Tobacco Substantial Equivalence Report Submission

Substantial Equivalence Applications for Tobacco Products

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0673 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 3965 Tobacco Substantial Equivalence Report Submission Form and Instruction
FDA 3965 Tobacco Substantial Evidence Report Submission FDA-3965.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Tobacco Substantial Equivalence Report Submission	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

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	FDA 3965	Tobacco Substantial Evidence Report Submission	FDA-3965.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

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: 100 %

	Requested	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	1,570	1,570
Annual IC Time Burden (Hours)	785	785
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.