Allergenic Products Advisory Committee; Notice of Meeting, 8093-8094 [E9-3786]
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8093
Federal Register / Vol. 74, No. 34 / Monday, February 23, 2009 / Notices
(1) describes the requirements for States
under the reauthorization of the Court
Improvement Program; (2) outlines the
programmatic and fiscal provisions and
reporting requirements of the program;
(3) specifies the application submittal
and approval procedures for the
program for Fiscal Years 2007 through
2011; and (4) identifies technical
resources for use by State courts during
the course of the program. This Program
Instruction contains information
collection requirements pursuant to
receiving a grant award that are found
in Public Law 103–66, as amended by
Public Law 105–89, Public Law 107–
133, Public Law 109–239, and Public
Law 109–288. The agency will use the
information received to ensure
compliance with the statute and provide
training and technical assistance to the
grantees.
Respondents: State Courts.
ANNUAL BURDEN ESTIMATES
Application .......................................................................................
Annual program report .....................................................................
Estimated Total Annual Burden
Hours: 3,952
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Administration, Office of Information
Services, 370 L’Enfant Promenade, SW.,
Washington, DC 20447, Attn: ACF
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. E-mail address:
infocollection@acf.hhs.gov.
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Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: February 18, 2009.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E9–3760 Filed 2–20–09; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jlentini on PROD1PC65 with NOTICES
[Docket No. FDA–2009–N–0664]
Allergenic Products Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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16:31 Feb 20, 2009
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Number of
responses per
respondent
Number of
respondents
Instrument
52
52
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: Allergenic
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 March 18, 2009, from 8 a.m. to
approximately 12:30 p.m.
Location: Food and Drug
Administration, Center for Drug
Evaluation and Research, Advisory
Committee Conference Room, rm. 1066,
5630 Fishers Lane, Rockville, MD.
Contact Person: Gail Dapolito or Jane
Brown, Food and Drug Administration
(HFM–71), 1401 Rockville Pike,
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
3014512388. 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 March 18, 2009, the
committee will discuss (1) a proposed
change of potency assay for short
ragweed pollen and cat allergen extracts
from radial immunodiffusion assay to
an enzyme-linked immunosorbent assay
and (2) structured product labeling. The
committee will also receive an update
on research programs in the Laboratory
of Immunobiochemistry, Division of
Bacterial, Parasitic and Allergenic
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Average burden
hours per
response
1
1
40
36
Total burden
hours
2,080
1,872
Products, Office of Vaccines Research
and Review, Center for Biologics
Evaluation and Research, FDA.
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 11, 2009.
Oral presentations from the public will
be scheduled between approximately
10:45 a.m. and 11:45 a.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 March 3,
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 March 4, 2009.
Persons attending FDA’s advisory
committee meetings are advised that the
E:\FR\FM\23FEN1.SGM
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8094
Federal Register / Vol. 74, No. 34 / Monday, February 23, 2009 / Notices
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 Gail Dapolito
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 12, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–3786 Filed 2–20–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY: National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of federally
funded research and development.
Foreign patent applications are filed on
selected inventions to extend market
coverage for companies and may also be
available for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Quantitative Real-Time RT–PCR Array
for Detection of Human Herpesvirus 6A
Gene Expression
Description of Technology: This
invention describes an RT–PCR array
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16:31 Feb 20, 2009
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that allows for the simultaneous
transcriptional profiling of the human
herpesvirus HHV6A genome. It may be
used to determine the contribution of
HHV6A to the development of
lymphomas, other types of cancer or
diseases where an infectious agent is
suspected. Primer pairs are designed to
amplify under identical reaction
conditions and are rigorously tested to
ensure specificity for the HHV6A ORFs
to the exclusion of all other human
herpesviruses including HHV6B and
HHV7.
Recent findings of the association of
active viral genes with cancer cells have
led to new proposed targets for cancer
vaccines and therapeutics. The ability to
distinguish HHV6A from other related
herpesviruses, and to independently
assay viral gene activity, may lead to the
identification of new viral targets for the
treatment of cancers and other diseases
where HHV6A transcription is active.
Applications:
• Analysis of whole HHV6A genome
expression.
• Identification of HHV6A gene
expression and its association with
disease states.
Development Status: Late stage.
Inventors: Rachel K. Bagni (NCI/
SAIC), Francis W. Ruscetti (NCI), et al.
Patent Status: U.S. Provisional
Application No. 61/114,753 filed 14
Nov 2008 (HHS Reference No. E–019–
2009/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jeffrey A. James,
PhD; 301–435–5474;
jeffreyja@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Advanced Technology Program, is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
virus specific quantitative real-time RT–
PCR arrays. Please contact John D.
Hewes, PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
In Vivo Quantitative Tissue Oxygen
Imaging Using Pulsed Time-Domain
Electron Paramagnetic Resonance—
Echo-Based Single Point Imaging (ESPI)
Description of Technology: Available
for licensing and commercial
development are patent rights covering
an EPR image formation strategy for in
vivo imaging of physiological function.
It emphasizes image resolution and
quantitative assessment of in vivo tissue
oxygen that are important in planning
radiation and chemotherapeutic
treatments for patients with cancers.
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The method pertains exclusively to
time-domain Fourier Transform EPR
imaging (FT–EPRT) with emphasis on
spatial and temporal resolution, since
physiological processes are generally
rapid and require accurate and rapid
time-course information.
Two most important existing methods
are Spin Echo Fourier (SEF) and Single
Point Imaging (SPI). ESPI (Echo-based
Single Point Imaging) enables the
combination of the advantages of the
quantitative T2 contrast of SEF strategy
and the super high resolution of the SPI
methodology, leading to reliable EPR
imaging for tissue physiological
function in vivo.
Applications:
• EPR (Electron Paramagnetic
Resonance).
• In vivo imaging.
• Tissue oxygen.
Inventors: Sankaran Subramanian,
Nallathamby Devasahayam, Shingo
Matsumoto, James Mitchell, Murali
Cheruki, John Cook (NCI).
Patent Status: U.S. Provisional
Application No. 61/200,579 filed 29
Nov 2008 (HHS Reference No. E–250–
2008/0–US–01), entitled ‘‘Pulsed TimeDomain Electron Paramagnetic
Resonance In Vivo Tissue Oxygen
Imaging Via Cooperative ESE/ESPI’’.
Licensing Status: Available for
licensing.
Licensing Contact: Michael A.
Shmilovich, Esq.; 301–435–5019;
shmilovm@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute Radiation
Biology Branch is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize Echo-based Single Point
Imaging. Please contact John D. Hewes,
PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Microwave-Assisted Freeze
Substitution of Biological and
Biomedical Samples (MWFS)
Description of Technology: Freeze
substitution fixation (FS) of hydrated
samples frozen in vitreous ice provides
exceptional preservation of structure for
light and electron microscopy, and
enables immunological detection of
thermo-labile antigens that otherwise
are damaged/destroyed by processing at
ambient or elevated temperatures. Its
use as a research tool or in clinical
pathology has, however, been limited by
the relatively lengthy periods required
for passive diffusion of fixatives and
organic solvents into the frozen
hydrated material.
E:\FR\FM\23FEN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 34 (Monday, February 23, 2009)]
[Notices]
[Pages 8093-8094]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-3786]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Allergenic 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). The meeting will
be open to the public.
Name of Committee: Allergenic 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 March 18, 2009, from 8
a.m. to approximately 12:30 p.m.
Location: Food and Drug Administration, Center for Drug Evaluation
and Research, Advisory Committee Conference Room, rm. 1066, 5630
Fishers Lane, Rockville, MD.
Contact Person: Gail Dapolito or Jane Brown, Food and Drug
Administration (HFM-71), 1401 Rockville Pike, 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 3014512388. 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 March 18, 2009, the committee will discuss (1) a
proposed change of potency assay for short ragweed pollen and cat
allergen extracts from radial immunodiffusion assay to an enzyme-linked
immunosorbent assay and (2) structured product labeling. The committee
will also receive an update on research programs in the Laboratory of
Immunobiochemistry, Division of Bacterial, Parasitic and Allergenic
Products, Office of Vaccines Research and Review, Center for Biologics
Evaluation and Research, FDA.
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 11, 2009. Oral presentations from the public will be scheduled
between approximately 10:45 a.m. and 11:45 a.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 March 3, 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 March 4, 2009.
Persons attending FDA's advisory committee meetings are advised
that the
[[Page 8094]]
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 Gail Dapolito 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 12, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-3786 Filed 2-20-09; 8:45 am]
BILLING CODE 4160-01-S
