Since enactment of the Tobacco Control Act in 2009, FDA has worked to create a regulatory framework to oversee the manufacture, sale, and distribution of tobacco products, and has made great strides in implementing the Act. In April 2014, FDA announced the development of a set of performance measures that will help improve the timeliness and predictability of the review of certain applications for cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco products:

1. Regular SE Reports
2. Exemption Requests
3. Modified Risk Tobacco Product Applications (MRTPAs)
4. Meeting requests

Performance measures were implemented on October 1, 2014, for these applications on statutory tobacco products. In September 2015, in accordance with the publication of the Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions guidance, FDA established performance measures for “Streamlined SE Reports”: Same Characteristics SE Reports and Product Quantity Change SE Reports. However, based on an August 2016 decision from the United States District Court for the District of Columbia, FDA significantly changed the program for Streamlined SE Reports and the only remaining Streamlined SE Reports are for product quantity changes.

In April 2018, FDA extended performance measures for Regular SE Reports and Exemption Requests to Fiscal Year (FY) 2022 with a few changes as listed below:

• Regular SE Reports
  • Full and streamlined Regular SE Reports are reported as a single category to capture key performance measures while maintaining a degree of simplicity and clarity in the measures.
  • Original SE Reports and resubmissions (amendments) are reported as a single category. Review of resubmissions continues to be comparable to that of original SE Reports because resubmissions contain significant amounts of new information that was determined to be deficient in the original SE Report and require significant effort to evaluate.
• Exemption Requests: The performance measures for “Exemption Requests” have been updated to maintain consistency with measures for Regular SE Reports.

As part of a re-examination of the review queue of “Provisional SE Reports,” FDA also announced new performance measures for these reports. These performance measures are similar to those used for Regular SE Reports but are tailored for the unique circumstances of these types of reports. For example, there is no performance measure for Acknowledgement or Refuse-To-Accept letters because those actions occurred in the past and should not occur moving forward. The establishment of these performance measures will guide FDA’s efforts and will allow for all interested stakeholders to stay up-to-date on progress in reviewing these applications.

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Table: CTP Performance Measures for Cigarettes, Cigarette Tobacco, Smokeless Tobacco, and Roll-Your-Own Tobacco Products, Table: FY17-FY22 

^{1ACK and RTA is 21 days from date original SE Report received. Withdrawal ACK is 21 days from date withdrawal amendment is received. ACK= Acknowledgement letter. RTA= Refuse To Accept letter
2 90 days from date original SE Report received. 90 days from date complete response to A/I or PFind letter received, or date response to A/I or PFind letter is due, whichever is sooner.
3 21 days from date withdrawal amendment is received.
4 120 days from date review of original SE Report expected to start (i.e., as indicated in the Notification letter). 120 days from date complete response to A/I or PFind letter received, or date response to A/I or PFind letter is due, whichever is sooner.
5ACK and RTA is 21 days from date original EX REQ received. Withdrawal ACK is 21 days from date withdrawal amendment is received.
6 60 days from date original EX REQ received. 60 days from date complete response to A/I letter received, or date response to A/I letter is due, whichever is sooner.
7This timetable is FDA’s best estimate, but it is based on limited information.
8 Responding means that CTP accepts or denies the meeting request. This performance goal refers only to requests from entities external to government (e.g., stakeholders and regulated industry). CTP determines when a request is a formal meeting request. The request is not complete until the CTP has enough information to make a decision.}

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Table:  CTP Performance Measures for Cigarettes, Cigarette Tobacco, Smokeless Tobacco, and Roll-Your-Own Tobacco Products, FY15-FY16

^{9 Number of days in each performance measure refers to the calendar days since FDA receipt of the submission by CTP Document Control Center
10 N = the number received during the FY
11 Does not include Product Quantity SE Reports
12 And issue letter as appropriate
13 Does not include Product Quantity SE Reports
14 A “resubmission” is a complete response to FDA’s Advice/Information Request or Preliminary Finding letter
15 Does not include Product Quantity SE Reports
16 And issue Acknowledgement letter or Refuse to Accept letter as appropriate
17 Does not include Product Quantity SE Reports
18 A “resubmission” is a complete response to FDA’s Advice/Information Request or Preliminary Finding letter
19 If an Exemption Request is submitted for a modification to a pending provisional product, the decision on the Exemption Request will be made after the decision on the provisional SE Report. Therefore, such Exemption Requests are not included in performance measures
20 This timetable is FDA’s best estimate, but it is based on limited information.
21 Responding means that CTP accepts or denies the meeting request. This performance goal refers only to requests from entities external to government (e.g., stakeholders and regulated industry). CTP determines when a request is a formal meeting request. The request is not complete until the CTP has enough information to make a decision.}

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Note: For purposes of the performance measures listed above, “Review and act on” means issuance of an Advice/Information Request Letter, Preliminary Finding Letter, NSE or SE Order after the review of an accepted regular SE Report or resubmission; issuance of an order or letter after the review of an Exemption Request; or issuance of an order or letter after the review of a filed MRTPA. Advice/Information Request and Preliminary Finding Letters are written communications that list deficiencies in an application which preclude further scientific review or issuance of an order. A “resubmission” is a complete response to FDA’s deficiency letter.

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Discussion of Performance Measure Results

FY19

FDA met and exceeded all of the performance goals for Regular SE Reports, Provisional SE Reports, Exemption Requests and Meeting Management in FY19. The data for MRTP applications is not available yet as there are open cohorts for applications received by FDA in FY19. The cohort for MRTP applications only close 360 days after FDA receipt of the application. Once the cohorts close, the updated performance measures for MRTP applications will be added to the table.

FY18

FDA met all of the performance goals for Regular SE Reports, Exemption Requests and Meeting Management in FY18. FDA was not able to meet the goals to review and act on a complete MRTPA within 360 days.

FY17

FDA met most of the performance goals for Regular SE Reports and Exemption Requests in FY17. FDA was not able to meet the goals to review and act on a complete MRTPA within 360 days or for Exemption Requests issue to Issue A/I, Cancellation, Closure, EX or NEX order letter within 60 days.

FY15 and FY16

In FY15 and FY16, FDA met all of the performance goals for Regular Full SE Reports and meeting requests but missed the performance goals for Regular Streamlined SE Reports. At that time, both manufacturers and FDA had little experience with these new Streamlined SE Reports, which were created in 2015. Furthermore, in October 2015, a lawsuit was filed regarding FDA’s final SE FAQ Guidance: Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions (Edition 2), which contained guidance concerning these Streamlined SE Reports. In August 2016, the United States District Court for the District of Columbia made a decision that led to FDA significantly changing the program for Streamlined SE Reports. Between October 2015 and August 2016, FDA ceased issuance of deficiency letters or NSE orders for Streamlined SE Reports; this precluded FDA from meeting the Streamlined SE Reports performance measures. Now that the legal issues have been addressed, FDA expects that, as manufacturers and FDA gain more experience with these types of SE Reports, FDA will meet its performance goals. Additionally, as FDA was only beginning to develop experience in reviewing Exemption Requests and MRTPAs, FDA did not meet performance goals for Exemption Requests or MRTPAs in FY15 and FY16, but FDA expects to meet these performance goals in future fiscal years.

It is also worth noting that when FY15 performance results were previously reported, FDA explained that Streamlined SE Reports were included in the results for Regular SE Reports but that starting in FY 2016, Streamlined SE Reports would be reported under separate performance measures. FDA has now implemented that change in reporting methodology. To ensure that FY15 and FY16 data can be compared, the data for FY15 are now presented comparably with the data for FY16. Due to this change in reporting methodology and the 2016 court decision, the number of Regular SE Reports received in FY15 is substantially less than previously reported.