Department of Health and Human Services January 25, 2006 – Federal Register Recent Federal Regulation Documents

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The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for the opportunity for public comment on proposed data collection projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of 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: 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. This will be accomplished through baseline and follow-up surveys of a representative sample of clinical laboratories in the U.S. Information will be used to establish baseline data necessary to measure an anticipated increased in use of estimated GFR, following the implementation of the NKDEP'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 follow: Estimated Number of Respondents: Anticipate 4,126 completed surveys; Estimated Number of Responses per Respondent: Respondents will complete one paper-and-pencil or online survey; Average Burden Hours Per Response: .083 hours [5 minutes]; and Estimated Total Annual Burden Hours Requested: 342.46 hours. The annualized total cost to respondents is estimated at $11,759.10. (Note: Completing this survey is similar to other data reporting carried out by lab directors. Since lab directors will be able to responded 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.