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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
601.12(a)(5) - Changes to an Approved Application
New
13059
13059
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(b)(1)/(b)(3)/(e) - Changes to an Approved Application
New
698
55840
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(c)(1) and (c)(3) - Changes to an Approved Application
New
538
26900
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(c)(5) - Changes to an Approved Application
New
29
1450
0
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
Form and Instruction
2567
Transmittal of Labels and Circulars
601.12(d)(1)/(d)(3)/(f)(3) - Changes to an Application
New
742
17808
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(f)(1) - Changes to an Approved Application
New
166
6640
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(f)(2) - Changes to an Approved Application
New
128
2560
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.12(f)(4)/601.45 - Changes to an Approved Application
New
10578
105780
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.2(a) - Applications for Biologics Licenses; procedures for filing and 610.60 through 610.65 - Container Label
Modified
45
38700
0
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
Form and Instruction
2567
Transmittal of Labels and Circulars
601.26(f) - Additional Studies and Labeling
New
1
1
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.27(b) - Pediatric Studies - Deferred Submission
New
4
96
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.27(c) - Pediatric Studies
New
6
48
0
Form and Instruction
2568
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.5(a) - Revocation of License
Modified
8
3
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.6(a) - Suspension of License
Modified
1
0
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.6(a) - Suspension of License
New
20
7
0
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
601.70(b) and (d)/601.28 - Annual Progress Reports of Postmarketing Studies and Annual reports of postmarketing pediatric studies
New
107
2568
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
610.15(d) - Constituent Materials
New
1
1
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
680.1(b)(3)(iv) - Allergenic Products
New
1
2
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
680.1(c) - Allergenic Products
New
9
18
0
Form and Instruction
2567
Transmittal of Labels and Circulars
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
Amendments/Resubmissions
New
2664
53280
0
Form and Instruction
356h
Application to Market a New Drug Biologic or an Antibiotic Drug for Human Use
Total burden requested under this ICR:
28805
324761
0
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