The Atherosclerosis Risk in Communities Study (ARIC)

Forms and Documents

Document Name	Status
Form 1 Participants Form and Instruction	Modified
Form 1 Physician (for heart failure) Form and Instruction	New
Form 1 Physicians (or coroner) (for CHD) Form and Instruction	New
Form 1 Participants (Next of Kin) Form and Instruction	New
ARIC Supporting Statement B.doc Supporting Statement B	2011-01-19
Attach #6.pdf Supplementary Document	2011-01-19
Attach #5.pdf Supplementary Document	2011-01-19
Attachment #4 .pdf Supplementary Document	2011-01-19
Attach #3.pdf Supplementary Document	2011-01-19
Attach #2.pdf Supplementary Document	2011-01-19
Attach #1.docx Supplementary Document	2011-01-19
ARIC Supporting Statement A.doc Supporting Statement A	2011-01-20

IC Document Collections

IC ID	Document Title	Status
7266	Participants Form and Instruction	Modified
196031	Physician (for heart failure) Form and Instruction	New
196030	Physicians (or coroner) (for CHD) Form and Instruction	New
196029	Participants (Next of Kin) Form and Instruction	New

ICR Details

OMB Control No: 0925-0281	ICR Reference No: 201101-0925-009
Status: Historical Active	Previous ICR Reference No: 201003-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
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 without change	Conclusion Date: 03/21/2011
	Date Received in OIRA: 01/25/2011
Terms of Clearance: Approved consistent with the understanding that the study will not begin prior to receiving IRB approval from all sites and, if changes are made to the protocol as a result of IRB review, those changes will be submitted to OMB for review and approval. Similarly, if changes are made to the collection as a result of the pilot study, those changes will be submitted to OMB through a change request.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2014	36 Months From Approved	04/30/2013
Responses	34,539	0	11,992
Time Burden (Hours)	20,435	0	2,877
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:
	75 FR 62544	10/12/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 3146	01/19/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Physician (for heart failure)	1	survey
Participants	1, 2	Clinic Examination ,   SEMI-ANNUAL FOLLOW-UP FORM
Participants (Next of Kin)	1, 2	Clinic Examination ,   SEMI-ANNUAL FOLLOW-UP FORM
Physicians (or coroner) (for CHD)	1	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	34,539	11,992	0	22,547	0	0
Annual Time Burden (Hours)	20,435	2,877	0	17,558	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: No

Burden Reduction Due to:

Short Statement: During the last OMB approval period (April 1, 2010 - April 30, 2013) there was continued morbidity and mortality surveillance of the ARIC Cohort and ARIC Communities, and there was continued Cohort Follow-up in the form of annual telephone calls. A revision to the previous OMB submission is requested because (1) the Cohort will be re-examined over a two-year period, 2011-2013, and (2) the Cohort follow-up phone contacts will occur biennially rather than annually).

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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]? 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: 01/25/2011

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