National Institute of Mental Health;, 20964-20965 [E9-10430]
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Federal Register / Vol. 74, No. 86 / Wednesday, May 6, 2009 / Notices
with a ‘‘vCJD-implicated’’ plasmaderived coagulation factor VIII (pdFVIII)
and whether this information or any
other recent scientific information about
the vCJD epidemic substantially alters
FDA’s risk assessment for U.S.-licensed
preparations of pdFVIII products. In the
afternoon the committee will hear
informational presentations on animal
models of vCJD, diagnostic test
development for transmissible
spongiform encephalopathies (TSEs)
and bovine spongiform encephalopathy
(BSE) surveillance and risk
management.
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 will
be 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 June 4, 2009. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. and 11:15 a.m. and between 5:00
p.m. and 5:30 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 26, 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 28, 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
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18:36 May 05, 2009
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a disability, please contact William
Freas or Rosanna Harvey 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 28, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–10454 Filed 5–5–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Research
Resources; Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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 Center for
Research Resources Special Emphasis Panel.
RCMI 1.
Date: June 10–11, 2009.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892. (Telephone
Conference Call).
Contact Person: Steven Birken, PhD,
Scientific Revew Officer, Office of Review,
National Center for Research Resources,
National Institutes of Health, 6701
Democracy Blvd., Dem. 1, Room 1078, MSC
4874, Bethesda, MD 20892–4874. 301–435–
0815. birkens@mail.nih.gov.
Name of Committee: National Center for
Research Resources Special Emphasis Panel.
Comparative Medicine.
Date: July 9, 2009.
Time: 11 a.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892. (Telephone
Conference Call).
Contact Person: Guo Zhang, MD, PhD,
Scientific Review Officer, Office of Review,
National Center for Research Resources,
National Institutes of Health, 6701
Democracy Blvd., 1 Democracy Plaza, Rm.
1064, Bethesda, MD 20892–4874. 301–435–
0812. zhanggu@mail.nih.gov.
Name of Committee: National Center for
Research Resources Special Emphasis Panel.
Pre-application for a Biomedical Technology
Research Resource.
Date: July 20, 2009.
Time: 8 a.m. to 11 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892. (Virtual
Meeting).
Contact Person: Martha F. Matocha, PhD,
Scientific Review Officer, Office of Review,
National Center for Research Resources,
National Institutes of Health, 6701
Democracy Blvd., 1 Democracy Plaza, Rm.
1070, Bethesda, MD 20892. 301–435–0810.
matocham@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.371, Biomedical
Technology; 93.389, Research Infrastructure,
93.306, 93.333, National Institutes of Health,
HHS)
Dated: April 29, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–10444 Filed 5–5–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
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 following 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel. SBIR
Contract Review.
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Federal Register / Vol. 74, No. 86 / Wednesday, May 6, 2009 / Notices
Date: May 20, 2009.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852. (Telephone
Conference Call).
Contact Person: Aileen Schulte, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd, Room 6140, MSC 9608,
Bethesda, MD 20892–9608. 301–443–1225.
aschulte@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: April 29, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–10430 Filed 5–5–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0197]
Psychopharmacologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on PROD1PC66 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:
Psychopharmacologic 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 9, 2009 from 8 a.m. to 6
p.m. and June 10, 2009, from 8 a.m. to
5 p.m.
Addresses: Electronic comments
should be submitted to https://
www.regulations.gov. Enter ‘‘FDA–
2009–N–0197 Use of Antipsychotics for
Schizophrenia and Bipolar Disorder in
Pediatric and Adolescent Patients’’ 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.
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1061, Rockville, MD 20852. All
comments received will be posted
without change, including any personal
information provided. Comments
received on or before May 26, 2009, will
be provided to the committee before the
meeting.
Location: Marriott Conference
Centers, UMUC Inn and Conference
Center, 3501 University Blvd. East,
Adelphi, MD. The hotel telephone
number is 301–985–7385.
Contact Person: Diem-Kieu Ngo,
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:
diem.ngo@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512544. 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 both days, the committee
will discuss safety and efficacy issues
for the following new drug applications
(NDAs): (1) NDA 20–639/S–045 and S–
046: SEROQUEL (quetiapine fumarate)
Tablets, AstraZeneca Pharmaceuticals
LP, for the acute treatment of
schizophrenia in adolescents from 13 to
17 years of age, and the acute treatment
of bipolar mania in children from 10 to
12 years of age and adolescents from 13
to 17 years of age; (2) NDA 20–825/S–
032: GEODON (ziprasidone
hydrochloride) Capsules, Pfizer Inc., for
the acute treatment of manic or mixed
episodes associated with bipolar
disorder, with or without psychotic
features in children and adolescents
ages from 10 to 17 years of age; and (3)
NDA 20–592/S–040 and S–041:
ZYPREXA (olanzapine) Tablets, Eli Lilly
and Co., for the acute treatment of
manic or mixed episodes associated
with bipolar I disorder and the acute
treatment of schizophrenia in
adolescents. The committee will be
asked to vote on whether or not these
products have been shown to be
effective and acceptably safe for these
pediatric indications.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
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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 26, 2009. Oral
presentations from the public will be
scheduled between approximately 4
p.m. and 6 p.m. on June 9, 2009. 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 22,
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 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 Diem-Kieu
Ngo 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).
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Agencies
[Federal Register Volume 74, Number 86 (Wednesday, May 6, 2009)]
[Notices]
[Pages 20964-20965]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-10430]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
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 following
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 contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Mental Health Special
Emphasis Panel. SBIR Contract Review.
[[Page 20965]]
Date: May 20, 2009.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852. (Telephone Conference
Call).
Contact Person: Aileen Schulte, PhD, Scientific Review Officer,
Division of Extramural Activities, National Institute of Mental
Health, NIH, Neuroscience Center, 6001 Executive Blvd, Room 6140,
MSC 9608, Bethesda, MD 20892-9608. 301-443-1225.
aschulte@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.242,
Mental Health Research Grants; 93.281, Scientist Development Award,
Scientist Development Award for Clinicians, and Research Scientist
Award; 93.282, Mental Health National Research Service Awards for
Research Training, National Institutes of Health, HHS)
Dated: April 29, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E9-10430 Filed 5-5-09; 8:45 am]
BILLING CODE 4140-01-P