Intent to Sole Source: NAICS Code: 511210 Software Publishers - Applications software, computer, packaged. The US Environmental Protection Agency (EPA) intends to negotiate, on a sole source basis, with Lhasa Limited (Lhasa Ltd), a firm fixed-price purchase order under Federal Acquisition Regulation (FAR) Part 13 Simplified Acquisition Procedures (SAP) for the purchase of annual license(s) for Derek Nexus (DX), an extensive expert knowledge-based toxicity software package, and related Meteor Nexus (MX), an expert knowledge-based biotransformation software package, for EPA's Office of Research and Development (ORD), National Center for Computational Toxicology (NCCT), Immediate Office (IO) located in the Research Triangle Park (RTP), NC. The purchased license(s) will allow for the use of Lhasa Ltd.'s proprietary software for 5 users at 1 primary site for the term of 1 year with the option to extend the purchase order for an additional two 1-year periods of performance. The NCCT has an innovative program which includes the generation of high-throughput screening data for thousands of chemicals and the development and application of quantitative structure-activity relationship ((Q)SAR) models for the prediction of relevant toxicities. The DX software package is a unique knowledge-based expert system that houses a vast collection of +500 structural-alerting rules for more than 50 toxicity outcomes of interest to the Agency. The related MX software package is a metabolism prediction system similarly built upon expert knowledge of biotransformation structural-alerting rules, particularly focused on capturing biotransformations that are known to mediate chemical toxicity. The MX software is distinguished from other commercial metabolism predictors by its extensive coverage of nonCYP (Cytochrome P-450) type metabolic transformations known to pertain to toxicity, which are estimated to account for more than half of the known metabolically activated carcinogens in the ToxCast Phase I dataset, its reliance on expert rules (rather than predictive models), and its extensive documentation and linkage to literature sources. This type of functionality has been developed over decades and supplemented by funding from Companies and other agencies to bring together as broad and comprehensive a pair of expert systems as possible. Re-creating this type of knowledge base is not feasible given the difficulties of compiling metabolism information and the insights from many experts to generate the mapped pathways and structure-activity relationship (SAR) rules. The DX and MX expert software packages are not open source, but the mechanistic underpinning is transparent and the breadth of comparable coverage is not replicated in any other commercial or public tool. Both software have been licensed by NCCT in the past, but the results need to be updated based on the additional chemistries that have since been tested in the different ToxCast and Tox21 assay platforms. A major limitation of the ToxCast and Tox21 testing programs, to date, has been the absence of metabolic activation in most of the current assay technologies. Past work with the DX and MX software systems within NCCT has shown that the combined use of these two programs can significantly enhance abilities to identify chemicals for which metabolic activation is likely to be required to produce toxicity. This knowledge will be used to refine toxicity prediction models and inform Adverse Outcome Pathway approaches. In addition, the systems are complementary to software used by other Lab/Centers within the EPA. Thus providing a unique opportunity to collaborate more effectively with other research groups and to exploit this expenditure to the fullest extent possible. Lhasa Ltd. is the only source capable of providing the proprietary DX software and related MX software packages. This purchase order is therefore being directed, without competition, to Lhasa Ltd. The circumstances permitting Other than Full and Open Competition at this time is FAR 13.106-1(b) Soliciting from a single source, only one responsible source and no other supplies or service will satisfy agency requirements. The intent of this synopsis is to state the Government's intention to sole source this acquisition and to determine if any other source(s) exist; and, therefore, no solicitation (RFQ) is available. All interested parties who believe they can provide the required service should 1) fully explain their capabilities and qualifications in writing and submit same via FedConnect, a government web portal, within 15 days from the date of this announcement; and 2) must submit itemized pricing, in US dollars, that is sufficient to make a determination that competition is feasible. Consequently, any responder(s) failing to provide the aforementioned data but instead choosing merely to submit a routine letter requesting a copy of the RFQ will not be honored. Offerors must submit all technical questions / responses concerning this synopsis electronically through FedConnect at www.fedconnect.net/Fedconnect/. This notice and any amendments will be available via the Internet at the following URL: www.fedconnect.net/FedConnect/ . You must register with FedConnect as an interested party to submit questions and to view responses. Vendors can register with FedConnect at www.fedconnect.net/FedConnect/. For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at
[email protected]. FedConnect is a web portal that connects agencies and vendors to streamline the process of doing business with the federal government. Through FedConnect contractors will be able to receive, review and respond to contract pre- and post-award actions and documents such as correspondence, request for proposals, tasking instruments and contract modifications. The use of FedConnect also furthers the EPA's commitment to moving towards a paperless acquisition environment by reducing its carbon footprint and conducting its business in an ecologically friendly manner. There is no charge to use FedConnect. In addition, all vendors must be registered in the System for Award Management (SAM), as this facilitates registration for FedConnect. Please note that vendors MUST have their SAM profile set to "public" otherwise FedConnect will not be able to access the SAM information required to validate vendor credentials. Registration may be completed and information regarding the registration process may be obtained at http://www.sam.gov. There is no charge for registration in SAM.