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Agenda
Reg Review
ICR
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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