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

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

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) 143,200 0 0 0 0 143,200
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
CLIA Guidance 0910-0598 final guidance 09.doc 01/08/2010
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