This ICR supports the recordkeeping, reporting, and labeling requirements for the manufacture and distribution of infant formula. Respondents to this collection are infant formula manufacturers who must ensure that their products adhere to the quality control provisions and procedures found in FDA regulations, and that nutrient information and directions for use are disclosed in their product labeling.
The latest form for Infant Formula Requirements expires 2021-05-31 and can be found here.
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Form and Instruction |
Form and Instruction |
Form and Instruction |
Form and Instruction |
Form and Instruction |
Form and Instruction |
Form and Instruction |
Form and Instruction |
Supporting Statement A |
Federal Enterprise Architecture: Health - Consumer Health and Safety
Form Form FDA 3978 | Infant Formula Tracking System | Fillable Fileable | Form and instruction |
Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.