Substances Generally Recognized as Safe: Notification Procedure

Forms and Documents

Document Name	Status
Form FDA 3667 GRAS Notice under 21 CFR Parts 170 and 570 Form	Modified
Form FDA 3667 ONE TIME Reporting Burden Form	New
0342 GRAS FRIA.pdf Supplementary Document	2016-08-22
0342 SS for FR Revision 2016.pdf Supporting Statement A	2016-08-22

IC Document Collections

IC ID	Document Title	Status
5950	GRAS Notice under 21 CFR Parts 170 and 570 Form	Modified
223140	ONE TIME Reporting Burden Form	New

ICR Details

OMB Control No: 0910-0342	ICR Reference No: 201608-0910-012
Status: Historical Active	Previous ICR Reference No: 201602-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Substances Generally Recognized as Safe: Notification Procedure
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/27/2016
	Date Received in OIRA: 08/22/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	36 Months From Approved	03/31/2019
Responses	600	0	60
Time Burden (Hours)	59,475	0	9,900
Cost Burden (Dollars)	0	0	0

---

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.

---

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

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH15	Final or interim final rulemaking	81 FR 54960	08/17/2016

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	62 FR 18938	04/17/1997
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 54960	08/17/2016
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

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

---

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	600	60	0	540	0	0
Annual Time Burden (Hours)	59,475	9,900	0	49,575	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

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

Burden Reduction Due to:

Short Statement: Information collection finalized through rulemaking.

---

Annual Cost to Federal Government: $1,204,000

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

---

Common Form ICR:  No

---

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: 08/22/2016

---