Assay Development for AlphaLISA needed for COVID-19 research in NCATS TDB

AMENDMENT No.: 01, from February 23, 2021 PROPOSAL DUE DATE: 11:00 a.m., Eastern Time, on February 26, 2021 (changed) This amendment No.: 1 is to modify the combined synopsis/solicitation 75N95021Q00073, in order to provide with a revised Statement of Work (SOW) and to respond to formal questions submitted in response to the solicitation. The amendment No.:1 (G. Mod_1_5932377 -75N95021Q00073_Mod_and_questions) is attached in full. END OF AMENDMENT No.: 01 from February 23, 2021 (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is 75N95021Q00073 and the solicitation is issued as a request for quotation (RFQ). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13'Simplified Acquisition Procedures; and FAR Part 12'Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold. THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition to Southern Research Institute, 2000 Ninth Avenue South, Birmingham, Alabama 35205 for the Assay Development for AlphaLISA needed for COVID-19 research in NCATS TDB. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). The rationale for not providing full and open competition is based on the fact that the vendor has been involved in previous tests involving the same research. Moreover, NCATS does not have a lab biosafety level 3 (BSL-3). Thus, for consistency of data and continuity of research, this requirement shall be sole sourced to Southern Research Institute. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2021-04, with effective date January 19, 2021. (iv) The associated NAICS code 541380 and the small business size standard $16.5M. This requirement is not set-aside. DESCRIPTION (v) National Center for Advancing Translational Sciences (NCATS) Therapeutic Development Branch (TDB) program is requesting to measure SARS CoV-2 antiviral effect of remdesivir and the development of assay for AlphaLISA in biosafety level 3 (BSL-3) conditions. The current pandemic of SARS-CoV-2 requires the emergency response of NCATS to develop high-throughput cell-based assays for drug screening (HTS). The research conducted will target the infection and replication of the virus in various cell types that are clinically relevant. Moreover, NCATS is investigating the effect and toxicity of various compounds to cell-based assays against SARS-CoV-2. Specifically, the program is requesting to test the antiviral effect of remdesivir in VeroE6 cells using AlphaLISA assay. NCATS does not have a BSL-3 facility and therefore must procure this service from a contractor able to fulfill the requirement (vi) SCOPE OF WORK 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 Statement of Work below: The vendor shall set up the assay to do the testing. Testing shall be conducted in a high-throughput, 384-well plate format. NCATS is requesting the test in 30 plates. NCATS will ship vendor duplicate sets of assay ready plates (ARP) containing compounds. Vendor shall dispense media, cells, and SARS-CoV-2 virus into one set of ARP to run in vitro infection assay. After incubation, vendor will measure viability by ATP content. Vendor shall dispense media and cells to second set of ARP to run cytotox assay using ATP content. Vendor shall return raw data and control plate data to NCATS for analysis. SPECIFIC REQUIREMENTS The scope of this work will be divided into two different tasks: 1. Task - Measure SARS CoV-2 antiviral effect of remdesivir (non-GLP) Measure SARS CoV-2 antiviral effect of remdesivir with and without 24 hour pre-incubation in VeroE6 cells using AlphaLisa assay for nucleocapsid and spike proteins Compound will be tested in 10-point dose response with parallel cytotoxicity evaluation 2. Task - Assay Development for AlphaLISA (non-GLP) Determine optimal virus dilution, time course and assay volume to measure SARS-CoV-2 nucleocapsid and spike proteins by AlphaLISA in 384-well plates using A549 cells expressing ACE-2. Measure EC50 values of reference compounds (chloroquine, hydroxychloroquine, remdesivir, calpain inhibitor IV) in 10-point dose response in both assays using optimized conditions. Measure cytotoxic effects of compounds in a parallel A549 cell viability assay. Development will be conducted under biosafety level 3 (BSL-3) conditions. Government Responsibilities: 1. Provide assay-ready plates. 2. Perform data analysis.. Delivery or Deliverables: Raw data files and a calculated data report for references compounds shall be provided as the final report. Control plates shall also be returned to NCATS. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance to be 3 (three) months from the receipt of order (ARO) including the receipt of the assay-ready plates by the vendor. TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS (viii) The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items, applies to this acquisition. (ix) Offerors are to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications'Commercial Items, with offers. (x) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.212-4 Addendum - Supplier License Agreements, attached. FAR 52.212-4(g), Invoice, is supplemented by: NIH Invoice and Payment Instructions (Feb 2021) The following FAR provisions or clauses are incorporated by reference: 52.204-7, System for Award Management (Oct 2018) 52.204-13, System for Award Management Maintenance (Oct 2018) 52.204-16, Commercial and Entity Code Reporting (Aug 2020) 52.204-18, Commercial and Entity Code Maintenance (Aug 2020) 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015). (xi) FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders'Commercial Items, applies to this acquisition. (xii) HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A'Health Resources Priorities and Allocations System. EVALUATION (xiii) The provision at FAR clause 52.212-2, Evaluation-Commercial Items, applies to this acquisition. The Government plans to award a fixed-price purchase order resulting from this solicitation. The resulting award will be made to Southern Research Institute provided it is technically acceptable and at a fair and reasonable price. If multiple quotations are received, the Government will use comparative evaluations to evaluate quotations for technical capability, past performance, and price. An award will be made to the vendor whose quotation is most advantageous to the Government. SUBMISSION INSTRUCTIONS (xiv) In addition to 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) www.sam.gov. This synopsis is not a request for competitive proposals. All responsible sources may submit a bid, proposal or quotation which shall be considered by the agency. All responses must be received by 11:00 a.m., Eastern Time, on February 24, 2021 and reference Solicitation Number 75N95021Q00073. Responses must be submitted by email to Renato Gomes, Contract Specialist, contact@example.gov, tel. +1 (555) 000-0000. ATTACHMENTS (xvi) Attachments: Statement of Work (SOW) The provision at FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Oct 2020) FAR 52.212-4 Addendum - Supplier License Agreements The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders'Commercial Items (Jan 2021) NIH Invoice and Payment Provisions (Feb 2021)