Rapid Nicotine Pouch Data Analysis Services

Rapid Nicotine Pouch Data 3.1 Background FDA’s Center for Tobacco Products (CTP) regulates the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use, particularly among youth. CTP oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the Agency’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions. On August 8, 2016, the U.S. Food and Drug Administration finalized a rule that extends its regulatory authority to all tobacco products, including e-cigarettes, cigars, and hookah and pipe tobacco, as part of its goal to improve public health. Additionally, effective April 14 (2022), Congress passed a federal law which went into effect on April 14, 2022, clarifying FDA’s authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine. 3.2 Objective To effectively regulate the rapidly changing U.S. commercial tobacco and nicotine marketplace for ENDS and nicotine pouches, as required by the law, the Government intends to obtain sentinel surveillance reports summarizing findings from existing surveys and other data collection efforts aimed at obtaining rapid and sentinel information on predominant and emerging ENDs and nicotine pouch brands and tobacco use among youth and young adults. 3.3 Scope For the base period and option period 1 – 4, as outlined below, the contractor shall provide FDA with reports summarizing data from their data collection efforts related to ENDS and nicotine pouches. At a minimum, reports should include data on the following topics: (i) ENDS and nicotine pouch use overall, (ii) sources of purchase, and (iii) use by top and emerging brands among youth and young adults, and (iv) other potential topics both parties agree upon. 3.4 Tasks Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults For the base year and option years 1 – 4, the contractor shall provide a total of 12 monthly reports (1/month) summarizing findings from their existing continuous tracking survey implemented with an online sample of youth and young adults or similar data collection effort to obtain sentinel surveillance information from youth and young adults. Each monthly report shall be delivered no more than 30 days after the last day of that month (e.g., a report based on data from May 1st- May 31st, 2026, should be delivered no later than June 30th, 2026). Each monthly report shall be delivered with thorough and detailed documentation of relevant survey questions, sampling approach, data collection methods employed, and response rates achieved; data analysis methods and relevant data/analytic assumptions. The report shall include: A brief, organized summary of the key findings and overall results in a tabular format or other simple format approved by the government, A technical appendix documenting in detail the relevant survey questions, sampling approach, data collection methods employed, and response rates achieved; data analysis methods and assumptions used by the Contractor to obtain the results described; and any additional detail related to the methodology necessary to help the government appropriately interpret the key findings and overall results, PowerPoint slides with plugged aggregated monthly and quarterly estimates and charts that include youth use and brand information noted above to present the summary of the report that includes an appendix with a table of monthly estimates for each slide (wherever applicable). Task 2: Reports from Existing Nationally-Representative Longitudinal Cohort Study of Youth and Young Adults For the base year and option years 1 – 4, the contractor shall provide a total of 2 reports from each wave/data collection effort of their longitudinal cohort study implemented with a nationally representative online panel (2 reports). Each report shall be delivered no more than 30 days after the last date of data collection for that wave. Each report shall be delivered with a thorough and detailed documentation of the methodology employed for data collection and analysis. The report shall include: A brief, organized summary of the key findings and overall results in a tabular format or other simple format approved by the government, A technical appendix documenting in detail the data collection methods employed including the sampling design/approach and response rates achieved; data analytical methods and assumptions used by the Contractor to obtain the results described; and any additional detail related to the methodology necessary to help the government appropriately interpret the key findings and overall results, and A PowerPoint file PowerPoint slides with plugged aggregated monthly and quarterly estimates and charts that include survey findings to present the summary of the report. Task 3: Ad Hoc Topic-Specific Reports For the base year and option years 1 – 4, the contractor shall provide topic-specific reports (2 reports summarizing tobacco data from youth and young adults pertaining to a specific topic to be determined by the government after contract award, e.g., use of flavored tobacco products). These reports shall be delivered by the end of each base period/option year. Task 4: Meetings Kick-Off Meeting- The contractor shall participate in a project kick-off call with the CTP project team, including the COR, within 14 business days after start of the Period of Performance. The purpose of this meeting is to discuss the proposed work plan and proposed progress schedule. The contractor shall provide meeting minutes to the COR within 48 hours of meeting date. Monthly Status Meetings-The contractor shall share PowerPoint slides and meeting agenda with latest aggregated monthly and quarterly estimates at least 24 hours ahead of scheduled 30-minute monthly meetings and one-hour quarterly meetings with FDA staff (via teleconference). During these meetings, the contractor shall present and discuss deliverables completed during period; problems or issues projected or identified; and alternatives and/or recommended solution(s) for identified or projected problems or issues. The contractor shall also provide meeting minutes to FDA staff within 48 hours of meeting date. 3.5 Deliverables Monthly reports from existing online Continuous Tracking Survey of youth and young adults (12 monthly reports (1/month) for the base year and option years 1 – 4) Reports from existing nationally-Representative Longitudinal Cohort Study of youth and young adults (2 reports from each wave/data collection effort of their longitudinal cohort study implemented with a nationally representative online panel (2 reports/year) for the base year and option years 1 – 4.) Ad hoc topic-specific reports (2 reports/year for the base year and option years 1 – 4) Kickoff meeting (1 kickoff meeting) Monthly status meetings (Monthly status meetings (1/month), quarterly meetings, and meeting notes for the base year and option years 1 – 4) 3.6 Government-Furnished Property (GFP) No government furnished property will be provided to the Contractor. 3.7 Security Considerations Not applicable 3.8 Travel No travel is anticipated in the performance of this contract. 3.9 Special Material Requirements None 3.10 Other Unique Requirements and Considerations None 3.11 Place of performance It is expected that the Contractor shall perform all Task work at its own place of business. Monthly and quarterly meetings shall be held via teleconference or video conference. A kick-off meeting will be held after award via teleconference. 3.12 Period of Performance The base period is expected to be 12 months from the date of contract execution. Option Year 1 will be 12 months from the end of the base period. All subsequent base periods (i.e., Option years 2-4) will also be 12 months from the end of the previous option year. The total duration of the contract will be 60 months from the date of contract execution.

• NAICS541618
• PSCR405

• RFQ_75F40126Q00407_Final.docx

  .docx87 KBNot yet available

• Madeline Bryant
  madeline.bryant@fda.hhs.gov2404027611
• Pamela T Lee
  pamela.lee@fda.hhs.gov2404023847