Requests to Issue an EUA or a Substantive Amendment to an Existing EUA

Guidance: Emergency Use Authorization of Medical Products

OMB: 0910-0595

IC ID: 43607

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

View Information Collection (IC)

Requests to Issue an EUA or a Substantive Amendment to an Existing EUA
 
No Modified
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance 0595 EUA Final Guidance 12-18-12.pdf Yes Yes Printable Only

Health Consumer Health and Safety

 

9 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 12 0 0 2 0 10
Annual IC Time Burden (Hours) 396 0 0 246 0 150
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
No associated records found
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

© 2024 OMB.report | Privacy Policy