The Atherosclerosis Risk in Communities Study (ARIC)

Forms and Documents

Document Name	Status
Form 2 Participants Form and Instruction	Modified
Form 1 Physician Questionaire Form Form and Instruction	New
Form 1 Physician (for heart failure) Form and Instruction	Modified
Form 1 Non-Participant Informant Interview Form Form and Instruction	Modified
Form 1 Non-Participant Coroner/Medical Examiner Form Form and Instruction	Modified
ARIC Supporting Statement B JW.docx Supporting Statement B	2014-03-10
Attach 11 UNC CC Privacy Policy.pdf Supplementary Document	2014-03-10
Attach 10 Privacy Act System Notice.pdf Supplementary Document	2014-03-10
Attach 9 IRB Approvals.pdf Supplementary Document	2014-03-10
Attach 8 ARIC 2013 OSMB Meeting Minutes.pdf Supplementary Document	2014-03-10
ARIC Certificate of Confidentiality Couper.pdf Supplementary Document	2014-03-10
Attach 7 ARIC Publications.docx Supplementary Document	2014-03-10
ARIC Supporting Statement REVISED 4 24 2014.doc Supporting Statement A	2014-04-28

IC Document Collections

IC ID	Document Title	Status
7266	Participants Form and Instruction	Modified
210831	Physician Questionaire Form Form and Instruction	New
196031	Physician (for heart failure) Form and Instruction	Modified
196030	Non-Participant Informant Interview Form Form and Instruction	Modified
196029	Non-Participant Coroner/Medical Examiner Form Form and Instruction	Modified

ICR Details

OMB Control No: 0925-0281	ICR Reference No: 201403-0925-007
Status: Historical Active	Previous ICR Reference No: 201101-0925-009
Agency/Subagency: HHS/NIH	Agency Tracking No: 21543
Title: The Atherosclerosis Risk in Communities Study (ARIC)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/02/2014
	Date Received in OIRA: 03/20/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2017	36 Months From Approved	05/31/2014
Responses	65,514	0	34,539
Time Burden (Hours)	15,714	0	20,435
Cost Burden (Dollars)	0	0	0

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Abstract: ARIC study was initiated in 1985 to examine the major factors contributing to the occurrence of and the trends for cardiovascular diseases among men, women, African Americans and white persons in four U.S. communities: Forsyth County, North Carolina; Jackson, Mississippi; suburbs of Minneapolis, Minnesota; and Washington County, Maryland. The cohort in Jackson is selected to represent only African American residents of the city. The primary objectives of the study are to: 1) investigate factors associated with both atherosclerosis and clinical cardiovascular diseases and 2) measure occurrence of and trend in coronary heart disease (CHD) and relate them to community levels of risk factors, medical care, and atherosclerosis.

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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:
	78 FR 77138	12/20/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 11800	03/03/2014
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
Participants	2, 1	Semiannual Follow-up Form ,   Annual Follow-up Form
Non-Participant Coroner/Medical Examiner Form	1	Coroner/Medical Examiner Form
Non-Participant Informant Interview Form	1	Informant Interview Form
Physician (for heart failure)	1	Heart Failure
Physician Questionaire Form	1	Physician Questionaire Form

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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	65,514	34,539	0	2,760	28,215	0
Annual Time Burden (Hours)	15,714	20,435	0	230	-4,951	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: No

Burden Reduction Due to:

Short Statement: During the last OMB approval period (March 1, 2011 -March 31, 2014) there was a re-examination of cohort participants by clinical exam in 2011-2013 and follow-up contacts occurred twice yearly. This revision does not include a clinical exam and thus represents a decrease in the burden, but does request continued cohort follow-up in the form of telephone calls and continued morbidity and mortality surveillance of the ARIC Cohort and ARIC Communities. Follow-up forms have been reformatted to facilitate automated administration in the data management system.

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Annual Cost to Federal Government: $11,286,000

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]? 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: 03/20/2014

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