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Proposed Collection; Comment Request; Case-Cohort Study of Cancer and Related Disorders Among Benzene-Exposed Workers in China (OMB No. 0925-0454)

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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.


Title: Case-Cohort Study of Cancer and Related Disorders Among Benzene-Exposed Workers in China. Type of Information Collection Request: Emergency Extension. Need and Use of Information Collection: Since 1987, the National Cancer Institute has collaborated with the Chinese Academy of Preventive Medicine (currently designated Chinese Centers for Disease Control) in a factory-based investigation of cancer mortality and incidence of lymphohematopoietic disorders in a cohort of 75,000 and 36,000 comparison workers in 12 cities in China. Our initial study revealed elevated risks of leukemia, myelodysplastic syndromes, non-Hodgkin lymphoma, benzene poisoning, and lung cancer among the benzene-exposed workers. During the past five years, data have been collected to enable more precise quantification of risks of the malignancies and related disorders with an additional 12 years of follow-up of the subjects using a case-control study design. Cases included all workers from the exposed and unexposed groups who were diagnosed with leukemia, myelodysplastic syndromes, non-Hodgkin lymphoma and all other hematopoietic disorders; benzene poisoning; and lung cancer. Controls were frequency matched to cases and selected from the exposed (N=1200) and unexposed (N=300) cohort members. Data have been collected from factories, hospitals, and directly from interviews of all living and next of kin of deceased cases and controls. Information collected from the interviews focuses on potential confounding exposures including smoking, non-occupational benzene exposure, level of education, medical conditions, use of specific medications, and family cancer history. This study Start Printed Page 5576will provide better understanding of occupational and environmental risks from benzene exposure in the United States. It will be important to complete all data collection for the study to realize the full scientific benefit of this 20 year international collaboration. However, due to unexpected and unforeseen personnel problems and training issues in China, the researchers are requesting an emergency extension of three months to complete data collection. A detailed plan has been discussed and developed with the collaborators in China to complete all remaining data collections in the next three months.

Frequency of Response: One-time study. Affected Public: Individuals or households.

Type of Respondents: Workers or their next of kin. The annual reporting burden is reported in the following table:

Type of respondentsEstimated number of respondentsEstimated number of responses per respondentAverage burden hours per responseEstimated total annual burden hours requested
1 (22 minutes).

There are no Capital Costs to report. There are also no Operating and/or Maintenance Costs to report.

Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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.

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To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Richard Hayes, Project Officer, OEB/EBP/DCEG/NCI 6120 Executive Blvd., EPS Room 8114, Bethesda, MD 20892-7364, or call non-toll-free number (301) 435-3973 or fax your request to (301) 402-1819 or E-mail your request, including your address to:

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.

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Dated: January 24, 2008.

Vivian Horovitch-Kelley,

NCI Project Clearance Liaison, National Institutes of Health.

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[FR Doc. E8-1550 Filed 1-29-08; 8:45 am]