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  Federal Register  

Link:  Pharm/Biotech Resources
 


Notice: Submission for OMB Review; Comment Request; The Atherosclerosis 
Risk in Communities Study (ARIC)
Federal Register: February 19, 2010 (Volume 75, Number 33)              
                  Page 7482-7483
Agency: DEPARTMENT OF HEALTH AND HUMAN SERVICES
        National Institutes of Health


    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 November 16, 2009, page 58962, and allowed 60 days for 
public comment. Only one comment was 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 Atherosclerosis Risk in Communities Study (ARIC). Type 
of Information Collection Request: Extension of a currently approved 
collection (OMB No. 0925-0281). Need and Use of Information Collection: 
This project involves annual follow-up by telephone of participants in 
the ARIC 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 middle aged and older men and women. Frequency of Response: The 
participants will be contacted annually. Affected Public: Individuals 
or households; Businesses or other for profit; Small businesses or 
organizations. Type of Respondents: Individuals or households; doctors 
and staff of hospitals and nursing homes. The annual reporting burden 
is as follows: Estimated Number of Respondents: 11,992; Estimated 
Number of Responses per Respondent: 1.0; Average Burden Hours per 
Response: 0.2399; and Estimated Total Annual Burden Hours Requested: 
2,877.4. The annualized cost to respondents is estimated at $54,583, 
assuming respondents' time at the rate of $17.5

[[Page 7483]]

per hour for family and patient respondents, and $75 per hour for 
physicians. There are no Capital Costs to report. There are no 
Operating or Maintenance Costs to report.

                                         Estimate of Annual Hour Burden
                                                   [2010-2013]
----------------------------------------------------------------------------------------------------------------
                                                     Number of     Frequency of    Average time     Annual hour
                Type of response                    respondents      response      per response       burden
----------------------------------------------------------------------------------------------------------------
Participant Follow-up...........................          10,735             1.0          0.2500         2,683.8
Physician or Coroner (for CHD) \1\..............             491             1.0          0.1667            81.8
Physician (for heart failure) \1\...............             190             1.0          0.0833            15.8
Participant's next-of-kin \1\...................             575             1.0          0.1667            95.9
                                                 ---------------------------------------------------------------
    Total.......................................          11,992             1.0          0.2399         2,877.4
----------------------------------------------------------------------------------------------------------------
\1\ Annual burden is placed on doctors, hospitals, nursing homes, and respondent relatives/informants through
  requests for information which will help in the compilation of the number and nature of new fatal and nonfatal
  events.

    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, OIRA_submission@omb.eop.gov 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: Dr. Hanyu Ni, NIH, NHLBI, 6701 Rockledge Drive, 
MSC 7934, Bethesda, MD 20892-7934, or call non-toll-free number (301) 
435-0448 or E-mail your request, including your address to: 
nihanyu@nhlbi.nih.gov.
    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: January 29, 2010.
Suzanne Freeman,
NHLBI Project Clearance Liaison, National Institutes of Health.
Michael Lauer,
Director, DCVS, National Institutes of Health.
[FR Doc. 2010-3204 Filed 2-18-10; 8:45 am]
BILLING CODE 4140-01-P
 

 
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