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Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 209930002, email:
AAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1800
7418138 3014430572 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 FDAs 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 coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committees will discuss biologics license application BLA 761130, tanezumab subcutaneous injection, submitted by Pfizer Inc., for the proposed indication of relief of signs and symptoms of moderate to severe osteoarthritis in adult patients for whom use of other analgesics is ineffective or not appropriate.
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 FDAs website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at https www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee meeting link. 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 committees. All electronic and written submissions submitted to the Docket see ADDRESSES on or before March 10, 2021, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 3:30 p.m. and 4:30 p.m.
Eastern Time on March 24, 2021. Those individuals interested in making formal oral presentations should notify the
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contact person and submit 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 2, 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 March 3, 2021.
For press inquiries, please contact the Office of Media Affairs at fdaoma@
fda.hhs.gov or 3017964540.
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 Moon Hee V.
Choi see FOR FURTHER INFORMATION
CONTACT 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 10, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202103068 Filed 21221; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2020N0008

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

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA or the Agency announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices
SUMMARY:

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Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDAs 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 COVID19 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 209930002, Patricio.Garcia@
fda.hhs.gov, 3017966875, or FDA
Advisory Committee Information Line, 18007418138 3014430572 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 Agencys 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 FDAs website at the time of the advisory committee meeting, and the background
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