In vitro metabolic stability and metabolite identification of 14C-Benserazide

PURSUANT TO FAR Subpart 5.2-Synopses of Proposed Contract Actions, THIS IS A PRE-SOLICITATION NOTICE OF A PROPOSED CONTRACT TO ACTION. THIS IS A PRE-SOLICITATION NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The Office of Acquisition (OA) at the National Institute on Drug Abuse (NIDA) at the National Institutes of Health (NIH) under the Department of Health & Human Services (DHHS), on behalf of the National Center for the Advancement of Transalational Sciences (NCATS) intends to negotiate and award a contract for services to obtain contractor services for vitro metabolic stability test and metabolite identification (MetID) of 14C-Benserazide in hepatocytes of mouse, rat, dog and human to compare in vitro drug metabolism among different species by Covance Laboratories, Inc. located at 3301 Kinsman Blvd, Madison, WI 53704. The determination by the Government to award a contract without providing for full and open competition is based upon consistency with prior data results and continuity of science and on market research conducted. Specifically, sources sought type of notice, number NIHDA201800490, released on FedBizOpps from August 22, 2018 through August 29, 2018, indicates only one source of supply or service is capable of achieving this Government requirement. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541380 Testing Laboratories with associated small business size standard of $15 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular (FAC) 2005-99-1 / 07-16-2018. STATUTORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source. DESCRIPTION OF REQUIREMENT Project Description Statement of Work: 14C-Benserazide will be added to hepatocytes of mouse, rat, dog and human at a concentration of 1 uM for the metabolic stability test and 10 uM for the MetID study. After incubation at 37oC, aliquots of samples will be collected over 2 hours. The metabolic stability will be assessed by the disappearance rate of parent drug over time. The metabolic profiles will be generated by HPLC with a radioactivity detector. The mass spectrum characterization will also be conducted for major metabolite peaks to elucidate possible structures of these metabolites for each species. Controls with known metabolic rates and metabolic pathways should be used. Previously, Covance conducted in vivo MetID work for 14C-benserazide in micefor NCATS as a part of the pharmacokinetics, biodistribution, metabolism andexcretion (ADME) study, which was performed under a previous contract through Leidos, contract number 15x093T1. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the following tasks. Specifically: 1. Protocol generation 2. Dosing solution prep aration 3. Conducting in vitro metaboli c stability test in hepatocytes of mouse, rat, dog and human 4. Determine metabolic stability of 14C-benserazide 5. Generate metabolic profiles of 14C-benserazide f rom samples collected from hepatocytes of 4 species 6. Characterize the major metabolite structures for each species by mass spectrometry 7. Additional services include study scheduling, record keeping, in vitro study report gen eration. Period of Performance The in vitro metabolic st ability and MetID study in hepatocytes of 4 species should be completed in 2 months after contractor receipt of order. Award is anticipated not later than September 30, 2018. GOVERNMENT RESPONSIBILITIES NCATS will provide the materials to be profiled. NCATS will provide the study outline, review study protocol, provide test article, and communicate with Study Director or Staff Scientist during the study period to ensure that the study is conducted according to the protocol. DELIVERY OR DELIVERABLES 1. In vitro metabolic stability of be nserazide in hepatocytes of 4 species (mouse, rat, dog and human). 2. Structure identification of major benserazide metabolites generated from hepatocytes of 4 species (mouse, rat, dog and human). 3. In vitro metabo lic stability and MetID study report. 4. Contractor will confirm that the remaining 14C-ben erazide solution will be discarded per NCATS' instruction. Purpose and Objectives: The purpose of this requirement is to obtain contractor results of testing of differncees in vitro drug metabolism among different species prior to Phase I clinical trials in studying in vitro metabolic stability test andmetabolite identification (MetID) of 14C-Benserazide in hepatocytes of mouse, rat, dog and human. Results from this study will be used to: 1. Correlate in vitro and in vivo metabolic stability rates and metabolite formation profiles in mice, and 2. Compare in vitro metabolic stability and metabolite formation profiles among lab animal species and humans prior to the clinical trial in human subjects. For benserazide project, a mouse disease model is used to evaluate the drug efficacy, and rat (rodent) and dog (non-rodent) are used as safety evaluation species. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. In addition the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) at www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by September 10, 2018 at 12:00 PM Eastern and must reference the subject announcement number on all correspondences. Responses must be submitted electronically to Mr. Hunter Tjugum at contact@example.gov. FAX requests are not accepted. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.