[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11136-11137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4347]
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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
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Average time
Category of respondents Types of Number of Frequency of per response Annual burden
respondents respondents response (minutes/hour) hours
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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
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Total..................... ................ .............. .............. .............. 5,302
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[[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