[Federal Register Volume 65, Number 221 (Wednesday, November 15, 2000)]
[Notices]
[Pages 69031-69032]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29132]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Heart, Lung, and Blood Institute; Proposed Collection; 
Comment Request, The Jackson Heart Study, Annual Follow-Up Component--
Phase III

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 
Component--Phase III. Type of Information Collection Request: Revision 
(OMB 0925-0464; expiration 04/30/2002). Need and use of Information 
Collection: The Jackson Heart Study (JHS) Clinical Component will 
involve 6,500 African-American men and women aged 35-84, representative 
of African-American residents of Jackson, Mississippi. Family members 
are to be included in order to permit future studies of familial and 
genetic contributions to cardiovascular disease (CVD). The examination 
includes a series of questionnaires, physical assessments and 
laboratory measurements. Data collected in this study includes both 
conventional risk factors and new or emerging factors that may be 
related to CVD. Some of the newer areas of focus include early 
indicators of disease, genetics, sociocultural influences such as 
socioeconomic status and discrimination, and physiological relations 
between common disorders such as high blood pressure, obesity and 
diabetes and their influence on CVD and will take three years to 
complete. The JHS Clinical Component has received Clinical Exemption 
(CE-99-11-09) from the NIH Clinical Exemption Review

[[Page 69032]]

Committee. However, collection of follow 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: 480. Estimated Number of Responses per 
Respondent: 1. Average Burden Hours Per Response are shown in the table 
below; and Estimated Total Annual Burden Hours Requested: 160. The 
annualized cost to respondents is estimated at: $3,600.
    Estimates of the annual reporting burden to respondents.

----------------------------------------------------------------------------------------------------------------
                                                         Estimated
                                   Estimated             number of           Average burden      Estimated total
      Type of respondents          number of      x    responses per    x      hours per      =   annual burden
                                  respondents            respondent             response         hours requested
----------------------------------------------------------------------------------------------------------------
Morbidity and Mortality AFU                240                     1                  0.33                   80
 3rd party next-of-kin
 decedents....................
Morbidity and Mortality AFU                240                     1                  0.33                   80
 3rd party Physicians.........
                               ---------------------------------------------------------------------------------
      Total...................             480        ...............       ...............                160
----------------------------------------------------------------------------------------------------------------
Note.--There are no Capital Costs, Operating Costs or Maintenance Cost for this study.


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.

FOR FURTHER INFORMATION: 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: <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="aac9c4929ac4ea84c4c3c284cdc5dc">[email protected]</a>

COMMENTS DUE DATE: Comments regarding this information collection are 
best assured of having their full effect if received on or before 
January 16, 2001.

    Dated: October 20, 2000.
Peter Savage,
Acting Director, Division of Epidemiology and Clinical Applications, 
National Heart, Lung, and Blood Institute.
[FR Doc. 00-29132 Filed 11-14-00; 8:45 am]
BILLING CODE 4140-01-M


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