Promotional Materials for Accelerated Approval Under Section 314.550

Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

OMB: 0910-0765

IC ID: 209911

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

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Promotional Materials for Accelerated Approval Under Section 314.550
 
No New
 
Voluntary
 
21 CFR 314.550

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Guidance GUIDANCE 9-24-13.pdf Yes Yes Printable Only

Health Consumer Health and Safety

 

20 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 140 0 140 0 0 0
Annual IC Time Burden (Hours) 16,800 0 16,800 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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