Substances Generally Recognized as Safe: Notification Procedure

Forms and Documents

Document	Type	Status	Availability
Form Form FDA 3667 GRAS Notice under 21 CFR Parts 170 and 570	Form and Instruction	Modified	Repair queued
Form FDA 3667 ONE TIME Reporting Burden	Form	Removed	Available
0342 GRAS Notification SSA 2019 Ext.pdf	Supporting Statement A	Uploaded 2019-07-16	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5950	GRAS Notice under 21 CFR Parts 170 and 570	Form and Instruction	Modified
223140	ONE TIME Reporting Burden	Form	Removed

ICR Details

OMB Control No: 0910-0342	ICR Reference No: 201907-0910-015
Status: Active	Previous ICR Reference No: 201608-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Substances Generally Recognized as Safe: Notification Procedure
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/23/2019
	Date Received in OIRA: 07/16/2019
Terms of Clearance: We have removed one-time burden previously included and attributed to rulemaking because we believe respondents have realized burden associated with review of the new requirements. At the same time, we have received an increase in submissions since last OMB review. Cumulatively these changes result in an overall reduction to the collection by 475 responses and 38,225 burden hours. We have also uploaded cost information that, although previously included, had not been reflected at omb.report.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	09/30/2019
Responses	125	0	600
Time Burden (Hours)	21,250	0	59,475
Cost Burden (Dollars)	1,159,400	0	0

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Abstract: This ICR collects information from food manufactures 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 information being submitted so that a GRAS determination can be made. Food additives that are not GRAS must obtain premarket approval.

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

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 8876	03/19/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 29216	06/21/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
GRAS Notice under 21 CFR Parts 170 and 570	Form FDA 3667	GRAS Notification
ONE TIME Reporting Burden	FDA 3667	Generally Recognized as Safe (GRAS) Notice

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ICR Summary of Burden

	Total Approved	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	125	600	0	0	-475	0
Annual Time Burden (Hours)	21,250	59,475	0	0	-38,225	0
Annual Cost Burden (Dollars)	1,159,400	0	0	0	1,159,400	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:

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Annual Cost to Federal Government: $1,284,360

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? Uncollected

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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: 07/16/2019

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