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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Audit plan; ongoing review and updating
Unchanged
5
40
0
Audit plan; regular audits
Unchanged
260
1040
0
Controls to Prevent Adulteration due to Automatic (mechanical or electronic) Equipment (first year only)
Unchanged
5
32000
0
Controls to prevent adulteration by equipment or utensils
Unchanged
260
55
0
Controls to prevent adulteration by equipment or utensils (maintenance schedule)
Unchanged
260
49
0
Controls to prevent adulteration by equipment or utensils (sanitation)
Unchanged
260
55
0
Controls to prevent adulteration caused by facilties; testing for radiological contaminants
Unchanged
21
32
0
Controls to prevent adulteration caused by ingredients, containers, and closures
Unchanged
260
44
0
Controls to prevent adulteration due to automatic equipment
Unchanged
5
2600
0
Controls to prevent adulteration due to automatic equipment (revalidation)
Unchanged
10
6400
0
Controls to prevent adulteration during manufacturing
Unchanged
260
60
0
Controls to prevent adulteration during packaging and labeling
Unchanged
12
3
0
Controls to prevent adulteration from microorganisms
Unchanged
260
65
0
Controls to prevent adulteration; bacteriological contaminants in water
Unchanged
260
21
0
Controls to prevent adulteration; testing for bacteriological contaminants
Unchanged
260
21
0
Controls to prevent adulteration; water testing for radiological contaminants
Unchanged
21
2
0
Exampt Infant Formula; Terms and Conditions
Unchanged
6
24
0
Exempt Infant Formula; Notification Requirements
Unchanged
1
4
0
Exempt Infant Formula; Recordkeeping Requirements
Unchanged
30
9000
0
General quality control; testing
Unchanged
4
8
0
Infant Formula; Ingredient Control
Unchanged
1
4
0
Infant Formula; Labeling (3rd Party Disclosure) Requirements
Unchanged
65
543
765439
Infant Formula; Recordkeeping Requirements
Unchanged
50
20000
0
New Infant Formula Registration
Unchanged
35
18
0
New Infant Formula Submission
Unchanged
35
350
0
Production and In-process Control System (first year only)
Unchanged
5
200
0
Quality Factors -- Records (first year only)
Unchanged
46
920
0
Quality control; nutrients
Unchanged
208
31
0
Quality control; sampling
Unchanged
208
31
0
Quality control; shelf-life substantiation
Unchanged
208
31
0
Quality factors; PER data collection
Unchanged
1
8
0
Quality factors; PER written report
Unchanged
1
1
0
Quality factors; anthropometric data
Unchanged
672
336
0
Quality factors; data comparisons
Unchanged
672
54
0
Quality factors; data plotting
Unchanged
672
54
0
Quality factors; formula intake
Unchanged
672
168
0
Quality factors; written study report
Unchanged
1
16
0
Requirements for Infant Formula
Unchanged
65
650
0
Requirements for Quality Factors -- PER Exemption
Unchanged
34
408
0
Requirements for Quality Factors GMS Exemption
Unchanged
34
680
0
Requirements for Quality Factors for Eligible Formulas - Data Plotting (first year only)
Unchanged
2688
215
0
Requirements for Quality Factors for Eligible Infant Formulas - Anthropometric Data (first year only)
Unchanged
2688
1344
0
Requirements for Quality Factors for Eligible Infant Formulas - Data Comparison (first year only)
Unchanged
2688
215
0
Requirements for Quality Factors for Eligible Infant Formulas - Formula Intake (first year only)
Unchanged
2688
672
0
Requirements for Quality Factors for Eligible Infant Formulas -- Written Study Report (first year only)
Unchanged
4
64
0
Total burden requested under this ICR:
16901
78536
765439
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