[Federal Register Volume 71, Number 84 (Tuesday, May 2, 2006)]
[Notices]
[Pages 25848-25849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4087]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Environmental Health Sciences; Submission 
for OMB Review; Comment Request; The Sister Study: A Prospective Study 
of the Genetic and Environmental Risk Factors for Breast Cancer

    Summary: Under the provisions of section 3507(a)(1)(D) of the 
Paperwork Reduction Act of 1995, the National Institute of 
Environmental Health Sciences (NIEHS), the National Institutes of 
Health (NIH) has submitted to the Office of Management and Budget (OMB) 
a request for review and approval of the information collection listed 
below. This proposed information collection was previously published in 
the Federal Register on February 23, 2006 on pages 9358-9359 and 
allowed 60 days for public comment. No public comments were received. 
The purpose of this notice is to allow an additional 30 days for public 
comment. The National Institutes of Health may not conduct or sponsor, 
and the respondent is not required to respond to, an information 
collection that has been extended, revised, or implemented on or after 
October 1, 1995, unless it displays a currently valid OMB control 
number.
    5 CFR 1320.5: Reporting and Recordkeeping Requirements: Final Rule: 
Respondents to this collection of information are not required to 
respond unless the data collection instruments display a currently 
valid OMB control number.
    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 July 31, 2006.
    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 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 2000 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 1500 breast cancer cases over five 
years (approximately 300 new cases per year once the cohort is fully 
enrolled).
    Frequency of Response: Burden calculations include eligibility 
screening for 22,750 more women, and completion of enrollment 
activities for 25,000 more women (difference due to expected 2,250 
women, and completion of enrollment activities for 25,000 more women 
(difference due to expected 2,250 women whose time lag between initial 
screening and fully completing enrollment baseline activities is 
expected to cross OMB expiration/revision date) to reach 50,000. These 
women will complete one initial 15-minute screening (either on the 
telephone OR on the Internet), two 1-hour telephone interviews, 4 
mailed self-administered questionnaires (90 minutes total), and will 
collect biological and household specimens. Also in the next 3 years, 
all 50,000 sisters will complete one annual update (10 minutes) and one 
biennial follow-up questionnaire (60 minutes); in addition 25,000 will 
complete a second annual update. Women diagnosed with breast cancer or 
other health outcomes of interest (~1800 allowing for 300 bc/year over 
our first 6 years, plus 1800 other outcomes) will be asked to provide

[[Page 25849]]

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). In addition to 
direct Sister Study participants, up to 300 women will be recruited to 
provide an anonymous blood sample for Sister Study laboratory quality 
control activities. A total of up to 200 women (70 during the first 
year) will be recruited to provide a one-time blood and urine sample 
and complete a past 24-hour questionnaire. These samples will be used 
to test long-term storage effects and to provide quality control pools 
for future assays. Up to 100 women will be sampled on four occasions 
over the course of a year (20 in the first year), providing blood, 
urine, and dust samples. On each occasion an abbreviated version of the 
previously approved past 24-hour questionnaire will be completed. Thus 
up to 300 women will complete a 5-minute telephone screener to 
determine eligibility. The 200 women (maximum) who provide a one-time 
sample will complete a short form describing activities and medication 
use in the 24 hours prior to blood draw (10 minutes). The 100 women 
(maximum) will complete the 24-hour form with each of 4 blood draws.
    Estimated Number of Respondents: The estimated total number of 
respondents is 67,800, which includes ~12,500 enrolled per year over ~4 
years, plus ~14,000 persons ultimately determined ineligible or 
refusals at initial screening, 3,500 persons who partially complete 
enrollment before terminating, and up to 300 women for anonymous 
quality sample collection.
    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 Responses per Respondent: The table below shows 
the estimated number of responses per respondent per activity over the 
next 3 years.
    Average Burden Hours per Response: 6.0;
    Estimated Total Burden Hours Requested: 194,131 (over 3 years). The 
average annual burden hours requested is 64,710.
    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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                                                                                                     Estimated
                                                     Estimated       Estimated        Average      total burden
                Activity  (3-yrs)                    number of     responses per   burden hours        hours
                                                    respondents     respondent     per response      requested
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Eligibility Screening...........................          22,750               1            0.25           5,688
Enrollment Interviews...........................          25,000               1            2             50,000
Enrollment SAQs.................................          25,000               1            1.5           37,500
Enrollment Specimen Collection*.................          25,000               1            1             25,000
1st Annual Update...............................          50,000               1            0.17           8,500
1st Biennial 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......................            1800               1            0.33             594
Incident Other Case Follow-Up...................             300               1            0.33              99
Incident Case/Physician Contact.................            2100               1            0.25             525
QC Sample Collection A[dagger]..................             200               1            0.15             200
QC Sample Collection B[dagger]..................             100               4            0.15             400
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............         194,131
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*includes waiting time, and scheduling appointment for blood draw.
**expect 17% ineligible at screening plus 7% dropout during enrollment activities.
[dagger] includes travel time, 10 minutes for Past-24 hour Qx, and blood draw.

    Request for Comments Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate 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) Evaluate 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) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) 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.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the item(s) contained in this notice, especially regarding 
the estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, New Executive Office Building, Room 10235, Washington, DC 
20503, Attention: Desk Officer for NIH. To request more information on 
the proposed project or to obtain a copy of the data collection plans 
and instruments, contact: (Insert IC applicable information. Include 
automated, electronic, mechanical, or other technological collection 
techniques, if applicable.)
    Comments Due Date: Comments regarding this information collection 
are best assured of having their full effect if received within 30 days 
of the date of this publication.

    Dated: April 20, 2006.
Laurie K. Johnson, NIEHS,
Acting Associate Director for Management
[FR Doc. 06-4087 Filed 5-1-05; 8:45 am]
BILLING CODE 4140-01-M