Submit evidence of commercial marketing in the United States as of February 15, 2007

Establishing That a Tobacco Product Was Commercially Marketed in the United States As of February 15, 2007

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0775 can be found here:

Documents and Forms

Document Name Document Type
Establishing a Tobacco Was Commercially Marketed in the US Guidance-508ed.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed- Other-Guidance
Establishing a Tobacco Was Commercially Marketed in the US Guidance-508ed.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed- Other-Guidance
Establishing a Tobacco Was Commercially Marketed in the US Guidance.docx Other-Revised guidance
Establishing a Tobacco Was Commercially Marketed in the US Guidance.docx Other-Revised guidance

Information Collection (IC) Details

IC Title:	Submit evidence of commercial marketing in the United States as of February 15, 2007	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			Establishing a Tobacco Was Commercially Marketed in the US Guidance-508ed.pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishing-tobacco-product-was-commercially-marketed-united-states-february-15-2007	Yes	Yes	Fillable Printable
Other-Revised guidance			Establishing a Tobacco Was Commercially Marketed in the US Guidance.docx		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,000	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 99 %

	Approved	Previously Approved
Annual Number of Responses for this IC	1,000	1,000
Annual IC Time Burden (Hours)	5,000	5,000
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

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.