OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Infant Formula Requirements

OMB 0910-0256 ยท HHS/FDA.

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 2026-10-31 and is listed under ICR 202412-0910-007.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form Form FDA 3978 Infant Formula Tracking SystemForm and Instruction
Form Form FDA 3978 Reports under FFDCA section 412(d)Form and Instruction
Form Form FDA 3978 Infant Formula Tracking SystemForm and Instruction
Form Form FDA 3978 New Infant Formula SubmissionForm and Instruction
Form Form FDA 3978 Infant Formula Tracking SystemForm and Instruction
Form Form FDA 3978 New Infant Formula RegistrationForm and Instruction
Form Form FDA 3978 Infant Formula Tracking SystemForm and Instruction
Form Form FDA 3978 Requirements for Quality Factors -- PER ExemptionForm and Instruction
Form Form FDA 3978 Infant Formula Tracking SystemForm and Instruction
Form Form FDA 3978 Requirements for Quality Factors GMS ExemptionForm and Instruction
Form Form FDA 3978 Infant Formula Tracking SystemForm and Instruction
Form Form FDA 3978 Exempt Infant Formula; Notification RequirementsForm and Instruction
Form Form FDA 3978 Infant Formula Tracking SystemForm and Instruction
Form Form FDA 3978 Reports for exampt Infant FormulaForm and Instruction
Form Form FDA 3978 Infant Formula Tracking SystemForm and Instruction
Form Form FDA 3978 Notifications under 106.120(b)Form and Instruction
0256 IF Non Sub 2024 for MoCRA Authority.docxJustification for No Material/Nonsubstantive Change
0256 IF to add recalls from 0188 SSA 2023.docxSupporting Statement A
Reports under FFDCA section 412(d) Form and Instruction
Reports under FFDCA section 412(d) Form and Instruction
Infant formula recalls Information collection
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) Information collection
New Infant Formula Submission Form and Instruction
New Infant Formula Submission Form and Instruction
New Infant Formula Registration Form and Instruction
New Infant Formula Registration Form and Instruction
Requirements for Quality Factors -- PER Exemption Form and Instruction
Requirements for Quality Factors -- PER Exemption Form and Instruction
Requirements for Quality Factors GMS Exemption Form and Instruction
Requirements for Quality Factors GMS Exemption Form and Instruction
Infant Formula; Labeling (3rd Party Disclosure) Requirements Information collection
Recordkeeping under Part 106; Subparts C-G - quality control, audits, testing, records Other-Agency guidance
Part 107; Subpart C - Exempt Infant Formulas (records) Information collection
Exempt Infant Formula; Notification Requirements Form and Instruction
Exempt Infant Formula; Notification Requirements Form and Instruction
Exempt Infant Formula; Notification Requirements Other-Agency Guidance
Reports for exampt Infant Formula Form and Instruction
Reports for exampt Infant Formula Form and Instruction
Notifications under 106.120(b) Form and Instruction
Notifications under 106.120(b) Form and Instruction
Notifications under 106.120(b) Other-Agency guidance

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202412-0910-007 No material or nonsubstantive change to a currently approved collection 2025-06-03
202309-0910-014 Revision of a currently approved collection 2023-09-29 Approved without change
202303-0910-019 Revision of a currently approved collection 2023-03-27 Approved without change
202209-0910-009 Revision of a currently approved collection 2022-09-28 Approved with change
202104-0910-013 Extension without change of a currently approved collection 2021-04-23 Approved without change
201903-0910-014 No material or nonsubstantive change to a currently approved collection 2019-03-18 Approved without change
201804-0910-005 Extension without change of a currently approved collection 2018-04-11 Approved with change
201702-0910-006 No material or nonsubstantive change to a currently approved collection 2017-02-15 Approved without change
201610-0910-012 No material or nonsubstantive change to a currently approved collection 2016-11-08 Improperly submitted and continue
201502-0910-012 Revision of a currently approved collection 2015-03-04 Approved without change
201411-0910-006 Revision of a currently approved collection 2014-11-14 Comment filed on proposed rule and continue
201407-0910-003 Revision of a currently approved collection 2014-09-12 Approved without change
201310-0910-005 Extension without change of a currently approved collection 2013-10-28 Approved without change
201006-0910-008 Extension without change of a currently approved collection 2010-06-30 Approved without change
200703-0910-015 Extension without change of a currently approved collection 2007-03-29 Approved without change
200401-0910-009 Extension without change of a currently approved collection 2004-01-23 Approved without change
200011-0910-002 Extension without change of a currently approved collection 2000-11-07 Approved without change
199712-0910-005 Extension without change of a currently approved collection 1997-12-23 Approved without change
199505-0910-002 Revision of a currently approved collection 1995-05-30 Approved without change
199204-0910-002 Reinstatement with change of a previously approved collection 1992-04-10 Approved without change
198902-0910-001 New collection (Request for a new OMB Control Number) 1989-02-07 Approved without change

OMB Details

Reports under FFDCA section 412(d)

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
FormNameElectronic accessType
Form Form FDA 3978Infant Formula Tracking SystemFillable FileableForm and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.