Amend2_RFP_FDA-SOL-1234457.pdf

RFP Number: FDA-SOL-1234457 Evaluation of the Center for Tobacco Products Public Education Campaigns, Communication Programs and Channels

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

2.4 Scope

2.5 Task Areas

Task Area 1: Design Evaluation Methodology Task Area 2: Pre-Testing Evaluation Methodologies Task Area 3: Perform Research on Secondary Data

Transition

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)

6.12 Government Furnished Equipment (GFE)

6.12.1. FDA Information Technology (IT) Help Desk Support

6.12.2. Government Furnished Information

6.12.3. Contractor Equipment Requirements

6.12.4. Government Furnished Data

6.13 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) .. 28

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 Handling of Non-Public Records Material

7.16 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) ... 61 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

10.3.6.1 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 Factor 6 - Price Evaluation

11.3 Responsibility

12. List of Attachments

1. SOLICITATION INFORMATION

1.1 BACKGROUND

Tobacco smoking remains the leading cause of preventable death and disease in the United States, killing more than 480,000 Americans each year. Additionally, for every person who dies because of smoking, at least 30 people live with a serious smoking-related illness. The Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) was established by the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act, TCA) and tasked with developing and implementing effective regulatory strategies for reducing the enormous public health burden of tobacco products. Such strategies include public education activities to inform a variety of audiences about tobacco products and their regulation. Given that nine out of ten adult people who smoke started smoking before the age of 18, public education activities place a special emphasis on preventing and reducing tobacco use among young people in the United States. Using the best available science, CTP is executing a comprehensive mix of health communication and education activities designed to discourage tobacco use. Health communication activities, such as public education campaigns are known to shape tobacco-related knowledge, opinions, attitudes, and behaviors among individuals and within communities (National Cancer Institute, 2008).

CTP seeks to conduct timely evaluations of its health communication and education activities on reducing tobacco-related death and disease to measure its impact and effectiveness. These activities will include pre-testing of evaluation methodologies to assess effectiveness of new evaluation approaches, process evaluations to assess whether activities were conducted as planned, and outcome evaluations to assess how well program activities achieved the intended goals and objectives. Health communication outcome evaluation measures will include gauging target audience exposure to, awareness of, and receptivity to messages in relation to resultant changes in tobacco-related knowledge, attitudes, beliefs, and behaviors.

Evaluation of CTP's education activities, particularly campaigns, is complicated by the multiple factors that influence tobacco initiation, use, and cessation behaviors. These include, but are not limited to, tobacco policies, regulatory enforcement, other tobacco prevention education programs, community tobacco prevention efforts, media exposure, and socioeconomic and demographic factors. CTP evaluation activities are further complicated by the evolving tobacco product landscape, and the emergence of new products has implications for campaign message strategies and target audience. Also, measuring exposure to specific campaigns is increasingly complicated, particularly given the increased reliance on digital media for reaching campaign target audiences. Self-reported exposure to media can be unreliable, and simultaneous exposure to other media messages (including both tobacco industry messages and other tobacco prevention messaging) is unavoidable. CTP therefore requires rigorous scientific evaluations of its tobacco-related public education activities and programs that account for these complex factors. Successful evaluation should include quantitative and qualitative methodologies that measure progress toward successful outcomes, identify the need for mid-course adjustments to improve effectiveness, and assess long-term public health impact.

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 $60,000,000.00, 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 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 541910 (Marketing Research and Public Opinion Polling). 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

Tobacco smoking remains the leading cause of preventable death and disease in the United States, killing more than 480,000 Americans each year. Additionally, for every person who dies because of smoking, at least 30 people live with a serious smoking-related illness. The Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) was established by the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act, TCA) and tasked with developing and implementing effective regulatory strategies for reducing the enormous public health burden of tobacco products. Such strategies include public education activities to inform a variety of audiences about tobacco products and their regulation. Given that nine out of ten adult people who smoke started smoking before the age of 18, public education activities place a special emphasis on preventing and reducing tobacco use among young people in the United States. Using the best available science, CTP is executing a comprehensive mix of health communication and education activities designed to discourage tobacco use. Health communication activities, such as public education campaigns are known https://beta.sam.gov/ to shape tobacco-related knowledge, opinions, attitudes, and behaviors among individuals and within communities (National Cancer Institute, 2008).

CTP seeks to conduct timely evaluations of its health communication and education activities on reducing tobacco-related death and disease to measure its impact and effectiveness. These activities will include pre-testing of evaluation methodologies to assess effectiveness of new evaluation approaches, process evaluations to assess whether activities were conducted as planned, and outcome evaluations to assess how well program activities achieved the intended goals and objectives. Health communication outcome evaluation measures will include gauging target audience exposure to, awareness of, and receptivity to messages in relation to resultant changes in tobacco-related knowledge, attitudes, beliefs, and behaviors.

Evaluation of CTP's education activities, particularly campaigns, is complicated by the multiple factors that influence tobacco initiation, use, and cessation behaviors. These include, but are not limited to, tobacco policies, regulatory enforcement, other tobacco prevention education programs, community tobacco prevention efforts, media exposure, and socioeconomic and demographic factors. CTP evaluation activities are further complicated by the evolving tobacco product landscape, and the emergence of new products has implications for campaign message strategies and target audience. Also, measuring exposure to specific campaigns is increasingly complicated, particularly given the increased reliance on digital media for reaching campaign target audiences. Self-reported exposure to media can be unreliable, and simultaneous exposure to other media messages (including both tobacco industry messages and other tobacco prevention messaging) is unavoidable. CTP therefore requires rigorous scientific evaluations of its tobacco-related public education activities and programs that account for these complex factors. Successful evaluation should include quantitative and qualitative methodologies that measure progress toward successful outcomes, identify the need for mid-course adjustments to improve effectiveness, and assess long-term public health impact.

2.2 CTP Tobacco Public Education Campaigns

The Government plans to continue assessing its ongoing public health education campaigns and requires services from a contractor to perform research and evaluation services, with a proven track record of success in designing and implementing impact evaluations of paid media campaigns. The contractor will require significant scientific expertise and institutional capacity to evaluate large, complex behavior change-focused broadcast and digital paid media campaigns targeting both national and hard-to-reach audiences.

CTP’s public education campaign program was initiated in 2012 and has grown to include three active campaigns, targeting different audiences at risk for tobacco use, with one additional campaign anticipated to launch in 2021. In CTP’s eight years of campaign development, implementation and evaluation, 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 to ensure successful implementation of best practices for public health campaigns. These changes include, but are not limited to:

• Tobacco 21 legislation: 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, as well as how this legislation may impact tobacco usage.

• FDA guidance and policy on flavored tobacco products: 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, with the goal of curbing 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 and how this may impact the campaign program and message approaches.

• New and emerging tobacco products on the market: As authorized by the TCA, FDA has regulatory authority over all 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. CTP is 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.

• Changes in consumer media consumption behaviors, especially for youth audiences: The media environment has changed significantly, with dramatic declines in broadcast television viewership and a shift to digital streaming and other digital media platforms for content consumption and entertainment. This shift has impacted CTP’s ability to ensure sufficient reach and frequency levels of advertising to youth audiences, requiring CTP to adjust campaign strategies and implementation tactics. CTP anticipates further changes in the media landscape and is currently exploring different methodologies for how best to adjust paid media delivery strategies to meet the changing media landscape.

CTP plans to continue evaluation of campaigns and programs similar, but not limited to, those listed below in the coming years and is seeking to obtain services from a company with extensive and proven experience successfully providing a full-range of activities associated with evaluating national and niche public health campaigns.

“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: (a) educate at-risk youth about the harmful effects of cigarette use to prevent youth who are open to cigarette use from trying it and (b) reduce the number of youth who move from experimenting with tobacco to regular use. Grounded in behavior change theory, the campaign delivers relevant and relatable health consequence messages with the goal of 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 https://www.sciencedirect.com/science/article/pii/S0749379719302806 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. 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.

CTP plans to continue implementation and evaluation of the “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 electronic nicotine delivery systems (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 may also provide prevention and fact-based messaging on other tobacco products, such as smokeless tobacco, across the campaign’s social media channels and website. Currently, the evaluation for “The Real Cost” campaigns targeting both ENDS and cigarettes is ongoing through a nationally representative longitudinal cohort of youth aged 11-16 at baseline.

“Fresh Empire” Multicultural Youth Tobacco Prevention Campaign - In October 2015, CTP launched a national public education campaign to prevent and reduce cigarette 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 “Fresh Empire” campaign that went on air in 2015 had an evaluation that ran from 2015 – 2017. The campaign was evaluated using a treatment control design with 15 campaign-targeted treatment and 15 control media markets. We conducted surveys among 12- to 17-year-olds before campaign launch and at approximately 6-month intervals. Results from the campaign show that awareness of the “Fresh Empire” brand was higher among treatment participants and increased more over time among the treatment group compared to the control group. Additionally, youth in the treatment markets were more likely to report high awareness of video advertisements than youth in control markets at most follow-up waves.

“Next Legends” American Indian/Alaska Native Tobacco Use Prevention Campaign - CTP is developing a tobacco prevention campaign designed to reach American Indian and Alaska Native (AI/AN) youth, ages 12-17, who are at-risk for using e-cigarettes and cigarettes. Studies show that AI/AN youth initiate tobacco use at an earlier age than their non-AI/AN peers and are more likely to currently use tobacco compared to the general population, including cigarettes, cigars, smokeless tobacco, and e-cigarettes.

The disproportional ways in which tobacco use affects the AI/AN population can be addressed through a culturally tailored and targeted public health education campaign. “Next Legends” will be FDA’s first campaign to educate AI/AN youth about the harms of tobacco use. The campaign is scheduled to launch in 2021.

CTP is conducting multi-phase formative research with the target audience to better understand tobacco product usage and identify promising messaging approaches for campaign implementation. CTP will conduct post-market research on the effectiveness of the “Next Legends” campaign with the overall goal of assessing levels of receptivity to FDA’s “Next Legends” public education campaign among the AI/AN community. Evaluation research must consider the scope of the “Next Legends” campaign, including the niche AI/AN youth target audience, campaign reach limitations, and the diffuse nature of the AI/AN population. To achieve this goal, the Contractor may propose designs that are community- or market-based, and regional or geographic in scope.

Evaluation of The Impact of Digital Media in Campaign Delivery

Evaluation activities of FDA’s tobacco health communication and education campaigns have been largely successful. However, accurately evaluating the effectiveness of public education campaigns is increasingly challenging as campaign delivery becomes more fractured across digital and social media platforms. These digital platforms offer unique targeting capabilities, are preferred by more members of the target audience(s), and have lower costs driving up the use of digital media among at risk groups, such as youth and young adults. There is a need to more sufficiently explore the differences in digital and broadcast advertising to accurately evaluate the impact and effectiveness of digital advertising.

CTP is interested in continuing to pursue evaluation activities to answer questions such as:

• How do we accurately measure behavior change prompted by digital advertising?

• What are best practices to change tobacco attitudes and beliefs and encourage viewers to retain and act on information across different digital media platforms?

• Do ads placed on television vs. video ads on digital media platforms have different effects on tobacco-related knowledge, attitudes, beliefs, and behaviors?

Process Evaluation on Other Tobacco Education Activities

CTP continues to take a wholistic approach to developing effective health communication and education programs with outside groups and at times producing non-branded communication efforts.

For example, FDA has collaborated with the publishing, education, and media company, Scholastic, to develop and disseminate educational materials. These materials include items such as videos, lesson plans, activity sheets and other items that are designed to be used by middle and high school educators and students in an effort to reduce e-cigarette use among youth. Scholastic grounded these lessons in core subjects and weaved in activities that involve statistics, reading comprehension, writing, presenting, and media.

CTP is interested in pursuing process evaluation activities of these efforts, including, but not limited to:

• understanding CTP’s return on investment (ROI) on these projects;

• demonstrating the added value of these activities;

• gathering insights for future planning and optimization.

2.3 OBJECTIVES

The objective of this IDIQ contract is to establish a mechanism for CTP to elicit assessments of tobacco-related health communication and education activities on an as-needed basis. Evaluations (process and outcome) conducted under this mechanism will inform FDA about methodologies to assess effectiveness of new evaluation approaches, and the effects of tobacco-related health communication and education activities, including the degree to which the activities led to successful outcomes and long-term public health impact. Such outcomes could include:

• Awareness of and receptivity to campaign messages;

• Changes in tobacco-related knowledge, attitudes and beliefs;

• Decrease in perceptions of prevalence, approval, and popularity of tobacco use;

• Pro-health changes in normative beliefs about tobacco product use;

• Decrease in tobacco use susceptibility; and

• Increased intention to quit and/or reduce daily consumption.

The evaluations will also help identify the need for mid-course adjustments to improve effectiveness, if necessary.

2.4 SCOPE

The scope of this IDIQ contract is to design process and outcome evaluation studies utilizing proven scientific methodologies that assess the effectiveness of tobacco-related public education activities.

Evaluation studies shall use quantitative and qualitative methodologies that measure progress, identify mid-course adjustments (if necessary) and assess long-term public health impact. This IDIQ contract also includes pre-testing of evaluation methodologies to assess effectiveness of new evaluation approaches.

2.5 TASK AREAS

Task Orders issued under this IDIQ contract will detail required services from these general task areas, which will be defined by stated objectives at the task order level.

Task Area 1: Design Evaluation Methodology

The contractor shall collaborate with CTP staff and campaign contractors and subcontractors to develop initial recommendations for appropriate evaluation frameworks. The framework shall allow for consistency in the approach for planning and conducting evaluations and include specific steps (e.g., data collection, goal of data analysis). Evaluation frameworks must include recommendations for evaluating the effects of campaign messages delivered across different digital platforms. Detailed information, such as the campaign target audience, will be specified by each individual task order prior to development. This includes, but is not limited to, the creation of evaluation plans, data collection protocols and data management plans. Evaluation methodologies could include longitudinal cohort or cross-sectional designs, as well as one-time assessments and continuous tracking mechanisms.

Task Area 2: Pre-Testing Evaluation Methodologies

The contractor shall collaborate with CTP staff and campaign contractors and subcontractors to identify, develop, and test novel and innovative evaluation approaches and methodologies to address the challenges associated with evaluating a national public education campaign. Such challenges include measuring exposure to digital media messages, identifying appropriate terminology to describe the evolving tobacco product landscape in survey instruments, and understanding the appropriate tobacco knowledge, attitudes and beliefs to measure.

Task Area 3: Perform Research on Secondary Data

The contractor shall collect comprehensive background information using literature reviews, secondary data analysis, informational interview with subject matter experts and other methodologies to assess evaluations of public education campaigns and their impact and effectiveness on reducing tobacco-related death and disease; past and current tobacco use rates; and the state of evaluation research for related public education activities.

Task Area 4: Develop Primary Research Documents and Analysis Plans

The contractor shall develop planning documents; including Office of Management and Budget and Institutional Review Board packages (including instruments, assent and consent forms, etc.) and data analysis plans for process and outcome evaluations of CTP public education activities.

Task Area 5: Perform Primary Research

The contractor shall collect primary data through implementation of approved studies and perform secondary data such as analyses of population health statistics, to assess impact and inform specified recommendations around public education programs' impact and effectiveness in reducing tobacco-related death and disease. As part of primary data collection, the contractor shall ensure appropriate training is completed by all field interviewer/data collection staff. Training shall require field interviewer/data collection staff to either train virtually or travel to in-person training at the discretion of the COR.

Task Area 6: Primary Analysis and Reporting of Findings

The contractor shall perform in-depth analyses of primary and secondary data on knowledge, attitudes, beliefs, and behaviors linked to CTP’s public education campaigns. In-depth analysis will be shared in the form of reports and presentations that summarize research results for internal CTP use, as well as manuscripts for submission to peer reviewed journals and external use. This includes, but is not limited to, interim reports, short turn around analyses, written reports, journal manuscripts and briefing/testimony responses. The contractor shall provide the government with all materials developed as part of this work, to include but not limited to, datasets created for data management and data analysis purposes, data analysis coding script/programming, qualitatively coded datasets, data analysis output, presentations and reports. FDA considers the sharing of FDA-funded research, including digital data, an important means to enhance its value and support future research. Results will be shared in the form of reports and presentations that summarize research results for internal CTP use, as well as manuscripts for submission to peer reviewed journals and external use. This includes, but is not limited to, interim reports, short turn around analyses, written reports, presentations, journal manuscripts and briefing/testimony responses. Travel to conferences to support presentations may be required. When findings associated with research developed with FDA funds are published, they may be required to be made readily available to the public.

Task Area 7: Secondary Analysis and Reporting of Findings

The contractor shall perform analyses of data to answer research questions not directly related to campaign effectiveness, but may help inform future campaign directions. This shall include analyzing trends in tobacco product use to assess for transitions between products types. Results will be shared in the form of reports and presentations that summarize research results for internal CTP use, as well as manuscripts for submission to peer reviewed journals and external use. This includes, but is not limited to, interim reports, short turn around analyses, written reports, presentations, journal manuscripts and briefing/testimony responses. Travel to conferences to support presentations may be required.

Task Area 8: Program Management

The contractor shall be responsible for the all program management and coordination with the Government on all tasks within the IDIQ SOW. The Government requires exceptional budget planning, execution and reporting capabilities to ensure detailed tracking of expenditures across multiple evaluations, including the ability to provide regular reports accounting for labor and other direct costs (ODC) billing by task order.

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 IDIQ 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 IDIQ contract.

• Maintain continuous and effective communication, such as acknowledgement within 24 hours 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.

• Within 5 days of award of the IDIQ the contractor shall provide a staff directory including contact information, hierarchy, and list of core areas of responsibility for all staff working on the

IDIQ.

As identified in each individual task order, the contractor shall:

• Host a transition planning meeting at FDA facilities or alternative location. The Government will work with the Contractor to determine a mutually agreed-upon date and time no later than 15 business days after the first task order is awarded. The purpose of the meeting shall be to walk through the Contractor’s initial transition plan.

• Consult with OHCE 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 key personnel and new hires, shifts in staff responsibilities, or departing staff within three to five business days. Upon task order award, the Contractor shall also provide a full staff directory including contact information, hierarchy, and list of core areas of responsibility for all staff working on the task order.

• Provide monthly status, expenditure, and progress reports per campaign to the COR, DR&E team, and the Contracting Officer (CO), including a written status report detailing expenses incurred to date; correlate money spent to work completed; expected expenditures over the 30 days following each monthly report; and other pertinent information to be specified by the COR as the program evolves. The expenditure report shall include estimates for all costs including labor and other direct costs, etc. Information shall also include, but not be limited to:

o Project milestones o Problems encountered and anticipated, recommended solutions o Deliverables due o Deliverables submitted and dates completed o Key staff responsibilities

• Deliver comprehensive program completion report with recommendations for next steps, including “lessons learned” and recommendations for future evaluation efforts.

• At the request of CTP, 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 public health education campaigns. This may include participation in milestone meetings, strategy sessions, or discussions concerning the work product of one Contractor being provided to another as Government-furnished information. Contractors are advised that any technical direction must come from the Contracting Officer’s Representative (COR). Other CTP contractors may include but are not limited to CTP’s Division of Regulatory Communications Contractor and CTP’s Campaign Contractor.

TRANSITION

Transition activities take place to efficiently transition all activities from the incumbent Contractor to the new Contractor. As tasked, the Contractor shall develop transition plans and conduct transition activities for task orders issued against this IDIQ vehicle, as applicable.

Transition-In The Contractor shall transition-in and assume the responsibility for activities and duties from the prior (incumbent) Contractor in a manner that ensures minimal disruption to ongoing evaluation activities as well as complete transparency to ensure total data transfer from the outgoing Contractor. The purpose of the Transition-In requirement is to provide an orderly and efficient transition from the prior Contractor. The Contractor shall work with the incumbent Contractor to affect a smooth transition of work.

Representative activities include, but are not limited to:

• Develop a Transition-In Plan to ensure full operating accountability and responsibility of the task orders. The contractor shall provide a final Transition-In Plan, no later than 30 days after the first transition meeting, which is to be held within 15 days after the first task order kickoff meeting.

• Familiarize the incoming Contractor staff with FDA processes and requirements and work with the incumbent Contractor as related to transferring tasks and work activities being performed.

• Coordinate with COR to obtain access to the required data, applications, and required training.

• Participate in Transition-in meetings and other technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the incumbent Contractor. The first transition-in planning meeting will occur no later than 15 business days after the task order kick-off meeting. The purpose of the initial meeting shall be to walk through the incumbent Contractor’s detailed plan for transitioning all activities and all Government assets to the new Contractor in a manner that is the least disruptive to ongoing activities.

• Certify that employees working on the contract have completed their review and understand the requirements of the contract, documentation, processes, and technical environments prior to the completion of the Transition-in activities.

• Verify to the COR that all Transition-in documents are available.

Transition-out

As specified per the task order, the Contractor shall facilitate the transition-out of contracted activities and services to the Government or, to a follow-on Contractor by the end of the period of performance.

During the transition out period, the Contractor shall ensure that no degradation in service or support is experienced, per each task order. Between the turnover date designated by the CO and the end of the task order period of performance, the incumbent Contractor shall ensure all task order activities are closed-out and provide sustainment support to complete the transition.

Representative activities include, but are not limited to:

• Develop and submit a Transition-Out Plan and Schedule to the Contracting Officer and Contracting Officer Representative within 120 days of performance end date or within 20% of contract ceiling price, whichever occurs first.

• Provide the Government with current versions of all documentation and all datasets (i.e., electronic and hardcopies).

• Provide the Government with a current inventory of all Government-Furnished Equipment (GFE) and Government Furnished Information (GFI) utilized by the Contractor along with full support in the reconciliation of this inventory.

• Provide the follow-on Contractor with the ability to “shadow” and participate in technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor.

3. CONTRACT TYPE AND MINIMUM/MAXIMUM AMOUNTS

3.1 CONTRACT TYPE

This is a single-award Indefinite Delivery-Indefinite Quantity (IDIQ) type contract, per FAR 16.5.

Authorized contract types under this IDIQ contract are: Labor-Hour (LH), Time-and-Materials (T&M), and Firm-Fixed-Price (FFP).

3.2 MINIMUM AND MAXIMUM CONTRACT VALUE

IDIQ Minimum: The minimum guarantee for this IDIQ contract is $3,000.00, which will be obligated at the time of IDIQ award.

IDIQ Maximum: The maximum aggregate dollar value of all task orders awarded over the 5-year ordering period of this IDIQ shall not exceed the IDIQ ceiling amount of $60,000,000.00.

See FAR Clause 52.216-19 (OCT 1995) for individual order limitations.

4. PRICING AND ORDERING OF SERVICES

4.1 OVERVIEW OF PRICING SCHEDULE

The Contractor’s pricing schedules for labor categories shall contain fully burdened hourly rates. The fully burdened hourly rates for each labor category shall include wages, indirect costs, fringe benefits, overhead, general and administrative, and profit. Hourly rates shall apply to services at both Government and non-Government sites.

By mutual agreement of the parties, additional labor categories may be added to this IDIQ contract to support the tasks of this contract.

4.2 PRICING TERMS

The Contractor shall comply with FAR Clause 52.212-4, Alt I, Contract Terms and Conditions – Commercial Items (OCT 2018)with regard to the ceiling price for each labor-hour or time-and-materials type task order.

The total amount specified in Firm-Fixed Price (FFP) task orders shall be fixed for the task order period of performance and shall not be subject to adjustment; except, as a result of a direct action or inaction by the Government which delays the Contractor from completing the task order within the time specified in the order. The Contractor shall comply with FAR Clause 52.212-4, Contract Terms and Conditions – Commercial Items (OCT 2018) in regard to the firm-fixed-prices for individual task orders.

4.3 ORDERING

A request for task order proposal (RFTOP) will be issued via email for individual task orders. Task orders against the IDIQ contract will be issued via email and will be in accordance with FAR 16.505 and FAR Clause 52.216-18.

4.3.1. Ordering Procedures

Any Contracting Officer of the Food and Drug Administration (FDA) is authorized and may place orders under this IDIQ contract. Each individual task order will describe the specific performance requirements.

The process for issuing task orders is as follows:

1. The FDA CO will issue a RFTOP via email. The RFTOP will include the following information:

a. SOW

b. Period of performance

c. Anticipated contract type

d. Reporting requirements and deliverables

e. Key Personnel (If applicable)

f. Any special terms and conditions specifically applicable to the task order

2. The Contractor will typically have a minimum of ten (10) business days, unless otherwise specified, to provide a proposal in response to the RFTOP. The proposal shall include:

a. Description of the technical approach to the task order requirements

b. Price buildup (including labor categories, hours for each labor category, extended pricing, total task order pricing, other direct costs, and concurrence with the anticipated contract type)

c. Resumes of any key personnel identified in the RFTOP

3. The FDA will evaluate the task order proposal for technical acceptability and price reasonableness. If the FDA has questions or concerns, the Contracting Officer will contact the Contractor and may request a revised proposal.

4. If the task order proposal is determined acceptable, the Contracting Officer will issue a task order. All task orders will, at a minimum, include the following:

a. Task Order number

b. Date of Task Order

c. Funding for the Task Order

d. Task order SOW and specific deliverables and due dates

e. Task order pricing

f. Period of performance of the task order

g. Any terms, conditions and instructions specific to the task order

Any work that the Contractor undertakes prior to receiving a fully executed task order that has been signed by the Contracting Officer (or the Contractor has received prior authorization to proceed from the Contracting Officer) shall be at the Contractor’s risk.

4.3.2. Pricing of Orders

a. Proposals submitted in response to a RFTOP must be in accordance with the Ordering Period rates in the IDIQ Price Schedule based on the performance start date of the task order, and that rate must be used for the duration of the task order performance period; however, if a task order’s performance period is longer than 12 months, the Contractor may propose the applicable ordering period rate for that portion of the performance period after the 12 month period. The Contractor may propose lower rates in response to a RFTOP.

b. RFTOPs may include option periods in accordance with FAR Clause 52.217-9 (MAR 2000). However, option periods must utilize the Ordering Period rates listed in the IDIQ Price Schedule, based on the performance start date of the option period.

c. Labor-Hour (LH) and Time-and-Materials (T&M) type task orders will include a ceiling price.

d. If a task order’s stated period of performance must be extended as a result of Government delay, the Contractor may request that the most current labor rates be used to price the work effort during the extended period for LH and/or T&M task orders.

These Ordering Pricing terms and conditions apply to all task orders issued against this IDIQ contract.

5. DELIVERABLES AND ACCEPTANCE

5.1 DELIVERABLES

Specific deliverables and a schedule of deliverables will be identified in each task order.

A. FDA does not accept documents which contain the use of “macros.” Document submissions required throughout the period of performance of this IDIQ contract, including any task orders under this IDIQ, shall not have macro-enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

B. All non-electronically submitted deliverables required under this contract shall be packaged, marked and shipped in accordance with the requirements and specifications contained herein this contract. At a minimum, all deliverables shall be marked with the Contract Number and Contractor Name. The

Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

C. Reports not submitted electronically shall be delivered F.O.B. Destination, as set forth in FAR Clause 52.247-35, F.o.b. Destination, Within Consignee’s Premises (APR 1984), and as specified in the delivery schedule in the task order.

D. Unless otherwise specified, deliveries shall be made to the COR on Mondays through Fridays (excluding Federal Holidays and Executive Order), between the hours of 8:00 a.m. and 5:00 p.m., Eastern Time, only. Supplies or services scheduled for delivery on a Federal holiday shall be made the following day.

5.2 INSPECTION AND ACCEPTANCE

A. Satisfactory performance of this contract shall be deemed to occur upon performance of the work and upon delivery and acceptance. The Task Order Contracting Officer’s Representative (TO COR) or duly authorized representative will perform inspection and acceptance of materials and services to be provided in each task order. For the purpose of this section, the Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer.

B. The contractor shall only tender for acceptance those items that conform to the requirements. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair/replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. In some task orders, the deliverable must be 100% accepted by the delivery date. The deliverables and delivery dates will be specified in the task order.

C. A Quality Assurance Surveillance Plan (QASP) may be included in individual task orders.

D. Acceptance may be presumed within 10 days of receipt, unless otherwise indicated in writing by the Contracting Officer or duly authorized representative (COR).

6. CONTRACT ADMINISTRATION DATA

6.1 PERIOD OF PERFORMANCE

The anticipated period of performance for this contract consists of five (5), 12-month ordering periods, as follows:

Ordering Period 1: March 26, 2021 – March 25, 2022 Ordering Period 2: March 26, 2022 – March 25, 2023 Ordering Period 3: March 26, 2023 – March 25, 2024 Ordering Period 4: March 26, 2024 – March 25, 2025

Ordering Period 5: March 26, 2025 – March 25, 2026

The period of performance for task orders will be specified in individual orders. Two (2) constraints apply to the period of performance for task orders:

1. Individual task orders may not exceed five (5) years (inclusive of option periods)

2. The period of performance end date of the last option period on individual task orders may not extend more than 24 months beyond the last IDIQ Ordering Period end date

6.2 PLACE OF PERFORMANCE

The place of performance will be identified in individual task orders, but is expected to occur primarily at the Contractor’s facility. CTP facilities are predominantly located in Silver Spring, MD.

Specific working arrangements, such as work approved for performance at alternate contractor locations, will be described in individual task orders.

6.3 HOURS OF OPERATION

Unless otherwise specified in the individual task order, Contractor staff must be available during normal FDA business hours, from 8:00 am – 5:00 pm Eastern Time (ET), Monday through Friday, except on Government Closures.

6.4 OBSERVANCE OF GOVERNMENT CLOSURES

The Contractor may not bill the Government for any hours that Contractor employees did not work due to any Government closure under this contract or any task orders under this contract that include labor-hour or time-and-materials contract types. In the event Contractor personnel work during a holiday observed by the Contractor other than those below, no form of holiday or premium compensation will be reimbursed as either a direct or indirect cost.