RMAT Designation Requests - CBER

Expedited Programs for Serious Conditions-Drugs and Biologics

OMB: 0910-0765

IC ID: 233190

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

View Information Collection (IC)

RMAT Designation Requests - CBER
 
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 RMAT Expedited Designation GFI.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

33 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 36 0 0 -2 0 38
Annual IC Time Burden (Hours) 2,160 0 0 -120 0 2,280
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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