Infant Formula Requirements

OMB 0910-0256

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.

Latest Forms, Documents, and Supporting Material

Document Name
Form Form FDA 3978 Reports under FFDCA section 412(d) Form and Instruction
Form Form FDA 3978 New Infant Formula Submission Form and Instruction
Form Form FDA 3978 New Infant Formula Registration Form and Instruction
Form Form FDA 3978 Requirements for Quality Factors -- PER Exemption Form and Instruction
Form Form FDA 3978 Requirements for Quality Factors GMS Exemption Form and Instruction
Form Form FDA 3978 Exempt Infant Formula; Notification Requirements Form and Instruction
Form Form FDA 3978 Reports for exampt Infant Formula Form and Instruction
Form Form FDA 3978 Notifications under 106.120(b) Form and Instruction
0256 IF to add recalls from 0188 SSA 2023.docx Supporting Statement A
Reports under FFDCA section 412(d) Form and Instruction
Infant formula recalls
Voluntary submission of testing results for Cronobacter spp. or Salmonella Other-Agency Communication
IC in support of enforcement discretion Other-Agency Guidance
Exempt Infant Formula Production; GMP; Audits, Records & Records Other-Agency Guidance
Part 106; Subpart B - CGMP Requirements (records)
New Infant Formula Submission Form and Instruction
New Infant Formula Registration Form and Instruction
Requirements for Quality Factors -- PER Exemption Form and Instruction
Requirements for Quality Factors GMS Exemption Form and Instruction
Infant Formula; Labeling (3rd Party Disclosure) Requirements
Recordkeeping under Part 106; Subparts C-G - quality control, audits, testing, records
Part 107; Subpart C - Exempt Infant Formulas (records)
Exempt Infant Formula; Notification Requirements Form and Instruction
Reports for exampt Infant Formula Form and Instruction
Notifications under 106.120(b) Form and Instruction

All Historical Document Collections

202309-0910-014 Approved without change	Revision of a currently approved collection	2023-09-29
202303-0910-019 Approved without change	Revision of a currently approved collection	2023-03-27
202209-0910-009 Approved with change	Revision of a currently approved collection	2022-09-28
202104-0910-013 Approved without change	Extension without change of a currently approved collection	2021-04-23
201903-0910-014 Approved without change	No material or nonsubstantive change to a currently approved collection	2019-03-18
201804-0910-005 Approved with change	Extension without change of a currently approved collection	2018-04-11
201702-0910-006 Approved without change	No material or nonsubstantive change to a currently approved collection	2017-02-15
201610-0910-012 Improperly submitted and continue	No material or nonsubstantive change to a currently approved collection	2016-11-08
201502-0910-012 Approved without change	Revision of a currently approved collection	2015-03-04
201411-0910-006 Comment filed on proposed rule and continue	Revision of a currently approved collection	2014-11-14
201407-0910-003 Approved without change	Revision of a currently approved collection	2014-09-12
201310-0910-005 Approved without change	Extension without change of a currently approved collection	2013-10-28
201006-0910-008 Approved without change	Extension without change of a currently approved collection	2010-06-30
200703-0910-015 Approved without change	Extension without change of a currently approved collection	2007-03-29
200401-0910-009 Approved without change	Extension without change of a currently approved collection	2004-01-23
200011-0910-002 Approved without change	Extension without change of a currently approved collection	2000-11-07
199712-0910-005 Approved without change	Extension without change of a currently approved collection	1997-12-23
199505-0910-002 Approved without change	Revision of a currently approved collection	1995-05-30
199204-0910-002 Approved without change	Reinstatement with change of a previously approved collection	1992-04-10
198902-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	1989-02-07

OMB Details

Reports under FFDCA section 412(d)

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.