Subpart B - Applications

Applications for FDA Approval to Market a New Drug

OMB: 0910-0001

IC ID: 5662

Documents and Forms
Document Name
Document Type
Form and Instruction
Instruction
Instruction
Instruction
Instruction
Other-Performance Goals
Other-Performance Goals
Other-Legislative Authority
Other-Legislative Authority
Other-Statutory Authority
Other-Statutory Authority
Instruction
Instruction
Instruction
Instruction
Instruction
Instruction
Form and Instruction
Form and Instruction
Form
Form
Form
Form
Form
Form
Form
Form
Form
Form
Information Collection (IC) Details

View Information Collection (IC)

Subpart B - Applications
 
No Modified
 
Mandatory
 
21 CFR 314.50-314.90 21 CFR 310.306

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction FDA 3331a NDA - Field Alert Report Form FDA 3331a DRAFT FEB 2020.pdf https://www.fda.gov/drugs/surveillance/field-alert-reports Yes Yes Fillable Fileable
Form FDA 2252 Transmittal of annual drug and biologic report under 314.81 FDA 2252 reports rev 2021.pdf Yes Yes Fillable Fileable
Instruction 2252 instructions rev 2021.pdf Yes Yes Fillable Fileable
Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE Form FDA 2253 propchanges 9-9-2021.pdf Yes Yes Fillable Fileable
Instruction FDA-2253-Instructions rev 2021.pdf Yes Yes Fillable Fileable
Other-Performance Goals PDUFA Committment Goals.pdf Yes Yes Paper Only
Other-Legislative Authority FDARA 2017.pdf Yes Yes Paper Only
Other-Statutory Authority 21 USC 355 New Drugs.pdf Yes Yes Fillable Fileable
Form FDA 356h Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use Form FDA 356h with comments noting changes Aug 2022.pdf Yes Yes Fillable Fileable
Instruction FDA-form-356h_R13_instructional-supplement_508_FINAL_CDERProposedEdits.pdf Yes Yes Fillable Fileable
Form FDA 3542a Patent Information Submitted with an NDA, or Supplement 0001 Form FDA 3542a_Dyn_Sec_Ext_07-17-2023.pdf Yes Yes Fillable Fileable
Instruction Form FDA 3542a instructions_07-18-2023.pdf Yes Yes Fillable Fileable
Form FDA 3542 Patent Information Submitted Upon and After Approval of an NDA or Supplement 0001 Form FDA 3542_Dyn_Sec_Ext_07-17-2023.pdf Yes Yes Fillable Fileable
Instruction 0001 Form FDA 3542_instructions_07-17-2023.pdf Yes Yes Fillable Fileable

Health Public Health Monitoring

 

354 0
   
Private Sector Businesses or other for-profits
 
   99 %

  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 57,630 0 0 -9,294 0 66,924
Annual IC Time Burden (Hours) 1,084,042 0 0 -150,153 0 1,234,195
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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