03-31403. Submission for OMB Review; Comment Request; The Atherosclerosis Risk in Communities Study (ARIC)

SUMMARY:

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on July 14, 2003, pages 41591-41592, and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

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: This project involves annual 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 annually. Affected Public: Individuals or households: Businesses or other for profit; Small Businesses or organizations. Type of Respondents: Middle aged and elderly adults; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 13,640; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 0.1667; and Estimated Total Annual Burden Hours Requested; 6,865. The annualized cost to respondents is estimated at $25,808, assuming respondents' time at the rate of $16.50 per hour for family and patient respondents, and $75 per hour for physicians. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Estimate of Annual Hour Burden

Type of response	Number of respondents	Frequency of response	Average time per response	Annual hour burden
Participant Follow-up	13,050	1.0	0.1667	6,525
Physician, hospital, nursing home staff 1	180	1.0	0.2500	135
Participant's next-of-kin 1	410	1.0	0.1667	205
Total	13,640	1.0		6,865
1 Annual burden is placed on doctors, hospitals, nursing homes, and respondent relatives/informants through requests for information which will help in the compilation of the number and nature of new fatal and nonfatal events.

Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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.

Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC. 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact: Dr. Merle Myerson, NIH, NHLBI, 6701 Rockledge Drive, MSC 7934, Bethesda, MD 20892-7934, or call non-toll-free number 301-435-0707 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 30-days of the date of this publication.

Dated: December 11, 2003.

Peter Savage,

Director, DECA, NHLBI, National Institutes of Health.