A--Services-Mifepristone Levels in Human Plasma Samples - waiting on other teams BC to explain

THIS IS A NOTICE OF INTENT TO AWARD A SOLE-SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. The Department of Veteran Affairs NC03 would like to acquire a company specializing in specific DMPK and regulated bioanalysis methods necessary for successful assessment of mifepristone and its metabolites (RU 42633, RU 42698, and RU 42848). As such, GOL-11-080 requires either: a 'highly specialized' Contract Research Organization (CRO); or equipment capable of performing the required bioanalysis assays (not feasible as this would cost tens of thousands of dollars). A highly specialized CRO, with regard to the analysis of mifepristone and its metabolites, will be defined, for the purpose of our research study, as a company capable of performing the following tasks: " CRO must be able to handle a compound that is classified as hazardous according to OSHA. " CRO must have developed and validated a robust bioanalytical method for the quantification of mifepristone and its metabolites (RU 42633, RU 42698, and RU 42848). " CRO must have LC/MS/MS capability (see techniques available on Microconstant's website: http://www.microconstants.com/services/method-development-and-validation). " CRO must be able to evaluate measurements of both parent compound and metabolites as this is essential to fully interpret the results of our study (i.e., prior studies have demonstrated that a specific level may be associated with response to the drug in other mental conditions, e.g., psychotic depression). " CRO must utilize an assay sensitive enough to measure concentrations at the ng/mL level. " CRO must have prior experience with the specific analysis of mifepristone and its metabolites (RU 42633, RU 42698, and RU 42848). " CRO performing assay must be able to promptly repair any equipment needed to run the analysis via certified technicians. . The North American Classification System (NAICS) code for this acquisition is 541711. The Government intends to solicit and negotiate directly with Microconstants Inc. No solicitation package will be issued. This notice of intent is not a request for competitive proposals. However, if any interested party believes they can meet the above requirement, it may submit a statement of capabilities. The statement of capabilities must be submitted in writing and must contain material in sufficient detail to allow the government to determine if the party can perform the requirement. A determination to compete this action based on the responses received is in the sole discretion of the Government. All interested parties must express their interest and capabilities in writing via email to contact@example.gov. No faxed documents will be accepted. If no responsive statements are received by 7/17/15 at 4 PM EST, an award will be made to Microconstants Inc.