600.80(h)(2)

Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements - Final Rule

OMB: 0910-0770

IC ID: 211825

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600.80(h)(2)
 
No Unchanged
 
Mandatory
 
21 CFR 600.80(h)(2)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form 3500A MedWatch FORM FDA 3500A.pdf Yes Yes Fillable Fileable Signable

Health Health Care Services

 

5 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 5 0 5 0 0 0
Annual IC Time Burden (Hours) 5 0 5 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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