Notify FDA When Normal Reporting is Not Feasible

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic: Agency Guidance

OMB: 0910-0701

IC ID: 198612

Documents and Forms
Document Name
Document Type
Other-Agency Guidance
Information Collection (IC) Details

View Information Collection (IC)

Notify FDA When Normal Reporting is Not Feasible CDER
 
No Modified
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0701 AER Pandemic GFI 2020.pdf Yes Yes Fillable Fileable

Health Public Health Monitoring

 

500 0
   
Private Sector Businesses or other for-profits
 
   80 %

  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 500 0 0 0 0 500
Annual IC Time Burden (Hours) 4,000 0 0 0 0 4,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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