[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Notices]
[Pages 66851-66852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27237]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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 15 August 2012 on page 48993 and allowed 60-days for public comment.
1 public comment was received. The purpose of this notice is to allow
an additional 30 days for public comment.
5 CFR 1320.5 (General requirements) Reporting and Recordkeeping
Requirements: Final Rule requires that the agency inform the potential
persons who are to respond to the collection of information that such
persons are not required to respond to the collection of information
unless it displays a currently valid OMB control number. This
information is required to be stated in the 30-day Federal Register
Notice.
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. Need and Use of
Information Collection: This is to continue the Phase II follow-up of
the Sister Study -- a study of 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. 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. From August 2003 through July 2009, we enrolled a
cohort of 50,884 women who had not had breast cancer. We estimated that
after the cohort was fully enrolled, approximately 300 new cases of
breast cancer will be diagnosed during each year of follow-up. Thus far
1,634 participants have reported being diagnosed with breast cancer.
Frequency of Response: For the remainder of the study, women will be
contacted once each year (when not scheduled for ``triennial'') to
update contact information and health status (10 minutes per response);
and asked to complete short (75 minutes per response) follow-up
interviews or questionnaires (``triennial'') every three years. Follow-
up and validation of reported incident breast cancer and other health
outcomes is conducted under Clinical Exemption CE 2009-09-004. Affected
Public: Study participants, next-of-kin/proxies. Type of Respondents:
Participants enrolled in high-risk cohort study of risk factors for
breast cancer; next-of-kin/proxies. The annual reporting burden is as
follows: Estimated Number of Respondents: 50,884 study participants or
next-of-kin/proxies. Estimated Number of Responses per Respondent: See
annualized table below:
Estimated Annualized Burden Hours
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Estimated
Estimated Estimated Average burden total burden
Activity number of responses per hours per hours
respondents respondent response requested
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Annual Updates.................................. 33,923 1 10/60 5,654
Follow-Up II (triennial)........................ 16,961 1 1.25 21,202
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Total....................................... .............. .............. .............. 26,856
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Average Burden Hours Per Response: 42 minutes; and Estimated Total
Annual Burden Hours Requested: 26,856. The estimated total annualized
cost to respondents $537,120 (assuming $20 hourly wage x 26,856). There
are no capital, operating, or maintenance costs.
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
[[Page 66852]]
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.
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, [email protected] or by fax to 202-395-6974,
Attention: Desk Officer for NIH. 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, P.O. Box 12233, Research Triangle Park, NC
27709, or call non-toll free number (919) 541-4668 or Email 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 30-days
of the date of this publication.
Dated: October 25, 2012.
Joellen M. Austin,
Associate Director for Management.
[FR Doc. 2012-27237 Filed 11-6-12; 8:45 am]
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