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

Forms and Documents

Document Name	Status
Form 1 Annual Updates Form and Instruction	Modified
Form 1 Incident Case Medical Office Contact Form and Instruction	New
Form 1 Incident Other Case Follow-Up Form and Instruction	New
Form 1 Incident BC Case Follow-Up Form and Instruction	New
Form 1 Bi/Trienniel Follow-Up Form and Instruction	New
SISOMB2009suppstatementB.pdf Supporting Statement B	2009-09-28
SISOMB2009att9consent.pdf Supplementary Document	2009-09-28
SISOMB2009att5sssconf.pdf Supplementary Document	2009-09-28
SISOMB2009att3consults.pdf Supplementary Document	2009-09-28
SISOMB2009att8IRBCRAPPR.pdf Supplementary Document	2009-09-28
SISOMB2009att7irbinit.pdf Supplementary Document	2009-09-28
SISOMB2009att6CofC.pdf Supplementary Document	2009-09-28
SISOMB2009att4sysrec.pdf Supplementary Document	2009-09-28
SISOMB2009att10stress.pdf Supplementary Document	2009-09-28
SISOMB2009suppstatementArev3.pdf Supporting Statement A	2009-09-28

IC Document Collections

IC ID	Document Title	Status
43630	Annual Updates Form and Instruction	Modified
190836	Incident Case Medical Office Contact Form and Instruction	New
190835	Incident Other Case Follow-Up Form and Instruction	New
190834	Incident BC Case Follow-Up Form and Instruction	New
190833	Bi/Trienniel Follow-Up Form and Instruction	New

ICR Details

OMB Control No: 0925-0522	ICR Reference No: 200909-0925-005
Status: Historical Active	Previous ICR Reference No: 200604-0925-004
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 without change	Conclusion Date: 11/06/2009
	Date Received in OIRA: 09/29/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2012	36 Months From Approved	11/30/2009
Responses	154,200	0	82,340
Time Burden (Hours)	72,218	0	64,710
Cost Burden (Dollars)	0	0	0

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Abstract: The NIEHS Sister Study is a prospective epidemiological study to examine environmental and familial risk factors for breast cancer and other diseases in a high-risk cohort of 50,000 sisters of women who have had breast cancer. Such sisters have at least twice the risk of developing breast cancer as other women. The frequency of any relevant genes and shared risk factors will also be higher, increasing the statistical power of the study to detect risks. Sisters in the cohort are highly motivated, and response rates and compliance over time continue to be high. Thus, studying these sisters will enhance our ability to assess the interplay of genes and environment in breast cancer risk and to identify potentially preventable risk factors. The prospective design will allow us to assess exposures before the onset of disease and avoid biases common to retrospective studies. The study creates a framework from which to test new hypotheses as they emerge.

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 33259	07/10/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 49877	09/29/2009
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Annual Updates	1, 2	survey ,   survey
Bi/Trienniel Follow-Up	1, 2	survey ,   survey
Incident BC Case Follow-Up	1, 2	survey ,   survey
Incident Other Case Follow-Up	1, 2	survey ,   survey
Incident Case Medical Office Contact	1, 2	survey ,   survey

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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	154,200	82,340	0	71,860	0	0
Annual Time Burden (Hours)	72,218	64,710	0	7,508	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: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Changes in burden and annualized cost merely reflect the anticipated progress and the next scheduled phases of the longitudinal study. With enrollment now complete, total burden request decreases from 194,131 hours over 3 years (in 2006 revision) to 72,218 hours over 3 years (for 2009 revision). This does not however represent a change in Protocol -- merely completion of the Enrollment Phase of the Protocol, and normal as-planned progression of follow-up.

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Annual Cost to Federal Government: $7,447,122

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)? No

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: 09/29/2009

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