E9-23510. National Institute of Environmental Health Sciences; Submission for OMB Review; Comment Request; The Sister Study PHASE 2: 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 10 July 2009 on page 33259 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.

5 CFR 1320.5: Reporting and Recordkeeping Requirements: Final Rule: Respondents to this collection of information are not required to respond unless the data collection instruments display a currently valid OMB control number.

Proposed Collection: Title: The Sister Study PHASE 2: Environmental and Genetic Risk Factors for Breast Cancer. Type of Information Collection Request: Revision of OMB No. 0925-0522 and expiration date 30 September 2009. Need and Use of Information Collection: The purpose of the Sister Study is to study genetic and environmental risk factors for the development of breast cancer in a high-risk cohort of sisters of women who have had breast cancer. In the United States, approximately 192,370 new cases of invasive breast cancer are anticipated in 2009. 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 at least 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. In addition, a cohort of sisters should be enriched with regard to the prevalence of relevant genes and/or exposures, further enhancing the ability to detect gene-environment interactions. Sisters of women with breast cancer will also be at increased risk for ovarian cancer and possibly for other hormonally-mediated diseases. We have enrolled a cohort of 50,000 women who have not had breast cancer. Recruitment took place from August 2003 through July 2009. We estimate that in the cohort of 50,000 sisters, aged 35-74 at enrollment, approximately 300 new cases of breast cancer will be diagnosed during each year of follow-up. Frequency of Response: For the remainder of the study, women will be contacted once each year to update contact information and health status (5-10 minutes per response); and asked to complete short (60-75 minutes, total) updates every two-to-three years. Women diagnosed with breast cancer or other health outcomes of interest are asked to provide additional information about their diagnosis (20 minutes per response) and their doctors will be contacted to provide medical records related to diagnosis and treatments (15 minutes per response). Affected Public: Study participants; medical office staff. Type of Respondents: Participants enrolled in high-risk cohort study of risk factors for breast cancer. The annual reporting burden is as follows: Estimated Number of Respondents: 50,000 study participants and 2100 medical office staff. Estimated Number of Responses per Respondent: See table below:

Activity (3-yrs)	Estimated number of respondents	Estimated responses per respondent	Average burden hours per response	Estimated total burden hours requested
Annual Updates	50,000	2	0.085	8,500
Bi/Trienniel Follow-Up	50,000	1	1.25	62,500
Incident BC Case Follow-Up	1800	1	0.33	594
Incident Other Case Follow-Up	300	1	0.33	99
Incident Case Medical Office Contact	2100	1	0.25	525
Total				72,218

Average Burden Hours Per Response: 0.7 hour; and Estimated Total Burden Hours Requested: 72,218 (over 3 years). The average annual burden hours requested is 24,073. The annualized cost to respondents is estimated at $14 (assuming $20 hourly wage × 0.7 hour). 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 should address one or more of the following points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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, [e-mail] or by fax to 202-395-6974, 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 P. Sandler, Chief, Epidemiology Branch, NIEHS, Rall Building A3-05, PO 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 within 30-days of the date of this publication.

Dated: September 22, 2009.

Marc Hollander,

NIEHS, Associate Director for Management.