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  
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