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  
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