[Federal Register Volume 69, Number 177 (Tuesday, September 14, 2004)]
[Notices]
[Pages 55442-55443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-20658]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; The Multi-Ethnic
Study of Atherosclerosis (MESA)
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 June 21, 2004, pages 34375-34376, and allowed 60 days for
public comment. No public 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 Multi-Ethnic Study of
Atherosclerosis. Type of Information Collection Request: Reinstatement
of a currently approved collection (OMB No. 0925-0493). Need and Use of
Information Collection: This study will identify and quantify factors
associated with the presence and progression of subclinical
cardiovascular disease (CVD)--that is, atherosclerosis and other forms
of CVD that have not produced signs and symptoms. The findings will
provide important information on subclinical CVD in individuals of
different ethnic backgrounds and provide information for studies on new
interventions to prevent CVD. The aspects of the study that concern
direct participant evaluation received a clinical exemption from OMB
clearance (CE-99-11-08) in April 2000. OMB clearance is being sought
for the contact of physicians and participant proxies to obtain
information about clinical CVD events that participants experience
during the follow-up period. Frequency of Response: Once per CVD event.
Affected Public: Individuals. Type of Respondents: Physicians and
selected proxies of individuals recruited for MESA. The annual
reporting burden is as follows: Estimated Number of Respondents: 555;
Estimated Number of
[[Page 55443]]
Responses per Respondent: 1.0; Average Burden Hours Per Response:
0.225; and Estimated Total Annual Burden Hours Requested: 42. The
annualized cost to respondents is estimated at $6,733. There are no
Capital Costs to report. There are no Operating or Maintenance Costs to
report.
There are no capital operating, or maintenance costs to report.
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Estimated
Estimated Average total
Estimated number of burden annual
Type of respondents number of responses hours per burden
respondents per response hours
respondent requested
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Physicians.................................................. 279 1.0 0.20 19
Participant proxies......................................... 276 1.0 0.25 23
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Total................................................... 555 1.0 0.225 42
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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.
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, New Executive Office Building, Room 10235, Washington, DC
20503, 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: Dr. Diane Bild, NIH, NHLBI, 6701 Rockledge
Drive, MSC 7938, Bethesda, MD 20892-7934, or call non-toll-free number
(301) 435-0457 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 30 -
days of the date of this publication.
Dated: August 31, 2004.
Peter Savage,
Director, DECA, NHLBI.
[FR Doc. 04-20658 Filed 9-13-04; 8:45 am]
BILLING CODE 4140-01-M