Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0 Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0 Form and Instruction FDA 2567 Transmittals of Labels and Circulars
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0 Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0 Form and Instruction FDA 2567 Transmittals of Labels and Circulars
Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0 Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0 Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0 Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0 Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0 Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0 Form and Instruction FDA 2567 Transmittals of Labels and Circulars
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0 Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567 Removed 0 0 0
Section 601, recordkeeping, Forms FDA 356h & 2567 New 1 1 0 Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
Section 680, Forms FDA 356h & 2567 New 10 20 0 Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
Sections 601, Forms FDA356h & 2567 Modified 20070 341676 0 Form and Instruction FDA 356h Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use
Total burden requested under this ICR: 20081 341697 0  
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