Amend1_RFP_FDA-SOL-1230974.pdf

RFP Number: FDA-SOL-1230974 The Center for Tobacco Products Public Education Campaign

Table of Contents

1. Solicitation Information

1.1 Background

1.2 Notice of Combined Synopsis/Solicitation

1.3 Notice of FAC

1.4 Notice of NAICS/Set-Aside

2. Description of Requirements/Statement of Work

2.1 Introduction

2.3 Objectives

As a whole, the campaign program seeks to achieve the following objectives across a range of target audiences:

• Increased awareness of and receptivity to campaign messages

• Increased knowledge of health risks associated with tobacco product use

• Increased perceived risks of tobacco product use

• Decreased appeal of tobacco products

• Reduced susceptibility to tobacco initiation

• Positive changes in normative beliefs about tobacco product use

• Increased self-efficacy to quit using tobacco products

• Increased motivation and intention to quit using tobacco products

• Decreased intention to initiate use of tobacco products

2.4 Scope

2.5 Task Areas

Task Area 1: Strategic Planning & Research Task Area 2: Creative Development & Production Task Area 3: Campaign Implementation

3.3 Strategic Partnerships and Outreach

Transition Transition-In Transition-out

3. Contract Type and Minimum/Maximum Amounts

3.1 Contract Type

3.2 Minimum and Maximum Contract Value

4. Pricing and Ordering of Services

4.1 Overview of Pricing Schedule

4.2 Pricing Terms

4.3 Ordering

4.3.1. Ordering Procedures

4.3.2. Pricing of Orders

5. Deliverables and Acceptance

5.1 Deliverables

5.2 Inspection and Acceptance

6. Contract Administration Data

6.1 Period of Performance

6.2 Place of Performance

6.3 Hours of Operation

6.4 Observance of Government Closures

6.5 Contracting Officer (CO)

6.6 Contract Specialist (CS)

6.7 Contracting Officer’s Representatives (CORs)

6.7.1. Contracting Officer’s Representative’s Authority:

6.7.2. IDIQ Contracting Officer’s Representative (IDIQ COR):

6.7.3. Task Order Contracting Officer’s Representative (TO COR):

6.8 Task Order Project Managers (TO PMs):

6.9 Technical Direction

6.10 Invoicing procedures

6.11 Government Furnished Property (GFP)

6.11.1. Government Furnished Information

6.11.2. Government Furnished Data

6.12 Post-Award Evaluation of Contractor Performance

7. FDA-Specific Contract Requirements

7.1 Non-Personal Services and Inherently Governmental Functions

7.2 Identification of Contractor Employees

7.3 Contractor Personnel Security Clearance Standards and Residency Requirements (Oct 2017) .. 34

7.4 Security Requirements for Procurements Requiring Information Security and/or Physical Access

Security

7.5 Accountability and Security

7.6 Briefings

7.7 Organizational Conflicts of Interest

7.8 Disclosure of Information

7.9 Additional Security and Confidentiality Requirements

7.10 Travel

7.11 Other Direct Costs

7.12 Reporting Matters Involving Fraud, Waste, and Abuse

7.13 Contractor Conformance with Applicable Laws, Regulations, Policies, and Standards

7.14 Contractor Advertising of Contract Award

7.15 Site Visits

8. Contract Clauses

8.1 FAR 52.252-2 – Clauses Incorporated by Reference (Feb 1998)

8.2 HHSAR Clauses Incorporated by Reference

8.3 FAR Clauses in Full Text

FAR 52.216-18 – Ordering (Aug 2020) FAR 52.216-19 – Order Limitations (Oct 1995) FAR 52.216-22 – Indefinite Quantity (Oct 1995) FAR 52.222-42 – Statement of Equivalent Rates for Federal Hires (May 2014) FAR 52.217-8 – Option to Extend Services (Nov 1999) FAR 52.217-9 – Option to Extend the Term of the Contract (Mar 2000) FAR 52.212-5 – Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Oct 2020)

8.4 HHSAR Clauses in Full Text

HHSAR 352.237-75 – Key Personnel (Dec 2015) HHSAR 352.239-74 – Electronic and Information Technology Accessibility (Dec 2015)

9. Solicitation Provisions

9.1 Solicitation Provisions

9.1.1. FAR 52.252-1 – Solicitation Provisions Incorporated by Reference (Feb 1998)

9.1.2. FAR 52.216-1 – Type of Contract (Apr 1984)

9.2 Offeror Representations and Certifications

FAR 52.212-3 – Offeror Representations and Certifications – Commercial Items (Aug 2020) ... 64 FAR 52.204-16 – Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.209-7 – Information Regarding Responsibility Matters (Oct 2018)

10. Proposal Instructions

10.1 Solicitation Inquiries and Questions

10.2 Proposal Submission Due Date

10.3 Proposal Format and Instructions

10.3.1. General Format of Proposals

10.3.2. Cover Letter

10.3.3. Volume I – Technical Factor 1 - Conflict of Interest (Pass/Fail)

10.3.4. Volume II – Technical

10.3.9.1 Business Proposal – No Page Limitation

10.4 General Proposal Information

10.4.1. Communications Prior to Contract Award

10.4.2. Release of Information

10.4.3. Preparation Costs

10.4.4. Restrictions on Disclosure

11. Basis for Award and Evaluation Factors

11.1 FAR 52.212-2 – Evaluation-Commercial Items (Oct 2014)

11.2 Evaluation Factors

11.2.1.1 Technical Evaluation

11.2.2.3 Price Evaluation

11.3 Responsibility

12. List of Attachments

1. SOLICITATION INFORMATION

1.1 BACKGROUND

To protect the public's health, the 2009 Family Smoking Prevention and Tobacco Control Act (TCA) gave FDA the authority to regulate tobacco products and educate the public about the dangers of tobacco use. FDA’s authority extends to all tobacco products, including, but not limited to, cigarettes, cigarette tobacco, roll-your-own, smokeless tobacco, e-cigarettes, cigars, hookah, heat-not-burn, and pipe tobacco. FDA’s authority also extends to reviewing and approving new tobacco products before they can be marketed and sold to consumers. Tobacco use is the leading preventable cause of disease, disability, and death in the U.S., resulting in more than 480,000 deaths each year. Despite this, each day in the U.S.

more than 4,700 youth and young adults aged 12-25 smoke their first cigarette. If these current trends continue, an estimated 5.6 million children alive today will die prematurely as a result of smoking.

Additionally, in 2020 3.6 million youth reported using e-cigarettes within the past 30 days. Youth e-cigarette usage rates have decreased from 2019 but usage remains high and there has been a significant increase in youth usage of disposable e-cigarettes and flavored products; 8 out of 10 youth e-cigarette users report using a flavored product. With the continued high rates of youth usage of Electronic Nicotine Delivery Systems (ENDS), FDA is currently prioritizing ENDS prevention messaging to youth.

To reduce the public health burden of tobacco use in the U.S. and to educate the public—especially young people—about the dangers of tobacco product use, the FDA Center for Tobacco Products (CTP) has developed and is implementing public education campaigns that directly support our mission.

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, the paid media campaigns of today must navigate a fragmented, competitive media environment to find and motivate hard-to-reach audiences who aren't particularly interested in the topic of tobacco.

The purpose of this requirement is to provide CTP with a mechanism to obtain technical services supporting a full range of communications activities, including: conducting formative research, planning, developing, producing, and delivering consumer-based communication programs; strategies and materials for multiple paid media multichannel public health education campaigns; applying unique combinations of geographic, demographic, psychographic, socioeconomic and cultural factors to target both national and niche audiences.

The campaign program’s website is http://www.fda.gov/tobaccocampaigns.

It is the FDA’s intent to award an indefinite delivery-indefinite quantity (IDIQ) contract, with a performance period of five (5) years. The Government anticipates awarding an IDIQ contract with a ceiling of $900,000,000.00, and a guaranteed minimum of $3,000.00.

1.2 NOTICE OF COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation http://www.fda.gov/tobaccocampaigns will not be issued. This is a request for proposal (RFP) for commercial items IAW the procedures of FAR Part 12 – Acquisition of Commercial Items, in conjunction with FAR Part 15 – Contracting by Negotiation.

1.3 NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2021-02, effective October 23, 2020.

1.4 NOTICE OF NAICS/SET-ASIDE

This requirement is issued full and open. The associated North American Industry Classification System (NAICS) code is 541810 (Advertising Agencies). Offerors must have an active registration in SAM.gov (https://beta.sam.gov/), with completed representations and certifications, by the close date of the solicitation. Proposals submitted by offerors without an active registration in SAM.gov will not be considered.

2. DESCRIPTION OF REQUIREMENTS/STATEMENT OF WORK

2.1 INTRODUCTION

To protect the public's health, the 2009 Family Smoking Prevention and Tobacco Control Act (TCA) gave FDA the authority to regulate tobacco products and educate the public about the dangers of tobacco use. FDA’s authority extends to all tobacco products, including, but not limited to, cigarettes, cigarette tobacco, roll-your-own, smokeless tobacco, e-cigarettes, cigars, hookah, heat-not-burn, and pipe tobacco. FDA’s authority also extends to reviewing and approving new tobacco products before they are allowed to be marketed and sold to consumers. Tobacco use is the leading preventable cause of disease, disability, and death in the U.S., resulting in more than 480,000 deaths each year. Despite this, each day in the U.S. more than 4,700 youth and young adults aged 12-25 smoke their first cigarette. If these current trends continue, an estimated 5.6 million children alive today will die prematurely as a result of smoking. Additionally, in 2020 3.6 million youth reported using e-cigarettes within the past 30 days.

Youth e-cigarette usage rates have decreased from 2019 but usage remains high and there has been a significant increase in youth usage of disposable e-cigarettes and flavored products; 8 out of 10 youth e-cigarette users report using a flavored product. With the continued high rates of youth usage of Electronic Nicotine Delivery Systems (ENDS), FDA is currently prioritizing ENDS prevention messaging to youth.

To reduce the public health burden of tobacco use in the U.S. and to educate the public—especially young people—about the dangers of tobacco product use, the FDA Center for Tobacco Products (CTP) has developed and is implementing a number of public education campaigns that directly support our mission. 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, the paid media campaigns of today must navigate a fragmented, competitive media environment to find and motivate hard-to-reach audiences who aren't particularly interested in the topic of tobacco.

https://beta.sam.gov/

The purpose of this requirement is to provide CTP with a mechanism to obtain technical services supporting a full range of communications activities, including: conducting formative research, planning, developing, producing, and delivering consumer-based communication programs; strategies and materials for multiple paid media multichannel public health education campaigns; applying unique combinations of geographic, demographic, psychographic, socioeconomic and cultural factors to target both national and niche audiences.

The campaign program’s website is http://www.fda.gov/tobaccocampaigns.

2.2 CTP Tobacco Public Education Campaigns

CTP’s public education campaign program was initiated in 2012 and has different efforts that target unique audiences at-risk for tobacco use. In CTP’s nearly 10 years of campaign development and implementation, there have been several changes in the tobacco control landscape, new FDA policies and laws, and shifts in consumer media channels and consumption of digital media. These changes have required CTP to adjust priorities and campaign strategies and to ensure successful implementation of best practices for public health campaigns. Some of these changes include, but are not limited to:

• Tobacco 21 legislation

• FDA guidance and policy on flavored tobacco products

• New and emerging tobacco products on the market

• Changes in consumer media consumption behaviors, especially for youth audiences

In December 2019, federal law increasing the minimum age to buy tobacco products from 18 years to 21 years went into effect. CTP is exploring how this change impacts current campaign audiences and marketing strategies for the Center’s public education program. CTP is investing in research to better understand audiences’ perceptions of how the new legislation may impact tobacco usage and how best to message to at-risk audiences. Research in this area is ongoing and will continue to be evaluated;

findings may be adapted or implemented into CTP’s campaigns and audience targeting approaches.

In January 2020, FDA guidance and enforcement policies went into effect to remove the unauthorized sale of flavored cartridge-based e-cigarettes from the market. This policy is meant to curb the dramatic increase in youth ENDS usage. CTP is exploring how this policy may impact usage and perceptions of flavored tobacco products among our target audiences. Ongoing research is being conducted to better understand these shifts and how they impact the campaign program and messaging approaches. This research and future research will be applied to develop audience-tested approaches for the campaigns.

As authorized by the TCA, FDA has regulatory authority overall tobacco products, including cigarettes, e-cigarettes, cigars, hookah tobacco, pipe tobacco, heat-not-burn products, and other emerging tobacco products that may become authorized for sale by FDA in the future. Through ongoing research, CTP is currently assessing how best to educate consumers about the risks associated with these different tobacco products and anticipates incorporating information about these products into future education efforts within the period of performance of this contract.

As the tobacco landscape has shifted with new laws, policies, and products on the market, the media environment has also changed significantly requiring CTP to adjust campaign strategies and implementation tactics. There has been a significant decline in broadcast television viewership in recent http://www.fda.gov/tobaccocampaigns years and a shift to digital streaming and other digital media platforms for content consumption and entertainment. This shift has been noticed across all campaigns but has impacted CTP’s ability to ensure sufficient reach and frequency levels of advertising to youth audiences. Traditionally, broadcast television has been the main driver in delivering the campaign advertising to 75 percent of the audience at least 15 times per quarter, which has been proven to be effective levels for public health campaigns to achieve behavior change. With lower teen viewership on broadcast television and the increased consumption of digital media, CTP is noticing that higher levels of reach and frequency across a combination of traditional and digital media channels is required to sustain and deliver adequate levels of messaging to achieve changes in tobacco-related knowledge, attitudes and beliefs. CTP anticipates further changes in the media landscape that will impact required reach and frequency levels of advertising to ensure effective campaigns. CTP is currently exploring different methodologies for how best to adjust paid media delivery strategies to meet the changing media landscape.

CTP plans to continue all the campaign efforts described below in the coming years and is seeking to obtain services from an agency with extensive and proven experience successfully providing a full-range of activities associated with researching, developing, producing, and delivering national public health campaigns and niche advertising and initiatives that are coordinated with both internal and external stakeholders at a national, regional, state, and local level. Additional campaign background materials can be found in Attachment A.

“The Real Cost” Youth Tobacco Prevention Campaign - FDA’s first national youth tobacco prevention campaign—“The Real Cost”—launched in February 2014 and seeks to educate at-risk youth about the harmful effects of cigarette use to prevent youth who are open to cigarette use from trying it and reduce the number of youth who move from experimenting with tobacco to regular use. Given the challenges with reaching at-risk youth, FDA developed “The Real Cost” brand to ensure campaign messages speak directly to teens in a straightforward, authentic and peer-to-peer manner. “The Real Cost” brand is grounded in science and uses compelling and personally relevant messages specifically designed to make the target audience hyperconscious of the risks of tobacco use by highlighting consequences that concern youth (e.g., loss of control due to addiction and cosmetic health effects). The goal of this approach is to clearly demonstrate that each use of tobacco comes with a “cost”. The brand is a personal call to action to teens, encouraging them to be in the know and understand the real costs of using tobacco.

The foundation and theoretical communications framework for “The Real Cost” campaign is grounded in proven behavior change theories, specifically the Theory of Reasoned Action and the Social Cognitive Theory. Grounding the campaign in this theoretic approach along with delivering relevant and relatable health consequence messages at effective media levels to teens has proven to be successful at changing behavior and tobacco-related knowledge attitudes and beliefs among the campaign target audience.

According to third-party research analysis from February 2014 to November 2016, “The Real Cost” cigarette campaign prevented up to 587,000 youth ages 11 to 19 from initiating smoking, half of whom might have gone on to become established adult smokers. By preventing these youth from becoming established smokers, the campaign will save the country more than $53 billion by reducing smoking-related costs, such as early loss of life, costly medical care, lost wages, lower productivity, and increased disability. That is more than $180,000 in savings for each of nearly 300,000 youth that would likely have become an established smoker. This is a savings of $180 for every dollar invested in the campaign proving that investing in public education can save lives and achieve significant returns.

https://www.sciencedirect.com/science/article/pii/S0749379719302806

Based on proven successes, CTP plans to continue “The Real Cost” campaign. Under the “The Real Cost” brand CTP has maintained a robust cigarette prevention campaign and further expanded efforts to focus on ENDS and other tobacco products. Due to the dramatic increase in youth initiation and usage, CTP is prioritizing “The Real Cost” ENDS campaign while still maintaining paid media to support cigarette prevention efforts. “The Real Cost” campaign will also provide prevention and fact-based messaging on other tobacco products, such as smokeless tobacco, across the campaign’s social media channels and website.

ENDS Campaign - In 2020, due to the dramatic increase in youth initiation and usage of ENDS, from 2017 to 2018 FDA launched a full-scale effort, “The Real Cost” ENDS prevention campaign in 2018. In 2020, youth ENDS usage rates decreased but still remain high with 3.6 million middle and high school students reporting past 30 day use of ENDS. These high usage rates required FDA to continue to invest heavily in the campaign and prevention efforts. “The Real Cost” ENDS campaign targets the over 10 million teens who have used e-cigarettes or are open to trying them and urges them to “know the real cost of vaping.”

Prior to launching “The Real Cost” ENDS campaign, CTP conducted multiple rounds of formative research to understand the teen audience and their perception of e-cigarettes and to develop compelling scientific messaging that will educate youth on the health consequences and risks of ENDS usage. CTP plans to continue conducting formative research to refine messaging and develop and test new messaging areas for future creative executions and implementation.

ENDS campaign activities to reach this target are currently being implemented nationally across the United States through a multi-channel approach that breaks through a very crowded media environment to surround teens with the campaign’s messages. The paid media plan includes advertising through traditional broadcast media such as television and radio ads, as well as advertising through a mix of other channels including, streaming audio and video, digital, cinema, and out-of-home (e.g., malls). “The Real Cost” also manages robust social media communities for youth on Facebook, Instagram, Tumblr, and Twitter and maintains a campaign-specific website, www.therealcost.gov/vapes.

FDA plans to continue paid media efforts and is investing heavily to ensure message delivery exceeds reaching 75 percent of the audience, 15 times per quarter. With the fragmented media landscape and decline in traditional advertising tactics, it is essential that CTP deliver the maximum amount of messaging to prevent further youth ENDS usage and initiation. FDA plans to continue implementation of ENDS campaign at high media levels and will continue research activities to develop compelling messaging for the audience.

“The Real Cost” ENDS campaign is currently under a longitudinal outcome evaluation being administered by a separate research vendor. This evaluation will determine the campaign’s impact on tobacco-related knowledge, attitudes and beliefs around ENDS.

Cigarette Campaign - Nearly 10 million at-risk general market youth ages 12-17 are open to smoking or are already experimenting with cigarettes (i.e., smoked fewer than 100 cigarettes in their lifetime).

These at-risk youth are particularly challenging to reach as many of them do not consider themselves to be smokers, do not believe they will become addicted, and are not particularly interested in the topic of tobacco. Additionally, they are more likely to live chaotic, stressful lives due to factors such as socioeconomic conditions; be exposed to smoking by friends and family; and use tobacco as a coping mechanism or a way to exert control or independence.

https://www.facebook.com/KnowTheRealCost/ https://www.instagram.com/therealcost/ http://knowtherealcost.tumblr.com/ https://twitter.com/knowtherealcost http://www.therealcost.gov/

Campaign activities to reach this target are currently being implemented nationally across the United States through a multi-channel approach, combining traditional and digital advertising to break through the crowded media environment. The paid media plan includes advertising through traditional broadcast media such as television and radio ads, as well as advertising through a mix of other channels including, streaming video, digital, cinema, and out-of-home. “The Real Cost” also manages robust social media communities for youth on Facebook, Instagram, Tumblr, SnapChat, TikTok and Twitter and maintains a campaign-specific website, www.therealcost.gov.

“Fresh Empire” Multicultural Youth Tobacco Prevention Campaign - In October 2015, FDA launched a national public education campaign to prevent and reduce tobacco use among multicultural youth.

Approximately 4.9 million multicultural youth are open to smoking or are already experimenting with cigarettes (i.e., have smoked fewer than 100 cigarettes in their lifetime), highlighting a critical need for youth tobacco prevention efforts targeted to this at-risk audience. “Fresh Empire” shares its messages through a variety of interactive marketing strategies, including the use of paid media, such as broadcast television, radio, streaming video and audio, digital advertising and paid social media. The campaign also engages with the audience through multiple social media platforms such as Facebook, Instagram, Twitter, SnapChat, TikTok, and a campaign-specific website, www.freshempire.gov. CTP is currently analyzing outcome evaluation results for “Fresh Empire.”

CTP intends to continue investing in youth prevention and is conducting research to explore the next phase of campaign development, including potentially messaging on other tobacco products, such as little cigars and cigarillos (LCCs). Current and ongoing research will help CTP better understand the audience’s perceptions on other tobacco products and will be used to develop a new strategic approach and implementation strategy for reaching at-risk youth, including multicultural audiences.

“Every Try Counts” Adult Cessation Education Campaign - In January 2018, FDA launched “Every Try Counts,” the agency’s first adult smoking cessation campaign. Despite evidence that 2 out of 3 adult smokers have a desire to quit, data show that of those who made a quit attempt, very few succeed.

Research suggests it often takes smokers multiple quit attempts to achieve long-term cessation. The objective of the campaign is to motivate smokers to both increase the frequency of their quit attempts and decrease the time between attempts to get them closer to quitting for good. During the first two years of the campaign, out of home and digital advertisements were placed in select U.S. counties with high adult smoking rates. In 2020, “Every Try Counts” expanded to a national, fully integrated digital campaign to reach a larger audience of smokers. CTP is analyzing data to better assess how the changing tobacco landscape has impacted perceptions of quitting among adult cigarette smokers. CTP plans to continue some level of adult cessation messaging and develop content based on the audience’s quitting experience. Additionally, CTP is exploring different approaches to develop tailored messaging for sub-populations, such as young adult and LGBTQ+ smokers.

American Indian/Alaska Native Tobacco Use Prevention Campaign - FDA is developing a tobacco prevention campaign designed to reach American Indian and Alaska Native (AI/AN) youth, ages 13-17, who are at-risk for using e-cigarettes and cigarettes. There are roughly 400,000 AI/AN teens in the United States, and more than half are at-risk for tobacco use. Additionally, studies show that AI/AN youth initiate tobacco use at an earlier age than their non-AI/AN peers. FDA is conducting multi-phase formative research with the target audience to better understand tobacco product usage and identify promising messaging approaches for campaign implementation.

https://www.facebook.com/KnowTheRealCost/ https://www.instagram.com/therealcost/ http://knowtherealcost.tumblr.com/ https://twitter.com/knowtherealcost http://www.therealcost.gov/ https://www.facebook.com/FreshEmpire/ https://www.instagram.com/freshempire/ https://twitter.com/freshempire http://www.freshempire.gov/

The AI/AN campaign is expected to launch in 2021. In order for the campaign to be effective, FDA recognizes the importance of working closely with Native stakeholders to inform the campaign strategy, messaging, and implementation plan. The campaign development process will continue to apply a careful, community-based approach that acknowledges the sovereignty and cultural norms among the AI/AN community.

2.3 OBJECTIVES

CTP’s Tobacco Education Campaign Program seeks to prevent and reduce tobacco use among at-risk and underserved populations with unique combinations of geographic, demographic, psychographic, socioeconomic, and cultural factors. Since a critical factor in reducing tobacco use is to produce and maintain high levels of campaign awareness of effective messages with the target population, priority campaigns would need to exceed reaching 75 percent of the target audience, more than 15 times a quarter. With the fragmented media landscape, the reduction in viewership on traditional broadcast television, and the rise in digital media consumption, CTP recognizes it is likely that higher levels of reach and frequency are required to achieve sustained audience awareness through paid media and to drive positive change in tobacco-related knowledge, attitudes and beliefs.

The campaign program’s effectiveness is measured through ongoing outcome evaluations 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.

As a whole, the campaign program seeks to achieve the following objectives across a range of target audiences:

• Increased awareness of and receptivity to campaign messages

• Increased knowledge of health risks associated with tobacco product use

• Increased knowledge of the risks of different tobacco products

• Increased perceived risks of tobacco product use

• Decreased appeal of tobacco products

• Reduced susceptibility to tobacco initiation

• Reduced experimentation with tobacco products

• Positive changes in normative beliefs about tobacco product use

• Increased self-efficacy to quit using tobacco products

• Increased motivation and intention to quit using tobacco products

• Decreased intention to initiate use of tobacco products

2.4 SCOPE

The purpose of this contract is to provide the FDA Center for Tobacco Products with a mechanism to obtain technical services supporting a full range of communications activities. Such activities include planning, developing, producing, and delivering consumer-based messaging, strategies, and materials for multiple multichannel public health education campaigns targeting both national and niche audiences using unique combinations of geographic, demographic, psychographic, socioeconomic, and cultural factors. The Contractor shall provide comprehensive campaign services for multiple public education campaigns targeting audiences as small as 400,000 people to as large as 25 million people, to include, but not limited to, financing and placing annual media buys in excess of $100 million. FDA may also develop and implement additional public education campaigns to support other activities related to its regulatory authorities under the Tobacco Control Act and the changing tobacco product landscape regarding newly approved products and policies.

Contractors shall ensure that unique characteristics, experiences, norms, values, behaviors, and beliefs of the targeted audience, and relevant historical, environmental, and social forces are taken into consideration in the development and execution of a targeted creative strategy to improve public health.

The Contractor’s management responsibilities shall include all activities necessary to ensure the accomplishment of timely and effective support. Specifically, the Contractor shall be responsible for the development and execution of comprehensive public education campaigns with diverse intended audiences that enable CTP to meet its public health objectives.

2.5 TASK AREAS

Task Area 1: Strategic Planning & Research

The Contractor shall support the campaign program by providing comprehensive planning, including (1) identifying goals and measurable objectives; (2) defining and researching targeted audiences; (3) identifying niche and sub-group audiences and developing tailored approaches to messaging (4) exploring settings, channels, and activities to effectively reach targeted audiences; (5) identifying potential media vendors; (6) developing communication strategies and partnership plans; (7) identifying emerging audience trends with tobacco product usage; (8) developing novel approaches for delivering tobacco prevention, reduction and cessation messaging in changing tobacco product landscape; and (9) coordinating with the Campaign Outcome Evaluation Contractor.

The Contractor shall develop marketing plans that contain the rationale for executing the public education campaign, measurable objectives, audience information, message and materials testing plans, strategy development, tactics, evaluation plan, 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, and outreach and provide innovative and comprehensive strategies. Plans shall include strategies and tactics that are feasible for FDA as a regulatory, science-based Government organization as well as actionable and measurable.

The Contractor shall analyze and build upon the promising themes identified through prior and future research and apply key findings to the development of new creative concepts. The Contractor shall have the ability to track and analyze related scientific literature. The Contractor shall conduct research on tobacco products, including executing literature reviews, target audience analyses and message and creative development. Additionally, the Contractor shall propose and execute additional formative and evaluative research in support of new and existing advertising concepts that guide strategies, message development, and implementation for CTP’s public education campaigns. Formative research may include online and in-person research, such as focus groups, in-depth individual interviews, online panels, key informant interviews, survey instruments, or other methods, including strategic insights research, creative concept research, quantitative copy testing. Evaluative research may include social media monitoring and ongoing media tracking but will not include designing or implementing large or long-term outcome evaluation studies, which is handled via a different contract. The Contractor shall propose and execute research to inform strategic messaging approaches to emerging tobacco products and changes in the tobacco landscape. These additional rounds of research shall be briefly summarized in a formative research plan and approved by FDA prior to implementation.

The Contractor is responsible for consulting with CTP to identify information collections that require Institutional Review Board (IRB) and/or Office of Management and Budget (OMB). The Contractor shall prepare the Institutional Review Board (IRB) and/or Office of Management and Budget (OMB) clearance packages for data collection as necessary. The Contractor shall provide all the applicable information necessary for the IRB/OMB packages, including testing surveys or moderator guides, stimuli, information about informed consent, incentives, and recruitment methods. OMB approval for specific activities shall be sought through the Center’s existing generic clearances whenever practical. Other information collection needs, and the appropriate mechanism for obtaining IRB/OMB approval, shall be evaluated on a case-by-case basis. The timeline for securing these packages may take months and shall begin well in advance of the anticipated data collection dates. The Contractor shall also be prepared to execute all aspects of the research including study recruitment, data collection, records management, data analysis, and reporting.

In order 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 experts in each subject matter area for the purpose of contributing new information and insights and work closely with other Government and non- Government organizations, as directed by the Center, with which the Office may rely upon for additional expertise.

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 public health agency. Messaging shall focus on FDA’s key areas of 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.

Detailed annual media strategy and tactical media plans for each campaign that 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 buy plans shall include the specific media properties and markets proposed, schedules, costs, and other relevant details such as the use of local events and influencers to extend media reach and frequency.

In crafting plans, the Contractor shall take into consideration the fragmented and evolving media landscape and available and emerging tactics, like streaming video and new social media platforms. The Contractor shall recommend opportunities in digital media with the potential to reach intended audiences with health messages and educational information more effectively and efficiently than traditional media buys, as determined by media consumption patterns among the particular target audience.

https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/index.html

The Contractor shall also demonstrate an understanding of the existing campaign strategies and provide a clear rationale for new recommendations and changes in campaign strategic direction. At the direction of the COR, the Contractor shall coordinate with other FDA Contractors as necessary.

When developing strategic campaign 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

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

Task Area 2: Creative Development & Production

Based on approved marketing plans, formative research summaries, and creative briefs, the Contractor shall create messages and materials to support targeted public education efforts, which may consist of traditional advertising, social media, digital media, collateral materials, and materials for partners and other audience influencers. The Contractor’s capacity to take complex science-based information and convey it in the most understandable and salient way to key audiences, such as teens and their influencers, those who use tobacco, and communication intermediaries, such as partners and community-based groups, is critical.

The Contractor shall ensure that unique characteristics, experiences, norms, values, behaviors, and beliefs of the targeted audiences, and relevant historical, environmental, and social forces, are taken into consideration in the development and execution of creative advertising; ensure that all messages and materials are consistent with existing audience segmentation, targeting and brand characteristics and take into consideration the campaign creative that has already been developed and placed in market; develop and implement a brand management strategy that may include activities such as maintaining and enhancing existing social media platforms and partnership collaborations; ensure that all messages and materials are consistent with FDA authority under the Tobacco Control Act; develop new creative concepts based on the approved marketing plan, formative research findings, and creative brief; conduct additional formative research with the target audiences (e.g., strategic and creative concept focus groups); and copy test all rough cut advertising to ensure potential effectiveness with the intended audience, including accuracy, consistency, clarity, relevance, credibility, and appeal, and deliver results to the Government for approval to launch ads in market.

The Contractor shall ensure that all materials—traditional, digital, and non-traditional—are prepared in a format consistent with HHS and FDA requirements and have all necessary approvals from HHS and FDA. 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. TV 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 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 usage rights for television, radio, print, and digital materials, 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 TV, radio, digital, outdoor and print advertisements are 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.

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 - 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 broadcast television, cinema and digital), audio (including traditional and streaming radio), digital, and print advertising for CTP’s 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. Prior to production, the Contractor shall draft scripts and storyboards and advise on other components.

The Contractor shall support the development and pretesting of campaign messages and materials to ensure effectiveness with the intended audiences. This shall include (1) conducting literature reviews and environmental scans of related health communications campaigns outside of the Center; (2) using audience research to draft message concepts; and (3) pretesting the concepts with intended audiences to understand which messages are most effective, identifying any potential problems, and uncovering new concepts. Message concept development research will ideally be conducted through focus groups or in-depth interviews, but the Contractor may suggest other alternative or innovative methods that provide increased transparency or cost-efficiencies. The Contractor shall use the results of the message concept development research and the overall strategic plan to develop preproduction draft materials to quantitatively test with intended audiences using validated measures (e.g., Perceived Ad Effectiveness Scale) to ensure accuracy, consistency, clarity, relevance, credibility, and appeal, and to identify any potential unintended consequences.

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.

Task Area 3: Campaign Implementation

3.1 Paid Media Strategy

The Government requires dedicated account management staff of exceptional breadth and depth–with expertise in concurrently developing and implementing complex advertising campaigns, strategic media planning, paid and owned media, and emerging technologies. In addition, the Contractor shall be able to manage national, regional, and local campaigns, as well as have a firm understanding of health communication and paid media campaigns designed to change health behaviors, with specific knowledge of tobacco control being preferred. Finally, the Contractor shall demonstrate expertise in reaching at-risk and underserved populations.

In accordance with advertising industry best practices, the Contractor shall plan, purchase, coordinate, and conduct post-buy analysis of all paid media activity. The Contractor shall also develop comprehensive paid media strategies across all campaign programs that meet the needs of CTP and incorporate effective methods for reaching niche or hard-to-reach populations. Media plans shall include multimedia and demonstrate in-depth knowledge of the unique media consumption habits of intended audiences; documentation of how the buys support campaign objectives; estimated reach, frequency, and cost; and 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.

The Contractor shall provide adequate staffing to prepare multiple media plans across campaigns, provide expertise on reaching sub-populations through media, deliver recommended media buys, and provide subsequent quarterly updates in support of all public education campaign initiatives. This shall include demographic research, appropriate submission of advertising to varied outlets, capture of tear sheets and screenshots of Internet advertisements, maintenance of budgets, and process evaluation for campaign media buys. The Contractor shall also provide monthly and/or quarterly paid media reports on Target Rating Points (TRP) data, and delivery and viewership of advertisements as necessary to CTP for the campaign outcome evaluation studies. The Contractor must be prepared to revise media plans as requirements change, including having the staffing capability to shift paid media allocations rapidly and deploying new or revised ads on any channel with a minimum of delay from direction to implementation.

The Contractor shall have the ability to pay as much as $100 million annually in upfront advertising costs and then seek reimbursement from the Government.

3.2 Interactive, Mobile, and Digital Strategy

The Contractor shall maintain and optimize implementation of the campaign programs’ interactive, mobile, and digital media strategies including, but not limited to, existing social media platforms such as Facebook, Twitter, YouTube, Tumblr, Instagram, SnapChat, TikTok and emerging platforms; mobile applications; texting programs; and user-centered websites. The Contractor shall ensure social media and digital strategies align with overarching paid media strategies and plans to ensure creative messaging is consistent across digital channels, delivery of paid media aligns with each campaign’s digital platforms, and enhancement to the existing digital platforms aligns with campaign branding and CTP objectives. The Contractor shall determine how to share data and analytics information from all campaign digital platforms to inform digital optimizations and enhancements, ensuring the highest possible relevance to and engagement with intended audiences.

As detailed in approved marketing plans and creative strategies, the Contractor shall research, develop, and implement an interactive digital media strategy including, but not limited to, the creation and implementation of new social media tools and user-centered websites, and online gaming. The Contractor shall develop and maintain digital policies, user-centric content, navigation, and architecture for all digital campaign products. When needed, offsite hosting shall be required. All digital products must consider the unique needs of audience segments. The Contractor shall have experience in online and digital campaign elements; developing digital content and functionality; and maintaining and tracking online/digital communications, including compliance with Government requirements such as Section 508 using WCAG 2.0 508 standards, security and privacy issues, and data-gathering techniques.

The Contractor shall provide website support for each individual campaign, including but not limited to, developing science-based content and usability-validated design; day-to-day web management;

technical development support, including Drupal 8+, and other appropriate technologies; conducting and analyzing usability and satisfaction assessments; and implementing changes as directed by the FDA.

Knowledge of the Drupal environment is required.