Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions, and Electronic Submission Using FDA Form 3503

Forms and Documents

Document Name	Status
Form Form FDA 3503 Submission of Petitions: Food Additive Including Labeling Form	Modified
0016 ss 8-18-2017.docx Supporting Statement A	2017-08-18

IC Document Collections

IC ID	Document Title	Status
5672	Submission of Petitions, Color Additive Including Labeling Instruction	Modified
180098	Form FDA 3503 Instruction	Modified
180097	Submission of Petitions: Food Additive Including Labeling Form	Modified
180096	Submission of Petitions Generally Recognized As Safe Affirmation Instruction	Removed

ICR Details

OMB Control No: 0910-0016	ICR Reference No: 201707-0910-008
Status: Historical Active	Previous ICR Reference No: 201406-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions, and Electronic Submission Using FDA Form 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: Approved without change	Conclusion Date: 09/22/2017
	Date Received in OIRA: 08/22/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2020	36 Months From Approved	09/30/2017
Responses	11	0	12
Time Burden (Hours)	23,959	0	26,573
Cost Burden (Dollars)	5,600	0	5,600

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Abstract: Currently, respondents may transmit food or color additive petition submissions in electronic format or paper format to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition using Form FDA 3503. Form FDA 3503 helps the respondent organize a submission to focus on the information needed for FDA's safety review. Form FDA 3503 can also be used to organize information within a Master File submitted in support of petitions according to the items listed on the form.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	82 FR 24718	05/30/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 39793	08/22/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Submission of Petitions, Color Additive Including Labeling	3503	Food and Color Additive Petition and Food and Color Master File
Submission of Petitions: Food Additive Including Labeling	Form FDA 3503	Food Additive; Color Additive; Food Master File, Color Master File Submissions
Form FDA 3503	Form FDA 3503	Food Additive; Color Additive; Food Master File, Color Master File Submissions
Submission of Petitions Generally Recognized As Safe Affirmation	Form FDA 3503	Food Additive; Color Additive; Food Master File, Color Master File Submissions

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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	11	12	0	0	-1	0
Annual Time Burden (Hours)	23,959	26,573	0	0	-2,614	0
Annual Cost Burden (Dollars)	5,600	5,600	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: The information collection reflects adjustments. As discussed more fully at Q12, we have decreased our estimate by 2,614 reporting hours, with a corresponding decrease in responses by 1. This directly correlates to fewer respondents to the information collection.

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Annual Cost to Federal Government: $1,083,831

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 08/22/2017

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