Submission of Petitions, Color Additive Including Labeling

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

OMB: 0910-0016

IC ID: 5672

Documents and Forms
Information Collection (IC) Details

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Submission of Petitions, Color Additive Including Labeling CFSAN
 
No Modified
 
Mandatory
 
21 CFR 70.25 21 CFR 71.1

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Instruction FDA 3503 Instructions.pdf Yes Yes Fillable Fileable
Form 3503 Food and Color Additive Petition and Food and Color Master File FDA 3503.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

2 0
   
Private Sector Businesses or other for-profits
 
   80 %

  Approved Program Change Due to New Statute Program Change Due to Agency Discretion Change Due to Adjustment in Agency Estimate Change Due to Potential Violation of the PRA Previously Approved
Annual Number of Responses for this IC 2 0 0 0 0 2
Annual IC Time Burden (Hours) 2,674 0 0 0 0 2,674
Annual IC Cost Burden (Dollars) 5,600 0 0 0 0 5,600

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