Information Collection

Prescription Drug Marketing: Reporting

IC 43602 under ICR 202502-0910-009 · OMB 0910-0435.

Documents and Forms

Document Name Document Type
Form 3911 Prescription Drug Marketing: Reporting Form
FDA-form-3911_instructions_04-05-2024.pdf www.fda.gov/about-fda/reports-manuals-forms/forms Instruction
FDA-form-3911_instructions_04-05-2024.pdf www.fda.gov/about-fda/reports-manuals-forms/forms Instruction
3911 Drug Notification FDA-3911_Dyn_Sec_Ext_04-09-2024.pdf www.fda.gov/about-fda/reports-manuals-forms/forms Form
3911 Drug Notification FDA-3911_Dyn_Sec_Ext_04-09-2024.pdf www.fda.gov/about-fda/reports-manuals-forms/forms Form

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Prescription Drug Marketing: Reporting	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 203

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-3911_Dyn_Sec_Ext_04-09-2024.pdf	https://www.fda.gov/about-fda/reports-manuals-forms/forms	Yes	Yes	Fillable Fileable
Instruction			FDA-form-3911_instructions_04-05-2024.pdf	https://www.fda.gov/about-fda/reports-manuals-forms/forms	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 140	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	Previously Approved
Annual Number of Responses for this IC	8,323	8,323
Annual IC Time Burden (Hours)	2,080	2,080
Annual IC Cost Burden (Dollars)	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.