The Atherosclerosis Risk in Communities Study (ARIC)

Forms and Documents

Document Name	Status
Form 3 The Atherosclerosis Risk in Communities Study (ARIC) Form and Instruction	Modified
Supporting Statement Part B (2).doc Supporting Statement B	2010-01-21
ARIC Publications list as of 30Sept2009.doc Supplementary Document	2010-01-21
Privact Act Memo from Karen Pla .pdf Supplementary Document	2010-01-21
WA County IRB Approval 2009.pdf Supplementary Document	2010-01-21
Minnesota IRB Approval 2009.pdf Supplementary Document	2010-01-21
Jackson IRB Approval 2009.pdf Supplementary Document	2010-01-21
Forsyth IRB Approval 2009.pdf Supplementary Document	2010-01-21
CSCC IRB Approval 2009.pdf Supplementary Document	2010-01-21
Cont Rev App Notice ARIC WC EXp 04 15 2010.pdf Supplementary Document	2010-01-21
Supporting Statement Part A FINAL Revision 01.21.10.doc Supporting Statement A	2010-01-21

IC Document Collections

IC ID	Document Title	Status
7266	The Atherosclerosis Risk in Communities Study (ARIC) Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0281	ICR Reference No: 201003-0925-002
Status: Historical Active	Previous ICR Reference No: 200702-0925-001
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: The Atherosclerosis Risk in Communities Study (ARIC)
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: 04/01/2010
	Date Received in OIRA: 03/17/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2013	36 Months From Approved	05/31/2010
Responses	11,992	0	12,845
Time Burden (Hours)	2,877	0	2,954
Cost Burden (Dollars)	0	0	0

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Abstract: The ARIC Study will collect morbidity and mortality follow-up of 15,800 original participants for the purpose of studying the deterinants of cardiovascular disease. It will conduct community surveillance to monitor the trends in MI and CHD.

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Authorizing Statute(s): US Code: 42 USC 421 Name of Law: NHLBI mandate
  

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:
	74 FR 58962	11/16/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 7482	02/19/2010
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
The Atherosclerosis Risk in Communities Study (ARIC)	3, 1, 2, 4, 5, 6	survey ,   survey ,   survey ,   survey ,   survey ,   survey

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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	11,992	12,845	0	0	-853	0
Annual Time Burden (Hours)	2,877	2,954	0	0	-77	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: $6,905,000

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)? 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: 03/17/2010

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