Tobacco Product Establishment Registration

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⚠️ Notice: This information collection may be referencing outdated material.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
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
Create CTPe_Submissions UCM189565.pdf Instruction
eSubmitter Quick Guide UCM162419.pdf Instruction
FDA 3741 Registration and Listing for Owners and Operators of Dom FDA-3741 view only.pdf Form
FDA 3741 and 3742 FDA 3741 & 3742 eSubmitter Registration Screen shot-061512.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	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			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
Instruction			Create CTPe_Submissions UCM189565.pdf	Yes	Yes	Printable Only
Instruction			eSubmitter Quick Guide UCM162419.pdf	Yes	No	Printable Only
Form	FDA 3741	Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments	FDA-3741 view only.pdf	Yes	No	Printable Only
Form and Instruction	FDA 3741 and 3742 eSubmitter form	FDA 3741 & 3742	eSubmitter Registration Screen shot-061512.pdf	Yes	No	Printable Only

Line of Business: Health

Subfunction: Immunization Management

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 125	Number of Respondents for Small Entity: 115

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

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	200	-98,800	99,000
Annual IC Time Burden (Hours)	750	-370,500	371,250
Annual IC Cost Burden (Dollars)	1	1	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.