Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)

MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)

OMB: 0910-0291

IC ID: 216796

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Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors)
 
No Modified
 
Voluntary
 
21 CFR 600; 1271 21 CFR 310; 314; 329  (To search for a specific CFR, visit the Code of Federal Regulations.)

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

Health Consumer Health and Safety

 

14,727 0
   
Private Sector Businesses or other for-profits
 
   20 %

  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 14,727 0 0 0 0 14,727
Annual IC Time Burden (Hours) 9,720 0 0 0 0 9,720
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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