Inactive

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Testing of Compounds for Block of Cardiac Ion Channels (i) This is a combined synopsis/solicitation for commercial items prepared in accordance ... NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION Title: Testing of Compounds for Block of Cardiac Ion Channels (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 75N95024Q000123 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 (including brand-name) to Pharmaron, Inc., 201 East Jefferson Street, Louisville, KY 40202 T:1-313-618-1689 for testing of compounds for block of cardiac ion channels. This acquisition is conducted as non-competitive for a commercial item or service and is conducted pursuant to FAR 13.106-1(b)(1). (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-06, with effective date December 4, 2023. (iv) The associated NAICS code 541380 and the small business size standard $19 million. This requirement is full and open with no set-aside restrictions. (v) This requirement is for testing of compounds for block of cardiac ion channels. (vi) Background: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives. The National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its tremendously productive pipeline and is innovative in a number of ways. NCATS brings together a diverse range of scientists, including medicinal chemists, biologists, toxicologists, and engineers, in order to ultimately translate basic science into real products and services that help improve people’s lives. Included in this process is the development of unique small molecules as potential anticancer agents. The kinases LATS1 and AKT are of interest to NCATS, especially in terms of the cellular inhibition of these enzymes. The objective of this requisition is to test 100 compounds against select kinases in a cellular NanoBret assay, in order to determine their relative inhibition of the relevant enzymes. In addition, the objective of this requisition is is to test 400 compounds against at least one of these kinases and/or, selected off target kinases in a biochemical inhibitory assay, in order to determine their relative inhibition of the relevant enzymes. Purpose: Project Requirements: 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 requirements of the purchase description. Specific Requirements: Small molecule inhibitors of IRAK1 and FLT3 kinase enzymes may be useful in the treatment of cancers such as MDS and AML. We have an ongoing program aimted at developing inhibitors of these enzymes, and have tested previous compounds in this series against these and other kinases using Pharmaron’s ion channel assays. The requirement: Test sixty (60) compounds in the series for block of the cardiac ion channels hERG, hNAV1.4 and hCav1.2 using Pharamaron’s patch-clamp or FLIPR assays. In performing the study described above, we need to employ the same assay platforms (Pharmaron’s patch-clamp or FLIPR assays) that were used to generate prior date on the program in order to maintain continuity of and and will: 1. Perform IC50-determining experiments, testing each of 60 small molecule compounds at 5 dose concentrations in duplicate, in patch-clamp assays for block of hERG and hNav1.5, and in FLIPR assays for block of hCAv1.2. The 60 compounds will be submitted for testing in four separate batches of 15 compounds per batch. 2. Contractor will run the assays using scientists that have significant experience (>5 years) in the testing of small molecule compounds in patch-clamp or FLIPR assays for block of hERG hNAV1.5 and hCav1.2. 3. In patch-clamp experiments, contractor must utilize equipment that allows for a gigaohm seal around the channel to ensure the generation of high-quality data. 4. Provide four comprehensive reports with the results of the experiments of each of the 60 compounds against hERG, hNav1.5 and hCav1.2; one report for each of the four batches of compounds. Level of Effort: Estimated personnel: 1 PhD level-Manager. 1 Ph.D. level scientist. 1 - 2 months total. (vii) The Government anticipates award of a firm fixed-price contract for this acquisition, with a one year period of performance. (viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference: • FAR 52.204-7, System for Award Management (Oct 2018) • FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) • FAR 52.212-1, Instructions to Offerors-Commercial Items (Sep 2023) • FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2023) • FAR 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification (May 2014) • HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference: • FAR 52.204-13, System for Award Management Maintenance (Oct 2018) • FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) • FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2023). Addendum to this FAR clause applies to this acquisition and is attached. • HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. • FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) • FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) • FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Dec 2023) • NIH Invoice and Payment Provisions (Mar 2023) (ix) The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: a. Technical capability of the item offered to meet the Government requirement; b. Price; and c. Past performance [see FAR 13.106-2(b)(3)]. (x) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2023), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xiii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xiv) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations. The Unique Entity ID (UEI), 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. 2:00 p.m., Eastern Daylight/Standard Time, on February 5, 2024 and reference solicitation number 75N95024Q000123. Responses must be submitted electronically to Michelle Cecilia, Contracting Officer at michelle.cecilia@nih.gov. Fax responses will not be accepted.