Federal Register / Vol. 74, No. 131 / Friday, July 10, 2009 / Notices 33259 

Seleda Perryman, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. E9–16381 Filed 7–9–09; 8:45 am] 

BILLING CODE 4150–30–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; The Sister Study: A 

Prospective Study of the Genetic and 

Environmental Risk Factors for Breast 

Cancer 

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. 

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 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 highrisk 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 geneenvironment 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 (10 minutes per 

response); and asked to complete short 

(60–75 minutes, total) follow-up 

interviews or questionnaires 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: 

Activity (3–yrs) 

Estimated 

number of 

respondents 

Estimated 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated 

total burden 

hours requested 

Annual Updates ............................................................................................... 50,000 1 0.17 8,500 

Biennial Follow-Up Questionnaire ................................................................... 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 × 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 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 

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. 

FOR FURTHER INFORMATION CONTACT: 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, 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: 

‘‘sandler@niehs.nih.gov.’’ 

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. 

Dated: July 1, 2009. 

Marc S. Hollander, 

Associate Director for Management. 

[FR Doc. E9–16372 Filed 7–9–09; 8:45 am] 

BILLING CODE 4140–01–P 


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