Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 77688-77689 [2013-30579]
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emcdonald on DSK67QTVN1PROD with NOTICES
77688
Federal Register / Vol. 78, No. 247 / Tuesday, December 24, 2013 / Notices
Science Coordination, followed by a
report from the National Toxicology
Program of the National Institutes of
Environmental Health Sciences on
current and future collaboration.
On January 30, 2014, the Arkansas
Bioinformatics Consortium will present
concepts and ideas on defining and
meeting NCTR and FDA’s scientific
computing needs and discuss how it can
partner with FDA to foster the
development of collaborative efforts in
this area. To facilitate the discussion
representatives from each of the product
centers will discuss their bioinformatic
needs, how those needs are being
addressed and areas of possible
collaboration.
Following an open discussion of all
the information presented, the open
session of the meeting will close so that
SAB members can discuss personnel
issues at NCTR.
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: On January 29, 2014, from
8:45 a.m. to 5 p.m., the meeting is open
to the public. 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 January 21, 2014.
Oral presentations from the public will
be scheduled between approximately 12
p.m. to 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 January
13, 2014. 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
VerDate Mar<15>2010
16:36 Dec 23, 2013
Jkt 232001
notify interested persons regarding their
request to speak by January 14, 2014.
Closed Committee Deliberations: On
January 30, 2014, from 11 a.m. to 2 p.m.,
the meeting will be closed to permit
discussion where disclosure would
constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). This portion of the meeting
will be closed to permit discussion of
information concerning individuals
associated with the research programs at
NCTR.
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 physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Margaret
Miller 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: December 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–30578 Filed 12–23–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Ophthalmic 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: Ophthalmic
Devices Panel of the Medical Devices
Advisory Committee.
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
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 February 14, 2014, from 8 a.m.
to 6 p.m.
Location: Gaithersburg Marriott
Washingtonian Center, Salons A, B, C
and D, 9751 Washingtonian Blvd.,
Gaithersburg, MD 20878.
Contact Person: James Swink, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66,
Rm.1609, Silver Spring, MD 20993,
James.Swink@fda.hhs.gov, 301–796–
6313, 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: On February 14, 2014, the
committee will discuss, make
recommendations, and vote on
information regarding the premarket
approval application for the Visian
Toric Implantable Collamer Lens (TICL)
sponsored by STAAR Surgical
Company. ‘‘Visian TICL proposed
indications for use:
• For adults 21–45 years of age;
• For correction of myopic
astigmatism in adults with spherical
equivalent ranging from ¥3.0D to
≤¥15.0D with cylinder of 1.0D to 4.0D;
• For the reduction of myopic
astigmatism in adults with spherical
equivalent ranging from greater than
¥15.0D to ¥20.0D with cylinder 1.0D
to 4.0D;
• With an anterior chamber depth
(ACD) of 3.0 mm or greater, when
measured from the corneal endothelium
to the anterior surface of the crystalline
lens and a stable refractive history
(within 0.5 Diopter for 1 year prior to
implantation); and
• The Visian TICL is intended for
placement in the posterior chamber
(ciliary sulcus) of the phakic eye.’’
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
E:\FR\FM\24DEN1.SGM
24DEN1
emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 247 / Tuesday, December 24, 2013 / Notices
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 February 7, 2014.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. on February 14, 2014.
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 January 30, 2014. 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 3, 2014.
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 physical
disabilities or special needs. If you
require special 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).
VerDate Mar<15>2010
16:36 Dec 23, 2013
Jkt 232001
Dated: December 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–30579 Filed 12–23–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–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 February 21, 2014, from 8 a.m.
to 3 p.m.
Location: 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.
Contact Person: Sara Anderson,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 1643, Silver Spring, MD 20993–
0002, 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: On February 21, 2014, the
committee will discuss and make
recommendations regarding the 515(i)
order issued by FDA on April 9, 2009
PO 00000
Frm 00047
Fmt 4703
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77689
[Docket No. FDA–2009–M–0101],
relating to the regulatory classification
of iontophoresis devices, one of the
remaining preamendments class III
devices. Iontophoresis is a method of
non-invasive transdermal delivery in
which a substance bearing a charge is
propelled through the skin by an
electric current. Iontophoresis devices
generally consist of a controller, active
and return electrode(s), and power
supply used to deliver currents to
transport drugs, soluble salts, or ionic
solutions across the skin.
The regulation for iontophoresis
devices (21 CFR 890.5525) currently has
two parts. Part (a) of the regulation
classifies iontophoresis devices as class
II when indicated to introduce drugs or
soluble salts to induce sweating for use
in the diagnosis of cystic fibrosis or for
other uses if the drug intended for use
with the device bears adequate
directions for the device’s use with that
drug. Devices identified in part (a) of the
regulation will not be considered in the
scope of the committee meeting. Part (b)
of the regulation classifies iontophoresis
devices as class III when intended to use
direct current to introduce soluble salts
or other drugs into the body for
purposes other than those specified in
part (a). Devices identified in part (b) of
the regulation are the subject of the
committee meeting.
On August 28, 1979, FDA published
a proposed rule (44 FR 50520) for
classification of iontophoresis devices
for specialized uses (for the diagnosis of
cystic fibrosis, fluoride uptake
acceleration in dentistry, and for local
anesthesia of the intact tympanic
membrane) into class II and for all other
uses into class III. FDA recommended
class III for iontophoresis devices when
used for purposes other than those
specifically considered because such
use presents ‘‘a potential unreasonable
risk of injury without benefit to the
patient because substantial data and
clinical investigations do not exist to
support the claims made for the
devices.’’ In addition, the Agency noted
that insufficient information exists to
determine that general controls would
provide reasonable assurance of the
safety and effectiveness of the device
and that insufficient information exists
to establish a performance standard to
provide this assurance.
Subsequent to the proposed rule, FDA
published a final rule (48 FR 53047) on
November 23, 1983, classifying
iontophoresis devices for use in the
diagnosis of cystic fibrosis or other uses
if the labeling of the drug intended for
use with the device bears adequate
directions for the device’s use with that
drug as class II (performance standards)
E:\FR\FM\24DEN1.SGM
24DEN1
]]>Agencies
[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Notices]
[Pages 77688-77689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30579]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Ophthalmic 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: Ophthalmic 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 February 14, 2014, from
8 a.m. to 6 p.m.
Location: Gaithersburg Marriott Washingtonian Center, Salons A, B,
C and D, 9751 Washingtonian Blvd., Gaithersburg, MD 20878.
Contact Person: James Swink, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm.1609, Silver Spring, MD 20993, James.Swink@fda.hhs.gov, 301-796-
6313, 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: On February 14, 2014, the committee will discuss, make
recommendations, and vote on information regarding the premarket
approval application for the Visian Toric Implantable Collamer Lens
(TICL) sponsored by STAAR Surgical Company. ``Visian TICL proposed
indications for use:
For adults 21-45 years of age;
For correction of myopic astigmatism in adults with
spherical equivalent ranging from -3.0D to <=-15.0D with cylinder of
1.0D to 4.0D;
For the reduction of myopic astigmatism in adults with
spherical equivalent ranging from greater than -15.0D to -20.0D with
cylinder 1.0D to 4.0D;
With an anterior chamber depth (ACD) of 3.0 mm or greater,
when measured from the corneal endothelium to the anterior surface of
the crystalline lens and a stable refractive history (within 0.5
Diopter for 1 year prior to implantation); and
The Visian TICL is intended for placement in the posterior
chamber (ciliary sulcus) of the phakic eye.''
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
[[Page 77689]]
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
February 7, 2014. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on February 14, 2014. 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
January 30, 2014. 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 3,
2014.
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
physical disabilities or special needs. If you require special
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: December 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-30579 Filed 12-23-13; 8:45 am]
BILLING CODE 4160-01-P
