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	Modified
Form FDA 3480A Amendment to existing notification, prenotification consultation, or Master File (concerning a food contact substance) Form	Modified
0495_Supporting Statement_2022.docx Supporting Statement A	2022-02-11

IC Document Collections

IC ID	Document Title	Status
37671	21 CFR 170.106 (Category A) Form and Instruction	Modified
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	Modified
204985	Prenotification Consultation or Master File (concerning a food contact substance) Instruction	Modified
187511	Use of Recycled Plastics in Food Packaging Other-guidance document	Modified
187510	21 CFR 170.1 Indirect Food Additives	Unchanged
187509	21 CFR 170.101 (Category E) Instruction	Modified
187508	21 CFR 170.101 (Category D) Instruction	Modified
187507	21 CFR 170.101 (Category C) Instruction	Modified
187506	21 CFR 170.101 (Category B) Instruction	Modified

ICR Details

OMB Control No: 0910-0495	ICR Reference No: 202201-0910-011
Status: Received in OIRA	Previous ICR Reference No: 201902-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food Additives; Food Contact Substances Notification System
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: 02/14/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2022
Responses	458	463
Time Burden (Hours)	32,675	31,330
Cost Burden (Dollars)	0	0

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Abstract: Food contact substances must be preapproved by FDA for marketing. Respondents to the collection are manufacturers who must provide information, including: (1) the identity and intended use of the food contact substance and (2) the basis for the manufacturer's or supplier's determination that the food contact substance is safe. FDA uses the information to determine whether a food contact substance should be preapproved.

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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:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 51358	09/15/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 7190	02/08/2022
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 10

IC Title	Form No.	Form Name
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
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	458	463	0	0	-5	0
Annual Time Burden (Hours)	32,675	31,330	0	0	1,345	0
Annual Cost Burden (Dollars)	0	0	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: Our estimated burden for the information collection reflects an overall increase of 1,345 hours and a corresponding decrease of 5 responses. We attribute this adjustment to a decrease in Pre-Notification Consultations or Master Files by 40 responses, a subsequent decrease of amendments to Pre-Notification Consultations or Master Files by 20 responses, and an increase of 55 respondents using the recommendations in the guidance document entitled, “Use of Recycled Plastics in Food Packaging: Chemistry Considerations.” As the average burden for preparing recycling submissions is higher than for Pre-notification Consultations or Master Files, this results in an overall increase in total burden even with an overall decrease in responses.

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Annual Cost to Federal Government: $6,360,000

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: 02/14/2022

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