[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Pages 66548-66549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27586]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; A Multi-Center 
International Hospital-Based Case-Control Study of Lymphoma in Asia 
(AsiaLymph) (NCI)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Cancer Institute (NCI), the 
National Institutes of Health, has submitted to the Office of 
Management and Budget (OMB) a request for review and approval of the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on August 
28, 2015, page number 52325 and allowed 60-days for public comment. One 
public comment was received. The purpose of this notice is to allow an 
additional 30 days for public comment. The National Cancer Institute 
(NCI), National Institutes of Health, may not conduct or sponsor, and 
the respondent is not required to respond to, an information collection 
that has been extended, revised, or implemented on or after October 1, 
1995, unless it displays a currently valid OMB control number.
    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: Office of Management and Budget, Office of Regulatory 
Affairs, [email protected] or by fax to 202-395-6974, 
Attention: NIH Desk Officer.

DATES: Comment 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.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments, 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, Rockville, MD 20850 or call non-toll-free number 
(240) 276-7169 or Email your request, including your address to: 
[email protected].
    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., organochlorines, 
trichloroethylene, and benzene) and genetic susceptibility. Other 
factors potentially related to lymphoma, such as viral infections,

[[Page 66549]]

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 cases with 
lymphoma or leukemia 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 3,262.
Estimated Annualized Burden Hours

                                 Table A.12-1--Estimates of Annual Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Time per
     Types of respondents          Instrument        Number of     Frequency of      response      Annual burden
                                                    respondents      response         (hours)          hours
----------------------------------------------------------------------------------------------------------------
Potential Study Subjects......  Screening                  2,110               1            5/60             176
                                 Questions.
Eligible Potential Study        Consent Form....           1,801               1            5/60             150
 Subjects.
Consented Patient Cases.......  Core                         967               1          105/60           1,692
                                 Questionnaire &
                                 Occupational
                                 Job Module.
Consented Patient Controls....  Core                         300               1          105/60             525
                                 Questionnaire &
                                 Occupational
                                 Job Module.
Study Pathologists............  Pathology sample              10              97            5/60              81
                                 request and
                                 tracking form.
Interviewers..................  Tracking forms..              15              85           30/60             638
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    Dated: October 16, 2015.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, NIH.
[FR Doc. 2015-27586 Filed 10-28-15; 8:45 am]
 BILLING CODE 4140-01-P