Anti-Infective Drugs Advisory Committee; Notice of Meeting, 39032 [2010-16591]
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39032
Federal Register / Vol. 75, No. 129 / Wednesday, July 7, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES≤
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Anti-Infective Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on DSK8KYBLC1PROD 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: Anti-Infective
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 September 7, 2010, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD. The
hotel phone number is 301–977–8900.
Contact Person: Minh Doan, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., WO31–2417, Silver
Spring, MD 20993–0002, 301–796–9001,
FAX: 301–847–8533, e-mail:
minh.doan@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512530. 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 September 7, 2010, the
committee will discuss new drug
application (NDA) 20–0327, for
ceftaroline fosamil for injection,
submitted by Cerexa, Inc., and the
requested indications of: (1) Treatment
of adults with community acquired
bacterial pneumonia (CABP); and (2)
complicated skin and skin structure
infections (cSSSI). The morning session
will be devoted to discussing the CABP
indication, and the afternoon session to
discussing the cSSSI indication.
FDA intends to make background
material available to the public no later
VerDate Mar<15>2010
15:28 Jul 06, 2010
Jkt 220001
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 August 23, 2010.
Oral presentations from the public will
be scheduled between approximately 11
a.m. to 11:30 a.m. and 3:30 p.m. to 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 August
13, 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 August 16, 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 Minh Doan
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/AboutAdvisory
Committees/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).
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Dated: July 1, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–16591 Filed 7–6–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES≤
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
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 August 19, 2010, from 8 a.m. to
4:30 p.m.
Location: Bethesda Marriott, The
Ballrooms, 5151 Pooks Hill Rd.,
Bethesda, MD. The hotel telephone
number is 301–897–9400.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, e-mail:
kalyani.bhatt@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
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 hot line/phone line to learn
about possible modifications before
coming to the meeting.
Agenda: On August 19, 2010, the
committee will discuss the available
safety and efficacy data for new drug
application (NDA) 22–516, CYMBALTA
(duloxetine HCL) Capsules, by Eli Lilly
E:\FR\FM\07JYN1.SGM
07JYN1
]]>Agencies
[Federal Register Volume 75, Number 129 (Wednesday, July 7, 2010)]
[Notices]
[Page 39032]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-16591]
[[Page 39032]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES>
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Anti-Infective 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: Anti-Infective 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 September 7, 2010, from
8 a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD. The hotel phone number is 301-977-
8900.
Contact Person: Minh Doan, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., WO31-2417,
Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-8533, e-mail:
minh.doan@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512530. 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 September 7, 2010, the committee will discuss new drug
application (NDA) 20-0327, for ceftaroline fosamil for injection,
submitted by Cerexa, Inc., and the requested indications of: (1)
Treatment of adults with community acquired bacterial pneumonia (CABP);
and (2) complicated skin and skin structure infections (cSSSI). The
morning session will be devoted to discussing the CABP indication, and
the afternoon session to discussing the cSSSI indication.
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
August 23, 2010. Oral presentations from the public will be scheduled
between approximately 11 a.m. to 11:30 a.m. and 3:30 p.m. to 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 August 13, 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 August 16, 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 Minh Doan 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: July 1, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-16591 Filed 7-6-10; 8:45 am]
BILLING CODE 4160-01-S
