National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 7697 [E9-3437]
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Federal Register / Vol. 74, No. 32 / Thursday, February 19, 2009 / Notices
about possible modifications before
coming to the meeting.
Agenda: The committee will discuss,
make recommendations, and vote on a
premarket approval application,
sponsored by TherOx, Inc., for the
TherOx Aqueous Oxygen System (AO
System). The system is intended for use
in acute myocardial infarction (AMI)
patients, who have undergone
successful revascularization less than or
equal to 6 hours from symptom onset.
These patients were randomized to AO
Therapy or not. The endpoint is
reduction in the final size of the infarct.
The system draws blood from the
patient, hyperoxygenates it with the AO
cartridge component of the system, and
reinfuses the blood via the infusion
catheter directly to the infarction site of
the heart. This therapy is intended to be
performed for 90 minutes post
percutaneous coronary intervention/
stenting.
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 4, 2009. Oral
presentations from the public will be
scheduled approximately 30 minutes at
the beginning of committee
deliberations and approximately 30
minutes near the end of the
deliberations. 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 February 25, 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
VerDate Nov<24>2008
17:38 Feb 18, 2009
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regarding their request to speak by
February 26, 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, 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: February 10, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–3488 Filed 2–18–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings 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.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, Sexually Transmitted
Infections Cooperative Research Centers.
Date: March 3–5, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Crowne Plaza Hotel, 8777
Georgia Avenue, Silver Spring, MD 20910.
PO 00000
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7697
Contact Person: Michelle M. Timmerman,
PhD, Scientific Review Officer, Scientific
Review Program, NIH/NIAID/DHHS, Room
3147, 6700B Rockledge Drive, MSC–7616,
Bethesda, MD 20892–7616, 301–451–4573,
timmermanm@niaid.nih.gov.
NAME OF COMMITTEE: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, Review of Unsolicited P01
Application.
Date: March 10, 2009.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Eleazar Cohen, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, Room 3129, 6700B
Rockledge Drive, Bethesda, MD 20892, (301)
435–3564, ec17w@nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, Review of Unsolicited P01
Application.
Date: March 12, 2009.
Time: 11 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817
(Telephone Conference Call).
Contact Person: Eleazar Cohen, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, Room 3129, 6700B
Rockledge Drive, Bethesda, MD 20892, (301)
435–3564, ec17w@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: February 11, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–3437 Filed 2–18–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Center for Substance Abuse
Treatment; Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given of the meeting of
the Center for Substance Abuse
Treatment (CSAT) National Advisory
Council on March 19, 2009.
The meeting is open to the public and
will include discussion of the Center’s
policy issues, and current
administrative, legislative, and program
developments.
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[Federal Register Volume 74, Number 32 (Thursday, February 19, 2009)]
[Notices]
[Page 7697]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3437]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of
Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of the following
meetings.
The meetings 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.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel, Sexually Transmitted Infections
Cooperative Research Centers.
Date: March 3-5, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: The Crowne Plaza Hotel, 8777 Georgia Avenue, Silver
Spring, MD 20910.
Contact Person: Michelle M. Timmerman, PhD, Scientific Review
Officer, Scientific Review Program, NIH/NIAID/DHHS, Room 3147, 6700B
Rockledge Drive, MSC-7616, Bethesda, MD 20892-7616, 301-451-4573,
timmermanm@niaid.nih.gov.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel, Review of Unsolicited P01
Application.
Date: March 10, 2009.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6700B Rockledge Drive,
Bethesda, MD 20817 (Telephone Conference Call).
Contact Person: Eleazar Cohen, PhD, Scientific Review Officer,
Scientific Review Program, Division of Extramural Activities, NIAID/
NIH/DHHS, Room 3129, 6700B Rockledge Drive, Bethesda, MD 20892,
(301) 435-3564, ec17w@nih.gov.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel, Review of Unsolicited P01
Application.
Date: March 12, 2009.
Time: 11 a.m. to 2:30 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6700B Rockledge Drive,
Bethesda, MD 20817 (Telephone Conference Call).
Contact Person: Eleazar Cohen, PhD, Scientific Review Officer,
Scientific Review Program, Division of Extramural Activities, NIAID/
NIH/DHHS, Room 3129, 6700B Rockledge Drive, Bethesda, MD 20892,
(301) 435-3564, ec17w@nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: February 11, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-3437 Filed 2-18-09; 8:45 am]
BILLING CODE 4140-01-P
