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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
Modified
28
24080
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
New
100
1000
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
New
5400
129600
0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
New
10
20
0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
New
3563
71260
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
New
1
1
0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
New
144
4824
0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
New
21
7
0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
New
2983
2983
0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
New
903
72240
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
New
540
5400
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
New
3
72
0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
New
7
56
0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
New
30
720
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
New
1
240
0
General Licensing Provisions: Biologics License App., Changes to an Approved App., Labeling, Revocation & Suspension, Postmarketing Studies Status Reports & Forms FDA356h & 2567
New
255
12750
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
New
47
2350
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
New
227
5108
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
New
20
2400
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
New
12
480
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
New
10
200
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
New
50
17
0
Total burden requested under this ICR:
14355
335808
0
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