MOU 225-24-012

MEMORANDUM OF UNDERSTANDING
BETWEEN THE
U.S. FOOD AND DRUG ADMINISTRATION
CENTER FOR TOBACCO PRODUCTS
AND
TRUTH INITIATIVE

I. Purpose:

The U.S. Food and Drug Administration (FDA)’s Center for Tobacco Products (CTP) and Truth Initiative® have a shared interest in tobacco use prevention and public education efforts for young people. The purpose of this collaboration is to foster and improve that shared interest.
FDA and Truth Initiative are referred to individually as “Party” and collectively as the “Parties.” This Memorandum of Understanding (MOU) establishes the framework for collaboration between the Parties to promote this shared interest.

II. Background and Authority:

FDA CTP is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which was signed into law in 2009 (Public Law 111-31 [H.R.
1256]). The purposes of the Tobacco Control Act include ensuring that FDA has the authority to address the use of tobacco by young people and that consumers are better informed regarding the health and dependency effects of tobacco products. FDA is authorized to collaborate with experts in science, medicine, and public health to, among other things, promote the public health. See Federal Food, Drug, and Cosmetic Act (FD&C Act), section 1003(b)(4), 21 U.S.C. § 393(b)(4). Additionally, FDA is authorized to conduct educational and public information programs related to the responsibilities of the FD&C Act. See FD&C Act, section 1003(d)(2)(D), 21 U.S.C. § 393(d)(2)(D). In 2014, CTP launched “The Real Cost” public education campaign with the goal of preventing tobacco use among teens. The impact of “The Real Cost” campaign is assessed through numerous research activities, including a nationally representative longitudinal cohort study.

Truth Initiative is a non-profit public health organization focused on tobacco prevention among youth and young adults. Truth Initiative utilizes mass media campaigns (truth®) to educate youth and young adults about the dangers of tobacco use, and evaluates the impact of this campaign on changing tobacco-related attitudes, beliefs, and behaviors with a longitudinal cohort study - the Truth Longitudinal Cohort (TLC).

III. Goals:

The MOU seeks to further the missions of both Parties. The goals of this collaboration (described below) are to:

• Increase understanding of the impact of the combined effect of tobacco use prevention campaigns on psychosocial and behavioral outcomes (e.g., tobacco harm perceptions, tobacco use intentions, tobacco use initiation, tobacco use cessation) by analyzing outcome evaluation data from “The Real Cost,” the truth campaigns, and other relevant studies such as PATH; and
• Increase understanding of effective approaches for measuring youth and young adult awareness, attention, and reactions to tobacco product messaging, with a focus on ENDS and cigarettes.

The Parties intend to achieve these goals through harmonizing data from past evaluations and surveillance studies, which will allow for using different measures for similar constructs to assess similar outcomes. The primary goal of the proposed study will be to conduct retrospective analyses on collected data from evaluation studies of “The Real Cost,” the truth campaigns, and other relevant studies. Depending on the findings from the retrospective analyses, we may explore future prospective analyses. This effort would allow for the synchronization of data for future outcome evaluation studies from CTP’s and Truth Initiative’s ENDS/cigarette prevention and cessation campaigns.

IV. Roles and Responsibilities of the Parties:

Under an existing IDIQ contract, FDA CTP and Truth Initiative will collaborate with a third- party contractor, RTI International (RTI), to coordinate data sharing and harmonization. In order to safeguard and protect each Parties’ campaign evaluation data, FDA CTP will not have access to Truth Initiative’s campaign evaluation data, nor will Truth Initiative have access to FDA CTP’s campaign evaluation data. RTI will serve as an intermediary who will house, harmonize, and analyze data from both FDA CTP and Truth Initiative. RTI can enter into a data use agreement(s) (DUA) with Truth Initiative and FDA CTP to facilitate data sharing. RTI will be the only entity that has access to FDA and Truth Initiative’s data, and the combined and harmonized dataset will be housed on RTI’s secured servers.

• FDA CTP will be responsible for:
  1. Designating staff members and a study liaison to oversee study activities;
  2. Coordinating the sharing of data and data documentation (e.g., codebooks, survey documents) from CTP’s ENDS/cigarette prevention campaign longitudinal evaluation to be harmonized with Truth Initiative data;
  3. Identifying, in conjunction with Truth Initiative, measures from FDA CTP’s longitudinal survey that could be added to future waves of the Truth longitudinal survey;
  4. Developing, in conjunction with Truth Initiative, a data analysis plan that includes the specific aims and research questions, as well as the methods, analysis, and plans for dissemination. Both FDA CTP and Truth Initiative must agree on the analysis plan before any data analyses are conducted, by RTI. The agreement must be in writing, with the agreement made by delegated liaisons;
  5. Reviewing all analyses and results from the data harmonization analyses;
  6. Approving all documents drafted as part of this collaboration (e.g., manuscripts, presentations, reports) for dissemination and ensuring that all authors included on external publications, abstracts, and presentations adhere to the guidelines for authorship as established by the 2022 International Committee of Medical Journal Editors (ICMJE). Both Parties must agree to the content and format of the dissemination;
  7. Obtaining all required FDA clearances for external dissemination of findings resulting from the collaboration discussed in this MOU (e.g., presentations and manuscripts).
• Truth Initiative will be responsible for:
  1. Designating staff members and a study liaison to oversee study activities;
  2. Coordinating the sharing of data and data documentation (e.g., codebooks, survey documents) from Truth Initiative’s ENDS/cigarette prevention and cessation campaign longitudinal evaluation to be harmonized with FDA CTP data;
  3. Identifying, in conjunction with FDA CTP, measures from CTP’s longitudinal survey that could be added to future waves of the Truth longitudinal survey;
  4. Developing, in conjunction with FDA CTP, a data analysis plan that includes the specific aims and research questions, as well as the methods, analysis, and plans for dissemination. Both FDA and Truth Initiative must agree on the analysis plan before any data analyses are conducted. The agreement must be in writing, with the agreement made by delegated liaisons; ;
  5. Reviewing all analyses and results from the data harmonization analyses;
  6. Approving all documents drafted as part of this collaboration (e.g., manuscripts, presentations, reports) for dissemination and ensuring that all authors included on external publications, abstracts, and presentations adhere to the guidelines for authorship as established by the 2022 International Committee of Medical Journal Editors (ICMJE). Both Parties must agree to the content and format of the dissemination.
  7. Obtaining all required Truth Initiative clearances for external dissemination of findings resulting from the collaboration discussed in this MOU (e.g., presentations and manuscripts).

V. General Provisions:

This MOU represents the broad outline of the Parties’ intentions to collaborate in areas of mutual interest. All activities discussed in this MOU that the Parties may undertake are subject to the availability of personnel and resources. This MOU does not affect or supersede any existing or future understandings or arrangements between the Parties and does not affect the ability of the Parties to enter into other understandings or arrangements related to this MOU. This MOU does not create binding, enforceable obligations against either Party. This MOU and all associated agreements will be subject to the applicable policies, regulations, and statutes under which FDA and Truth Initiative operate. Nothing in this MOU alters the statutory authorities or obligations of FDA CTP. The Parties recognize that this MOU is not intended to and may not be relied on to create any right or benefit, substantive or procedural, enforceable by law by any Party or against any Party.

With respect to any information gained as a result of the collaboration established by this MOU, neither Party may use information in any way so as to suggest the other Party’s endorsement of any third-party product, program, person and/or initiative without the explicit written consent of the other Party.

VI. Information Sharing:

Either Party’s access to any deliberative, pre-decisional, confidential, non-public information of the other Party shall be governed by separate Confidential Disclosure Agreements in which the Parties will agree and certify in writing that they shall not further release, publish or disclose such information, except as required by law, and that they shall protect such information in accordance with the provisions of 21 U.S.C. § 331(j), 21 U.S.C. § 360j(c), 18 U.S.C. § 1905, and other pertinent laws and regulations governing the confidentiality of such information. No proprietary data, trade secrets or patient confidential information shall be disclosed among the Parties unless the Parties have executed a Confidential Disclosure Agreement covering such data and such disclosure is permitted by applicable law. Such Confidential Disclosure Agreements may be part of, or be executed pursuant to, Supplemental Agreements covering specific collaborations.

VII. Term, Termination, and Modification:

1. This MOU, when accepted by both Parties, will have an effective period from the date of the latest signature until five years from the date of such signature, unless earlier terminated under the terms of this MOU.
2. This MOU may be terminated by either Party upon a 30-day advance written notice to the other Party.
3. FDA CTP reserves the right to terminate this MOU immediately when, in FDA CTP’s sole judgment, immediate termination is necessary to prevent fraud or malfeasance, to protect public health and safety, or to prevent harm to FDA CTP resources and reputation.
4. This MOU may be extended, renewed, or modified only by mutual, written consent by both Parties.
5. This MOU creates a non-exclusive relationship between the Parties. Either Party may collaborate with multiple organizations on any given public education campaign with no exclusive collaboration association, implied or actual; and
6. This MOU is not a contractually binding agreement between the Parties, nor is it a funds or resource obligating document.

VIII. Dispute Resolution:

The Parties agree that in the event of a dispute between them, FDA CTP and Truth Initiative shall promptly use their best efforts to resolve the dispute in an informal fashion through communication and consultation, or other forms of non-binding alternative dispute resolution that are mutually acceptable to the Parties.

IX. Contacts

Food and Drug Administration

Anh (“Bao”) Zarndt
Director, Research and Evaluation
Center for Tobacco Products
Office of Health Communication and Education
U.S. Food and Drug Administration
Phone: (240) 994-2023
Email: anh.zarndt@fda.hhs.gov

Kathleen Case
Social Scientist, Division of Research and Evaluation
Center for Tobacco Products
Office of Health Communication and Education
U.S. Food and Drug Administration
Phone: (240) 695-4886
Email: kathleen.case@fda.hhs.gov

Morgane Bennett
Supervisory Scientist, Division of Research and Evaluation
Center for Tobacco Products
Office of Health Communication and Education
U.S. Food and Drug Administration
Phone: (240) 750-5996
Email: morgane.bennett@fda.hhs.gov

Truth Initiative®
Elizabeth C. Hair
Senior Vice President, Schroeder Institute
Truth Initiative®
Phone: (202) 454-5760
Email: ehair@truthinitiative.org

Jessica Rath
Vice President, Schroeder Institute
Truth Initiative®
Phone: 202-454-5772
Email: jrath@truthinitiative.org

Shreya Tulsiani
Research Manager, Schroeder Institute
Truth Initiative®
Email: stulsiani@truthinitiative.org

MOU Execution

Executed in duplicate on the dates indicated below:

/s/
April Brubach, Deputy Director, Office of Health Communication and Education Center for Tobacco Products, U.S. Food and Drug Administration
Date: 06/04/2024

/s/
Truth Initiative
Anthony T. O'Toole
Executive Vice President and Chief Financial and Investment Officer
Date: 06/11/2024