# National Heart, Lung, and Blood Institute Proposed Collection; Comment Request Exam 2—The Jackson Heart Study, Annual Follow-Up Component
**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:* Exam 2—The Jackson Heart Study, Annual Follow-up Component. *Type of Information Collection Request:* Revision (OMB 0925-0491; expiration 07/31/2004). *Need and Use of Information Collection:* The Jackson Heart Study (JHS) Clinical Component will involve 5,500 African-American men and women aged 21-84, representative of African-American residents of Jackson, Mississippi. Family members are included in order to permit future studies of familial and genetic contributions to cardiovascular disease (CVD). The JHS Clinical Component has received Clinical Exemption (CE-99-11-09) from the NIH Clinical Exemption Review Committee. The continuation of the study will allow 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. The continuation of the JHS in FY05 is proposed to support 2 clinical examinations 4 years apart and continued cohort follow-up for events. The collection of follow-up information also involves third party individuals (next-of-kin decedents and physicians). This information is necessary for the interpretation and analysis of clinical findings and outcomes to ascertain the relationship between mortality and morbidity in the clinical study cohort. The information collected will be used by the public and private sector for public health planning, medical education, other epidemiologic studies, and biomedical research.
*Frequency of Response:* One-time. *Affected Public:* Individuals or families; Businesses or other for profit; not-for-profit institutions. *Type of Respondents:* Third party respondents (next-of-kin decedents and physicians). The annual reporting burden is as follows: *Estimated Number of Respondents:* 600; *Estimated Number of Responses per Respondent:* 1; *Average Burden Hours Per Response:* 0.50; 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.
| Type of respondents | Estimated number of respondents | Estimated number of responses per respondent | Average burden hours per response | Estimated total annual burden hours requested |
| --- | --- | --- | --- | --- |
| Morbidity & Mortality AFU 3rd party next-of-kin decedents | 300 | 1 | 0.50 | 150 |
| Morbidity & Mortality AFU 3rd party Physicians | 300 | 1 | 0.50 | 150 |
| Total | | | | 300 |
*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: Cheryl Nelson, Jackson Heart Study Project Officer, 6701 Rockledge Drive, Room 8152, MSC 7934, Rockville, MD 20892-7934, or call non-toll-free number (301) 435-0451 or E-mail your request, including your address to: *[email protected]* .
*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 20, 2003.
Peter Savage,
Director, Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute.