[Federal Register Volume 71, Number 36 (Thursday, February 23, 2006)]
[Notices]
[Pages 9358-9359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1690]


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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 of OMB No. 0925-0522 and 
expiration date 31 July 2006. Need and Use of Information Collection: 
The purpose of the Sister Study is to study genetic and environmental 
risk factors for the

[[Page 9359]]

development of breast cancer in a cohort of sisters of women who have 
had breast cancer. In the United States, there were approximately 
210,000 new cases in 2003, accounting for 30% of all new cancer cases 
among women. 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 about 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 will 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 are enrolling a 
cohort of 50,000 women who have not had breast cancer. Initial 
recruitment of the first 2,000 women took place from August 2003-
September 2004 before beginning nationwide recruitment in October 2004. 
The data collected in the initial phase allowed us to evaluate subject 
recruitment and data collection procedures, and helped us better target 
our recruitment efforts. We estimate that a cohort of 50,000 sisters 
aged 35-74 years would provide about 1,500 breast cancer cases over 
five years (approximately 300 new cases per year once the cohort is 
fully enrolled). Frequency of Response: At enrollment, one initial 15-
minute screening (either on the telephone OR on the internet), 2 one-
hour telephone interviews, 3 mailed self-administered questionnaires 
(90 minutes total), and some biological and household specimens 
collected. Women are advised that they will be contacted every year to 
update contact information and health status and asked to complete 
shorter (45-60 minutes, total) follow-up interviews or questionnaires 
every two years. Women diagnosed with breast cancer or other health 
outcomes of interest will be asked to provide additional information 
about their diagnosis (20 minutes per response) and their doctors will 
be contacted to provide documentation regarding diagnosis and 
treatments (15 minutes per response). Affected Public: Individuals or 
households; doctors' offices. Type of Respondents: Unaffected sisters 
of women diagnosed with breast cancer, aged 35-74, from all 
socioeconomic backgrounds and ethnicities. The annual reporting burden 
is as follows: Estimated Number of Respondents: 67,500 (~12,500 
enrolled per year over ~4 years, plus ~14,000 persons ultimately 
determined ineligibles or refusals at initial screening, and 3,500 
persons who partially complete enrollment before terminating). 
Estimated Number of Responses per Respondent: See table below. Average 
Burden Hours per Response: 6.0; and Estimated Total Burden Hours 
Requested: 176,553 (over 3 years). The average annual burden hours 
requested is 58,851. The annualized cost to respondents is estimated at 
$135 (assuming $20 hourly wage x 6 hours + $15 babysitting estimate). 
There are no Capital Costs to report. There are no Operating or 
Maintenance Costs to report.

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                                                                                       Average       Estimated
                                                        Estimated       Estimated       burden     total burden
                  Activity (3-yrs)                      number of     responses per   hours per        hours
                                                       respondents     respondent      response      requested
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Eligibility Screening..............................          22,750               1         0.25           5,688
Enrollment Interviews..............................          22,750               1         2             45,500
Enrollment SAQs....................................          22,750               1         1.5           34,125
Enrollment Specimen Collection *...................          22,750               1         1             22,750
1st Annual Update..................................          50,000               1         0.17           8,500
1st Bienniel Follow-Up Questionnaire...............          50,000               1         1             50,000
2nd Annual Update..................................          25,001               1         0.17           4,250
Ineligible **......................................          14,000               1         0.25           3,500
Dropout **.........................................           3,500               1         2.25           7,875
Incident BC Case Follow-Up.........................           1,800               1         0.33             594
Incident Other Case Follow-Up......................             300               1         0.33              99
Incident Case/Physician Contact....................           2,100               1         0.25             525
                                                    ------------------------------------------------------------
    Total..........................................  ..............  ..............  ...........        183,406
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* Includes waiting time, and scheduling appointment for blood draw.
** Expect 17% ineligible at screening plus 7% dropout during enrollment activities.

    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: [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: February 13, 2006.
Richard Freed,
NIEHS, Associate Director for Management.
[FR Doc. 06-1690 Filed 2-22-06; 8:45 am]
BILLING CODE 4140-01-M