View Information Collection (IC)

View Information Collection (IC)

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Other-guidance			2016 Revised Draft Guidance for NDI Notifications.pdf		Yes	Yes	Fillable Fileable

Federal Enterprise Architecture Business Reference Module

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 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

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.