02-24965. 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.

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 [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 within 30 days of the date of this publication.

Dated: September 3, 2002.

Francine Little,

NIEHS, Associate Director for Management.