Women's Health Initiative Observational Study (NHLBI)

Forms and Documents

Document Name	Status
Form 33 OS Participants Form and Instruction	Removed
Form 4 Initial Notification of Death Physician/Office Staff Form	New
Form 4 Initial Notification of Death Next of Kin Form	New
Form 3 Participants Personal Information Update Form	New
Form 2 Participants Activities of Daily Life Form	New
Form 1 Participants Medical History Update Form	New
Form 120 Physician/Office Staff Form and Instruction	Removed
Form 23 Next of Kin Form and Instruction	Removed
30-day FRN2016-14057.pdf Supplementary Document	2016-06-15
Revised_Supporting Statement A Passback SEL comments Passback.doc Supporting Statement A	2016-08-02
SSB_Attachment 3_Participant Newsletter.pdf Supplementary Document	2016-06-08
SSB_Attachment 2_OS Adjudicator Forms List.pdf Supplementary Document	2016-06-08
SSB_Attachment 1_Data Collection Background.pdf Supplementary Document	2016-06-08
Revised_Supporting Statement B FINAL.doc Supporting Statement B	2016-08-02
SSA Attachment 4 IRBs.pdf Supplementary Document	2016-06-08
SSA Attachment 3 Cert of Conf.pdf Supplementary Document	2016-06-08
SSA Attachment 2 Council Minutes.pdf Supplementary Document	2016-06-08
SSA Attachment 1 Study Procedures.pdf Supplementary Document	2016-06-08

IC Document Collections

IC ID	Document Title	Status
7310	OS Participants Form and Instruction	Removed
221833	Initial Notification of Death Physician/Office Staff Form	New
221832	Initial Notification of Death Next of Kin Form	New
221828	Participants Personal Information Update Form	New
221827	Participants Activities of Daily Life Form	New
221821	Participants Medical History Update Form	New
188611	Physician/Office Staff Form and Instruction	Removed
188610	Next of Kin Form and Instruction	Removed

ICR Details

OMB Control No: 0925-0414	ICR Reference No: 201606-0925-004
Status: Historical Active	Previous ICR Reference No: 201306-0925-001
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: 08/02/2016
	Date Received in OIRA: 06/15/2016
Terms of Clearance: The agency is required to display the OMB Control Number and inform respondents of its legal significance in accordance with 5 CFR 1320.5(b).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved	07/31/2016
Responses	121,524	0	42,448
Time Burden (Hours)	10,796	0	13,927
Cost Burden (Dollars)	0	0	0

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Abstract: The Women's Health Initiative (WHI) is a long-term national health study that has focused on strategies for preventing heart disease, breast and colorectal cancer, and osteoporotic fractures in postmenopausal women. These chronic diseases are the major causes of death, disability, and frailty in older women of all races and socioeconomic backgrounds. This multi-million dollar, 15-year project, sponsored by the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), involves 161,808 women aged 50-79, and is one of the most definitive, far-reaching clinical trials of post-menopausal women's health ever undertaken in the U.S. The WHI Clinical Trial and Observational Study focused on many of the inequities in women's health research and will continue to provide practical information to women and their physicians about hormone therapy, dietary patterns, calcium/vitamin D supplementation, and their effects on the prevention of heart disease, cancer and osteoporotic fractures. The WHI had two major parts: a randomized Clinical Trial and an Observational Study. The randomized controlled Clinical Trial (CT) enrolled 68,132 postmenopausal women between the ages of 50-79 into trials testing three prevention strategies. If eligible, women could choose to enroll in one, two, or all three of the trial components.

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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:
	81 FR 19207	04/04/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 39058	06/15/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
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
Next of Kin	23, 120	Search to Locate Participants ,   Initial Notification of Death
Participants Medical History Update	1	Medical History Update
Participants Personal Information Update	3	Personal Information Update
Participants Activities of Daily Life	2	Activities of Daily Life
Initial Notification of Death Next of Kin	4	Initial Notification of Death
Initial Notification of Death Physician/Office Staff	4	Initial Notification of 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	121,524	42,448	0	79,076	0	0
Annual Time Burden (Hours)	10,796	13,927	0	-3,131	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: REVISION - This reduction is primarily due to the completion of data collection for Form 156 (Supplemental Questionnaire) that was included in the last three-year OMB submission.

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Annual Cost to Federal Government: $3,313,170

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: 06/15/2016

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