Proposed Collection; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI), 22108-22109 [2011-9509]
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Federal Register / Vol. 76, No. 76 / Wednesday, April 20, 2011 / Notices
Management and Budget, at
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact Eddie
Billingslea, PhD, Division of
Neuroscience, National Institute on
Aging, NIH, DHHS, 7201 Wisconsin
Avenue, Suite 350, Bethesda, Maryland
20892–9205 or call non-toll-free number
301–496–9350 or e-mail your request,
including your address to:
billingsleae@nia.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
Dated: April 11, 2011.
Taryn Ayoub,
Project Clearance Liaison, National Institute
on Aging, National Institutes of Health.
[FR Doc. 2011–9511 Filed 4–19–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; Prostate, Lung, Colorectal
and Ovarian Cancer Screening Trial
(PLCO) (NCI)
In compliance with the
requirement of section 3506(c)(2)(A) of
SUMMARY:
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: Prostate,
Lung, Colorectal and Ovarian Cancer
Screening Trial (PLCO) (NCI). Type of
Information Collection Request:
Revision (OMB #: 0925–0407, current
expiry date 10/31/2011). Need and Use
of Information Collection: This trial is
designed to determine if screening for
prostate, lung, colorectal and ovarian
cancer can reduce mortality from these
cancers which currently cause an
estimated 254,570 deaths annually in
the U.S. The design is a two-armed
randomized trial of men and women
aged 55 to 74 at entry. OMB first
approved this study in 1993 and has
approved it every 3 years since then
through 2011. During the first approval
period a pilot study was conducted to
evaluate recruitment methods and data
collection procedures. Recruitment was
completed in 2001 and data collection
continues through 2014. When
participants enrolled in the trial they
agreed to be followed for at least 13
years from the time of enrollment. The
current number of respondents in the
study is 122,655; this is down from the
initial total due to deaths. The primary
endpoint of the trial is cancer specific
mortality for each of the four cancer
sites (prostate, lung, colorectal, and
ovary). In addition, cancer incidence,
stage shift, and case survival are to be
monitored to help understand and
explain results. Biologic prognostic
characteristics of the cancers will be
measured and correlated with mortality
to determine the mortality predictive
value of these intermediate endpoints.
Basic demographic data, risk factor data
for the four cancer sites and screening
history data, as collected from all
subjects at baseline, will be used to
assure comparability between the
screening and control groups and make
appropriate adjustments in analysis.
Further, demographic and risk factor
information may be used to analyze the
differential effectiveness of screening in
high versus low risk individuals.
Frequency of Response: Annually.
Affected Public: Individuals.
Type of Respondents: Adult men and
women. The annual reporting burden is
provided for each study component as
shown in the Table 1 below. There are
no Capital Costs, Operating Costs, and/
or Maintenance Costs to report.
TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS
Survey
instrument
Type of respondents
Male and Female Participants .........................
Number of
respondents
Average time per
response
(minutes/hour)
Frequency of
response
srobinson on DSKHWCL6B1PROD with NOTICES
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17:52 Apr 19, 2011
Jkt 223001
1.00
2,000
1.00
SQX
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) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
function 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 proposed collection of
information, including the validity of
the methodology and assumptions used;
92,941
HSQ
Total ..........................................................
ASU
92,941
1.00
............................
............................
............................
(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 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 Dr. Christine D.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
5/60
(0.08)
5/60
(0.08)
30/60
(0.50)
............................
Annual burden
hours
7,745
167
46,471
54,383
Berg, Chief, Early Detection Research
Group, National Cancer Institute, NIH,
EPN Building, Room 3100, 6130
Executive Boulevard, Bethesda, MD
20892, or call non-toll-free number 301–
496–8544 or e-mail your request,
including your address to:
bergc@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 the date of
this publication.
E:\FR\FM\20APN1.SGM
20APN1
Federal Register / Vol. 76, No. 76 / Wednesday, April 20, 2011 / Notices
Dated: April 13, 2011.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
Publications:
1. Baek SJ, Okazaki R, Lee SH, Martinez J,
Kim JS, Yamaguchi K, Mishina Y, Martin
DW, Shoieb A, McEntee MF, Eling TE.
Nonsteroidal anti-inflammatory drug
activated gene-1 overexpression in
transgenic mice suppresses intestinal
neoplasia. Gastroenterology. 2006
Nov;131(5):1553–1560. [PubMed:
17101328]
2. Cekanova M, Lee SH, Donnell RL,
Sukhthankar M, Eling TE, Fischer SM,
Baek SJ. Nonsteroidal anti-inflammatory
drug-activated gene-1 expression inhibits
urethane-induced pulmonary
tumorigenesis in transgenic mice. Cancer
Prev Res (Phila). 2009 May;2(5):450–458.
[PubMed: 19401523]
[FR Doc. 2011–9509 Filed 4–19–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
srobinson on DSKHWCL6B1PROD with NOTICES
NAG–1 Transgenic Mouse Model
Description of Technology: The
nonsteroidal anti-inflammatory drugactivated gene-1 (NAG–1) encodes a
protein that has anti-inflammatory,
proapoptotic, and antitumor properties.
It plays a pivotal role in
antitumorigenesis induced by
chemopreventive compounds.
Transgenic mice expressing human
NAG–1 have been developed by the NIH
investigator and collaborator.
The NAG–1 transgenic mice are
shown to develop few tumors in
response to carcinogenic stimuli than
wild type mice. They are also leaner
with less fat than their wild type
counterparts. As such, these mice can be
used to investigate the development of
cancers, and they could be of value in
studying obesity and the relationship to
cancer risk, and inflammation.
Inventors: Thomas E. Eling (NIEHS),
et al.
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17:52 Apr 19, 2011
Jkt 223001
Patent Status: HHS Reference No. E–
093–2011/0—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for
licensing under a Biological Materials
License Agreement.
Licensing Contact: Betty B. Tong,
PhD; 301–594–6565;
tongb@mail.nih.gov.
Collaborative Research Opportunity:
The NIEHS is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology. Please
contact Elizabeth M. Denholm, NIEHS
Office of Technology Transfer,
denholme@niehs.nih.gov, 919–541–
0981, for more information.
Altered miRNA Expression as
Diagnostics and Therapeutics for
Adrenocortical Carcinomas
Description of Technology: This
technology describes that altered human
miRNA expression such as miRNA–483
and miRNA 100 can accurately predict
if a patient’s adrenal cortex tumor is
benign or malignant. Adrenocortical
carcinomas (ACC) are rare but
aggressive cancers and typically have a
poor prognosis. Currently, there are
limited options for molecular diagnosis
to distinguish malignant tumors from
benign tumors of this type. As a result
there are few treatment strategies for
ACC.
Additionally, preliminary results
suggest that altering the expression of
this miRNA in ACC cells can effect
cancer cell growth. Therefore, inhibiting
a miRNA may serve as a therapeutic
option for ACC.
Applications:
• Technology can be developed into a
diagnostic and prognostic marker for
ACC.
• Inhibiting miRNA can serve as a
potential therapeutics for ACC.
Advantages:
PO 00000
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22109
• Distinguishes malignant Adrenal
cortex tumor from a benign tumor,
options for such distinction are limited
at this time.
• Technology can help in increased
and improved diagnosis and therapeutic
options for ACC.
Development Status:
• Pre-clinical.
• Clinical study to test the markers in
biopsy and serum samples being
planned.
Inventors: Electron Kebebew (CCR,
NCI) and Erin E. Patterson (CCR, NCI)
Publication: Patterson E. E. et al.
(Cancer, 2010). [PubMed: 21061324]
Patent Status: U.S. Provisional
Application No. 12/961,298 filed
December 6, 2010 (HHS Reference No.
E–026–2011/0–US–01)
Licensing Status: Available for
licensing.
Licensing Contact: Sabarni Chatterjee,
PhD, M.B.A.; 301–435–5587;
chatterjeesa@mail.nih.gov
Collaborative Research Opportunity:
The Center for Cancer Research, Surgery
Branch, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize the use of diagnostic
miRNAs and to target these miRNAs for
treatment. Please contact John Hewes,
PhD at 301–435–3121 or
hewesj@mail.nih.gov for more
information.
Novel Inhibitors of Thymic Stromal
Lymphopoietin (TSLP) for Cancer
Therapy
Description of Technology: With
estimated overall costs in the U.S. in
2006 at $206.3 billion and WHO
predictions of 15 million new cases
globally by 2020, the overall economic
cost of cancer is staggering. There
remains a significant unmet need for
therapies to control the spread
(metastasis) of cancers to other organs in
the body. Available for licensing are
compositions and methods of using
antagonists of thymic stromal
lymphopoietin (TSLP) to prevent cancer
progression and metastasis.
TSLP, an IL–7-like type 1
inflammatory cytokine that is often
associated with the induction of Th2type allergic responses in the lungs, is
also expressed in cancers regulating
their escape (1–3). The cancerpromoting activity of TSLP primarily
required signaling through the TSLP
receptor on CD4+ T cells, promoting
Th2-skewed immune responses and
production of immunosuppressive
factors such as IL–10 and IL–13.
Expression of TSLP therefore may be a
useful prognostic marker and its
E:\FR\FM\20APN1.SGM
20APN1
]]>Agencies
[Federal Register Volume 76, Number 76 (Wednesday, April 20, 2011)]
[Notices]
[Pages 22108-22109]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9509]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Prostate, Lung, Colorectal
and Ovarian Cancer Screening Trial (PLCO) (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: Prostate, Lung, Colorectal and Ovarian
Cancer Screening Trial (PLCO) (NCI). Type of Information Collection
Request: Revision (OMB : 0925-0407, current expiry date 10/31/
2011). Need and Use of Information Collection: This trial is designed
to determine if screening for prostate, lung, colorectal and ovarian
cancer can reduce mortality from these cancers which currently cause an
estimated 254,570 deaths annually in the U.S. The design is a two-armed
randomized trial of men and women aged 55 to 74 at entry. OMB first
approved this study in 1993 and has approved it every 3 years since
then through 2011. During the first approval period a pilot study was
conducted to evaluate recruitment methods and data collection
procedures. Recruitment was completed in 2001 and data collection
continues through 2014. When participants enrolled in the trial they
agreed to be followed for at least 13 years from the time of
enrollment. The current number of respondents in the study is 122,655;
this is down from the initial total due to deaths. The primary endpoint
of the trial is cancer specific mortality for each of the four cancer
sites (prostate, lung, colorectal, and ovary). In addition, cancer
incidence, stage shift, and case survival are to be monitored to help
understand and explain results. Biologic prognostic characteristics of
the cancers will be measured and correlated with mortality to determine
the mortality predictive value of these intermediate endpoints. Basic
demographic data, risk factor data for the four cancer sites and
screening history data, as collected from all subjects at baseline,
will be used to assure comparability between the screening and control
groups and make appropriate adjustments in analysis. Further,
demographic and risk factor information may be used to analyze the
differential effectiveness of screening in high versus low risk
individuals.
Frequency of Response: Annually.
Affected Public: Individuals.
Type of Respondents: Adult men and women. The annual reporting
burden is provided for each study component as shown in the Table 1
below. There are no Capital Costs, Operating Costs, and/or Maintenance
Costs to report.
Table 1--Estimates of Annual Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average time per
Type of respondents Survey Number of Frequency of response Annual burden
instrument respondents response (minutes/hour) hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Male and Female Participants.................................. ASU 92,941 1.00 5/60 7,745
(0.08)
HSQ 2,000 1.00 5/60 167
(0.08)
SQX 92,941 1.00 30/60 46,471
(0.50)
-----------------------------------------------------------------------------------------
Total..................................................... ................ ................ ................ ................ 54,383
--------------------------------------------------------------------------------------------------------------------------------------------------------
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) Evaluate whether the proposed collection of
information is necessary for the proper performance of the function 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 proposed 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 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 Dr. Christine D. Berg, Chief, Early Detection
Research Group, National Cancer Institute, NIH, EPN Building, Room
3100, 6130 Executive Boulevard, Bethesda, MD 20892, or call non-toll-
free number 301-496-8544 or e-mail your request, including your address
to: bergc@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 the date of this publication.
[[Page 22109]]
Dated: April 13, 2011.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2011-9509 Filed 4-19-11; 8:45 am]
BILLING CODE 4140-01-P
