OBJECTIVES:   We describe the process and progress of the Foundation for the NIH Biomarkers Consortium Project Team, a public-private partnership of government, academia, non-profit, and industry.  The goal is development and qualification of a new ABSSSI PRO instrument incorporating reliable, well-defined and relevant endpoints for patients in terms of how they feel and function in clinical trials of antibacterial drugs for ABSSSI.  METHODS:  We adhered to the U.S. Food and Drug Administration (FDA) PRO Guidance for instrument development (2009) and the 2010 FDA qualification process for drug development tools (DDTs). This guidance describes the process for DDTs intended for use in multiple drug development programs, the goal of the current effort.  Once qualified, drug developers can use DDTs for the qualified context in Investigational New Drug (IND) and New Drug Application (NDA)/Biological License Application (BLA) submissions without FDA reconsideration of the DDTs suitability.  RESULTS:   The initial phase of instrument development included a literature review and gap analysis (see Cimms et al., 2013 ISPOR abstracts) and interviews with 9 clinical experts.  The most commonly reported symptoms were pain and tenderness across all ABSSSI subtypes- cellulitis (n=8), wound infection (n=7), and abscess (n=7).  These efforts led to the development of a study protocol and interview guide to elicit concepts from ABSSSI patients.  Following qualitative analysis of the interview transcripts, the team will draft a PRO instrument based on key concepts identified from ABSSSI patients and experts.  The draft PRO will be evaluated by an expert panel and refined through cognitive debriefing interviews with patients.  CONCLUSIONS:  A consortium-based approach was useful and efficient in developing a new draft PRO measure for ABSSSI, which incorporates published literature and data from qualitative interviews.  The team is planning a similar approach for development of a draft clinician reported outcome for ABSSSI and a CABP PRO.