Requests for Consideration; No Application pending

Draft Guidance: Emergency Use Authorization of Medical Products

OMB: 0910-0595

IC ID: 191140

Information Collection (IC) Details

View Information Collection (IC)

Requests for Consideration; No Application pending
 
No New
 
Mandatory
 

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-guidance document 0910-0595 Guidance--Emergency Use Authorization of Medical Products.htm http://www.fda.gov/RegulatoryInformation/Guidances/ucm125127.htm Yes Yes Printable Only

Health Illness Prevention

 

4 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 8 0 0 8 0 0
Annual IC Time Burden (Hours) 400 0 0 400 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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