Food Additives; Food Contact Substances Notification System

Forms and Documents

Document Name	Status
Form FDA 3479 Food Additives; Food Contact Substances Notification System Form and Instruction	Modified
Form FDA3480 Food Additives; Food Contact Substances Notification System Form and Instruction	New
Form FDA3480 Food Additives; Food Contact Substances Notification System Form and Instruction	New
Form FDA3480 Food Additives; Food Contact Substances Notification System Form and Instruction	New
Form FDA3480 Food Additives; Food Contact Substances Notification System Form and Instruction	New
0495 Supporting Statement revised May 6 2009 clean.doc Supporting Statement A	2009-05-07

IC Document Collections

IC ID	Document Title	Status
37671	Food Additives; Food Contact Substances Notification System Form and Instruction	Modified
187511	Food Additives; Food Contact Substances Notification System Other-guidance document	New
187510	Food Additives; Food Contact Substances Notification System	New
187509	Food Additives; Food Contact Substances Notification System Form and Instruction	New
187508	Food Additives; Food Contact Substances Notification System Form and Instruction	New
187507	Food Additives; Food Contact Substances Notification System Form and Instruction	New
187506	Food Additives; Food Contact Substances Notification System Form and Instruction	New

ICR Details

OMB Control No: 0910-0495	ICR Reference No: 200812-0910-002
Status: Historical Active	Previous ICR Reference No: 200606-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
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
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/26/2009
	Date Received in OIRA: 12/10/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2012	36 Months From Approved	05/31/2009
Responses	128	0	126
Time Burden (Hours)	37,975	0	15,985
Cost Burden (Dollars)	0	0	23,500,000

---

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.

---

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 50628	08/27/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 73936	12/04/2008
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Food Additives; Food Contact Substances Notification System
Food Additives; Food Contact Substances Notification System	FDA 3479	Notification for a Food Contact Substance Formulation
Food Additives; Food Contact Substances Notification System	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System	FDA3480	NOTIFICATION FOR NEW USE OF A FOOD
Food Additives; Food Contact Substances Notification System

---

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	128	126	0	0	2	0
Annual Time Burden (Hours)	37,975	15,985	0	0	21,990	0
Annual Cost Burden (Dollars)	0	23,500,000	0	0	-23,500,000	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:

---

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

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

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: 12/10/2008

---