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

Premarket Notification for a New Dietary Ingredient

Documents and Forms

Document Name Document Type
Form Form FDA 3880 Reporting - Submission of a Premarket Notification for a New Dietary Ingredient Form and Instruction
2016 Revised Draft Guidance for NDI Notifications.pdf Other-guidance
2016 Revised Draft Guidance for NDI Notifications.pdf Other-guidance
Form FDA 3880 New Dietary Ingredient Notification (NDIN): Electronic S 0330 NDI Screenshots.docx cfsan-onlinesubmissions.fda.gov/farmonline/#/login Form and Instruction
Form FDA 3880 New Dietary Ingredient Notification (NDIN): Electronic S 0330 NDI Screenshots.docx cfsan-onlinesubmissions.fda.gov/farmonline/#/login Form and Instruction

Information Collection (IC) Details

IC Title:	Reporting - Submission of a Premarket Notification for a New Dietary Ingredient	Agency IC Tracking Number:	CFSAN

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 190.6

Information Collection Instruments:

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Other-guidance			2016 Revised Draft Guidance for NDI Notifications.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 55	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	55	0	55
Annual IC Time Burden (Hours)	1,435	335	1,100
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.