General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 59194-59195 [E9-27491]
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<![CDATA[
mstockstill on DSKH9S0YB1PROD with NOTICES
59194
Federal Register / Vol. 74, No. 220 / Tuesday, November 17, 2009 / Notices
trade name HEXVIX
(hexaminolevulinate as hydrochloride)
Kit, for the preparation of HEXVIX
solution for intravesical use, by
Photocure ASA. The product is a
diagnostic imaging agent that becomes
visible when illuminated by blue light,
a special type of light that causes the
agent to appear a certain (fluorescent)
color. The agent is proposed for
administration into the bladder to help
in the examination of the bladder wall
with a cystoscope, a surgical instrument
used to detect some types of cancer. The
proposed indication (use) for this
product is for blue light cystoscopy
performed with the Karl Storz
Photodynamic Diagnosis (PDD) system
(equipment that produces blue light) as
an adjunct to white light cystoscopy in
the detection of non-muscle invasive
papillary cancer of the bladder.
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 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 9, 2009.
Oral presentations from the public will
be scheduled between approximately 11
a.m. and 12 noon. Those desiring to
make 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 December 1, 2009. 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
December 2, 2009.
Persons attending FDA’s advisory
committee meetings are advised that the
VerDate Nov<24>2008
20:50 Nov 16, 2009
Jkt 220001
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 Nicole
Vesely 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/Advisory
Committees/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: November 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27493 Filed 11–16–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
General and Plastic Surgery 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: General and
Plastic Surgery 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 25, 2010, from 8 a.m. to
6 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Ballroom, 620 Perry
Pkwy., Gaithersburg, MD.
Contact Person: Peter L. Hudson,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., White Oak
66, rm. 3618, Silver Spring, MD 20993,
301–796–6440 or FDA Advisory
Committee Information Line, 1–800–
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512519. Please call the Information
Line for up-to-date information on this
meeting. 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 and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On March 25, 2010, the
committee will review and discuss
recent information, including recent
literature regarding the possible risks to
the general public from intentional
exposure to ultraviolet radiation (UV)
from use of tanning lamps. There
continues to be a growing body of
literature showing association of skin
cancer with use of tanning lamps and
the committee will discuss this
information and other information
related to the association of UV and skin
cancer (both melanoma and nonmelanoma). The committee will be
asked to recommend whether changes to
current classification or current
regulatory controls of UV emitting
devices (lamps) used for tanning are
needed.
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 link.
Procedure: Interested persons may
present data, information, or views
orally or in writing on the issues
pending before the committee. Written
submissions may be made to the contact
person on or before March 11, 2009.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those desiring to make
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 March 3, 2009. Time allotted
for each presentation may be limited. If
E:\FR\FM\17NON1.SGM
17NON1
Federal Register / Vol. 74, No. 220 / Tuesday, November 17, 2009 / Notices
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 4, 2009.
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, 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/Advisory
Committees/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: November 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27491 Filed 11–16–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD 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: Oncologic Drugs
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 December 16, 2009, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
VerDate Nov<24>2008
20:50 Nov 16, 2009
Jkt 220001
Perry Pkwy., Gaithersburg, MD. The
hotel phone number is 301–977–8900.
Contact Person: Nicole Vesely, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane, (for express delivery,
5630 Fishers Lane, rm. 1093) Rockville,
MD 20857, 301–827–6793, FAX: 301–
827–6776, e-mail:
nicole.vesely@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512542. Please call the Information
Line for up-to-date information on this
meeting. 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 and call the appropriate advisory
committee hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On December 16, 2009,
during the morning session, the
committee will discuss supplemental
new drug application (sNDA) 021–743/
S–016, TARCEVA (erlotinib) tablets, by
OSI Pharmaceuticals, Inc. The proposed
indication (use) for this product is firstline maintenance, monotherapy (firstchoice, single drug) treatment in
patients with a form of lung cancer
called non-small cell lung cancer
(NSCLC) that is either locally advanced
(has spread regionally within the lung
and/or within chest lymph nodes) or
metastatic (has spread beyond the lung),
and who have not progressed (including
those patients with stable disease) on
first-line treatment with platinum-based
chemotherapy (a regimen including a
platinum drug (cisplatin or carboplatin)
plus another chemotherapy drug).
During the afternoon session, the
committee will discuss supplemental
new drug application (sNDA) 022–059/
S–007, TYKERB (lapatinib) tablets, by
SmithKline Beecham Ltd. doing
business as GlaxoSmithKline. The
proposed indication (use) for this
product is in combination with an
aromatase inhibitor for the treatment of
hormone sensitive advanced or
metastatic breast cancer. 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://
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
59195
www.fda.gov/AdvisoryCommittees/
Calendar/default.htm. Scroll down to
the appropriate advisory committee
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 9, 2009.
Oral presentations from the public will
be scheduled between approximately
10:30 a.m. and 11 a.m., and 3:30 p.m.
and 4 p.m. Those desiring to make
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 December 1, 2009. 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
December 2, 2009.
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 Nicole
Vesely 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/Advisory
Committees/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: November 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27490 Filed 11–16–09; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\17NON1.SGM
17NON1
]]>Agencies
[Federal Register Volume 74, Number 220 (Tuesday, November 17, 2009)]
[Notices]
[Pages 59194-59195]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27491]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
General and Plastic Surgery 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: General and Plastic Surgery 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 25, 2010, from 8
a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620
Perry Pkwy., Gaithersburg, MD.
Contact Person: Peter L. Hudson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., White Oak 66, rm. 3618, Silver Spring, MD 20993, 301-796-6440 or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 3014512519. Please call the
Information Line for up-to-date information on this meeting. 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 and call the appropriate
advisory committee hot line/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On March 25, 2010, the committee will review and discuss
recent information, including recent literature regarding the possible
risks to the general public from intentional exposure to ultraviolet
radiation (UV) from use of tanning lamps. There continues to be a
growing body of literature showing association of skin cancer with use
of tanning lamps and the committee will discuss this information and
other information related to the association of UV and skin cancer
(both melanoma and non-melanoma). The committee will be asked to
recommend whether changes to current classification or current
regulatory controls of UV emitting devices (lamps) used for tanning are
needed.
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 link.
Procedure: Interested persons may present data, information, or
views orally or in writing on the issues pending before the committee.
Written submissions may be made to the contact person on or before
March 11, 2009. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Those desiring to make 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 March 3, 2009. Time allotted for each presentation may be
limited. If
[[Page 59195]]
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 4, 2009.
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,
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: November 10, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27491 Filed 11-16-09; 8:45 am]
BILLING CODE 4160-01-S
