Submission for OMB Review; Comment Request; The Multi-Ethnic Study of Atherosclerosis (MESA)

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 the information collection listed below. This proposed information collection was previously published in the Federal Register on June 21, 2004, pages 34375-34376, 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 Multi-Ethnic Study of Atherosclerosis. Type of Information Collection Request: Reinstatement of a currently approved collection (OMB No. 0925-0493). Need and Use of Information Collection: This study will identify and quantify factors associated with the presence and progression of subclinical cardiovascular disease (CVD)—that is, atherosclerosis and other forms of CVD that have not produced signs and symptoms. The findings will provide important information on subclinical CVD in individuals of different ethnic backgrounds and provide information for studies on new interventions to prevent CVD. The aspects of the study that concern direct participant evaluation received a clinical exemption from OMB clearance (CE-99-11-08) in April 2000. OMB clearance is being sought for the contact of physicians and participant proxies to obtain information about clinical CVD events that participants experience during the follow-up period. Frequency of Response: Once per CVD event. Affected Public: Individuals. Type of Respondents: Physicians and selected proxies of individuals recruited for MESA. The annual reporting burden is as follows: Estimated Number of Respondents: 555; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 0.225; and Estimated Total Annual Burden Hours Requested: 42. The annualized cost to respondents is estimated at $6,733. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

There are no capital operating, or maintenance costs to report.

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. Diane Bild, NIH, NHLBI, 6701 Rockledge Drive, MSC 7938, Bethesda, MD 20892-7934, or call non-toll-free number (301) 435-0457 or e-mail your request, including your address to: BildD@nhlbi.nih.gov.

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.