[Federal Register Volume 67, Number 191 (Wednesday, October 2, 2002)]
[Notices]
[Pages 61911-61913]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Environmental Health Sciences; Submission 
for OMB review; comment request; The Sister Study: Environmental and 
Genetic Risk Factors for Breast Cancer

SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institute of Environmental Health 
Sciences (NIEHS), 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 June 20, 2001, page 33103-4 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 number.

Proposed Collection

    Title: The Sister Study: Environmental and Genetic Risk Factors for 
Breast Cancer. Type of Information Collection Request: New. Need and 
Use of Information Collection: We will study environmental and genetic 
risk factors for the development of breast cancer in a cohort of 
sisters of women who have had breast cancer. In the United States, 
approximately 192,000 new cases were diagnosed in 2001, accounting for 
30% of all new cancer cases among women. The etiology of breast cancer 
in complex, with both genetic and environmental factors likely playing 
a role. Environmental risk factors, however, have been difficult to 
identify. Sisters of women with breast cancer have nearly twice the 
risk of developing breast cancer themselves. By focusing on a 
susceptible population, more precise estimates of the contribution of 
environmental and other non-genetic factors to disease risk may be 
possible.The increased risk of cancer, and the expected higher 
prevalence of both relevant genes and exposures (both shared with their 
sister who had breast cancer) will facilitate the study of gene-
environment interactions. Once assembled, the cohort will be useful for 
studying other diseases in women. We will enroll a cohort of 50,000 
women who have not had breast cancer over a 4-year period, with 37,500 
enrolled during the first 3 years of the study. These breast cancer-
free sisters will be followed annually for the development of breast 
cancer and other diseases. We expect 300 cases of breast cancer per 
year (on average) to develop in a cohort of 50,000 women. In addition, 
we will enroll and follow 1,500 of the index sisters (1125 during the 
first 3 years) whose breast cancer diagnosis was within four months 
prior to enrollment. These ``index'' cases will allow comparison of 
case-control pairs of sisters and prospective study of the impact of 
environmental exposures and genes on prognosis.
    Frequency of Response: On occasion. For those who qualify and 
enroll: one initial 15-minute screening contact [telephone or internet, 
one 2-hour telephone interview, one mailed self-administered 
questionnaire (1.5 hours), biological and environmental specimen 
collection (1 hours), and annual follow-up questionnaires (0.5 hours). 
for those who don't enroll: one 15-minute screening contact (internet 
or phone). For women with breast cancer or who develop breast cancer 
during follow-up: validation of diagnosis through doctor's office. 
Affected Pubic: Individuals or households, doctor's office. Types of 
Respondents: Unaffected sisters of women diagnosed with breast cancer, 
aged 35-74, from all socioeconomic backgrounds and ethnicities and 
women with recently diagnosed breast cancer. The annual reporting 
burden in as follows: Estimated Number of Respondents: 151,800-50,000 
study respondents per year, of whom 12,875 will qualify and enroll--
including 12,500 unaffected women plus 500 index cases of incident 
breast cancer. (Note: Total cohort enrollment of 50,000 cancer-free 
sisters and 1,500 index cases of incident breast cancer will take 4 
years to achieve, requiring an estimated 2000, 000 respondents in all.) 
In addition, there will be a total of 1,575 doctor office respondents 
to validate diagnoses. The first year cost per women who enrolls in the 
study is estimated to be $95 (based on 4.75 hours of $20 hourly wage). 
Cost equivalent per follow-up year for enrolled women is $10. Total 
cost to women who don't enroll is $5. Cost to doctor's offices is $10 
(assuming $40 per hour). Estimated Number of Responses per Respondent 
See table below. Average Burden Hours Per Response: See table below. 
Estimated Total Burden Hours Requested: 231,240 over 3 years (see 
table). There are no Capital Costs to report. There are no Operating or 
Maintenance Costs to report.
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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 items(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. Dale Sandler, Acting Chief, Epidemiology Branch, NIEHS, Building 
101, A-304, P.O. Box 122233, 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 within 30 days of the date of this 
publication.

    Dated: September 3, 2002.
Francine Little,
NIEHS, Associate Director for Management.
[FR Doc. 02-24965 Filed 10-1-02; 8:45 am]
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