Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions, and Electronic Submission Using FDA Form 3503

ICR 201707-0910-008

OMB: 0910-0016

Federal Form Document

Forms and Documents
ICR Details
0910-0016 201707-0910-008
Historical Active 201406-0910-013
HHS/FDA CFSAN
Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions, and Electronic Submission Using FDA Form 3503
Extension without change of a currently approved collection   No
Regular
Approved without change 09/22/2017
Retrieve Notice of Action (NOA) 08/22/2017
  Inventory as of this Action Requested Previously Approved
09/30/2020 36 Months From Approved 09/30/2017
11 0 12
23,959 0 26,573
5,600 0 5,600

Currently, respondents may transmit food or color additive petition submissions 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 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  82 FR 24718 05/30/2017
82 FR 39793 08/22/2017
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 11 12 0 0 -1 0
Annual Time Burden (Hours) 23,959 26,573 0 0 -2,614 0
Annual Cost Burden (Dollars) 5,600 5,600 0 0 0 0
No
No
The information collection reflects adjustments. As discussed more fully at Q12, we have decreased our estimate by 2,614 reporting hours, with a corresponding decrease in responses by 1. This directly correlates to fewer respondents to the information collection.

$1,083,831
No
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [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.
08/22/2017


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