Women's Health Initiative Observational Study (NHLBI)

Forms and Documents

Document Name	Status
Form 1 OS Participants Form	Modified
Rev.Supporting Statement Part B.doc Supporting Statement B	2009-03-04
SS_B_Attachment_16-Sample Participant Newsletter.pdf Supplementary Document	2009-03-04
SS_B_Attachment_15-Model_Medical_Release_Form.pdf Supplementary Document	2009-03-04
SS_B_Attachment_14-OS_Adjudicator_Form_Instructions.pdf Supplementary Document	2009-03-04
SS_B_Attachment_13-OS_Adjudicator_Forms.pdf Supplementary Document	2009-03-04
SS_A_Attachment_9-NHLBI_Advisory_Council_Minutes.pdf Supplementary Document	2009-03-04
SS_A_Attachment_1-Legislative_Authority.pdf Supplementary Document	2009-03-04
SS_A_Attachment_12-IRB_Approvals.pdf Supplementary Document	2009-03-04
SS_A_Attachment_11-Certificate_of_Confidentiality.pdf Supplementary Document	2009-03-04
SS_A_Attachment_10-Privacy_Act_System_of_Records.pdf Supplementary Document	2009-03-04
Rev Supporting Statement Part A.doc Supporting Statement A	2009-03-04

IC Document Collections

IC ID	Document Title	Status
7310	OS Participants Form	Modified
188611	Physician/Office Staff Instruction	New
188610	Next of Kin Instruction	New

ICR Details

OMB Control No: 0925-0414	ICR Reference No: 200903-0925-003
Status: Historical Active	Previous ICR Reference No: 200602-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Women's Health Initiative Observational Study (NHLBI)
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/08/2009
	Date Received in OIRA: 03/31/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2012	36 Months From Approved	05/31/2009
Responses	70,725	0	88,131
Time Burden (Hours)	23,607	0	18,319
Cost Burden (Dollars)	0	0	0

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Abstract: The WHI Observational Study will provide needed information on health and disease risk for women. The study will collect data from 86,886 menopausal women on biomarkers and risk factors for disease and the women will be followed for an average of 8 years to determine associations of these requirements with disease. The aggregate information will be analyzed and reported in appropriate journals.

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Authorizing Statute(s): US Code: 42 USC 241(c) Name of Law: Public Health Service 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:
	73 FR 79889	12/30/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 10944	03/13/2009
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
OS Participants	1	questionaire
Next of Kin	2	questionaire
Physician/Office Staff	3	questionaire

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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	70,725	88,131	0	0	-17,406	0
Annual Time Burden (Hours)	23,607	18,319	0	0	5,288	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:

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Annual Cost to Federal Government: $3,973,184

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: 03/31/2009

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