FDA Review of a Pre-EUA Package or an Amendment Thereto

Guidance on Emergency Use Authorization of Medical Products and Related Authorities

OMB: 0910-0595

IC ID: 191140

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

View Information Collection (IC)

FDA Review of a Pre-EUA Package or an Amendment Thereto
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance 0595_Guidance_2019.pdf Yes Yes Printable Only

Health Illness Prevention

 

32 0
   
Private Sector Businesses or other for-profits
 
   40 %

  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 57 0 0 41 0 16
Annual IC Time Burden (Hours) 1,938 0 0 1,378 0 560
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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