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OMB Control No: 0910-0016	ICR Reference No: 202609-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202301-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
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	Date Submitted to OIRA: 10/02/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2026
Responses	12	10
Time Burden (Hours)	26,632	23,958
Cost Burden (Dollars)	11,200	5,600

Abstract: This collection of information is used to transmit food and color additive and labeling requirements to FDA using FDA Form 3503 in paper or electronic format from businesses engaged in the manufacture or sale of food, food ingredients, color additives, or substances used in materials that come into contact with food. Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides that a food additive shall be deemed to be unsafe, unless it can be safely used under section 409(h), the additive and its use, or intended use, conform to the terms of an exemption for investigational use; or a food contact notification submitted under section 409(h) is effective. Food additive petitions (FAPs) are submitted by individuals or companies to obtain approval of a new food additive or to amend the conditions of use permitted under an existing food additive regulation. Section 721(a) of the FD&C Act provides that a color additive shall be deemed to be unsafe unless the additive and its use are in conformity with a regulation that describes the condition(s) under which the additive may safely be used, or the additive and its use conform to the terms of an exemption for investigational use issued under section 721(f). Color additive petitions (CAPs) are submitted by individuals or companies to obtain approval of a new color additive or a change in the conditions of use permitted for a color additive that is already approved. FDA’s color additive labeling requirements in § 21 CFR 70.25 require that color additives that are to be used in food, drugs, medical devices, or cosmetics be labeled with sufficient information to ensure their safe use. Respondents may transmit FAP or CAP regulatory submissions in electronic or paper format to the Human Foods Program (HFP) using Form FDA 3503 which helps the respondent organize their submission to focus on the information needed for FDA’s safety review and to organize information within a master file submitted in support of petitions according to the items listed on the form.

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

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 18466	04/10/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 61408	09/29/2026
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Form FDA 3503	FDA 3503
Submission of Petitions, Color Additive Including Labeling	FDA 3503
Submission of Petitions: Food Additive Including Labeling	FDA 3503

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	12	10	2
Annual Time Burden (Hours)	26,632	23,958	2,674
Annual Cost Burden (Dollars)	11,200	5,600	5,600

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: Based on a review of the information collection since our last request for OMB approval, we have adjusted our burden estimate for CAPs since the average number submitted has increased over the last 10 years. Due to the increase of submissions, we estimate that 4 CAPs will be submitted annually. Thus, the estimated burden for the information collection reflects an overall increase of 2,674 hours.

Annual Cost to Federal Government: $1,420,840

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? No

Agency Contact: Christopher Colburn 301-415-6157 cxc7@nrc.gov

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