Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 47752-47753 [2017-22174]
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47752
Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices
Fax: 240–641–9042, email:
simone.katz@strategicresults.com no
later than October 20, 2017, for the
III. Participating in the Public Meeting
Charlotte, NC, meeting and no later than
Registration: To register for a public
October 27, 2017, for the San Francisco,
meeting, please include your name,
CA, meeting.
title, firm name, address, and phone and
Requests for Oral Presentations:
fax numbers in your registration
During online registration you may
information and send to: Simone Katz,
indicate if you wish to present during a
Strategic Results, 101 Lakeforest Blvd.,
public comment session or participate
Suite 390, Gaithersburg, MD 20877,
in a specific session, and which topic(s)
240–449–8427, Fax: 240–641–9042,
you wish to address. We will do our
email: simone.katz@
strategicresults.com. You can register for best to accommodate requests to make
public comments. Individuals and
one or both meetings.
organizations with common interests are
Registration is free and based on
space availability, with priority given to urged to consolidate or coordinate their
presentations, and request time for a
early registrants. Persons interested in
joint presentation, or submit requests for
attending this public meeting must
designated representatives to participate
register by October 30, 2017, for the
Charlotte, NC, meeting and must register in the focused sessions. Following the
close of registration, we will determine
by November 6, 2017, for the San
the amount of time allotted to each
Francisco, CA, meeting. Early
presenter and the approximate time
registration is recommended because
each oral presentation is to begin, and
seating is limited; therefore, FDA may
will select and notify participants by
limit the number of participants from
October 24, 2017, for the meeting in
each organization. Registrants will
Charlotte, NC, and by November 1,
receive confirmation when they have
2017, for the meeting in San Francisco,
been accepted.
CA. All requests to make oral
If you need special accommodations
presentations must be received by
due to a disability, please contact
October 20, 2017, for the meeting in
Simone Katz, Strategic Results, 101
Charlotte, NC, and by October 27, 2017,
Lakeforest Blvd., Suite 390,
Gaithersburg, MD 20877, 240–449–8427, for the meeting in San Francisco, CA.
for FDA’s Agricultural Biotechnology
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participate by webcast are asked to
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Food/NewsEvents/
WorkshopsMeetingsConferences/
default.htm
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transcript will also be available on the
internet at https://www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConferences/
default.htm.
Other Issues for Consideration: A
summary of key information on
participating in a meeting follows:
TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING
Address
Preregister
Electronic address
November 7,
2017, from 8:30
a.m. to 1 p.m.
EST.
Omni Charlotte
Hotel, 132 E
Trade St.,
Charlotte, NC
28202.
October 30,
2017: Closing
date for registration.
Please preregister at https://
www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConferences/default.htm.
November 14,
2017, from 8:30
a.m. to 1 p.m.
PST.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Date
San Francisco
Marriott Marquis, 780 Mission St., San
Francisco, CA
94103.
November 6,
2017: Closing
date for registration.
Please preregister at https://
www.fda.gov/Food/
NewsEvents/
WorkshopsMeetingsConferences/default.htm.
You may also register via email, mail,
or fax. Please include your name, title,
firm name, address, and phone and Fax
numbers in your registration
information and send to: Simone Katz,
Strategic Results, 101 Lakeforest Blvd.,
Suite 390, Gaithersburg, MD 20877,
240–449–8427, Fax: 240–641–9042,
email: simone.katz@
strategicresults.com.
Individuals who wish to participate
by webcast are asked to preregister at:
https://www.fda.gov/Food/NewsEvents/
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Request to
make an oral
presentation
Special
accommodations
Submit either electronic or
written comments
October 20,
2017.
October 20,
2017: Closing
date to request special
accommodations due to a
disability.
October 27,
2017.
October 27,
2017: closing
date to request special
accommodations due to a
disability.
Submit Comments by November
17,
2017,
to:
https://
www.regulations.gov, or Dockets Management Staff (HFA–
305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD
20852.
Same as above.
WorkshopsMeetingsConferences/
default.htm.
Dated: October 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22172 Filed 10–12–17; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5953]
Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Frm 00066
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Notice.
13OCN1
Federal Register / Vol. 82, No. 197 / Friday, October 13, 2017 / Notices
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Orthopaedic and
Rehabilitation 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 be held on
December 12, 2017, from 8 a.m. to 6
p.m.
ADDRESSES: Hilton Washington DC
North/Gaithersburg, salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD
20877. The hotel’s telephone number is
301–977–8900.
FOR FURTHER INFORMATION CONTACT: Sara
J. Anderson, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G616, Silver Spring,
MD 20993–0002, 301–796–7047,
Sara.Anderson@fda.hhs.gov, 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 Web site 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: On December 12, 2017, the
committee will discuss, make
recommendations, and vote on
information regarding the premarket
approval application (PMA) for the
Barricaid Anular Closure Device by
Intrinsic Therapeutics. The proposed
Indication for Use, as stated in the PMA,
is as follows: The Barricaid is intended
to be implanted following a limited
discectomy, to prevent reherniation and
the recurrence of pain or dysfunction.
The Barricaid is indicated for patients
with radiculopathy (with or without
back pain), a posterior or posterolateral
herniation, characterized by
radiographic confirmation of neural
compression using magnetic resonance
imaging, and a large anular defect (e.g.,
between 4–6 mm tall and between 6–12
mm wide) post discectomy, at one level
between L4 and S1.
FDA intends to make background
material available to the public no later
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:05 Oct 12, 2017
Jkt 244001
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
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 December 1, 2017.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. 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
November 3, 2017. 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 November 9, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
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 Web site 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).
PO 00000
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47753
Dated: October 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22174 Filed 10–12–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
patent applications listed below may be
obtained by emailing the indicated
licensing contact at the National Heart,
Lung, and Blood, Office of Technology
Transfer and Development Office of
Technology Transfer, 31 Center Drive
Room 4A29, MSC2479, Bethesda, MD
20892–2479; telephone: 301–402–5579.
A signed Confidential Disclosure
Agreement may be required to receive
copies of the patent applications.
SUPPLEMENTARY INFORMATION: This
notice is in accordance with 35 U.S.C.
209 and 37 CFR part 404 to achieve
expeditious commercialization of
results of federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing. A description of the
technology follows.
SUMMARY:
Derivatives of
Docosahexaenoylethanolamide (DEA)
for Neurogenesis
The invention pertains to derivatives
of docosahexaenoylethanolamide
(synaptamide or DEA) and their use in
inducing neurogenesis, neurite growth,
and/or synaptogenesis. As such, these
DEA derivatives can be used as
therapeutics for neurodegenerative
diseases such as traumatic brain injury,
spinal cord injury, peripheral nerve
injury, stroke, multiple sclerosis,
autism, Alzheimer’s disease,
Huntington’s disease, Parkinson’s
disease, amyotrophic lateral sclerosis.
The DEA derivatives of the invention
have increased potency and hydrolysis
resistance as compared to native DEA.
Docosahexaenoic acid (DHA), an n-3
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]]>Agencies
[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Pages 47752-47753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22174]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5953]
Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 47753]]
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Orthopaedic and Rehabilitation
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 be held on December 12, 2017, from 8 a.m. to 6
p.m.
ADDRESSES: Hilton Washington DC North/Gaithersburg, salons A, B, C, and
D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is 301-977-8900.
FOR FURTHER INFORMATION CONTACT: Sara J. Anderson, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G616, Silver Spring, MD 20993-0002, 301-
796-7047, Sara.Anderson@fda.hhs.gov, 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 Web site 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: On December 12, 2017, the committee will discuss, make
recommendations, and vote on information regarding the premarket
approval application (PMA) for the Barricaid Anular Closure Device by
Intrinsic Therapeutics. The proposed Indication for Use, as stated in
the PMA, is as follows: The Barricaid is intended to be implanted
following a limited discectomy, to prevent reherniation and the
recurrence of pain or dysfunction. The Barricaid is indicated for
patients with radiculopathy (with or without back pain), a posterior or
posterolateral herniation, characterized by radiographic confirmation
of neural compression using magnetic resonance imaging, and a large
anular defect (e.g., between 4-6 mm tall and between 6-12 mm wide) post
discectomy, at one level between L4 and S1.
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 Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
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
December 1, 2017. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. 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 November 3, 2017. 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 November 9, 2017.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
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 Web site 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: October 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22174 Filed 10-12-17; 8:45 am]
BILLING CODE 4164-01-P
