[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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