Food Additives; Food Contact Substances Notification System

Forms and Documents

Document Name	Status
Form Form FDA 3479 21 CFR 170.106 (Category A) Form and Instruction	Unchanged
Form FDA 3480A Amendment to existing notification, prenotification consultation, or Master File (concerning a food contact substance) Form	Unchanged
0495 FCN adding threshold substances from 0298.docx Justification for No Material/Nonsubstantive Change	2025-12-31
0495 FCN FRIA Docket FDA-2021-N-0403.pdf Supplementary Document	2024-04-01
FCN Final Rule 0495 Rev 2024 SSA for RIN AI01.docx Supporting Statement A	2024-03-21

IC Document Collections

IC ID	Document Title	Status
37671	21 CFR 170.106 (Category A) Form and Instruction	Unchanged
278644	170.39: Threshold of regulation for substances used in food-contact articles	New
266196	Determination that a FCN is no longer effective	Unchanged
235128	Preparation for FCS in contact w/infant formula and/or human milk Other-Agency Guidance	Unchanged
204986	Amendment to existing notification, prenotification consultation, or Master File (concerning a food contact substance) Form	Unchanged
204985	Prenotification Consultation or Master File (concerning a food contact substance) Instruction	Unchanged
187511	Use of Recycled Plastics in Food Packaging Other-guidance document	Unchanged
187510	21 CFR 170.1 Indirect Food Additives	Unchanged
187509	21 CFR 170.101 (Category E) Instruction	Unchanged
187508	21 CFR 170.101 (Category D) Instruction	Unchanged
187507	21 CFR 170.101 (Category C) Instruction	Unchanged
187506	21 CFR 170.101 (Category B) Instruction	Unchanged

ICR Details

OMB Control No: 0910-0495	ICR Reference No: 202512-0910-012
Status: Received in OIRA	Previous ICR Reference No: 202403-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Food Additives; Food Contact Substances Notification System
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/31/2025

	Requested	Previously Approved
Expiration Date	04/30/2027	04/30/2027
Responses	472	465
Time Burden (Hours)	33,171	32,835
Cost Burden (Dollars)	0	0

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Abstract: This information collection request supports FDA rulemaking. We are revising current regulations (21 CFR part 170) relating to the procedures for determining that a premarket notification for a food contact substance (FCN) is no longer effective. The regulations provide for additional reasons that could form the basis for FDA to determine that an FCN is no longer effective. The regulations are also intended to ensure that manufacturers or suppliers have the opportunity to provide input before FDA determines that an FCN is no longer effective.

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Authorizing Statute(s): US Code: 21 USC 348(h) Name of Law: Notification relating to food contact substance.
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AI01	Final or interim final rulemaking	89 FR 20306	03/22/2024

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

IC Title	Form No.	Form Name
170.39: Threshold of regulation for substances used in food-contact articles
21 CFR 170.1 Indirect Food Additives
21 CFR 170.101 (Category B)	FDA 3480	FOOD CONTACT SUBSTANCE NOTIFICATION FOR NEW USE PRE-NOTIFICATION CONSULTATION FOOD MASTER FILE
21 CFR 170.101 (Category C)	FDA 3480	Food Contact Substance Notification For New Use Pre-Notification Consultation Food Master File
21 CFR 170.101 (Category D)	FDA 3480	Food Contact Substance Notification For New Use Pre-Notification Consultation Food Master File
21 CFR 170.101 (Category E)	FDA 3480	Food Contact Substance Notification For New Use Pre-Notification Consultation Food Master File
21 CFR 170.106 (Category A)	Form FDA 3479	NOTIFICATION FOR A FOOD CONTACT
Amendment to existing notification, prenotification consultation, or Master File (concerning a food contact substance)	FDA 3480A	Amendment To An Existing Food Contact Notification Pre-Notification Consultation Food Master File
Determination that a FCN is no longer effective
Prenotification Consultation or Master File (concerning a food contact substance)	FDA 3480	Food Contact Substance Notification For New Use Pre-Notification Consultation Food Master File
Preparation for FCS in contact w/infant formula and/or human milk
Use of Recycled Plastics in Food Packaging

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ICR Summary of Burden

	Total Request	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	472	465	0	7	0	0
Annual Time Burden (Hours)	33,171	32,835	0	336	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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: No

Burden Reduction Due to:

Short Statement: For efficiency of agency operations, we are requesting to incorporate related information collection activity currently approved in OMB control no. 0910-0298 and applicable to regulatory requirements found in 21 CFR 170.39 (threshold of regulation for substances used in food-contact articles) into this ICR. We have therefore added a new IC element corresponding with the regulation into our summary table to reflect 7 responses and 336 hours annually, burden we attribute to information collection activity under 21 CFR 170.39. Upon OMB approval, we intend to discontinue control no. 0910-0298.

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Annual Cost to Federal Government: $1,332,030

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

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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: 12/31/2025

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