Attachment_3_Statement_of_Work_Fresh_Empire.pdf

Attachment 3 16-223-SOL-00027

Statement of Work – (Fresh Empire) TASK ORDER

1. BACKGROUND

To protect the public’s health, the 2009 Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration (FDA) the authority to regulate tobacco products and educate the public about the dangers of tobacco use. Tobacco use is the leading preventable cause of disease, disability, and death in the United States, resulting in more than 480,000 deaths each year. Despite this, each day, nearly 2,900 people younger than 18 years of age smoke their first cigarette, and approximately 2,100 youth and young adults who are occasional smokers become daily smokers.

To reduce the public health burden of tobacco use in the United States and educate the public—especially young—people about the dangers of tobacco use, the FDA Center for Tobacco Products (CTP) is developing and implementing several different public education campaigns. FDA’s “Fresh Empire” public education campaign, aims to reduce tobacco use among at-risk youth ages 12–17 in the United States. The “Fresh Empire” campaign focuses on reducing tobacco use among youth who affiliate with a Hip Hop peer crowd, and predominantly among African American, Hispanic, and Asian/Pacific Islander youth.

A complementary evaluation study, "Evaluation of the Fresh Empire Campaign on Tobacco (EFECT)," was also designed and implemented to measure awareness of and exposure to “Fresh Empire” among multicultural youth ages 12–17 in targeted areas of the United States to assess the campaign’s impact on outcome variables of interest from July 2015 – October 2017.

As the “Fresh Empire” campaign continues, FDA has a need to continue the associated outcome evaluation. Details about the current outcome evaluation are available via http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201603-0910-010

2. OBJECTIVES

The purpose of this task order is to provide FDA with the required resources to conduct an outcome evaluation that meets the objectives and specifications below within specified time frames. The goal of the outcome evaluation is to further demonstrate how and to what extent FDA’s “Fresh Empire” public education campaign contributes to reducing tobacco use among at-risk multicultural youth ages 12–17.

More specifically, FDA would like to evaluate whether future waves of “Fresh Empire” public education campaign have an effect on any of the following outcome objectives:

• 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.

http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201603-0910-010

The goal of the outcome evaluation is to demonstrate how and to what extent the “Fresh Empire” public education campaigns have contributed to preventing tobacco product use among vulnerable and underserved multicultural youth aged 12-17. This evaluation shall employ innovative quantitative research designs that represent the state-of-the-art in advertising and social marketing evaluation research.

3. SCOPE OF WORK

Propose and implement an evaluation plan that continues current evaluation studies in progress to determine whether FDA’s “Fresh Empire” campaign meets the objectives, outlined in Section 2. The parameters of the evaluation design should assess the scope and effectiveness of the program. To achieve these goals, the Contractor may propose designs that are community- or market-based, and regional or geographic in scope, and may suggest the adjustment or alteration of activities and message exposure levels among test and control groups.

At minimum, the Contractor is expected to carry out the following tasks, but is encouraged to propose other innovative solutions that meet the objectives of the tasks and deliverables outlined by FDA and are within the scope of work awarded under the base IDIQ.

TASK 1: Collaborate with CTP staff and campaign contractors and sub-contractors (at the direction of CTP) 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).

1.1: Draft Evaluation Plan

The primary evaluation questions, outline in the Objectives (Section 2) shall be answered through analysis of primary evaluation data gathered from campaign-specific measurement tools (e.g., surveys) and existing national surveys of tobacco use (e.g., National Youth Tobacco Survey, National Adult Tobacco Survey and the National Survey on Drug Use and Health).

Within four (4) weeks after the effective date of the call order, the Contractor shall submit to the Contracting Officers Representative (COR) a draft evaluation plan for continuing data collections of “Fresh Empire” that includes the following, at a minimum: (1) objectives of the evaluation; (2) scope of the evaluation; (3) outline of key elements of the evaluation; (4) evaluation methods (including detailed information on the qualifications and number of human subjects, and on the size and complexity of the protocol); and (5) a preliminary sample design. The Contractor shall submit the preliminary evaluation plan to the COR electronically in Microsoft Word-compatible format and in hard copy.

1.2: Final Evaluation Plan

Within two (2) weeks after receiving the COR’s feedback on the draft evaluation plan, the Contractor shall submit to the COR a final evaluation plan that incorporates the COR’s comments and expands on elements contained in the draft plan.

1.3: Draft Data Collection Protocols and Procedures Manual

The Contractor shall develop and submit draft data collection protocols and a procedures manual to the COR at the same time the final evaluation plan is delivered—eight (8) weeks after the effective date of the call order. [As noted, the Contractor shall submit to the COR a final evaluation plan that incorporates COR comments provided in Task 1.1 and expands on elements contained in the draft plan as needed within two (2) weeks of receiving COR feedback on the draft evaluation plan.] This submission shall include materials related to the campaign evaluation activities, including Federal Wide Assurance and internal operating procedures that facilitate compliance with federal guidelines such as data collection protocols (number, size and complexity to be determined), quality assurance procedures and a data collection procedures manual. The procedures manual shall include information that specifies how data on human subjects will be handled to preserve confidentiality. The Contractor shall submit these materials to the COR electronically in Microsoft Word-compatible format.

1.4: Final Data Collection Protocols and Procedures Manual

Within two (2) weeks of receiving the COR’s feedback on the draft protocols and manual, the Contractor shall submit to the COR final draft data collection protocols and a final procedures manual that incorporate the COR’s comments.

1.5: Draft Data Management and Analysis Plans

The Contractor shall develop and submit draft data management and analysis plans to the COR at the same time the final evaluation plan is delivered—eight (8) weeks after the effective date of the call order. [As noted, the Contractor shall submit to the COR a final evaluation plan that incorporates the COR’s comments provided in Task 1.3 and expands on elements contained in the draft plan as needed within two (2) weeks of receiving COR feedback on the draft evaluation plan.] The data management plan shall include system requirements and types of data to be inputted into the system. The data analysis plan shall detail how national survey data and any new data shall be analyzed for the purpose of assessing campaign impact. The Contractor shall submit the draft plans to the COR electronically in Microsoft Word-compatible format.

1.6: Final Data Management and Analysis Plans

Within one (1) week of receiving the COR’s feedback on the draft plans submitted under Task 1.5, the Contractor shall submit to the COR final data management and analysis plans that incorporate the COR’s comments.

TASK 2: 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.

2.1: Discussions with Subject-Matter Experts

Upon receiving the prior approval of the COR, the Contractor shall make arrangements with up to 12 subject-matter experts (SMEs) from Federal, State and local governments, private industry, and academia to provide specialized expertise on selected and particular scientific, technical, and methodological issues pertaining to the study, such as statistical methods for analysis of evaluation data, cohort-retention plans and procedures, the validation of self-report data, non-response and follow-up procedures, and other issues of interest to FDA. As specified by the COR, the Contractor shall draft summaries from discussions with individual SMEs, including recommended action items, and provide them to the COR for review within one (1) month of receiving COR approval.

TASK 3: Develop planning documents; including Office of Management and Budget and Research Involving Human Subjects Committee protocols (including instruments, assent and consent forms, etc.), an associated timeline for development, submission and revisions, and data analysis plans for process and outcome evaluations of CTP public education activities.

3.1: Draft Information Collection Request (ICR) Documentation for Clearance Packages

Within two (2) weeks of the COR providing approval of the final data collection protocols and procedures and data management and analysis plans, the Contractor shall develop and submit the draft ICR documentation required for clearance. This documentation includes Office of Management and Budget (OMB) clearance packages for all campaign outcome evaluation data collection efforts involving more than nine (9) human subjects and/or Research Involving Human Subjects Committee (RIHSC) clearance packages for any data collection that includes human research subjects. Up to six (6) clearance packages may be requested. All associated protocols (e.g., discussion guides, consent forms) must be submitted as part of the clearance packages. All materials shall be submitted to the COR electronically in Microsoft Word-compatible format. These clearances shall be obtained prior to the initiation of any data collection activities, although all other planning and development work in the design of the evaluation plan and in preparation of the clearance packages can be conducted prior to obtaining clearance. For RIHSC clearance submissions, the study’s principle investigator must complete human subjects research training through the Collaborative Institutional Training Initiative (available at www.citiprogram.org). Only the http://www.citiprogram.org/

Social and Behavioral module is required; this training must be repeated every three (3) years and provided upon request. The COR shall deliver the revised clearance package to OMB and RIHSC for review.

3.2: Final ICR Documentation for Clearance Packages

The COR will transmit proposed revisions from OMB and/or RIHSC to the Contractor. The Contractor shall deliver final clearance packages to the COR that incorporate all comments from the COR, OMB, and RIHSC within one (1) week of receiving OMB and RIHSC comments (via the COR).

TASK 4: Collect primary data through implementation of approved studies and 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.

4.1: Data Collection and Analysis (Evaluation Implementation)

Within three (3) weeks of receiving notice from the COR of final OMB and RIHSC approvals, the Contractor shall implement the approved data collection procedures for the campaign outcome evaluations as outlined in the final evaluation plan, data collection protocols, and procedures manual.

TASK 5: Perform in-depth analyses of primary and secondary data on knowledge, attitudes, beliefs, and behaviors linked to CTP’s “Fresh Empire” campaign. 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.

5.1: Interim Written Reports

The Contractor shall submit up to eight (8) interim written reports that synthesize data collection and analyses to date over the 48 month performance period. Each individual interim report shall be submitted within three (3) weeks of the COR requesting an interim report from the Contractor. The reports shall summarize the key findings and results of “Fresh Empire” campaign evaluation project to date, including all necessary background information on the objectives, scope, and methodology of the project, as well as challenges encountered and mitigation strategies. The reports shall be comprised of three (3) parts, including an executive summary, the body of the report, and a technical appendix comprising all statistical details. The technical appendix shall document all the algorithms, methods, and assumptions used by the Contractor in developing their assessment. The reports shall be a stand-alone reference documents, usable by researchers, practitioners, and policy makers.

The reports shall be formatted in Microsoft Word and PDF and include a table of contents.

The reports shall also include graphics, figures, and tables as necessary.

5.2 Data Sets & Code Books

The Contractor shall submit participant screener and full questionnaire data sets along with associated code books within four (4) weeks of the COR request. The data sets shall be provided in SAS or Stata format. The data sets will be organized by waves of data collection and thus, the number of required data sets will be dependent on the number of waves of data collection proposed by the Contractor.

5.3 Short-Turnaround Analyses

Contractor shall conduct short-turnaround analyses to address high-priority, time-sensitive questions and issues as specified by the COR. The products of short-turnaround analyses may vary, from producing a Power Point document, an extensive set of tables, a poster presentation, and/or a brief report which, as specified by the COR, may be developed for publication in peer-reviewed journals. The Contractor shall produce a draft of the specified deliverable and verify the quality, accuracy, and precision of its estimates before it is submitted to the COR. The Contractor shall submit up to sixteen (16) short-turnaround analysis over the 48 month performance period.

5.4: Final Written Report

The Contractor shall submit a final written report synthesizing all data collection and analyses conducted over the 48 month performance period. This report shall be submitted within two (2) weeks of the task order expiration date. The report shall summarize the key findings and results of each campaign evaluation project overall, including all necessary background information on the objectives, scope, and methodology of the project, as well as challenges encountered and mitigation strategies. The report shall be comprised of three (3) parts, including an executive summary, the body of the report, and a technical appendix comprising all statistical details. The technical appendix shall document all the algorithms, methods, and assumptions used by the Contractor in developing their assessment. The report shall be a stand-alone reference document, usable by researchers, practitioners, and policy makers. The report shall be formatted in Microsoft Word and PDF and include a table of contents. The report shall also include graphics, figures, and tables as necessary.

5.5: Manuscript Development Support

The Contractor shall develop manuscripts that summarize research results upon the COR’s request. These manuscripts may include background information on CTP, the purpose of each campaign and corresponding evaluation efforts, preliminary findings using primary and secondary data sources, implications of these findings, recommendations, and sources. CTP shall own the rights to this research. The Contractor will not have rights to publish findings without being granted permission by CTP. The COR may make up to six (6) manuscript development requests. The Contractor shall submit each manuscript concept within two (2) weeks of COR request.

5.6: Briefings/Testimony, Response and Conference Support

Within two (2) weeks of the COR’s request The Contractor shall prepare, provide, and present briefing materials that summarize the campaign evaluation research results. These materials may include a summary of the objectives, scope and methodology of the project;

key findings; challenges encountered; mitigation strategies; and graphics, figures and tables.

Each set of briefing materials shall be in the form of concise Microsoft PowerPoint presentations (maximum thirty (30) slides in length) and/or written documentation (no more than twelve (12) pages in length). The COR may request up to six (6) PowerPoint presentations and/or sets of briefing materials.

5.7: Ongoing Communication and Status Reports

Beginning in the first month after the effective date of the task order, the Contractor shall submit via email on the tenth (10th) business day of each month, monthly status and expenditure reports, which document progress toward key tasks and money spent or incurred to date. Information shall also include, but not be limited to:

• Project milestones

• Identification of challenges

• Recommended solutions for problems encountered and anticipated

• Deliverables due

• Deliverables submitted and upcoming

• Estimates for all costs associated with the task order

• Correlation of money spent/incurred to work completed

The Contractor shall also participate in ongoing conference calls as requested by the COR to report on the status of the deliverables required under the contract. The Contractor shall attend up to six (6) in-person meetings per contract performance year at CTP offices at 10903 New Hampshire Ave, Silver Spring, MD 20993.

4. DELIVERABLES AND PERFORMANCE

The due dates associated with each task are estimated. Therefore, the Contractor may, based on industry best practices, propose alternative due dates relating to each task.

DELIVERABLE QUANTITY DELIVERY DATE

Draft Evaluation Plan

Task 1.1

One (1) Within four (4) weeks after the effective date of the call order.

Final Evaluation Plan

Task 1.2

One (1) Within two (2) weeks after receiving the COR’s feedback on the draft evaluation plan.

Draft Data Collection Protocols and Procedures Manual

Task 1.3

Number of protocols approved in final evaluation plan;

One (1) manual

Within eight (8) weeks after the effective date of

DELIVERABLE QUANTITY DELIVERY DATE

Final Data Collection Protocols and Procedures Manual

Task 1.4

Number of protocols approved in final evaluation plan;

One (1) manual

Within two (2) weeks after receiving the COR’s feedback on the draft protocols and manual.

Draft Data Management and Analysis Plans

Task 1.5

One (1) each Within eight (8) weeks after the effective date of

Final Data Management and Analysis Plans

Task 1.6

One (1) each Within one (1) week of receiving the COR’s feedback on the draft plans.

Discussions with Subject- Matter Experts

Task 2.1

Ongoing Within one (1) month of receiving COR approval.

Draft ICR Documentation for Clearance Packages

Task 3.1

Up to six (6) Within two (2) weeks after COR approval of the data collection protocols and procedures and data management and analysis plans.

Final ICR Documentation for Clearance Packages

Task 3.2

Based on number of draft packages

Within one (1) week after receiving comments from the COR, OMB and RIHSC (via the COR).

Data Collection and Analysis (Evaluation Implementation)

Task 4.1

Based on number of data collection waves.

Within three (3) weeks of receiving notice from the COR of final OMB and RIHSC approvals.

Interim Written Reports

Task 5.1

Up to eight (8) Within three (3) weeks of the COR’s request.

Data Sets & Code Books

Task 5.2

Based on number of data collection waves.

Within four (4) weeks of the COR’s request.

Short-Turnaround Analyses

Task 5.3

Up to sixteen (16)

Over the 48 month performance period.

DELIVERABLE QUANTITY DELIVERY DATE

Final Written Report – Synthesis of all data collection and analyses conducted over 48 month performance period

Task 5.4

One (1) Within two (2) weeks the end of the contract performance period.

Manuscript Development Support

Task 5.5

Up to six (6) Within two (2) weeks of the COR’s request.

Briefings/Testimony, Response and Conference Support

Task 5.6

Up to six (6) Within two (2) weeks of the COR’s request.

Ongoing Communications and Status Reports

Task 5.7

Ongoing The Contractor shall deliver to the COR monthly e-mail status and expenditure reports on the tenth (10th) business day of each month following the month of the effective date of the contract;

participate in ongoing conference calls to report on the status of the deliverables required under the contract; and attend up to six (6) in-person meetings per contract performance year at CTP offices in Silver Spring.

5. CONTRACT TYPE

Time and Materials Task Order

6. PERIOD OF PERFORMANCE

The period of performance shall be for four consecutive years beginning date of award up to 48 months.