The Multi-Ethnic Study of Atherosclerosis (MESA)

Forms and Documents

Document Name	Status
Form 1 The Multi-Ethnic Study of Atherosclerosis (MESA) Form and Instruction	Modified
MESA B.doc Supporting Statement B	2007-10-12
UCLA MESA Approval (expires 8.21.08).pdf Supplementary Document	2007-10-12
Northwestern MESA IRB (expires 9-1-08).pdf Supplementary Document	2007-10-12
Minn MESA IRB approval (expires 2.21.08).pdf Supplementary Document	2007-10-12
JHU MESA IRB Approval (expires 10-16-07).pdf Supplementary Document	2007-10-12
Columbia IRB approval (expires 4.24.08).pdf Supplementary Document	2007-10-12
Columbia approval from NYC for MESA MESA Family MESA Air (expires 1-29-08).pdf Supplementary Document	2007-10-12
WFU IRB approval (expires 1-7-2008).pdf Supplementary Document	2007-10-12
Working Group report.doc Supplementary Document	2007-10-12
NHLBI Council Minutes.doc Supplementary Document	2007-10-12
MESA Timeline.doc Supplementary Document	2007-10-12
Sample letters for MESA events.doc Supplementary Document	2007-10-12
MESA A.doc Supporting Statement A	2007-10-12

IC Document Collections

IC ID	Document Title	Status
7413	The Multi-Ethnic Study of Atherosclerosis (MESA) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0493	ICR Reference No: 200710-0925-004
Status: Historical Active	Previous ICR Reference No: 200408-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The Multi-Ethnic Study of Atherosclerosis (MESA)
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: 12/05/2007
	Date Received in OIRA: 10/30/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2010	36 Months From Approved	12/31/2007
Responses	183	0	555
Time Burden (Hours)	37	0	42
Cost Burden (Dollars)	0	0	0

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Abstract: The Multi-Ethnic Study of Atherosclerosis (MESA) an ongoing observational cohort study that is identifying and quantifying factors associated with the presence and progression of subclinical cardiovascular disease (CVD)-- that is, atherosclerosis and other forms of CVD that have not produced signs and symptoms. The findings provide important information on subclinical CVD and its progression to clinical CVD in individuals of different ethnic backgrounds and provide information for studies on new interventions to prevent CVD. The aspects of MESA that concern direct participant evaluation received a clinical exemption from OMB clearance (CE-99-11-08) in April 2000. Extension of OMB clearance is being sought for the contact of physicians and selected participant proxies to obtain information about clinical CVD events that study participants experience during the follow-up period.

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Authorizing Statute(s): US Code: 42 USC 285b Name of Law: Investigation into Epidemiology
  

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:
	72 FR 46640	08/21/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 60863	10/26/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
The Multi-Ethnic Study of Atherosclerosis (MESA)	2, 3, 4, 1	Informant ,   Cardiac ,   Cardiac ,   Stroke

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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	183	555	0	-372	0	0
Annual Time Burden (Hours)	37	42	0	-5	0	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: Miscellaneous Actions

Short Statement: MESA Event Surveillance is an ongoing collection of information. No substantial program changes have been made since the 2004 Supporting Statement submission. The estimated number of respondents has been adjusted slightly from the previous submission based upon actual experience in the study to date.

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Annual Cost to Federal Government: $514,000

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)? Uncollected

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: 10/30/2007

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