AER records under 314.80 (marketing applications)

Postmarketing Adverse Drug Experience Reporting

OMB: 0910-0230

IC ID: 188678

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

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AER records under 314.80 (marketing applications) CDER
 
No Unchanged
 
Mandatory
 
21 CFR 314.80(j)

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

Health Consumer Health and Safety

 

352 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 658,240 0 0 0 0 658,240
Annual IC Time Burden (Hours) 10,531,840 0 0 0 0 10,531,840
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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