Tobacco Substantial Equivalence Report Submission

Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product

Documents and Forms

Document Name Document Type
Form FDA 3965 Tobacco Substantial Equivalence Report Submission Form and Instruction
FDA 3965 Tobacco Substantial Equivalence 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 Equivalence Report Submission	FDA 3965.pdf		Yes	Yes	Fillable Fileable

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: 85 %

	Requested	Program Change Due to Agency Discretion
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.