Information Collection

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

IC 5914 under ICR 202401-0910-005 · OMB 0910-0330.

Documents and Forms

Documents and forms in this information collection
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2016 Revised Draft Guidance for NDI Notifications.pdf	Other-guidance
2016 Revised Draft Guidance for NDI Notifications.pdf	Other-guidance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

IC Title:

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:

table that charts list of 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Other-guidance			2016 Revised Draft Guidance for NDI Notifications.pdf		Yes	Yes	Fillable Fileable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 %

table that charts list of burden
	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

table that charts IC Documents
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.