Substances Generally Recognized as Safe: Notification Procedure

Forms and Documents

Document Name	Status
Form FDA 3667 GRAS Notice for 21 CFR 170.36 Form	Modified
0910 0342 Supporting Statement 2013 Rev Final.docx Supporting Statement A	2013-02-15

IC Document Collections

IC ID	Document Title	Status
5950	GRAS Notice for 21 CFR 170.36 Form	Modified

ICR Details

OMB Control No: 0910-0342	ICR Reference No: 201211-0910-010
Status: Historical Active	Previous ICR Reference No: 200905-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
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 with change	Conclusion Date: 02/18/2013
	Date Received in OIRA: 11/30/2012
Terms of Clearance: In accordance with the terms of 5 CFR 1320, this ICR is approved for a period of three years. OMB notes that the Supporting Statement claims that the new form will be more efficient than the existing form, but it does not calculate a reduction in the burden on the public or a reduction in Agency processing time. Please examine this as the form is in use and consider updating these figures, as appropriate, when resubmitting to OMB.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2016	36 Months From Approved	02/28/2013
Responses	60	0	30
Time Burden (Hours)	9,900	0	4,950
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from food manufactures who wish to obtain a determination from the Agency 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:
	77 FR 2552	01/18/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 38638	06/28/2012
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 for 21 CFR 170.36	FDA 3667	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	60	30	0	0	30	0
Annual Time Burden (Hours)	9,900	4,950	0	0	4,950	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: FDA is requesting an extension of approval for this ICR, for which there is an increase in burden. The burden change is due to an adjustment based on the number of GRAS notices received by the agency from 2008 to 2011.

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Annual Cost to Federal Government: $1,176,630

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

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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: 11/30/2012

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