Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 11815 [2016-04927]
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Federal Register / Vol. 81, No. 44 / Monday, March 7, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Orthopaedic and Rehabilitation
Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Orthopaedic and
Rehabilitation Devices Panel of the
Medical Devices Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on Wednesday, April 20, 2016,
from 8 a.m. to 6 p.m.
Location: Hilton Washington, DC/
North, Salons A, B, C, and D, 620 Perry
Pkwy., Gaithersburg, MD 20877. The
hotel telephone number is 301–977–
8900.
Contact Person: S.J. Anderson, Center
for Devices and Radiological Health,
Food and Drug Administration, Bldg.
66, rm. 1643, 10903 New Hampshire
Ave., Silver Spring, MD 20993, email:
Sara.Anderson@fda.hhs.gov, 301 796–
7047, 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.
Agenda: The Committee will discuss,
make recommendations, and vote on the
premarket approval application for the
Cartiva Synthetic Cartilage Implant
(SCI), sponsored by Cartiva, Inc. The
Cartiva Synthetic Cartilage Implant
(SCI) is an organic polymer-based
biomaterial to mimic biologic cartilage.
The device is to be indicated for
treatment of degenerative and posttraumatic arthritis in the first
metatarsophalangeal joint in the
VerDate Sep<11>2014
18:37 Mar 04, 2016
Jkt 238001
presence of good bone stock along with
the following clinical conditions: hallux
valgus or hallux limitus, hallux rigidus,
and an unstable or painful
metatarsophalangeal joint.
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 April 13, 2016. 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 April 5,
2016. 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 April 6, 2016.
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 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
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
11815
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: February 29, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–04927 Filed 3–4–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request
ACTION:
Notice.
In compliance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), the Health Resources and
Services Administration (HRSA) will
submit an Information Collection
Request (ICR) to the Office of
Management and Budget (OMB).
Comments submitted during the first
public review of this ICR will be
provided to OMB. OMB will accept
further comments from the public
during the review and approval period.
To request a copy of the clearance
requests submitted to OMB for review,
email paperwork@hrsa.gov or call the
HRSA Reports Clearance Office at (301)
443–1984.
DATES: Deadline: Comments on this ICR
should be received no later than April
6, 2016.
ADDRESSES: Submit your comments to
the desk officer for HRSA, either by
email to OIRA_submission@
omb.eop.gov or by fax to 202–395–5806.
Please direct all correspondence to the
‘‘attention of the desk officer for HRSA.’’
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Health Center Controlled Networks
(OMB No. 0915–0360) Extension.
Abstract: One goal of the Health
Resources and Services Administration
(HRSA) is to ensure that all Health
Center Program grantees effectively
implement health information
technology (HIT) systems that enable all
providers to adopt and implement HIT,
including Electronic Health Records
(EHRs); to become meaningful users of
EHRs and use HIT systems to increase
access to care, improve quality of care,
and reduce the costs of care delivered.
SUMMARY:
E:\FR\FM\07MRN1.SGM
07MRN1
]]>Agencies
[Federal Register Volume 81, Number 44 (Monday, March 7, 2016)]
[Notices]
[Page 11815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04927]
[[Page 11815]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Orthopaedic and Rehabilitation Devices Panel of
the Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on Wednesday, April 20,
2016, from 8 a.m. to 6 p.m.
Location: Hilton Washington, DC/North, Salons A, B, C, and D, 620
Perry Pkwy., Gaithersburg, MD 20877. The hotel telephone number is 301-
977-8900.
Contact Person: S.J. Anderson, Center for Devices and Radiological
Health, Food and Drug Administration, Bldg. 66, rm. 1643, 10903 New
Hampshire Ave., Silver Spring, MD 20993, email:
Sara.Anderson@fda.hhs.gov, 301 796-7047, 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.
Agenda: The Committee will discuss, make recommendations, and vote
on the premarket approval application for the Cartiva Synthetic
Cartilage Implant (SCI), sponsored by Cartiva, Inc. The Cartiva
Synthetic Cartilage Implant (SCI) is an organic polymer-based
biomaterial to mimic biologic cartilage. The device is to be indicated
for treatment of degenerative and post-traumatic arthritis in the first
metatarsophalangeal joint in the presence of good bone stock along with
the following clinical conditions: hallux valgus or hallux limitus,
hallux rigidus, and an unstable or painful metatarsophalangeal joint.
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
April 13, 2016. 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 April 5, 2016. 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 April 6, 2016.
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 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: February 29, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-04927 Filed 3-4-16; 8:45 am]
BILLING CODE 4164-01-P
