[Federal Register Volume 81, Number 38 (Friday, February 26, 2016)]
[Notices]
[Page 9865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04179]



[[Page 9865]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request The Sister 
Study: A Prospective Study of the Genetic and Environmental Risk 
Factors for Breast Cancer (NIEHS)

SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, 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 02 December 2015, Vol. 80, page 75465 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 Institute of Environmental Health Sciences (NIEHS), 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 October 1, 1995, unless 
it displays a currently valid OMB control number.
    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: NIH Desk Officer.

DATES: Comment 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.

FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data 
collection plans and instruments 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.
    Proposed Collection: Revision: The Sister Study: A Prospective 
Study of the Genetic and Environmental Risk Factors for Breast Cancer, 
0925-0522, National Institute of Environmental Health Sciences (NIEHS), 
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.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 16,350.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                  Annual  number     Number of      burden per     Total burden
                    Activity                            of         reponses per      response     hours per year
                                                    respondents     respondent        (hours)
----------------------------------------------------------------------------------------------------------------
Annual Update...................................          32,215               1           10/60           5,369
Follow-Up III (triennial).......................          16,108               1           40/60          10,739
Follow-Up III Telephone Prompting Script........         4,832 *               1            3/60             242
                                                 ---------------------------------------------------------------
    Total per year..............................          48,323  ..............  ..............          16,350
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* These Respondents are included in the 16,108 for Follow-Up III, thus not added into Total Respondents per
  year.


    Dated: February 19, 2016.
Jane Lambert,
Project Clearance Liaison, NIEHS.
[FR Doc. 2016-04179 Filed 2-25-16; 8:45 am]
 BILLING CODE 4140-01-P