E7-23515. 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 proposed information collection was previously published in the Federal Register on September 12, 2007, page 52155, and allowed 60 days for public comment. One comment was 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, any 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 Request: Reinstatement (OMB No. 0925-0334). Need and Use of Information Collection: This study quantifies 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; characterizing the natural history of CHD and stroke; and identifying factors associated with clinical course. The findings 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 that may be important in disease prevention. OBM clearance is being sought for data collection activities at only one of the four CHS field centers (the Pittsburgh field center), which are expected to end on May 31, 2008. Other data collection efforts in the CHS cohort are supported by various non-contract funding sources. Frequency of response: Twice a year (participants) or once per cardiovascular disease event (proxies); Affected public: Individuals. Types of Respondents: Individuals recruited for CHS and their selected proxies. The annual reporting burden is as follows: Estimated Number of Respondents: 467; Estimated Number of Responses per Respondent: 1.2; and Estimated Total Annual Burden Hours Requested: 281. The annualized cost to respondents is estimated at: $5,225.

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	346	1.2	0.5	208
Participant proxies	121	1.2	0.5	73
Total	467	1.2	0.5	281

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, Epidemiology Branch, Division of Prevention and Population Sciences, NHLBI, NIH, II Rockledge Centre, 6701 Rockledge Drive, Suite 10018, MSC # 7936, Bethesda, MD 20892-7936, or call 301-435-0397 (non-toll-free number), 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: November 1, 2007.

Mike Lauer,

Director, Division of Prevention and Population Sciences, NHLBI, National Institutes of Health.

Dated: November 20, 2007.

Suzanne Freeman,

OMB Clearance Officer, NHLBI, National Institutes of Health.