The Agency has not yet received an MRTP application. It therefore does not have experience in reviewing such applications, and has no information based on prior experience regarding the length of time required for review of such applications. Moreover, the MRTP application review process and approval criteria are new, and the Agency is likely to encounter a number of questions of first impression involving science, law, policy, and procedure. Resolving questions of first impression may mean that the initial applications will require more time than later submitted ones.
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Based on all these considerations, FDA has determined that, as a reasonable preliminary timetable, the Agency intends to issue a decision on a MRTP application within 360 days of its receipt by FDA. Because section 911 is designed to protect the public health, it is important to allow the Agency sufficient time to fully evaluate all data and information submitted in an application. Nevertheless, although the Agency believes that the 180-day time periods provided for review of drug and device applications in sections 505(c) and 515(d) will not be adequate for the Agencys review of MRTP applications, it may be able to proceed more quickly than the 540-day timeframe sustained by the court in Nutritional Health Alliance v. Shalala. Further, the statute contemplates in section 911(l) that the Agency will issue a timetable for review of MRTP applications together with more comprehensive regulations or guidance regarding MRTP applications within two years and nine months of the enactment of the Tobacco Control Act. At that time, the Agency may have more information regarding MRTP applications that will allow it to assess the time requirements with more specificity, and more experience that could help expedite the application review process.
