2010-25641. Proposed Collection; Comment Request; the Atherosclerosis Risk in Communities Study (ARIC)

SUMMARY:

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

Proposed Collection: Title: The Atherosclerosis Risk in Communities Study (ARIC). Type of Information Collection Request: Revision of a currently approved collection (OMB NO. 0925-0281). Need and Use of Information Collection: ARIC will conduct a clinical examination of the cohort over a 24-month period (May 2011 to April 2013). In addition, this project involves biennual follow-up by telephone of participants in the ARIC study, review of their medical records, and interviews with doctors and family to identify disease occurrence. Interviewers will contact doctors and hospitals to ascertain participants' cardiovascular events. Information gathered will be used to further describe the risk factors, occurrence rates, and consequences of cardiovascular disease in middle aged and older men and women. Frequency of Response: The participants will be contacted bi-annually for follow-up. A subset of the cohort may choose to volunteer for the clinical examination; these individually will be contacted once in a 3 year period. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 12,673; Estimated Number of Responses per Respondent: 2.7; Average Burden Hours Per Response: 0.5916; and Estimated Total Annual Burden Hours Requested: 20,434. The annualized cost to respondents is estimated at $355,882, assuming respondents time at the rate of $17.00 per hour and physician time at the rate of $75.00 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Table A.12.1 Estimates of Hour Burden

Type of respondents	Estimated number of respondents	Estimated number of responses per respondent	Average burden hours per response	Estimated total annual burden hours requested
Participants	10,933	3	0.6165	20220.6.
Physician (or coroner) (for CHD)	420	1	0.1667	70.
Physician (for heart failure)	920	1	0.0833	76.6.
Participants' next of kin	400	1	0.1667	66.7.
Totals	12,673			20433.9 or 20434.
Note: Reported and calculated numbers differ slightly due to rounding.

Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

For Further Information: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Dr. Hanyu Ni, Project Officer, NIH, NHLBI, 6701 Rockledge Drive, MSC 7934, Bethesda, MD 20892-7934, or call non-toll-free number [phone] or E-mail your request, including your address to: [e-mail].

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60-days of the date of this publication.

Dated: October 6, 2010.

Suzanne Freeman,

NHLBI Project Clearance Liaison, National Institutes of Health.

Michael Lauer,

Director, DCVS, National Institutes of Health.