01-6009. National Heart, Lung and Blood Institute; Submission for OMB Review; Comment Request; The Cardiovascular Health Study

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 December 4, 2000, pages 75722-3 and allowed 60-days for public comment. No pubic 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 Cardiovascular Health Study. Type of Information Collection Request: Revision (OMB No. 0925-0334). Need and Use of Information Collection: This study will quantify association between conventional and hypothetical risk factors and coronary heart disease (CHD) and stroke in people age 65 years and older. The primary objectives include quantifying association of risk factors with subclinical disease; characterize the natural history of CHD and stroke; and identify factors associated with clinical course. The findings will provide important information on cardiovascular disease in an older U.S. population and lead to early treatment of risk factors associated with disease and identification of factors which may be important in disease prevention. Frequency of Response: Twice a year (participants) or once per cardiovascular disease event (proxies and physicians); Affected Public: Individuals. Type of Respondents: Individuals recruited for CHS and their selected proxies and physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 4,606; Estimated Number of Responses Per Respondent: 4.55; and Estimated Total Annual Burden Hours Requested: 1,719. 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
Participants	3,580	5.6	0.25	1,665
Physicians	606	1.0	0.10	20
Participants proxies	420	1.0	0.25	35
Total	4,606	4.55	0.246	1,719
*Total over 3-pear period.

Request for Comments: Written comments and/or suggestions from the pubic 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 estimated 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.

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 Build, National Institutes of Health, Division of Epidemiology and Clinical Applications, Epidemiology and Biometry Program, NHLBI, 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 April 11, 2001.

Dated: March 1, 2001.

Peter J. Savage,

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