Women's Health Initiative Observational Study (NHLBI)

Forms and Documents

Document Name	Status
Form 1 OS Participants Form	Modified
Form 1 Physician/Office Staff Form	Modified
WHI Supporting Statement Part B 12-09.docx Supporting Statement B	2010-03-31
SSB_Attachment 1_Data Collection Background.pdf Supplementary Document	2010-03-31
SSA_Attachment 7_IRB Approvals.pdf Supplementary Document	2010-03-31
SSA_Attachment 6_Cert of Confidentiality.pdf Supplementary Document	2010-03-31
SSA_Attachment 5_NHLB Council Minutes.pdf Supplementary Document	2010-03-31
SSA_Attachment 4_Data Collection Background.pdf Supplementary Document	2010-03-31
SSA_Attachment 3_HCP Data Collection List.pdf Supplementary Document	2010-03-31
SSA_Attachment 2_Next of Kin Data Collection List.pdf Supplementary Document	2010-03-31
SSB_Attachment 3_Sample participant newsletter.pdf Supplementary Document	2010-03-31
SSA_Attachment 1_OS Data Collection Instrument List.pdf Supplementary Document	2010-03-31
SSB_Attachment 2_OS Adjudicator Forms List.pdf Supplementary Document	2010-03-31
WHI Supporting Statement Part A revised 2-26-10.docx Supporting Statement A	2010-03-31

IC Document Collections

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

ICR Details

OMB Control No: 0925-0414	ICR Reference No: 201005-0925-001
Status: Historical Active	Previous ICR Reference No: 200903-0925-003
Agency/Subagency: HHS/NIH	Agency Tracking No:
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: 07/20/2010
	Date Received in OIRA: 05/10/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2013	36 Months From Approved	05/31/2012
Responses	48,549	0	70,725
Time Burden (Hours)	19,880	0	23,607
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:
	75 FR 3237	01/20/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 17411	04/06/2010
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, 2, 3, 4, 4, 6, 7, 8	33 Medical History Update ,   F151 Activities of Daily Living ,   F80 Physical Measurements ,   Functional Status ,   F100 Blood Collection ,   F153 Meds ,   F154 Breast CA meds ,   F155 Lifestyle
Next of Kin	2, 1	questionaire ,   F24 Retention Worksheet
Physician/Office Staff	1	F120 Death

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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	48,549	70,725	0	0	-22,176	0
Annual Time Burden (Hours)	19,880	23,607	0	0	-3,727	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: $3,338,733

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]? 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: 05/10/2010

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