Application for Biosimilars - 351(l)(6)(C)

General Licensing Provisions; Section 351(k) Biosimilar Applications

OMB: 0910-0719

IC ID: 202640

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Application for Biosimilars - 351(l)(6)(C)
 
No New
 
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
 
   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
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Annual IC Time Burden (Hours) 4 0 0 4 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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