[Federal Register Volume 78, Number 16 (Thursday, January 24, 2013)]
[Notices]
[Pages 5188-5189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-01441]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 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 October 24, 2012, pages 65001-2, 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 
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, 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. The JHS Community 
Health Advisor Networks (CHANs) comprise another component of the 
study. The JHS data shows high prevalence of risk factors: 73% of 
recruited participants are hypertensive, 29% are diabetic, 56% are 
obese (BMI > 30kg/m2), and 30% have the metabolic syndrome. Exploration 
of the impact on and interaction of high risk factor levels with other 
measures of clinical and subclinical disease will help identify unique 
approaches through epidemiology and prevention research to reduce the 
disproportionate burden of CVD in African-Americans. . The JHS CHANs 
play an important role to address CVD prevention by providing training 
to community members to spread health promotion and prevention messages 
within the Jackson community. The JHS Community Health Advisors (CHAs) 
are trained and certified to organize and conduct various outreach 
activities in five Jackson-area communities. Data on the JHS CHAs will 
be collected. 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: 478; 
Estimated Number of Responses per Respondent: 1.0; Average Burden Hours 
Per Response: 2.47); and Estimated Total Annual Burden Hours Requested: 
1253. The annualized cost to respondents is estimated at $24,206. There 
are no Capital Costs to report. There are no Operating or Maintenance 
Costs to report.

                                         Estimate of Annual Hour Burden
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                                              Number of       Frequency of    Average time per     Annual hour
           Type of respondents               respondents        responses         response           burden
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Families................................               200                 1               1/6                33
Physicians..............................               200                 1             15/60                50
Communities:

[[Page 5189]]

 
    Bolton..............................                16                10             90/60               240
    Canton..............................                14                10             90/60               210
    Clinton.............................                13                10             90/60               195
    Jackson.............................                15                10             90/60               225
    Rankin..............................                20                10             90/60               300
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        Total...........................               478  ................  ................             1,253
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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.
    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, [email protected] 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 email 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 30-days 
of the date of this publication.

Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2013-01441 Filed 1-23-13; 8:45 am]
BILLING CODE 4140-01-P