Attachment 2_DRAFT SOW.docx

DRAFT STATEMENT OF WORK

Protecting Americans from Tobacco-Related Death and Disease

Estimated Period of Performance: May 2027 – April 2032

I. Background To protect the public’s health, the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 (Pub. L. No. 111-31, 123 Stat. 1776) granted the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products and educate the public about the dangers of tobacco product use. As part of its comprehensive efforts to fulfill its mandate and reduce the burden of tobacco-related disease across the population, FDA’s Center for Tobacco Products (CTP) implements a coordinated, science-based public education strategy to prevent tobacco product initiation among youth and young adults and provide adults who use tobacco products with accurate information to support harm reduction and cessation. These efforts are closely integrated with CTP’s regulatory responsibilities, including tobacco product application review and post-authorization oversight.

Starting in 2025, FDA began a centralized model for communications services. CTP now works in close collaboration with the FDA Office of Operations for support of its public education campaigns, with the FDA Office of External Affairs providing staff-level support with oversight and guidance from CTP regulatory experts.

Cigarette smoking remains the leading preventable cause of disease, disability, and death in the United States, responsible for more than 490,000 deaths annually. According to the U.S. Centers for Disease Control and Prevention, each day, over 1,344 youth and young adults smoke their first cigarette, and 5.6 million children alive today are projected to die prematurely from smoking-related disease. Because nearly 90 percent of tobacco use leading to addiction begins before adulthood, preventing initiation among youth and young adults is a critical public health priority.

CTP protects youth through regulatory education strategies. As part of its review of tobacco product applications, CTP evaluates proposed marketing plans to identify tactics that could unduly appeal to or reach youth and, where appropriate, applies marketing restrictions to mitigate this risk. These regulatory responsibilities are directly informed by the same real-world marketing expertise used to design and manage CTP’s national youth tobacco prevention campaigns. That practical understanding of audience targeting, messaging, channels, and industry marketing practices strengthens CTP’s ability to assess applications, set appropriate guardrails, and monitor compliance after authorization. This integrated approach requires deep tobacco subject-matter expertise and close collaboration with scientists, behavioral researchers, and regulatory experts.

CTP’s national youth tobacco prevention campaigns proactively educate young people about the health consequences of tobacco use to deter initiation. By reducing youth cigarette and e-cigarette use, these efforts help prevent nicotine addiction and support improved short- and long-term health outcomes, including reductions in asthma exacerbations, respiratory complications, and exposure to toxic chemicals found in tobacco products. By helping youth avoid exposure to more than 7,000 harmful chemicals in cigarette smoke—including at least 70 known carcinogens—CTP’s campaigns protect children’s health, support longer lives and reduce lifelong healthcare costs.

Evidence from controlled field experiments and population studies shows that paid media campaigns are a proven strategy to prevent and reduce population-level tobacco use and have contributed to significant declines in tobacco use over the past several decades. However, CTP’s youth tobacco prevention campaigns must navigate a fragmented, competitive media environment to find and motivate audiences who may not be naturally engaged with tobacco-related issues. To reduce tobacco use, it is critical to sustain high levels of campaign awareness and deliver effective messages with the intended population. In today’s media landscape, characterized by declining viewership of traditional broadcast television, increasing digital media consumption, AI/big data-led algorithmic audience segmentation and rapid shifts in audience behavior, CTP requires a multi-faceted media strategy, that leverages first-rate media industry expertise to achieve its public health and regulatory mission.

CTP’s public education efforts have produced measurable, independent evidence of impact. A longitudinal evaluation found that from 2014 to 2016, “The Real Cost” Youth Cigarette Prevention Campaign prevented up to 587,000 youth from initiating smoking, saving more than $53 billion in healthcare costs. A separate cost-effectiveness analysis found that for every $1 of user fees invested in the campaign, approximately $180 was returned to the public in health-related savings. Youth e-cigarette use remains a significant concern, with 2.25 million youth reporting current use in 2024. However, evaluation findings indicate that between 2023 and 2024, “The Real Cost” Youth E-Cigarette Prevention Campaign prevented nearly 450,000 youth from starting to use e-cigarettes. These outcomes demonstrate that CTP’s youth-focused prevention efforts are both effective and fiscally responsible.

In parallel, CTP, in collaboration with FDA OEA and other federal partners, also conducts public education efforts for adults who use tobacco, recognizing that many adults continue to smoke and deserve access to clear, evidence-based information to support harm reduction and cessation, empowering adults to make informed decisions about their health. For example, the “Every Try Counts” campaign encouraged adult smokers to persist in quit attempts and seek support. Overall, these efforts helped connect more than 45 million adult smokers with quitting resources, contributing to reduced risk of chronic diseases such as cancer, heart disease, and chronic lung disease.

Across both youth and adult efforts, CTP’s public education portfolio is grounded in rigorous science and best practices in health communication. Programs are informed by behavioral change theory, extensive audience research, and systematic message testing. Continuous performance measurement supports ongoing improvement, while independent evaluations assess population-level impact. Through this evidence-driven, integrated approach—linking education, regulation, and scientific expertise—CTP has prevented more than one million young people from initiating tobacco use and has expanded access to cessation and harm-reduction information for millions of adults.

II. OBJECTIVES

CTP’s public education efforts seek to prevent and reduce tobacco use among the American population. To achieve these goals, CTP’s public education program grounds campaign development, implementation, and evaluation in robust behavioral change frameworks and best practices with pursuit of objectives that include (but are not limited to) the following:

· Increased awareness of and receptivity to brand and public education messages

· Increased engagement, interactivity, and sharing of public education resources

· Increased knowledge of the risks of tobacco product use

· Increased perceived risks of tobacco product use

· Decreased appeal of tobacco products

· Reduced susceptibility to tobacco product initiation

· Reduced experimentation with tobacco products

· Reduced initiation of tobacco products

· Changes in normative beliefs about tobacco product use

· Increased knowledge about the harms of tobacco product use

· Increased knowledge about the relative risk, or continuum of risk, of tobacco product use and evidence-based harm reduction techniques

· Increased self-efficacy to quit using tobacco products

· Increased motivation to quit using tobacco products

· Increased intention to quit using tobacco products

· Increased cessation or discontinuance of tobacco products

· Complete transitioning from a higher risk tobacco product to a lower risk tobacco product

· Significantly reducing use of a high-risk tobacco product

· Increased trust and perceived credibility of public education sources

· Increased dissemination of program strategies, resources, and findings

· Maintenance of expertise in the fields of media, marketing, and the tobacco use landscape

The campaign program’s effectiveness is measured through ongoing scientific outcome evaluations, media metrics, monthly assessments, and digital measurement that inform refinements and determine if campaign exposure is associated with positive changes in tobacco-related knowledge, attitudes, beliefs, and behaviors. Outcome evaluation study design and implementation is handled through a separate contract that is not part of this scope of work.

III. SCOPE

The purpose of this contract is to provide CTP with technical services to support a full range of public education activities. Such activities include planning, developing, producing, and delivering public education campaigns or programs that effectively reach intended audiences using proven and privacy-safe marketing tools. Further specifications will be defined at the Task Order level.

The Contractor shall provide comprehensive services for multiple public education campaigns targeting audiences as small as 10,000 people to as large as 100 million people, to include, but not limited to, financing and placing annual media buys up to or in excess of $100 million. CTP may also direct the Contractor to develop and implement additional public education campaigns, efforts, or activities to support other goals related to its regulatory authorities under the TCA.

The Contractor’s management responsibilities shall include all activities necessary to ensure the accomplishment of timely and effective support. The contract is inclusive of labor and Other Direct Costs (ODCs), both of which will be funded annually throughout the period of performance.

IV. TASK AREAS

The Contractor shall support the public education program by providing services in the following six task areas.

Task Area 1: Strategic Planning & Research The Contractor shall support the public education program by providing comprehensive planning, including (1) identifying goals and measurable objectives; (2) defining and researching targeted audiences; (3) developing audience-tailored messaging (4) exploring settings, channels, and activities to effectively reach targeted audiences; (5) identifying potential media vendors; (6) developing education strategies and partnership plans; (7) identifying emerging audience trends as it relates to tobacco product and media usage; (8) developing novel approaches for delivering tobacco education messaging in a changing tobacco product landscape; (9) under the government’s direction, coordinating with the campaign research (formative and outcome evaluation) Contractor; and (10) monitoring digital media trends to understand which channels, platforms, and tactics are most likely to reach key audiences.

Strategic Marketing Planning The Contractor shall develop marketing plans that contain the rationale for executing the public education program, measurable objectives, audience information, message and materials testing plans, strategy development, tactics, timetables, and work plans. Detailed marketing plans shall be based on research and reflect the latest science and trends in tobacco control, health communications, audience segmentation, dissemination, outreach, and digital media, and provide innovative and comprehensive strategies. Plans shall include strategies and tactics that are actionable and measurable as well as feasible for the FDA as a regulatory, science-based Government agency. The Contractor shall analyze and build upon the promising message areas identified through prior research and apply key findings to the development of new creative concepts. The Contractor shall have the ability to track and analyze relevant scientific literature. The Contractor shall ensure that characteristics, experiences, norms, values, behaviors, and beliefs of the intended audience are taken into consideration in the development of the strategy.

When developing strategic plans, the Contractor shall prepare:

· Supplementary materials (e.g., literature reviews, environmental scans and situation analyses of emerging tobacco products, and consumer behavior and trends)

· A slide presentation summarizing the plan, including the creative brief;

· A review and summary of formative campaign research and relevant tobacco control and health communication research and how those research insights inform the strategic plan; and

· If applicable, details on any future research needed to understand intended audience and messaging approaches.

Formative Research The Contractor may be asked to conduct research on tobacco products, including executing literature reviews, intended audience analyses and message and creative development. Additionally, the Contractor may be asked to propose and execute additional formative research in support of new and existing advertising concepts that guide strategies, message development, and implementation for FDA’s tobacco public education campaigns and programs.

Formative research may include online and in-person research, such as focus groups, in-depth individual interviews, online panels, key informant interviews, or other methods, including strategic insights research, creative concept research, and quantitative copy testing. Other research and testing for the program may include digital measurement tests, surveillance on emerging digital media and use pattern trends, social media monitoring, and ongoing media tracking, but will not include designing or implementing large or long-term outcome evaluation studies, which is handled through a different contract.

The Contractor shall use the results of any formative research to develop rough cut or draft materials to quantitatively test with intended audiences using validated measures (e.g., Perceived Effectiveness Scale) to ensure believability, comprehension, relevance, and to identify any potential unintended consequences.

If directed to conduct formative research, the Contractor shall consult with the COR to identify information collections that require Institutional Review Board (IRB) and/or Office of Management and Budget (OMB) review and clearance. The Contractor shall coordinate with CTP scientific staff to prepare the IRB and/or OMB clearance packages for data collection as necessary. The Contractor shall provide all the applicable information necessary for the IRB/OMB packages, including surveys or discussion guides, stimuli, informed consent forms, incentives, and recruitment methods. The timeline for securing these packages may take more than one year and preparations shall begin well in advance of the anticipated data collection dates. If directed, the Contractor shall also be prepared to execute all aspects of the research including study recruitment, data collection, records management, data analysis, and reporting.

To conduct research on behalf of the Government, the Contractor shall ensure they have an approved assurance, also known as a Federal-wide Assurance (FWA) and that all IRBs designated under the FWA are registered with the Department of Health and Human Services’ Office for Human Research Protections. For more information on the assurance approval process and IRB(s), visit: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/index.html.

The Contractor shall engage professional, scientific, and/or subject matter experts (SMEs) for the purpose of contributing new information and insights to the public education program. This may include identification and recruitment, interviews, meetings, or other engagement activities, such as panel discussions, with SMEs as directed by the COR. A report summarizing SME discussions and recommendations shall be provided to the COR upon request. In addition, the Contractor shall work closely with other Government and non-Government organizations, as directed by the COR, with which the Office may rely upon for additional expertise.

The Contractor shall provide strategic planning and research for the following campaigns, efforts, or activities, including:

· Youth Tobacco Prevention:

· Strategic planning and research for youth tobacco prevention efforts includes support for “The Real Cost” campaigns or other youth-focused campaigns. Youth prevention may also include activities such as stakeholder outreach, print or digital materials development, or education for secondary audiences who influence youth, such as adults. These efforts may focus on cigarettes, e-cigarettes, nicotine pouches, or other tobacco products as needed. The Contractor may be asked to conduct one round of qualitative research or quantitative research and one round of consultations with SMEs.

· Adult Tobacco Education:

· Support strategic planning and research activities for adult-focused efforts including cessation education, harm reduction or relative risk education, and nicotine education. The Contractor may be asked to conduct one round of qualitative research or quantitative research and one round of consultations with SMEs.

· Consumer Education Related to Product Authorization:

· Support strategic planning and research activities, message development, digital tool development, and/or implementation activities to support consumer education and engagement regarding FDA-authorized tobacco products.

Additional work may be required to develop new audiences, strategies, tactics, partnerships, or other yet to be identified activity.

Creative Brief The Contractor shall develop creative briefs to build upon intended audience insights for current campaigns and other efforts or activities, as directed by the COR. Creative briefs shall include audience insights on demographics, psychographics, and other characteristics and creative considerations such as messaging approaches, tone, and branding.

The Contractor shall carefully consider the constraints of working with the Government when determining the appropriate balance between creativity and appropriate communications tactics for a regulatory, science-based public health agency. Messaging shall focus on key areas of tobacco regulatory authority including addiction/loss of control, negative health consequences/health benefits of quitting, and the harmful and potentially harmful constituents (HPHCs) in tobacco products; additional messaging areas may be provided.

Task Area 2: Creative Development & Production Based on approved strategic marketing plans, formative research summaries, and creative briefs, the Contractor shall develop materials to support the public education program, which may consist of traditional advertising, social media, digital media, collateral materials, and partnerships. The Contractor’s capacity to take complex science-based information and convey it in the most understandable and salient way to intended audiences, such as youth or adults who use tobacco, and intermediaries, such as partners and community-based groups, is critical.

In the creative development/production process, the Contractor shall conduct activities, including:

· Ensure the characteristics, experiences, norms, values, behaviors, and beliefs of the intended audiences, and relevant other information, are taken into consideration in the development and execution of creative advertising;

· Ensure all messages and materials are consistent with existing audience insights, targeting and brand characteristics and take into consideration the previously developed and distributed campaign creative;

· Ensure all productions adhere to mutually agreed upon guidelines established with the Government;

· Develop and implement a brand management strategy that may include partnership collaborations and collateral materials;

· Ensure all messages and materials are consistent with CTP authority under the Tobacco Control Act;

· Develop new creative concepts based on the approved marketing plan, formative research findings, and creative brief.

The Contractor shall ensure all materials are prepared in a format consistent with HHS and FDA requirements and have all necessary approvals from HHS and FDA before being accepted as final deliverables. Files shall be Macintosh platform in Adobe Creative Cloud (CC) applications, such as InDesign, Photoshop, and Illustrator. File format will depend on the output, but could possibly be indd, ai, png, gif, jpeg, tiffs, and pdfs. Video and radio master files of filming/recording shall be provided in a format acceptable for future media placement on digital and streaming platforms. Digital media/website finalized files shall be provided for posting on the Internet in format acceptable for future media placement.

The Contractor shall ensure that all materials developed for electronic and online distribution comply with Section 508 of the Rehabilitation Act; and that all necessary federal, HHS and FDA terms of services, privacy, security and other best practices and legal requirements are completed prior to developing creative materials for any new dissemination channels (e.g., new social media sites).

The Contractor shall negotiate talent usage rights as necessary, and procure the proper ad usage rights for placement, to include that all talent, images, and other materials procured are negotiated to include buy-out rights as available. The Contractor may be asked to ensure that all advertisements are made available to be localized by groups qualified by FDA and allow for the insertion of the qualified organization’s name and contact information in the advertisement.

As requested, the Contractor shall provide to the COR, in accordance with the delivery schedule, all finalized creative materials, including supporting paperwork regarding usage rights, contacts for renewing usage rights, and signed talent release forms. Creative materials files shall include print and collateral materials, including all the native graphic electronic files and all supporting high-resolution artwork, fonts, images, and illustrations used to create the product.

The Contractor shall create video (including online video pre-roll, over-the-top (OTT), connected TV (CTV) and social media platforms), audio (including streaming radio), and content for social media channels/platforms for tobacco public education campaigns. Any product of this type must be prepared in a format consistent with HHS and FDA requirements and must obtain the necessary approvals from HHS and FDA before they are accepted as final deliverables. Prior to production, the Contractor shall draft scripts and storyboards and advise on other components such as casting, location, wardrobe, etc.

Within FDA and Federal printing guidelines, the Contractor shall support campaign printing needs. This shall include preparing all necessary paperwork and monitoring print jobs through to completion. As required, the Contractor shall support campaign printing through the Government Printing Office.

Specifically, the Contractor shall develop the following creative:

· Youth tobacco prevention:

· Up to six rounds of creative development and production that may include content for online video, radio, web, social media, or collateral materials. All talent costs, including residuals, affiliated with these productions shall be included as well.

· Adult tobacco education:

· Creative development and production activities will support adult cessation and harm reduction education resources for consumers and public health stakeholders. Activities may include up to three rounds of creative development that includes production of collateral materials and digital content. All talent costs, including residuals, affiliated with these productions shall be included as well.

· Any future campaigns, efforts or activities as requested by the COR

Task Area 3: Implementation

Strategic and Tactical Paid Media Plans The Contractor shall develop and implement strategic and tactical media plans for each campaign and program, where relevant. The detailed annual media strategy and tactical media plans for each campaign shall include opportunities for media buys, purchased by the Contractor on behalf of the Government, to ensure appropriate exposure of intended audiences to campaign messages and content. Media plans shall demonstrate in-depth knowledge of the unique media consumption habits of intended audiences via rigorous market intelligence research; recommendations on how to reach key audiences through media plans; provide documentation of how the buys support campaign objectives; document estimated reach, frequency, and cost; and include participation in any available network upfront media opportunities designed to deliver maximum reach, frequency, and effectiveness at the lowest cost to the Government. Plans shall also include suggestions for enhancing media buys with value-added assets, including influencer engagement strategies, custom placements, etc., while also taking advantage of the latest programming, platforms, and technologies. Media plans shall also detail how to extend media reach and frequency through events or other novel paid media programs. Media plans shall maximize audience exposure to messaging and content at the greatest cost savings possible.

In crafting plans, the Contractor shall take into consideration the fragmented and evolving media landscape and inventory availability, like streaming video and new digital and social media platforms as well as new and emerging tactics, as appropriate to meet outreach goals. The Contractor shall recommend any new media opportunities with the potential to reach intended audiences with education content more effectively and efficiently than previous or existing media buys, as determined by media consumption patterns among the intended audience.

Since there may be multiple campaigns in market, media coverage may overlap. To address this, the Contractor shall also provide documentation describing in detail how they will coordinate all paid media efforts to avoid market saturation, ensure each intended audience is receiving the appropriate message, and maximize cost efficiencies. Contractor will be asked to develop media plans that decrease the chances of viewership among specific populations to avoid message exposure among unintended audiences.

The contractor shall also develop and implement, as directed by the COR, annual strategic and tactical media plans for:

· Youth tobacco prevention, such as “The Real Cost” campaigns; and

· Adult cessation/relative risk or harm reduction education

· Any future campaigns, efforts or activities as requested by the COR

In alignment with contract objectives, the Contractor shall fully support FDA in its efforts to gain the greatest efficiencies in its use of paid and owned media. Additionally, the Contractor shall clearly communicate value added and amplification opportunities based on the paid media buy to the government, including ancillary costs, estimated level of effort to bring the opportunity into the market, and a risk/benefit analysis of the opportunity.

Social Media and Web Implementation The Contractor shall maintain and optimize implementation of the campaign programs’ social media, mobile and web activities including, but not limited to, existing social media platforms such as Facebook, X, YouTube, Instagram, Snapchat, and emerging platforms; mobile applications; texting programs; and user-centered websites. The Contractor shall ensure social media activities align with overarching paid media strategies.

The Contractor shall research, develop, and implement social media activities including, but not limited to, the creation and implementation of social media content, features, and tools. Social media content should be based on approved strategic and creative briefs and should, unless directed otherwise, align with flagship campaign ads and messaging ecosystems. As directed by the COR, the Contractor shall develop and maintain digital policies, user-centric content, navigation, and architecture for all social media campaign products.

The Contractor shall provide website content and design support for various campaigns, efforts or activities, which may include developing science-based content and usability-validated design; technical development support, and implementing changes as directed by the COR. At the COR’s direction, the Contractor shall also work collaboratively with other CTP Contractors or other Federal government partners on technical aspects of campaign website development and hosting. The Contractor is encouraged to propose web activities that align with campaign goals, such as content syndication, widgets, blogs, data visualization, virtual reality, or others. All websites should be optimized for mobile use, unless otherwise directed by the COR.

As directed by the COR, the Contractor shall conduct usability tests to identify ways to improve public education social media and web communication products. For all usability tests, the Contractor shall recruit participants; draft scenarios; develop prototypes (if needed); design usability test plans, including evaluation measures such as performance and preference metrics; conduct debriefing sessions to discuss findings and implementing solutions and prepare a report. The report shall include raw data from participants, user metrics, and recommended fixes or implementations based on the data to address issues of navigation, usability, or content. Depending on the size and scope of the testing, IRB and OMB clearance may be required.

Specific requirements for social media and web implementation include:

· Youth tobacco prevention:

· Social media and web activities shall support “The Real Cost” campaigns or other tobacco education campaigns, efforts or activities. Activities may include up to one round of website usability testing to gather intended audience insights on new website design and functionality. Provide support for website and social media management requirements including, but not limited to, community management fees; website hosting and development costs; and analytics and reporting tools.

· Adult tobacco education:

· Provide support as needed for website and social media management requirements including, but not limited to, community management fees; website hosting and development costs; and analytics and reporting tools.

· Any future campaigns, efforts or activities as requested by the COR

Strategic Partnership and Outreach At the direction of the COR, the Contractor shall support the creation and maintenance of positive partner relationships for various public education efforts, events, and activities. The Contractor may be asked to develop a partnership plan to work with appropriate partners to deliver messages, collateral materials, and extend the reach to the designated intended audience. The Contractor shall develop a method for assessing the needs of interested organizations, coordinating engagement with those organizations, developing associated materials, and providing technical assistance as appropriate. The Contractor shall provide expertise and experience to create and maintain relationships with partners. Where applicable, broader media planning should strategically align with partnership-driven outreach and reinforce paid media messaging to maximize public education campaign or program impact.

The Contractor may also be asked to develop collateral materials, such as print or digital materials, to educate various audiences about tobacco products. This may include providing 508 compliant, print-ready files to the Government or coordinating with other Contractors who provide web or printing services.

The Contractor may be asked to create materials to promote the public education program or to communicate about tobacco products, such as conference presentations, manuscripts, blog posts, white papers, webinars, PowerPoint decks, fact sheets, templates, videos, web content, or other types of content that communicate information about the public education program and/or tobacco products. Content and materials should support integration across paid, earned, and owned media efforts, where applicable. This work may also require strategic partnerships with public health organizations and partners.

At the direction of the COR, the Contractor shall coordinate with other government Contractors on earned and owned media content and the Campaign Outcome Evaluation Contractor as necessary.

Task Area 4: Measurement, Performance and Refinement The Government requires detailed monitoring and reporting of public education program performance and the ability to measure messaging impact with the intended audience on a routine basis to help inform strategic planning and future development, implementation, and ongoing campaign optimization.

Performance Monitoring and Reporting The Contractor shall develop a reporting strategy and/or framework that details how the Contractor will deliver timely, relevant, and actionable data about ad and campaign performance to the Government. The Contractor shall then deliver reports in accordance with the agreed upon strategy/framework and make changes as requested by the COR. Reports shall include recommendations for program optimization, as needed.

The Contractor shall conduct social media monitoring on topics related to tobacco product use, brand use, audience trends, behavior change, and other topics of interest to the Government as directed by the COR.

Additionally, the Contractor may be asked to conduct media tracking activities, including the development of digital tests to understand digital metrics and impacts of digital media on audience exposure, awareness, and beliefs about tobacco products. The Contractor shall have significant digital media expertise to provide digital media strategies and design tests and measurement plans to make recommendations to improve digital measurement on campaigns and optimize digital performance. The Contractor must be skilled in digital measurement for paid ads across a variety of digital media as well as for other placement types, including events, out of home marketing, and novel executions. The Contractor shall maintain internal quality control processes to ensure impression data are thoroughly reviewed for accuracy, completeness, and consistency prior to timely submission to the Government.

The Contractor shall provide CTP's Outcome Evaluation Contractor with reports on media delivery for the campaign as directed by the COR.

Marketing and Media Intelligence To support campaign strategic planning and refinement in the changing tobacco landscape, the Contractor shall provide ongoing marketing and media trend analysis and expert consultation to FDA/CTP campaign managers. The Contractor shall monitor and analyze tobacco industry marketing tactics, messaging strategies, and channel utilization to inform campaign counter-marketing strategies and identify emerging threats.

The Contractor shall provide quarterly briefings to campaign managers on emerging marketing trends, platforms, and audience targeting approaches that may impact youth tobacco prevention campaign effectiveness. The Contractor shall deliver expert consultation and responses to campaign manager questions regarding marketing and media trends, tactics, and competitive landscape analysis.

Campaign Refinement and Optimization Based on evaluation data obtained from CTP's Outcome Evaluation Contractor, as well as ongoing campaign tracking and reporting activities conducted by the campaign Contractor, the campaign Contractor shall execute the following tasks as required by the COR:

· Refine strategies, channels, and tactics to enhance access to and receptivity of targeted audience segments; and

· Refine and optimize content to ensure that the public education message in-market continues to be relevant for its intended audiences.

Task Area 5: Communication and Coordination with the Government

Conferences The Contractor shall support FDA in promoting the tobacco public education program to stakeholders and public health practitioners at conferences, through award submissions, and other opportunities. This may include developing abstracts, posters and presentations, including supporting materials or videos, for stakeholders at conferences or other events as directed by the Government. The Contractor may be asked to attend conferences and/or present at conferences on behalf of the Government. If attending a conference on behalf of the Government, the Contractor shall prepare a detailed report summarizing learnings from relevant sessions. All conference support is contingent on approval from the Government.

Risk Management The Contractor shall develop and maintain a detailed Risk Inventory as part of the Contractor’s process for identifying, addressing, and preventing key public education program risks throughout the entire period of performance.

Travel The Contractor may be asked to travel for strategic and creative concept research, production, or coordination meetings with the government or external stakeholders (such as conferences). In addition, all task-related travel shall be accounted for including, but not limited to, research, creative production, and campaign implementation.

The Contractor will submit a travel justification for each trip. The travel justification shall include the purpose of the travel, the origin and destination, number of travelers, as well as estimates for transportation, M&IE, and per diem costs. A proxy location may be used for the purposes of estimating the travel costs when the location is unknown.

All travel will occur at the written direction of the COR and must be approved in advance. Travel shall adhere to the Federal Travel Regulations. Information on Federal Travel Regulations and current per diem rates may be obtained at the following website:

https://www.gsa.gov/travel/plan-book/per-diem-rates

Coordination with the Government The Contractor shall be responsible for the overall management and coordination with the Government on all activities within the scope of this contract. As such, the Contractor must ensure integration and coordination of all campaign elements under the technical direction of the COR.

The Government requires exceptional budget planning, execution, and reporting capabilities to ensure detailed tracking of expenditures across multiple public education initiatives, including the ability to provide regular reports accounting for labor and ODC billing by project and across all initiatives, as well as reporting across product types or intended audiences.

The Contractor shall:

· Participate in a kick-off meeting at FDA facilities or virtually at the COR’s discretion. The Government shall work with the Contractor to determine a mutually agreed-upon date and time no later than fifteen (15) business days after contract award. The purpose of the meeting will be to introduce the key Government and Contractor staff and to review the scope and requirements of the contract. The Contractor shall provide comprehensive meeting minutes to the COR within five business days after the kick-off meeting.

· Maintain continuous and effective communication, such as acknowledgement within 1 business day to emails and requests for phone calls, with the FDA Center for Tobacco Products, Office of Health Communication and Education (OHCE) and the Office of Acquisitions and Grants Services (OAGS) during the period of performance.

· Consult with FDA staff at FDA facilities or virtually as determined by the COR, including participating in coordination meetings or briefings with other FDA Contractors regarding major deliverables or milestones.

· Notify FDA of any changes to the staffing plan on a monthly basis, particularly changes to new hires, shifts in staff responsibilities, and list of departing staff. In addition to the monthly reporting requirement, the contractor must notify the COR within three to five business days in advance of any staff departing the contract. Any changes to key personnel must be submitted in writing to the Contracting Officer and COR at least 30 days prior to the personnel leaving, whenever possible. When it’s not possible, notification must occur as soon as practicable. The notification must identify the proposed replacement and include their resume. See HHSAR clause 352.237-75 (Key Personnel).

· Schedule and participate in weekly calls on each campaign with FDA and provide the COR and Project Leads, on a weekly basis, a written status report after the weekly meeting outlining current and upcoming activities related to the contract such as pending decisions, action items, and accomplishments.

· Provide monthly progress report to the COR, including a written status report detailing work and activities conducted to date for each individual campaign or effort. Ensure that time billed in monthly labor invoices correlates to work completed in the monthly progress report. Information shall also include, but not be limited to:

· Work completed over the last month

· Major project milestones

· Deliverables submitted and dates completed

· Provide quarterly expenditure and budget reports to the COR. Expenditure reports shall include estimates and actualized costs for all activities including labor and ODCs.

· As requested by the COR, deliver comprehensive project completion report with recommendations for next steps, including “lessons learned” and recommendations for future public education efforts.

· At the request of the COR, the Contractor shall work collaboratively with other federal partners and CTP Contractors to facilitate office and Center-wide programs and plans. The Contractor may need to communicate with other Contractors and staff performing related work in support of the Office including formative research and outcome evaluation. This may include participation in milestone meetings, strategy sessions, or other types of meetings. In some instances, the work product of one Contractor may need to be provided to another Contractor as Government-furnished information to facilitate program success. Contractors are advised that any technical direction must come from the COR. Other CTP contractors may include but are not limited to CTP’s Division of Regulatory Communications Contractor, CTP’s Campaign Outcome Evaluation Contractor, and CTP’s Website Hosting Contractor.