AER records for Rx products not subject of marketing application

Postmarketing Adverse Drug Experience Reporting

OMB: 0910-0230

IC ID: 188677

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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AER records for Rx products not subject of marketing application CDER
 
No Modified
 
Mandatory
 
21 CFR 310.305

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

Health Public Health Monitoring

 

25 0
   
Private Sector Businesses or other for-profits
 
   90 %

  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 25 0 0 0 0 25
Annual IC Time Burden (Hours) 400 0 0 0 0 400
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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