Importer Reporting, Death and Serious Injury - Third-Party

Medical Device Reporting

OMB: 0910-0437

IC ID: 202637

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Information Collection (IC) Details

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Importer Reporting, Death and Serious Injury - Third-Party
 
No Modified
 
Mandatory
 
21 CFR 803

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

Health Consumer Health and Safety

 

112 6
   
Private Sector Businesses or other for-profits
 
   99 %

  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 2,800 0 0 -11,650 0 14,450
Annual IC Time Burden (Hours) 980 0 0 -4,078 0 5,058
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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