[Federal Register Volume 74, Number 187 (Tuesday, September 29, 2009)]
[Notices]
[Pages 49877-49878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23510]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute of Environmental Health Sciences; Submission 
for OMB Review; Comment Request; The Sister Study PHASE 2: 
Environmental and Genetic 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 10 July 2009 on page 33259 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 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

[[Page 49878]]

October 1, 1995, unless it displays a currently valid OMB control 
number.
    5 CFR 1320.5: Reporting and Recordkeeping Requirements: Final Rule: 
Respondents to this collection of information are not required to 
respond unless the data collection instruments display a currently 
valid OMB control number.
    Proposed Collection: Title: The Sister Study PHASE 2: Environmental 
and Genetic Risk Factors for Breast Cancer. Type of Information 
Collection Request: Revision of OMB No. 0925-0522 and expiration date 
30 September 2009. Need and Use of Information Collection: The purpose 
of the Sister Study is to study 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. In the United States, 
approximately 192,370 new cases of invasive breast cancer are 
anticipated in 2009. 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. We 
have enrolled a cohort of 50,000 women who have not had breast cancer. 
Recruitment took place from August 2003 through July 2009. We estimate 
that in the cohort of 50,000 sisters, aged 35-74 at enrollment, 
approximately 300 new cases of breast cancer will be diagnosed during 
each year of follow-up. Frequency of Response: For the remainder of the 
study, women will be contacted once each year to update contact 
information and health status (5-10 minutes per response); and asked to 
complete short (60-75 minutes, total) updates every two-to-three years. 
Women diagnosed with breast cancer or other health outcomes of interest 
are asked to provide additional information about their diagnosis (20 
minutes per response) and their doctors will be contacted to provide 
medical records related to diagnosis and treatments (15 minutes per 
response). Affected Public: Study participants; medical office staff. 
Type of Respondents: Participants enrolled in high-risk cohort study of 
risk factors for breast cancer. The annual reporting burden is as 
follows: Estimated Number of Respondents: 50,000 study participants and 
2100 medical office staff. Estimated Number of Responses per 
Respondent: See table below:

----------------------------------------------------------------------------------------------------------------
                                                                                                     Estimated
                                                     Estimated       Estimated    Average burden   total burden
                Activity (3-yrs)                     number of     responses per     hours per         hours
                                                    respondents     respondent       response        requested
----------------------------------------------------------------------------------------------------------------
Annual Updates..................................          50,000               2           0.085           8,500
Bi/Trienniel Follow-Up..........................          50,000               1            1.25          62,500
Incident BC Case Follow-Up......................            1800               1            0.33             594
Incident Other Case Follow-Up...................             300               1            0.33              99
Incident Case Medical Office Contact............            2100               1            0.25             525
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............          72,218
----------------------------------------------------------------------------------------------------------------

    Average Burden Hours Per Response: 0.7 hour; and Estimated Total 
Burden Hours Requested: 72,218 (over 3 years). The average annual 
burden hours requested is 24,073. The annualized cost to respondents is 
estimated at $14 (assuming $20 hourly wage x 0.7 hour). There are no 
Capital Costs to report. There are no Operating or Maintenance Costs to 
report.
    Request for Comments: Written comments and/or suggestions from the 
public and affected agencies should address one or more of the 
following points: (1) Evaluate whether the proposed collection of 
information is necessary for the proper performance of the function of 
the agency, including whether the information will have practical 
utility; (2) Evaluate 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) Enhance the 
quality, utility, and clarity of the information to be collected; and 
(4) 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 
proposed 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, PO Box 12233, Research Triangle Park, NC 
27709 or call non-toll-free number (919) 541-4668 or E-mail 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: September 22, 2009.
Marc Hollander,
NIEHS, Associate Director for Management.
[FR Doc. E9-23510 Filed 9-28-09; 8:45 am]
BILLING CODE 4140-01-P