Subpart B - Applications

Applications for FDA Approval to Market a New Drug

OMB: 0910-0001

IC ID: 5662

Information Collection (IC) Details

View Information Collection (IC)

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

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 3331 NDA-Field Alert Report FORM FDA 3331 1-19-2016.pdf Yes Yes Fillable Fileable
Form 2252 Transmittal of Annual Report for Drug and Biologics for Human Use FORM FDA 2252 9-11-14.pdf Yes Yes Fillable Fileable
Form 2253 Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use FORM FDA 2253 9-11-14.pdf Yes Yes Fillable Fileable
Form 356 Application to Market a New or Abbreviated New Drug or Biologic for Human Use FORM 356h - 9-11-14.pdf Yes Yes Fillable Fileable

Health Public Health Monitoring

 

378 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 71,706 0 0 2,153 0 69,553
Annual IC Time Burden (Hours) 2,644,204 0 0 2,789 0 2,641,415
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

Title Document Date Uploaded
FDA Form 3331 FORM FDA 3331 1-19-2016.pdf 01/19/2016
            Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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