Reporting; Tobacco Substantial Equivalence Report Amendment and General Correspondence Report (Form FDA 3965a)

Substantial Equivalence Reports for Tobacco Products

Documents and Forms

Document Name Document Type
Form Form FDA 3965a Reporting; Tobacco Substantial Equivalence Report Amendment and General Correspondence Report (Form FDA 3965a) Form and Instruction
Form FDA 3965a Tobacco Substantial Equivalence Report Amendment and Gen FDA_Form_3965a (2024).pdf Form and Instruction
FDA Web Form 3965a Tobacco Substantial Equivalence Report Amendment Final Wireframes for FDA Web Form 3965a (SE Amendment) (2024).pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Reporting; Tobacco Substantial Equivalence Report Amendment and General Correspondence Report (Form FDA 3965a)	Agency IC Tracking Number:	CTP

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 3965a	Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission	FDA_Form_3965a (2024).pdf		Yes	Yes	Fillable Fileable Signable
Form and Instruction	FDA Web Form 3965a	Tobacco Substantial Equivalence Report Amendment	Final Wireframes for FDA Web Form 3965a (SE Amendment) (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: 628	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	628	628
Annual IC Time Burden (Hours)	100	100
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.