Fast track designation request

Expedited Programs for Serious Conditions-Drugs and Biologics

OMB: 0910-0765

IC ID: 230038

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

View Information Collection (IC)

Fast track 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 0765 GFI Expedited Programs for Drugs and Biologics.pdf No   Paper Only

Health Consumer Health and Safety


205 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 261 0 0 74 0 187
Annual IC Time Burden (Hours) 15,660 0 0 4,440 0 11,220
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
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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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