Food Additives; Food Contact Substances Notification System

Forms and Documents

Document Name	Status
Form FDA 3479 Food Additives; Food Contact Substances Notification System Category A Form and Instruction	Modified
Form FDA Form 3480A Food Additives; Food Contact Substances Notification System; Amendment Form and Instruction	New
Form FDA Form 3480 Food Additives; Food Contact Substances Notification System Prenotification Consult or MF Form and Instruction	New
Form FDA3480 Food Additives; Food Contact Substances Notification System Category E Form and Instruction	Modified
Form FDA3480 Food Additives; Food Contact Substances Notification System Category D Form and Instruction	Modified
Form FDA3480 Food Additives; Food Contact Substances Notification System Category C Form and Instruction	Modified
Form FDA3480 Food Additives; Food Contact Substances Notification System Category B Form and Instruction	Modified
0495 2012 SS.doc Supporting Statement A	2012-08-29

IC Document Collections

IC ID	Document Title	Status
37671	Food Additives; Food Contact Substances Notification System Category A Form and Instruction	Modified
203911	Food Additives; Food Contact Substances Notification System; Amendment Form and Instruction	New
203910	Food Additives; Food Contact Substances Notification System Prenotification Consult or MF Form and Instruction	New
187511	Food Additives; Food Contact Substances Notification System; Food Packaging Other-guidance document	Modified
187510	Food Additives; Food Contact Substances Notification System Indirect FAP	Modified
187509	Food Additives; Food Contact Substances Notification System Category E Form and Instruction	Modified
187508	Food Additives; Food Contact Substances Notification System Category D Form and Instruction	Modified
187507	Food Additives; Food Contact Substances Notification System Category C Form and Instruction	Modified
187506	Food Additives; Food Contact Substances Notification System Category B Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0495	ICR Reference No: 201208-0910-008
Status: Historical Inactive	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: Improperly submitted and continue	Conclusion Date: 11/05/2012
	Date Received in OIRA: 08/30/2012
Terms of Clearance: In accordance with 5CFR 1320, OMB considers this collection to have been improperly submitted. The supporting statement describes a program change that has been listed in ROCIS. In addition, the Abstract section describes the program as a whole, not the specific information being collected and its purpose. Please correct these issues and resubmit the collection to OMB.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2012	36 Months From Approved	02/28/2013
Responses	128	0	128
Time Burden (Hours)	37,975	0	37,975
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration's regulations at 21 CFR 170.101 and 170.106 implement the premarket notification process for food contact substances (FCSs). The notification process is the primary method for authorizing new uses ofFCS. The regulations: 1) identify the circumstances under which a food additive petition will be required to authorize the use of an FCS, 2) specify the information required in a notification for an FCS, 3) describe the administration of the notification process, and 4) establish the procedure by which the agency may deem a notification to no longer be effective.

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Authorizing Statute(s): US Code: 21 USC 348(h) Name of Law: 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:
	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
Food Additives; Food Contact Substances Notification System Category D	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System Category E	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System Indirect FAP
Food Additives; Food Contact Substances Notification System; Food Packaging
Food Additives; Food Contact Substances Notification System Prenotification Consult or MF	FDA Form 3480	NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System; Amendment	FDA Form 3480A	Amendment to an Existing FCN, Prenotification Consultation, Master File
Food Additives; Food Contact Substances Notification System Category A	FDA 3479	Notification for a Food Contact Substance Formulation
Food Additives; Food Contact Substances Notification System Category B	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System Category C	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD

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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:

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Annual Cost to Federal Government: $6,400,000

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: 08/30/2012

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