Anti-Infective Drugs Advisory Committee; Notice of Meeting, 49880 [E9-23437]
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49880
Federal Register / Vol. 74, No. 187 / Tuesday, September 29, 2009 / Notices
MSC 7890, Bethesda, MD 20892, 301–435–
2514, stassid@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: September 21, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–23240 Filed 9–28–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0443]
Anti-Infective Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
jlentini on DSKJ8SOYB1PROD with NOTICES
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 October 26, 2009, from 8:30 a.m. to 4 p.m.
Addresses: Electronic comments should be
submitted to https://www.regulations.gov.
Enter ‘‘FDA–2009–N–0443’’ and follow the
prompts to submit your statement. Written
comments should be submitted to the
Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. All
comments received will be posted without
change, including any personal information
provided. Comments received on or before
October 5, 2009, will be provided to the
committee before the meeting.
Location: Hilton Washington DC/Silver
Spring, The Ballrooms, 8727 Colesville Rd.,
Silver Spring, MD. The hotel phone number
is 301–589–5200.
Contact Person: Minh Doan, 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:
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
VerDate Nov<24>2008
16:18 Sep 28, 2009
Jkt 217001
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
updating susceptibility test information in
systemic antibacterial drug product labeling.
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
October 16, 2009. Oral presentations from the
public will be scheduled between
approximately 12:45 p.m. and 1:45 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
October 9, 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 October 12, 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 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).
Dated: 9/23/09.
David Horowitz,
Assistant Commissioner for Policy
[FR Doc. E9–23437 Filed 9–28–09; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Blood Products 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). At least one portion of the
meeting will be closed to the public.
Name of Committee: Blood Products
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 November 16, 2009, from 8 a.m. to 5:30
p.m. and on November 17, 2009, from 8 a.m.
to 5 p.m.
Location: Bethesda Marriott Hotel, 5151
Pooks Hill Rd., Bethesda, MD 20814.
Contact Person: William Freas or Pearline
K. Muckelvene, Center for Biologics
Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike
(HFM–71), Rockville, MD 20852, 301–827–
0314, or FDA Advisory Committee
Information Line, 1–800–741–8138 (301–
443–0572 in the Washington, DC area), code
3014519516. 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 November 16, 2009, in the
morning the Committee will hear updates on
the following topics: the HHS Advisory
Committee on Blood Safety and Availability,
Dengue virus outbreak, and 2009 A/H1N1
Pandemic and the impact on blood safety and
availability. The Committee will then discuss
blood donor deferral for malaria risk
associated with travel to Mexico. In the
afternoon the Committee will discuss the
design of a new phase III study of pathogen
inactivation of human platelets using the
Cerus, INTERCEPT Blood System. On
November 17, 2009, in the morning the
Committee will discuss blood pressure and
pulse as blood donor eligibility criteria, and
in the afternoon the committee will discuss
the public health need and performance
characteristics of over-the-counter home-use
HIV test kits.
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
E:\FR\FM\29SEN1.SGM
29SEN1
]]>Agencies
[Federal Register Volume 74, Number 187 (Tuesday, September 29, 2009)]
[Notices]
[Page 49880]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23437]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0443]
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 October 26, 2009,
from 8:30 a.m. to 4 p.m.
Addresses: Electronic comments should be submitted to https://www.regulations.gov. Enter ``FDA-2009-N-0443'' and follow the
prompts to submit your statement. Written comments should be
submitted to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. All comments received will be posted without change,
including any personal information provided. Comments received on or
before October 5, 2009, will be provided to the committee before the
meeting.
Location: Hilton Washington DC/Silver Spring, The Ballrooms,
8727 Colesville Rd., Silver Spring, MD. The hotel phone number is
301-589-5200.
Contact Person: Minh Doan, 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:
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: The committee will discuss updating susceptibility test
information in systemic antibacterial drug product labeling.
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
October 16, 2009. Oral presentations from the public will be
scheduled between approximately 12:45 p.m. and 1:45 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 October 9, 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 October 12,
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 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: 9/23/09.
David Horowitz,
Assistant Commissioner for Policy
[FR Doc. E9-23437 Filed 9-28-09; 8:45 am]
BILLING CODE 4160-01-S
