The U.S. Food and Drug Administration intends to award a single award Indefinite Delivery Indefinite Quantity (IDIQ) contract for services in support of the requirement entitled, “Multi-Method Consumer Perception Investigations.”
The FDA requires, on an as-needed basis, data on reactions and interpretations of consumers and other individuals regarding questions of immediate concern to CTP through formative, qualitative, and/or quantitative research methodologies to support CTP’s enforcement of matters relating to tobacco products’ labeling, marketing, advertising, and promotion and/or to support CTP’s rulemaking efforts, policy decisions, and guidance development…
The Contractor shall conduct and furnish all of the necessary personnel, materials, services, facilities, (except as otherwise provided), and otherwise do all things necessary for or incidental
to the performance of the functional areas set forth below:
- Copy Tests
- Focus Groups
- In Depth Interviews
- Literature Reviews…
The Contractor shall provide copy test services that may include stimuli construction, sample selection, and data collection on a national basis (with the capability of collecting data via internet), statistical analysis, and interpretation. The timing of the copy tests will be dictated by the needs of FDA and delineated in each task order. The Contractor may be required to complete multiple tests concurrently.
Representative activities under this functional area include but are not limited to:
- Develop protocol, questionnaire, and other study materials for data collection (including locating, editing, and/or creating stimuli provided by FDA), and obtain the stimuli (e.g., actual label, package, advertisement) in U.S. commerce and provide documentation of when and where the stimuli were located
- Provide FDA with a draft protocol, questionnaire, and screener and incorporate feedback and revisions to the final documents
- When necessary, obtain dual human subjects approval. Obtain IRB (Institutional Review Board) approval from contractor’s IRB to assure human subjects protection, and work in conjunction with FDA to obtain FDA RIHSC (Research Involving Human Subjects Committee) approval. Otherwise, ensure an appropriate IRB Authorization Agreement (IAA) is put in place to address human subject protections…
