Documenting transaction information

Pharmaceutical Distribution Supply Chain

Documents and Forms

Document Name Document Type
Form 3911 Documenting transaction information Form
3911 Drug Notification FDA FORM 3911.pdf Form

Information Collection (IC) Details

IC Title:	Documenting transaction information	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 Notification	FDA FORM 3911.pdf		Yes	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 70,000	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	70,000,000,000	69,999,999,500	500
Annual IC Time Burden (Hours)	119,000	118,500	500
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.