Submission of Petitions: Food Additive, Color Additive (Including Labeling), GRAS Affirmation; Master File Information to Support Petition & Electronic Submission Using FDA Forms 3503

Forms and Documents

Document Name	Status
Form 3503 Electronic Submission Using Form FDA 3503 Form	Modified
Form 3503 Submission of Petitions: Food Additive Inciuding Labeling Form	Modified
SS-0910-0016.doc ( Rev. 08-31-10).doc Supporting Statement A	2010-08-31

IC Document Collections

IC ID	Document Title	Status
5672	Submission of Petitions: Color Additive Including Labeling Instruction	Modified
180098	Electronic Submission Using Form FDA 3503 Form	Modified
180097	Submission of Petitions: Food Additive Inciuding Labeling Form	Modified
180096	Submission of Petitions: Generally Recognized as Safe Affirmation Instruction	Modified

ICR Details

OMB Control No: 0910-0016	ICR Reference No: 201008-0910-010
Status: Historical Inactive	Previous ICR Reference No: 200705-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Submission of Petitions: Food Additive, Color Additive (Including Labeling), GRAS Affirmation; Master File Information to Support Petition & Electronic Submission Using FDA Forms 3503
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 10/18/2010
	Date Received in OIRA: 08/31/2010
Terms of Clearance: In accordance with 5 CFR 1320, OMB notes that this collection has been improperly submitted. FDA has classified the request as an extension. The supporting statement correctly notes that the changest made by the agency constitute a "revision" to the package. Please correct this error and resubmit the collection for OMB review.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2010	36 Months From Approved	10/31/2010
Responses	12	0	12
Time Burden (Hours)	49,186	0	49,186
Cost Burden (Dollars)	8,200	0	8,200

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Abstract: FDA is revising Form FDA 3503 with instructions to better enable its use for electronic submission and to permit its use for multiple types of submissions, which eliminates the need for for form FDA 3504 which will be discontinued. The revised form FDA 3503 can be used to submit information to FDA in electronic format using the Electronic Submission Gateway portal. Because Form FDA 3503 helps the respondent organize their submission to focus on the information needed for FDA safety review , FDA now recommends that this form be used for food and color additive petitions., whether submitted in electronic or paper format. In addition the form accomodates GRAS affirmation petitions and can also be used to organize information within a Master File submitted in support of Petitions.

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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:
	75 FR 33624	06/14/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 52954	08/30/2010
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: Color Additive Including Labeling	3503	Food Additive ( FAP); Color Additive ( CAP); Food Master File ; Color Master File
Submission of Petitions: Generally Recognized as Safe Affirmation	3503	Food Additive ( FAP); Color additive ( CAP); Food Master File; Color Master File
Submission of Petitions: Food Additive Inciuding Labeling	3503	Food Additive ( FAP); Color Additive ( CAP); Food Master FIle; Color Master File
Electronic Submission Using Form FDA 3503	3503	Food Additive( FAP); Color Additive ( CAP); Food Master File ; Color Master File

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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: $935,498

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: 08/31/2010

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