Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 19230-19231 [E9-9642]
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Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Complementary &
Alternative Medicine; 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 National Advisory
Council for Complementary and
Alternative Medicine (NACCAM)
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/or contract proposals and the
discussion could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council for Complementary and Alternative
Medicine.
Date: May 5, 2009.
Closed: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: National Institutes of Health, 6707
Democracy Blvd., Suite 401, Bethesda, MD
20892 (Teleconference).
Contact Person: Martin H. Goldrosen, PhD,
Executive Secretary, Director, Division of
Extramural Activities, National Center for
Complementary and Alternative Medicine,
National Institutes of Health, 6707
Democracy Blvd., Suite 401, Bethesda, MD
20892, (301) 594–2014.
This notice is being published less than 15
days prior to the meeting due to scheduling
conflicts.
Dated: April 22, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–9681 Filed 4–27–09; 8:45 am]
hereby given of a meeting of the
National Advisory Neurological
Disorders and Stroke Council.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: National Advisory
Neurological Disorders and Stroke Council;
Basic and Preclinical Programs
Subcommittee.
Date: May 28, 2009.
Time: 8 a.m. to 10 a.m.
Agenda: To discuss basic and preclinical
programs policy.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 7, Bethesda, MD 20892.
Contact Person: Jill E. Heemskerk, PhD,
Acting Chief, Technology Development,
National Institute of Neurological Disorders
and Stroke, National Institutes of Health,
6001 Executive Boulevard, Suite 2229, MSC
9527, Bethesda, MD 20892–9527, (301) 496–
1779, jh440o@nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
www.ninds.nih.gov, where an agenda and
any additional information for the meeting
will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: April 21, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–9670 Filed 4–27–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
National Institutes of Health
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BILLING CODE 4140–01–P
Anesthesiology and Respiratory
Therapy Devices Panel of the Medical
Devices Advisory Committee; Notice of
Meeting
National Institute of Neurological
Disorders and Stroke; Notice of
Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
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[Docket No. FDA–2009–N–0664]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
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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: Anesthesiology and
Respiratory Therapy 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 May 28, 2009, from 8 a.m. to 5 p.m.
Location: Holiday Inn, Ballroom, Two
Montgomery Village Ave., Gaithersburg, MD.
Contact Person: Neel J. Patel, Center for
Devices and Radiological Health (HFZ–480),
Food and Drug Administration, 9200
Corporate Blvd., 240–276–3700, or FDA
Advisory Committee Information Line, 1–
800–741–8138 (301–443–0572 in the
Washington, DC area), code 3014512624.
Please call the Information Line for up-todate 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 for the SEDASYSTM
Computer-Assisted Personalized Sedation
System sponsored by Ethicon Endo-Surgery,
Inc. The device is indicated for the
intravenous administration of 1% (10
milligrams/milliliters) propofol injectable
emulsion for the initiation and maintenance
of minimal to moderate sedation, as
identified by the American Society of
Anesthesiologists Continuum of Depth of
Sedation, in adult patients (American Society
of Anesthesiology physical status I, II, or III)
undergoing colonoscopy and
esophagogastroduodenoscopy procedures.
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
15, 2009. Oral presentations from the public
will be scheduled for approximately 30
minutes at the beginning of the committee
deliberations and for approximately 30
minutes near the end of committee
deliberations. Those desiring to make formal
oral presentations should notify the contact
person and submit a brief statement of the
E:\FR\FM\28APN1.SGM
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Federal Register / Vol. 74, No. 80 / Tuesday, April 28, 2009 / Notices
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
6, 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 7, 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: April 22, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–9642 Filed 4–27–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Science Board to the Food and Drug
Administration; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
erowe on PROD1PC64 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: Science Board to the
Food and Drug Administration (Science
Board).
General Function of the Committee: The
Science Board provides advice primarily to
the Commissioner of Food and Drugs and
other appropriate officials on specific
complex and technical issues, as well as
emerging issues within the scientific
community in industry and academia.
Additionally, the Science Board provides
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advice to the agency on keeping pace with
technical and scientific evolutions in the
fields of regulatory science, on formulating
an appropriate research agenda, and on
upgrading its scientific and research facilities
to keep pace with these changes. It will also
provide the means for critical review of
agency sponsored intramural and extramural
scientific research programs.
Date and Time: The meeting will be held
on Monday, May 18, 2009, from 9 a.m. to 3
p.m.
Addresses: Hilton Washington DC/
Rockville Hilton, 1750 Rockville Pike,
Rockville, MD 20852.
˜
Contact Person: Carlos Pena, Office of the
Commissioner, Food and Drug
Administration (HF–33), 5600 Fishers Lane,
Rockville, MD 20857, 301–827–6687, or FDA
Advisory Committee Information Line, 1–
800–741–8138 (301–443–0572 in the
Washington, DC area), code 3014512603.
Please call the Information Line for up-todate 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 Science Board will hear about
and discuss updates from the following
subcommittees: (1) The review of each
Center’s projects within scientific priority
areas, (2) the review of research at the Center
for Veterinary Medicine, and (3) the review
of FDA’s scientific information technology
infrastructure modernization initiatives. The
Science Board will also hear updates on
rapid detection of Salmonella in foods and
the handling of biospecimens used for
genomic and proteomic analyses.
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
11, 2009. Oral presentations from the public
will be scheduled between approximately 1
p.m. and 2 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 7, 2009. Time allotted for each
presentation may be limited. If the number of
registrants requesting to speak is greater than
PO 00000
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19231
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 8, 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 Dr. Carlos
˜
Pena 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: April 22, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–9643 Filed 4–27–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Neurological Devices Panel of the
Medical Devices 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: Neurological 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 May 14, 2009, from 8 a.m. to 5 p.m.
Location: Holiday Inn, Ballroom, Two
Montgomery Village Ave., Gaithersburg, MD.
Contact Person: Peter L. Hudson, Center for
Devices and Radiological Health, (HFZ–410),
Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240–
276–3737, or FDA Advisory Committee
Information Line, 1–800–741–8138 (301–
443–0572 in the Washington, DC area), code
3014512513. Please call the Information Line
for up-to-date information on this meeting. A
E:\FR\FM\28APN1.SGM
28APN1
]]>Agencies
[Federal Register Volume 74, Number 80 (Tuesday, April 28, 2009)]
[Notices]
[Pages 19230-19231]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-9642]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Anesthesiology and Respiratory Therapy Devices Panel of the
Medical Devices 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: Anesthesiology and Respiratory Therapy
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 May 28, 2009, from 8
a.m. to 5 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Neel J. Patel, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., 240-276-3700, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512624. 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 for the SEDASYS\TM\
Computer-Assisted Personalized Sedation System sponsored by Ethicon
Endo-Surgery, Inc. The device is indicated for the intravenous
administration of 1% (10 milligrams/milliliters) propofol injectable
emulsion for the initiation and maintenance of minimal to moderate
sedation, as identified by the American Society of Anesthesiologists
Continuum of Depth of Sedation, in adult patients (American Society
of Anesthesiology physical status I, II, or III) undergoing
colonoscopy and esophagogastroduodenoscopy procedures.
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 15, 2009. Oral presentations from the public will be scheduled
for approximately 30 minutes at the beginning of the committee
deliberations and for approximately 30 minutes near the end of
committee deliberations. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the
[[Page 19231]]
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 6, 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 7, 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: April 22, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-9642 Filed 4-27-09; 8:45 am]
BILLING CODE 4160-01-S
