Agency information collection activities: Proposed collection; comment request,

[Federal Register: November 15, 2000 (Volume 65, Number 221)]

[Notices]

[Page 69031-69032]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr15no00-103]

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: cn80n@.nih.gov

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. 00-29132Filed11-14-00; 8:45 am]

BILLING CODE 4140-01-M