Tobacco Product Establishment Registration (electronic)

Tobacco Product Establishment Registration and Submission of Certain Health Information

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Document Name Document Type
eSubmissionUserManual.pdf Instruction
eSubmitter Quick Guide.pdf Instruction
AdobeDigitalSignatures.pdf Instruction
PackagingSubmissionUsingDigitalSignatures.pdf Instruction
Import_905_Owner Establishment Registration_v1.xls Other-Import Spreadsheet Owner Estab
Import_905_Product Identification_v1.xls Other-Import Spreadsheet Product Ide
Import_905_Operator Establishment Registration_v1.xls Other-Import Spreadsheet Operator Es
Technical Working Instructions_clean_11_03_09.doc Instruction
FDA 3741 Registration and Product Listing for Owners and Operator Screen Shots 905_11_03_09_OMB.pdf Form and Instruction
905 final guidance 11-05-09.doc 905 final guidance 11-05-09 IC Document

Information Collection (IC) Details

IC Title:	Tobacco Product Establishment Registration (electronic)	Agency IC Tracking Number:

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	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			eSubmissionUserManual.pdf	Yes	No	Printable Only
Instruction			eSubmitter Quick Guide.pdf	Yes	No	Printable Only
Instruction			AdobeDigitalSignatures.pdf	Yes	No	Printable Only
Instruction			PackagingSubmissionUsingDigitalSignatures.pdf	Yes	No	Printable Only
Other-Import Spreadsheet Owner Establishment Registration			Import_905_Owner Establishment Registration_v1.xls	Yes	Yes	Fillable Printable
Other-Import Spreadsheet Product Identification			Import_905_Product Identification_v1.xls	Yes	Yes	Fillable Printable
Other-Import Spreadsheet Operator Establishment Registration			Import_905_Operator Establishment Registration_v1.xls	Yes	Yes	Fillable Printable
Instruction			Technical Working Instructions_clean_11_03_09.doc	Yes	No	Printable Only
Form and Instruction	FDA 3741	Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments	Screen Shots 905_11_03_09_OMB.pdf	Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 99,000	Number of Respondents for Small Entity: 10,000

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Previously Approved
Annual Number of Responses for this IC	99,000	99,000
Annual IC Time Burden (Hours)	371,250	371,250
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
905 final guidance 11-05-09	905 final guidance 11-05-09.doc	11/05/2009

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.