Pre-EUA submissions or amendments

Authorization of Medical Products for Use Emergencies

OMB: 0910-0595

IC ID: 191140

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

View Information Collection (IC)

Pre-EUA submissions or amendments
 
No Modified
 
Required to Obtain or Retain Benefits
 

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
Other-Submission Template Pre-EUA-Interactive-Review-Template.pdf Yes Yes Fillable Fileable
Other-Submission Template Surgical Masks EUA Template.pdf Yes Yes Fillable Fileable
Other-Submission Template Ventilator EUA Interactive Review Template.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

2,001 0
   
Private Sector Businesses or other for-profits
 
   95 %

  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 2,001 0 0 0 0 2,001
Annual IC Time Burden (Hours) 68,034 0 0 0 0 68,034
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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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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