Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 11796-11797 [2014-04522]
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11796
Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Notices
FDA estimates that approximately 400
firms (‘‘number of respondents’’ in table
1) distribute scientific and medical
publications that discuss unapproved
new uses for FDA-approved or -cleared
products. FDA also estimates that each
firm would include some or all of the
additional information described
previously when distributing annually a
total of approximately 40,000 scientific
or medical journal articles, scientific or
medical reference texts, or CPGs (‘‘total
annual disclosures’’ in table 1) that
discuss unapproved new uses for FDA-
approved or -cleared products. FDA
estimates that it will take each firm
approximately 4 hours (‘‘hours per
disclosure’’ in table 1) to make the
disclosures recommended in this draft
guidance.
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Draft guidance on distributing scientific and medical
information on unapproved new uses
Number of
respondents
Number of
disclosures
per respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Distribution of scientific and medical information on unapproved
new uses ..................................................................................
400
100
40,000
4
160,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://www.
fda.gov/Drugs/GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, https://www.fda.gov/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
default.htm, or https://
www.regulations.gov.
Dated: February 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–04560 Filed 2–28–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2014–N–0001]
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Mar<15>2010
19:40 Feb 28, 2014
Jkt 232001
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. The meeting of the Ophthalmic
Devices Panel Advisory Committee
scheduled for February 14, 2014, was
postponed due to unanticipated weather
conditions and rescheduled for March
14, 2014.
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 March 14, 2014, from 8 a.m. to
6 p.m. This meeting is being
rescheduled because of a postponed
meeting announced in the Federal
Register of December 24, 2013 (78 FR
77688), originally scheduled for
February 14, 2014.
Location: Hilton Washington, DC/
North, 620 Perry Pkwy., Gaithersburg,
MD 20877. The hotel’s phone number is
301–977–8900.
Contact Person: Natasha Facey, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
1544, Silver Spring, MD 20933, 301–
796–5920, Natasha.Facey@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/Advisory
Committees/default.htm and scroll
down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
PO 00000
Frm 00047
Fmt 4703
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learn about possible modifications
before coming to the meeting.
Agenda: On March 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
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
E:\FR\FM\03MRN1.SGM
03MRN1
Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Notices
submissions may be made to the contact
person on or before March 7, 2014. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. on March 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 February 27, 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
March 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).
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: February 25, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2014–04522 Filed 2–28–14; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
19:40 Feb 28, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Risk Communications 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: Risk
Communications 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 May 5 and 6, 2014, from 9 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20993–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Entrance for the public
meeting 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/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
Contact Person: Luis G. Bravo, Risk
Communication Staff, Office of
Planning, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, rm. 3274, Silver Spring,
MD 20993–0002, 240–402–5274, email
Luis.Bravo@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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
11797
information line to learn about possible
modifications before coming to the
meeting.
If you are unable to join us in person,
we encourage you to watch the free Web
cast. Visit the Risk Communication
Advisory Committee Web site at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/
RiskCommunicationAdvisory
Committee/default.htm. The link will
become active shortly before the open
session begins at 9 a.m.
Agenda: On May 5 and 6, 2014, the
committee will meet to discuss methods
for identifying the impact and
increasing the reach of communications
on topics of interest to consumers. The
discussion will also address how FDA
can evaluate whether its Consumer
Updates (https://www.fda.gov/
ForConsumers/ConsumerUpdates/
default.htm) are reaching the targeted
population, and whether they are
increasing awareness and understanding
of the key risk messages. The discussion
will also assess whether the
communications are having the
intended impact on knowledge,
behaviors and/or outcomes.
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 28, 2014. 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 18,
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
E:\FR\FM\03MRN1.SGM
03MRN1
]]>Agencies
[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Notices]
[Pages 11796-11797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04522]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-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. The meeting of the Ophthalmic Devices Panel
Advisory Committee scheduled for February 14, 2014, was postponed due
to unanticipated weather conditions and rescheduled for March 14, 2014.
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 March 14, 2014, from 8
a.m. to 6 p.m. This meeting is being rescheduled because of a postponed
meeting announced in the Federal Register of December 24, 2013 (78 FR
77688), originally scheduled for February 14, 2014.
Location: Hilton Washington, DC/North, 620 Perry Pkwy.,
Gaithersburg, MD 20877. The hotel's phone number is 301-977-8900.
Contact Person: Natasha Facey, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 1544, Silver Spring, MD 20933, 301-796-5920,
Natasha.Facey@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.
Agenda: On March 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 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
[[Page 11797]]
submissions may be made to the contact person on or before March 7,
2014. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on March 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 February 27, 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 March 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: February 25, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-04522 Filed 2-28-14; 8:45 am]
BILLING CODE 4160-01-P
