Electronic Submissions via ESG - Mandatory Reports

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

OMB: 0910-0291

IC ID: 253750

Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details

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Electronic Submissions via ESG - Mandatory Reports
 
No Unchanged
 
Mandatory
 
21 CFR Parts 1-1299 as applicable  (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 Health Care Services

 

956 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 1,836 0 0 0 0 1,836
Annual IC Time Burden (Hours) 1,486 0 0 0 0 1,486
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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