OMB control number
Gluten-Free Labeling of Fermented or Hydrolyzed Foods
OMB 0910-0817 · HHS/FDA.
OMB 0910-0817
Respondents to the information collection are manufacturers of foods that are fermented, hydrolyzed, or contain fermented or hydrolyzed ingredients and bear the claim “gluten-free,” “no gluten,” “free of gluten,” or “without gluten.” It imposes recordkeeping that FDA believes will provide a reasonable assurance that food so labeled is gluten-free before fermentation or hydrolysis; that the manufacturer has evaluated the potential for cross-contact with gluten during the manufacturing process; and that measures have been taken to prevent the introduction of gluten into the food during the manufacturing process.
The latest form for Gluten-Free Labeling of Fermented or Hydrolyzed Foods expires 2023-08-31 and is listed under ICR 202008-0910-016.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0817 Gluten SSA Final Rule August 2020.pdf | Supporting Statement A |
| FDA Gluten RIA.pdf | Supplementary Document |
 Maintenance of outside lab testing results |
Information collection |
| Collecting samples for testing by outside lab |
Information collection |
| Maintenance of test kit test results |
Information collection |
| Collecting samples for test kit testing |
Information collection |
| Maintenance of SOP records for gluten control |
Information collection |
| "Gluten Free" recordkeeping |
Information collection |
| ONE TIME Recordkeeping for rule implementation |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202008-0910-016 | New collection (Request for a new OMB Control Number) | 2020-08-13 | Approved without change | |
| 201605-0910-011 | New collection (Request for a new OMB Control Number) | 2016-05-16 | Comment filed on proposed rule |
OMB Details
ONE TIME Recordkeeping for rule implementation
Federal Enterprise Architecture: Health - Consumer Health and Safety