601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application

General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, and Forms FDA 356h & 2567

OMB: 0910-0338

IC ID: 209314

Information Collection (IC) Details

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601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application
 
No New
 
Mandatory
 
21 CFR 601.12(b)(3) 21 CFR 601.12(b)(1)

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction 2567 Transmittal of Labels and Circulars FORM 2567 11-5-13.pdf Yes Yes Fillable Printable
Form and Instruction 356h Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use FORM FDA 356h 11-5-13.zip Yes Yes Fillable Printable

Health Consumer Health and Safety

 

174 0
   
Private Sector Businesses or other for-profits
 
   20 %

  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 698 0 0 698 0 0
Annual IC Time Burden (Hours) 55,840 0 0 55,840 0 0
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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