The Sister Study is approved for three years with the following terms: 1. Prior to enrolling women in the study, NIEHS will provide OMB with a list of the individuals, their expertise and affiliations, who conducted scientific peer review of this study, indicating which individuals reviewed and approved the final protocol. Information on the extent of each individual's review should also be provided (i.e. written comments vs. oral feedback). 2. Prior to enrolling women in the study, NIEHS will provide OMB with a detailed written description of the anticipated role of the advisory board and the NIEHS BSC in oversight of the study and biological samples. 3. NIEHS will report back to OMB with the results of the Vanguard phase prior to full-fielding of the study. Any revisions to the forms or protocol resulting from the Vanguard phase must be submitted to OMB for approval. 4. Pursuant to NIEHS and OMB agreement, the Sister Study will create an advisory board with representatives from NCI, NTP, EPA, CDC, and any other Federal Agency engaged in research activities looking at the biological or environmental causes of breast cancer as appropriate. The advisory board shall have the opportunity to advise the Sister Study on the collection, storage and decisions for use of the biological samples. 5. Women will be enrolled in this study over a three year period. NIEHS will not analyze the biological samples collected from the Sister Study participants within the first three years of the study. Upon the next submission of this study, NIEHS will provide a detailed analysis and oversight plan for the biological samples, as well as details regarding how specific determinations will be made related to who uses the samples and for what specific purposes. 6. Upon the next submission of this study, NIEHS will provide a complete description of the effectiveness of the recruitment plan including: how many responded by particular mode, how many initially were enrolled; how many dropped out and at what point; and how many are still enrolled to date.
Inventory as of this Action
Requested
Previously Approved
07/31/2006
07/31/2006
67,527
0
0
63,438
0
0
0
0
0
This is an investigationof the independent and joint effects of genetic susceptibility and environmental, biological, and lifestyle factors on the risk of breast cancer. A cohort of 50,000 women ages 35-74 who are the cancer-free sisters of women who have had breast cancer will be followed for 10 or more years. Baseline questionnaire data, fasting blood, first morning urine, dust and toenail samples will be obtained.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
The Sister Study: Environmental and Genetic Risk Factors for Breast Cancer