Women's Health Initiative Observational Study (NHLBI)

ICR 201005-0925-001

OMB: 0925-0414

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Modified
Form
Modified
Supporting Statement B
2010-03-31
Supplementary Document
2010-03-31
Supplementary Document
2010-03-31
Supplementary Document
2010-03-31
Supplementary Document
2010-03-31
Supplementary Document
2010-03-31
Supplementary Document
2010-03-31
Supplementary Document
2010-03-31
Supplementary Document
2010-03-31
Supplementary Document
2010-03-31
Supplementary Document
2010-03-31
Supporting Statement A
2010-03-31
IC Document Collections
IC ID
Document
Title
Status
7310 Modified
188611 Modified
188610 Modified
ICR Details
0925-0414 201005-0925-001
Historical Active 200903-0925-003
HHS/NIH
Women's Health Initiative Observational Study (NHLBI)
Revision of a currently approved collection   No
Regular
Approved without change 07/20/2010
Retrieve Notice of Action (NOA) 05/10/2010
  Inventory as of this Action Requested Previously Approved
07/31/2013 36 Months From Approved 05/31/2012
48,549 0 70,725
19,880 0 23,607
0 0 0

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.

US Code: 42 USC 241(c) Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  75 FR 3237 01/20/2010
75 FR 17411 04/06/2010
Yes

  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
No
No

$3,338,733
Yes Part B of Supporting Statement
No
No
Uncollected
No
Uncollected
Mikia Currie 3014350941

  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.
05/10/2010


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