E7-18012. Proposed Collection; Comment Request; The Cardiovascular Health Study (CHS)

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: 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 and physicians); Affected public: Individuals. Types of Respondents: Individuals recruited for CHS and their selected proxies and physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 556; Estimated Number of Responses per respondent: 1.2; and Estimated Total Annual Burden Hours Requested: 289. The annualized cost to respondents is estimated at: $14,450.

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
Physicians	70	1.2	0.1	8
Participant proxies	121	1.2	0.5	73
Total	537	1.2	0.45	289
*Total for 3 years.

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. 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 60 days of the date of this publication.

Dated: August 29, 2007.

Mike Lauer,

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

Suzanne Freeman,

Chief, FOIA, NHLBI, National Institutes of Health.