Proposed Collection; Comment Request; The Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer, 33259 [E9-16372]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• National Institutes of Health

[Federal Register Volume 74, Number 131 (Friday, July 10, 2009)]
[Notices]
[Page 33259]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16372]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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 of OMB No. 0925-0522 and 
expiration date 30 September 2009. Need and Use of Information 
Collection: The purpose of the Sister Study is to study 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. In the 
United States, approximately 192,370 new cases of invasive breast 
cancer are anticipated in 2009. 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. 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. We have enrolled a cohort of 50,000 women who have 
not had breast cancer. Recruitment took place from August 2003 through 
July 2009. We estimate that in the cohort of 50,000 sisters, aged 35-74 
at enrollment, approximately 300 new cases of breast cancer will be 
diagnosed during each year of follow-up. Frequency of Response: For the 
remainder of the study, women will be contacted once each year to 
update contact information and health status (10 minutes per response); 
and asked to complete short (60-75 minutes, total) follow-up interviews 
or questionnaires every two to three years. Women diagnosed with breast 
cancer or other health outcomes of interest are asked to provide 
additional information about their diagnosis (20 minutes per response) 
and their doctors will be contacted to provide medical records related 
to diagnosis and treatments (15 minutes per response). Affected Public: 
Study participants; medical office staff. Type of Respondents: 
Participants enrolled in high-risk cohort study of risk factors for 
breast cancer. The annual reporting burden is as follows: Estimated 
Number of Respondents: 50,000 study participants and 2100 medical 
office staff. Estimated Number of Responses per Respondent: See table 
below:

 
----------------------------------------------------------------------------------------------------------------
                                                                                                     Estimated
                                                     Estimated       Estimated    Average burden   total burden
                Activity (3-yrs)                     number of     responses per     hours per         hours
                                                    respondents     respondent       response        requested
----------------------------------------------------------------------------------------------------------------
Annual Updates..................................          50,000               1            0.17           8,500
Biennial Follow-Up Questionnaire................          50,000               1            1.25          62,500
Incident BC Case Follow-Up......................            1800               1            0.33             594
Incident Other Case Follow-Up...................             300               1            0.33              99
Incident Case Medical Office Contact............            2100               1            0.25             525
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          72,218
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    Average Burden Hours per Response: 0.7 hour; and Estimated Total 
Burden Hours Requested: 72,218 (over 3 years). The average annual 
burden hours requested is 24,073. The annualized cost to respondents is 
estimated at $14 (assuming $20 hourly wage x 0.7 hour). There are no 
Capital Costs to report. There are no Operating or Maintenance Costs to 
report.
    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 E-mail 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: July 1, 2009.
Marc S. Hollander,
Associate Director for Management.
[FR Doc. E9-16372 Filed 7-9-09; 8:45 am]
BILLING CODE 4140-01-P