[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
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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 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