Maintain Records to Identify What Reports Have Been Stored and When the Reporting Process was Restored

Guidance for Industry; Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic

OMB: 0910-0701

IC ID: 198615

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Maintain Records to Identify What Reports Have Been Stored and When the Reporting Process was Restored CDER
 
No Modified
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-guidance Med Products and Diet Supp-Influenza Pandemic guidance for ROCIS.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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