Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications

CLIA Waiver Applications

OMB: 0910-0598

IC ID: 46257

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Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications
 
No Modified
 
Mandatory
 
42 CFR 400.493

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Consumer Health and Safety

 

40 0
   
Private Sector Businesses or other for-profits
 
   0 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 40 0 0 0 0 40
Annual IC Time Burden (Hours) 160,000 0 0 16,800 0 143,200
Annual IC Cost Burden (Dollars) 350,000 0 0 350,000 0 0

Title Document Date Uploaded
CLIA Guidance CLIA Guidance.pdf 04/19/2013
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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