Inactive Total Small Business Set-Aside (FAR 19.5)

(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 annou... (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 75N95022Q00508 and the solicitation is issued as a request for quotation (RFQ). The anticipated award date is September 16, 2022. 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. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2022-07, with effective date August 10, 2022. (iv) The associated NAICS code is 325414 - Biological Product (except Diagnostic) Manufacturing and the small business size standard is 1,250 employees. This requirement is a total small business set-aside. (v) 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. NCATS is one of 27 Institutes and Centers at the NIH and its mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The NCATS DPI plans, conducts and uses both internal and contract resources to advance collaborative research projects across the preclinical phases of the translational science spectrum. The goal of the NCATS DPI TDB is to help close the gap between basic research and preclinical testing of new small-molecule and biologic drugs, as well as cell-based and gene therapies. Work spans the entire preclinical development pipeline, including medicinal chemistry, toxicology, formulation, and other studies required to support an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) The NCATS DPI TDB requires multi-well microelectrode array (MEA) plates to meet the needs of the N=1 ASO project. An ASO is a single-stranded, synthetic RNA (or DNA) sequence. ASOs are designed to selectively bind via complementary base-pairing to messenger RNA (mRNA) and are the basis for one type of RNA-based therapeutics being explored to treat cancer and genetic disorders. RNA-based therapeutics are categorized as a type of gene therapy. An integral part of this project is developing assays for predictive neurotoxicity of ASOs to facilitate streamlining the safety approval process of ASO treatments for rare diseases. MEAs are used for recording electrical signals from neuronal networks and are composed of a grid of planar metal microelectrodes dispersed across a small surface, typically incorporated into flat bottom wells of “cell culture”-like plates. Neurons seeded and cultured directly onto MEAs plates allows for the measurement of changes in extracellular voltage as neurons spontaneously produce action potentials and generate network connections between cells. Neurotoxic MEA screening assays with ASOs permit the testing of both acute and chronic toxicity by measuring alterations in neuronal network signaling over the course of hours, days, and weeks after compound dosing. MEAs have been successfully used by NCATS scientists to characterize neuronal toxicity by measuring changes in electrical signaling between neurons after exposure to ASOs of different toxicities. 48-well MEA plates have a total of 16 electrodes per well, allowing for high resolution data, but limits scientists by the number of ASOs that can be screened. 96-well MEA plates only have 8 electrodes per well, cutting the data resolution in half, but allows scientists to screen double the number of ASOs per plate. MEA plates with 96-wells will be used for first pass screening, and subsequent “hits” will be further evaluated in the 48-well MEA plates. Combining the benefits of both plate formats into the assay will significantly increase the screening capacity required for this project. NCATS DPI TDB requires the MEA plates to have transparent bottoms, allowing for additional toxicity parameters such as cell morphology that can also be assessed throughout the experiment. These plates must also be compatible with Axion Biosystem Maestro Pro MEA reader for measuring the electrical activity and is analyzed with Axion software previously purchased by NCATS. Thus, without acquisition of the sixteen (16) boxes of 48-well and (16) boxes of 96-well Axion CytoView microelectrode array plates (Brand-name or equal), NCATS will be unable to perform electrophysiological experiments required for toxicity screening as part of the N=1 ASO project. (vi) The Purchase Description (PD) with a description of the products to be acquired is included as an attachment to this Solicitation. The Therapeutic Development Branch (TDB) within the National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) seeks to purchase multi-well microelectrode array (MEA) plates for electrophysiological experiments required for toxicity screening as part of the N=1 antisense oligonucleotides (ASOs) project. (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated delivery date within thirty (30) days after receipt of order (ARO). Delivery will be f.o.b. destination. The place of delivery and acceptance will be 9800 Medical Center Drive, Rockville, MD 20850. (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 52.211-6, Brand Name or Equal (Aug 1999) FAR 52.212-1, Instructions to Offerors—Commercial Products and Commercial Services (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services (May 2022) FAR 52.214-34 Submission of Offers in the English Language (Apr 1991) FAR 52.214-35 Submission of Offers in U.S. Currency (Apr 1991) FAR 52.225-25 Prohibition on Contracting With Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications (Jun 2020) 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 Products and Commercial Services (Nov 2021). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.225-3 Buy American-Free Trade Agreements-Israeli Trade Act (Nov 2021) Alternate I (Jan 2021) FAR 52.225-13 Restrictions on Certain Foreign Purchases (Feb 2021) 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 Products and Commercial Services (May 2022) Invoice and Payment Provisions with and without IPP (Apr 2022) The following clauses is attached and in included in full text: FAR 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate (Feb 2021) Alternate I (Jan 2021) (ix) The Government will perform a comparative evaluation of responses in accordance with FAR 13.106-2(b) to award a purchase order from this solicitation to the responsible offeror whose response meets the solicitation’s requirements and, as a whole, provides the best value, considering price and other factors in this solicitation. The evaluation will compare: (a) Technical capability of the service offered to meet the Government requirement; (b) Price; and (c) Past Performance as defined under FAR 13.106-2(b)(3). If only one quotation is received it will be evaluated on the preceding basis. Responses may exceed capability or performance characteristics of the solicitation’s requirements. The Government reserves the right, but is not required, to award to a response that exceeds capability or performance characteristics of the solicitation’s requirements if it provides a benefit to the Government; and the Government is not requesting or accepting alternate proposal(s). (x) The Offerors are to include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2022), with offers. If the offeror has completed FAR provision 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 Products and Commercial Services (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xii) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. 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 service. The quote must be for a firm-fixed-price total amount inclusive of all costs and fees and include. any other information or factors that may be considered in the award decision. The Unique Entity ID from SAM.gov, 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. All quotations must be received by 9 a.m., Eastern Time, on September 7, 2022, and reference Solicitation Number 75N95022Q00508. Responses must be submitted electronically to Renato Gomes at renato.gomes@nih.gov. Fax responses will not be accepted. Attachments: Purchase Description 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) Addendum to FAR 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services. FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Products and Commercial Services (May 2022) FAR 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate (Feb 2021) Alternate I (Jan 2021) Invoice and Payment Provisions with and without IPP (Apr 2022)