FDA-SS-1238678 ATTACHMENT SOW DRAFT 1 27 2021 4 05 PM.pdf

DRAFT

Center for Tobacco Products

Office of Science

Tobacco Youth and Young Adult

Sentinel Surveillance Reports

Statement of Work

1.0 Background

On June 22, 2009, President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act. This historic legislation granted the U.S. Food and Drug Administration (FDA) the authority to regulate tobacco products. The FDA then established the Center for Tobacco Products (CTP) to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by youth. CTP oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. To inform tobacco regulation, CTP’s Office of Science needs sentinel surveillance reports summarizing findings from existing data collection efforts implemented with youth and young adults about their use of tobacco products and other tobacco products, including e-cigarettes/vaping products; and related measures including access; experimentation; device type and flavor; knowledge, beliefs, and attitudes; exposure to pro-tobacco and anti-tobacco marketing.

1.1 Objectives

As a result of this Request for Proposal, the Government intends to obtain sentinel surveillance reports summarizing findings from existing surveys and other data collection efforts aimed at obtaining rapid and sentinel information on tobacco use (including use of e-cigarettes and vaping products) and related measures from youth and young adults.

2.0 WORK STATEMENT

a. For the base year and option years 1 – 4, the contractor shall provide FDA with reports summarizing data from their data collection efforts: including monthly reports from a continuous tracking survey implemented with an online sample of youth and young adults. This tracking survey should yield data from approximately 250 respondents (aged 15 – 24 years of age)/week(12 reports);

final reports from each wave/data collection effort of a longitudinal cohort study implemented with a nationally representative online panel of youth and young adults every 6 months (2 reports) OPTIONAL; and topic-specific reports (2 reports summarizing recent tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored e-cigarettes;

use of newly FDA-authorized tobacco products; do-it-yourself behaviors of youth and young adults related to tobacco products, such as mixing of e-liquids).

2.1 Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults

For the base year and option years 1 – 4, the contractor shall provide a total of 12 monthly reports (1/month) summarizing findings from their existing continuous tracking survey implemented with an online sample of youth and young adults. Each monthly report shall be delivered no more than 30 days after the last day of that month (e.g., a report based on data from May 1st- May 31st, 2021, should be delivered no later than June 30th, 2021). Each monthly report shall be delivered with a thorough and detailed documentation of the methodology employed for data collection and analysis.

The report shall include:

• A brief, organized summary of the key findings and overall results in a tabular format or other simple format approved by the government,

• A technical appendix documenting in detail the data collection methods employed and response rates achieved; data analytical methods and assumptions used by the Contractor to obtain the results described; and any additional detail related to the methodology necessary to help the government appropriately interpret the key findings and overall results, and

• A PowerPoint file to present the summary of the report.

2.2 Task 2: Reports from Existing Nationally-Representative Longitudinal Cohort Study of Youth and Young Adults - OPTIONAL For the base year and option years 1 – 4, the contractor shall provide a total of 2 reports report from each wave/data collection effort of their longitudinal cohort study implemented with a nationally representative online panel (2 reports). Each report shall be delivered no more than 30 days after the last date of data collection for that wave. Each report shall be delivered with a thorough and detailed documentation of the methodology employed for data collection and analysis.

The report shall include:

• A brief, organized summary of the key findings and overall results in a tabular format or other simple format approved by the government,

• A technical appendix documenting in detail the data collection methods employed and response rates achieved; data analytical methods and assumptions used by the Contractor to obtain the results described; and any additional detail related to the methodology necessary to help the government appropriately interpret the key findings and overall results, and

• A PowerPoint file to present the summary of the report.

2.3 Task 3: AdHoc Topic-Specific Reports

For the base year and option years 1 – 4, the contractor shall provide topic-specific reports (2 reports summarizing tobacco data from youth and young adults pertaining to a specific topic, e.g., access to tobacco products; use of flavored tobacco products). These reports shall be delivered by the end of each base period/option year.

2.4: Task 4: Meetings

A- Kick-Off Meeting- The contractor shall participate in a project kick-off call with FDA staff within 14 business days after award. The contractor shall meet with FDA staff to discuss the proposed work plan and proposed progress schedule. The contractor shall provide meeting minutes to FDA staff within 48 hours of meeting date.

B- Monthly Status Meetings-The contractor shall meet with FDA staff (via teleconference) on a monthly basis, or more frequently if necessary, to discuss progress. The contractor shall present and discuss deliverables completed during period; problems or issues projected or identified; and alternatives and/or recommended solution(s) for identified or projected problems or issues. The contractor shall provide meeting agendas at least 24 hours prior to meeting with FDA and shall provide meeting minutes to FDA staff within 48 hours of meeting date.

SECTION 5- DELIVERIES OR PERFORMANCE

5.1 CONTRACT PERIOD OF PERFORMANCE

If exercised, the contract period of performance for Tasks exercised during the Option Years is to be identified in each modification that exercises the respective option. The aforementioned period of performance terms for the options shall apply only if the Government exercises the option in accordance with FAR 52.217-9.

The actual Period of Performance shall be established at the time of contract award, but estimated dates are provided below for planning purposes:

Base Year Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults Task 2: Reports from Existing Nationally- Representative Longitudinal Cohort Study of Youth and Young Adults (OPTIONAL) Task 3: Ad-Hoc Topic-Specific Reports Task 4: Meetings

September 2021– September 2022

Option Year 1 Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults Task 2: Reports from Existing Nationally- Representative Longitudinal Cohort Study of Youth and Young Adults (OPTIONAL) Task 3: Ad-Hoc Topic-Specific Reports Task 4: Meetings

September 2022 – September 2023

Option Year 2 Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults Task 2: Reports from Existing Nationally- Representative Longitudinal Cohort Study of Youth and Young Adults (OPTIONAL) Task 3: Ad-Hoc Topic-Specific Reports Task 4: Meetings

September 2023 – September 2024

Option Year 3 Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults

September 2024 – September 2025

Task 2: Reports from Existing Nationally- Representative Longitudinal Cohort Study of Youth and Young Adults (OPTIONAL) Task 3: Ad-Hoc Topic-Specific Reports Task 4: Meetings Option Year 4 Task 1: Monthly Reports from Existing Online Continuous Tracking Survey of Youth and Young Adults Task 2: Reports from Existing Nationally- Representative Longitudinal Cohort Study of Youth and Young Adults (OPTIONAL) Task 3: Ad-Hoc Topic-Specific Reports Task 4: Meetings

September 2025 – September 2026

5.2 CONTRACTOR NOTICE REGARDING LATE DELIVERY

In the event the contractor, for any reason, anticipates or encounters difficulty in complying with the contract delivery schedule or performance date or in meeting any of the requirements of the contract, the contractor shall immediately provide written notification to the Contracting Officer, via the cognizant Contract Administration Service Office, if assigned, giving pertinent details.

This data shall be informational in character and that its receipt by the Government shall not be construed as a waiver by the Government of (a) any delivery schedule or date or (b) compliance with other requirements by the contractor or (c) any other rights or remedies provided to the Government by law or under this contract.

5.3 PLACE OF PERFORMANCE

It is expected that the Contractor shall perform all of its Task work at its own place of business.

Monthly status meetings can be held via teleconference or video conference. A kick-off meeting will be held after award via teleconference.

CONFLICT OF INTEREST

Organizational Conflict of Interest

a) The purpose of this section is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. The language of section VII applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co- sponsor, joint venture, consultant, or in any similar capacity.

(c) Definition of Conflict of Interest Conflict of interest means that because of other activities or relationships with other persons or organizations, a person is unable or potentially unable to render impartial assistance or advice to the Government, that the person's objectivity in performing the contract is or might be otherwise impaired, or that the person has or might acquire an unfair competitive advantage (see FAR 9.501).

(d) Contractor’s Conflict of Interest Responsibilities The individual contractor must be free of interest prior to performing under this contract. Any time prior to or during the performance of the contract the individual contractor believes that a potential or actual conflict exists, the individual should notify the contract officer and project officer. The contract officer will determine whether or not a conflict of interest exists and how to resolve or mitigate it. The contractor should not commence or continue working on the contract until directed by the contract officer.

(e) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

Prior to award, contractors that disclose potential or actual conflicts of interest shall submit a mitigation of conflicts of interest plan along with their technical and business proposals.

(f) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for default, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(g) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(h) Prime Contractor Responsibilities.– The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(i) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.