[Federal Register Volume 77, Number 158 (Wednesday, August 15, 2012)]
[Pages 48993-48994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-20067]



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 
    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:

                                                     Estimated       Estimated    Average burden   total burden
                    Activity                         number of     responses per     hours per         hours
                                                     responses      respondent       response        requested
Annual Updates..................................          33,923               1           10/60          85,654
Triennial Update................................          16,961               1            1.25          21,202
    Total.......................................  ..............  ..............  ..............          26,856

    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: [email protected].
    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]