Premeeting packages

Expedited Programs for Serious Conditions-Drugs and Biologics

OMB: 0910-0765

IC ID: 230039

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

View Information Collection (IC)

Premeeting packages
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
Other-Agency Guidance RMAT Expedited Designation GFI.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety


224 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 392 0 0 250 0 142
Annual IC Time Burden (Hours) 39,200 0 0 25,000 0 14,200
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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