Infant Formula Requirements

OMB 0910-0256

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 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
All Historical Document Collections
Approved without change
Revision of a currently approved collection 2023-09-29
Approved without change
Revision of a currently approved collection 2023-03-27
Approved with change
Revision of a currently approved collection 2022-09-28
Approved without change
Extension without change of a currently approved collection 2021-04-23
Approved without change
No material or nonsubstantive change to a currently approved collection 2019-03-18
Approved with change
Extension without change of a currently approved collection 2018-04-11
Approved without change
No material or nonsubstantive change to a currently approved collection 2017-02-15
Improperly submitted and continue
No material or nonsubstantive change to a currently approved collection 2016-11-08
Approved without change
Revision of a currently approved collection 2015-03-04
Comment filed on proposed rule and continue
Revision of a currently approved collection 2014-11-14
Approved without change
Revision of a currently approved collection 2014-09-12
Approved without change
Extension without change of a currently approved collection 2013-10-28
Approved without change
Extension without change of a currently approved collection 2010-06-30
Approved without change
Extension without change of a currently approved collection 2007-03-29
Approved without change
Extension without change of a currently approved collection 2004-01-23
Approved without change
Extension without change of a currently approved collection 2000-11-07
Approved without change
Extension without change of a currently approved collection 1997-12-23
Approved without change
Revision of a currently approved collection 1995-05-30
Approved without change
Reinstatement with change of a previously approved collection 1992-04-10
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 3978Infant Formula Tracking SystemFillable FileableForm and instruction

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


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