OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Generally Recognized as Safe (GRAS) Notices

OMB 0910-0342 ยท HHS/FDA.

OMB 0910-0342

This ICR collects information from food manufacturers who wish to obtain a determination from FDA that a food additive is generally recognized as safe (GRAS) and therefore not subject to premarket approval requirements. Respondents submit information as provided in agency regulations regarding GRAS notification, including a description of the substance, intended use, previous communications with the agency, contact information, etc. FDA has developed Form 3667 to facilitate its review of GRAS notices.

The latest form for Generally Recognized as Safe (GRAS) Notices expires 2028-09-30 and is listed under ICR 202501-0910-001.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form Form FDA 3667 GRAS NotificationForm
Form Form FDA 3667 Reporting; GRAS Notice under 21 CFR Parts 170 and 570Form
0342 GRAS SSA 2025 REV.docxSupporting Statement A
0342 GRAS SSA 2025 REV.docxSupporting Statement A
Reporting; GRAS Notice under 21 CFR Parts 170 and 570 Form
Reporting; GRAS Notice under 21 CFR Parts 170 and 570 Form
Reporting; GRAS Notice under 21 CFR Parts 170 and 570 Instruction
Best Practices for Convening a GRAS Panel Other-Agency Guidance

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202501-0910-001 Revision of a currently approved collection 2025-08-26
202204-0910-014 Extension without change of a currently approved collection 2022-06-09 Approved without change
201907-0910-015 Extension without change of a currently approved collection 2019-07-16 Approved without change
201608-0910-012 Revision of a currently approved collection 2016-08-22 Approved without change
201602-0910-001 Extension without change of a currently approved collection 2016-02-18 Approved without change
201211-0910-010 Revision of a currently approved collection 2012-11-30 Approved with change
201208-0910-009 Revision of a currently approved collection 2012-08-30 Improperly submitted and continue
200905-0910-003 Extension without change of a currently approved collection 2009-05-15 Approved without change
200604-0910-001 Extension without change of a currently approved collection 2006-04-12 Approved without change
200302-0910-001 Extension without change of a currently approved collection 2003-02-05 Approved without change
200003-0910-006 Extension without change of a currently approved collection 2000-03-29 Approved without change
199704-0910-003 New collection (Request for a new OMB Control Number) 1997-04-21 Approved without change

OMB Details

Reporting; GRAS Notice under 21 CFR Parts 170 and 570

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
FormNameElectronic accessType
Form Form FDA 3667GRAS NotificationFillable FileableForm

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