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

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Summary: In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for emergency review and processing this information collection by March 5, 2012. NCI is requesting emergency processing of this information collection, pursuant to 5 CFR 1320.13, because NCI cannot reasonably comply with the normal clearance procedures which would cause a delay and likely prevent or substantially disrupt the collection of information. A delay in starting the information collection would hinder the agency in accomplishing its mission to the detriment of the public good. Public harm could result through the loss of critically needed information to understand and reduce the cancer burden from lymphoid malignancies in the Asian population. The 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.

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 several centers in Asia thereby increasing the cancer burden in these populations, but the causes remain unknown. AsiaLymph is a multi-disciplinary case-control study that will confirm and extend previous findings and yield novel insights into the causes of lymphoma in both Asia and the West. 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. Patterns of key risk factors, including range of exposures, prevalence of exposures, correlations between exposures, and variation in gene regions are of particular interest. 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 Hong Kong, Taiwan, and Chengdu and Tianjin, China will be enrolled at treating hospitals. The annual reporting burden is estimated at 3,377 hours (see Table below). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.

Estimates of Annual Burden Hours

Category of respondentsTypes of respondentsNumber of respondentsFrequency of responseAverage time per response (Hours)Annual burden hours
IndividualsPatients to be Screened3,10015/60258
Patients with Lymphoma1,1001105/60963
Other Patients1,1001105/60963
Study Pathologists19585/6092

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.

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 Attention: NIH Desk Officer, Office of Management and Budget, at or by fax to 202-395-6974. 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

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 15 days of the date of this publication.

Dated: February 13, 2012.

Vivian Horovitch-Kelley,

NCI Project Clearance Liaison, National Institutes of Health.

[FR Doc. 2012-3830 Filed 2-16-12; 8:45 am]