Breakthrough Therapy Designation Requests - CDER

Expedited Programs for Serious Conditions-Drugs and Biologics

OMB: 0910-0765

IC ID: 209910

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

View Information Collection (IC)

Breakthrough Therapy Designation Requests - CDER
 
No Unchanged
 
Required to Obtain or Retain Benefits
 
21 CFR 312; subpart E  (To search for a specific CFR, visit the Code of Federal Regulations.)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Other-Agency Guidance 0765_Agency Guidance.pdf No   Printable Only

Health Consumer Health and Safety

 

71 0
   
Private Sector Businesses or other for-profits
 
   100 %

  Requested 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 77 0 0 -79 0 156
Annual IC Time Burden (Hours) 5,390 0 0 -5,530 0 10,920
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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