[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Pages 66851-66852]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-27237]



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 
    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
                                                     Estimated       Estimated    Average burden   total burden
                    Activity                         number of     responses per     hours per         hours
                                                    respondents     respondent       response        requested
Annual Updates..................................          33,923               1           10/60           5,654
Follow-Up II (triennial)........................          16,961               1            1.25          21,202
    Total.......................................  ..............  ..............  ..............          26,856

    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 
    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 
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: 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: October 25, 2012.
Joellen M. Austin,
Associate Director for Management.
[FR Doc. 2012-27237 Filed 11-6-12; 8:45 am]