Information Collection

Reporting: Notifications to FDA

IC 218211 under ICR 202107-0910-010 · OMB 0910-0806.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0806 can be found here:

Documents and Forms

Document Name Document Type
Form 3911 Reporting: Notifications to FDA Form
21 USC 360eee-1 Drug Supply Chain Security.pdf Other-21 USC 360eee-1
21 USC 360eee-1 Drug Supply Chain Security.pdf Other-21 USC 360eee-1
3911 Drug Notifications FDA FORM 3911.pdf Form
3911 Drug Notifications FDA FORM 3911.pdf Form

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Reporting: Notifications to FDA	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form	3911	Drug Notifications	FDA FORM 3911.pdf		Yes	No	Paper Only
Other-21 USC 360eee-1			21 USC 360eee-1 Drug Supply Chain Security.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: 500	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	14,100	13,950	150
Annual IC Time Burden (Hours)	112,800	112,650	150
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.