Women's Health Initiative Observational Study (NHLBI)

Forms and Documents

Document Name	Status
Form 33 OS Participants Form and Instruction	Modified
Form 120 Physician/Office Staff Form and Instruction	Modified
Form 23 Next of Kin Form and Instruction	Modified
WHI Support_Stmt_B2013.docx Supporting Statement B	2013-05-10
SSA_Attachment 1_Data Collection Instruments v2.pdf Supplementary Document	2013-05-29
SSB_Attachment 3_Participant Newsletter.pdf Supplementary Document	2013-05-10
SSB_Attachment 2_OS Adjudicator Forms List.pdf Supplementary Document	2013-05-10
SSB_Attachment 1_Data Collection Background.pdf Supplementary Document	2013-05-10
SSA_Attach5_IRB Authorizations.pdf Supplementary Document	2013-05-10
SSA_Attachment 4_Certificate of Confidentiality.pdf Supplementary Document	2013-05-10
SSA_Attachment 2_Data Collection Background.pdf Supplementary Document	2013-05-10
SSA_Attachment 3_NHLB Council Minutes.pdf Supplementary Document	2013-05-10
F156S Supplemental OMB-1-22-13.pdf Supplementary Document	2013-05-29
WHI support_stmt_a2013 revised 5-10-2013.docx Supporting Statement A	2013-05-23

IC Document Collections

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

ICR Details

OMB Control No: 0925-0414	ICR Reference No: 201306-0925-001
Status: Historical Active	Previous ICR Reference No: 201005-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No: 19557
Title: Women's Health Initiative Observational Study (NHLBI)
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: 07/08/2013
	Date Received in OIRA: 06/05/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2016	36 Months From Approved	07/31/2013
Responses	42,448	0	48,549
Time Burden (Hours)	13,927	0	19,880
Cost Burden (Dollars)	0	0	0

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Abstract: This study will be used by the NIH to evaluate risk factors for chronic disease among older women by developing and following a large cohort of postmenopausal women and relating subsequent disease development to baseline assessments of historical, physical, psychosocial, and physiologic characteristics. In addition, the observational study will complement the clinical trial (which has received clinical exemption) and provide additional information on the common causes of frailty, disability and death for postmenopausal women, namely, coronary heart disease, breast and colorectal cancer, and osteoporotic fractures. Continuation of follow-up for ascertainment of medical history update forms will provide essential data for outcomes assessment for this population of aging women.

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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:
	78 FR 8152	02/05/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 32406	05/30/2013
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
Next of Kin	23, 120	Search to Locate Participants ,   Initial Notification of Death
Physician/Office Staff	120	Initial Notification of Death
OS Participants	33, 20, 151, 156	Medical History Update ,   Personal Information Update ,   Activities of Daily Life ,   Supplemental 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	42,448	48,549	0	-6,105	4	0
Annual Time Burden (Hours)	13,927	19,880	0	-5,969	16	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: Yes

Burden Reduction Due to: Changing Forms

Short Statement: The total annual respondent hours requested in this submission is 14,023, compared to the current inventory of 19,880. This reduction in burden results from a program adjustment. It is primarily due to the completion of face to face visits and medication inventories that were included in the last three-year period.

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Annual Cost to Federal Government: $3,338,733

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: 06/05/2013

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