01-10205. National Heart, Lung, and Blood Institute; Proposed Collection; Comment Request; Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance

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: Multi-Ethnic Study of Atherosclerosis (MESA) Event Surveillance. Type of Information Request: New. 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.

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
Particpant 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) ways 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.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of data collection plans and instruments, contact Dr. Diane Bild, Epidemiology and Biometry Program, Division of Epidemiology and Clinical Applications, NHLBI, NIH, II Rockledge Centre, 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 on or before June 25, 2001.

Dated: April 13, 2001.

Peter J. Savage,

Acting Director, Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute.