Food Additives; Food Contact Substances Notification System

ICR 200606-0910-004

OMB: 0910-0495

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0495 200606-0910-004
Historical Active 200510-0910-004
HHS/FDA
Food Additives; Food Contact Substances Notification System
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 06/27/2006
Retrieve Notice of Action (NOA) 06/27/2006
  Inventory as of this Action Requested Previously Approved
12/31/2008 12/31/2008 12/31/2008
126 0 116
15,985 0 15,735
23,500,000 0 23,500,000

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.

None
None


No

1
IC Title Form No. Form Name
Food Additives; Food Contact Substances Notification System 3479, 3480

  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 126 116 0 10 0 0
Annual Time Burden (Hours) 15,985 15,735 0 250 0 0
Annual Cost Burden (Dollars) 23,500,000 23,500,000 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
06/27/2006


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