Reporting; Tobacco Substantial Equivalence Report Submission (Form FDA 3965)

Substantial Equivalence Reports for Tobacco Products

Documents and Forms

Document Name Document Type
Form Form FDA 3965 Reporting; Tobacco Substantial Equivalence Report Submission (Form FDA 3965) Form and Instruction
Form FDA 3965 Tobacco Substantial Equivalence Report Submission FDA_Form_3965 (2024).pdf Form and Instruction
FDA Web Form 3965 Tobacco Substantial Equivalence Report Final Wireframes for FDA Web Form 3965 (SE) (2024).pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Reporting; Tobacco Substantial Equivalence Report Submission (Form FDA 3965)	Agency IC Tracking Number:

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 and Instruction	Form FDA 3965	Tobacco Substantial Equivalence Report Submission	FDA_Form_3965 (2024).pdf		Yes	Yes	Fillable Fileable
Form and Instruction	FDA Web Form 3965	Tobacco Substantial Equivalence Report	Final Wireframes for FDA Web Form 3965 (SE) (2024).pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,570	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 83 %

	Requested	Previously Approved
Annual Number of Responses for this IC	1,570	1,570
Annual IC Time Burden (Hours)	1,178	1,178
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.