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

ICR 201406-0910-013

OMB: 0910-0016

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-06-27
ICR Details
0910-0016 201406-0910-013
Historical Active 201104-0910-003
HHS/FDA CFSAN
Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Recognized as Safe Affirmation; and Electronic Submission Using FDA Form 3503
Extension without change of a currently approved collection   No
Regular
Approved without change 08/27/2014
Retrieve Notice of Action (NOA) 06/30/2014
  Inventory as of this Action Requested Previously Approved
08/31/2017 36 Months From Approved 08/31/2014
12 0 12
26,573 0 26,573
5,600 0 5,600

Currently, respondents may transmit food or color additive petition submissions and "generally recognized as safe" (GRAS) affirmations in electronic format or paper format to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition using Form FDA 3503. Form FDA 3503 helps the respondent organize a submission to focus on the information needed for FDA's safety review. Form FDA 3503 can also be used to organize information within a Master File submitted in support of petitions according to the items listed on the form.

US Code: 21 USC 348 Name of Law: FFDCA
  
None

Not associated with rulemaking

  79 FR 21469 04/16/2014
79 FR 39186 06/30/2014
Yes

  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 12 12 0 0 0 0
Annual Time Burden (Hours) 26,573 26,573 0 0 0 0
Annual Cost Burden (Dollars) 5,600 5,600 0 0 0 0
No
No

$1,028,127
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
06/30/2014


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