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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Exempt Infant Formula Production; GMP; Audits, Records & Records
Unchanged
1902
85590
0
Other-Agency Guidance
Exempt Infant Formula; Notification Requirements
Unchanged
1
4
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Other-Agency Guidance
IC in support of enforcement discretion
Unchanged
115
3805
0
Other-Agency Guidance
Infant Formula; Labeling (3rd Party Disclosure) Requirements
Unchanged
65
520
0
Infant formula recalls
New
10
12854
0
New Infant Formula Registration
Unchanged
36
18
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
New Infant Formula Submission
Unchanged
36
360
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Notifications under 106.120(b)
Unchanged
1
4
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Part 106; Subpart B - CGMP Requirements (records)
Unchanged
2149
9414
0
Part 107; Subpart C - Exempt Infant Formulas (records)
Unchanged
30
9000
0
Recordkeeping under Part 106; Subparts C-G - quality control, audits, testing, records
Unchanged
3634
21818
0
Reports for exampt Infant Formula
Unchanged
6
24
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Reports under FFDCA section 412(d)
Unchanged
65
650
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Requirements for Quality Factors -- PER Exemption
Unchanged
34
408
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Requirements for Quality Factors GMS Exemption
Unchanged
36
720
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Voluntary submission of testing results for Cronobacter spp. or Salmonella
Unchanged
20
5
0
Other-Agency Communication
Total burden requested under this ICR:
8140
145194
0
To view an IC, click on IC Title