Food Contact Substance Notification

Forms and Documents

Document Name	Status
Form FDA 3479 Reporting- 21 CFR 170.106 - (Category A) Form and Instruction	Modified
Form FDA3480A Reporting: Amendment to An Existing Notification or Master File Form and Instruction	New
Form FDA3480 Reporting: 21 CFR 171 - Pre- Notification Consultation or Master File Form and Instruction	Modified
Form FDA3480 Reporting: 21 CFR 107.101 ( Category E ) Form and Instruction	Modified
Form FDA3480 Reporting: 21 CFR107.101 ( Category D ) Form and Instruction	Modified
Form FDA3480 Reporting: 21CFR 107.101 ( Category C ) Form and Instruction	Modified
Form FDA3480 Reporting - 21 CFR 170.101 ( Category (B) Form and Instruction	Modified
SS- 0910-0495 -clean- 05-30-12.doc Supporting Statement A	2012-05-31

IC Document Collections

IC ID	Document Title	Status
37671	Reporting- 21 CFR 170.106 - (Category A) Form and Instruction	Modified
202531	Reporting: 21 CFR 171.1- Indirect Food Additive Petitions	New
202530	Reporting: Amendment to An Existing Notification or Master File Form and Instruction	New
187511	Reporting- Guidance - Use of Recycled Plastics in Food Packaging Chemistry Consideration Other-guidance document	Modified
187510	Reporting: 21 CFR 171 - Pre- Notification Consultation or Master File Form and Instruction	Modified
187509	Reporting: 21 CFR 107.101 ( Category E ) Form and Instruction	Modified
187508	Reporting: 21 CFR107.101 ( Category D ) Form and Instruction	Modified
187507	Reporting: 21CFR 107.101 ( Category C ) Form and Instruction	Modified
187506	Reporting - 21 CFR 170.101 ( Category (B) Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0495	ICR Reference No: 201205-0910-009
Status: Historical Inactive	Previous ICR Reference No: 200812-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Food Contact Substance Notification
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn and continue	Conclusion Date: 08/27/2012
	Date Received in OIRA: 05/31/2012
Terms of Clearance: This collection has been withdrawn at the request of the Agency. We note that FDA has developed a new form and that FDA has recommended that respondents alter their responses to this collection. The changes in burden related to these changes are program changes, but have been improperly classified as adjustments. Please review this collection and resubmit it for review as a revision, rather than as an extension to an existing collection.

	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 348h Name of Law: null
  

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	04/01/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 19670	04/01/2012
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
Reporting- 21 CFR 170.106 - (Category A)	FDA 3479	Notification for a Food Contact Substance Formulation
Reporting - 21 CFR 170.101 ( Category (B)	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Reporting: 21CFR 107.101 ( Category C )	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Reporting: 21 CFR107.101 ( Category D )	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Reporting: 21 CFR 107.101 ( Category E )	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Reporting: 21 CFR 171 - Pre- Notification Consultation or Master File	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Reporting- Guidance - Use of Recycled Plastics in Food Packaging Chemistry Consideration
Reporting: Amendment to An Existing Notification or Master File	FDA3480A	Amendment to An Existing Food Contact Notification Pre Notification Consultation Food Master File
Reporting: 21 CFR 171.1- Indirect Food Additive Petitions

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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

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: 05/31/2012

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