[Federal Register Volume 69, Number 231 (Thursday, December 2, 2004)]
[Notices]
[Page 70155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26540]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

[OMB No. 0925-0454]


Submission for OMB Review; Comment Request; Case-Cohort Study of 
Cancer and Related Disorders Among Benzene-Exposed Workers in China

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 (NIH) 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 and allowed 
60 days for public comment. No public comments were received. The 
purpose of this notice is to allow an additional 30 days for public 
comment. 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: Case-Cohort Study of Cancer and Related 
Disorders Among Benzene-Exposed Workers in China. Reinstatement With 
Change. Need and Use of Information Collection: A case-cohort study 
will be performed to examine the risks of lymphohematopoietic cancers, 
other lymphohematopoietic disorders, benzene poisoning, and lung cancer 
among workers exposed to benzene. The study will attempt to determine 
with greater precision the risks of these disorders at low levels of 
benzene exposure, and to characterize the dose and time-specific 
relationship between benzene exposure and disease risk. Cases and 
controls will be selected from an existing cohort of 75,000 benzene-
exposed workers and 36,000 comparison workers in 12 Chinese cities. 
There are 2 changes to the study from that previously approved by OMB 
in July 2001: (1) 386 more subjects (including 155 more cases with 
benzene poisoning, 111 more cases with lung cancer, and 120 more 
controls) will be evaluated in the currently planned case-cohort study, 
which is now targeting a total of 2,156 subjects compared with 1,770 
subjects as previously estimated; and (2) the questionnaire has been 
revised somewhat, although the average total time estimated for a 
subject to complete the questionnaire is unchanged from previously.
    Frequency of Response: Single-time study. Affected Public: 
Individuals or households. Type of Respondents: Cases with 
lymphohematopoietic malignancies and related disorders, benzene 
poisoning and lung cancer among Chinese benzene-exposed and comparison 
workers; controls consist of a random sample of the Chinese worker 
cohort. The annual reporting burden is as follows: Estimated Number of 
Respondents: 862; Estimated Number of Responses per Respondent: 1; 
Average Burden Hours per Response: 0.3674; and Estimated Total Annual 
Burden Hours Requested: 396. The annualized cost to respondents is 
estimated at $476. There are no Capital Costs to report. There are also 
no Operating or Maintenance Costs to report.

                                   Estimates of Hour Burden: Burden Requested
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                                                                     Estimated        Average
                                                     Estimated     frequency of     burden time      Estimated
               Type of respondents                   number of     responses per    (in hours)    average annual
                                                    respondents     respondent     per response     hour burden
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Workers in factories in China using or producing           1,078               1            0.37             396
 benzene and in comparison factories in which no
 benzene is used................................
----------------------------------------------------------------------------------------------------------------

    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.
    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, New Executive Office Building, Room 10235, Washington, DC 
20503, Attention: Desk Officer for NIH. To request more information on 
the proposed project or to obtain a copy of the data collection plans 
and instruments, contact: Dr. Richard Hayes, OEB/EBP/DCEG/NCI 6120 
Executive Boulevard, EPS Room 8114, Bethesda, MD 20892, or call non-
toll-free number (301) 435-3973 or e-mail your request, including your 
address to: [email protected].
    Comments 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.

    Dated: November 19, 2004.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 04-26540 Filed 12-1-04; 8:45 am]
BILLING CODE 4140-01-P