ARRA-OS-PACES-Special_Notice

Per FAR 5.7 this notice is provided for information purposes only; therefore, FAR 5.203 does not apply. Recovery - For informational purposes only in compliance with the Transparency and Accountability Requirements associated with the American Recovery and Reinvestment Act. The Department of Health and Human Services/Food and Drug Administration intends on issuing a solicitation for a requirement that if awarded will use Recovery funds. THE NAICS CODE IS 541712 WITH A SMALL BUSINESS SIZE STANDARD OF 500 EMPLOYEES. This upcoming requirement is for the Partnership in Applied Comparative Effectiveness Science (PACES) which is an initiative that seeks to advance the science for such CER studies through leveraging available data, in particular the joint ARRA FDA-CER efforts, to form an enhanced standardized database, Janus. The Contractor will provide biological and clinically relevant computational expertise. The Contractor will work with FDA scientific and statistical experts to define questions, datasets and approaches for performing complex analyses for comparative and multi-study analyses on FDA and other large clinical datasets. As part of this effort the Contractor will conduct analyses on defined datasets including datasets previously developed as part the joint Janus initiative, where FDA Center specific questions will drive the data transformed, standardized and loaded into the Janus data warehouse. Additionally, the Contractor will be expected to participate in FDA-hosted scientific workshops that address issues such as methods for cross-study and other comparative analyses, best practices in CER, and candidate studies and their design and analysis methods. These strategies will also encompass clinical trial designs that can help advance personalized medicine and health outcomes both within and outside of the FDA.