E6-17898. Proposed Collection; Comment Request; The Jackson Heart Study (JHS)

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 Jackson Heart Study: Annual Follow-up with Third Party Respondents.

Type of Information Collection Request: Revision of a currently approved collection (OMB NO. 0925-0491).

Need and Use of Information Collection: This project involves annual follow-up by telephone of participants in the JHS study, review of their medical records, and interviews with doctors and family to identify disease occurrence. Interviewers will contact doctors and hospitals to ascertain participants' cardiovascular events. Information gathered will be used to further describe the risk factors, occurrence rates, and consequences of cardiovascular disease in African American men and women. Recruitment of 5,500 JHS participants began in September 2000 and was completed in March 2004. 5,302 participants completed a baseline Exam 1 that included demographics, psychosocial inventories, medical history, anthropometry, resting and ambulatory blood pressure, phlebotomy and 24-hour urine collection, ECG, echocardiography, and pulmonary function. JHS Exam 2 began September 26 2005, with a more comprehensive Exam 3 beginning in February 2009. The two new exams include some repeated measures from Exam 1 and several new components, including distribution of self-monitoring blood pressure devices. The continuation of the study allows continued assessment of subclinical coronary disease, left ventricular dysfunction, progression of carotid atherosclerosis and left ventricular hypertrophy, and responses to stress, racism, and discrimination as well as new components such as renal disease, body fat distribution and body composition, and metabolic consequences of obesity.

Frequency of Response: One-time.

Affected Public: Individuals or households; Businesses or other for profit; not-for-profit institutions.

Type of Respondents: Middle aged and elderly adults; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows:

Estimated Number of Respondents: 600;

Estimated Number of Responses per Respondent: 1.0;

Average Burden Hours per Response: 0.5; and

Estimated Total Annual Burden Hours Requested: 300.

The annualized cost to respondents is estimated at $6,500. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

Estimate of Annual Hour Burden

Type of response	Number of respondents	Frequency of response	Average time per response	Annual hour burden
Morbidity & Mortality AFU 3rd Party/Next-of-kin decedents	200	1	0.17	34
Morbidity & Mortality AFU 3rd Party Physicians	200	1	0.25	50
Total	400			84

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 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 estimate 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.

FOR FURTHER INFORMATION CONTACT:

To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Ms. Cheryl Nelson, Project Officer, NIH, NHLBI, 6701 Rockledge Drive, MSC 7934, Bethesda, MD 20892-7934, or call non-toll-free number 301-435-0451 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: October 18, 2006.

Suzanne Freeman,

NHLBI Project Clearance Liaison, National Institutes of Health.

Dated: September 26, 2006.

Peter Savage,

Acting Director, DPPS, National Institutes of Health.