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Information Collection

Disclosing illegitimate products: notifications to trading partners

IC 218217 under ICR 202407-0910-009 · OMB 0910-0806.

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

View Information Collection (IC)

Disclosing illegitimate products: notifications to trading partners CDER
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0806 DSCSA Implementation GFI 2021 - ID of Suspect Product and Notification.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

500 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested 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 310,000 0 0 155,000 155,000 0
Annual IC Time Burden (Hours) 1,860,000 0 0 620,000 1,240,000 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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