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⚠️ Notice: This information collection may be referencing outdated material.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
FDA 3741 Registration and Listing for Tobacco Product Establishme FDA Form 3741.pdf Form
905 final guidance 11-05-09.doc 905 final guidance 11-05-09 IC Document
New Registration and Product Listing Package Screenshots.pdf New Registration and Product Listing Package Screenshots IC Document
Update Registration Package Screenshots.pdf Update Registration Package Screenshots 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
Form	FDA 3741	Registration and Listing for Tobacco Product Establishments	FDA Form 3741.pdf	Yes	Yes	Fillable Fileable Signable

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	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	200	0	200
Annual IC Time Burden (Hours)	488	-262	750
Annual IC Cost Burden (Dollars)	1	0	1

Documents for IC

Title	Document	Date Uploaded
905 final guidance 11-05-09	905 final guidance 11-05-09.doc	11/05/2009
New Registration and Product Listing Package Screenshots	New Registration and Product Listing Package Screenshots.pdf	04/15/2013
Update Registration Package Screenshots	Update Registration Package Screenshots.pdf	04/15/2013

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