Generally Recognized as Safe (GRAS) Notices

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form Form FDA 3667 GRAS Notification	Form	Unchanged	Available
0342 - SSA - GRAS Proposed Rule_2026.docx	Supporting Statement A	Uploaded 2026-08-11	Available
GRAS PRIA 07102025 CLEAN.docx	Supplementary Document	Uploaded 2026-08-11	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5950	Reporting; GRAS Notice under 21 CFR Parts 170 and 570	Instruction	Unchanged
5950	Reporting; GRAS Notice under 21 CFR Parts 170 and 570	Form	Unchanged	GRAS Notification
281871	One Time Adjustment for Rule		New
281870	Proposed Rule Estimated Recurring Requirements August 2026		New
273523	Best Practices for Convening a GRAS Panel	Other-Agency Guidance	Unchanged

ICR Details

OMB Control No: 0910-0342	ICR Reference No: 202608-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202501-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Generally Recognized as Safe (GRAS) Notices
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/11/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2028
Responses	3,388	1,936
Time Burden (Hours)	152,242	31,712
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports agency rulemaking as required under 5 CFR 1320.11 (RIN No. 0910-AJ02.) 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 the Food and Drug Administration (FDA or we) 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 generally recognized as safe (GRAS) by qualified experts.

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Authorizing Statute(s): US Code: 21 USC 348 Name of Law: FFDCA
   US Code: 21 USC 321 Name of Law: FFDCA
  

Citations for New Statutory Requirements: US Code: 21 USC 321, 348 Name of Law: FFDCA

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AJ02	Proposed rulemaking	91 FR 51834	08/11/2026

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Best Practices for Convening a GRAS Panel
One Time Adjustment for Rule
Proposed Rule Estimated Recurring Requirements August 2026
Reporting; GRAS Notice under 21 CFR Parts 170 and 570	Form FDA 3667	GRAS Notification

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ICR Summary of Burden

table that charts list of burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	3,388	1,936	0	0	1,452	0
Annual Time Burden (Hours)	152,242	31,712	0	0	120,530	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Rulemaking will revise OMB control no. 0910-0342. As a result, we have revised our estimate adding 101,490 hours and 2,736 responses annually to reflect the information collection associated with new regulatory requirements.

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Annual Cost to Federal Government: $24,796,380

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 08/11/2026

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