Consultation with FDA and Termination of Notification - Manufacturers and Repackagers

Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

OMB: 0910-0806

IC ID: 218217

Documents and Forms
Information Collection (IC) Details

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Consultation with FDA and Termination of Notification - Manufacturers and Repackagers CDER
 
No New
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance FINAL GUIDANCE Suspect product notification.docx Yes No Paper Only
Form 3911 Drug Notification FDA FORM 3911.pdf Yes No Paper Only

Health Health Care Services

 

800 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 800 0 800 0 0 0
Annual IC Time Burden (Hours) 800 0 800 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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