Biological products Reporting

Biological Products; General records and postmarket adverse experience reporting

OMB: 0910-0308

IC ID: 5877

Information Collection (IC) Details

View Information Collection (IC)

Biological products Reporting CBER
 
No Modified
 
Mandatory
 
21 CFR 600.80 21 CFR 610.18

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form 3500A MEDWATCH FORM FDA 3500A MEDWATCH.pdf Yes Yes Fillable Fileable Signable
Form and Instruction VAERS-1 Vaccine Adverse Event Reporting System VAERS-1 FORM.pdf Yes Yes Fillable Fileable Signable

Health Consumer Health and Safety

 

117 0
   
Private Sector Businesses or other for-profits
 
   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 354,486 0 0 47,748 0 306,738
Annual IC Time Burden (Hours) 5,329,676 0 0 147,249 0 5,182,427
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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