Document ID: FDA-2017-N-6888-0002
Agency: fda
Document Type: Notice
Title: Neurological Devices Panel of the Medical Devices Advisory Committee;
Amendment of Notice
Posted Date: 2018-02-13T05:00Z

[Federal Register Volume 83, Number 30 (Tuesday, February 13, 2018)]
[Notices]
[Page 6188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02766]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6888]

Neurological Devices Panel of the Medical Devices Advisory 
Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Neurological Devices Panel of 
the Medical Devices Advisory Committee. This meeting was announced in 
the Federal Register of December 28, 2017. The amendment is being made 
to reflect a change in the Procedure portion of the document. There are 
no other changes.

FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. G642, Silver Spring, MD 20993-0002, 
[email protected], 301-796-0400, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area) code NE. Please call the Information Line for up-to-date 
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 28, 
2017, 82 FR 61574, FDA announced that a meeting of the Neurological 
Devices Panel of the Medical Devices Advisory Committee would be held 
on March 1, 2018, from 8 a.m. to 6 p.m. On page 61574, in the 3rd 
column, the Procedure portion of the document is changed to read as 
follows:
    Procedure: FDA will work with affected industry organizations that 
have an interest in intracranial aneurysm treatment devices and who 
wish to make a presentation separate from the general Open Public 
Hearing; time slots on March 1, 2018, between approximately 9:40 a.m. 
and 11 a.m. Representatives from industry organizations interested in 
making formal presentations to the committee should notify the contact 
person on or before February 16, 2018.
    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 16, 
2018. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon. Those individuals interested in 
making formal oral presentations should notify the 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 February 9, 2018. 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 12, 2018.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: February 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02766 Filed 2-12-18; 8:45 am]
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