Reporting - Submission of a Premarket Notification for a New Dietary Ingredient

Premarket Notification for a New Dietary Ingredient

OMB: 0910-0330

IC ID: 5914

Information Collection (IC) Details

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Reporting - Submission of a Premarket Notification for a New Dietary Ingredient CFSAN
 
No Modified
 
Mandatory
 
21 CFR 190.6

Document Type Form No. Form Name Instrument File URL Available Electronically? Can Be Submitted Electronically? Electronic Capability
Form and Instruction Form FDA 3880 New Dietary Ingredient Notification (NDIN): Electronic Submission 0330 NDI Screenshots.docx https://cfsan-onlinesubmissions.fda.gov/farmonline/#/login Yes Yes Fillable Fileable
Other-guidance 2016 Revised Draft Guidance for NDI Notifications.pdf Yes Yes Fillable Fileable

Health Consumer Health and Safety

 

55 0
   
Private Sector Businesses or other for-profits
 
   95 %

  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 55 0 0 0 0 55
Annual IC Time Burden (Hours) 1,435 0 335 0 0 1,100
Annual IC Cost Burden (Dollars) 0 0 0 0 0 0

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