Notice of certification of invalidity or infringement of a patent

Abbreviated New Drug Applications and 505(b)(2) Applications

OMB: 0910-0786

IC ID: 214786

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Notice of certification of invalidity or infringement of a patent CDER
 
No Removed
 
Mandatory
 
21 CFR 314.52(c)

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

Health Health Care Services

 

7 0
   
Private Sector Businesses or other for-profits
 
   75 %

  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) 0 0 0 0 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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