[Federal Register Volume 66, Number 88 (Monday, May 7, 2001)]
[Notices]
[Pages 23034-23035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11401]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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 on December 
28, 2000, pages 82382-82383 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 (formerly Case-Control) 
Study of Cancer and Related Disorders Among

[[Page 23035]]

Benzene-Exposed Workers in China, OMB Number 0925-0454, Revised. 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 3 changes to 
the 60-day Federal Register notice for this study published on December 
28, 2000: (1) more subjects will be evaluated in the currently planned 
case-cohort study (N=1,770, including 225 with benzene poisoning) than 
in the previously described case-control study (N=1,545); (2) each 
subject (or their next of kin will be asked fewer questions (average 
hours per response will decrease from 0.42 to 0.3674 hours); and (3) 
the more efficient case-cohort design will be used, rather than an 
individually-matched case-control study design. 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 without these disorders. The annual reporting 
burden is as follows: Estimated Number of Respondents: 590; Estimated 
Number of Respondents per Respondent: 1; Average Burden Hours per 
Response: 0.3674; and Estimated Total Annual Burden Hours Requested: 
216. The annualized cost to respondents is estimated at $216. There are 
no Capital Costs to report. There are no Operating 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 or 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/DECEG/NCI 6120 
Executive Blvd., 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 on or before 
June 6, 2001.

    Dated: April 27, 2001.
Reesa Nichols,
NCI Project Clearance Liaison.
[FR Doc. 01-11401 Filed 5-4-01; 8:45 am]
BILLING CODE 4140-01-M