Interchangeable Product Applications or Supplements - 351(k)(2)(B) and (k)(4)

General Licensing Provisions; Section 351(k) Biosimilar Applications

OMB: 0910-0719

IC ID: 202639

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Interchangeable Product Applications or Supplements - 351(k)(2)(B) and (k)(4) CDER
 
No Modified
 
Mandatory
 
21 CFR 601.2(a) and 601.60-601.65

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability

Health Illness Prevention

 

2 0
   
Private Sector Businesses or other for-profits
 
   95 %

  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 2 0 0 1 0 1
Annual IC Time Burden (Hours) 1,720 0 0 860 0 860
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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