[Federal Register Volume 66, Number 119 (Wednesday, June 20, 2001)]
[Notices]
[Pages 33103-33104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15460]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Environmental Health Sciences; Proposed 
Collection; Comment Request; The Sister Study: A Prospective Study of 
the Genetic and Environmental Risk Factors for Breast Cancer

SUMMARY: 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 Institute of 
Environmental Health Sciences (NIEHS), 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.
    Proposed Collection: Title: The Sister Study: A Prospective Study 
of the Genetic and Environmental Risk Factors for Breast Cancer.
    Type of Information Collection Request: NEW. Need and Use of 
Information Collection: We are proposing to study genetic and 
environmental risk factors for the development of breast cancer in a 
cohort of sisters of women who have had breast cancer. In the United 
States, there were approximately 180,000 new cases in 1997, accounting 
for 30% of all new cancer cases among women. The etiology of breast 
cancer is complex, with both genetic and environmental factors likely 
playing a role. Environmental risk factors, however, have been 
difficult to identify. By focusing on genetically susceptible 
subgroups, more precise estimates of the contribution of environmental 
and other non-genetic factors to disease risk may be possible. Sisters 
of women with breast cancer are one group at increased risk for breast 
cancer; we would expect about 2 times as many breast cancers to accrue 
in a cohort of sisters as would accrue in a cohort identified through 
random sampling or other means. Sisters of women with breast cancer 
will also be at increased risk for ovarian cancer and possibly for 
other hormonally-mediated diseases. The sister design will also 
facilitate study of sib-pairs to evaluate similarities in tumor 
characteristics, prognosis, and risk factors. We propose to enroll a 
cohort of 50,000 women who have not had breast cancer. In addition, we 
will enroll 500 of the index sisters whose breast cancer diagnosis was 
within the past four months. Initial recruitment of the first 2,000 
women will take place from October 2001-January 2002 before beginning 
recruitment in earnest in April 2002. The data collected in the initial 
phase will allow us to evaluate subject recruitment and data collection 
procedures, and collect other data that will help us better target our 
recruitment efforts. We estimate that a cohort of 50,000 sisters aged 
30-74 years would provide about 1,500 breast cancer cases over five 
years.
    Frequency of Response: On occasion (one initial 15-minute screening 
[either on the telephone OR on the internet], followed by an hour and a 
half-long telephone interview, one mailed self-administered 
questionnaire, and some biological specimens collection). Women will be 
advised that subsequent shorter interviews or questionnaires will be 
sought every 1-2 years for follow-up.
    Affected Public: Individuals or households.
    Type of Respondents: Unaffected sisters of women diagnosed with 
breast cancer, aged 30-74, from all socioeconomic backgrounds and 
ethnicities and women with recently diagnosed breast cancer. The annual 
reporting burden is as follows:
    Estimated Number of Respondents: 63,000 (20,833 unaffected sisters 
per year, on average, plus a total of 500 index sisters with incident 
breast cancer).
    Estimated Number of Responses per Respondent: See table below.
    Average Burden Hours Per Response: 4.6; and
    Estimated Total Burden Hours Requested: 293,500 (over 3 years). The 
average annual burden hours requested is 97,833. The annualized cost to 
respondents is estimated at $115 (assuming $20 hourly wage  x  5 hours 
+ $15 babysitting/travel allowance). There are no Capital Costs to 
report. There are no Operating or Maintenance Costs to report.

[[Page 33104]]



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                                                                Estimated
                                              Estimated         number of       Average burden   Estimated total
           Type of respondents                number of       responses per       hours per        burden hours
                                             respondents       respondent          response         requested
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Women calling in (Eligibility Screening).           63,000                1               0.25            15,750
Telephone Interview (CATI)...............           50,500                1               1.5             75,750
Questionnaires (self-administered).......           50,500                1               1.0             50,500
Biological Collections...................           50,500                1               3.0 \2\        151,500
                                          ----------------------------------------------------------------------
      Total..............................       \1\ 63,000  ................  .................         293,500
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\1\ Expect 20% (12,500) ineligible after screening, + 500 incident cases.
\2\ Includes waiting and travel time, and scheduling appointment for blood draw.

    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.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Dr. Dale P. Sandler, Acting Chief, Epidemiology 
Branch, NIEHS, Building 101, A-304, P.O. Box 12233, Research Triangle 
Park, NC 27709 or call non-toll-free number (919) 541-4668 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 
August 20, 2001.

    Dated: June 12, 2001.
Francine Little,
NIEHS, Associate Director for Management.
[FR Doc. 01-15460 Filed 6-19-01; 8:45 am]
BILLING CODE 4140-01-M