Approved consistent with NIH documents and memos submitted to OMB. With respect to the prior terms of clearance:
1 and 2) OMB had reviewed NIEHS' responses to items 1 and 2 (re: study oversight) in 2003. Documentation was provided.
3) There was likely a miscommunication regarding the Vanguard phase; perhaps the terms of clearance were actually written before the agreement was reached. Regardless, however, the "term" was meant to cover substantive changes in content. Since NIEHS did not make any such changes (as per the response provided), there is nothing additional that they needed to do here (other than document that no changes in content were made).
4) The concept behind this term was really to assure that all relevant agencies were involved so that consistent decisions could be made about investments in laboratory methods, capacity, and storage for biomarkers as well as ensuring broad knowledge of this resource across agencies to so that other agencies could capitalize on both the methods generated and the data available, thereby avoiding duplication of effort. Appropriate agencies seem to be on the advisory board. Publication of articles regarding the study design and recruitment are in the works which will further disseminate information.
5) In general, the oversight plan looks fine. OMB suggested that the "Sister Study Collaborative Application" be modified to include questions regarding the availability of data for the confounders and effect modifiers appropriate for the hypothesis being tested (this is slightly different from the questions being asked in E10).
6) The recruitment, enrollment, and (limited) follow up rates for the Sister Study thus far are impressive.
Inventory as of this Action
Requested
Previously Approved
09/30/2009
36 Months From Approved
09/30/2006
82,340
0
67,527
64,710
0
63,438
0
0
0
This is an investigation of 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 Generic Risk Factors for Breast Cancer