Food Additives; Food Contact Substances Notification System

Forms and Documents

Document Name	Status
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	New
Form FDA 3480 Prenotification Consultation or Master File (concerning a food contact substance) Form	New
Form FDA 3480 21 CFR 170.101 (Category E) Form	Modified
Form FDA 3480 21 CFR 170.101 (Category D) Form	Modified
Form FDA 3480 21 CFR 170.101 (Category C) Form	Modified
Form FDA 3480 21 CFR 170.101 (Category B) Form	Modified
0495 SS 2012.docx Supporting Statement A	2012-11-29

IC Document Collections

IC ID	Document Title	Status
37671	21 CFR 170.106 (Category A) Form and Instruction	Modified
204986	Amendment to existing notification, prenotification consultation, or Master File (concerning a food contact substance) Form	New
204985	Prenotification Consultation or Master File (concerning a food contact substance) Form	New
187511	Use of Recycled Plastics in Food Packaging Other-guidance document	Modified
187510	21 CFR 170.1 Indirect Food Additives	Modified
187509	21 CFR 170.101 (Category E) Form	Modified
187508	21 CFR 170.101 (Category D) Form	Modified
187507	21 CFR 170.101 (Category C) Form	Modified
187506	21 CFR 170.101 (Category B) Form	Modified

ICR Details

OMB Control No: 0910-0495	ICR Reference No: 201211-0910-009
Status: Historical Active	Previous ICR Reference No: 200812-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Food Additives; Food Contact Substances Notification System
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/13/2013
	Date Received in OIRA: 11/30/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2016	36 Months From Approved	02/28/2013
Responses	237	0	128
Time Burden (Hours)	27,035	0	37,975
Cost Burden (Dollars)	0	0	0

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Abstract: Food contact substances must be preapproved by FDA for marketing. Manufacturers 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 submitted 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:
	77 FR 19670	04/02/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 34955	06/12/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
21 CFR 170.106 (Category A)	FDA 3479	Notification for a Food Contact Substance Formulation
21 CFR 170.101 (Category B)	FDA 3480	Food Contact Substance Notification
21 CFR 170.101 (Category C)	FDA 3480	Food Contact Substance Notification
21 CFR 170.101 (Category D)	FDA 3480	Food Contact Substance Notification
21 CFR 170.101 (Category E)	FDA 3480	Food Contact Substance Notification
21 CFR 170.1 Indirect Food Additives
Use of Recycled Plastics in Food Packaging
Prenotification Consultation or Master File (concerning a food contact substance)	FDA 3480	Food Contact Substance Notification
Amendment to existing notification, prenotification consultation, or Master File (concerning a food contact substance)	FDA 3480A	Amendment to Existing Food Contact Notification Prenotification Consultation Food Master File

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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	237	128	0	110	-1	0
Annual Time Burden (Hours)	27,035	37,975	0	55	-10,995	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: A decrease of one annual response to this ICR resulted in a downward adjustment of 10,995 hours. Our recommended use of Form FDA 3480A resulted in a program change of an additional 110 responses and 55 hours.

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Annual Cost to Federal Government: $6,040,000

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: 11/30/2012

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