Consumer Misuse of Nonprescription Drug Products: Expert Literature Assessment and Action Recommendation

Description: Consumer Misuse of Nonnprescription Drug Products: Expert Literature Assessment and Action Recommendation This is an RFI NOTICE to determine the availability and capability of small businesses (i.e. certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and woman-owned small businesses) for Consumer Misuse of Nonprescription Drug Products: Expert Literature Assessment and Action Recommendation This information is being sought 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). 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. No telephone inquiries will be accepted. FDA may consider soliciting services for a two year contract. Draft Objective: The objective of this project is to enhance the foundation on which CDER makes decisions about policy toward nonprescription products, specifically about how to use the existing health behavior and safety literature to better ensure proper use and prevent misuse. Draft Scope of Work: There are three principal tasks associated with this project: 1) Complete a comprehensive review of the literature from various pertinent health behavior domains (e.g., medical, safety, health literacy, marketing, consumer education, etc.) regarding the occurrence, causes, and outcomes of consumer misuse of nonprescription products. 2) Conduct a qualitative analysis of the available literature to identify major themes in the existing information and information gaps. 3) Acquire input from a representative group of nonprescription drug consumer behavior experts about the literature review and seek from them recommendations about policy improvements that CDER can consider for implementation. We may anticipate a firm fixed price type contract for one year. Viable parties shall provide the following: Part A. Capabilities and Technical Experience - Provide a capability statement describing how your company would provide Consumer Misuse of Nonprescription Drug Products: Expert Literature Assessment and Action Recommendation. Part B. Size of Business- Please provide your business size and submit copies of any documentation such as letters or certificates to indicate the firm's status. Part C. Organizational Conflict of Interest (OCI) - If any, provide disclosure of business activities of your company, your affiliates, your team members and affiliates of your team members which create either a conflict of interest or the appearance of a conflict of interest in the Consumer Misuse of Nonprescription Drug Products: Expert Literature Assessment and Action Recommendation. Part D. Cost Estimate- Provide a cost estimate in accordance with FAR Part 10, Market Research for the services (i.e. hourly rates, hours/days) and the number of hours for Consumer Misuse of Nonprescription Drug Products: Expert Literature Assessment and Action Recommendation Part E. Small Business - Describe your ability to meet the requirements in accordance with 52.219.14 - Limitation on Subcontracting. Responses shall be:  RFI Sought number ;  no more than ten (10) pages in length;  not submit marketing materials;  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.