Proposed Collection; Comment Request; a Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI), 11136-11137 [2012-4347]
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11136
Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices
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.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the
Attention: NIH Desk Officer, Office of
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: George
Chacko, Office of Planning, Analysis,
and Evaluation, Center for Scientific
Review, 6701 Rockledge Drive, Suite
3030, Bethesda, MD 20892 or call nontoll-free at 301–435–1111 or email your
request, including your address to:
chackoge@mail.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.
George Chacko,
Director, Office of Planning, Analysis, and
Evaluation, Center for Scientific Review,
National Institutes of Health.
[FR Doc. 2012–4271 Filed 2–23–12; 8:45 am]
BILLING CODE 4104–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; a Multi-Center International
Hospital-Based Case-Control Study of
Lymphoma in Asia (AsiaLymph) (NCI)
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: A MultiCenter International Hospital-Based
Case-Control Study of Lymphoma in
Asia (AsiaLymph) (NCI). Type of
Information Collection Request:
Emergency. Need and Use of
Information Collection: Incidence rates
of certain lymphomas have increased in
the United States and in many other
parts of the world. The contribution of
environmental, occupational, and
genetic factors to the cause of
lymphoma has generated a series of
novel findings from epidemiological
studies conducted in the United States
that have attempted to explain this
increase. However, none of the chemical
associations have been conclusively
established and the identification of the
key, functional alleles in gene regions
associated with risk of NHL requires
further elucidation. Further, the ability
to follow-up, confirm, and extend these
observations in the United States is
limited by the low prevalence and
limited range of several important
chemical and viral exposures and the
high to complete linkage disequilibrium
among key candidate genetic loci in
Western populations. To optimize the
ability to build on and clarify these
findings, it is necessary to investigate
populations that differ from those in the
SUMMARY:
West in both exposure patterns and
underlying genetic structure. A
multidisciplinary case-control study of
lymphoma in Asia, where lymphoma
rates have also risen, provides an
opportunity to replicate and extend
recent and novel observations made in
studies in the West in a population that
is distinctly different with regard to
patterns of key risk factors, including
range of exposures, prevalence of
exposures, correlations between
exposures, and variation in gene regions
of particular interest. It will also
improve the ability to understand the
causes of certain types of rare
lymphoma tumors in the United States
that occur at much higher rates in Asia.
As such, AsiaLymph will confirm and
extend previous findings and yield
novel insights into the causes of
lymphoma in both Asia and in the
United States. The major postulated risk
factors for evaluation in this study are
chemical exposures (i.e.,
organochlorines, trichloroethylene, and
benzene) and genetic susceptibility.
Other factors potentially related to
lymphoma, such as viral infections,
ultraviolet radiation exposure, medical
conditions, and other lifestyle factors
will also be studied. Patients from 19
participating hospitals will be screened
and enrolled. There will be a one-time
computer-administered interview, and
patients will also be asked to provide a
one-time blood and buccal cell mouth
wash sample and lymphoma cases will
be asked to make available a portion of
their pathology sample. Frequency of
Response: Once. Affected Public:
Individuals. Type of Respondents:
Newly diagnosed patients with
lymphoma or patients undergoing
surgery or other treatment for noncancer related medical issues who live
in Taiwan and in Hong Kong, Chengdu
and Tianjin, China will be enrolled at
treating hospitals. The annual reporting
burden is estimated at 5,302 hours (see
Table below). There are $77,000 in
Capital Costs, Operating Costs, and/or
Maintenance Costs to report.
ESTIMATES OF ANNUAL BURDEN HOURS
Number of
respondents
Frequency of
response
Average time
per response
(minutes/hour)
Annual
burden hours
Types of respondents
Individuals .........................................
srobinson on DSK4SPTVN1PROD with NOTICES
Category of respondents
Patients to be Screened ..................
Patients with Lymphoma ..................
Other Patients ..................................
Study Pathologists ...........................
Interviewers ......................................
3,100
1,100
1,100
19
19
1
1
1
58
116
5/60
105/60
105/60
5/60
30/60
258
1,925
1,925
92
1,102
Total ...........................................
...........................................................
........................
........................
........................
5,302
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Federal Register / Vol. 77, No. 37 / Friday, February 24, 2012 / Notices
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address 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 Nathaniel
Rothman, Senior Investigator for the
Occupational and Environmental
Epidemiology Branch, Division of
Epidemiology and Genetics, National
Cancer Institute, 6120 Executive
Boulevard, Room 8118, Rockville, MD
20892 or call non-toll-free number 301–
496–9093 or email your request,
including your address to: rothmann
@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.
Dated: February 21, 2012.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2012–4347 Filed 2–23–12; 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.
srobinson on DSK4SPTVN1PROD with NOTICES
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
SUMMARY:
VerDate Mar<15>2010
18:34 Feb 23, 2012
Jkt 226001
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.
11137
0—Research Tools. Patent protection is
not being pursued for these
technologies.
Licensing Contact: Suryanarayana
(Sury) Vepa, Ph.D., J.D.; 301–435–5020;
vepas@mail.nih.gov.
Novel Biomarkers for Alcohol-Induced
Liver Disease (ALD)
Description of Technology: Alcoholinduced liver disease (ALD) is a leading
cause of non accident-related deaths
worldwide. ALD is reversible if
identified in the early stages, but early
diagnosis is difficult with existing tools.
One problem associated with
developing a new diagnostic tool is the
genetic background associated
heterogeneity in physiological responses
Polyclonal Antibodies Useful for the
to chronic alcohol consumption. The
Detection of Vangl1 and Vangl2
inventors of the present technology have
Proteins Which Play a Role in
solved this problem and have
Developmental Processes
discovered background-independent
novel biomarkers for ALD. In the
Description of Technology: Vangl1
(Van Gogh like 1) and Vangl2 (Van Gogh current studies, the inventors generated
two genetically distinct lines of
like 2) are two core proteins mediating
PPARalpha-null mice and evaluated the
establishment of Planar Cell Polarity
levels of urine metabolites after alcohol
(PCP), which refers to the polarity of
exposure. The inventors have identified
epithelial cells within a plane
indole-3-lactic acid and phenyllactic
orthogonal to their apical-basal axis.
Disruption of core PCP proteins leads to acid as putative biomarkers for ALD.
Indole-3-lactic acid and phenyllactic
many developmental defects, including
acid levels were significantly elevated
open neural tube, misorientation of
in both lines of PPARalpha-null mice
sensory hair cells in the inner ear,
after two to three months of alcohol
polycystic kidney disease and skeletal
administration. The inventors had
deformations. In humans, mutations in
Vangl1 and Vangl2 have been identified identified indole-3-lactic acid and
phenyllactic acid to be background
in patients with neural tube defects,
independent markers for ALD.
such as spina bifida, the most common
Potential Commercial Applications:
permanently disabling birth defect in
Useful for early non-invasive screening
the United States. NHGRI researchers
of ALD in large numbers of subjects
have recently generated rabbit
irrespective of their genetic background.
polyclonal antibodies against Vangl1
Competitive Advantages:
and phosphorylated Vangl2 proteins
• Easily adaptable for the
that are suitable for endogenous Vangl1
development of highly sensitive
and Vangl2 detection.
spectroscopy-based assay kits.
Potential Commercial Applications:
• Amenable for the development of
Anti-Vangl1 and Vangl2 antibodies
high-throughput mass spectrometric
could be used in the development of
analysis of urine samples to detect early
diagnostic and therapeutic treatments
onset of ALD.
for PCP-related developmental defects.
Development Stage:
Development Stage:
• Early-stage.
• Pre-clinical.
• Pre-clinical.
• In vitro data available.
• In vivo data available (animal).
Inventors: Yingzi Yang and Bo Gao
Inventors: Soumen Kanti Manna and
(NHGRI); Yingzi Yang and Hai Song
Frank J. Gonzalez (NCI).
(NHGRI).
Publications:
Publications:
1. Manna SK, et al. UPLC–MS-based
1. Gao B, et al. Wnt signaling
urine metabolomics reveals indole-3gradients establish planar cell polarity
lactic acid and phenyllactic acid as
by inducing Vangl2 phosphorylation
conserved biomarkers for alcoholthrough Ror2. Dev Cell. 2011 Feb
induced liver disease in the Ppara-null
15;20(2):163–176. [PMID 21316585]
mouse model. J Proteome Res. 2011 Sep
2. Song H, et al. Planar cell polarity
breaks bilateral symmetry by controlling 2;10(9):4120–4133. [PMID 21749142]
2. Manna SK, et al. Identification of
ciliary positioning. Nature. 2010 Jul
15;466(7304):378–382. [PMID 20562861] noninvasive biomarkers for alcoholinduced liver disease using urinary
Intellectual Property: HHS Reference
metabolomics and the Ppara-null
Nos. E–135–2011/0 and E–136–2011/
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]]>Agencies
[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11136-11137]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4347]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; a Multi-Center
International Hospital-Based Case-Control Study of Lymphoma in Asia
(AsiaLymph) (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: A Multi-Center International Hospital-
Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI). Type of
Information Collection Request: Emergency. Need and Use of Information
Collection: Incidence rates of certain lymphomas have increased in the
United States and in many other parts of the world. The contribution of
environmental, occupational, and genetic factors to the cause of
lymphoma has generated a series of novel findings from epidemiological
studies conducted in the United States that have attempted to explain
this increase. However, none of the chemical associations have been
conclusively established and the identification of the key, functional
alleles in gene regions associated with risk of NHL requires further
elucidation. Further, the ability to follow-up, confirm, and extend
these observations in the United States is limited by the low
prevalence and limited range of several important chemical and viral
exposures and the high to complete linkage disequilibrium among key
candidate genetic loci in Western populations. To optimize the ability
to build on and clarify these findings, it is necessary to investigate
populations that differ from those in the West in both exposure
patterns and underlying genetic structure. A multidisciplinary case-
control study of lymphoma in Asia, where lymphoma rates have also
risen, provides an opportunity to replicate and extend recent and novel
observations made in studies in the West in a population that is
distinctly different with regard to patterns of key risk factors,
including range of exposures, prevalence of exposures, correlations
between exposures, and variation in gene regions of particular
interest. It will also improve the ability to understand the causes of
certain types of rare lymphoma tumors in the United States that occur
at much higher rates in Asia. As such, AsiaLymph will confirm and
extend previous findings and yield novel insights into the causes of
lymphoma in both Asia and in the United States. The major postulated
risk factors for evaluation in this study are chemical exposures (i.e.,
organochlorines, trichloroethylene, and benzene) and genetic
susceptibility. Other factors potentially related to lymphoma, such as
viral infections, ultraviolet radiation exposure, medical conditions,
and other lifestyle factors will also be studied. Patients from 19
participating hospitals will be screened and enrolled. There will be a
one-time computer-administered interview, and patients will also be
asked to provide a one-time blood and buccal cell mouth wash sample and
lymphoma cases will be asked to make available a portion of their
pathology sample. Frequency of Response: Once. Affected Public:
Individuals. Type of Respondents: Newly diagnosed patients with
lymphoma or patients undergoing surgery or other treatment for non-
cancer related medical issues who live in Taiwan and in Hong Kong,
Chengdu and Tianjin, China will be enrolled at treating hospitals. The
annual reporting burden is estimated at 5,302 hours (see Table below).
There are $77,000 in Capital Costs, Operating Costs, and/or Maintenance
Costs to report.
Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
Average time
Category of respondents Types of Number of Frequency of per response Annual burden
respondents respondents response (minutes/hour) hours
----------------------------------------------------------------------------------------------------------------
Individuals................... Patients to be 3,100 1 5/60 258
Screened.
Patients with 1,100 1 105/60 1,925
Lymphoma.
Other Patients.. 1,100 1 105/60 1,925
Study 19 58 5/60 92
Pathologists.
Interviewers.... 19 116 30/60 1,102
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 5,302
----------------------------------------------------------------------------------------------------------------
[[Page 11137]]
Request for Comments: Written comments and/or suggestions from the
public and affected agencies should address 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 Nathaniel Rothman, Senior Investigator for the
Occupational and Environmental Epidemiology Branch, Division of
Epidemiology and Genetics, National Cancer Institute, 6120 Executive
Boulevard, Room 8118, Rockville, MD 20892 or call non-toll-free number
301-496-9093 or email your request, including your address to: rothmann
@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.
Dated: February 21, 2012.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2012-4347 Filed 2-23-12; 8:45 am]
BILLING CODE 4140-01-P
