Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
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
Removed
0
0
0
Audit plan; regular audits
Removed
0
0
0
Controls to Prevent Adulteration due to Automatic (mechanical or electronic) Equipment (first year only)
Removed
0
0
0
Controls to prevent adulteration by equipment or utensils
Removed
0
0
0
Controls to prevent adulteration by equipment or utensils (maintenance schedule)
Removed
0
0
0
Controls to prevent adulteration by equipment or utensils (sanitation)
Removed
0
0
0
Controls to prevent adulteration caused by facilties; testing for radiological contaminants
Removed
0
0
0
Controls to prevent adulteration caused by ingredients, containers, and closures
Removed
0
0
0
Controls to prevent adulteration due to automatic equipment
Removed
0
0
0
Controls to prevent adulteration due to automatic equipment (revalidation)
Removed
0
0
0
Controls to prevent adulteration during manufacturing
Removed
0
0
0
Controls to prevent adulteration during packaging and labeling
Removed
0
0
0
Controls to prevent adulteration from microorganisms
Removed
0
0
0
Controls to prevent adulteration; bacteriological contaminants in water
Removed
0
0
0
Controls to prevent adulteration; testing for bacteriological contaminants
Removed
0
0
0
Controls to prevent adulteration; water testing for radiological contaminants
Removed
0
0
0
Exempt Infant Formula; Notification Requirements
Modified
1
4
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
General quality control; testing
Removed
0
0
0
Infant Formula; Labeling (3rd Party Disclosure) Requirements
Modified
65
520
0
New Infant Formula Registration
Modified
35
18
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
New Infant Formula Submission
Modified
36
360
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Notifications under 106.120(b)
Modified
1
4
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Part 106; Subpart B - CGMP Requirements (records)
Modified
2149
9414
0
Part 107; Subpart C - Exempt Infant Formulas (records)
Modified
30
9000
0
Quality Factors -- Records (first year only)
Removed
0
0
0
Quality control; nutrients
Removed
0
0
0
Quality control; sampling
Removed
0
0
0
Quality control; shelf-life substantiation
Removed
0
0
0
Quality factors; PER data collection
Removed
0
0
0
Quality factors; PER written report
Removed
0
0
0
Quality factors; anthropometric data
Removed
0
0
0
Quality factors; data comparisons
Removed
0
0
0
Quality factors; data plotting
Removed
0
0
0
Quality factors; formula intake
Removed
0
0
0
Quality factors; written study report
Removed
0
0
0
Recordkeeping under Part 106; Subparts C-G - quality control, audits, testing, records
Modified
3634
21818
0
Reports for exampt Infant Formula
Modified
6
24
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Reports under FFDCA section 412(d)
Modified
65
650
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Requirements for Quality Factors -- PER Exemption
Modified
34
408
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Requirements for Quality Factors GMS Exemption
Modified
36
720
0
Form and Instruction
Form FDA 3978
Infant Formula Tracking System
Requirements for Quality Factors for Eligible Formulas - Data Plotting (first year only)
Removed
0
0
0
Requirements for Quality Factors for Eligible Infant Formulas - Anthropometric Data (first year only)
Removed
0
0
0
Requirements for Quality Factors for Eligible Infant Formulas - Data Comparison (first year only)
Removed
0
0
0
Requirements for Quality Factors for Eligible Infant Formulas - Formula Intake (first year only)
Removed
0
0
0
Requirements for Quality Factors for Eligible Infant Formulas -- Written Study Report (first year only)
Removed
0
0
0
Total burden requested under this ICR:
6092
42940
0
To view an IC, click on IC Title