[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]


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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.

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                                                     Estimated       Number of    Average burden
                    Activity                       annual number   reponses per    per response    Total burden
                                                  of respondents    respondent      (in hours)    hours per year
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Annual Update...................................          32,215               1           10/60           5,369
Follow-Up III (triennial).......................          16,108               1           40/60          10,739
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    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