Report Demonstrating Tobacco Product Mod under 905(j)(3), Commercially Mkted and Compliant, and Modifications covered under 905(j)(3)

Multiple STNs, see Appendix A

Page 5 of 5

Appendix B
FDA’s Recommended Format for Submitting an Abbreviated Report
Mock-up Tobacco Company

April 3, 2015

US Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

RE: Abbreviated Report
To Whom It May Concern:
Mock-Up Tobacco Company provides this Abbreviated Report at least 90 days prior to the introduction
or delivery for introduction into interstate commerce for commercial distribution of the new product,
Cigarette Brand A. We submitted an Exemption Request (EX0000XXX) under section 905(j)(3) for the
new product on February 1, 2015, and received a found exempt order from FDA on March 20, 2015.
I, John Doe, on behalf of Mock-Up Tobacco Company, certify that Cigarette Brand A is modified
within the meaning of section 905(j)(3), the modifications are to a product that is commercially
marketed and in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act,
all the modifications are covered by exemptions granted by the Secretary pursuant to section
905(j)(3), and I have taken actions to comply with the requirements under section 907 that are
applicable to the product. I certify that this information is true and correct, and that I am
authorized to submit this on the company’s behalf. I understand that under section 1001 of title
18 of the United States Code, anyone who knowingly and willfully makes a materially false,
fictitious, or fraudulent statement to the Government of the United States is subject to criminal
penalties.

Sincerely,
John Doe [ink or digital signature]
Vice President
Mock-Up Tobacco Company