Mandatory Adverse Event Reporting via the SRP (other than RFR reports)

FDA Adverse Event and Products Experience Reports; Electronic Submissions

OMB: 0910-0645

IC ID: 192361

Documents and Forms
Information Collection (IC) Details

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Mandatory Adverse Event Reporting via the SRP (other than RFR reports)
 
No Unchanged
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-(Screen shots for CVM collection) 0645 IC2 CVM adverse drug experiences and product defects RQ screenshots 2013.pdf Yes No Paper Only
Other-eForm Submission 0645 IC2 Mandatory DSR Wireframes.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

3,360 0
   
Individuals or Households
 
   100 %

  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 3,360 0 0 0 0 3,360
Annual IC Time Burden (Hours) 3,360 0 0 0 0 3,360
Annual IC Cost Burden (Dollars) 157,647 0 0 0 0 157,647

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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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