Information Collection

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

IC 245286 under ICR 202402-0910-004 · OMB 0910-0673.

Documents and Forms

Documents and forms in this information collection
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

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.