75 FR 66 pgs. 17744-17745 - Submission for OMB Review; Comment Request; the Jackson Heart Study (JHS)

Type: NOTICEVolume: 75Number: 66Pages: 17744 - 17745
FR document: [FR Doc. 2010-7895 Filed 4-6-10; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: National Institutes of Health
Official PDF Version:  PDF Version

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Submission for OMB Review; Comment Request; the Jackson Heart Study (JHS)

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 January 13, 2010, page 1789, and allowed 60 days for public comment. No 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 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 contacting next-of-kin and family physicians of deceased participants who were part of the Jackson Heart Study exam. 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, followed by a more comprehensive Exam 3 that began 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: Adults; doctors and staff of hospitals and nursing homes. The annual reporting burden is as follows: Estimated Number of Respondents: 400; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours per Response: (84 hours/400 respondents) 0.20; and Estimated Total Annual Burden Hours Requested: 84. The annualized cost to respondents is estimated at $3,760, assuming $15 per burden hour for informants and $65 per burden hour for physicians. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

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 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, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, 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: 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: NelsonC@nhlbi.nih.gov.

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.

Suzanne Freeman,

NHLBI Project Clearance Liaison, National Institutes of Health.

Michael Lauer,

Director, DCVS, National Institutes of Health.

[FR Doc. 2010-7895 Filed 4-6-10; 8:45 am]

BILLING CODE 4140-01-P