Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting, 27809-27810 [E9-13767]
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Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Biomedical Imaging and Bioengineering
Special Grant Opportunities (RC2) ARRA.
Date: July 15–16, 2009.
Time: 7 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Hyatt Regency Hotel,
Bethesda, MD.
Contact Person: Ruth Grossman, DDS,
Scientific Review Officer, National Institute
of Biomedical Imaging and Bioengineering,
6707 Democracy Boulevard, Room 960,
Bethesda, MD 20892. 301–496–8775.
grossmanrs@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.701, ARRA Related
Biomedical Research and Research Support
Awards., National Institutes of Health, HHS)
Dated: June 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–13677 Filed 6–10–09; 8:45 am]
(Catalogue of Federal Domestic Assistance
Program Nos. 93.701, ARRA Related
Biomedical Research and Research Support
Awards, National Institutes of Health, HHS)
Dated: June 4, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–13668 Filed 6–10–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Peripheral and Central Nervous
System Drugs Advisory Committee;
Notice of Meeting
AGENCY:
ACTION:
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Biomedical
Imaging and Bioengineering; Notice of
Closed Meeting
jlentini on PROD1PC65 with NOTICES
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 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
Biomedical Imaging and Bioengineering
Special ARRA Revisions Competing
Supplements.
Date: July 16, 2009.
Time: 12:30 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Biomedical
Imaging and Bioengineering, 6707
Democracy Boulevard, Suite 920, Bethesda,
MD 20892 (Telephone Conference Call).
Contact Person: John K. Hayes, PhD,
Scientific Review Officer, 6707 Democracy
Boulevard, Suite 959, Bethesda, MD 20892,
301–451–3398, hayesj@mail.nih.gov.
VerDate Nov<24>2008
16:37 Jun 10, 2009
Jkt 217001
Food and Drug Administration,
HHS.
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: Peripheral and
Central Nervous System 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 August 11, 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: 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
3014512543. 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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
27809
about possible modifications before
coming to the meeting.
Agenda: The committee will discuss a
new drug application (NDA) for a
radiopharmaceutical proposed for a
special type of brain imaging in patients
with movement disorders. NDA 22–454,
Ioflupane I 123 Injection (proposed
trade name DaTSCAN), GE HealthCare,
is proposed for detecting loss of
functional nigrostriatal dopaminergic
neurons by single photon emission
computed tomography (SPECT) imaging
in patients presenting with symptoms or
signs of dopaminergic
neurodegeneration.
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 July 28, 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 July 20, 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 July 21, 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
E:\FR\FM\11JNN1.SGM
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27810
Federal Register / Vol. 74, No. 111 / Thursday, June 11, 2009 / Notices
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).
Dated: May 29, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–13767 Filed 6–10–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Forms I–600/I–600A,
Extension of a Currently Approved
Information Collection; Comment
Request
jlentini on PROD1PC65 with NOTICES
ACTION: 60-Day Notice of Information
Collection Under Review: Forms I–600/
I–600A, Petition To Classify Orphan as
an Immediate Relative and Application
for Advance Processing of Orphan
Petition; OMB Control No. 1615–0028.
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services has submitted the
following information collection request
for review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection is
published to obtain comments from the
public and affected agencies. Comments
are encouraged and will be accepted for
60 days until August 10, 2009.
During this 60-day period USCIS will
be evaluating whether to revise the
Form I–600/I–600A. Should USCIS
decide to revise the Form I–600/I–600A
it will advise the public when it
publishes the 30-day notice in the
Federal Register in accordance with the
Paperwork Reduction Act. The public
will then have 30 days to comment on
any revisions to the Form I–600/I–600A.
Written comments and suggestions
regarding items contained in this notice,
and especially with regard to the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), USCIS, Chief, Regulatory
Products Division, Clearance Office, 111
Massachusetts Avenue, NW.,
VerDate Nov<24>2008
16:37 Jun 10, 2009
Jkt 217001
Washington, DC 20529–2210.
Comments may also be submitted to
DHS via facsimile to 202–272–8352, or
via e-mail at rfs.regs@dhs.gov. When
submitting comments by e-mail please
add the OMB Control Number 1615–
0028 in the subject box.
Written comments and suggestions
from the public and affected agencies
concerning the collection of information
should address one or more of the
following four points:
(1) Evaluate whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
collection of information, including the
validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques, or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Overview of This information
collection:
(1) Type of Information Collection:
Extension of an existing information
collection.
(2) Title of the Form/Collection:
Petition To Classify Orphan as an
Immediate Relative and Application for
Advance Processing of Orphan Petition
(3) Agency form number, if any, and
the applicable component of the
Department of Homeland Security
sponsoring the collection: Form I–600/I–
600A. U.S. Citizenship and Immigration
Services.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract: Primary: Individuals and
households. The Form I–600 is used by
the U.S. Citizenship and Immigration
Services (USCIS) to determine whether
an alien is an eligible orphan. Form I–
600A is used to streamline the
procedure for advance processing of
orphan petitions.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond: 34,000 responses at 30 minutes
(.50) per response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 17,000 annual burden hours.
If you need a copy of the information
collection instrument, please visit:
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
https://www.regulations.gov/search/
index.jsp
We may also be contacted at: USCIS,
Regulatory Products Division, 111
Massachusetts Avenue, NW.,
Washington, DC 20529–2210, telephone
number 202–272–8377.
Dated: June 8, 2009
Stephen Tarragon,
Deputy Chief, Regulatory Products Division,
U.S. Citizenship and Immigration Services,
Department of Homeland Security.
[FR Doc. E9–13752 Filed 6–10–09; 8:45 am]
BILLING CODE9111–97–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Citizenship and Immigration
Services
Agency Information Collection
Activities: Form N–600K, Extension of
a Currently Approved Information
Collection; Comment Request
ACTION: 60-Day Notice of Information
Collection Under Review: Form N–
600K, Application for Citizenship and
Issuance of Certificate Under Section
322. OMB Control Number 1615–0087.
The Department of Homeland
Security, U.S. Citizenship and
Immigration Services has submitted the
following information collection request
for review and clearance in accordance
with the Paperwork Reduction Act of
1995. The information collection is
published to obtain comments from the
public and affected agencies. Comments
are encouraged and will be accepted for
60 days until August 10, 2009.
During this 60-day period USCIS will
be evaluating whether to revise the
Form N–600K. Should USCIS decide to
revise the Form N–600K it will advise
the public when it publishes the 30-day
notice in the Federal Register in
accordance with the Paperwork
Reduction Act. The public will then
have 30 days to comment on any
revisions to the Form N–600K.
Written comments and suggestions
regarding items contained in this notice,
and especially with regard to the
estimated public burden and associated
response time, should be directed to the
Department of Homeland Security
(DHS), USCIS, Chief, Regulatory
Products Division, Clearance Office, 111
Massachusetts Avenue, NW.,
Washington, DC 20529–2210.
Comments may also be submitted to
DHS via facsimile to 202–272–8352, or
via e-mail at rfs.regs@dhs.gov. When
submitting comments by e-mail please
E:\FR\FM\11JNN1.SGM
11JNN1
Agencies
[Federal Register Volume 74, Number 111 (Thursday, June 11, 2009)]
[Notices]
[Pages 27809-27810]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-13767]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Peripheral and Central Nervous System 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: Peripheral and Central Nervous System 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 August 11, 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: 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 3014512543. 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 a new drug application (NDA) for
a radiopharmaceutical proposed for a special type of brain imaging in
patients with movement disorders. NDA 22-454, Ioflupane I 123 Injection
(proposed trade name DaTSCAN), GE HealthCare, is proposed for detecting
loss of functional nigrostriatal dopaminergic neurons by single photon
emission computed tomography (SPECT) imaging in patients presenting
with symptoms or signs of dopaminergic neurodegeneration.
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 July
28, 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 July 20, 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 July 21,
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
[[Page 27810]]
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).
Dated: May 29, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-13767 Filed 6-10-09; 8:45 am]
BILLING CODE 4160-01-S