[Federal Register Volume 86, Number 8 (Wednesday, January 13, 2021)]
[Notices]
[Pages 2676-2677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00469]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0008]
Circulatory System 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 Circulatory
System 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 February 17, 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: Aden Asefa, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002,
aden.asefa@fda.hhs.gov, 301-796-0400, 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 February
17, 2021, the committee will discuss, make recommendations, and vote on
information regarding the premarket approval application (PMA) for the
Lutonix 014 Drug Coated Balloon Percutaneous Transluminal Angioplasty
(PTA) catheter. The proposed Indication for Use for the Lutonix 014
Drug Coated Balloon PTA catheter is indicated for percutaneous
transluminal angioplasty, after appropriate vessel preparation, of
obstructive de novo or non-stented restenotic lesions in native
popliteal, tibial, and peroneal arteries up to 320 mm in length and 2.0
to 4.0 mm in diameter.
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 material
and the link to the online teleconference meeting room will be
available at https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/circulatory-system-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
February 10, 2021. Oral presentations from the public will be scheduled
between approximately 1 p.m. Eastern Time and 2 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
[[Page 2677]]
requested to make their presentation on or before February 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 February 3, 2021.
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/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: January 6, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-00469 Filed 1-12-21; 8:45 am]
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