Information Collection

Tobacco Product Establishment Initial Registration and Listing; Form FDA 3741 Registration and Product Listing for Owners and Operators of Domestic Establishments (Electronic and Paper submissions)

IC 191227 under ICR 202303-0910-009 · OMB 0910-0650.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0650 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3471 Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments Tobacco Product Establishment Initial Registration and Listing; Form FDA 3741 Registration and Product Listing for Owners and Operators of Domestic Establishments (Electronic and Paper submissions)	Form and Instruction
Form FDA 3741a Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments Tobacco Product Establishment Initial Registration and Listing; Form FDA 3741 Registration and Product Listing for Owners and Operators of Domestic Establishments (Electronic and Paper submissions)	Form and Instruction
0650_Guidance_2023.docx	Other-Guidance
0650_Guidance_2023.docx	Other-Guidance
TRLM-NGPresentation-Screenshots.pptx	Other-TRLM
TRLM-NGPresentation-Screenshots.pptx	Other-TRLM
eSubmitterscreenshots.pdf	Other-eSubmitter
eSubmitterscreenshots.pdf	Other-eSubmitter
FDA 3471 Registration and Listing for Owners and Operators of Dom FDA-3741.pdf	Form and Instruction
FDA 3471 Registration and Listing for Owners and Operators of Dom FDA-3741.pdf	Form and Instruction
FDA 3741a Registration and Listing for Owners and Operators of Dom FDA-3741a.pdf	Form and Instruction
FDA 3741a Registration and Listing for Owners and Operators of Dom FDA-3741a.pdf	Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Tobacco Product Establishment Initial Registration and Listing; Form FDA 3741 Registration and Product Listing for Owners and Operators of Domestic Establishments (Electronic and Paper submissions)

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	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			0650_Guidance_2023.docx	Yes	No	Printable Only
Form and Instruction	FDA 3471	Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments	FDA-3741.pdf	Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3741a	Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments	FDA-3741a.pdf	Yes	Yes	Fillable Fileable
Other-TRLM			TRLM-NGPresentation-Screenshots.pptx	Yes	Yes	Fillable Fileable Signable
Other-eSubmitter			eSubmitterscreenshots.pdf	Yes	Yes	Fillable Fileable Signable

Federal Enterprise Architecture Business Reference Module

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 200

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	200	200
Annual IC Time Burden (Hours)	320	320
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.