[Federal Register Volume 71, Number 138 (Wednesday, July 19, 2006)]
[Notices]
[Pages 41029-41030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11380]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; Survey of Estimated 
Glomerular Filtration Rate Reporting Practices of Clinical Laboratories

SUMMARY: Under the provisions of section 3507(a)(1)(D) of the Paperwork 
Reduction Act of 1995, the National Institute of Diabetes and Digestive 
and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) 
has submitted to the Office of Management and Budget (OMB) a request 
for review and approval of the information collection listed below. 
This proposed information collection was previously published in the 
Federal Register on January 25, 2006, page 4151-4152 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. 
This 30-day submission is modified in order to reflect an increase in 
sample size. 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: A Survey of Estimated GFR Reporting Practices of Clinical 
Laboratories.
    Type of Information Collection Request: New.
    Need and Use of Information Collection: This study will assess the 
level of U.S. clinical laboratory reporting of estimated GFR as a 
measure of kidney function through a baseline survey of a 
representative sample of clinical laboratories in the U.S. Results will 
later serve as comparison to measure an anticipated increase in use of 
estimated GFR, following implementation of the National Kidney Disease 
Education Program's communications and Lab Working Group (LWG) 
activities promoting use of estimated GFR for patients at risk for 
kidney disease. The LWG, whose members are experts in their field, 
strongly believes that routine reporting of estimated GFR will result 
in a significant increase in early detection of chronic kidney disease, 
therefore enabling treatment that can slow or prevent patients' 
progression to kidney failure.
    Frequency of Response: Baseline survey only.
    Affected Public: Clinical laboratory community.
    Type of Respondents: Laboratory directors.
    The annual reporting burden is as follows:
    Estimated Number of Respondents: Anticipate 5,085 completed 
surveys;
    Estimated Number of Responses per Respondent: Respondents will 
complete one paper-and-pencil or Web-based survey;
    Average Burden Hours Per Response: .083 hours [5 minutes]; and
    Estimated Total Annual Burden Hours Requested: 422.06 hours. The 
annualized total cost to respondents is estimated at $14,408.96.

    Note: Completing this survey is similar to other data reporting 
carried out by lab directors. Since lab directors will be able to 
respond to the survey within their usual workday, this collection of 
information will not cost labs/employers additional time and money.
    There are no Capital Costs to report. There are no Operating or 
Maintenance Costs to report.


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                                                                Estimated
                                              Estimated         number of      Average  burden    Annual total
           Type of respondents                number of       responses per      hours  per       burden hours
                                             respondents       respondent         response          requested
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Clinical Laboratory Directors...........             5,085               1.0              .083            422.06
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    Total...............................             5,085               1.0              .083            422.06
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[[Page 41030]]

    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: 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 Elisa Gladstone, MPH, Project Officer, 
Associate Director, National Kidney Disease Education Program, National 
Institute of Diabetes and Digestive and Kidney Diseases, National 
Institutes of Health, Building 31, Center Dr., Room 9A06, Bethesda, MD 
20892, or call non-toll free number 301-435-8116 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: July 7, 2006.
Elisa H. Gladstone,
Project Officer, Associate Director, National Kidney Disease Education 
Program, National Institute of Diabetes and Digestive and Kidney 
Diseases, National Institutes of Health.
 [FR Doc. E6-11380 Filed 7-18-06; 8:45 am]
BILLING CODE 4140-01-P