[Federal Register Volume 80, Number 231 (Wednesday, December 2, 2015)]
[Notices]
[Pages 75465-75466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30527]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; The Sister Study: A
Prospective Study of the Genetic and Environmental Risk Factors for
Breast Cancer (NIEHS)
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.
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
[[Page 75466]]
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.
To Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, 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]. Formal requests for additional plans and
instruments must be requested in writing.
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.
Proposed Collection: The Sister Study: A Prospective Study of the
Genetic and Environmental Risk Factors for Breast Cancer, Revision OMB
#0925-0522 Expiration Date: 2/29/2016, National Institute of
Environmental Health Sciences (NIEHS), the National Institutes of
Health (NIH).
Need and Use of Information Collection: This is to continue the
long-term 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 2,904 participants have reported being
diagnosed with breast cancer.
----------------------------------------------------------------------------------------------------------------
Estimated Number of Average burden
Activity annual number reponses per per response Total burden
of respondents respondent (in hours) hours per year
----------------------------------------------------------------------------------------------------------------
Annual Update................................... 32,215 1 10/60 5,369
Follow-Up III (triennial)....................... 16,108 1 40/60 10,739
----------------------------------------------------------------------------------------------------------------
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 16,108.
Dated: November 23, 2015.
Laurie K. Johnson,
Acting Deputy Associate Director for Management, NIEHS.
[FR Doc. 2015-30527 Filed 12-1-15; 8:45 am]
BILLING CODE 4140-01-P