OMB control number
Generally Recognized as Safe (GRAS) Notices
OMB 0910-0342 · HHS/FDA.
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 can be found here.
Form Form FDA 3667 Reporting; GRAS Notice under 21 CFR Parts 170 and 570
0342 GRAS SSA 2025 REV.docx
Reporting; GRAS Notice under 21 CFR Parts 170 and 570 Reporting; GRAS Notice under 21 CFR Parts 170 and 570
Federal Enterprise Architecture: Health - Consumer Health and Safety
| Form Form FDA 3667 | GRAS Notification | Fillable Fileable | Form |
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