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

ICR 201602-0925-013

OMB: 0925-0522

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
New
Form and Instruction
Modified
Supplementary Document
2016-02-26
Supporting Statement B
2016-02-24
Supplementary Document
2016-02-22
Supplementary Document
2016-02-22
Supplementary Document
2016-02-22
Supplementary Document
2016-02-22
Supplementary Document
2016-02-22
Supplementary Document
2016-02-22
Supplementary Document
2016-02-22
Supporting Statement A
2016-02-22
ICR Details
0925-0522 201602-0925-013
Historical Active 201211-0925-004
HHS/NIH
The Sister Study: PHASE 3 Environmental and Generic Risk Factors for Breast Cancer
Revision of a currently approved collection   No
Regular
Approved without change 05/26/2016
Retrieve Notice of Action (NOA) 02/29/2016
  Inventory as of this Action Requested Previously Approved
05/31/2019 36 Months From Approved 05/31/2016
53,155 0 50,884
16,350 0 26,855
0 0 0

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).

US Code: 42 USC Chap.6A,Subchap. III Sect. 281 Name of Law: Health Research Extension Act
  
None

Not associated with rulemaking

  80 FR 75465 12/02/2015
81 FR 9865 02/26/2016
No

  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
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
This ICR is being submitted as a revision request.

$4,156,725
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Tawanda Abdelmouti 240 276-5530 ta401@nih.gov

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
02/29/2016


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