01-15460. 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 × 5 hours + $15 babysitting/travel allowance). There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Type of respondents	Estimated number of respondents	Estimated number of responses per respondent	Average burden hours per response	Estimated total burden hours requested
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
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 [phone] or E-mail your request, including your address to: “[e-mail].”

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.