Form FDA 3542a

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

OMB: 0910-0513

IC ID: 179904

Information Collection (IC) Details

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

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form 35421 Patent Information Submitted With the Filing of an NDA, Amendment, or Supplement FORM FDA 3542a.pdf Yes No Printable Only

Health Consumer Health and Safety

 

201 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 563 0 0 163 0 400
Annual IC Time Burden (Hours) 11,260 0 0 9,260 0 2,000
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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