website after the meeting. Background 
material and the link to the online teleconference meeting room will be 
available at: https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/general-and-plastic-surgery-devices-panel. 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. 
Written submissions may be made to the contact person on or before 
March 9, 2021. Oral presentations from the public and organizations 
will be scheduled on March 23, 2021, between approximately 12:40 p.m. 
Eastern Time to 1:40 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 March 11, 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 sessions. 
The contact person will notify interested persons regarding their 
request to speak by March 12, 2021.
    For press inquiries, please contact the Office of Media Affairs at 
<a href="/cdn-cgi/l/email-protection#56303237393b3716303237783e3e2578313920"><span class="__cf_email__" data-cfemail="56303237393b3716303237783e3e2578313920">[email protected]</span></a> 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 Artair Mallet at <a href="/cdn-cgi/l/email-protection#107162647179623e7d717c7c756464507674713e7878633e777f66"><span class="__cf_email__" data-cfemail="24455650454d560a49454848415050644240450a4c4c570a434b52">[email protected]</span></a> or 301-796-9638 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/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory 
committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03066 Filed 2-12-21; 8:45 am]
BILLING CODE 4164-01-P


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