Completion of Pharmacokinetics for the MAD Portion of the RR-HNK Phase 1 Study

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source basis with Labcorp Early Development Laboratories Inc for the Completion of Pharmacokinetics for the MAD Portion of the RR-HNK Phase 1 Study. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541380 - Testing Laboratories with a Size Standard of $19 million. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13'Simplified Acquisition Procedures. Contracts awarded using FAR Part 13'Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6'Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization). The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-01 dated December 30, 2022. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The National Center for Advancing Translational Sciences (NCATS) is currently developing a novel chemical entity for the treatment of depression. The lead compound has undergone extensive preclinical toxicology, demonstrating its excellent safety profile. In addition, its excellent antidepressant efficacy has been demonstrated in several animal models of depression. In alignment with the NCATS goals to advance translational science, the advancement of the novel chemical entity into clinical studies aimed to elucidate its antidepressant efficacy within man is of great importance. At present, NCATS has completed the phase 1 single ascending dose (SAD) and multiple ascending doses (MAD) studies in healthy volunteers. The goal of this contract is to finalize the pharmacokinetics of the MAD study and perform reconciliation of the two datasets alongside the clinical study report (CSR). This contract will provide for the shipping, receiving, processing, and analysis of all MAD pharmacokinetic samples (Plasma and Urine) from the phase 1 healthy volunteer study. This contract will also provide for the reconciliation process of all SAD and MAD PK data. The Contractor shall: Provide sample manifest documentation of the primary and back-up sample shipments including receiving declarations. Follow HHS, FISMA and IRB guidelines on the protection of human subjects assurance identification. Follow protocol and MOP requirements on sample handling and processing. Provide appropriate quality control review of all procedures, data, and reports. Provide final reports with complete data appendixes consistent with standard reporting of human pharmacokinetics data including standard parameters (e.g. AUC, Cmax, T1/2, Volume of distribution, etc.). Perform a full data reconciliation of the SAD and MAD pharmacokinetics datasets in support of the final Clinical Study Report and data close-out. DELIVERABLES: The Contractor must provide all final reports and data tables to the sponsor's representative for review prior to final sign-off and contract completion. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Labcorp Early Development Laboratories Inc is the only vendor in the marketplace that can provide the services required by NCATS . The intended source is: Labcorp Early Development Laboratories Inc 3301 Kinsman Blvd. Madison, WI 53704 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. 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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NCATS-23-002383. Responses must be submitted electronically to Sarah Adan, Contract Specialist, at contact@example.gov and Valerie Whipple, Contracting Officer, at contact@example.gov. U.S. Mail and fax responses will not be accepted.