Intitial Submittal of Manufacturer Information by Initial Importers (One time)

Electronic Submission of Medical Device Registration and Listing

OMB: 0910-0625

IC ID: 203608

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Information Collection (IC) Details

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Intitial Submittal of Manufacturer Information by Initial Importers (One time)
 
No Unchanged
 
Mandatory
 
21 CFR 807.20

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

Health Consumer Health and Safety

 

5,736 0
   
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 5,736 0 0 0 0 5,736
Annual IC Time Burden (Hours) 10,038 0 0 0 0 10,038
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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