[Federal Register Volume 77, Number 206 (Wednesday, October 24, 2012)]
[Notices]
[Pages 65001-65002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26226]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request: The Jackson Heart Study 
(JHS)

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 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

[[Page 65002]]

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 prevalences 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
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Frequency of    Average time     Annual hour
               Type of respondents                  respondents      responses     per response       burden
----------------------------------------------------------------------------------------------------------------
Families........................................             200               1             1/6         33\1/3\
Physicians......................................             200               1           15/60              50
Communities:
    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
                                                 ---------------------------------------------------------------
        Total...................................             478  ..............  ..............      1253 \1/3\
----------------------------------------------------------------------------------------------------------------

    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 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 60-days 
of the date of this publication.

    Dated: October 18, 2012.
Lynn Susulske,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2012-26226 Filed 10-23-12; 8:45 am]
BILLING CODE 4140-01-P