All Centers - Form 3500B (Consumer Reporting)

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

OMB: 0910-0291

IC ID: 216812

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All Centers - Form 3500B (Consumer Reporting)
 
No Unchanged
 
Voluntary
 
21 CFR 310; 314; 329 21 CFR 600; 1271 21 CFR 803  (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

 

13,750 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 13,750 0 0 0 0 13,750
Annual IC Time Burden (Hours) 6,325 0 0 0 0 6,325
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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