Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504

Forms and Documents

Document Name	Status
Form FDA3504 Submission of Petitions: Food Additive, Color Additive (Incliuding Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using FDA Forms 3503 and 3504 Form and Instruction	New
0016 21cfr171.1.pdf Supplementary Document	2007-04-18
0016 21cfr170.35.pdf Supplementary Document	2007-04-18
0016 21cfr70.25.pdf Supplementary Document	2007-04-18
0016 abstract 4-17-2007.doc Supplementary Document	2007-04-18
0016 ss 4-26-2007.doc Supporting Statement A	2007-04-26

IC Document Collections

IC ID	Document Title	Status
5672	Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504	Modified
180098	Submission of Petitions: Food Additive, Color Additive (Incliuding Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using FDA Forms 3503 and 3504	New
180097	Submission of Petitions: Food Additive, Color Additive (Incliuding Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using FDA Forms 3503 and 3504	New
180096	Submission of Petitions: Food Additive, Color Additive (Incliuding Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using FDA Forms 3503 and 3504 Form and Instruction	New

ICR Details

OMB Control No: 0910-0016	ICR Reference No: 200705-0910-002
Status: Historical Active	Previous ICR Reference No: 200308-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504
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 with change	Conclusion Date: 08/17/2007
	Date Received in OIRA: 05/10/2007
Terms of Clearance: This information collection request is approved. Please note that the burden table has been modified to reflect FDA's email confirming that the changes are a result of adjustment, not program changes. A program change would need to be submitted as a revision, not an extension.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2010	36 Months From Approved	08/31/2007
Responses	12	0	13
Time Burden (Hours)	49,186	0	31,385
Cost Burden (Dollars)	8,200	0	560,000

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Abstract: Please see attached.

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Authorizing Statute(s): 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:
	72 FR 2533	01/19/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 20553	04/25/2007
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504
Submission of Petitions: Food Additive, Color Additive (Incliuding Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using FDA Forms 3503 and 3504	FDA3504, FDA3503	Color Additive Petition Submission ,   Food Additive Petition Submission
Submission of Petitions: Food Additive, Color Additive (Incliuding Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using FDA Forms 3503 and 3504
Submission of Petitions: Food Additive, Color Additive (Incliuding Labeling), and Generally Recognized as Safe Affirmation; Electronic Submission Using FDA Forms 3503 and 3504

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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	12	13	0	0	-1	0
Annual Time Burden (Hours)	49,186	31,385	0	0	17,801	0
Annual Cost Burden (Dollars)	8,200	560,000	0	0	-551,800	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The change in burden is primarily due to the increase in the estimated hours per response for food additive petitions. The change in cost is actually an increase from the previous approval. The supporting statement requested approval of $5,600 total capital costs but the NOA incorrectly indicates $560,000. For this approval extension request, FDA is estimating a total capital cost of $8,200. The increase of $2,600 reflects one additional category A petition expected to be submitted.

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Annual Cost to Federal Government: $583,100

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 05/10/2007

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