Pretest

Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs in Prescription Drug User Fee Act

OMB: 0910-0746

IC ID: 206911

Documents and Forms
Information Collection (IC) Details

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Pretest
 
No Unchanged
 
Voluntary
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Interview Script FDA PDUFA V Program Evaluation_Post-Action Interview Script-Sponsor_4-22-2013.docx No No Printable Only

Health Consumer Health and Safety

 

5 0
   
Private Sector Businesses or other for-profits
 
   0 %

  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 5 0 0 0 0 5
Annual IC Time Burden (Hours) 8 0 0 0 0 8
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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