Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice, 6188 [2018-02766]
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6188
Federal Register / Vol. 83, No. 30 / Tuesday, February 13, 2018 / Notices
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Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–02869 Filed 2–12–18; 8:45 am]
BILLING CODE 4184–23–P
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.
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.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
23:12 Feb 12, 2018
Jkt 244001
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, 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) 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.
PO 00000
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Dated: February 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–02766 Filed 2–12–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0235]
Orthopaedic Sensing, Measuring, and
Advanced Reporting Technology
Devices; Public Workshop; Request
for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Orthopaedic
Sensing, Measuring, and Advanced
Reporting Technology (SMART)
Devices.’’ The purpose of the public
workshop is to discuss the development
of Orthopaedic SMART Devices. The
workshop is intended to enhance
engagement with stakeholders to
facilitate device development and to
discuss scientific and regulatory
challenges associated with Orthopaedic
SMART Devices. Public input and
feedback gained through this workshop
may aid in the efficient development of
innovative, safe, and effective
Orthopaedic SMART Devices for better
patient care.
DATES: The public workshop will be
held on April 30, 2018, from 8:30 a.m.
to 5 p.m. Submit either electronic or
written comments on this public
workshop by May 29, 2018. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503 (The Great Room), Silver
Spring, MD 20993. Entrance for the
public workshop participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/Working
atFDA/BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before May 29, 2018. The https://
SUMMARY:
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13FEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4164-01-P
