The Sister Study: Environmental and Generic Risk Factors for Breast Cancer

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
43630	The Sister Study: Environmental and Generic Risk Factors for Breast Cancer	Migrated

ICR Details

OMB Control No: 0925-0522	ICR Reference No: 200604-0925-004
Status: Historical Active	Previous ICR Reference No: 200305-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The Sister Study: Environmental and Generic Risk Factors for Breast Cancer
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/19/2006
	Date Received in OIRA: 04/20/2006
Terms of Clearance: Approved consistent with NIH documents and memos submitted to OMB. With respect to the prior terms of clearance: 1 and 2) OMB had reviewed NIEHS' responses to items 1 and 2 (re: study oversight) in 2003. Documentation was provided. 3) There was likely a miscommunication regarding the Vanguard phase; perhaps the terms of clearance were actually written before the agreement was reached. Regardless, however, the "term" was meant to cover substantive changes in content. Since NIEHS did not make any such changes (as per the response provided), there is nothing additional that they needed to do here (other than document that no changes in content were made). 4) The concept behind this term was really to assure that all relevant agencies were involved so that consistent decisions could be made about investments in laboratory methods, capacity, and storage for biomarkers as well as ensuring broad knowledge of this resource across agencies to so that other agencies could capitalize on both the methods generated and the data available, thereby avoiding duplication of effort. Appropriate agencies seem to be on the advisory board. Publication of articles regarding the study design and recruitment are in the works which will further disseminate information. 5) In general, the oversight plan looks fine. OMB suggested that the "Sister Study Collaborative Application" be modified to include questions regarding the availability of data for the confounders and effect modifiers appropriate for the hypothesis being tested (this is slightly different from the questions being asked in E10). 6) The recruitment, enrollment, and (limited) follow up rates for the Sister Study thus far are impressive.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2009	36 Months From Approved	09/30/2006
Responses	82,340	0	67,527
Time Burden (Hours)	64,710	0	63,438
Cost Burden (Dollars)	0	0	0

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Abstract: This is an investigation of the independent and joint effects of genetic susceptibility and environmental, biological, and lifestyle factors on the risk of breast cancer. A cohort of 50,000 women ages 35-74 who are the cancer free sisters of women who have had breast cancer will be followed for 10 or more years. Baseline questionnaire data, fasting blood, first morning urine, dust and toenail samples will be obtained.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
The Sister Study: Environmental and Generic Risk Factors for Breast Cancer

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	82,340	67,527	0	14,813	0	0
Annual Time Burden (Hours)	64,710	63,438	0	1,272	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 04/20/2006

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