Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504

ICR 200308-0910-001

OMB: 0910-0016

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0016 200308-0910-001
Historical Active 200008-0910-001
HHS/FDA
Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Forms 3503 and 3504
Extension without change of a currently approved collection   No
Regular
Approved with change 11/18/2003
Retrieve Notice of Action (NOA) 08/15/2003
  Inventory as of this Action Requested Previously Approved
11/30/2006 11/30/2006 11/30/2003
13 0 13
31,385 0 69,320
560,000 0 0

This is a consolidation of OMB 0910-0016, 0910-0132, 0910-0185, and 0910-0480. Food and Color additive petitions are reviewed by FDA scientific personnel to assure identity of the substance, its use in or on food (or drugs, medical devices, or cosmetics for a color additive), and that the intended use is safe. Petitions may be submitted in electronic format. Failure to require petitions would block new products from coming to market.

None
None


No

  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 13 13 0 0 0 0
Annual Time Burden (Hours) 31,385 69,320 0 -160 -37,775 0
Annual Cost Burden (Dollars) 560,000 0 0 560,000 0 0
No
Yes

$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.
08/15/2003


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