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 202301-0910-007

OMB: 0910-0016

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2023-09-21
ICR Details
0910-0016 202301-0910-007
Received in OIRA 202008-0910-006
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
Revision of a currently approved collection   No
Regular 09/21/2023
  Requested Previously Approved
36 Months From Approved 09/30/2023
10 11
23,958 23,959
5,600 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

  88 FR 6757 02/01/2023
88 FR 65173 09/21/2023
No

  Total Request 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 10 11 0 0 -1 0
Annual Time Burden (Hours) 23,958 23,959 0 0 -1 0
Annual Cost Burden (Dollars) 5,600 5,600 0 0 0 0
No
No
We have adjusted our burden estimate, which has resulted in a decrease to the currently approved burden by 1 hour. We estimate that 1 less Form FDA 3503 will be submitted to FDA creating the reduction in the burden estimate.

$1,306,830
No
    No
    No
No
No
No
Yes
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  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.
09/21/2023


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