601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application

General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Form FDA 356h

OMB: 0910-0338

IC ID: 209317

Information Collection (IC) Details

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601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application
 
No Unchanged
 
Mandatory
 
21 CFR 601.12(d)(1) 21 CFR 601.12(d)(3) 21 CFR 601.12(f)(3)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 356h Application to Market a New Drug or Biologic for Human Use FORM FDA 356h revised 2-28-14.pdf Yes Yes Fillable Printable
Form and Instruction Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE FDA Form 2253.pdf Yes Yes Fillable Printable

Health Consumer Health and Safety

 

246 0
   
Private Sector Businesses or other for-profits
 
   95 %

  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 822 0 0 0 0 822
Annual IC Time Burden (Hours) 19,728 0 0 0 0 19,728
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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