Inactive

Modification 0002 changes the response date from July 1, 2021 to Aug 2, 2021 at 10:00AM Modification 0001 changes the response date from June 1, 2021 to July 1, 2021 at 10:00AM. The Drug Enforcement A... Modification 0002 changes the response date from July 1, 2021 to Aug 2, 2021 at 10:00AM Modification 0001 changes the response date from June 1, 2021 to July 1, 2021 at 10:00AM. The Drug Enforcement Administration’s (DEA) Diversion Control Division (DC), Drug and Chemical Evaluation Section is responsible for evaluating drugs and chemicals to determine whether these substances have abuse potential. These evaluations are used by DEA to support its domestic scheduling activities. In order for DEA to determine the abuse potential of drugs and chemicals, pharmacological, medical, epidemiological, and other scientific data for these drugs, when necessary, are needed to initiate the administrative procedure to place these substances under regulatory control according to the guidelines of the Controlled Substances Act (CSA). Recently, numerous designer substances with benzodiazepine-like activity have been abused in the United States and pose a significant risk to the public safety. Law enforcement and forensic laboratory databases have reported increased encounters of designer benzodiazepine substances. Severe consequences of designer benzodiazepine abuse include non-fatal overdoses and deaths. An increase in the likelihood of death occur especially when the designer benzodiazepines are combined with opioids. In the midst of the opioid epidemic, it is noteworthy that more than 30% of overdoses involving opioids also involve benzodiazepines according to the National Institutes of Health. Due to the immediate public health threat associated with these designer benzodiazepine substances, several of them have been placed under international control. In order to place designer benzodiazepine substances under national permanent control, pharmacological data is required. Anxiolysis is a pharmacological property that is associated with benzodiazepine drugs. The anxiolytic effects associated with benzodiazepines and related drugs have been reported to lead to abuse of this drug class. As such, DEA would like the vendor to assess the anxiolytic properties of the selected designer benzodiazepines in an in vivo pharmacological assay. Due to the time-sensitivity of this work, DEA is requesting that the pharmacological studies be initiated and completed in an expedient manner. Brief Description of work: For this project, DEA shall provide the designer benzodiazepine substances to the potential vendor. Therefore, the vendor should already have a Schedule II through V researcher registration (ideal) or be in the process of obtaining a Schedule II through V researcher registration. Researchers may obtain a schedule II through V research registration no later than 30 calendar days following notification of award. The vendor shall conduct preclinical anxiolytic evaluations of these substances in comparison to appropriate controls and reference standard benzodiazepine substances (e.g., midazolam, diazepam, alprazolam etc.). Each compound shall be assessed for benzodiazepine anxiolytic effects. The vendor shall provide DEA with investigational study results and a description of the methodology used to conduct the investigation in the form of a study report based on the timeline specified in this statement of work (SOW), if not earlier. The vendor shall evaluate up to 15 designer benzodiazepine substances. Upon award of the contract, the vendor shall be notified of the number of substances that shall be tested and the identity of these substances. The designer benzodiazepine substances shall be provided by DEA to the vendor in quantities sufficient for the proposed pharmacological studies. It is the vendor’s responsibility to purchase reference (control) compounds for the anxiolysis studies. Additional information is included in the attached RFQ. All questions, technical or otherwise, shall be in writing and received by the FACD.Proposal.Submission@dea.usdoj.gov no later than May 11, 2021 at 10:00 am EST. All questions and answers will be provided to contractors as an amendment to the solicitation prior to the quote due date. Quotes shall be submitted electronically by Aug 2, 2021 at 10:00 AM EST via email at FACD.Proposal.Submission@dea.usdoj.gov and Jennifer.b.jordan@usdoj.gov. Please reference 15DDHQ21Q00000059 in the subject line of the email quote submission.