Information Collection

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

IC 245288 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 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

IC Title:

Agency IC Tracking Number:

CTP

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 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 %

table that charts list of burden
	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

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.