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	Removed
Form 1 Incident Other Case Follow-Up Form and Instruction	Removed
Form 1 Incident BC Case Follow-Up Form and Instruction	Removed
Form 1 Bi/Trienniel Follow-Up Form and Instruction	Modified
SISOMB2012suppstmtBver1final.doc Supporting Statement B	2012-10-26
SISOMB2012att3consults.pdf Supplementary Document	2012-10-26
SISOMB2012att4StaffConf.pdf Supplementary Document	2012-10-26
SISOMB2012att5CofC.pdf Supplementary Document	2012-10-26
SISOMB2012att6irbinit.pdf Supplementary Document	2012-10-26
SISOMB2012att7CGIRBinit.pdf Supplementary Document	2012-10-26
SISOMB2012att8IRBCR.pdf Supplementary Document	2012-10-26
SIS_CGIRB_CR_Approval_20120927_Att9.pdf Supplementary Document	2012-10-26
SISOMB2012att10consent.pdf Supplementary Document	2012-10-26
SISOMB2012att11stress.pdf Supplementary Document	2012-10-26
SISOMB2012suppstmtAver1_1final10-24.doc Supporting Statement A	2012-10-26

IC Document Collections

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

ICR Details

OMB Control No: 0925-0522	ICR Reference No: 201211-0925-004
Status: Historical Active	Previous ICR Reference No: 200909-0925-005
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: 02/04/2013
	Date Received in OIRA: 11/09/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2016	36 Months From Approved	02/28/2013
Responses	50,884	0	154,200
Time Burden (Hours)	26,855	0	72,218
Cost Burden (Dollars)	0	0	0

---

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.

---

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 48993	08/15/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 66851	11/07/2012
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
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
Annual Updates	1, 1	SIS_OMB_2012_WebScreenShots_20121024 Att 12 ,   SIS_Annual_Forms_20121018_Att 1A
Bi/Trienniel Follow-Up	1, 1	SIS_Triennial_Forms_20121018_Att 2A ,   SIS_Biennial_Triennial_FollowupScripts_20121018_Att 2C

---

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	50,884	154,200	0	0	-103,316	0
Annual Time Burden (Hours)	26,855	72,218	0	0	-45,363	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $5,682,612

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]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

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: 11/09/2012

---