Reporting: Notifications to FDA

Pharmaceutical Distribution Supply Chain

OMB: 0910-0806

IC ID: 218211

Information Collection (IC) Details

View Information Collection (IC)

Reporting: Notifications to FDA CDER
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form 3911 Drug Notifications FDA FORM 3911.pdf Yes No Paper Only
Other-21 USC 360eee-1 21 USC 360eee-1 Drug Supply Chain Security.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

500 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 14,100 0 0 13,950 0 150
Annual IC Time Burden (Hours) 112,800 0 0 112,650 0 150
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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