04-14776. Submission for OMB Review; Comment Request; The Cardiovascular Health Study (CHS)

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 proposal information collection was previously published in the Federal Register on March 25, 2004, pages 15346-15347, 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 Cardiovascular Health Study. Type of Information Collection Request: Revision of a currently approved collection (OMB NO. 0925-0334). Need and Use of Information Collection: This study will quantify associations 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 associations 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: 3,915; Estimated Number of Responses per Respondent: 3.2; Average Burden Hours Per Response: 0.21; and Estimated Total Annual Burden Hours Requested: 868. The annualized cost to respondents is estimated at $55,633. 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.

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	2,506	3.9	0.21	681
Physicians	380	1.0	0.09	11
Participant proxies	1029	2.3	0.22	176
Total	3,915	3.2	0.21	868
* Total for 3 years.

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. Jean Olson, NIH, NHLBI, 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 within 30-days of the date of this publication.

Dated: June 21, 2004.

Peter Savage,

Director, DECA, NHLBI.