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 65 520 0
Infant Formula; Recordkeeping Requirements Unchanged 50 20000 0
Minimum and maximum levels of selenium to infant formula and related labeling New 46 23 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: 16947 78536 0  
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