01-18729. National Heart, Lung, and Blood Institute Submission for OMB Review; Comment Request; Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance

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 4/25/01 pages 20820-20821, 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: Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance. Type of Information Request: New. (OMB No. 0925-XXXX). Need and Use of Information Collection: The study, MESA, 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. Types 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; and Estimated Total Annual Burden Hours Requested: 42. The annualized cost to respondents is estimated at $6,733. There are no capital, operating, or maintenance costs to report.

Type of respondents	Estimated number of respondents	Estimated number of responses per respondent	Average burden hours per response	Estimated total annual burden hours requested
Physicians	279	1.0	0.20	19
Participant proxies	276	1.0	0.25	23
Total	555	1.0	0.225	42

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 will have practical utility; (2) The accuracy of the agency's estimate of 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) Way to minimize the burden of 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, Project Officer, NIH, NHLBI, Division of Epidemiology and Clinical Applications, 6701 Rockledge Drive, MSC 7934, Bethesda, MD 20892, 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 are best assured of having their full effect if received on or before August 27, 2001.

Dated: July 17, 2001.

Peter J. Savage,

Acting Director, Division of Epidemiology and Clinical Applications.