Form FDA 3542

Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...

OMB: 0910-0513

IC ID: 6229

Information Collection (IC) Details

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Form FDA 3542
 
No Unchanged
 
Mandatory
 
21 CFR 314.53 21 CFR 314.50(h)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form 3542 Patent Information Submitted Upon and After Approval of an NDA or Supplement FORM FDA 3542.pdf Yes No Printable Only

Health Consumer Health and Safety

 

200 0
   
Private Sector Businesses or other for-profits
 
   25 %

  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 680 0 0 0 0 680
Annual IC Time Burden (Hours) 3,400 0 0 0 0 3,400
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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