Information Collection Request

Infant Formula Requirements

ICR 202303-0910-019 · OMB 0910-0256 · Received in OIRA

⚠️ Notice: This information collection may be outdated.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

Forms and Documents

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

IC Document Collections

IC ID	Collection	Type	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

Status	Received in OIRA
Agency/Subagency	HHS/FDA
OMB Control No	0910-0256
Type of Information Collection	Revision of a currently approved collection
Previous ICR Reference No	202209-0910-009
Agency Tracking No	CFSAN
Date Submitted to OIRA	1969-12-31
Requested Expiration Date	1969-12-31