Notice of Intent to Sole Source - Emergent Screwworm Analysis

The United States Department of Agriculture, Agricultural Research Services (USDA-ARS) is issuing a notice of intent to sole source a contract for Emergent Screwworm Analysis. The objective of the intended sole source award is for the analyzation of samples for emergent screwworm research study in collaboration with the Food and Drug Administration (FDA) using validated, proprietary high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods to quantify drug concentrations of ivermectin and doramectin in bovine plasma samples. The following technical assessments for approximately 1,262 samples will be used: • Validation of a proprietary LC-MS/MS method in accordance with CVM guidance documents and applicable regulatory guidelines to ensure accuracy, precision, selectivity, and reliability for use in veterinary drug studies conducted in the United States. • Quantitative Verification of drug concentrations using the validated LC-MS/MS method: precise quantification of ivermectin and doramectin in bovine plasma samples to meet the protocol requirements and allow for an estimation of the time to steady state as well as to compare initial and accumulated steady state concentrations for each animal; and the calculation of other PK parameters, as appropriate.