The Sister Study: PHASE 3 Environmental and Generic Risk Factors for Breast Cancer

Forms and Documents

Document Name	Status
Form 1 Annual Updates Form and Instruction	Modified
Form 3 Follow-up III Telephone Prompting Script Form and Instruction	New
Form 2 Follow-Up (triennial) Form and Instruction	Modified
0925-0522 Sister Study 30-Day FR Published 2016-04179.pdf Supplementary Document	2016-02-26
SISOMB2016SuppStmtB20160219.docx Supporting Statement B	2016-02-24
SISOMB2016ATTACHMENT9ReportsREVISED20160219.pdf Supplementary Document	2016-02-22
SISOMB2016ATTACHMENT8Stress20160219.pdf Supplementary Document	2016-02-22
SISOMB2016ATTACHMENT7IRBcopernicusIRBCR20160219.pdf Supplementary Document	2016-02-22
SISOMB2016ATTACHMENT6NIEHSIRBCR20160219.pdf Supplementary Document	2016-02-22
SISOMB2016ATTACHMENT5CertificateOfConfidentiality20160219.pdf Supplementary Document	2016-02-22
SISOMB2016ATTACHMENT4StaffConfidentiality20160219.pdf Supplementary Document	2016-02-22
SISOMB2016ATTACHMENT3consultation20160219.pdf Supplementary Document	2016-02-22
SISOMB2016SuppStmtAfinal20160219.docx Supporting Statement A	2016-02-22

IC Document Collections

IC ID	Document Title	Status
43630	Annual Updates Form and Instruction	Modified
220199	Follow-up III Telephone Prompting Script Form and Instruction	New
190833	Follow-Up (triennial) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0522	ICR Reference No: 201602-0925-013
Status: Historical Active	Previous ICR Reference No: 201211-0925-004
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The Sister Study: PHASE 3 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: 05/26/2016
	Date Received in OIRA: 02/29/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2019	36 Months From Approved	05/31/2016
Responses	53,155	0	50,884
Time Burden (Hours)	16,350	0	26,855
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 50,884 sisters of women who have had breast cancer. The cohort was initially recruited between Aug 2003 and Aug 2009. T The intention is for the cohort to be followed for 10 or more years. This approval is for administering triennial questionnaires on the remaining cohort (48,323 women). Approval is requested for 3 years. Annual Update form (ATTACHMENT 1A) used yearly is submitted here with minor changes for continued approval. Detailed Follow-Up II forms have been modified and are submitted here for continued use in Follow-Up III (triennial; ATTACHMENT 2A).

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Authorizing Statute(s): US Code: 42 USC Chap.6A,Subchap. III Sect. 281 Name of Law: Health Research Extension Act
  

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:
	80 FR 75465	12/02/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 9865	02/26/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Follow-up III Telephone Prompting Script	3	Follow-Up Phone script
Annual Updates	1	Attachment 1 Annual Update screenshot
Follow-Up (triennial)	2	Attachment 2d Follow-up WebScreen shot

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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	53,155	50,884	0	2,271	0	0
Annual Time Burden (Hours)	16,350	26,855	0	-10,505	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: This ICR is being submitted as a revision request.

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Annual Cost to Federal Government: $4,156,725

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

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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: 02/29/2016

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