Proposed Collection; Comment Request; California Health Interview Survey Cancer Control Module (CHIS-CCM) 2009 (NCI), 49685-49686 [E8-19453]
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Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices
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Dated: August 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–19490 Filed 8–21–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: August 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–19491 Filed 8–21–08; 8:45 am]
Food and Drug Administration
[Docket No. FDA–2008–N–0447]
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Achieving a Future Vision at the 2008
Parenteral Drug Association and the
Food and Drug Administration Joint
Regulatory Conference
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration,
HHS.
ACTION:
Date and Time: The meeting will be
held on September 8 through 12, 2008,
7 a.m. to 6.
Location: The meeting will be held at
Renaissance Hotel, 999 9th St., NW.,
Washington, DC 20001.
Contact: Wanda Neal-Ballard,
Parenteral Drug Association, PDA
Global Headquarters, Bethesda Towers,
4350 East West Hwy., Suite 200,
Bethesda, MD 20814 or by telephone on
301–986–0293, ext. 111.
Registration and Meeting Information:
See PDA Web site, www.pda.org/
pdafda2008 or contact Wanda NealBallard on 301–986–0293, ext. 111.
From now until August 25, 2008,
registration fees are as follows:
$1,600.00 for Members, $2,000.00 for
Non-members, $615.00 for Government/
Health Authority/Academic and
$230.00 for Students. After August 25,
2008, registration fees are as follows:
$1,800.00 for Members, $2,200.00 for
Non-members, $700.00 for Government/
Health Authority/Academic and
$260.00 for Students.
If you need special accommodations
due to a disability, please contact
Wanda Neal-Ballard at least 7 days in
advance.
Notice of meeting.
The Food and Drug Administration
(FDA) is announcing the following
meeting: Achieving a Future Vision at
the 2008 Parenteral Drug Association
and the Food and Drug Administration
Joint Regulatory Conference. The topics
to be discussed are: FDA’s
Pharmaceutical Inspectorate and the
Global Harmonization Task Force; Trans
Atlantic initiative; Product
development; and legacy products;
Supply chain; Combination products;
and Recall root causes.
National Institutes of Health
Proposed Collection; Comment
Request; California Health Interview
Survey Cancer Control Module (CHIS–
CCM) 2009 (NCI)
SUMMARY: In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: California
Health Interview Survey Cancer Control
Module (CHIS–CCM) 2009. Type of
Information Collection Request: New.
Need and Use of Information Collection:
The NCI has sponsored four Cancer
Control Modules in the California
Health Interview Survey (CHIS), and
will be sponsoring a fifth to be
administered in 2009. CHIS is a
telephone survey that collects
population-based, standardized healthrelated data to assess California’s
progress in meeting Healthy People
2010 objectives for the nation and the
state. The CHIS sample is designed to
provide statistically reliable estimates
statewide, for California counties, and
for California’s ethnically and racially
diverse population. Initiated by the
UCLA Center for Health Policy
Research, the California Department of
Health Services, and the California
Public Health Institute, the survey is
funded by a number of public and
private sources. It was first administered
in 2001 to 55,428 adults and
subsequently in 2003 to 42,043 adults,
in 2005 to 43,020 adults, and in 2007 to
48,150 adults. These adults are a
representative sample of California’s
non-institutionalized population living
in households. CHIS 2009, the fifth biannual survey, is planned for
administration to 55,000 adult
Californians. This study will allow NCI
to examine patterns and trends in
cancer screening and follow-up, as well
as to study other cancer-related topics
such as tobacco control, diet, physical
activity, and obesity. Additionally, CHIS
is designed to be comparable to the
National Health Interview Survey
(NHIS) data in order to conduct
comparative analyses. CHIS provides
enhanced estimates for cancer risk
factors and screening among racial/
ethnic minority populations. Frequency
of Response: Once. Affected public:
Individuals or households. Types of
Respondents: U.S. adults and
adolescents (persons 12 years of age and
older). The total annual burden hours
requested are 3,276.94 (see Table A).
The annualized cost to respondents is
estimated at: $55,071.88. There are no
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
jlentini on PROD1PC65 with NOTICES
TABLE A—ANNUALIZED BURDEN ESTIMATES FOR CHIS 2009
Number of
respondents
Type of respondent
Form type
Adults ........................................................
..............................................................
Adult Pilot .................................................
Adult Survey .............................................
VerDate Aug<31>2005
17:12 Aug 21, 2008
Jkt 214001
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Frequency
of response
75
24,000.00
1
1
E:\FR\FM\22AUN1.SGM
22AUN1
Average
time per
response
(hours)
8/60
8/60
Annual hour
burden
10.00
3,200.00
49686
Federal Register / Vol. 73, No. 164 / Friday, August 22, 2008 / Notices
TABLE A—ANNUALIZED BURDEN ESTIMATES FOR CHIS 2009—Continued
Frequency
of response
Adolescent Pilot ........................................
Adolescent Survey ...................................
8
2,000.00
1
1
2/60
2/60
.27
66.67
...................................................................
26,083
....................
....................
3,276.94
Form type
Adolescents ..............................................
Total ...................................................
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the
proposed performance of the function of
the agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Nancy Breen,
Ph.D., Project Officer, National Cancer
Institute, EPN 4005, 6130 Executive
Boulevard MSC 7344, Bethesda,
Maryland 20852–7344, or call non-toll
free number 301–496–8500 or email
your request, including your address to:
breenn@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of this
publication.
FOR FURTHER INFORMATION CONTACT:
Dated: August 13, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office,
National Institutes of Health.
[FR Doc. E8–19453 Filed 8–21–08; 8:45 am]
jlentini on PROD1PC65 with NOTICES
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Licensing and/or Cooperative
Research and Development Agreement
(CRADA) Opportunities—Enhanced Tcell Activation by Costimulation: A
Potentially Novel Approach for the
Prevention and/or Therapy of Cancer
(Excluding Prostate Diseases and
Melanoma) and for Infectious Diseases
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
ACTION:
Notice.
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. Cooperative Research and
Development Agreement (CRADA)
opportunities are also available.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by contacting Mojdeh
Bahar, J.D., Office of Technology
Transfer, National Institutes of Health,
6011 Executive Boulevard, Suite 325,
Rockville MD 20852; telephone: 301/
435–2950; e-mail:
baharm@mail.nih.gov. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications. If interested in a
Cooperative Research and Development
Agreement (CRADA) Opportunity,
please submit a statement of interest
and capability to Kevin Brand, J.D., in
the NCI Technology Transfer Center,
6120 Executive Boulevard, Suite 450,
Rockville MD 20852; telephone: 301/
451–4566; e-mail: kb229t@nih.gov.
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
17:12 Aug 21, 2008
Jkt 214001
Average
time per
response
(hours)
Number of
respondents
Type of respondent
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Annual hour
burden
Description of Technology
Cancer immunotherapy is a recent
approach where tumor associated
antigens (TAAs), which are primarily
expressed in human tumor cells and not
expressed or minimally expressed in
normal tissues, are employed to
generate a tumor specific immune
response. Specifically, these antigens
serve as targets for the host immune
system and elicit responses that results
in tumor destruction. The initiation of
an effective T-cell immune response to
antigens requires two signals. The first
one is antigen specific via the peptide/
major histocompatibility complex and
the second or ‘‘costimulatory’’ signal is
required for cytokine production,
proliferation, and other aspects of T-cell
activation.
The present technology describes
recombinant poxvirus vectors encoding
at least three or more costimulatory
molecules and tumor associated
antigens (TAAs). The use of three
costimulatory molecules such as B7.1,
ICAM–1 and LFA–3 (TRICOM) has
been shown to act in synergy with
several tumor antigens and antigen
epitopes to activate T cells. The effects
with TRICOM were significantly
greater than with one or two
costimulatory molecules. Laboratory
results support the greater effect of
TRICOM to activate both CD4∂ and
CD8∂ T cells. The invention also
describes the use of at least one target
antigen or immunological epitope as an
immunogen or vaccine in conjunction
with TRICOM. The antigens include
but are not limited to carcinoembryonic
antigen (CEA) and MUC–1. The
combination of CEA, MUC–1, and
TRICOM is referred to as PANVAC.
Availability
The technology is available for
exclusive and non-exclusive license in
combinations and fields of use. Some
potential licensing opportunities
involving recombinant poxviral vectors
containing transgenes are as follows:
(1) TRICOM (alone or with a
transgene for a tumor antigen and/or an
immunostimulatory molecule);
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 73, Number 164 (Friday, August 22, 2008)]
[Notices]
[Pages 49685-49686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-19453]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; California Health Interview
Survey Cancer Control Module (CHIS-CCM) 2009 (NCI)
SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NCI), the National Institutes of Health (NIH) will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Proposed Collection: Title: California Health Interview Survey
Cancer Control Module (CHIS-CCM) 2009. Type of Information Collection
Request: New. Need and Use of Information Collection: The NCI has
sponsored four Cancer Control Modules in the California Health
Interview Survey (CHIS), and will be sponsoring a fifth to be
administered in 2009. CHIS is a telephone survey that collects
population-based, standardized health-related data to assess
California's progress in meeting Healthy People 2010 objectives for the
nation and the state. The CHIS sample is designed to provide
statistically reliable estimates statewide, for California counties,
and for California's ethnically and racially diverse population.
Initiated by the UCLA Center for Health Policy Research, the California
Department of Health Services, and the California Public Health
Institute, the survey is funded by a number of public and private
sources. It was first administered in 2001 to 55,428 adults and
subsequently in 2003 to 42,043 adults, in 2005 to 43,020 adults, and in
2007 to 48,150 adults. These adults are a representative sample of
California's non-institutionalized population living in households.
CHIS 2009, the fifth bi-annual survey, is planned for administration to
55,000 adult Californians. This study will allow NCI to examine
patterns and trends in cancer screening and follow-up, as well as to
study other cancer-related topics such as tobacco control, diet,
physical activity, and obesity. Additionally, CHIS is designed to be
comparable to the National Health Interview Survey (NHIS) data in order
to conduct comparative analyses. CHIS provides enhanced estimates for
cancer risk factors and screening among racial/ethnic minority
populations. Frequency of Response: Once. Affected public: Individuals
or households. Types of Respondents: U.S. adults and adolescents
(persons 12 years of age and older). The total annual burden hours
requested are 3,276.94 (see Table A). The annualized cost to
respondents is estimated at: $55,071.88. There are no Capital Costs,
Operating Costs, and/or Maintenance Costs to report.
Table A--Annualized Burden Estimates for Chis 2009
----------------------------------------------------------------------------------------------------------------
Average
Number of Frequency time per Annual hour
Type of respondent Form type respondents of response response burden
(hours)
----------------------------------------------------------------------------------------------------------------
Adults.............................. Adult Pilot........... 75 1 8/60 10.00
Adult Survey.......... 24,000.00 1 8/60 3,200.00
[[Page 49686]]
Adolescents......................... Adolescent Pilot...... 8 1 2/60 .27
Adolescent Survey..... 2,000.00 1 2/60 66.67
------------- ------------
Total........................... ...................... 26,083 ........... ........... 3,276.94
----------------------------------------------------------------------------------------------------------------
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proposed performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) Ways to minimize
the burden of the collection of information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Nancy Breen, Ph.D., Project Officer, National
Cancer Institute, EPN 4005, 6130 Executive Boulevard MSC 7344,
Bethesda, Maryland 20852-7344, or call non-toll free number 301-496-
8500 or email your request, including your address to:
breenn@mail.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of this publication.
Dated: August 13, 2008.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison Office, National Institutes of Health.
[FR Doc. E8-19453 Filed 8-21-08; 8:45 am]
BILLING CODE 4140-01-P
