National Institute of Environmental Health Sciences; Submission for OMB Review; Comment Request; The Sister Study PHASE 2: Environmental and Genetic Risk Factors for Breast Cancer, 49877-49878 [E9-23510]
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Federal Register / Vol. 74, No. 187 / Tuesday, September 29, 2009 / Notices
Time and Date: Tuesday, October 13th, 9
a.m.–1 p.m. and 2 p.m.–6 p.m. Eastern.
Place: Meetings will be held in person.
Location TBD.
Status: Open to the public, limited only by
the space available. Conference call line will
be available.
Purpose: The Council brings together
leaders and experts in fields related to the
work of faith-based and neighborhood
organizations in order to: Identify best
practices and successful modes of delivering
social services; evaluate the need for
improvements in the implementation and
coordination of public policies relating to
faith- based and other neighborhood
organizations; and make recommendations
for changes in policies, programs, and
practices.
Contact Person for Additional Information:
Mara Vanderslice, 202–260–1931,
mara.vanderslice@hhs.gov.
Supplementary Information: Please contact
Mara Vanderslice for more information about
how to attend the meeting or join via
conference call line.
Agenda: Topics to be discussed include
deliberation on draft recommendations for
Council report.
Dated: September 24, 2009.
Mara Vanderslice,
Special Assistant.
[FR Doc. E9–23483 Filed 9–28–09; 8:45 am]
BILLING CODE 4154–07–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request
The Impact of Continuing Medical
Education on Physician Practice
jlentini on DSKJ8SOYB1PROD with NOTICES
Summary: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Clinical
Center, 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 May 14, 2009, page 22749
and allowed 60-days for public
comment. One comment was received:
‘These meetings should be on computer
software and the general population of this
nation should be able to attend. This is a very
cheap way to distribute information, the
general public can have some understanding
of what you are telling doctors to do and the
open ness of the project will help all
americans. It is time to stop secret meetings.
They cost more for taxpayers, they don’t get
the message through when videotapes can be
made of the information transmitted. This
1935 style of getting out information is
seriously expensive and a stupid way to do
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16:18 Sep 28, 2009
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business in 2009. Obama said to open up the
process—its time to do that.’
49877
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
The purpose of this notice is to allow
comments and/or suggestions regarding
an additional 30 days for public
the item(s) contained in this notice,
comment. The National Institutes of
Health may not conduct or sponsor, and especially regarding the estimated
public burden and associated response
the respondent is not required to
time, should be directed to the: Office
respond to, an information collection
of Management and Budget, Office of
that has been extended, revised, or
Regulatory Affairs, or by fax to 202–
implemented on or after October 1,
1995, unless it displays a currently valid 395–6974, Attention: Desk Officer for
NIH. To request more information on
OMB control number.
Proposed Collection: Title: The Impact the proposed project or to obtain a copy
of the data collection plans and
of Continuing Medical Education on
Physician Practice. Type of information instruments, contact: Linda Wisniewski,
Collection Request: New. Need and Use Office of Clinical Research Training and
Medical Education, Clinical Center,
of Information Collection: This study
Building 10, Room: 1N252B, 9000
will assess the value of the training
Rockville Pike, Bethesda, MD 20892, or
programs administered by the Office of
call 301–496–9425 or E-mail your
Clinical research Training and Medical
Education. The primary objective of the request, including your address to:
wisniewskil@cc.nih.gov.
survey is to determine if training
Comments Due Date: Comments
programs have had an impact on
regarding this information collection are
whether the trainees are performing
best assured of having their full effect if
clinical research, hold an academic
appointment, have National Institutes of received within 30-days of the date of
this publication.
Health funding sources as well as to
Dated: September 15, 2009.
obtain information from the trainees as
to what part of the National Institutes of Laura Lee,
Health medical education program they Project Clearance Liaison, Warren Grant
feel could be improved upon, the
Magnuson Clinical Center, National Institutes
of Health.
quality of the mentoring program, and
how their National Institutes of Health
[FR Doc. E9–23334 Filed 9–28–09; 8:45 am]
training has contributed to their current BILLING CODE 4140–01–M
clinical competence. Frequency of
Response: On occasion. Affected Public:
DEPARTMENT OF HEALTH AND
Individuals and businesses. Type of
HUMAN SERVICES
Respondents: Physicians, dentists,
medical students, dental students,
National Institutes of Health
nurses, PhDs, and other Health Care
Providers. The annual reporting burden
National Institute of Environmental
is as follows: Estimated Number of
Health Sciences; Submission for OMB
Respondents: 10,000. Estimated Number
Review; Comment Request; The Sister
of Responses per Respondent: 2.
Study PHASE 2: Environmental and
Average Burden Hours per Response:
Genetic Risk Factors for Breast Cancer
0.017; and Estimated Total Annual
Burden Hours Requested: 340.
Summary: Under the provisions of
Request For Comments: Written
Section 3507(a)(1)(D) of the Paperwork
comments and/or suggestions from the
Reduction Act of 1995, the National
public and affected agencies are invited Institute of Environmental Health
on one or more of the following points:
Sciences (NIEHS), the National
(1) Whether the proposed collection of
Institutes of Health (NIH) has submitted
information is necessary for the proper
to the Office of Management and Budget
performance of the function of the
(OMB) a request for review and
agency, including whether the
approval of the information collection
information will have practical utility;
listed below. This proposed information
(2) The accuracy of the agency’s
collection was previously published in
estimate of the burden of the proposed
the Federal Register on 10 July 2009 on
collection of information, including the
page 33259 and allowed 60 days for
validity of the methodology and
public comment. No public comments
assumptions used; (3) Ways to enhance
were received. The purpose of this
the quality, utility, and clarity of the
notice is to allow an additional 30 days
information to be collected; and (4)
for public comment. The National
Ways to minimize the burden of the
Institutes of Health may not conduct or
collection of information on those who
sponsor, and the respondent is not
are to respond, including the use of
required to respond to, an information
appropriate automated, electronic,
collection that has been extended,
mechanical, or other technological
revised, or implemented on or after
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49878
Federal Register / Vol. 74, No. 187 / Tuesday, September 29, 2009 / Notices
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 PHASE 2: Environmental and
Genetic 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 hormonallymediated 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
Estimated
number of
respondents
Activity (3-yrs)
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 (5–10 minutes per
response); and asked to complete short
(60–75 minutes, total) updates 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
responses per
respondent
Average
burden hours
per response
Estimated total
burden hours
requested
50,000
50,000
1800
300
2100
2
1
1
1
1
0.085
1.25
0.33
0.33
0.25
8,500
62,500
594
99
525
Total ..........................................................................................................
jlentini on DSKJ8SOYB1PROD with NOTICES
Annual Updates ...............................................................................................
Bi/Trienniel Follow-Up ......................................................................................
Incident BC Case Follow-Up ...........................................................................
Incident Other Case Follow-Up .......................................................................
Incident Case Medical Office Contact .............................................................
........................
........................
........................
72,218
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 × 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 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
VerDate Nov<24>2008
16:18 Sep 28, 2009
Jkt 217001
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,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, 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: 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
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best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: September 22, 2009.
Marc Hollander,
NIEHS, Associate Director for Management.
[FR Doc. E9–23510 Filed 9–28–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
E:\FR\FM\29SEN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 187 (Tuesday, September 29, 2009)]
[Notices]
[Pages 49877-49878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23510]
-----------------------------------------------------------------------
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 PHASE 2:
Environmental and Genetic 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 10 July 2009 on page 33259 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
[[Page 49878]]
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 PHASE 2: Environmental
and Genetic 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 (5-10 minutes per response); and asked to
complete short (60-75 minutes, total) updates 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 2 0.085 8,500
Bi/Trienniel Follow-Up.......................... 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
----------------------------------------------------------------------------------------------------------------
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 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
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: 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 30-days
of the date of this publication.
Dated: September 22, 2009.
Marc Hollander,
NIEHS, Associate Director for Management.
[FR Doc. E9-23510 Filed 9-28-09; 8:45 am]
BILLING CODE 4140-01-P
