[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Notices]
[Pages 48993-48994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20067]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health/National Institute of Environmental
Health Sciences
Proposed Collection; Comment Request; The Sister Study: A
Prospective Study of the Genetic and Environmental Risk Factors for
Breast Cancer
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of
Environmental Health Sciences (NIEHS), the National Institutes of
Health (NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval.
Proposed Collection: Title: The Sister Study: A Prospective Study
of the Genetic and Environmental Risk Factors for Breast Cancer. Type
of Information Collection Request: Revision. Need and Use of
Information Collection: This is to continue the Phase II follow-up of
the Sister Study--a study of 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. 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.
[[Page 48994]]
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. From August 2003 through July 2009, we
enrolled a cohort of 50,884 women who had not had breast cancer. We
estimated that after the cohort was fully enrolled, approximately 300
new cases of breast cancer will be diagnosed during each year of
follow-up. Thus far 1,634 participants have reported being diagnosed
with breast cancer. Frequency of Response: For the remainder of the
study, women will be contacted once each year (when not scheduled for
``triennial'') to update contact information and health status (10
minutes per response); and asked to complete short (75 minutes per
response) follow-up interviews or questionnaires (``triennial'') every
three years. Follow-up and validation of reported incident breast
cancer and other health outcomes is conducted under Clinical Exemption
CE 2009-09-004. Affected Public: Study participants, next-of-kin/
proxies. Type of Respondents: Participants enrolled in high-risk cohort
study of risk factors for breast cancer; next-of-kin/proxies. The
annual reporting burden is as follows: Estimated Number of Respondents:
50,884 study participants or next-of-kin/proxies. Estimated Number of
Responses per Respondent: See annualized table below:
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Estimated
Estimated Estimated Average burden total burden
Activity number of responses per hours per hours
responses respondent response requested
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Annual Updates.................................. 33,923 1 10/60 85,654
Triennial Update................................ 16,961 1 1.25 21,202
Total....................................... .............. .............. .............. 26,856
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Average Burden Hours Per Response:42 minutes; and Estimated Total
Annual Burden Hours Requested: 26,856. The estimated total annualized
cost to respondents $537,120 (assuming $20 hourly wage x 26,856). There
are no capital, operating, or maintenance costs.
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.
FOR FURTHER INFORMATION CONTACT: To request more information on the
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 (919)-541-4668 or Email your
request, including your address to: sandler@niehs.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60 days
of the date of this publication.
Dated: August 7, 2012.
Joellen M. Austin,
Associate Director for Management.
[FR Doc. 2012-20067 Filed 8-14-12; 8:45 am]
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