[Federal Register Volume 68, Number 174 (Tuesday, September 9, 2003)]
[Notices]
[Pages 53177-53178]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22832]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

[[Page 53178]]

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.

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                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total annual
               Type of respondents                   number of     responses per     hours per     burden hours
                                                    respondents     respondent       response        requested
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Morbidity & Mortality AFU 3rd party next-of-kin              300               1            0.50             150
 decedents......................................
Morbidity & Mortality AFU 3rd party Physicians..             300               1            0.50             150
                                                 -----------------
    Total.......................................  ..............  ..............  ..............             300
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    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.
[FR Doc. 03-22832 Filed 9-8-03; 8:45 am]
BILLING CODE 4140-01-M