Breakthrough Therapy Designation Request

Expedited Programs for Serious Conditions-Drugs and Biologics

OMB: 0910-0765

IC ID: 209910

Documents and Forms
Information Collection (IC) Details

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Breakthrough Therapy Designation Request
No Modified
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 GFI Expedited Review for Serious conditions Contol No 0765.pdf No   Printable Only

Health Consumer Health and Safety


119 0
Private Sector Businesses or other for-profits
   100 %

  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 156 0 0 43 0 113
Annual IC Time Burden (Hours) 10,920 0 0 3,010 0 7,910
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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