[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
----------------------------------------------------------------------------------------------------------------
                                                                                   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
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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