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U.S. Department of Health and Human Services

Tobacco Products

Establishing Four Performance Measures

 

CTP Director Mitch Zeller on the Establishment of Performance Measures and Timeframes for the Review of Certain Types of Tobacco Products

In the nearly five years since enactment of the Tobacco Control Act, 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. Today, FDA is announcing that we have developed a set of performance measures that will help improve the timeliness and predictability of the review of certain types of tobacco products currently regulated by FDA.

FDA has established four performance measures that include timeframes: for review of regular SE Reports, review of Exemption from SE Requests, review of Modified Risk Tobacco Product (MRTP) Applications, and for meeting requests. Beginning on October 1, 2014, all four measures will be implemented, meaning that FDA will start monitoring the time it takes to review and take action. The interim time between now and October 1, 2014, will be used to develop tracking systems for monitoring progress in meeting the performance goals. As FDA gains more experience with reviewing provisional SE Reports, we intend to identify and implement performance standards for these submissions as well.

FDA has identified the following set of measures and timeframes for Fiscal Years 2015-2018:

 

CategoryPerformance GoalSubmission Cohort1
Regular SE ReportsFinalize jurisdiction and completeness review (and issue letter as appropriate) within 21 days of FDA receipt2 of SE Report.FY15: 50%, FY16: 60%,
FY17: 70%, FY18: 80%
 Review and act on an original SE Report within 90 days of FDA receipt.FY15: 50%, FY16: 60%,
FY17: 70%, FY18: 80%
Regular SE Report Resubmissions3Review and act on a SE Report resubmission within 90 days of FDA receipt.FY15: 50%, FY16: 60%,
FY17: 70%, FY18: 80%
Exemption from SEReview and act on an Exemption from SE Request within 60 days of FDA receipt.FY15: 50%, FY16: 60%,
FY17: 70%, FY18: 80%
MRTPAReview and act on a complete MRTP Application within 360 days4 of FDA receipt.FY15: 50%, FY16: 60%,
FY17: 70%, FY18: 80%
Meeting ManagementRespond to meeting requests within 21 calendar days5.6.FY15: 80%, FY16: 80%,
FY17: 90%, FY18: 90% 


  1. Submission cohort defined as original report received in that FY.
  2. Official receipt by CTP Document Control Center
  3. A “Resubmission,” is a complete response to FDA’s Scientific Advice and Information Letter or Preliminary Finding letter.
  4. This timetable is FDA’s best estimate, but it is based on limited information. FDA has not yet received a complete MRTPA.
  5. Guidance for Industry and Investigators: Meetings with Industry and Investigators on the Research and Development of Tobacco Products, May 2012. (http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatorylnformation/ucm305279.htm)
  6. 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 Offices determine when a request is a formal meeting request.  The request is not complete until the Office has enough information to make a decision. 

For purposes of the regulatory performance measures listed above, a brief explanation of several terms follows:

  • "Review and act on" means issuance of a letter (e.g., Scientific Advice and Information 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 from SE request; or the issuance of an order or letter after the complete review of a filed MRTPA application. This timetable for MRTPAs is FDA's best estimate, but it is based on limited information.
  • "Issue letter as appropriate" means the issuance of an Acknowledgement Letter or Refuse to Accept Letter.  If acknowledged, and the administrative review notes missing information, the information will be addressed during scientific review.
  • Scientific Advice and Information Letter or Preliminary Finding Letter means a written communication which lists deficiencies in a SE Report that preclude either further scientific review or issuance of an SE Order.

Over the past two years, CTP has made great progress in each of the three key steps within the SE review process:  1) jurisdiction review 2) administrative review and 3) scientific review.  As of March 24, 2014, there is no longer a backlog of regular SE reports awaiting scientific review. CTP is starting scientific review on regular SE reports as they are received. As of April 4, 2014, the SE review process has concluded for 23.6% of the 981 regular SE Reports that were received before March 31, 2014. As of March 31, 2014, FDA has received 61 Exemption from SE Requests, to which 36 Refusal to Accept letters were issued as manufacturers did not meet the requirements for such exemption. FDA has also begun review of provisional SE Reports and issued the first decisions on these reports on February 21, 2014. Our work is ongoing with the remaining reports and requests, and the agency intends to reach decisions as expeditiously as possible.

Of the seven MRTP Applications received as of December 31, 2013, FDA refused to file/accept for a substantive review six of the seven applications because they failed to include information required under the TCA and/or were about products that CTP does not currently regulate; the seventh was withdrawn by the manufacturer. FDA is committed to helping industry better understand the tobacco product review process and its requirements in the law, and will continue holding public webinars and educational meetings.

Conducting scientific reviews of product applications and meeting with external stakeholders are important aspects of our work. Going forward, FDA will continue to strengthen and expand these processes, which will enable us to be well positioned to meet more ambitious performance standards in the future.