Pharmapendium web based licenses

Notice of Intent to Sole Source The U.S. Food and Drug Administration intends to negotiate and award on a sole source basis to Elsevier B.V., under the authority 41 U.S.C. 253(c) (1), as set forth in FAR 6.302-1. This acquisition is in support of database software programs that are specific to FDA needs. The objective of the project is to provide the FDA Library with a site license for unlimited web based searching to PharmaPendium drug discovery resource tool that integrates excerpted preclinical, clinical, and post release safety data for 1500 users. The FDA requires online access to the accompanying Pharmacokinetics (PK) and Metabolizing Enzymes and Transporters (MET) Modules for drug discovery. Content includes: FDA Summary Basis of Approval, FDA Adverse Event Reporting System (AERS), Drug Monographs from Mosby's Drug Consult, Meyler's Side Effects of Drugs, RTECS data from the literature, European Medicine's Agency (EMA) European Public Assessment Reports - full scientific assessment reports of medicines authorized at the European Union level. The PK Module consists of a database with over 800,000 extracted lines of experimental pharmacokinetics exposure observations on animal and human studies reported in 1.4 million pages of FDA and EMEA regulatory content. Organized in hierarchical PK taxonomy. Unique data to the PK module. MET Module is the largest source of drug metabolizing enzyme data for drug-metabolizing enzymes and transporters and drug-drug interactions to avoid late stage drug failures due to unexpected changes in bioavailability. The Elsevier B.V. software program licenses must be maintained only by Elsevier B.V. who is, respectively, the manufactures. Only they have the specialized and proprietary source code knowledge of their software products. No other group has the rights to the source code and therefore is the only vendor capable of performing this requirement. The period of performance is for one (1) base year, plus two (2) one (1) year option periods. The NAICS code is 511120 and the size standard is 500. This notice of intent is not a request for competitive quotations. However, any firm that believes it can meet these requirements may submit a written response via email to Jacqueline Warren at the email address below by noon on August 21, 2015. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the above requirement. Information received will be considered; however, a determination by the Government not to compete the proposed acquisition based on responses to this notice is solely within the discretion of the Government. If no responses are received, the FDA will proceed with the sole source award to Elsevier B.V., Radarweg 29, 1043 NX Amsterdam, The Netherlands. The anticipated award date of this purchase order is around September 11, 2015. Any and all questions must be in writing only. If you have any questions regarding this announcement, please contact Jacqueline Warren at jacqueline.warren@fda.hhs.gov.