Infant Formula Requirements

ICR 202303-0910-019

OMB: 0910-0256

Federal Form Document

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0256 can be found here:

2023-09-29 - Revision of a currently approved collection

Forms and Documents

Document Name	Status
Form Form FDA 3978 Reports under FFDCA section 412(d) Form and Instruction	Modified
Form Form FDA 3978 New Infant Formula Submission Form and Instruction	Unchanged
Form Form FDA 3978 New Infant Formula Registration Form and Instruction	Unchanged
Form Form FDA 3978 Requirements for Quality Factors -- PER Exemption Form and Instruction	Unchanged
Form Form FDA 3978 Requirements for Quality Factors GMS Exemption Form and Instruction	Unchanged
Form Form FDA 3978 Exempt Infant Formula; Notification Requirements Form and Instruction	Unchanged
Form Form FDA 3978 Reports for exampt Infant Formula Form and Instruction	Unchanged
Form Form FDA 3978 Notifications under 106.120(b) Form and Instruction	Unchanged
0256⁭ IF Requirements + Shortages enforcemnt plan SSA 2023.docx Supporting Statement A	2023-03-25
0256 IF Emergency Request Memo 09.27.22.docx Supplementary Document	2022-09-27

IC Document Collections

IC ID	Document Title	Status
5835	Reports under FFDCA section 412(d) Form and Instruction	Modified
259321	Voluntary submission of testing results for Cronobacter spp. or Salmonella Other-Agency Communication	New
256173	IC in support of enforcement discretion Other-Agency Guidance	Modified
235376	Exempt Infant Formula Production; GMP; Audits, Records & Records Other-Agency Guidance	Unchanged
212199	Part 106; Subpart B - CGMP Requirements (records)	Unchanged
212198	New Infant Formula Submission Form and Instruction	Unchanged
212197	New Infant Formula Registration Form and Instruction	Unchanged
212196	Requirements for Quality Factors -- PER Exemption Form and Instruction	Unchanged
212194	Requirements for Quality Factors GMS Exemption Form and Instruction	Unchanged
179355	Infant Formula; Labeling (3rd Party Disclosure) Requirements	Unchanged
179354	Recordkeeping under Part 106; Subparts C-G - quality control, audits, testing, records	Unchanged
179353	Part 107; Subpart C - Exempt Infant Formulas (records)	Unchanged
179352	Exempt Infant Formula; Notification Requirements Form and Instruction	Unchanged
179351	Reports for exampt Infant Formula Form and Instruction	Unchanged
179350	Notifications under 106.120(b) Form and Instruction	Unchanged

ICR Details

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