[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