[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52325-52326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21273]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day 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,
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.
Written comments and/or suggestions from the public and affected
agencies are invited to address one or more of the following points:
(1) 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) 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) 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 Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Nathaniel
Rothman, Senior Investigator, Division of Cancer Epidemiology and
Genetics, 9609 Medical Center Drive, MSC 9776, Room 6E134, Bethesda,
Maryland 20892 or call non-toll-free number (240) 276-7169 or Email
your request, including your address to: [email protected]. Formal
requests for additional plans and instruments must be requested in
writing.
Comment 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.
Proposed Collection: A Multi-Center International Hospital-Based
Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI), 0925-0654,
Expiration Date 10/31/2015-REVISION, National Institutes of Health
(NIH).
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 and leukemia 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 lymphoma 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 and leukemia in both Asia and in
the United States. The major postulated risk factors for evaluation in
this study are chemical exposures (i.e.,
[[Page 52326]]
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 11
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.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 3,086.
Estimated Annualized Burden Hours
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Time per
Types of respondents Instrument Number of Frequency of response Annual burden
respondents response (hours) hours
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Potential Study Subjects....................... Screening Questions.................... 1,804 1 5/60 150
Consented Patient Cases........................ Core Questionnaire & Occupational Job 967 1 105/60 1,692
Module.
Consented Patient Controls..................... Core Questionnaire & Occupational Job 300 1 105/60 525
Module.
Study Pathologists............................. Pathology sample request and tracking 10 97 5/60 81
form.
Interviewers................................... Tracking forms......................... 15 85 30/60 638
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Dated: August 24, 2015.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2015-21273 Filed 8-27-15; 8:45 am]
BILLING CODE 4140-01-P