Main Total number of product submissions received or filed in the month (1) The Tobacco Control Act requires manufacturers of new or modified tobacco products to submit a premarket application and obtain a market authorization order before they market their products. To introduce a new or modified tobacco product, an applicant must submit an application to FDA providing information on the product sufficient to allow the agency to determine that an order authorizing the product’s introduction is appropriate for the protection of the public health. Alternately, a manufacturer may submit a substantial equivalence report demonstrating that its new tobacco product is substantially equivalent to a predicate tobacco product, as defined in the Tobacco Control Act. The <a href=http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/ucm238891.htm target=”_blank”>Substantial Equivalence</a> provision of the Tobacco Control Act requires nothing of manufacturers of unaltered tobacco products which were commercially available on February 15, 2007. Additional information about premarket review requirements for tobacco products can be found on the <a href=http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForIndustry/ucm237528.htm target=”_blank”>CTP website</a>. <i>Information is current as of November 30, 2012</i> (1) As submissions are reviewed, data may need to be updated to account for duplicates and multiple products on one submission. Number column 0 0 3200 2011 FY 2011 Total: 3,294 0 2012 FY 2012 Total: 412 2013 Target FY 2013 YTD: 8 Sub Total number of product submissions received or filed in the month (1) Number of Regular Substantial Equivalence Submissions (SE) received in the month Number column 0 2011 FY 2011 Total: 121 0 2012 FY 2012 Total: 395 6 2013 Target FY 2013 YTD: 7 Sub Total number of product submissions received or filed in the month (1) Number of Provisional SE Reports received in the month Number column 0 2011 FY 2011 Total: 3,162 0 2012 FY 2012 Total: 1 6 2013 Target FY 2013 YTD: 0 Sub Total number of product submissions received or filed in the month (1) Number of SE Exemption Submissions received in the month Number column 0 2011 FY 2011 Total: 10 0 2012 FY 2012 Total: 12 6 2013 Target FY 2013 YTD: 1 Sub Total number of product submissions received or filed in the month (1) Number of New Products Submissions (PMTA) filed in the month Number column 0 20 2011 FY 2011 Total: 0 0 2012 FY 2012 Total: 0 6 2013 Target FY 2013 YTD: 0 Sub Total number of product submissions received or filed in the month (1) Number of Modified Risk Products (MR) filed in the month (1) (1) Oct 2010 and Nov 2010 counts are amendments to previous submissions. Number column 0 20 2011 FY 2011 Total: 1 0 2012 FY 2012 Total: 4 6 2013 Target FY 2013 YTD: 0 http://www.fda.gov/AboutFDA/Transparency/track/ucm252849.htm FDA-TRACK CTP Dashboard ਍††਍਍਍਍਍਍਍