# Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe (GRAS): Notifications and Convening Panels
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
**SUMMARY:**
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
**DATES:**
Submit written comments (including recommendations) on the collection of information by September 25, 2025.
**ADDRESSES:**
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to *https://www.reginfo.gov/public/do/PRAMain.* Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0342. Also include the FDA docket number found in brackets in the heading of this document.
**FOR FURTHER INFORMATION CONTACT:**
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, *[email protected].*
**SUPPLEMENTARY INFORMATION:**
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
**Substances Generally Recognized as Safe (GRAS): Notifications and Convening Panels—21 CFR 170, Subpart E and 21 CFR 570, Subpart E**
**OMB Control Number 0910-0342—Revision**
The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that all food additives (as defined by section 201(s) (21 U.S.C. 321(s)) be approved by FDA before they are marketed. Section 409 of the FD&C Act (21 U.S.C. 348) establishes a premarket approval requirement for “food additives.” Section 201(s) of the FD&C Act provides an exclusion to the definition of food additive, and thus from the premarket approval requirement, for uses of substances that are GRAS by qualified experts. The GRAS provision of section 201(s) of the FD&C Act is implemented in 21 CFR part 170 (part 170) and 21 CFR part 570 (part 570) for human food and animal food, respectively. Part 170, subpart E, and part 570, subpart E, establish a standard format for the submission of a notice. Information submitted to FDA in a GRAS notice by respondents is necessary to allow us to administer efficiently the various FD&C Act provisions that apply to the use of substances added to food, specifically with regard to whether a substance is GRAS under the conditions of its intended use or is a food additive subject to premarket review. We use the information collected through the GRAS notification procedures to complete our evaluation within specific timelines.
Form FDA 3667, entitled “Generally Recognized as Safe Notice” ( *https://www.fda.gov/media/85886/download* ), provides a standardized format for the submission of information and is intended to assist respondents with the submission of GRAS notices. Form FDA 3667 and any attachments may be submitted in electronic format via the Centralized Online Submission Module ( *https://www.fda.gov/food/registration-food-facilities-and-other-submissions/centralized-online-submission-module-cosm* ), or may be submitted in paper format, or as electronic files on physical media with paper signature page. For submissions to the Center for Veterinary Medicine, respondents may continue to send GRAS notices in paper format, or as electronic files on physical media with paper signature page to the Agency.
For efficiency of Agency operations, we are revising the information collection to account for burden that may be attributable to the guidance document entitled “Best Practices for Convening a Generally Recognized as Safe Panel” (December 2022) ( *https://www.fda.gov/media/109006/download* ), currently approved in OMB control number 0910-0911. The guidance document was developed to assist persons who choose to convene a panel of experts in support of a conclusion that the use of a substance in food is GRAS. Specifically, the guidance document includes recordkeeping recommendations and disclosure recommendations pertaining to the administration of GRAS panel and GRAS panel membership.
*Description of Respondents:* The respondents to this collection of information are manufacturers of substances used in human food and animal food and feed. Respondents also include persons (“proponents”) who are responsible for a conclusion that a substance may be used in food on the basis of the GRAS provision of the FD&C Act when such persons convene a GRAS panel to evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. Respondents also include members and prospective members of GRAS panels. The term “GRAS panel” is defined as a panel of individuals convened for the purpose of evaluating whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in food.
In the *Federal Register* of June 27, 2025 (90 FR 27642), we published a 60-day notice soliciting comment on the proposed collection of information. No comments were received.
We estimate the burden of this collection of information as follows:
| Activity; 21 CFR section | Number of | Number of | Total annual responses | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| GRAS notification procedure for human food; 170.210-170.280 (part 170, subpart E) | 100 | 1 | 100 | 170 | 17,000 |
| GRAS notification procedure for animal food and animal feed; 570.210-570.280 (part 570, subpart E) | 12 | 1 | 12 | 170 | 2,040 |
| Total | | | 125 | | 19,040 |
In row 2 of table 1, we are decreasing our estimate for the number of respondents submitting GRAS notices for animal food and animal feed from 25 to 12, which results in a decrease of 2,210 burden hours (4,250 hours minus 2,040 hours). This estimate is based on the number of submissions we received over the last 3 years.
| Activity; guidance document section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| Maintaining written GRAS panel policy; V. Recommendations | 696 | 1 | 696 | 2 | 1,392 |
| Application of written GRAS panel policy to GRAS panel members; V. Recommendations | 94 | 6 | 564 | 16 | 9,024 |
| Total | | | 1,260 | | 10,416 |
Row 1 of table 2 reflects a decrease in our estimate of the average burden per recordkeeping from 40 hours to 2 hours annually. We believe that respondents will have realized burden associated with the initial documentation of written GRAS panel policies and have modified our estimate to reflect burden associated with maintaining the applicable records.
| Activity; guidance document section | Number of | Number of | Total annual disclosures | Average | Total hours |
| --- | --- | --- | --- | --- | --- |
| Potential GRAS panel members provide information to the proponents of GRAS conclusions; V. Recommendations | 564 | 1 | 564 | 4 | 2,256 |
We have made no change in our estimate associated with the disclosure recommendations discussed in the guidance document.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.