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