Amend2_Attachment J_SAMPLE Task Order SOW.docx

Evaluation of CTP Public Education Campaigns, Communication Programs and Channels Statement of Work – Task Order #1

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. 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 United States, resulting in more than 443,000 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 2019 more than 5 million youth reported using e-cigarettes within the past 30 days; over 10 percent, approximately 1.2 million, middle schoolers reported usage, and over 27 percent, more than 4 million high schoolers, reported usage. With the drastic increase in youth Electronic Nicotine Delivery Systems (ENDS) initiation, FDA is currently prioritizing ENDS prevention messaging to youth.

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 multiple public education campaigns. As one example, FDA launched “The Real Cost,” in February 2014, seeking to reduce tobacco use among at-risk youth ages 12–17 in the United States who are open to smoking cigarettes or have already smoked between 1-99 cigarettes in their lifetime. A complementary evaluation study, "Evaluation of the FDA’s Public Education on Teen Tobacco (ExPECTT)," was designed and implemented to measure awareness of and exposure to “The Real Cost” among youth ages 12–17 in targeted areas of the United States. This study assessed the campaign’s impact on outcome variables of interest from November 2013 – November 2016 (the full study can be found here, and the campaign’s website is here).

Accurately evaluating the effectiveness of FDA’s public education activities is increasingly challenging as message delivery becomes more fractured across digital and social media platforms. Traditionally, mass media tobacco public education efforts have used television as the primary channel to reach their target audience. This is still an effective way to achieve high reach and frequency among some populations; however, most tobacco education campaign messaging strategies also include use of digital and social media. These digital platforms offer unique targeting capabilities, are preferred by more users, and have lower costs driving up the use of digital media among at risk groups, such as youth and young adults. However, evaluating the effects of messages on these digital channels is an ongoing challenge. 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.

Patterns of youth tobacco use are also becoming highly varied in the United States. Youth are using multiple products or adopting new products at high rates. Target audiences for anti-tobacco public education campaigns are changing rapidly as companies develop new products and groups who use products shift. These challenges cause public education campaigns to need more and specific information more quickly.

To meet these challenges, this requirement has two components. First, developing a long-term evaluation study to measure the effectiveness of CTP’s public education campaigns across all media platforms. Second, to provide regular reporting on the ever-changing tobacco landscape. To understand this evolving landscape, the public education campaigns need additional data to make evidence-based decisions. An outcome study with a longitudinal design does not provide information rapidly enough for the public education campaigns to make these decisions. Therefore, in addition to the outcome evaluation study, there are a series of cross-sectional studies to be developed throughout the period of performance that will enable faster, data-driven decision-making.

2. OBJECTIVES

The purpose of this task order is to provide FDA with the required resources to conduct an outcome evaluation study and to report regularly on tobacco products, target audiences and challenges in maintaining an effective tobacco prevention and cessation effort.

Specifically, the outcome evaluation must meet 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 public education campaigns contribute to reducing tobacco use among at-risk youth and young adults ages 12 up to 25. FDA’s goal is to evaluate whether future waves of its public education campaigns, such as “The Real Cost”, aired across TV and digital media platforms, will influence any of the following outcome objectives:

· Awareness of and receptivity to campaign messages;

· Engagement with campaign messages on all forms of media (e.g., digital video, national television and social media);

· Changes in tobacco-related knowledge, attitudes and beliefs (KABs);

· 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.

· Assessing the influence of parents and/or other close family/friends on tobacco use and/or knowledge and attitudes related to tobacco use

In addition, FDA requires complementary rapid and frequent cross-sectional studies. These studies will gather, analyze and report on relevant key metrics (such as awareness, KABs, media use, brand awareness, perceptions about ads, etc.), as well as tobacco-related use patterns and demographics. This data will ensure FDA’s tobacco prevention and cessation efforts remain effective in face of the dynamic tobacco industry.

3. SCOPE OF WORK

The outcome evaluation study design will assess the scope and effectiveness of FDA’s tobacco related public health education campaigns. To achieve these goals, the Contractor may propose designs that are community- and/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.

The complementary cross-sectional studies will have sufficient size and diversity to assess a representative sample to inform a national or regional public education campaigns on either movement in KABs or awareness among the target audience, specific user group or certain demographics.

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 IDIQ contract.

4. TASKS

The Contractor shall furnish all necessary services, qualified personnel, materials, equipment and facilities, not otherwise provided by FDA, as needed to perform the requirements of this task order. Additionally, in the performance of these tasks, the Contractor may need to communicate with other Contractors performing work in support of FDA. Contractors are advised that any direction must come from the Contracting Officer’s Representative (COR).

Task 1: Transition The Contractor shall complete an orderly transfer of all activities from the previous Contractor within one hundred and eighty (180) calendar days of the task order award or before expiration of the previous Contractor’s order September 25, 2022, whichever comes first. Contractors shall coordinate and collaborate during the transition period, but all tasks will be directed by the COR. The Contractor shall:

· Lead a transition planning meeting no later than fifteen (15) days after the kick-off meeting. The purpose of the meeting shall be to walk through the Contractor’s detailed plan for transitioning all research and evaluation tasks and all government assets from the prior Contractor in a manner that is least disruptive to ongoing activities. The transition plan shall include at a minimum: a timeline for all activities, a list of all assets (materials, data and systems, codes, reports, documents, etc.) necessary to complete the transition, an initial schedule for regular transition meetings, and specific points of contact to manage and track all activities.

· Participate in meetings with the previous contractor and the Government as necessary and at the COR’s discretion to affect a smooth transition and receive detailed information on the operation of the prior contract.

· Verify receipt from the previous contractor or CTP of complete documentation and all Government furnished property, materials, data and systems, codes, and status reports on any outstanding elements of the order and promptly notify the COR of any omissions or deficiencies, including:

· Background materials and other relevant materials for materials development activities, to include resource files, planning documents, final contract documents.

· Systems developed or maintained, or any other program used to track work flow and archive projects maintained and developed under this contract.

· Administrative documents (plans, reports, etc.).

· Data-related items (questionnaires, data, etc.)

· 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.

TASK 2: Secondary Research: To inform the evaluation of FDA’s public education campaigns and related messages delivered on all types of media platforms, the contractor shall collect comprehensive background information using literature reviews, secondary data analysis, informational interviews with subject matter experts and other methodologies. The purpose of this research is to assess the impact and effectiveness of CTP’s public education campaigns on reducing tobacco-related death and disease.

CTP is currently exploring different methodologies for how best to adjust paid media delivery strategies to meet the changing media landscape. Additionally, this research shall assess 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 prior approval of the COR, the Contractor shall make arrangements with up to twelve (12) subject-matter experts (SMEs) from Federal, State and local governments, private industry, and academia to provide specialized expertise on selected scientific, technical, and methodological issues pertaining to the study. These may include gathering expertise on 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 to conduct the interviews.

TASK 3: Outcome Evaluation Study:

Task 3 is divided into two sections: Tasks 3.1 – 3.9 – study design and implementation, and Tasks 3.10 – 3.15 reporting and manuscript development.

Study Design and Implementation: The Contractor shall design and implement an outcome evaluation study for “The Real Cost” public education campaign. This includes developing an evidence-based study design, and the study implementation process, including obtaining the necessary approvals. Initial steps toward the creation of this evaluation include collaborating with CTP staff and campaign contractors and sub-contractors (at the direction of the COR) to develop initial recommendations for an appropriate evaluation framework. The framework shall include specific steps (e.g., data collection, goal of data analysis, etc.).

Reporting, Manuscript Development and Communication with the Government: The Contractor shall perform in-depth analyses of primary and secondary data on knowledge, attitudes, beliefs, and behaviors linked to CTP’s public education 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.

3.1: Draft Evaluation Plans

The primary evaluation questions outlined 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., including, but not limited to the National Youth Tobacco Survey, National Adult Tobacco Survey, the National Survey on Drug Use and Health, and Monitoring the Future).

Within sixteen (16) weeks after the effective date of the task order, the Contractor shall submit to the COR a draft evaluation plan for continuing data collections of public education campaigns 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) methods that address the need to assess the effectiveness of campaign messages delivered across media platforms (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.

3.2: Final Evaluation Plans

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 finalizes study design and implementation recommendations.

3.3: Draft Data Collection Protocols and Procedures Manuals

The Contractor shall develop and submit draft data collection protocols and a procedures manual to the COR twenty-four (24) weeks after the effective date of the task order. This submission shall include materials related to the campaign evaluation activities, including Federal Wide Assurance and internal operating procedures that ensure 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.

The Contractor shall ensure compliance with Federal privacy policies, laws, and regulations, including but not limited to Privacy Act and E-Government Act of 2002 requirements and Agency privacy trainings. This includes ensuring Privacy Impact Assessments (PIAs) are completed for federal information systems that process, contain, or store federal information under the management of the Contractor. The Contractor shall also ensure personally identifiable information (PII) in any format, electronic or hard copy, is protected and secured, and disposed of when no longer required in accordance to records disposition schedules. The Contractor, at the direction of the COR, may coordinate with the Agency’s Privacy Representative to complete these tasks.

If necessary to the work, the Contractor shall work with the COR to determine the security category of the information and information system in accordance with FIPS 199, “Standards for Security Categorization of Federal Information and Information Systems”, and then the Contractor shall apply the appropriately tailored set of Low, Moderate, or High impact baseline security controls in NIST 800-53. The Contractor shall use FDA technical guidelines, NIST guidelines, Center for Internet Security (CIS) guidelines (Level 1), or industry best practice guidelines in hardening their systems, as deemed appropriate by the Authorizing Official.

3.4: Final Data Collection Protocols and Procedures Manuals

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

3.5: 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. The data management plan shall include system requirements and types of data to be inputted into the system. The analysis plan(s) shall include proposals of how the Contractor intends to track, gather, analyze and report requested data, including descriptions of potential sources of data. At minimum, 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.

At minimum, the analysis plans shall include:

· research question(s) and hypotheses;

· dataset(s) to be used;

· if applicable, sampling criteria;

· if applicable, study procedure;

· sample inclusion/exclusion criteria;

· variables to be used in the main analysis (e.g., the main exposure, outcome, and stratifying variables); and

· statistical methods and software to be used.

3.6: Final Data Management and Analysis Plans

Within one (1) week of receiving the COR’s feedback on the draft plans submitted under Task 3.5, the Contractor shall submit to the COR final data management and analysis plans that incorporates the COR’s comments.

3.7: Data Collection and Analysis (Evaluation Implementation)

Within three (3) weeks of receiving notice from the COR of final OMB and FDA Institutional Review Board (IRB) 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.

The Contractor shall develop planning documents; including Office of Management and Budget and FDA IRB protocols (including instruments, assent and consent forms, etc.), an associated timeline for development, submission and revisions, and data analysis plans for the outcome evaluation of “The Real Cost”.

3.8: 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 FDA IRB clearance packages for any data collection that includes human research subjects. Up to twenty-four (24) clearance packages may be requested. All associated protocols (e.g., discussion guides, consent forms, etc.) 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 shall be conducted prior to obtaining clearance.

For research exempt from the requirements of 45 CFR Part 46:

1. The Contractor will submit to FDA a letter from their IRB or human subject protection entity that the proposed research is exempt (see 45 CFR 46.104).

1. In accordance with SMG 9001.4, FDA will follow its procedures for exempt research determination. Data collection from human subjects cannot commence under this contract until the FDA COR provides the Contractor with the outcome of the FDA determination.

For nonexempt human subjects research:

(a) The Contractor agrees to protect the rights and welfare of human subjects involved in research under this contract by complying with 45 CFR Part 46 and the clause at HHSAR 352.270-4b.

(b) Initial proof of compliance with 45 CFR Part 46 shall consist of:

(1) A copy of a current Federal-wide Assurance on file with OHRP (https://www.hhs.gov/ohrp/federalwide-assurances-fwas.html). The copy of a current Federal–wide Assurance shall be included with the Contractor’s proposal;

(2) A letter from the Contractor’s local IRB (the Institutional Review Board (IRB) specified in the Offeror’s Assurance of Compliance) stating that it has reviewed and approved the proposed research protocol. The letter from the local IRB shall be submitted to the Contracting Officer Representative (COR).

(3) In accordance with SMG 9001.4, the FDA will determine if FDA is considered engaged in the research for purposes of 45 CFR part 46. Data collection from human subjects cannot commence under this contract until the FDA COR provides the Contractor with the outcome of the FDA determination. When that determination is made, the FDA will confirm the extent to which the terms of “352.270-11 Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required” apply.

The COR shall deliver the clearance package to OMB and FDA IRB for review.

3.9: Final ICR Documentation for Clearance Packages The COR will transmit proposed revisions from OMB and/or FDA IRB to the Contractor. The Contractor shall deliver final clearance packages to the COR that incorporate all comments from the COR, OMB, and FDA IRB within one (1) week of receiving OMB and FDA IRB comments.

3.10: Interim Written Reports

The Contractor shall submit up to eight (8) interim written reports that synthesize data collection and analyses to date over the 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 “The Real Cost” 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 include graphics, figures, and tables as necessary.

3.11: 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.

3.12: 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 analyses over the performance period.

3.13: Final Written Report

The Contractor shall submit a final written report synthesizing all data collection and analyses conducted over the performance period. This report shall be submitted at least four (4) weeks prior to 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 also include graphics, figures, and tables as necessary.

3.14: Manuscript Development Support

The Contractor shall develop up to six (6) 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 Contractor shall submit each manuscript concept within three (3) weeks of COR request. Following approval, the Contractor will work with CTP to develop up to six (6) draft manuscripts for submission. CTP shall handle submission of manuscripts for publication in peer reviewed journals.

3.15: 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. The COR may request up to six (6) PowerPoint presentations and/or sets of briefing materials.

TASK 4: Ongoing Communication and Status Reports

The Contractor shall have regular/routine communication between the COR and Project Officer.

4.1: Kickoff Meeting

The Contractor shall conduct a kickoff teleconference with the COR to commence work on the task order and review the roles and responsibilities of all stakeholders within ten (10) working days of the effective date of this order.

The Contractor shall contact the COR within three (3) working days of the effective date to schedule the kick-off meeting. The Contractor shall also provide meeting minutes within two (2) working days after the kickoff meeting.

The Contractor shall plan for a monthly project status meeting with the COR to discuss the current status of the project. The Contractor shall provide an agenda at least two business days in advance of each meeting.

4.2 Monthly Progress Reporting

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. If the tenth business day falls on a holiday, then the report shall be submitted the next working day. 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; specifically, amount of labor and other direct costs spent over the past thirty days, as well as cumulatively for the period of performance to date; an estimate of the next 30 days spending for labor and ODCs, and showing how spending levels align to the remaining period of performance

· 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 may attend up to four (4) in-person meetings per contract performance year at CTP offices at 10903 New Hampshire Ave, Silver Spring, MD 20993.

4.3: Travel for In-Person Meetings

The Contractor may have up to four (4) meetings per year with CTP staff at the FDA White Oak campus. The Contractor shall estimate that up to four (4) people will be traveling for these meetings.

TASK 5: Cross-Sectional Study of Relevant Key Metrics for “The Real Cost”: The contractor shall collect primary cross-sectional data among the target audience for “The Real Cost” campaign to report on key metrics (e.g., such as awareness, KABs, media use, brand awareness, perceptions about ads, etc.) to assess ad impact and inform recommendations on the implementation of the public education campaign. This cross-sectional data will provide FDA rapid and ongoing insights on relevant key metrics, ensuring FDA’s tobacco prevention and cessation efforts remain effective in face of the dynamic tobacco industry. For the purposes of responding to this statement of work, assume a monthly panel recruitment of up to 2,000 youth and young adults age 12-25. The government expects this task will implement the same steps as Task 3.1 – 3.15, however, the Offeror may propose eliminating some tasks, as appropriate.

TASK 6: Cross-Sectional Study of Relevant Tobacco-related Use Patterns for Public Education Campaigns - OPTIONAL: Due to the ever-changing tobacco environment, timely information about public education campaigns stratified by groups of youth who use specific tobacco products is needed. To help FDA understand the perception of the agency’s communication interventions among ever changing populations, specific cross-sectional studies will need to be implemented. The Contractor shall collect primary cross-sectional data to report on the measurement of key metrics (e.g., such as awareness, KABs, media use, brand awareness, perceptions about ads, etc.), to assess information by categories of user groups of specific tobacco products. For the purposes of responding to this statement of work, assume a series of monthly cross-sectional studies using panel recruitment of up to 2,000 youth age 12-25 who use a specific tobacco product. The government expects this task will implement the same steps as Task 3-1 – 3.15, however, the Offeror may propose eliminating some tasks, as needed. The government anticipates this task to occur in Year 2 of the period of performance.

TASK 7: Cross-Sectional Study of Relevant Key Metrics for Public Education Campaigns by Demographics- OPTIONAL: FDA has additional public education campaigns that require information provided by timely cross-sectional research among different target populations (e.g., African American, Hispanic/Latino, Asian, or others), than is represented by the Task 5 study. This demographic based study will help the FDA understand perceptions of the agency’s interventions among these at-risk populations. The contractor shall collaborate with FDA to determine which demographic populations to target and then shall collect primary cross-sectional data among them, enabling the reporting of key metrics (e.g., such as awareness, KABs, media use, brand awareness, perceptions about ads, etc.), by certain demographics. For the purposes of responding to this statement of work, assume a series of monthly cross-sectional studies using panel recruitment of up to 2,000 youth age 12-25 of a specific demographic. The government expects this task will implement the same steps as Task 3-1 – 3.15, however, the Offeror may propose eliminating some tasks, as needed. The government anticipates this task to occur in Year 2 of the period of performance.

5. 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.

Transition-In Plan

Task 1

Draft Summaries of SME Interviews

Task 2

Draft Evaluation Plan

Task 3.1; (Also Task 5.1, 6.1 and Task 7.1, as needed and modified as appropriate)

Final Evaluation Plan

Task 3.2; (Also Task 5.2, 6.2 and Task 7.2, as needed and modified as appropriate) 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 3.3; (Also Task 5.3, 6.3 and Task 7.3, as needed and modified as appropriate) Number of protocols approved in final evaluation plan; One

(1) manual Within twenty-four (24) weeks of task order start.

Final Data Collection Protocols and Procedures Manual

Task 3.4; (Also Task 5.4, 6.4 and Task 7.4, as needed and modified as appropriate) Number of protocols approved in final evaluation plan; One

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

Draft Data Management and Analysis Plans

Task 3.5; (Also Task 5.5, 6.5 and Task 7.5, as needed and modified as appropriate)

Final Data Management and Analysis Plans

Task 3.6; (Also Task 5.6, 6.6 and Task 7.6, as needed and modified as appropriate)

Data Collection and Analysis (Evaluation Implementation)

Task 3.7; (Also Task 5.7, 6.7 and Task 7.7, as needed and modified as appropriate)

Draft ICR Documentation for Clearance Packages

Task 3.8; (Also Task 5.8, 6.8 and Task 7.8, as needed and modified as appropriate)

Final ICR Documentation for Clearance Packages

Task 3.9; (Also Task 5.9, 6.9 and Task 7.9, as needed and modified as appropriate)

Interim Written Reports

Task 3.10; (Also Task 5.10, 6.10 and Task 7.10, as needed and modified as appropriate)

Data Sets & Code Books

Task 3.11; (Also Task 5.11, 6.11 and Task 7.11, as needed and modified as appropriate)

Short-Turnaround Analyses

Task 3.12; (Also Task 5.12, 6.12 and Task 7.12, as needed and modified as appropriate)

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

Task 3.13; (Also Task 5.13, 6.13 and Task 7.13, as needed and modified as appropriate)

Manuscript Development Support

Task 3.14; (Also Task 5.14, 6.14 and Task 7.14, as needed and modified as appropriate)

Briefings/Testimony, Response and Conference Support

Task 3.15; (Also Task 5.15, 6.15 and Task 7.15, as needed and modified as appropriate)

Ongoing Communications and Status Reports

Task 4.2

6. CONTRACT TYPE

This is a time and materials task order

7. PERIOD OF PERFORMANCE

The period of performance shall be four years from the date of the award.

8. GOVERNMENT FURNISHED PROPERTY AND INFORMATION

There will be no Government furnished property or information as part of this task order.

9. TRAVEL

Travel will be billed in accordance with the Federal Travel Regulations.

10. PLACE OF PERFORMANCE

The place of performance is the contractor’s site, other than for required meetings at FDA’s White Oak campus or travel locations as associated with the scope of this task order.

ADDITIONAL INFORMATION

IRB AND OMB APPROVAL

The Contractor shall implement standard human subject protections, inclusive of security and privacy measures in accordance with the measures required of an Office of Human Research Protection registered Institutional Review Board (IRB) with an affiliated research institution.

No recruiting or data collection is to begin until IRB approval is given and there is approval from the Office of Management and Budget (OMB). The Contractor shall not deviate from the approved research protocol without prior written authorization from the Project Manager. In the event a change must be made to one of the research protocols, no matter how small the change appears, the Contractor must seek and receive approval from the Project Manager.