E6-11380. 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.

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

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 [e-mail].

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.