Substances Generally Recognized as Safe: Notification Procedure

Forms and Documents

Document Name	Status
Form FDA Form 3667 Substances Generally Recognized as Safe: Notification Procedure CFSAN Form	Modified
Form FDA Form 3667 Substances Generally Recognized as Safe: Notification Procedure CVM Form	New
0342 Supporting Statement 2012 Aug 27 CLEAN.doc Supporting Statement A	2012-08-29

IC Document Collections

IC ID	Document Title	Status
5950	Substances Generally Recognized as Safe: Notification Procedure CFSAN Form	Modified
203912	Substances Generally Recognized as Safe: Notification Procedure CVM Form	New

ICR Details

OMB Control No: 0910-0342	ICR Reference No: 201208-0910-009
Status: Historical Inactive	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: Improperly submitted and continue	Conclusion Date: 11/05/2012
	Date Received in OIRA: 08/30/2012
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB considers this package to have been improperly submitted. The supporting statement describes a request to approve a new form. However, no new form appears to have been uploaded, nor is this accounted for by a change in burden. Please review the collection and make any appropriate corrections before resubmitting this ICR to OMB.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2012	36 Months From Approved	02/28/2013
Responses	30	0	30
Time Burden (Hours)	4,950	0	4,950
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information used in making a GRAS determination, and the notifier would maintain a record of such data and information. FDA asks companies to provide information about whether a product that they wish to market qualifies for GRAS status.

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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: 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: 2

IC Title	Form No.	Form Name
Substances Generally Recognized as Safe: Notification Procedure CFSAN	FDA Form 3667	GENERALLY RECOGNIZED AS SAFE
Substances Generally Recognized as Safe: Notification Procedure CVM	FDA Form 3667	GENERALLY RECOGNIZED AS SAFE

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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: $1,176,630

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: 08/30/2012

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