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, 25848-25849 [06-4087]
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Federal Register / Vol. 71, No. 84 / Tuesday, May 2, 2006 / Notices
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VerDate Aug<31>2005
15:18 May 01, 2006
Jkt 208001
Dated: April 26, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6–6602 Filed 5–1–06; 8:45 am]
BILLING CODE 4160–01–S
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
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
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 hormonallymediated 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 15minute screening (either on the
telephone OR on the Internet), two 1hour 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
E:\FR\FM\02MYN1.SGM
02MYN1
25849
Federal Register / Vol. 71, No. 84 / Tuesday, May 2, 2006 / Notices
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.
Estimated
number of
respondents
Activity
(3-yrs)
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 × 6 hours + $15 babysitting
estimate). There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
Estimated
responses per
respondent
Average
burden hours
per response
Estimated total
burden hours
requested
Eligibility Screening ........................................................................................
Enrollment Interviews ....................................................................................
Enrollment SAQs ...........................................................................................
Enrollment Specimen Collection* ..................................................................
1st Annual Update .........................................................................................
1st Biennial Follow-Up Questionnaire ...........................................................
2nd Annual Update ........................................................................................
Ineligible** ......................................................................................................
Dropout** .......................................................................................................
Incident BC Case Follow-Up .........................................................................
Incident Other Case Follow-Up .....................................................................
Incident Case/Physician Contact ...................................................................
QC Sample Collection A† ..............................................................................
QC Sample Collection B† ..............................................................................
22,750
25,000
25,000
25,000
50,000
50,000
25,001
14,000
3,500
1800
300
2100
200
100
1
1
1
1
1
1
1
1
1
1
1
1
1
4
0.25
2
1.5
1
0.17
1
0.17
0.25
2.25
0.33
0.33
0.25
0.15
0.15
5,688
50,000
37,500
25,000
8,500
50,000
4,250
3,500
7,875
594
99
525
200
400
Total ........................................................................................................
........................
........................
..........................
194,131
rmajette on PROD1PC67 with NOTICES
*includes waiting time, and scheduling appointment for blood draw.
**expect 17% ineligible at screening plus 7% dropout during enrollment activities.
† 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
VerDate Aug<31>2005
15:18 May 01, 2006
Jkt 208001
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.)
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
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
E:\FR\FM\02MYN1.SGM
02MYN1
]]>Agencies
[Federal Register Volume 71, Number 84 (Tuesday, May 2, 2006)]
[Notices]
[Pages 25848-25849]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4087]
-----------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated Estimated Average total burden
Activity (3-yrs) number of responses per burden hours hours
respondents respondent per response requested
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
*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
