Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting, 64702 [E9-29211]
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64702
Federal Register / Vol. 74, No. 234 / Tuesday, December 8, 2009 / Notices
Date and Time: The meeting will be
held on December 16, 2009, from 9 a.m.
to 3 p.m.
On page 59195, in the second column,
the Agenda portion of the document is
changed to read as follows:
Agenda: On December 16, 2009, 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).
On page 59195, in the third column,
the third sentence in the Procedure
portion of the document is changed to
read as follows:
Procedure: Oral presentations from
the public will be scheduled between
approximately 1 p.m. to 2 p.m.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: December 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–29208 Filed 12–7–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Anesthetic and Life Support Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
WReier-Aviles on DSKGBLS3C1PROD 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: Anesthetic and
Life Support Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
VerDate Nov<24>2008
15:16 Dec 07, 2009
Jkt 220001
Date and Time: The meeting will be
held on January 28, 2010, from 8 a.m.
to 4:30 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD. The
hotel telephone number is 301–977–
8900.
Contact Person: Kalyani Bhatt, 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, 301–827–7001, FAX: 301–
827–6776, e-mail:
Kalyani.Bhatt@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in
Washington, DC area), code
3014512529. 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 hotline/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On January 28, 2010, the
committee will discuss the available
safety and efficacy data for new drug
application (NDA) 22516, CYMBALTA
(duloxetine HCL) Capsules, by Eli Lilly
and Co., as they relate to the proposed
indication of treatment of chronic pain.
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 January 13, 2010.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 1:30 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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
indication of the approximate time
requested to make their presentation on
or before January 5, 2010. 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 January 6, 2010.
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 Kalyani
Bhatt 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: December 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–29211 Filed 12–7–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
E:\FR\FM\08DEN1.SGM
08DEN1
]]>Agencies
[Federal Register Volume 74, Number 234 (Tuesday, December 8, 2009)]
[Notices]
[Page 64702]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29211]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Anesthetic and Life Support Drugs 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: Anesthetic and Life Support 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 January 28, 2010, from 8
a.m. to 4:30 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD. The hotel telephone number is 301-
977-8900.
Contact Person: Kalyani Bhatt, 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,
301-827-7001, FAX: 301-827-6776, e-mail: Kalyani.Bhatt@fda.hhs.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in Washington, DC area), code 3014512529. 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 hotline/phone line to learn about possible
modifications before coming to the meeting.
Agenda: On January 28, 2010, the committee will discuss the
available safety and efficacy data for new drug application (NDA)
22516, CYMBALTA (duloxetine HCL) Capsules, by Eli Lilly and Co., as
they relate to the proposed indication of treatment of chronic pain.
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
January 13, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 1:30 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 January 5, 2010. 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 January 6, 2010.
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 Kalyani Bhatt 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 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29211 Filed 12-7-09; 8:45 am]
BILLING CODE 4160-01-S
