Experimental Study on Little Cigars Topography

This is a Request for Information (RFI) to identify the capabilities of the marketplace of all interested parties, including individuals, academic institutions, businesses, or other public or private agencies. This request is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Food and Drug Administration (FDA) for any future solicitation. No official solicitation exists; therefore, please do not request a copy of a solicitation. If in the future an official solicitation is released, there is no guarantee that sources responding to this will be included on the source list. Telephone inquiries will not be accepted. The FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Do not send any material that requires a non-disclosure agreement or that may be business sensitive. Responses received that include a non-disclosure agreement or identify information that is business sensitive will not be accepted. Responses to this notice will not be returned. Mission and Objectives: FDA anticipates the need for data on flavored little cigars to assess if flavored little cigars, because of their appearance or type of tobacco used in the filler, are likely to be depicted as and consumed by tobacco users as a cigarette. This data will be critical to the FDA's understanding the risks to children and adolescents, how the risks of using these products are perceived by smokers and non-smokers, and how use of these products affects health. Such research may include, but is not limited to the following topics: - puff topography - physiological measures - subjective measures RFI Instructions: Please complete Part A, Specification Questionnaire, describing your company's capabilities; Part B, Size of Business and Part C, Estimated Dollar Value Range. Responses shall be: ? identified with the RFI number ; ? no more than five (5) pages in length; ? not submit published or unpublished completed analyses; ? Submitted to the email as indicated above. FDA makes no implied or in fact contract by issuing this RFI. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the FDA's view of the information received. Part A. Technical Capability Specification Questionnaire: 1. Do you or your company have access to existing smoking topography equipment? Please describe the types of smoking topography equipment you have access to, and your experience using it for research studies. 2. Does your company have the expertise to administer questionnaires on behavioral measures and for interpretation of the results (e.g. social scientists, statisticians)? Please describe the staff expertise in this area. 3. Does your company have the ability to provide a comprehensive written report, including tables, graphs, output arrays, etc? Please describe your experience with similar projects and the expertise of the staff utilized to perform that work. 4. What restrictions, if any, does your company place on sharing analyses with other government agencies or non-governmental organizations? Please describe the nature of any restriction (e.g., proprietary restrictions). Part B. Size of Business State whether your company is a large business, small business (and also state your socioeconomic status), College/University, or is a non-profit organization. Part C. Estimated Dollar Value Range Based on the government's mission and objectives, what dollar value range would you determine to be the most accurate rough estimate for the performance of such analyses. Based on the government's mission and objuective, what dollar value range would you determine to be the most accurate rough estimate for the performance of such analyses: More than $25,00 and under $100,000 Over $100,000 and under $600,00