Anti-Infective Drugs Advisory Committee; Notice of Meeting, 10746-10747 [E9-5288]
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cprice-sewell on PRODPC61 with NOTICES
10746
Federal Register / Vol. 74, No. 47 / Thursday, March 12, 2009 / Notices
Agenda: The committee will discuss
issues related to the development of
drugs for the treatment of tuberculosis,
including drug resistant tuberculosis.
Areas of discussion include diagnosis,
treatment duration, study design (such
as endpoints and duration of followup)
and safety issues.
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2009 and 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 May 18, 2009. Oral
presentations from the public will be
scheduled between approximately 11:30
a.m. and 12:30 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 May 8, 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 May 11, 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 Janie Kim 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/oc/advisory/
default.htm for procedures on public
VerDate Nov<24>2008
14:56 Mar 11, 2009
Jkt 217001
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C.app. 2).
Dated: March 3, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–5285 Filed 3–11–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
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 June 2, 2009, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
hotel telephone number is 301–589–
5200.
Contact Person: Janie Kim, 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:
Janie.kim@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 upto-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.
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Agenda: The committee will discuss
new drug application (NDA) 22–398,
cethromycin oral tablets, sponsored by
Advanced Life Sciences, for the
proposed indication of outpatient
treatment of adults with mild to
moderate community-acquired
pneumonia.
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2009 and 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 May 18, 2009. Oral
presentations from the public will be
scheduled between approximately 11:30
a.m. and 12:30 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 May 8, 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 May 11, 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 Janie Kim 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/oc/advisory/
default.htm for procedures on public
E:\FR\FM\12MRN1.SGM
12MRN1
Federal Register / Vol. 74, No. 47 / Thursday, March 12, 2009 / Notices
conduct during advisory committee
meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 3, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–5288 Filed 3–11–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Ophthalmic Devices Panel of the
Medical Devices Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on PRODPC61 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: 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 27, 2009, from 8 a.m. to
5 p.m.
Location: Hilton Washington DC
North/Gaithersburg, Salons A, B, and C,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: James Swink, Center
for Devices and Radiological Health
(HFZ–450), Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 240–276–4050, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area), code
3014512396. 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: The committee will discuss,
make recommendations, and vote on a
premarket approval application,
VerDate Nov<24>2008
14:56 Mar 11, 2009
Jkt 217001
sponsored by VisionCare Technologies,
Inc., for an implantable miniature
telescope (IMTTM). The IMTTM is
indicated for monocular implant in
patients greater than 65 years of age
with stable moderate to profound
central vision impairment, i.e., distance
BCVA of 20/80 to 20/800, due to
bilateral central scotomas associated
with end-stage macular degeneration,
defined as retinal findings of geographic
atrophy or disciform scar, with foveal
involvement as determined by
fluorescein angiography and evidence of
cataract.
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/ohrms/
dockets/ac/acmenu.htm, click on the
year 2009 and 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 March 20, 2009.
Oral presentations from the public will
be scheduled between approximately
9:30 a.m. and 10 a.m., and between
approximately 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 March
18, 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 March 19, 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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
10747
require special accommodations due to
a disability, please contact AnnMarie
Williams, Conference Management staff,
at 240–276–8932, 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/oc/advisory/
default.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: March 3, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–5303 Filed 3–11–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request
In compliance with the requirement
for opportunity for public comment on
proposed data collection projects
(section 3506(c)(2)(A) of Title 44, United
States Code, as amended by the
Paperwork Reduction Act of 1995, Pub.
L. 104–13), the Health Resources and
Services Administration (HRSA)
publishes periodic summaries of
proposed projects being developed for
submission to the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and draft instruments, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Officer on (301) 443–
1129.
Comments are invited on: (a) The
proposed collection of information for
the proper performance of the functions
of the agency; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology.
E:\FR\FM\12MRN1.SGM
12MRN1
]]>Agencies
[Federal Register Volume 74, Number 47 (Thursday, March 12, 2009)]
[Notices]
[Pages 10746-10747]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5288]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
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 June 2, 2009, from 8
a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel telephone number is 301-
589-5200.
Contact Person: Janie Kim, 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: Janie.kim@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: The committee will discuss new drug application (NDA) 22-
398, cethromycin oral tablets, sponsored by Advanced Life Sciences, for
the proposed indication of outpatient treatment of adults with mild to
moderate community-acquired pneumonia.
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/ohrms/dockets/ac/acmenu.htm, click on
the year 2009 and 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 May
18, 2009. Oral presentations from the public will be scheduled between
approximately 11:30 a.m. and 12:30 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 May 8, 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 May 11,
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 Janie Kim 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/oc/advisory/
default.htm for procedures on public
[[Page 10747]]
conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 3, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-5288 Filed 3-11-09; 8:45 am]
BILLING CODE 4160-01-S
