Main Total number of information request letters sent to report submitters in the month 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> Monthly total of information request letters sent. Each submission is reviewed for completeness. Letters will be sent to manufacturers advising them of missing information in their submissions. <i>Information is current as of November 30, 2012</i> Number column 0 0 2012 Measure implemented in March 2012. FY 2012 Total: 396 2013 Target FY 2013 YTD: 257 Sub Total number of information request letters sent to report submitters in the month Number of information request letters sent to non-provisional report submitters in the month Number column 0 2012 This sub-measure was retired September 2012. FY 2012 Total: 270 Sub Total number of information request letters sent to report submitters in the month Number of information request letters sent to provisional report submitters in the month Number column 0 2012 Measure implemented in March 2012 FY 2012 Total: 126 2013 Target FY 2013 YTD: 246 http://www.fda.gov/AboutFDA/Transparency/track/ucm252849.htm FDA-TRACK CTP Dashboard ਍††਍਍਍਍਍਍਍